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Tevogen Bio to study its investigational COVID-19 T cell therapy in immunocompromised patients who are unable to benefit from currently available prevention or treatment options

  • Tevogen’s investigational precision T cell product, TVGN-489, is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple precise targets across the entire SARS-CoV-2 genome.
  • The immunocompromised COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies are amongst the most vulnerable.
  • Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, half of whom were immunosuppressed patients, Tevogen now plans to move forward with a clinical trial to study the efficacy of its product in this patient population.
  • Tevogen’s research pipeline includes cell therapies for treatment of COVID-19, long COVID, viral-induced cancers and neurologic diseases, including multiple sclerosis; and several non-virally induced cancers.

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology today announced its intention to study the potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in immunocompromised patients.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and highly optimistic that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of high-risk COVID patients.” said Dr. Dolores Grosso, Tevogen’s Clinical Development Lead.

 

There exists a significant unmet need for the treatment of COVID-19 in immunocompromised patients. Currently, there are very few treatment options that have not been impacted by variants or are suitable for this patient population due to possible medication interactions. A comprehensive review, completed by the company’s Research and Development team, led by Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer, found that TVGN-489 is expected to retain activity against recent variants, including XBB and BQ and its subtypes, which appear to have the ability to evade some existing prophylactic options and immunity. “The lack of treatment options places immunocompromised patients at higher risk of developing poor outcomes if infected with SARS-CoV-2,” said Dr. Flomenberg.

 

“It is everyone’s responsibly to step up during a moment of crisis, and for those of us in the medical innovation industry, it is our moral obligation. And we will do everything in our power to save as many lives as we can,” said Tevogen CEO Ryan Saadi, M.D., M.P.H.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

 

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

 

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.

 

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 714

Communications@Tevogen.com

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Education Healthcare Local News Science

Leading NJ health school’s groundbreaking AmIOK program awarded $1 million to expand trauma-informed campus model to other colleges

TCNJ’s AmIOK program receives another round of funding from the Victims of Crime Act (VOCA) to spread its trauma-informed campus model.

 

 

Our program has given students a voice on campus.

Tulika Desai, TCNJ Nursing major, 2023

 

EWING, N.J. —  The newly rebrandedSchool of Nursingand Health Sciences (SNHS) at The College of New Jersey (TCNJ) today announced its trauma-informed campus initiative, AmIOK, has been awarded another $1 million Victims of Crime Act (VOCA) grant to expand to other colleges in the Mercer County, NJ area.

“We’re expanding services provided by the AmIOK program to other colleges to share our work with higher education institutions that might not have the resources to develop a trauma-informed campus community. In a recent college-student survey, 95% of respondents reported negative mental health symptoms due to the COVID-19 pandemic, and those with previous trauma caused by experiencing a criminal act are likely to have even higher rates. Our vision is to cultivate a trauma-informed campus community that supports and promotes healing for all,” says Dr. Dara Whalen, TCNJ Assistant Professor of Nursing and AmIOK Executive Director.

Along with colleagues, Dr. Whalen presented on the AmIOK model at the 2022 Philadelphia Trauma Training Conference and the 2022 Sigma International Nursing Research Congress in Edinburgh, Scotland.

Dr. Whalen and other healthcare experts at TCNJ developed AmIOK in 2021. The program provides college students and residents in the greater Mercer County area who experience a crime or traumatic event with a 24-hour confidential hotline operated by trained counsellors and nurse practitioners. AmIOK also supports peer-to-peer campus initiatives, including a student-run racial trauma workshop and art-themed healing events.

TCNJ student and AmIOK volunteer, Tulika Desai, Nursing major 2023, explains, “Our program has given students a voice on campus. They have the space to share their own experiences, and feel in control of their own care when their autonomy has been stripped from them.”

Adverse childhood experiences (ACEs) are potentially traumatic events experienced at a young age that can impact personal health outcomes. The Center for Disease Control (CDC) claims ACEs can increase chances of illness, early mortality, injury, involvement in criminal acts and chronic diseases. Trauma-informed care is a human service framework that promotes understanding trauma’s influence on people’s lives to encourage healing.

AmIOK Program Director and Clinical Supervisor, Liza Woods, adds, “The program’s impact goes far beyond the walls of TCNJ classrooms and even beyond the borders of our campus. Our culture and mindset are all about creating a space to heal now, while also educating to intervene and stop the systemic cycles of trauma. Our students learn skills that influence how they operate in the world and how they advocate for themselves and others. AmIOK refuses to accept the status quo and recognizes the changes that need to be made in our communities to address trauma.”

The Victims of Crime Act (VOCA) is a 1984 law enacted to assist crime victims through resources outside of the justice system. VOCA established the Crime Victim’s Fund, a funding source for crime victims throughout the nation.

