On October 6, 2020 BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) protein therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercial-stage biotechnology company, reported that the two companies have revised their previous global co-development and commercialization agreement for BioAtla’s investigational CAB CTLA-4 antibody, BA3071 (Press release, BeiGene, OCT 6, 2020, View Source [SID1234568149]). The previous agreement from April 2019 now becomes a global licensing agreement for BA3071, which was designed to be conditionally activated in the tumor microenvironment in order to reduce systemic toxicity and potentially enable safer combinations with checkpoint inhibitors, such as BeiGene’s anti-PD-1 antibody, tislelizumab.

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Under the amended terms of the agreement, BeiGene will hold an exclusive global license to BA3071 and will be solely responsible for its global clinical development and commercialization and have the right to receive all profits on any future sales net of royalty payments to BioAtla. In addition to the upfront payment BioAtla received upon execution of the original agreement, BioAtla is eligible to receive near-term development and regulatory milestone payments together with increased tiered royalties on worldwide sales. Additional terms of the amended agreement were not disclosed.

"BeiGene is a recognized leader in global clinical development, with broad oncology clinical programs, including tislelizumab, its anti-PD-1 antibody which is approved in China," said Scott Smith, President of BioAtla. "This amended agreement reflects both BeiGene’s commitment to BA3071 and BioAtla’s strategy of rapidly and broadly building our pipeline of innovative CAB oncology candidates. This amended agreement enhances BioAtla’s strategic execution capabilities to support the development of our product pipeline, advance compelling combination therapies, and address markets with strong growth potential and high unmet medical need. BA3071 is expected to become BioAtla’s third CAB candidate in clinical trials along with CAB-AXL-ADC and CAB-ROR2-ADC."

"BioAtla has developed a differentiated proprietary protein discovery and expression platform to generate CABs, which in turn have been applied to BA3071, a novel, investigational CTLA-4 inhibitor that is designed to be conditionally activated in the tumor microenvironment," commented Lai Wang, Ph.D., Senior Vice President, Head of Global Research, Clinical Operations & Biometrics and APAC Clinical Development at BeiGene. "The unique nature of BA3071 provides us with an exciting scientific rationale to investigate the combination of this investigational CTLA-4 antibody with our anti-PD-1 antibody, tislelizumab. We look forward to advancing the global development and commercialization of this potentially unique cancer therapy as a single agent or in combination with other therapies."

"We believe that our amended agreement with BeiGene will align and potentially accelerate the global development and potential commercialization of BA3071. BeiGene’s management of the global clinical trials of BA3071 in combination with BeiGene’s tislelizumab may advance the prospects of new combination therapies for the treatment of several cancer indications," stated Jay M. Short, Ph.D., Chairman, CEO and co-founder of BioAtla. "The expanded royalty rates also recognize the exceptional opportunity that CAB technology can provide for novel combination therapies."

About BA3071

BA3071 is a novel, investigational conditionally active CTLA-4 inhibitor. A Phase 1/2 multi-center, open-label study is planned to evaluate the safety, tolerability, pharmacokinetics, immunogenicity and antitumor activity of BA3071 alone and in combination with BeiGene’s tislelizumab, an anti-PD-1 antibody. The Investigational New Drug application for BA3071 has been cleared by the U.S. Food and Drug Administration.

Cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4) is an inhibitory receptor expressed on T cells. The CTLA-4 pathway is a key immune checkpoint pathway that provides a downregulating signal to T cells. The blockade of CTLA-4 is intended to induce an antitumor immune response by promoting the activation and proliferation of tumor-specific T cells. Although inhibition of CTLA-4 has been shown to significantly improve antitumor response, it may also lead to immune attack of healthy cells. To minimize on-target off-tumor toxicity, BioAtla has applied its proprietary CAB technology with the intent to activate binding to the CTLA-4 receptor only on T cells in the tumor microenvironment.

Inhibition of immune checkpoints using anti-programmed cell death-1 (PD-1) or anti-CTLA-4 monoclonal antibodies has revolutionized the management of patients with advanced-stage melanoma and are among the most promising components of treatment approaches for many other cancers. Employing BioAtla’s proprietary CAB technology, BA3071 is designed to improve the efficacy and safety of anti-CTLA-4 therapy, as a monotherapy and in combination with other therapies, by restricting its activation and that of tumor specific T cells to the tumor microenvironment.

