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Local News Politics

For NJ Primary Elections this June, voters can choose voting options

TRENTON, N.J. – This year, New Jersey Primary Elections will be June 8, and N.J. will be returning to a traditional election where voters can choose to vote at the polls, or by mail.

 

During the Coronavirus Pandemic, the State of N.J. required an exclusively vote-by-mail election, even though some voters had expressed a desire to be able to vote at a voting machine.

 

With elections returning to normal now, this means that voters will not receive a vote-by-mail ballot in their mailboxes unless they apply for one, or if they have requested to always receive a vote-by-mail ballot “for all future elections.”

 

Voters who remain concerned about contracting Covid-19, or who cannot otherwise get to the polls, are encouraged to apply to vote by mail for the upcoming Primary Election.

 

In New Jersey, any registered voter can vote by mail for any reason. Voters do not have to be sick, working, or out of town to request a ballot, so this remains a viable option for those who prefer to vote from home.

On the ballot this June, there will be races for offices ranging from, the Gov. of New Jersey, to the entire State legislature, to Mercer County, and local municipal races as well as for partisan State Committee seats.

 

The voter registration deadline for this election was May 18. A registered voter may apply for a ballot by completing and mailing an easy Vote-by-Mail application by June 1. The deadline for walk-in voters is June 7 at 3 p.m.

 

The County Administration building will also offer extended hours to walk into the County Clerk’s office to pick up a ballot to vote by mail. Those hours will be Saturday, June 5 from 9 a.m. to 1 p.m.

 

The County Clerk’s Office, located at 209 S. Broad St., Trenton, N.J. 08608, will offer vote by mail instructions in several languages such as English, Spanish, Hindi, Gujarati, Chinese, Polish, Urdu, and Haitian Creole.

 

Voters may call the office at 609-989-6494, or email them at MercerVotes@MercerCounty.org.

 

Vote-by-Mail applications are also available on the web at their Elections page at www.mercercounty.org/countyclerk.

 

The State Division of Elections also offers vote-by-mail in five languages at http://www.njelections.org/voting-information-vote-by-mail.html. They will print and mail you the ballots.

Categories
Local News Science

Four-year data from Phase 3 CheckMate -227 trial show durable, long-term survival with Opdivo (nivolumab) plus Yervoy (ipilimumab) in Patients with Non-Small Cell Lung Cancer with PD-L1 Expression ≥1%

Opdivo plus Yervoy continues to demonstrate a clinically meaningful survival benefit vs. chemotherapy with the longest follow-up of any Phase 3 trial for an immunotherapy combination in non-small cell lung cancer

Increased overall survival and improvements in key secondary endpoints observed at four years in the primary population of patients whose tumors express PD-L1 ≥1%

In exploratory analyses of patients with PD-L1 expression <1%, Opdivo plus Yervoy more than doubled four-year survival vs. chemotherapy

Data to be presented during the 2021 American Society of Clinical Oncology Annual Meeting

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ASCO21—Bristol Myers Squibb (NYSE: BMY) today announced that Part 1 of the Phase 3 CheckMate -227 trial continues to demonstrate the long-term survival benefits of first-line treatment with Opdivo (nivolumab) plus Yervoy (ipilimumab) compared to chemotherapy in patients with advanced non-small cell lung cancer (NSCLC), regardless of PD-L1 expression level or histology, with a minimum follow-up of over four years (49.4 months):

  • In the primary population of patients with PD-L1 expression ≥1%, the four-year survival rate for Opdivo plus Yervoy was 29%, compared to 18% for chemotherapy (Hazard Ratio [HR] 0.76; 95% Confidence Interval [CI]: 0.65 to 0.90).
  • In an exploratory analysis of patients with PD-L1 expression <1%, more than twice as many patients treated with Opdivo plus Yervoy were alive at four years compared to chemotherapy (24% vs. 10%, respectively; HR 0.64; 95% CI: 0.51 to 0.81).

The safety profile for the dual immunotherapy combination remained consistent with previously reported data in NSCLC and was manageable with established protocols, with no new safety signals identified. The full data will be presented in a poster discussion session (Abstract #9016), available on June 4, 2021 at 9:00 a.m. EDT during the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

“As clinicians, our aim in treating lung cancer is to extend the lives of patients with this disease, which remains the leading cause of cancer deaths,” said Luis G. Paz-Ares, M.D., Ph.D., chair of the medical oncology department, Hospital Universitario 12 De Octubre. “In CheckMate -227, nivolumab plus ipilimumab continues to demonstrate durable overall survival as well as impressive duration of response after four years of follow-up. These data illustrate how much progress we have made in addressing advanced non-small cell lung cancer and reinforce the importance of this dual immunotherapy regimen among first-line options.”

In exploratory, descriptive analyses of patients whose tumors express PD-L1, including in those with PD-L1 expression ≥50%, the combination of Opdivo plus Yervoy showed efficacy benefits relative to Opdivo monotherapy at four years, reinforcing the importance of Yervoy for improving long-term outcomes:

  • In patients with PD-L1 expression ≥1%, 29% of patients treated with Opdivo plus Yervoy were alive, relative to 21% with Opdivo monotherapy.
  • In patients with high PD-L1 expression (≥50%), 37% of Opdivo plus Yervoy patients were alive, relative to 26% for Opdivo alone.

Similarly, in exploratory, descriptive analyses of patients with PD-L1 expression <1%, Opdivo plus Yervoy was associated with an overall survival (OS) benefit relative to Opdivo plus chemotherapy, with four-year OS rates of 24% and 13%, respectively.

Patients in the study treated with Opdivo plus Yervoy also achieved more durable responses than those treated with chemotherapy. These responses continued after patients stopped treatment, which ended at a maximum of two years according to the trial protocol:

  • In patients with PD-L1 expression ≥1% who responded to Opdivo plus Yervoy, more than one third (34%) remained in response at four years, compared to 7% with chemotherapy.
  • In patients with PD-L1 expression <1%, 31% of Opdivo plus Yervoy responders remained in response vs. 0% with chemotherapy.

“With each additional year of follow-up, we continue to see the sustained benefits of the Opdivo plus Yervoy combination, not only in lung cancer, but in several different tumor types. The four-year results from CheckMate -227, showing improved long-term outcomes with Opdivo plus Yervoy, are the most mature Phase 3 data for an immunotherapy combination in first-line advanced non-small cell lung cancer,” said Abderrahim Oukessou, M.D., vice president, thoracic cancers development lead, Bristol Myers Squibb. “We thank the patients and investigators involved in the trial, who have made it possible to bring the proven benefit of dual immunotherapy to people living with non-small cell lung cancer around the world.”

Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase 3 clinical trials to date: CheckMate -227 and CheckMate -9LA in NSCLC, CheckMate -067 in metastatic melanoma, CheckMate -214 in advanced renal cell carcinoma, CheckMate -743 in malignant pleural mesothelioma and CheckMate -648 in esophageal squamous cell carcinoma.

About CheckMate -227

CheckMate -227 is a multi-part open-label Phase 3 trial evaluating Opdivo-based regimens versus platinum-doublet chemotherapy in patients with first-line advanced non-small cell lung cancer (NSCLC) across non-squamous and squamous tumor histologies.

There are two primary endpoints in Part 1 for Opdivo plus Yervoy (versus chemotherapy): overall survival (OS) in patients whose tumors express PD-L1 (assessed in patients enrolled in Part 1a) and progression-free survival (PFS) in patients with tumor mutational burden (TMB) ≥10 mutations/megabase (mut/mb) across the PD-L1 spectrum (assessed in patients enrolled across Parts 1a and 1b). Patients were dosed as follows:

  • Part 1a: Opdivo (3 mg/kg every 2 weeks) plus Yervoy (1 mg/kg every 6 weeks) or Opdivo monotherapy (240 mg every 2 weeks) versus chemotherapy (every 3 weeks for up to four cycles) in patients whose tumors express PD-L1 (≥1%)
  • Part 1b: Opdivo plus Yervoy or Opdivo (360 mg every 3 weeks) plus chemotherapy (every 3 weeks for up to four cycles) versus chemotherapy (every 3 weeks for up to four cycles) in patients whose tumors do not express PD-L1 (<1%)

Part 1 met both its co-primary endpoints of PFS with the Opdivo plus Yervoy combination versus chemotherapy in patients whose tumors have high (≥10 mut/mb) TMB, regardless of PD-L1 expression, and OS demonstrating a superior benefit for Opdivo plus Yervoy versus chemotherapy in first-line NSCLC patients whose tumors expressed PD-L1 ≥1%.

About Lung Cancer

Lung cancer is the leading cause of cancer deaths globally. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is one of the most common types of lung cancer, representing up to 84% of diagnoses. Survival rates vary depending on the stage and type of the cancer when diagnosed. For patients diagnosed with metastatic NSCLC, the five-year relative survival rate is approximately 6%.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming patients’ lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

About Opdivo

Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers.

Opdivo’s leading global development program is based on Bristol Myers Squibb’s scientific expertise in the field of Immuno-Oncology, and includes a broad range of clinical trials across all phases, including Phase 3, in a variety of tumor types. To date, the Opdivo clinical development program has treated more than 35,000 patients. The Opdivo trials have contributed to gaining a deeper understanding of the potential role of biomarkers in patient care, particularly regarding how patients may benefit from Opdivo across the continuum of PD-L1 expression.

In July 2014, Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Opdivo is currently approved in more than 65 countries, including the United States, the European Union, Japan and China. In October 2015, the Company’s Opdivo and Yervoy combination regimen was the first Immuno-Oncology combination to receive regulatory approval for the treatment of metastatic melanoma and is currently approved in more than 50 countries, including the United States and the European Union.

About Yervoy

Yervoy is a recombinant, human monoclonal antibody that binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activity. Yervoy binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including the anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is approved for unresectable or metastatic melanoma in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types.

Indications

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with unresectable or metastatic melanoma.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (≥1%) as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab) and 2 cycles of platinum-doublet chemotherapy, is indicated for the first-line treatment of adult patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

OPDIVO® (nivolumab) is indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving OPDIVO.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma (MPM).

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the first-line treatment of patients with intermediate or poor risk advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab), in combination with cabozantinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

OPDIVO® (nivolumab) is indicated for the treatment of patients with advanced renal cell carcinoma (RCC) who have received prior anti-angiogenic therapy.

OPDIVO® (nivolumab) is indicated for the treatment of adult patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and brentuximab vedotin or after 3 or more lines of systemic therapy that includes autologous HSCT. This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after platinum-based therapy.

OPDIVO® (nivolumab) is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), as a single agent, is indicated for the treatment of adult and pediatric (12 years and older) patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of adults and pediatric patients 12 years and older with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) metastatic colorectal cancer (CRC) that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

OPDIVO® (nivolumab) is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab), in combination with YERVOY® (ipilimumab), is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

OPDIVO® (nivolumab) is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection.

OPDIVO® (nivolumab) is indicated for the treatment of patients with unresectable advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC) after prior fluoropyrimidine- and platinum-based chemotherapy.

OPDIVO® (nivolumab), in combination with fluoropyrimidine- and platinum-containing chemotherapy, is indicated for the treatment of patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma.

Important Safety Information

Severe and Fatal Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions listed herein may not include all possible severe and fatal immune-mediated adverse reactions.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. While immune-mediated adverse reactions usually manifest during treatment, they can also occur after discontinuation of OPDIVO or YERVOY . Early identification and management are essential to ensure safe use of OPDIVO and YERVOY . Monitor for signs and symptoms that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and periodically during treatment with OPDIVO and before each dose of YERVOY . In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate.

Withhold or permanently discontinue OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). In general, if OPDIVO or YERVOY interruption or discontinuation is required, administer systemic corticosteroid therapy (1 to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Toxicity management guidelines for adverse reactions that do not necessarily require systemic steroids (e.g., endocrinopathies and dermatologic reactions) are discussed below.

Immune-Mediated Pneumonitis

OPDIVO and YERVOY can cause immune-mediated pneumonitis. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. In patients receiving OPDIVO monotherapy, immune-mediated pneumonitis occurred in 3.1% (61/1994) of patients, including Grade 4 (<0.1%), Grade 3 (0.9%), and Grade 2 (2.1%). In HCC patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 10% (5/49) of patients. In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated pneumonitis occurred in 3.9% (26/666) of patients, including Grade 3 (1.4%) and Grade 2 (2.6%). In NSCLC patients receiving OPDIVO 3 mg/kg every 2 weeks with YERVOY 1 mg/kg every 6 weeks, immune-mediated pneumonitis occurred in 9% (50/576) of patients, including Grade 4 (0.5%), Grade 3 (3.5%), and Grade 2 (4.0%). Four patients (0.7%) died due to pneumonitis.