TCNJ’s School of Nursing and Health Sciences’ Dean Carole Kenner explains, “Dr. Whalen’s efforts to export the successful AmIOK model to other college campuses in New Jersey inspires not just our School, but healthcare professionals across the nation and the globe. TCNJ’s School of Nursing and Health Sciences is honored to take the lead on the world stage in elevating trauma awareness and shaping healthier environments for future generations.” The School rebranded in 2022 to reflect its robust and diverse, cross-disciplinary health science curricula.

TCNJ’s School of Nursing and Health Sciences educates aspiring health professionals to become future leaders across the healthcare industry. Faculty work closely with local healthcare partners to provide students with applicative skills and foundational knowledge. The nationally acclaimed school is dedicated to preparing individuals—through programs in nursing, public health, exercise science and physical education teaching—for the many rewards of guiding people, communities, and populations toward improved health outcomes. The School is nationally recognized as a Healthy People 2030 Champion.

Contact Information

Crothers Consulting | info@crothersconsulting.co | (800) 831-3840

Source: TCNJ School of Nursing and Health Sciences

Categories
Business Healthcare Science

Lazurite™ and Hospital for Special Surgery announce a collaboration agreement focused on Lazurite’s ArthroFree™ wireless surgical camera system

CLEVELAND — (BUSINESS WIRE) — #Biomedevice — Medical device and technology company Lazurite and Hospital for Special Surgery (HSS), the world’s leading academic medical center focused on musculoskeletal health, today announced a new collaborative relationship based on Lazurite’s ArthroFree™ Wireless Surgical Camera System, the first wireless surgical camera system to receive market clearance from the U.S. Food and Drug Administration for arthroscopy and general endoscopy.


Through the HSS Innovation Institute, HSS and Lazurite will collaborate to advance surgical technology and techniques, including evaluation of specific aspects of ArthroFree and potential co-development of new arthroscopic technologies. HSS will conduct training sessions at the HSS Simulation Learning and Training Center and may also work with Lazurite on the co-development of future technologies that leverage the ArthroFree wireless camera and proprietary Meridiem™ light technology.

 

By eliminating conventional camera cables that tether surgeons to the surgical tower and hinder their movement, the ArthroFree System is expected to increase OR efficiency, improve OR safety and lower customer costs. With its solid-state, low-heat, high-efficiency Meridiem light technology, the system also promises to eliminate camera-related patient burns and OR fires. The modular system is designed to be drop-in compatible with existing patient data consoles, surgical displays and endoscopes found in minimally invasive operating rooms.

 

“HSS is excited to collaborate with Lazurite to evaluate the ArthroFree Wireless Surgical Camera System, provide insights into a next generation of the existing device, and potentially co-develop other medical device products utilizing this technology,” said Michael P. Ast, MD, Chief Medical Innovation Officer and a joint replacement surgeon at HSS. “As HSS physicians and innovators, our goal of continuously improving patient care and outcomes includes identifying and pursuing new technologies and developing partnerships that leverage HSS’s expertise and innovative spirit with cutting-edge industry advancements to drive new innovation forward.”

 

“Given HSS’s substantial capabilities in research, including the experience and expertise of its medical staff and the volume of orthopedic surgeries performed there, we believe that HSS is a great partner to conduct the various non-clinical assessments and other collaborations outlined in the agreement,” said Lazurite Board Chair Mark Froimson, MD.

 

“We’re pleased that a world-class clinical organization like HSS sees the potential for the ArthroFree System to become the standard of care in the minimally invasive OR,” Lazurite President and General Counsel Leah Brownlee said. “HSS has been a pioneer in orthopedic research and innovation for decades. The hospital performs more than 32,000 surgical procedures annually, including more hip surgeries and more knee replacements than any other hospital in the country. We believe this will be a beneficial experience for both HSS and Lazurite.”

 

About HSS

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the 13th consecutive year), No. 3 in rheumatology by U.S. News & World Report (2022-2023), and the best pediatric orthopedic hospital in NY, NJ and CT by U.S. News & World Report “Best Children’s Hospitals” list (2022-2023). In a survey of medical professionals in more than 20 countries by Newsweek, HSS is ranked No. 1 in orthopedics for a third consecutive year (2023). Founded in 1863, the Hospital has the lowest complication and readmission rates in the nation for orthopedics, and among the lowest infection rates. HSS was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center five consecutive times. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New Jersey, Connecticut and in the Long Island and Westchester County regions of New York State, as well as in Florida. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Innovation Institute works to realize the potential of new drugs, therapeutics and devices. The HSS Education Institute is a trusted leader in advancing musculoskeletal knowledge and research for physicians, nurses, allied health professionals, academic trainees, and consumers in more than 145 countries. The institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally. www.hss.edu.

