Author: Michelle Dryden

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Healthcare

ADC Therapeutics announces FDA accepts Biologics License Application and grants priority review for loncastuximab tesirine for treatment of relapsed or refractory diffuse large B-cell lymphoma

  • Prescription Drug User Fee Act target action date of May 21, 2021

LAUSANNE, Switzerland–(BUSINESS WIRE)–ADC Therapeutics SA (NYSE: ADCT), a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for loncastuximab tesirine (Lonca) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and granted priority review status. The FDA has set a Prescription Drug User Fee Act (“PDUFA”) target date of May 21, 2021.

“The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” said Chris Martin, Chief Executive Officer of ADC Therapeutics. “We look forward to working with the FDA during its review of our BLA submission for Lonca. Our organization remains focused on robust planning for a successful launch next year.”

The BLA submission is based on data from LOTIS 2, the pivotal Phase 2 multi-center, open-label, single-arm clinical trial evaluating the efficacy and safety of Lonca in patients with relapsed or refractory DLBCL following two or more lines of prior therapy. In June 2020, the Company presented maturing data from LOTIS 2 at the virtual 25th Congress of the European Hematology Association. As of the April 6th cutoff date, Lonca demonstrated an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1% (35/145 patients). The tolerability profile was manageable with the most common grade ≥3 treatment-emergent adverse events in ≥10% of patients being: neutropenia (25.5%) with low incidence of febrile neutropenia (3.4%), thrombocytopenia (17.9%), GGT increase (16.6%) and anaemia (10.3%).

Data from subgroup analyses of LOTIS 2 will be presented in a poster (abstract #1183) at the upcoming 62nd American Society for Hematology (ASH) Annual Meeting on Saturday, December 5, 2020.

About Loncastuximab Tesirine (Lonca)

Loncastuximab tesirine (Lonca, formerly ADCT-402) is an antibody drug conjugate (ADC) composed of a humanized monoclonal antibody directed against human CD19 and conjugated through a linker to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Once bound to a CD19-expressing cell, Lonca is designed to be internalized by the cell, following which the warhead is released. The warhead is designed to bind irreversibly to DNA to create highly potent interstrand cross-links that block DNA strand separation, thus disrupting essential DNA metabolic processes such as replication and ultimately resulting in cell death. CD19 is a clinically validated target for the treatment of B-cell malignancies.

Lonca, the Company’s lead product candidate, has been evaluated in a 145-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that showed a 48.3% overall response rate (ORR), which exceeded the target primary endpoint. Lonca is also being evaluated in LOTIS 3, a Phase 1/2 clinical trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma, and LOTIS 5, a Phase 3 confirmatory clinical trial in combination with rituximab in patients with relapsed or refractory DLBCL.

About ADC Therapeutics

ADC Therapeutics SA (NYSE: ADCT) is a late clinical-stage oncology-focused biotechnology company pioneering the development and commercialization of highly potent and targeted antibody drug conjugates (ADCs) for patients with hematological malignancies and solid tumors. The Company develops ADCs by applying its decades of experience in this field and using next-generation pyrrolobenzodiazepine (PBD) technology to which ADC Therapeutics has proprietary rights for its targets. Strategic target selection for PBD-based ADCs and substantial investment in early clinical development have enabled ADC Therapeutics to build a deep clinical and research pipeline of therapies for the treatment of hematological and solid tumor cancers. The Company has multiple PBD-based ADCs in ongoing clinical trials, ranging from first in human to confirmatory Phase 3 clinical trials, in the USA and Europe, and numerous preclinical ADCs in development.

Camidanlumab tesirine (Cami, formerly ADCT-301), the Company’s second lead product candidate, is being evaluated in a 100-patient pivotal Phase 2 clinical trial for the treatment of relapsed or refractory Hodgkin lymphoma (HL) after having shown in a Phase 1 clinical trial an 86.5% ORR in HL patients at the dose selected for Phase 2. The Company is also evaluating Cami as a novel immuno-oncology approach for the treatment of various advanced solid tumors.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

Forward-Looking Statements

This press release contains statements that constitute forward-looking statements. All statements other than statements of historical facts contained in this press release, including statements regarding our future results of operations and financial position, business strategy, product candidates, research pipeline, ongoing and planned preclinical studies and clinical trials, regulatory submissions and approvals, addressable patient population, research and development costs, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including those described in our filings with the U.S. Securities and Exchange Commission. No assurance can be given that such future results will be achieved. Such forward-looking statements contained in this document speak only as of the date of this press release. We expressly disclaim any obligation or undertaking to update these forward-looking statements contained in this press release to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based unless required to do so by applicable law. No representations or warranties (expressed or implied) are made about the accuracy of any such forward-looking statements.

