ADC Therapeutics Announces CEO Transition

On May 9, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that Chris Martin, DPhil, has stepped down as Chief Executive Officer (Press release, ADC Therapeutics, MAY 9, 2022, View Source [SID1234613962]). Dr. Martin will serve as a non-executive member of the Company’s Board of Directors and Chair of the Science and Technology Committee. He will also serve as an advisor to the Company for the next three months to ensure a seamless transition. ADC Therapeutics is pleased to announce that Ameet Mallik has been appointed as its new Chief Executive Officer. He will be based from ADC Therapeutics’ office in New Providence, New Jersey.

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"Since co-founding ADC Therapeutics in 2011, I have had the privilege of taking our proprietary ADC technology from discovery to the bench to our first FDA approval of ZYNLONTA," said Dr. Martin. "The Company has grown from a private startup to a New York Stock Exchange-listed company with over 300 employees and a commercial product addressing an unmet need in diffuse large B-cell lymphoma patients. In addition, the Company’s pipeline includes Cami, which is progressing towards a BLA submission, five promising solid tumor programs in development and a strong ADC platform and R&D pipeline. The approval and successful launch of ZYNLONTA was a particular highlight for me. With the Company and its pipeline in such a strong position, I am very pleased to be passing the baton to Ameet Mallik, whose deep commercial oncology experience and proven leadership qualities will drive the Company through its next chapter of growth. I look forward to partnering with Ameet to ensure a smooth transition and continuing to be a steward of the Company serving on the Board."

Ameet Mallik’s pharmaceutical career was highlighted by 16 years at Novartis, most recently as Executive Vice President and Head of U.S. Oncology. Prior to that, he held various leadership roles at Novartis Oncology including Head of Global Marketing, Value and Access and Head of Latin America and Canada. He also served as Global Head of Biopharmaceuticals and Oncology injectables at Sandoz, a division of the Novartis Group, and Head of Global Strategic Planning at Novartis Pharmaceuticals. Prior to Novartis, Mr. Mallik was an Associate Principal at McKinsey & Company. Most recently, Mr. Mallik served as CEO of Rafael Holdings, a biotech company focused on developing oncology and immune therapies. He serves on the Boards of Atara Biotherapeutics and Rafael Holdings. Mr. Mallik holds an M.B.A. from The Wharton School at the University of Pennsylvania, and an M.S. in Biotechnology and B.S. in Chemical Engineering, both from Northwestern University.

Mr. Mallik commented, "I am thrilled to join the ADC Therapeutics team and build on its solid foundation. I was drawn to the Company’s strong team and culture, its validated technology platform, a differentiated commercial product in ZYNLONTA, a portfolio of promising assets and an impressive research engine. It is truly remarkable what Dr. Martin and the ADC Therapeutics team have achieved in such a short period of time since the Company’s founding in 2011. It is a privilege to lead the Company through its next phase of growth, with the potential to create sustainable value for all of our stakeholders."

"On behalf of the Board of Directors, I would like to sincerely thank Chris for his many contributions to ADC Therapeutics over the last 11 years. His two decades of experience as a pioneer in the ADC space have been instrumental in building the Company, and he will be invaluable in his continued role on the Board," said Ron Squarer, Chairman of the Board of Directors of ADC Therapeutics. "I am delighted to welcome Ameet Mallik to the role of Chief Executive Officer. At this important juncture as the Company has transitioned to a fully-integrated research, development and commercial organization, I am confident that Mr. Mallik’s strong commercial background and strategic vision for the Company will lead ADC Therapeutics to bring leading-edge new therapies for patients suffering from cancer."

Bio-Thera Solutions Announces First Patient Dosed in Australia for BAT7104, a Bispecific Antibody Targeting PD-L1 and CD47 for the Treatment of Advanced Solid Tumors

On May 9, 2022 Bio-Thera Solutions, Ltd. (SH: 688177), a commercial-stage pharmaceutical company, reported that dosing has begun in a Phase 1 clinical study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of BAT7104, a bispecific antibody that specifically blocks the interaction of human PD-L1 and CD47 with their corresponding receptors (Press release, BioThera Solutions, MAY 9, 2022, View Source [SID1234613960]).