 

About Lazurite

Lazurite is a medical device and technology company. Its ArthroFree™ System—the wireless camera for arthroscopy and general endoscopy—is designed for surgeons seeking surgical tools for greater agility in the OR. ArthroFree is drop-in compatible with current OR technologies, and it promises to eliminate cable-related patient burns, OR fires, and staff trips and falls. With the ArthroFree System, Lazurite ushers in the wireless era of surgical visualization. Lazurite’s intellectual property portfolio also includes the low-heat Meridiem light technology and products in development. The pre-revenue company is located in Cleveland, OH (est. 2015), and to date has raised ~$25M from institutional investors, family offices, and more than 75 physician champions. The mission: solve impossible problems to improve people’s lives. The 10-year vision: better outcomes for 10 million patients—and thousands of clinicians, too. For more information, see: https://lazurite.co.

 

Forward-Looking Statements

This press release includes “forward-looking statements.” Forward-looking statements can be identified by words such as: “anticipate,” “intend,” “plan,” “believe,” “project,” “estimate,” “expect,” “may,” “should,” “will,” “designed,” “milestone,” “promises,” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the expected impact of the ArthroFree System on the field of minimally invasive surgery, and particularly arthroscopic surgery, and our future sales of the ArthroFree System. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations, and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and trends, the economy, and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks, and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

 

Lazurite™, ArthroFree™, and Meridiem™ are trademarks of Lazurite Holdings LLC.

 

Media Center

Visit lazurite.co/media for videos, logos, images, fact sheets, bios and more.

Contacts

Patrick Gallagher

+1 (216) 233-7473

p.gallagher@lazurite.co

Lazurite:

+1 (833) 214-4234

contact@lazurite.co

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Business Culture Education Environment Science

New Jersey American Water and Apex Solutions Group host graduation ceremony for ‘Water UP!’ training program

Second annual workforce development program offers Plainfield-based adults water utility industry training throughout 11-week program.

 

CAMDEN, N.J. — (BUSINESS WIRE) — Today, New Jersey American Water hosted a graduation ceremony for its second cohort of Water Utility Pipeline (Water UP!) training program graduates in partnership with Apex Solutions Group. Over 11 weeks of field training and classroom-based curriculum, 13 adults, mostly from Plainfield, learned about the water utility industry, New Jersey American Water’s role, and essential business skills necessary to successfully pursue a career in the industry upon graduation.

“The innovation and service that New Jersey American Water provides tomorrow will be driven by the next generation of diverse water quality workers today,” said Mark McDonough, President, New Jersey American Water. “The Water UP! program presents a unique opportunity to invest in our most important asset, people. We are proud to see the program continue as we expand the ways in which New Jersey American Water recruits and retains talented members of the communities where we do business, and we are thrilled to be able to partner with the City of Plainfield for this cohort, which is home to our largest operations center in the state.”

 

The training took place at New Jersey American Water’s Plainfield Operations Center and other nearby facilities in the company’s Central Operating Region, and included utility mechanic, field operations, water production, water quality, OSHA 30, customer service, software and procedures, resume writing, job interview skills and other classes provided by Apex Solutions Group and New Jersey American Water. A career fair was also held the last week of the program, in an effort to pair prospective employers with graduates for job opportunities.

 

“New Jersey American Water is a great partner in our community, and they are investing in service and success at all levels through their Water UP! program—including empowering the next generation of water utility leaders,” said Plainfield Mayor Adrian O. Mapp, who delivered the graduation address. “This Water UP! graduation is the result of a commitment to growth and innovation for Plainfield, paired with hard work from the participants. I’m excited to see the success of each graduate here today and encouraged by their focus on a stronger tomorrow.”

 

New Jersey American Water first launched the Water UP! training program in Camden in September 2021 as part of New Jersey American Water’s Workforce Development Program. The program is designed to create a career path to connect young adults from underserved populations in New Jersey American Water’s service areas with a career path by helping participants identify and pursue transformative career opportunities in the water and wastewater industry. Completion of the program uniquely prepares participants for open opportunities within New Jersey American Water, American Water, and its utility industry partners.

 

The Water UP! program is part of a broader workforce development initiative by New Jersey American Water that includes career education and outreach initiatives, as well as an ongoing GIS career development program between New Jersey American Water’s Engineering team and the Camden-based nonprofit career development organization Hopeworks. These workforce development initiatives provide innovative and collaborative opportunities that connect young adults in underserved communities to water utility careers.

 

To learn more about Water UP! and New Jersey American Water’s workforce development programs, visit the website, www.newjerseyamwater.com and click on Workforce Development under the About Us tab.

 

About APEX Solutions Group

APEX Solutions Group is a Minority, Disabled Veteran owned company that leverages the 100 plus years of combined professional experience to exceed the needs of clients while uplifting the communities it operates in. To learn more about APEX Solutions Group, visit https://apexsolgroup.com.

 

About New Jersey American Water

New Jersey American Water, a subsidiary of American Water (NYSE: AWK), is the largest investor-owned water utility in the state, providing high-quality and reliable water and/or wastewater services to approximately 2.8 million people. For more information, visit www.newjerseyamwater.com and follow New Jersey American Water on Twitter and Facebook.