Contacts

Investors
Amanda Hamilton

ADC Therapeutics

amanda.hamilton@adctherapeutics.com
Tel.: +1 917 288 7023

EU Media
Alexandre Müller

Dynamics Group

amu@dynamicsgroup.ch
Tel: +41 (0) 43 268 3231

USA Media
Annie Starr

6 Degrees

astarr@6degreespr.com
Tel.: +1 973-415-8838

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Network newscasts avoid Gov. Gavin Newsom dinner party controversy

There appears to have been a lack of interest from the mainstream media in covering the controversy surrounding California Gov. Gavin Newsom for attending a fancy dinner party amid his state’s tightening lockdown restrictions during the coronavirus pandemic.

 

— FOX News

Categories
Politics

GOP canvassers again oppose certifying Detroit-area votes

FILE – In this Nov. 7, 2020, file photo, Harjas Singh, 1, reaches out for his father, Umeet Singh, while held by his mother, Preet Kaur, as they attend a rally with their daughter, Nader Kaur, right, celebrating the election results in Detroit. (AP Photo/David Goldman, File)

 

DETROIT (AP) — Two Michigan Republicans who initially blocked certification of election results for the county that includes Detroit despite no evidence of fraud before approving them now say they want to rescind their certification.

Monica Palmer and William Hartmann, the two Republican canvassers in Wayne County, said in a statement issued late Wednesday that they only voted to certify the results after “hours of sustained pressure” and after getting promises that their concerns about the election would be investigated.

“We deserve better — but more importantly, the American people deserve better — than to be forced to accept an outcome achieved through intimidation, deception, and threats of violence,” they said in the statement. “Wayne County voters need to have full confidence in this process.”

Palmer and Hartmann initially voted against certification Tuesday, leaving the Wayne County Board of Canvassers deadlocked at 2-2 along party lines. Palmer complained that certain Detroit precincts were out of balance, meaning that absentee ballot books did not match the number of ballots cast.

The GOP move drew an immediate rebuke from the public and injected partisan politics into the business of an unsung panel that is supposed to confirm the will of the voters.

Biden crushed Trump in Wayne County, a Democratic stronghold, by a more than 2-1 margin on his way to winning Michigan by 146,000 votes, according to unofficial results. His victory reversed Trump’s 2016 gains in the industrial Midwest and put Biden on the path to achieving the 270 Electoral College votes needed to win the White House.

The county canvassers later voted again and certified the results, 4-0. Then, on Wednesday, Palmer and Hartmann signed affidavits saying they believe the county vote “should not be certified.” They said in their statement Wednesday that they’ve reported threats against them to law enforcement.

There has been no evidence of widespread voting fraud in Michigan or any other state. Federal and state officials from both parties have declared the 2020 election safe and secure. But Trump and his allies have spent two weeks raising false claims of fraud and refusing to concede to Biden.

 

— Associated Press

Categories
Business

Wipro selected as Dow Jones Sustainability World Index (DJSI) member for the 11th consecutive year

EAST BRUNSWICK, N.J. & BANGALORE, India–(BUSINESS WIRE)–#DJSI–Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has been selected as a member of the global Dow Jones Sustainability World Index (DJSI) – 2020 for the eleventh year in succession.

This year, 3429 companies were assessed from around the world, of which 323 made it to the final DJSI (World) index for 2020-2021. The IT Services sector saw 86 companies participating globally of which ten have been selected in the World Index. Wipro is also part of DJSI (Emerging Markets).

Launched in 1999, the S&P DJSI (World) is the leading global standard for corporate sustainability and represents the top 10% of an industry sector based on performance on a comprehensive range of Economic, Environmental, Social, and Governance (ESG) parameters. Inclusion in DJSI (World) index is based on a rigorous analysis of a company’s sustainability performance on nearly 1000 data points spread across 100 questions and three dimensions- Economic, Environmental, and Social.