In Checkmate 205 and 039, pneumonitis, including interstitial lung disease, occurred in 6.0% (16/266) of patients receiving OPDIVO. Immune-mediated pneumonitis occurred in 4.9% (13/266) of patients receiving OPDIVO, including Grade 3 (n=1) and Grade 2 (n=12).

Immune-Mediated Colitis

OPDIVO and YERVOY can cause immune-mediated colitis , which may be fatal . A common symptom included in the definition of colitis was diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. In patients receiving OPDIVO monotherapy, immune-mediated colitis occurred in 2.9% (58/1994) of patients, including Grade 3 (1.7%) and Grade 2 (1%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated colitis occurred in 25% (115/456) of patients, including Grade 4 (0.4%), Grade 3 (14%) and Grade 2 (8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated colitis occurred in 9% (60/666) of patients, including Grade 3 (4.4%) and Grade 2 (3.7%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated colitis occurred in 12% (62/511) of patients, including Grade 3-5 (7%) and Grade 2 (5%).

Immune-Mediated Hepatitis and Hepatotoxicity

OPDIVO and YERVOY can cause immune-mediated hepatitis. In patients receiving OPDIVO monotherapy, immune-mediated hepatitis occurred in 1.8% (35/1994) of patients, including Grade 4 (0.2%), Grade 3 (1.3%), and Grade 2 (0.4%). In patients receiving OPDIVO monotherapy in Checkmate 040, immune-mediated hepatitis requiring systemic corticosteroids occurred in 5% (8/154) of patients. In patients receiving OPDIVO 1 mg/ kg with YERVOY 3 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 15% (70/456) of patients, including Grade 4 (2.4%), Grade 3 (11%), and Grade 2 (1.8%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, immune-mediated hepatitis occurred in 7% (48/666) of patients, including Grade 4 (1.2%), Grade 3 (4.9%), and Grade 2 (0.4%).

In a separate Phase 3 trial of YERVOY 3 mg/kg monotherapy, immune-mediated hepatitis occurred in 4.1% (21/511) of patients, including Grade 3-5 (1.6%) and Grade 2 (2.5%).

OPDIVO in combination with cabozantinib can cause hepatic toxicity with higher frequencies of Grade 3 and 4 ALT and AST elevations compared to OPDIVO alone. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. In patients receiving OPDIVO and cabozantinib, Grades 3 and 4 increased ALT or AST were seen in 11% of patients.

Immune-Mediated Endocrinopathies

OPDIVO and YERVOY can cause primary or secondary adrenal insufficiency, immune-mediated hypophysitis, immune-mediated thyroid disorders, and Type 1 diabetes mellitus, which can present with diabetic ketoacidosis. Withhold OPDIVO and YERVOY depending on severity (please see section 2 Dosage and Administration in the accompanying Full Prescribing Information). For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field defects. Hypophysitis can cause hypopituitarism; initiate hormone replacement as clinically indicated. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism; initiate hormone replacement or medical management as clinically indicated. Monitor patients for hyperglycemia or other signs and symptoms of diabetes; initiate treatment with insulin as clinically indicated.

In patients receiving OPDIVO monotherapy, adrenal insufficiency occurred in 1% (20/1994), including Grade 3 (0.4%) and Grade 2 (0.6%). In patients receiving OPDIVO 1 mg/kg with YERVOY 3 mg/kg every 3 weeks, adrenal insufficiency occurred in 8% (35/456), including Grade 4 (0.2%), Grade 3 (2.4%), and Grade 2 (4.2%). In patients receiving OPDIVO 3 mg/kg with YERVOY 1 mg/kg every 3 weeks, adrenal insufficiency occurred in 7% (48/666) of patients, including Grade 4 (0.

Contacts

Bristol Myers Squibb

Media Inquiries:
Media@BMS.com

Investors:
Tim Power

609-252-7509

timothy.power@bms.com

Nina Goworek

908-673-9711

nina.goworek@bms.com

Read full story here

Categories
Local News Sports & Gaming

They’re back! Trenton Thunder to host Triple-A Buffalo Bisons during 2021 baseball season

 

TRENTON, N.J. – The Trenton Thunder, presented by NJM Insurance Group, along with County Executive Brian M. Hughes, are excited to announce that they will host the Triple-A Buffalo Bisons this year.

 

The 2021 season is expected to kickoff at the Trenton Thunder home park Monday, May 24th.

 

“After 27 years serving as the Double-A home of the Detroit Tigers, Boston Red Sox, and New York Yankees, we are excited to welcome the highest level of Minor League Baseball to New Jersey,” said jeff Hurley, GM & COO, Trenton Thunder.

 

“We look forward to working with the Bisons, Blue Jays and Major League Baseball to make this a successful season start,” he said.

 

The owner of Trenton Thunder, Joe Plumeri, also added that, “Mercer County and everyone at the Thunder are proud to welcome the Buffalo Bisons to one of the top ballparks in America. Our family of fans will be able to root for future Blue Jays big leaguers against the top prospects from the Phillies, Yankees, Mets, Red Sox, and Nationals, while enjoying the beautiful setting along the banks of the Delaware. Go Thunder!”

 

Mercer County has made this a top-rated facility year after year, so it was a welcome home for the Bisons to start the season.

 

“This is terrific news for Mercer County, our Capital City and baseball fans throughout the region who are eager to root for the Thunder again this season,” said Mr. Hughes.

 

“The county’s investments in the stadium in conjunction with Thunder management have ensured that it remains a first-rate facility for players and fans alike, and we look forward to another exciting summer at the ballpark,” he said.

 

Over the years, Mercer County has continued to make improvements around the ballpark to keep up with Major League standards. Some larger projects include updating ballpark lighting, new stadiums seats, new infield grass, and new wall pads along the lower level of the outfield wall to ensure player safety.

Categories
Local News

Mercer, Penn Princeton Health partner for COVID-19 vaccination program

 

TRENTON, N.J. – The County of Mercer and Penn Medicine Princeton Health have partnered to expand the availability of COVID-19 vaccination opportunities in the county, said Mercer County Executive Brian M. Hughes.

 

“This public-private partnership will provide convenient and free vaccinations to our residents, and we are excited to have Princeton Health come onboard to help us meet the needs of the community during this pandemic,” Mr. Hughes said.

 

Since last week, Princeton Health has been at one of Mercer County’s fixed-base vaccination sites at the lounge at Mercer County Park’s rink.  In addition, Princeton Health will provide staff to operate Mercer County’s new mobile unit. This unity will schedule community-based vaccination clinics at locations throughout the county to vaccinate underserved and hard-to-reach populations, such as the elderly, or for those without transportation.