 

About American Water

With a history dating back to 1886, American Water is the largest and most geographically diverse U.S. publicly traded water and wastewater utility company. The company employs more than 6,400 dedicated professionals who provide regulated and regulated-like drinking water and wastewater services to more than 14 million people in 24 states. American Water provides safe, clean, affordable and reliable water services to our customers to help keep their lives flowing. For more information, visit amwater.com and diversityataw.com. Follow American Water on Twitter, Facebook and LinkedIn.

Contacts

Denise Venuti Free

Sr. Director of Communications & External Affairs

New Jersey American Water

Denise.Free@amwater.com

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Business Healthcare Science

Amneal launches second Biosimilar with RELEUKO® (filgrastim-ayow) in the United States

Second of three approved U.S. oncology biosimilars Amneal expects to launch

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) (“Amneal” or the “Company”) today announced the commercial launch of RELEUKO® (filgrastim-ayow), a biosimilar referencing Neupogen®. RELEUKO® is used to treat neutropenia which is commonly experienced by patients undergoing chemotherapy. This product was developed in collaboration with Kashiv Biosciences, LLC located in Chicago, Illinois.

 

“RELEUKO is our second U.S. biosimilar launch and represents the next step in building out our biosimilars business. This product is another important oncology therapeutic offering for providers and their patients as we look to make essential medicines more accessible for all,” said Harsher Singh, SVP of Amneal Biosciences division.

 

According to IQVIA®, U.S. annual sales for filgrastim for the 12 months ended August 2022 were $390 million, of which $272 million represented biosimilar sales.

 

About RELEUKO

RELEUKO® in the U.S. is indicated:

  • To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti- cancer drugs associated with a significant incidence of severe neutropenia with fever.
  • To reduce the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of patients with acute myeloid leukemia (AML).
  • To reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g., febrile neutropenia, in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by bone marrow transplantation (BMT).
  • To reduce the incidence and duration of sequelae of severe neutropenia‚ (e.g., fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

 

IMPORTANT SAFETY INFORMATION

Patients with a history of serious allergic reactions to human granulocyte colony-stimulating factors such as filgrastim products or pegfilgrastim products.

 

Before you take RELEUKO®, tell your healthcare provider if you are pregnant or plan to breast feed, and if you have sickle cell disorder, kidney problems or receiving radiation therapy.

 

WARNINGS AND PRECAUTIONS

  • Fatal splenic rupture: Patients may experience enlarged spleen which can rupture and cause death.
  • Acute respiratory distress syndrome (ARDS): Patients may develop fever and lung infiltrates or respiratory distress for ARDS. Discontinue RELEUKO® in patients with ARDS.
  • Fatal sickle cell crises: Serious sickle cell crises have been reported in patients with sickle cell disorders receiving RELEUKO®. Discontinue RELEUKO® if sickle cell crisis occurs.
  • Serious allergic reactions, including anaphylaxis: Permanently discontinue RELEUKO® in patients with serious allergic reactions.
  • Kidney injury (Glomerulonephritis): Kidney injury have been reported in patients on RELEUKO®. Consider dose-reduction or interruption of RELEUKO® in patients with kidney injury.
  • Myelodysplastic Syndrome (MDS) and Acute Myeloid Leukemia (AML): Monitor patients with breast and lung cancer using RELEUKO® in conjunction with chemotherapy and/or radiotherapy for signs and symptoms of MDS/AML.
  • Decreased platelet count (thrombocytopenia); increased white blood cell count (leukocytosis) and inflammation of your blood vessels (cutaneous vasculitis) have been reported. Monitor platelet counts and white blood cell count.

 

ADVERSE REACTIONS

Most common adverse reactions in patients:

  • With nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs are pyrexia, pain, rash, cough, and dyspnea.
  • With AML are pain, epistaxis and rash.
  • With nonmyeloid malignancies undergoing myeloablative chemotherapy followed by Bone Marrow Transplant is rash.
  • With severe chronic neutropenia are pain, anemia, epistaxis, diarrhea, hypoesthesia and alopecia.

 

For full prescribing information, see package insert located here.

 

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated essential medicines company. We make healthy possible through the development, manufacturing, and distribution of generic and specialty pharmaceuticals, primarily within the United States. The Company has a diverse portfolio of over 250 products in its Generics segment and is expanding across a broad range of complex products and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceutical products focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more, please visit www.amneal.com.

 

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance, the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and expenditures. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words are intended to identify estimates and forward-looking statements.