Commenting on the achievement, Thierry Delaporte, CEO and Managing Director, Wipro Limited, said, “It is an honor to be named to the Dow Jones Sustainability World Index in recognition of our comprehensive sustainability approach. At Wipro, sustainability is more than just programs. It is infused throughout our company culture in how we make decisions and run our business. The DJSI recognition underscores our commitment to having a positive social and environmental impact.”

About Wipro Limited

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading global information technology, consulting and business process services company. We harness the power of cognitive computing, hyper-automation, robotics, cloud, analytics and emerging technologies to help our clients adapt to the digital world and make them successful. A company recognized globally for its comprehensive portfolio of services, strong commitment to sustainability and good corporate citizenship, we have over 180,000 dedicated employees serving clients across six continents. Together, we discover ideas and connect the dots to build a better and a bold new future.

Forward-Looking Statements

The forward-looking statements contained herein represent Wipro’s beliefs regarding future events, many of which are by their nature, inherently uncertain and outside Wipro’s control. Such statements include, but are not limited to, statements regarding Wipro’s growth prospects, its future financial operating results, and its plans, expectations and intentions. Wipro cautions readers that the forward-looking statements contained herein are subject to risks and uncertainties that could cause actual results to differ materially from the results anticipated by such statements. Such risks and uncertainties include, but are not limited to, risks and uncertainties regarding fluctuations in our earnings, revenue and profits, our ability to generate and manage growth, complete proposed corporate actions, intense competition in IT services, our ability to maintain our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies in which we make strategic investments, withdrawal of fiscal governmental incentives, political instability, war, legal restrictions on raising capital or acquiring companies outside India, unauthorized use of our intellectual property and general economic conditions affecting our business and industry. The conditions caused by the COVID-19 pandemic could decrease technology spending, adversely affect demand for our products, affect the rate of customer spending and could adversely affect our customers’ ability or willingness to purchase our offerings, delay prospective customers’ purchasing decisions, adversely impact our ability to provide on-site consulting services and our inability to deliver our customers or delay the provisioning of our offerings, all of which could adversely affect our future sales, operating results and overall financial performance. Our operations may also be negatively affected by a range of external factors related to the COVID-19 pandemic that are not within our control. Additional risks that could affect our future operating results are more fully described in our filings with the United States Securities and Exchange Commission, including, but not limited to, Annual Reports on Form 20-F. These filings are available at www.sec.gov. We may, from time to time, make additional written and oral forward-looking statements, including statements contained in the company’s filings with the Securities and Exchange Commission and our reports to shareholders. We do not undertake to update any forward-looking statement that may be made from time to time by us or on our behalf.

Contacts

Purnima Burman

Wipro Limited

purnima.burman@wipro.com

Categories
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Missing Tennessee boy, 9, found alive after spending 3 days in makeshift shelter in woods

A 9-year-old boy in Tennessee who had been missing for three days after running into the woods following an argument with his foster parents was found safe and wearing no jacket or shoes by a creek bed Tuesday afternoon, according to the Tennessee Bureau of Investigations.

 

— FOX News

Categories
Business

OwnBackup ranked number 79 fastest-growing company in North America on Deloitte’s 2020 Technology Fast 500™

Cloud Data Protection Leader Accelerates Momentum with 1,486% Three-Year Growth, New Executive Leadership, and Global Expansion

ENGLEWOOD CLIFFS, N.J.–(BUSINESS WIRE)–OwnBackup, a leading cloud-to-cloud business continuity platform, today announced it ranked 79 on Deloitte’s Technology Fast 500™, a listing of the fastest-growing technology, media, telecommunications, life sciences, and energy tech companies in North America. As highlighted by this distinguished award, OwnBackup’s revenues grew 1,486% and its customer base increased by 520% percent over the last three years.

To take this impressive momentum to the next level, OwnBackup recently expanded its world-class executive leadership team, appointing Jeannie Mun as chief financial officer, Leo Minervini as chief information officer, Travis Howe as chief information security officer, and Laura Cooper as chief people officer. In addition, new leaders in Asia Pacific and Europe joined to support growing customer demand for SaaS data protection in these markets. They will build on OwnBackup’s solid base of 2,600 customers worldwide—more than 29 percent of which are based outside the United States.