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BAT7104 was designed to inhibit the PD-1/PD-L1 and CD47/SIRP-α pathways. By an "imbalanced" design with finely tuned binding affinity to CD47 and high affinity to PD-L1, BAT7104 is expected to avoid RBC depletion and block CD47 on CD47+/PD-L1+ tumors in a more selective and tumor-enriched manner. BAT7104 was shown to effectively inhibit both pathways in vitro and demonstrated synergistic activity in inducing complete tumor regression in vivo. In non-human primates (NHP) study, BAT7104 was well tolerated with no adverse effects, suggesting a favorable therapeutic index in future clinical development. "BAT7104 has demonstrated higher anti-tumor activity with better safety profile in preclinical studies". Commented Dr. Shengfeng Li, CEO, Bio-Thera Solutions. "As the first bispecific antibody of Bio-Thera, we are pleased to see BAT7104 enter clinical development in Australia, and we will continue bringing more innovative anti-tumor drugs to cancer patients." Dr. Shengfeng Li continued.

The Phase 1, multi-center, open-label, dose-escalation clinical trial of BAT7104 is designed to assess the safety and tolerability of BAT7104. Key objectives of the study are to determine the maximum tolerated dose and recommended Phase 2 dose (RP2D), and to evaluate pharmacokinetics and preliminary efficacy in patients with advanced solid tumor. Another early stage Phase 1 clinical study evaluating BAT7104 is being conducted in China in patients with solid tumors and lymphoma. In addition, Bio-Thera Solutions is developing several additional innovative oncology assets directed at important IO targets, including PD-1, OX40, CTLA-4, and TIGIT, all in early stage clinical studies.

Repare Therapeutics to Participate at the 2022 Guggenheim Synthetic Lethality Day

On May 9, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported that members of its senior management team will participate in a fireside chat at the virtual 2022 Guggenheim Synthetic Lethality Day on Monday, May 16, 2022 at 9:00 a.m. Eastern Time (Press release, Repare Therapeutics, MAY 9, 2022, View Source [SID1234613959]).

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A live webcast of the fireside can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days.

Twist Bioscience Enters into Research, Exclusive Option and License Agreement with Astellas for Antibodies to Reduce Tumor Microenvironment-Mediated Immunosuppression

On May 9, 2022 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported it has entered into a research collaboration and exclusive option license agreement with Astellas Pharma Inc (Press release, Twist Bioscience, MAY 9, 2022, View Source [SID1234613958]). Under the terms of the agreement, the companies will jointly conduct research activities to identify and optimize proprietary Twist antagonist antibodies, targeting an undisclosed checkpoint inhibitor pathway in the tumor microenvironment (TME), as potential therapeutic development candidates. Ligands in this pathway are found in relatively high concentrations in the tumor microenvironment. Blocking the receptor’s activation has the potential to markedly enhance anti-tumor immunity with other Astellas therapies including chimeric antigen receptor-based (CAR) technologies combined with Universal Donor Cells. Astellas will have the exclusive option to license any development candidates generated as part of the collaboration.

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"Our robust antibody discovery and optimization capabilities uniquely position us to develop antibodies with high affinity and specificity for historically difficult targets, such as those mediating immune suppression in the TME," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "This out-licensing agreement validates the capabilities of Twist-generated antibodies to enable the discovery and advancement of next generation therapies. As the first out-licensing agreement for Twist Biopharma, this deal will serve as an initial base that we intend to build on as we pursue increasingly larger and later stage out-licensing opportunities with additional partners and targets."

Targeting this pathway with antibody therapeutics is a novel approach with no antibodies in clinical development. Developing next-generation checkpoint inhibitor immunotherapies using new modalities is promising as an innovative healthcare solution. Through this collaboration we expect to stimulate a highly specific and targeted attack on cancer cells by optimizing these development candidates, and leveraging Astellas’ flexible convertibleCAR cell therapy technology.

Under the terms of the agreement, Twist will receive an upfront payment from Astellas as well as an additional payment upon the exercise of the licensing option. Twist will receive payments connected to success-based clinical milestones as well as royalty payments on product sales for each licensed product. Astellas will be responsible for the development, manufacturing and commercialization of any licensed products.

Applied DNA Schedules Fiscal 2022 Second Quarter Financial Results Conference Call and Webcast for Thursday, May 12, 2022

On May 9, 2022 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in cell-free, enzymatic DNA production, reported that it will report fiscal 2022 second quarter financial results after market close on Thursday, May 12, 2022 (Press release, Applied DNA Sciences, MAY 9, 2022, View Source;id=230827&p=2228311&I=1206939-c7Z3G6f3m8 [SID1234613957]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘Company Events’ sub-page of the Company’s Investor Relations website and embedded into the live webcast.

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A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.