 

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

 

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry, in general, specifically from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to manage our growth through acquisitions and otherwise; our dependence on the sales of a limited number of products for a substantial portion of our total revenues; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods and any associated supply chain disruptions; existing and future legal proceedings, the outcome of which are uncertain and may divert management resources and require us to incur substantial defense or settlement payments and costs; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; the impact of severe weather; the impact of the ongoing COVID-19 pandemic, and the emergence of variant strains; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration (“FDA”) product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our dependence on third-party agreements for a portion of our product offerings; the impact of global economic conditions, including any economic effects stemming from adverse geopolitical events, an economic downturn, inflation and rising interest rates; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

Contacts

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

Categories
Business Healthcare Science

Tevogen Bio to study therapeutic potential of its investigational COVID-19 T cell therapy in long COVID

  • Tevogen’s investigational precision T cell product, TVGN 489, is designed to address the unmet need of COVID-19 patients who are unable to take or unlikely to benefit from currently available prevention or treatment strategies and potentially those with Long COVID, where there are no currently available treatment options
  • Given that no dose limiting toxicities or treatment-related adverse events were observed in the TVGN 489 POC trial, Tevogen intends to explore the potential of this therapy for the treatment of Long COVID
  • Tevogen’s research pipeline includes off-the-shelf, allogeneic genetically unmodified precision CD8+ T Lymphocyte therapeutics for the treatment of immunocompromised patients with COVID-19, patients with other serious viral infections, viral-induced cancers, several non-virally induced common cancers, and neurologic diseases, including multiple sclerosis
  • Tevogen’s inventions are designed to overcome both cost and geography related patient access barriers and aims to transform cancer treatment by developing cell therapies as first-line options

 

WARREN, N.J. — (BUSINESS WIRE) — #COVID19—Tevogen Bio, a late-stage clinical biotechnology company specializing in the development of cellular immunotherapies in oncology, neurology, and virology announced today its intention to study potential therapeutic use of its investigational COVID-19 T cell therapy, TVGN-489, in Long COVID. The finding that none of the patients in the TVGN 489 Proof-of-Concept (POC) trial, treated for their initial COVID infection, developed Long COVID to date is leading Tevogen to explore the potential of TVGN 489 to also treat Long COVID.

“I’m greatly encouraged by the POC trial experience of TVGN 489 and hopeful that our investigational COVID-19 therapy will eventually offer hope to a substantial segment of Long COVID patients.” said Dr. Neal Flomenberg, Tevogen’s Chief Scientific Officer.

 

“Anyone that knows someone who has been impacted by this debilitating disease understands the importance of advancing science to alleviate the suffering from Long COVID,” said Tevogen CEO Ryan Saadi, M.D., M.P.H. “I’m hopeful that our innovative T cell technology will eventually offer accessible immunotherapies to millions suffering from viral infections, cancers and other diseases with high unmet need.”

 

TVGN-489 is highly purified cytotoxic CD8+ T lymphocytes (CTLs) designed to detect and kill SARS-CoV-2 infected cells. These allogeneic genetically unmodified CTLs are enriched and expanded in the lab and recognize proteins from across the entire SARS-CoV-2 genome, not just the spike protein.

 

In July 2022, TVGN-489 completed proof-of-concept clinical trial enrollment with zero treatment-related adverse events. Patients treated were infected with a range of all COVID variants at the time, from Delta through Omicron BA.5. Additionally, each patient had co-morbidities rendering them high risk and 50 percent of those additionally met the definition of being immunocompromised.

 

About Tevogen’s Next Generation Precision T Cell Platform

Tevogen’s next generation precision T cell platform is designed to provide increased immunologic specificity to eliminate malignant and virally infected cells, while allowing healthy cells to remain intact. Multiple targets are selected in advance with the goal of overcoming the mutational capacity of cancer cells and viruses which can otherwise allow for escape from immunologic targeting.

 

Tevogen is investigating its technology’s potential to overcome the primary barriers to the broad application of personalized T cell therapies: potency, purity, production-at-scale, and patient-pairing, without the limitations of current approaches. Tevogen’s goal is to open the vast and unprecedented potential of developing personalized immunotherapies for large patient populations impacted by common cancers and viral infections.

 

Tevogen announced the completion of patient enrollment in the Proof-of-Concept clinical trial of its lead product, TVGN-489, for ambulatory, acute-risk COVID-19 patients, with no dose-limiting toxicities or significant treatment-related adverse events observed for any patient at any dose level.

 

TVGN-489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte (CTL) product with activity against multiple, precise targets across the entire SARS-CoV-2 genome.

 

About Tevogen Bio

Tevogen Bio is driven by a team of distinguished scientists and highly experienced biopharmaceutical leaders who have successfully developed and commercialized multiple franchises. Tevogen’s leadership believes that accessible personalized immunotherapies are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation in the post-pandemic world.