 

 

The other vaccination clinic, in collaboration with Capital Health, is at CURE Arena in the City of Trenton.

 

“COVID-19 is the greatest public health challenge in our lifetime and vaccinating as many members of our community as possible is a crucial step forward,” said Princeton Health CEO James Demetriades.

 

“We are excited to work with Mercer County to build on our efforts to date, which have included administering more than 25,000 vaccines to community members and our staff. This initiative has included providing pop-up clinics at more than a dozen locations across Mercer, Middlesex, and Somerset counties, where we administered 2,300 vaccines to educators and school employees,’’ he explained.

 

The next phase of the community-based vaccination program will include deploying the new mobile unit to locations on the eastern side of Mercer County, where there is a large older population and community diversity.

 

“Among my priorities is ensuring equitable access to vaccinations, and just as FEMA was able to target high-need communities in Trenton, which was hit particularly hard by the virus, we must ensure that all residents have ease of access and availability to the vaccine. We are grateful to our newest health partner, Penn Medicine Princeton Health, for this important collaboration,” Mr. Hughes added.

 

For about two months now, Mercer County has operated a COVID-19 vaccination clinic at the gymnasium of Mercer County Community College at West Windsor Campus, in conjunction with the college and municipal health departments.

 

The site has relied heavily on MCCC nursing students and volunteers to administer vaccine to residents. With nursing students leaving at the end of the spring semester in early May, the County is transitioning its MCCC vaccination site to the lounge area in the skating center. This is the proximity of the previous site – a county-owned venue – with parking and space convenient for elderly residents and individuals with disabilities.

 

At the fixed sites, vaccination appointments will be required, and individuals must be registered via the New Jersey Vaccination Scheduling System (NJVSS). Go to https://covidvaccine.nj.gov to register.

Categories
Local News Science

NJ Bio moves headquarters to Princeton, New Jersey

PRINCETON, N.J. — (BUSINESS WIRE) — #adc—NJ Biopharmaceuticals LLC (d/b/a NJ Bio), an expert provider of chemistry and biopharmaceutical services specializing in bioconjugation, custom synthesis, flow chemistry, and process development, announced the move of its headquarters from North Brunswick to Princeton, New Jersey.


The 35,000-square-foot, state-of-the-art laboratory space will be located at 350 Carter Road, at a site formerly occupied by Bristol Myers Squibb. Over time, the company plans to expand further within the same location. Current staff will move from North Brunswick to Princeton, and the facility will be fully operational by July 1, 2021. NJ Bio will continue to operate its facility in Bristol, PA, with plans for future growth at that site, including GMP manufacturing capabilities for small molecules as well as bioconjugation.

“On behalf of the board of directors and senior management at NJ Bio, I am excited to announce this move,” said Nareshkumar Jain, Ph.D., President and CEO of NJ Bio. “Our expansion to this advanced facility demonstrates the rapid growth of NJ Bio in just over two years. This new location, well-equipped with the latest instruments, and staffed by exceptional scientists, will ensure that NJ Bio continues to remain an outstanding partner to our clients, delivering high value and results for their most challenging research and development needs.”

About NJ Bio

NJ Bio is an integrated chemistry service provider with expertise in bioconjugation, payload-linker synthesis, nucleotide chemistry, and application of BioNMR to drug discovery programs, including protein degraders. NJ Bio also offers expertise in flow chemistry and process development and provides innovative solutions for large-scale continuous manufacturing needs. NJ Bio’s clients range from large pharmaceutical and biotechnology companies to start-ups.

For additional information, visit www.njbio.com.

Contacts

Media Contact
Reva Raghupathi, PhD, MBA

Vice-President, Strategic Alliances, NJ Bio

Email: info@njbio.com

Categories
Business Local News

Bristol Myers Squibb presents new clinical and real-world data on mavacamten and obstructive hypertrophic cardiomyopathy at upcoming American College of Cardiology’s 70th Annual Scientific Session

New analysis of EXPLORER-HCM trial assessing impact of mavacamten on patient’s health status to be presented as late-breaking oral presentation

Interim results of EXPLORER long-term extension study of mavacamten safety and efficacy data in patients with obstructive hypertrophic cardiomyopathy (oHCM) also to be presented

 

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #ACC—Bristol Myers Squibb (NYSE: BMY) today announced that data from multiple studies across the company’s clinical program investigating mavacamten in patients with obstructive hypertrophic cardiomyopathy (oHCM) will be presented at the upcoming American College of Cardiology’s 70th Annual Scientific Session (ACC.21), being held virtually May 15 to May 17, 2021.

Key presentations include:

  • A late-breaking oral presentation reporting results from a new analysis of data from the EXPLORER-HCM Phase 3 trial of mavacamten in patients with oHCM, which tested the impact of mavacamten on patients’ health status (symptoms, function and quality of life) as measured by the Kansas City Cardiomyopathy Questionnaire. These data will be presented as part of the Featured Clinical Research I Session in the Hot Topics Channel on Saturday, May 15 from 12:15 – 1:30 p.m. EDT.
  • A moderated poster session highlighting interim results from MAVA-LTE, an ongoing, dose-blinded 5-year extension study of the EXPLORER-HCM Phase 3 trial. Findings from the interim analysis demonstrated that in patients with oHCM, mavacamten was well tolerated and showed durable improvement in left ventricular outflow tract (LVOT) gradients, diastolic function, N-terminal-pro hormone B-type natriuretic peptide (NT-proBNP) and symptoms.
  • A poster presentation of results from a real-world data analysis measuring the clinical and economic burden of oHCM in the United States, which found the condition is associated with substantial healthcare resource utilization and costs.

“These data add to the growing body of evidence that further supports the goal of addressing a high unmet medical need in patients with oHCM with mavacamten as a first-in-class medicine,” said Jay Edelberg, M.D., Ph.D., head, Heart Failure and Cardiomyopathy Development at Bristol Myers Squibb. “We look forward to potentially bringing this therapy to oHCM patients early next year.”