“The current pandemic is shining a bright light on several key trends that have been fueling business resilience ever since we first imagined OwnBackup. In this ever-changing business environment, digital transformation, cloud complexity, and artificial intelligence are all accelerating faster than anyone expected,” said Sam Gutmann, CEO of OwnBackup. “We’re putting the right people and practices in place to scale our business as we help forward-looking leaders in our growing customer ecosystem rapidly adapt and prepare for whatever paradigm shift comes next.”

New c-level executives poised to supercharge growth

Joining OwnBackup as CFO, Mun’s financial leadership experience spans high growth technology organizations such as MediaMath, which achieved a six-year compound annual growth rate of over 100% during her tenure, and OysterBooks, which was acquired by Google. Earlier in her career, she was an investment banker with Jordan Edmiston Group and a management consultant with Deloitte Consulting. “I’m thrilled to join such a great company and help lay a solid foundation for long-term viability and continued scale,” said Jeannie Mun, CFO at OwnBackup. “We have a clear and compelling opportunity to leverage OwnBackup’s impressive technology and IP to further expand our customer base and product offerings into numerous new markets.”

Leo Minervini joined OwnBackup to head the company’s global IT organization, bringing strategic technology experience from Trifecta Technologies, Carlo’s Bakery, Oracle, and Trend Micro. As CISO, Travis Howe leads OwnBackup’s security, privacy, and compliance initiatives. He is a visionary executive with experience as a United States Navy cryptologist, the security lead for the western third of the U.S. power grid, and a U.S. space command classified network architect. Laura Cooper manages the company’s global human resources, talent, recruiting, and facilities operations, adding valuable HR operations expertise from her leadership roles at Bluecore, Franklin Templeton Investments, Samsung Electronics America, and NICE Systems.

About Deloitte’s 2020 Technology Fast 500™

Now in its 26th year, Deloitte’s Technology Fast 500 provides a ranking of the fastest-growing technology, media, telecommunications, life sciences, and energy tech companies — both public and private — in North America. Technology Fast 500 award winners are selected based on percentage fiscal year revenue growth from 2016 to 2019. Overall, 2020 Technology Fast 500™ companies achieved three-year revenue growth ranging from 175% to 106,508%, with median growth of 450%.

About OwnBackup

OwnBackup, the leading cloud-to-cloud backup and restore vendor, provides secure, automated, daily backups of SaaS and PaaS data, as well as sophisticated data compare and restore tools for disaster recovery. Helping more than 2,600 businesses worldwide protect critical cloud data, OwnBackup covers data loss and corruption caused by human errors, malicious intent, integration errors, and rogue applications. Built for security and privacy, OwnBackup exceeds the General Data Protection Regulation (GDPR) requirements for backed-up data. Co-founded by seasoned data-recovery, data-protection, and information-security experts, OwnBackup is a top-rated backup and restore ISV on Salesforce AppExchange and was awarded the Salesforce Appy Award in 2018. OwnBackup ranks number 25 on the 2020 Financial Times Americas’ Fastest Growing Companies list and 79 on the 2020 Deloitte Technology Fast 500™ list. Headquartered in Englewood Cliffs, N.J., with R&D, support, and other functions in Tel Aviv and London, OwnBackup is the vendor of choice for some of the world’s largest users of SaaS applications.

For more information, visit ownbackup.com.

About Deloitte

Deloitte refers to one or more of Deloitte Touche Tohmatsu Limited, a UK private company limited by guarantee (“DTTL”), its network of member firms, and their related entities. DTTL and each of its member firms are legally separate and independent entities. DTTL (also referred to as “Deloitte Global”) does not provide services to clients. In the United States, Deloitte refers to one or more of the US member firms of DTTL, their related entities that operate using the “Deloitte” name in the United States and their respective affiliates. Certain services may not be available to attest clients under the rules and regulations of public accounting. Please see www.deloitte.com/about to learn more about our global network of member firms.

Contacts

Mike Melone

908-229-6300

mike@ownbackup.com

Categories
Business

WB Wood and Haworth Partner to prepare companies and landlords for a safe return to the office

NEW YORK & HOLLAND, Mich.–(BUSINESS WIRE)–WB Wood, one of the oldest and largest commercial furniture dealerships and management companies in the United States, and Haworth Inc., privately-held and one of the largest office furniture manufacturers in the world, today announced a strategic partnership. WB Wood will become a Haworth Preferred Dealer in the greater New York metropolitan region effective November 17, 2020.