 

Forward Looking Statements

This press release contains certain forward-looking statements relating to Tevogen Bio™ Inc (the “Company”) and its business. These statements are based on management’s current expectations and beliefs as of the date of this release and are subject to several factors which involve known and unknown risks, delays, uncertainties, and other factors not under the Company’s control that may cause actual results, performance or achievements to be materially different from the results, performance or other expectations implied by these forward-looking statements. Forward-looking statements can sometimes be identified by terminology such as “may,” “will,” “should,” “intend,” “expect,” “believe,” “potential,” and “possible,” or their negatives or comparable terminology, as well as other words and expressions referencing future events, conditions, or circumstances. In any forward-looking statement in which the Company expresses an expectation or belief as to future results, there can be no assurance that the statement or expectation or belief will be achieved. Various factors may cause differences between the Company’s expectations and actual results, including, among others: the Company’s limited operating history; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, and approval and commercial development; risks associated with intellectual property protection; and risks related to matters that could affect the Company’s future financial results, including the commercial potential, sales, and pricing of the Company’s products. Except as required by law, the Company undertakes no obligation to update the forward-looking statements or any of the information in this release, or provide additional information, and expressly disclaims any and all liability and makes no representations or warranties in connection herewith or with respect to any omissions therefrom.

Contacts

Tevogen Communications

T: 1 877 TEVOGEN, Ext 714

Communications@Tevogen.com

Categories
Business Culture Environment Lifestyle Science Technology

GrowGeneration announces 60th location at Mount Holly, NJ store opening

DENVER — (BUSINESS WIRE) — GrowGeneration Corp. (NASDAQ: GRWG) (“GrowGen” or “the Company”), the largest chain of specialty hydroponic and organic garden centers in the United States, today announced the opening of the Company’s newest store in Mount Holly, New Jersey on November 21, 2022.


The Mount Holly location represents the Company’s 60th store and officially expands operations into 16 states. The new store is 7,700 square feet and will include vertical farming demonstrations and educational support for growers to build and maintain state-of-the-art grow operations to maximize their yields.

 

Darren Lampert, Co-Founder and Chief Executive Officer of GrowGen said, “We are excited to open our first store in New Jersey and increase our reach and operations into a fast-growing and strategically important market. We expect New Jersey to be highly active in the coming years, with a strong medical patient base, over 800 conditional licenses that have been issued, microenterprise and social equity licenses, as well as a pending law to allow for home cultivation.”

 

Mr. Lampert continued, “As we expand our footprint in the Northeastern United States, we are excited to continue our efforts in cooperation with Harvest 360 to support our national program with education and training for Social Equity License holders. The program focuses on delivering top-notch support and solutions to operators and their communities. To date, we have 30 holders of micro licenses who are active in the program within the New York and New Jersey markets.”

 

About GrowGeneration Corp:

GrowGen owns and operates specialty retail hydroponic and organic gardening centers. Currently, GrowGen has 60 stores across 16 states, which include 22 locations in California, 6 locations in Colorado, 6 locations in Michigan, 5 locations in Maine, 5 locations in Oklahoma, 4 locations in Oregon, 3 locations in Washington, 1 location in Arizona, 1 location in Florida, 1 location in Massachusetts, 1 location in Mississippi, 1 location in Missouri, 1 location in New Jersey, 1 location in New Mexico, 1 location in Rhode Island, and 1 location in Virginia. GrowGen also operates an online superstore for cultivators at growgeneration.com. GrowGen carries and sells thousands of products, including organic nutrients and soils, advanced lighting technology and state of the art hydroponic equipment to be used indoors and outdoors by commercial and home growers.

Contacts

Investor Contact
ICR, Inc.

GrowGenIR@icrinc.com

Categories
Business Healthcare Science

Blue Earth Diagnostics highlights presentations on Axumin® (Fluciclovine F 18) at upcoming RSNA® 2022 Annual Meeting

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on Axumin® (fluciclovine F 18) at the upcoming Radiological Society of North America (RSNA) 108th Scientific Assembly and Annual Meeting, to be held in Chicago, Ill., from November 27 to December 1, 2022. Details of selected oral and poster presentations are listed below.

Two presentations from Emory University will discuss additional analyses from EMPIRE-1, the first prospective, randomized controlled trial to demonstrate that 18F-fluciclovine PET/CT-guided radiation therapy improved event-free survival rates in men with biochemical recurrence of prostate cancer. Another presentation compares the diagnostic performance of bone scintigraphy with 18F-fluciclovine in detecting bone metastases in men with prostate cancer at various PSA levels. Details of selected oral and poster presentations by Blue Earth Diagnostics’ collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

Oral presentation

Thursday, December 1, 2022

Title:

Failure-free Survival of Prostate Cancer Patients After Conventional Imaging Versus 18F-fluciclovine PET-guided Salvage Radiotherapy Stratified by Serum PSA Level: A Secondary Sub-group Analysis of a Randomized Control Trial

Presenter:

Ismaheel Lawal, MD, Division of Nuclear Medicine and Molecular Imaging, Department of Radiology and Imaging Sciences, Emory University, Atlanta, Ga.