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

About Tislelizumab

Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed internationally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab is approved by the China National Medical Products Administration (NMPA) as a treatment for patients with classical Hodgkin’s lymphoma who received at least two prior therapies and for patients with locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

In addition, three supplemental new drug applications (sNDAs) for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the NMPA and are under review, for first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable hepatocellular carcinoma.

Currently, 16 potentially registration-enabling clinical trials are being conducted in China and globally, including 12 Phase 3 trials and four pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

On October 6, 2020 Arvinas, Inc. (Nasdaq: ARVN), a clinical-stage biotechnology company creating a new class of drugs based on targeted protein degradation, reported that John Houston, Ph.D., President and Chief Executive Officer, will present a keynote plenary session at the 3rd Annual Targeted Protein Degradation Summit being held virtually October 14-15, 2020 (Press release, Arvinas, OCT 6, 2020, View Source [SID1234568148]). The presentation will reflect on Arvinas’ advances in its PROTAC platform and introduce new pipeline programs.

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Presentation Details:

Title: The Promise of PROTAC Protein Degraders: What’s Next for Arvinas’ Pipeline & Platform
Date: Wednesday, October 14, 2020
Time: 11:30 a.m. ET

On October 6, 2020 Neogene Therapeutics, Inc., a pre-clinical stage biotechnology company pioneering a new class of fully personalized neo-antigen T cell therapies to treat cancer, reported the appointment of Franz B. Humer, Ph.D., as Executive Chairman of the Board of Directors (Press release, Neogene Therapeutics, OCT 6, 2020, View Source [SID1234568146]). A world-renowned pharmaceutical industry trailblazer, Dr. Humer served as Chairman and Chief Executive Officer of Roche Holding, Ltd. over a period of 16 years before retiring in 2014. As a result of the recent Series A financing, Rachel Mears of Jeito Capital, Elisa Petris, Ph.D., of Syncona Investment Management Ltd., Caroline Stout of EcoR1 Capital, and Katherine Wood of TPG Capital, also have joined the Neogene Board.

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"We are honored to welcome Franz as Executive Chairman of our Board of Directors. His vast experience in the development of ground-breaking therapies and decades of unparalleled leadership as a pioneer in the pharmaceutical industry will be invaluable as we advance the development of a novel class of engineered T cell therapies," said Carsten Linnemann, Ph.D., President, Chief Executive Officer and Co-Founder of Neogene Therapeutics. "With the recent completion of our $110 million Series A financing, I am looking forward to working closely with Franz and the Board to advance our differentiated technology and realize a new paradigm of personalized cancer treatment for patients."

Dr. Humer joined Roche in 1995 as Head of the Pharmaceuticals Division and Member of the Board. He was appointed CEO in 1998 and Chairman of the Board of Directors and CEO in April 2001. From March 2008 to March 2014, he served as Chairman of the Board of Directors of Roche Holding Ltd. Prior to Roche, Dr. Humer spent more than a decade at Glaxo Holdings, where he was appointed Managing Director of Glaxo Pharmaceuticals UK, Ltd. in 1987. He was elected to the Board in 1989 and became Chief Operating Director of worldwide operations (excluding the United States) in 1992. He earned a doctorate in law from Innsbruck University and an M.B.A. from INSEAD in Fontainebleau, France.

"I’m excited to join Neogene and its world-class team of cell therapy experts as they look to advance the development of neo-antigen T cell therapies and lead innovation in cancer treatment," said Dr. Humer. "The company has already made impressive progress as it develops therapies that have the potential to make a true difference for cancer patients. I look forward to contributing my experience in biopharma drug development, working closely with Carsten and the executive leadership as well as my fellow new board members to help grow the company and bring fully personalized engineered T cell therapies to patients living with advanced solid tumors."

Dr. Humer currently serves as an independent Director of Allogene Therapeutics, a company developing novel allogeneic CAR-T cell therapies. In addition, he holds private Board appointments across industries and serves as a non-executive Director of Cydar, Chairman of HMNC Holding, a healthcare advisor to a number of international institutions, and Chairman of the Board of the International Centre for Missing and Exploited Children and the Humer Foundation.