With offices in New York City and Basking Ridge, New Jersey, WB Wood provides a full range of procurement, furniture and project management services to businesses and institutions in the public and private sector, including J.P. Morgan, CBRE Inc., and Nielsen, among other industry-leading clients.

Haworth, headquartered in Holland, Michigan, designs and manufactures adaptable workspaces, including systems furniture, seating, storage, movable walls and wood casegoods. WB Wood now has access to all Haworth products, including Zody and Fern seating; Openest lounge and desking elements; Compose workspaces; and the soon-to-launch freestanding architectural workspace called Pergola. The WB Wood and Haworth partnership also includes additional design and technology brands such as Janus et Cie, BuzziSpace, Cassina, Cappellini, Poltrona Frau, Tuohy, Gan Rugs, Pablo Lighting and Bluescape.

“Our new partnership with Haworth is a perfect strategic and cultural fit for our clients and employees alike. We share a common vision for supporting return to workplace and work from anywhere strategies as companies and institutions diligently plan their next steps,” said Richard Mines, owner of WB Wood.

“In an unprecedented, challenging and rapidly evolving marketplace, WB Wood remains committed to its long-term vision of growth. This new partnership will position us as an even more significant industry player in the New York metro area, as we concurrently seek to expand our geographic footprint throughout the U.S.,” Mr. Mines added. “Haworth’s deep portfolio of products will provide WB Wood clients with a vast array of choices. Their culture, industry reputation and significant global presence has made it possible for successful adaptation in a very quickly changing market.”

“This exciting new partnership is born from shared values, mutual goals and a common vision for the future of work,” said Franco Bianchi, CEO of Haworth. “We had an opportunity to get to know the team at WB Wood and believe this is a perfect fit. As a leading dealer based in the New York region with a national reach, WB Wood will continue to excel in serving their clients in the same manner that the marketplace and existing clients have come to expect throughout their long and successful history.”

Mr. Bianchi added: “More than ever before, partnerships with customers, dealers and manufacturers are critical. Haworth is deeply committed to the commercial furniture market and working with WB Wood to ensure that clients have workspaces that are successful for the long term.”

About WB Wood

WB Wood, founded in 1905, is recognized as a prominent furniture dealership and management company based in the New York metro region serving clients across the United States. The company represents more than 300 manufacturers with products spanning the design and budget spectrum. WB Wood provides a full range of procurement, furniture and project management services to organizations, working with and partnering alongside architects, design firms and consultants. Learn more at wbwood.com.

About Haworth

Founded in 1948, Haworth is a family owned, privately held, $2 billion+ global leader in the contract furnishings industry. What began from humble roots – crafting wood furniture in a Midwestern town on the shores of Lake Michigan – has evolved into a global company with a focus on organic workspace that helps people perform their best. Haworth designs, sources and manufactures products in the markets where they are delivered, ensuring solutions are tailored for distinct cultures, client preferences, greater agility and more sustainable sourcing. We also scout internationally for talent and partner with today’s leading architects and designers to bring clients fresh ideas and the best possible products and solutions. Together with 7,500 members and 650 dealers worldwide, Haworth operates in over 120 countries to create spaces that result in effective people and efficient real estate. Learn more at haworth.com.

Contacts

Media Contact for WB Wood:

Bob Cavosi

RooneyPartners

rcavosi@rooneyco.com
646.638.9891

Media Contact for Haworth:

Julie Smith

Julie.smith@haworth.com
616-393-1453

Categories
For Edit

Kind bars to be acquired by maker of Snickers

Mars, a giant in the candy bar world, will purchase Kind North America, which emphasizes healthy snacks.

— NYT:  Top Stories

Categories
For Edit

Bucs’ Tom Brady sits down with Jim Gray: ‘I obsess over’ perfection

Tampa Bay Buccaneers quarterback Tom Brady sat down with legendary sportscaster Jim Gray to talk about what has allowed him to be so successful in his 21 NFL seasons and the difficulties he faces each game in trying to live up to a measure of perfection that he himself set.

 

— FOX News

Categories
For Edit

Moderna coronavirus vaccine trial volunteer says public should not be concerned about risk

A Moderna coronavirus vaccine trial volunteer from the University of North Carolina at Chapel Hill shared the side effects he experienced with “Fox & Friends” Tuesday after the company revealed its vaccine is nearly 95% effective against COVID-19.

 

— FOX News