Session Type:

Oral Scientific Session

Session Title:

Science Session with Keynote: Nuclear Medicine/Molecular Imaging (Prostate Cancer Imaging)

Presentation Time:

1:30 – 2:30 PM CT

Location:

S402, McCormick Place

Presentation No.:

R-6-SNMMI 08-1

Poster presentations

Tuesday, November 29, 2022

Title:

Bone Scan versus F-18 Fluciclovine PET/CT at Different PSA Levels: A Single Center Comparison Study

Presenter:

Hatice Savas, MD, Associate Professor, Feinburg School of Medicine, Northwestern University, Chicago, Ill.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion

Presentation Time:

9:00 – 9:30 AM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T2-SPNMMI-1

Title:

Impact of 18F-fluciclovine PET/CT on Failure-free Survival in Biochemical Recurrence of Prostate Cancer Following Salvage Radiation Therapy

Presenter:

Charles Marcus, MBBS, Assistant Professor, Department of Imaging and Radiology Sciences, Emory University School of Medicine, Atlanta, Ga.

Session Type:

Scientific Poster Session

Session Title:

Nuclear Medicine/Molecular Imaging Tuesday Poster Discussion – A

Presentation Time:

12:15 – 12:45 PM CT

Location:

Learning Center NMMI-DPS, McCormick Place

Session No.:

T5A-SPNMMI-2

 

Axumin® (fluciclovine F 18) presentations

Blue Earth Diagnostics invites participants at RSNA 2022 to attend the presentations above. For full session details and scientific presentation listings, please see the RSNA 2022 online program here.

 

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

 

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

 

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

 

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

 

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com

Categories
Business Lifestyle Science

inTEST Corporation to participate in the 11th Annual NYC Summit

MT. LAUREL, N.J. — (BUSINESS WIRE) — inTEST Corporation (NYSE American: INTT), a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, security, and semiconductor (“semi”), today announced that Nick Grant, President & CEO, and Duncan Gilmour, Chief Financial Officer, will participate in the 11th Annual NYC Summit, being held Tuesday, December 13th at Mastro’s New York.

 

The inTEST presentation is scheduled to begin at 9:30 a.m. Eastern Time, in a “round-robin” format consisting of small group meetings with company management teams. The presentation material utilized during the NYC Summit will be accessible on the events page of the Company’s website https://ir.intest.com.

 

Attendance at the NYC Summit is by invitation only and is available solely to accredited investors and publishing research analysts. During the event, investors and analysts will have the opportunity to meet with the majority of the 12 management teams during the small group meeting sessions, as well as opportunities to meet with management during the breakfast and lunch networking sessions.

 

The 12 management teams collectively hosting the 11th Annual NYC Summit 2022 include: ACM Research (ACMR), Advanced Energy (AEIS), Aehr Test (AEHR), Alpha & Omega Semiconductor (AOSL), Axcelis (ACLS), FormFactor (FORM), Ichor Systems (ICHR), inTEST (INTT), Intevac (IVAC), Kulicke & Soffa (KLIC), Onto Innovation (ONTO), and SkyWater Technology (SKYT). Both Cowen and Stifel are sponsors of the conference.

 

About inTEST Corporation

inTEST Corporation is a global supplier of innovative test and process solutions for use in manufacturing and testing in key target markets which include automotive, defense/aerospace, industrial, life sciences, and security, as well as both the front-end and back-end of the semiconductor manufacturing industry. Backed by decades of engineering expertise and a culture of operational excellence, inTEST solves difficult thermal, mechanical, and electronic challenges for customers worldwide while generating strong cash flow and profits. inTEST’s strategy leverages these strengths to grow organically and with acquisitions through the addition of innovative technologies, deeper and broader geographic reach, and market expansion. For more information, visit www.intest.com.

Contacts

inTEST Corporation

Duncan Gilmour

Chief Financial Officer, Treasurer and Secretary

(856) 505-8999

Investors:

Deborah K. Pawlowski

Kei Advisors LLC

dpawlowski@keiadvisors.com
(716) 843-3908

Categories
Business Science

Blue Earth Diagnostics highlights upcoming presentation of results from Phase 3 LIGHTHOUSE study of investigational PET imaging agent 18F-rhPSMA-7.3 in newly diagnosed prostate cancer

− First presentation of results to be made at 23rd Annual Scientific Meeting in Urologic Oncology (SUO) −

 

MONROE TOWNSHIP, N.J. & OXFORD, England — (BUSINESS WIRE) — Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced presentations on investigational rhPSMA compounds and Axumin® (fluciclovine F 18) at the upcoming 23rd Annual Scientific Meeting in Urologic Oncology (SUO), to be held in San Diego, Calif., from November 30 to December 2, 2022. They include the first presentation of key results from Blue Earth Diagnostics’ completed Phase 3 LIGHTHOUSE trial (NCT04186819) investigating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET in newly diagnosed prostate cancer. 18F-rhPSMA-7.3 is an investigational Prostate-Specific Membrane Antigen-targeted radiohybrid (rh) PET imaging agent. An rhPSMA presentation from Blue Earth Diagnostics’ sister company, Blue Earth Therapeutics, will report on its ongoing Phase 1/2 trial investigating the use of 177Lu-rhPSMA-10.1 for treatment in metastatic castrate-resistant prostate cancer. In addition, a further presentation will report findings from experiments designed to better understand PSMA regulation in castrate-resistant and neuroendocrine prostate cancer and the potential role of 18F-fluciclovine PET imaging when these tumors have low PSMA expression.