Mavacamten Presentations

  • Health Status Benefits of Mavacamten in Patients with Symptomatic Obstructive Cardiomyopathy: Results From the EXPLORER-HCM Randomized Clinical Trial
    • Author: John A. Spertus
    • Session 403-09 – Featured Clinical Research I
    • Session Type: Late-Breaking Clinical Trials, Hot Topics Channel
    • Saturday, May 15: 12:15 – 12:25 p.m. EDT
  • Long-Term Safety of Mavacamten in Patients with Obstructive Hypertrophic Cardiomyopathy: Interim Results of the MAVA-Long Term Extension (LTE) Story
    • Author: Florian Rader
    • Session 1033-03 – Advances in Hypertrophic Cardiomyopathy
    • Session Type: Moderated Poster Contributions, eAbstract Site
    • Saturday, May 15: 12:30 – 12:40 p.m. EDT
  • Clinical and Economic Burden of Obstructive Hypertrophic Cardiomyopathy in the United States
    • Author: Sneha S. Jain
    • Session 2192 – Heart Failure and Cardiomyopathies: Population Science 1
    • Session Type: Poster Contributions, eAbstract Site
    • Saturday, May 15: 2:45 – 3:30 p.m. EDT

About Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy, or HCM, is a chronic, progressive disease in which excessive contraction of the heart muscle and reduced ability of the left ventricle to fill can lead to the development of debilitating symptoms and cardiac dysfunction. HCM is estimated to affect one in every 500 people.

The most frequent cause of HCM is mutations in the heart muscle proteins of the sarcomere. In either obstructive or non-obstructive HCM patients, exertion can result in fatigue or shortness of breath, interfering with a patient’s ability to participate in activities of daily living. HCM has also been associated with increased risks of atrial fibrillation, stroke, heart failure and sudden cardiac death, with mortality among HCM patients shown to be approximately three-fold higher than the U.S. general population at similar ages.

There are currently approximately 160,000 to 200,000 people diagnosed with symptomatic obstructive HCM across the U.S. and EU, with no existing effective drug treatment options beyond limited symptomatic relief.

About Mavacamten

Mavacamten is a potential first-in-class, oral, allosteric modulator of cardiac myosin, under investigation for the treatment of conditions in which excessive cardiac contractility and impaired diastolic filling of the heart are the underlying cause. Mavacamten reduces cardiac muscle contractility by inhibiting excessive myosin-actin cross-bridge formation that results in hypercontractility, left ventricular hypertrophy and reduced compliance. In clinical and preclinical studies, mavacamten has consistently reduced biomarkers of cardiac wall stress, lessened excessive cardiac contractility and increased diastolic compliance.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, the possibility that future study results will be consistent with the results to date, that mavacamten may not receive regulatory approval for the indication(s) described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication(s) described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Contacts

Bristol Myers Squibb

Media Inquiries:
Media@bms.com

Susan Francis

Susan.Francis@bms.com
609-529-0676

Investors:
Tim Power

Timothy.Power@bms.com
609-252-7509

Categories
Business Local News

NRG Energy, Inc. to report First Quarter 2021 financial results on May 6, 2021

PRINCETON, N.J. — (BUSINESS WIRE) — NRG Energy, Inc. (NYSE:NRG) plans to report its First Quarter 2021 financial results on Thursday, May 6, 2021. Management will present the results during a conference call and webcast at 9:00 a.m. Eastern.

A live webcast of the conference call, including presentation materials, can be accessed through NRG’s website at http://www.nrg.com and clicking on “Presentations & Webcasts” in the “Investors” section found at the top of the home page. The webcast will be archived on the site for those unable to listen in real time.

About NRG Energy

At NRG, we’re bringing the power of energy to people and organizations by putting customers at the center of everything we do. We generate electricity and provide energy solutions and natural gas to approximately 6 million customers through our diverse portfolio of retail brands. A Fortune 500 company, operating in the United States and Canada, NRG delivers innovative solutions while advocating for competitive energy markets and customer choice, working towards a sustainable energy future. More information is available at www.nrg.com. Connect with NRG on Facebook, LinkedIn and follow us on Twitter @nrgenergy.

Contacts

Investors:

Kevin L. Cole, CFA

609.524.4526

investor.relations@nrg.com

Media:

Candice Adams

609.524.5428

candice.adams@nrg.com

Categories
Healthcare Local News

Bristol Myers Squibb presents positive data from two pivotal Phase 3 psoriasis studies demonstrating superiority of deucravacitinib compared to placebo and Otezla® (apremilast)

Significantly more patients treated with deucravacitinib achieved PASI 75 and sPGA 0/1 compared to patients treated with placebo and Otezla at Week 16, with an increased benefit versus Otezla at Week 24 and maintained through Week 52

Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events

Deucravacitinib is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action

Results presented as late-breaking research at the 2021 American Academy of Dermatology Virtual Meeting Experience

PRINCETON, N.J. — (BUSINESS WIRE) — $BMY #AADVMX2021—Bristol Myers Squibb (NYSE:BMY) today announced positive results from two pivotal Phase 3 trials evaluating deucravacitinib, an oral, selective tyrosine kinase 2 (TYK2) inhibitor, for the treatment of patients with moderate to severe plaque psoriasis. The POETYK PSO-1 and POETYK PSO-2 trials, which evaluated deucravacitinib 6 mg once daily, met both co-primary endpoints versus placebo, with significantly more patients achieving Psoriasis Area and Severity Index (PASI) 75 response and a static Physician’s Global Assessment score of clear or almost clear (sPGA 0/1) after 16 weeks of treatment with deucravacitinib. Deucravacitinib was well tolerated with a low rate of discontinuation due to adverse events (AEs).


Deucravacitinib demonstrated superior skin clearance compared with Otezla® (apremilast) for key secondary endpoints in both studies, as measured by PASI 75 and sPGA 0/1 responses at Week 16 and Week 24. Findings include:

PASI 75 Response in POETYK PSO-1 and POETYK PSO-2:

  • At Week 16, 58.7% and 53.6% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 12.7% and 9.4% receiving placebo and 35.1% and 40.2% receiving Otezla.
  • At Week 24, 69.0% and 59.3% of patients receiving deucravacitinib achieved PASI 75 response, respectively, versus 38.1% and 37.8% receiving Otezla.
  • Among patients who achieved PASI 75 response at Week 24 with deucravacitinib and continued treatment with deucravacitinib, 82.5% and 81.4%, respectively, maintained PASI 75 response at Week 52.

sPGA 0/1 Response in POETYK PSO-1 and POETYK PSO-2:

  • At Week 16, 53.6% and 50.3% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 7.2% and 8.6% receiving placebo and 32.1% and 34.3% receiving Otezla.
  • At Week 24, 58.4% and 50.4% of patients receiving deucravacitinib achieved sPGA 0/1 response, respectively, versus 31.0% and 29.5% receiving Otezla.