Newly Appointed Members of Neogene Board of Directors

Rachel Mears is a Partner at Jeito Capital. She has more than 20 years of transactional, operational and legal experience in the biotechnology and pharmaceutical industries. Ms. Mears led Strategy and International Business Operations at Forest Laboratories, where she worked on the successful development and commercialization of over 10 U.S. Food and Drug Administration-approved drugs and spearheaded the company’s integration with Allergan (then known as Actavis). Previously, Ms. Mears served as Chief Business Officer and General Counsel at Modern Meadow and as Senior Counsel, Chief of Staff, to PepsiCo’s General Counsel. Ms. Mears began her career as a patent attorney, first with Morrison & Forester and later with Kirkland & Ellis, specializing in complex intellectual property strategy and litigation. She currently serves on the Board of Trustees at Hackley School. Ms. Mears received a B.S. with honors in chemistry from Stanford University and a J.D. from New York University School of Law and was admitted to the U.S. Patent Bar.
Elisa Petris, Ph.D., is a Partner at Syncona Investment Management Ltd., a Director on the Board of Quell Therapeutics, and an observer on the Board of Achilles Therapeutics. She previously served on the Board of Blue Earth Diagnostics. She has been closely involved in the foundation of these companies, including their operational and strategic set-up. Previously, she was a Senior Associate at Michel Dyens & Co., where she worked on transactions covering the healthcare industry, and a member of the Life Science team at L.E.K. Consulting. While at L.E.K., she worked on projects for biotech, pharma and private equity clients. Dr. Petris earned a Ph.D. in molecular biology from Imperial College and an M.B.A. from London Business School.
Caroline Stout is a Principal at EcoR1 Capital. She also serves as Chief Investment Officer of Panacea Acquisition Corporation. At EcoR1 Capital, Ms. Stout focuses on investing in private and public biotechnology companies. She has led multiple investments in the cell and gene therapy space. She serves as a Board observer for Accent Therapeutics and Neurogene Inc. Previously, she served as a Board observer for Prevail Therapeutics. Prior to EcoR1, Ms. Stout was a healthcare investment banker at Credit Suisse, where she worked on a variety of transactions across the healthcare and biotechnology sectors. Ms. Stout graduated magna cum laude from Georgetown University with a B.A. in economics.
Katherine Wood is a Principal at TPG Capital, where she focuses on investments in the healthcare sector. She currently serves on the Boards of LifeStance Health, Convey Health Solutions, Kadiant, AskBio and Ellodi Pharmaceuticals and was previously on the Board of Adare Pharmaceuticals. She was involved in TPG’s investments in Allogene Therapeutics, Aptalis, EnvisionRx, IASIS and Par Pharmaceutical. Prior to joining TPG, Ms. Wood worked in healthcare investment banking at Goldman, Sachs & Co. She received a B.S. with honors in molecular and cell biology from Stanford University and an M.B.A. with distinction from Harvard Business School.
Existing Neogene Board members include the following:

Raul Jain, M.D., is a Director at Vida Ventures. He has more than 20 years of experience in science, medicine and academia, including in cell therapy and oncology development. Prior to Vida Ventures, he held roles of increasing responsibility at Kite Pharma, most recently as Vice President and Head of Development, where he oversaw the development and regulatory approvals of multiple CAR and TCR-engineered T cell programs. Previously, Dr. Jain served as Global Development Lead at Amgen, where his role included overseeing the development and regulatory approvals of small molecules and biologics in oncology. Dr. Jain currently serves on the Board of Directors for InnoSkel and Quanta. He completed his post-doctoral training in biophysics at Rockefeller University, and fellowship training at MD Anderson Cancer Center, where he was Chief Fellow. He completed a B.A. in chemistry and biochemistry at Rice University. He earned an M.D. and completed his internal medicine internship and residency at UT Southwestern Medical School, where he was a Howard Hughes Fellow.
Carsten Linnemann, Ph.D., is the President, Chief Executive Officer, and a Co-Founder of Neogene. Before Neogene, Dr. Linnemann served as Associate Director, Next Generation T Cell Therapies​ and Managing Director of Kite Pharma EU B.V. He has co-founded several biotech companies, including T-Cell Factory B.V. (acquired by Kite Pharma, Inc. in 2015). He has co-authored several publications in the field of genetic engineering of T cells, and done seminal work on human neo-antigen biology. Dr. Linnemann has been awarded numerous professional honors including the Thesis Prize from the Netherlands Society of Gene and Cell Therapy and the Antoni van Leeuwenhoek Career Achievement Award from The Netherlands Cancer Institute. Dr. Linnemann is an alumnus of the German Academic Foundation and the Boehringer Ingelheim Fonds – Foundation for Biomedical Research. He received a Ph.D. with honors for his work on engineering T cell immunity by TCR gene transfer in the laboratory of Dr. Ton Schumacher at The Netherlands Cancer Institute.
Ton N.M. Schumacher, Ph.D., is a Co-Founder of Neogene and Principal Investigator at The Netherlands Cancer Institute, Oncode Institute member, and Professor of Immunotechnology at Leiden University Medical Center. Dr. Schumacher previously co-founded AIMM Therapeutics, Neon Therapeutics and T Cell Factory and served as Chief Scientific Officer of Kite Pharma EU. In addition, Dr. Schumacher serves as Venture Partner at Third Rock Ventures. He is an internationally renowned researcher in the areas of cancer neoantigens and TCR therapies, and in recognition of his work in these areas, he has received, among others, the Amsterdam Inventor Award, the Queen Wilhelmina Cancer Research Award, the Meyenburg Cancer Research Award, the William B. Coley Award, and the Stevin Award of the Dutch Research Council.
David M. Tanen is Corporate Secretary of Neogene and a Partner and Co-Founder of Two River Consulting, which specializes in creating, operating and financing development-stage life science companies. Mr. Tanen is also a Co-Founder of Kite Pharma, where he served as an officer and General Counsel from its inception until its acquisition by Gilead Sciences; a Co-Founder of Kronos Bio, where he serves as an officer and member of the Board of Directors; and a Co-Founder and Officer of Allogene Therapeutics. He also serves as an advisor to Vida Ventures. Mr. Tanen received a B.A. from The George Washington University and a J.D. from Fordham University School of Law, where he has served on the Dean’s Planning Council for more than 10 years as well as the Entrepreneurial Law Advisory Council.

On October 6, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late- stage intratumoral cancer immunotherapies, reported the issuance of a new patent covering its interleukin-12 (IL-12) based immunotherapy platform, including its lead product candidate TAVO (Press release, OncoSec Medical, OCT 6, 2020, View Source [SID1234568145]). Specifically, on October 6, 2020, the United States Patent and Trademark Office issued U.S. Patent No. 10,792,375, entitled Method for the Treatment of Malignancies, which covers the Company’s interleukin-12 (IL-12) based immunotherapy platform, including its lead product candidate TAVO, and its proprietary EP gene delivery system . This patent covers the use of intratumoral electroporation of DNA encoding interleukins (such as IL-12) to treat cancer and is significant because it is not specific to which type of immune-stimulatory interleukin can be used to treat a patient, nor is it limited to a particular type of cancer.

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"This new patent further strengthens our core intellectual property estate, broadening the exclusivity of OncoSec’s novel combination drug-device platform for the intratumoral delivery of immune-stimulatory interleukins," said Keir Loiacono, General Counsel and Vice President, Corporate Development at OncoSec. "The new IP serves to secure our competitive position in the intratumoral oncology space and builds on our patent portfolio of growing scope."

On October 6, 2020 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it will be presenting at the Alliance for Regenerative Medicine’s (ARM) virtual Cell and Gene Meeting on the Mesa, taking place October 12-16, 2020 (Press release, Genprex, OCT 6, 2020, View Source [SID1234568142]). Michael Redman, Executive Vice President and Chief Operating Officer of Genprex, will lead the company’s presentation.

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The 2020 Cell and Gene Meeting on the Mesa will be delivered in a virtual format over the course of five days where attendees will be able to watch company presentations on-demand, in addition to two live-streaming panels each day. The Cell and Gene Meeting on the Mesa is the sector’s foremost annual conference, bringing together senior executives and top decision-makers in the industry to advance cutting-edge research into cures. Tackling the commercialization hurdles facing the cell and gene therapy sector today, this meeting covers a wide range of topics from clinical trial design to alternative payment models to scale-up and supply chain platforms for advanced therapies.