Details of selected presentations by Blue Earth Diagnostics and its collaborators are listed below.

 

NOTE: Axumin® (fluciclovine F 18) injection is FDA-approved for PET imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

 

HIGHLIGHTED SCIENTIFIC PRESENTATIONS

SUO has designed this year’s meeting to feature all presentations in digital poster format, presented in scheduled blocks and available in the online poster gallery.

Thursday, December 1, 2022

Investigational rhPSMA

18F-rhPSMA-7.3

Title:

Diagnostic Performance and Safety of 18F-rhPSMA-7.3 PET in Patients with Newly Diagnosed Prostate Cancer: Results from a Phase 3, Prospective, Multicenter Study (LIGHTHOUSE)

Presenter:

Brian Chapin, MD, Assistant Professor, Department of Urology, Division of Surgery, The University of Texas MD Anderson Cancer Center, on behalf of the LIGHTHOUSE Study Group

Time:

2:00 −3:00 PM PT

Number:

134

177Lu-rhPSMA-10.1

Title:

The Safety, Tolerability, Radiation Dosimetry and Efficacy of 177Lu-rhPSMA-10.1 for Metastatic Castrate-resistant Prostate Cancer: A Phase 1/2 Trial in Progress

Presenter:

Koby Amankwah, Weill Cornell Cancer Center, New York, NY

Time:

9:00 – 10:00 AM PT

Number:

73

Axumin® (fluciclovine F 18)

Title:

Detection of PSMA-Low Castration Resistant and Neuroendocrine Prostate Cancer with 18F-Fluciclovine PET Imaging

Presenter:

Himisha Beltran, MD, Associate Professor, Medical Oncology, Dana-Farber Cancer Institute, Boston, Mass.

Time:

9:00 − 10:00 AM PT

Number:

72

Blue Earth Diagnostics invites participants at the SUO 23rd Annual Meeting to attend the presentations above and to learn more about the company at its Medical Affairs educational booth. For session details and scientific presentation listings, please see the SUO online program here.

About Radiohybrid Prostate-Specific Membrane Antigen (rhPSMA)

rhPSMA compounds consist of a radiohybrid (“rh”) Prostate-Specific Membrane Antigen-targeted receptor ligand which attaches to and is internalized by prostate cancer cells and they may be radiolabeled with 18F for PET imaging, or with isotopes such as 177Lu or 225Ac for therapeutic use – creating a true theranostic technology. They may play an important role in patient management in the future, and offer the potential for precision medicine for men with prostate cancer. Radiohybrid technology and rhPSMA originated from the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. Blue Earth Diagnostics has completed two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845), in men with recurrent disease and (“LIGHTHOUSE,” NCT04186819), in men with newly diagnosed prostate cancer. Currently, rhPSMA compounds are investigational and have not received regulatory approval.

Indication and Important Safety Information About Axumin

INDICATION

Axumin® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

  • Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
  • Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
  • Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
  • Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full Axumin prescribing information is available at https://www.axumin.com/prescribing-information.pdf.

About Blue Earth Diagnostics

Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company’s success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics’ expanding oncology portfolio encompasses a variety of disease states, including prostate cancer and neuro-oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in imaging and therapy. For more information, please visit: www.blueearthdiagnostics.com.

About Bracco Imaging

Bracco Imaging S.p.A., part of the Bracco Group, is a world-leading diagnostic imaging provider. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions. It offers a product and solution portfolio for all key diagnostic imaging modalities: X-ray imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents to inform clinical management and guide care for cancer patients in areas of unmet medical need. Our continually evolving portfolio is completed by a range of medical devices, advanced administration systems and dose-management software. In 2019 Bracco Imaging also enriched its product portfolio by expanding the range of oncology nuclear imaging solutions in the urology segment and other specialties with the acquisition of Blue Earth Diagnostics. Visit: www.braccoimaging.com.

Contacts

For Blue Earth Diagnostics (U.S.)
Priscilla Harlan

Vice President, Corporate Communications

(M) (781) 799-7917

priscilla.harlan@blueearthdx.com

For Blue Earth Diagnostics (UK)
Clare Gidley

Associate Director Marketing and Communications

Tel: +44 (0)1865 784186

clare.gidley@blueearthdx.com

Media
Sam Brown Inc.

Mike Beyer

(M) (312) 961-2502

mikebeyer@sambrown.com