“In both pivotal studies, deucravacitinib was superior to Otezla across multiple endpoints, including measures of durability and maintenance of response, suggesting that deucravacitinib has the potential to become a new oral standard of care for patients who require systemic therapy and need a better oral option for their moderate to severe plaque psoriasis,” said April Armstrong, M.D., M.P.H., Associate Dean and Professor of Dermatology at the University of Southern California. “As many patients with moderate to severe plaque psoriasis remain undertreated or even untreated, it is also highly encouraging to see that deucravacitinib improved patient symptoms and outcomes to a greater extent than Otezla.”

Superiority of Deucravacitinib Versus Placebo and Otezla

Deucravacitinib demonstrated a robust efficacy profile, including superiority to placebo for the co-primary endpoints and to Otezla for key secondary endpoints. In addition to PASI 75 and sPGA 0/1 measures, deucravacitinib was superior to Otezla across both studies in multiple other secondary endpoints, demonstrating significant and clinically meaningful efficacy improvements in symptom burden and quality of life measures.

POETYK PSO-1 and POETYK PSO-2 Results at Week 16 and Week 24

Endpoint

POETYK PSO-1 (n=666)

POETYK PSO-2 (n=1,020)

Deucravacitinib

6 mg

(n=332)

Otezla

30 mg

(n=168)

Placebo

(n=166)

Deucravacitinib

6 mg

(n=511)

Otezla

30 mg

(n=254)

Placebo

(n=255)

PASI 75*a

Week 16

58.7%*†

35.1%

12.7%

53.6%*‡

40.2%

9.4%

Week 24

69.0%†

38.1%

–

59.3%†

37.8%

–

sPGA 0/1*b

Week 16

53.6%*†

32.1%

7.2%

50.3%*†

34.3%

8.6%

Week 24

58.4%†

31.0%

–

50.4%†

29.5%

–

(Scalp) ss-PGA 0/1c

Week 16

70.8%*†

39.1%

17.4%

60.3%*†

37.3%

17.3%

Week 24

71.8%†

42.7%

–

59.7%‡

41.6%

–

PSSD-Symptoms CFBd

Week 16

-26.7*†

-17.8

-3.6

-28.3*†

-21.1

-4.7

Week 24

-31.9†

-20.7

–

-29.1†

-21.4

–

DLQI 0/1e

Week 16

40.7%*†

28.6%

10.6%

38.0%*†

23.1%

9.8%

Week 24

47.8%‡

24.2%

–

41.8%†

21.5%

–

*Co-primary endpoints for POETYK PSO-1 and POETYK PSO-2 were PASI 75 and sPGA 0/1 for deucravacitinib vs placebo at Week 16.

a. PASI 75 is defined as at least a 75% improvement from baseline in Psoriasis Area and Severity Index (PASI) scores. *p<0.0001 vs placebo. †p<0.0001 vs Otezla. ‡p=0.0003 vs Otezla.

b. sPGA 0/1 is defined as a static Physician’s Global Assessment (sPGA) score of clear or almost clear. *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

c. ss-PGA 0/1 is defined as a scalp-specific Physician’s Global Assessment (ss-PGA) score of clear or almost clear in those with ss-PGA of at least 3 (moderate) at baseline. POETYK PSO-1: *p<0.0001 vs placebo. †p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. †p<0.0001 vs Otezla. ‡p=0.0002 vs Otezla.

d. Change from baseline (CFB) in Psoriasis Symptoms and Signs Diary (PSSD) captures improvement in symptoms of itch, pain, stinging, burning and skin tightness in patient eDiaries. *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

e. Dermatology Life Quality Index (DLQI) 0/1 scores reflect no effect at all on patient’s life in patients with a baseline DLQI score of ≥2. POETYK PSO-1: *p<0.0001 vs placebo. †p=0.0106 vs Otezla. ‡p<0.0001 vs Otezla. POETYK PSO-2: *p<0.0001 vs placebo. †p<0.0001 vs Otezla.

Safety and Tolerability

Deucravacitinib was well-tolerated and had a similar safety profile in both trials. At Week 16, 2.9% of 419 patients on placebo, 1.8% of 842 patients on deucravacitinib and 1.2% of 422 patients on Otezla experienced serious adverse events (SAEs) across both studies. The most common AEs (≥5%) with deucravacitinib treatment at Week 16 were nasopharyngitis and upper respiratory tract infection with low rates of headache, diarrhea and nausea. At Week 16, 3.8% of patients on placebo, 2.4% of patients on deucravacitinib and 5.2% of patients on Otezla experienced AEs leading to discontinuation. Across POETYK PSO-1 and POETYK PSO-2 over 52 weeks, SAEs when adjusted for exposure (exposure adjusted incidence per 100 patient-years [EAIR]) were 5.7 with placebo, 5.7 with deucravacitinib and 4.0 with Otezla. In the same timeframe across both studies, EAIRs for AEs leading to discontinuation were 9.4 with placebo, 4.4 with deucravacitinib and 11.6 with Otezla. No new safety signals were observed during Weeks 16‒52.

Across both Phase 3 trials, rates of malignancy, major adverse cardiovascular events (MACE), venous thromboembolism (VTE) and serious infections were low and generally consistent across active treatment groups. No clinically meaningful changes were observed in multiple laboratory parameters (including anemia, blood cells, lipids and liver enzymes) over 52 weeks.

“The findings from both studies affirm that deucravacitinib – a first-in-class, oral, selective TYK2 inhibitor with a unique mechanism of action that inhibits the IL-12, IL-23 and Type 1 IFN pathways – may become an oral treatment of choice for people living with psoriasis. We believe deucravacitinib has significant potential across a broad range of immune-mediated diseases, and we are committed to further advancing our expansive clinical program with this agent,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We are in discussions with health authorities with the goal of bringing this new therapy to appropriate patients as soon as possible. At Bristol Myers Squibb, we are committed to building an immunology portfolio that addresses pressing unmet needs that exist for those impacted by serious dermatologic conditions and other immune-mediated diseases, to ultimately deliver the promise of living a better life.”

These results are available as a late-breaking research presentation (Session S033 – Late-Breaking Research Abstracts) as part of the 2021 American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX). Full results of both studies will be submitted to a medical journal for peer review. In November 2020 and February 2021, respectively, Bristol Myers Squibb announced positive topline results from POETYK PSO-1 and POETYK PSO-2.

Visit www.bms.com/media/medical-meetings/bms-at-aad-vmx.html for more information on Bristol Myers Squibb’s scientific approach and resources on psoriasis and immune-mediated diseases.

Virtual Investor Event

Bristol Myers Squibb will host a virtual Investor Event on Friday, April 23, 2021 at 10:30 a.m. EDT to discuss the POETYK PSO-1 and POETYK PSO-2 data presented at AAD VMX. Company executives will provide an overview of data presented and address questions from investors and analysts.

Investors and the general public are invited to listen to a live webcast of the event at http://investor.bms.com. Materials related to the webcast will be available at the same website prior to the event. An archived edition of the Investor Event will be available later that day.

About Deucravacitinib

Deucravacitinib (pronounced doo-krav-a-sih-ti-nib) is a first-in-class, oral, selective tyrosine kinase 2 (TYK2) inhibitor with a unique mechanism of action. Deucravacitinib is the first and only TYK2 inhibitor in clinical studies across multiple immune-mediated diseases. Bristol Myers Squibb scientists designed deucravacitinib to selectively target TYK2, thereby inhibiting signaling of interleukin (IL)-12, IL-23 and Type 1 interferon (IFN), key cytokines involved in psoriasis pathogenesis. Deucravacitinib achieves a high degree of selectivity by uniquely binding to the regulatory, rather than the active, domain of TYK2, which is structurally distinct from the regulatory domains of Janus kinase (JAK) 1, 2 and 3. At therapeutic doses, deucravacitinib does not inhibit JAK1, JAK2 or JAK3. Due to the innovative design of deucravacitinib, Bristol Myers Squibb earned recognition with the 2019 Thomas Alva Edison Patent Award for the science underpinning the clinical development of deucravacitinib.

Deucravacitinib is being studied in multiple immune-mediated diseases, including psoriasis, psoriatic arthritis, lupus and inflammatory bowel disease. In addition to POETYK PSO-1 and POETYK PSO-2, Bristol Myers Squibb is evaluating deucravacitinib in three other Phase 3 studies in psoriasis: POETYK PSO-3 (NCT04167462); POETYK PSO-4 (NCT03924427); POETYK PSO-LTE (NCT04036435). Deucravacitinib is not approved for any use in any country.

About the Phase 3 POETYK PSO-1 and POETYK PSO-2 Studies

PrOgram to Evaluate the efficacy and safety of deucravacitinib, a selective TYK2 inhibitor (POETYK) PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) are global Phase 3 studies designed to evaluate the safety and efficacy of deucravacitinib compared to placebo and Otezla® (apremilast) in patients with moderate to severe plaque psoriasis. Both POETYK PSO-1, which enrolled 666 patients, and POETYK PSO-2, which enrolled 1,020 patients, were multi-center, randomized, double-blind trials that evaluated deucravacitinib (6 mg once daily) compared with placebo and Otezla (30 mg twice daily). POETYK PSO-2 included a randomized withdrawal and retreatment period after Week 24.

The co-primary endpoints of both POETYK PSO-1 and POETYK PSO-2 were the percentage of patients who achieved Psoriasis Area and Severity Index (PASI) 75 response and those who achieved static Physician’s Global Assessment (sPGA) score of 0 or 1 at Week 16 versus placebo. Key secondary endpoints of the trials included the percentage of patients who achieved PASI 75 and sPGA 0/1 compared to Otezla at Week 16 and other measures.

About Psoriasis

Psoriasis is a widely prevalent, chronic, systemic immune-mediated disease that substantially impairs patients’ physical health, quality of life and work productivity. Psoriasis is a serious global problem, with at least 100 million people worldwide impacted by some form of the disease, including around 14 million people in Europe and approximately 7.5 million people in the United States. Up to 90 percent of patients with psoriasis have psoriasis vulgaris, or plaque psoriasis, which is characterized by distinct round or oval plaques typically covered by silvery-white scales. Despite the availability of effective systemic therapy, many patients with moderate to severe psoriasis remain undertreated or even untreated and are dissatisfied with current treatments. People with psoriasis report an impact on their emotional well-being, straining both personal and professional relationships and causing a reduced quality of life. Psoriasis is associated with multiple comorbidities that may impact patients’ well-being, including psoriatic arthritis, cardiovascular disease, metabolic syndrome, obesity, diabetes, inflammatory bowel disease and depression.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Otezla® (apremilast) is a registered trademark of Amgen Inc.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that future study results will be consistent with the results to date, that deucravacitinib (BMS-986165) may not receive regulatory approval for the indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

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Contacts

Bristol Myers Squibb

Media Inquiries:

media@bms.com

Kirby Hosea

Kirby.Hosea@bms.com

Investors:
Tim Power

609-252-7509

Timothy.Power@bms.com

Nina Goworek

908-673-9711

Nina.Goworek@bms.com

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Asana BioSciences to present additional efficacy data from chronic hand eczema phase 2b trial of oral SYK/JAK inhibitor gusacitinib at AAD VMX late-breaking session

LAWRENCEVILLE, N.J. — (BUSINESS WIRE) — Asana BioSciences, a clinical stage biopharmaceutical company, announced that it will present additional positive results from a Phase 2b study evaluating the efficacy and safety of its investigational oral Janus kinase family (JAK) and spleen tyrosine kinase (SYK) inhibitor gusacitinib (ASN002) in adult patients with moderate-to-severe chronic hand eczema (CHE) in a late-breaking research program at the American Academy of Dermatology Virtual Meeting (AAD VMX 2021), to be held April 23 – 25, 2021.

The details of the presentation are as follows:

Study Title: Efficacy, Patient Reported Outcomes and Safety of Gusacitinib (ASN002) in Chronic Hand Eczema: Results of a Phase 2b, Randomized, Double-blind, Placebo-Controlled Study.

Presenter: Howard Sofen, M.D., Associate Clinical Professor of Medicine/Dermatology and Pediatrics, University of California, Los Angeles, and Chief of Dermatology at LA County/Olive View Medical Center United States

Session: Late Breaking Abstracts

Date/Time: 24th April 2021 /2:00 – 3:00 PM US EDT

Chronic hand eczema is often debilitating and affects approximately 10% of the U.S. population and millions of people worldwide. The Phase 2b study was a randomized, double-blind, placebo-controlled, parallel-group study evaluating oral gusacitinib (40 mg or 80 mg once daily) in moderate to severe CHE patients for up to 32 weeks, with the primary endpoint of mean modified total lesion severity score (mTLSS) at week 16 (NCT03728504). The physician global assessment (PGA) and pruritus were among the key secondary endpoints studied.

Howard Sofen, MD, the presenting and one of the lead investigators said, “The results of this trial are very impressive and provide evidence that gusacitinib may be an effective once-daily, oral treatment option for CHE patients who are unable to achieve adequate control with topical corticosteroids and other unapproved treatments. Gusacitinib showed a significant effect on mTLSS, PGA, pain, and pruritus at week 16. Rapid improvements in primary and secondary endpoints were observed during the first 2 weeks of treatment, and effects were sustained over the 32-week study. In addition, gusacitinib was effective in patients with chronic foot eczema and atopic dermatitis (as measured by vIGA in CHE patients who also had AD involvement) in this study. The most common treatment-emergent adverse events were upper respiratory tract infection, headache, nausea, and nasopharyngitis. No pulmonary embolism, opportunistic infections, malignancies, major adverse cardiovascular events, or deaths were reported in the study,” Dr. Sofen said.

About Asana BioSciences, LLC

Asana BioSciences is a clinical stage biopharmaceutical company based in Lawrenceville, NJ. Asana is focused on discovery and development of novel targeted investigational medicines in immunology/inflammation and oncology.

ASN003 is in Phase 1 development for BRAFV600 mutated metastatic melanoma, metastatic colorectal and advanced non-small cell lung cancer, and advanced solid tumors with PI3K pathway alterations (NCT02961283).

ASN004 is an antibody drug conjugate that targets the 5T4 oncofetal antigen, which is expressed in a wide range of malignant tumors but has very limited expression in normal tissues. ASN004 demonstrates robust and durable antitumor activity after single administration in multiple human tumor xenograft models. A First-in-Human Phase 1 trial is planned for the first half of 2021.

ASN008 is a novel, topical Na+-channel blocker with high functional selectivity for itch and pain sensing neurons without affecting motor neurons. In a Phase 1b study in atopic dermatitis patients, topical application of ASN008 showed rapid onset of pruritus relief after a single application, which lasted between 8-12 hours, and no tachyphylaxis to this response was observed after 2 weeks of daily application (NCT03798561). ASN008 also has potential for the treatment of pain, urologic and other chronic conditions.

ASN009 is a selective antagonist of the purinergic P2X3 ion channel that is activated by extracellular ATP and involved in various pain, urological and respiratory disease conditions. Preclinical proof-of-concept has been demonstrated with ASN009 in a cough model. ASN009 is currently in preclinical development.

www.asanabiosciences.com

Contacts

Louis Denis

Asana BioSciences

997 Lenox Drive, Suite 220

Princeton Pike Corporate Center

Lawrenceville, NJ 08648

Ph: +1(860) 941-5029

Louis.Denis@AsanaBio.com

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Business Local News

Rosemark, a new business focused on enhancing customer relationships, led by industry veteran Chris Kuenne, launches with equity investment from Newlight Partners

PRINCETON, N.J. — (BUSINESS WIRE) — Rosemark Group (“Rosemark”), a new company focused on helping brands build deeper relationships with their consumers, recently announced that it has entered into an agreement under which Newlight Partners LP (“Newlight”), a growth equity investor, will make an equity investment of up to $150 million in the company. Rosemark will use the investment to build the next leader in customer marketing by acquiring and accelerating the growth of tech-enabled marketing companies focused on deepening consumer relationships. Rosemark is founded and led by Chris Kuenne, an entrepreneurial pioneer with more than 35 years of experience converting deeper consumer insights into thriving brands.

Kuenne and his team are assembling best-in-class companies to join the Rosemark platform, which will support the unique culture of each company to enable its growth as an independent brand. Rosemark will create cohesion across the platform through its operational expertise, consumer connection strategy, and its cross-brand business development efforts, including Rosemark’s proprietary Quantitative Persona™(QP) method.

“Marketing has made a significant shift to the numeric, algorithmic, and the measurable where purchase conversion is king. This is creating a mercenary mindset where the connection between brand and consumer is increasingly transactional, without regard to the motivations and preferences that deepen the consumer’s connection to the brand,” explains Chris Kuenne, CEO of Rosemark. “Brand relationships based primarily on transactions diminish over time. That’s not good for either brands or the bottom line.”

Rosemark aims to reverse this trend through systematically deepening the relationship between brands and their most valuable consumers.

“We are building Rosemark from the ground up to reverse this trend through systematically deepening the relationship between brands and their most valuable consumers,” added Mr. Kuenne. “We will reduce the complexities that marketers face today, shine a light on their most valuable consumers, and deliver experiences and programs that build more enduring consumer-brand connections. In doing so, we believe we can help lead marketing into its next chapter. We are grateful to have the support from Newlight, whose approach of working closely with management to build great businesses is fully aligned with ours.”

“We are excited about supporting the Rosemark team and their mission to help companies enhance customer lifetime value. We believe the Rosemark Group model will be very attractive to high growth entrepreneurs and we look forward to partnering with them to acquire these businesses and drive incremental growth,” said Adam Stulberger, a Partner at Newlight Partners.

About Rosemark

Rosemark is an operating company focused on enhancing Consumer Lifetime Value. Rosemark will acquire and help accelerate the growth of best-in-class service and technology companies. Under the leadership of Chris Kuenne, the Rosemark team will partner with motivated entrepreneurs who are seeking a strategic and financial growth partner to help them achieve their vision for impact. Prior to founding Rosemark, Kuenne founded, built, and scaled, the global digital agency Rosetta. Several of Rosemark’s leadership team also held senior positions at Rosetta, which was sold to the Publicis Groupe for $575 Million.

About Newlight Partners LP

Newlight Partners LP is a growth equity firm focused on building businesses in partnership with founders and exceptional management teams. For more than 15 years, the Newlight team has helped build successful enterprises in five sectors, including telecommunications, financial services, power & infrastructure, healthcare and business services. Led by David Wassong and Ravi Yadav, the Newlight team has invested approximately $6 billion in over 100 investments since 2005, first as the Strategic Investments Group at Soros Fund Management LLC (Soros), and now as Newlight after the team’s spin out from Soros in 2018. Newlight has approximately $4 billion in capital commitments and assets under management.

For more information, please visit www.newlightpartners.com.

Contacts

Media Contacts:
For Rosemark

Shannon Hartley

(609) 651-5394

Shannon.Hartley@rosemark.com

For Newlight Partners LP

Nathaniel Garnick

Gasthalter & Co.

(212) 257-4170