On January 4, 2023 WuXi Biologics ("WuXi Bio") (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), reported a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics’ proprietary technology platforms (Press release, WuXi Biologics, JAN 4, 2023, View Source;multi-specific-t-cell-engagers-301713506.html [SID1234625838]).

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Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.

Dr. Chris Chen, CEO of WuXi Biologics, commented, "This license agreement with GSK represents an important validation of our potential best-in-class CD3 platform and WuXiBody platform, the ‘R’ in our CRDMO business model. This also demonstrates our efforts in offering global open-access technology platforms with premier quality and excellent execution. We are looking forward to enabling GSK to bring these potentially life-saving therapeutics to more patients worldwide."

John Lepore, Senior Vice President, Head of Research GSK, said, "This agreement with WuXi Biologics builds on our oncology portfolio of tumor cell targeting agents by providing GSK with access to potential best-in-class T-cell engaging antibodies that have been optimized for effective tumor killing with a desirable safety profile, offering the potential to address significant unmet medical need in patients with multiple tumor types."

On January 4, 2023 Caris Life Sciences (Caris), the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, reported that the company will present at the 41st Annual J.P. Morgan Healthcare Conference, which is being held January 9-12, 2023 in San Francisco (Press release, Caris Life Sciences, JAN 4, 2023, View Source [SID1234625837]). Caris will present at 11:00 a.m. (PST) on Tuesday, January 10, and will provide an overview of the business and discuss recent corporate achievements that position the organization to further extend its leadership position in the market.

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Caris will be represented by David D. Halbert, Founder, Chairman and Chief Executive Officer; Brian J. Brille, Vice Chairman; David Spetzler, MS, MBA, Ph.D., President and Chief Scientific Officer; Brian Lamon, Ph.D., Chief Business Officer, Head of BioPharma Business Development; Milan Radovich, Ph.D., Chief Precision Medicine Officer; Luke Power, Interim CFO and Chief Accounting Officer; and Narendra Chokshi, Corporate Vice President, Corporate Development.

On January 4, 2023 Immunitas Therapeutics ("Immunitas"), a clinical stage precision immunotherapy company committed to discovering and developing novel, differentiated therapeutics for patients with cancer, reported the first patient has been dosed in a Phase 1/2a clinical trial evaluating use of novel cancer immunotherapeutic IMT-009 in solid tumors and hematologic malignancies. The company also announced the addition of James Wooldridge, M.D., to their Clinical Advisory Board (Press release, Immunitas Therapeutics, JAN 4, 2023, View Source [SID1234625836]).

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"Despite significant therapeutic advancements, there are still a substantial number of patients who remain unresponsive to standard treatments and would benefit from more effective cancer immunotherapies," said Melissa L. Johnson, M.D., Director of Lung Cancer Research for Sarah Cannon Research Institute at Tennessee Oncology, Study Chair and Principal Investigator for the study. "IMT-009 inhibits the CD161/CLEC2D axis, a novel cancer immunotherapeutic target, and has been shown to re-stimulate the anti-cancer activity of key immune cell populations with a reasonable safety profile in preclinical studies. We look forward to further investigation of IMT-009 and its potential for patients awaiting improved treatment options."

The Phase 1 study (NCT05565417) is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D) for treatment of patients with advanced solid tumors or lymphomas. The trial will subsequently transition into Phase 2 to assess the safety and efficacy of IMT-009 as a monotherapy and in combination with another anticancer agent.

"The successful dosing of the first patient in this trial of IMT-009 marks an important milestone for Immunitas and, most importantly, brings us one step closer to delivering novel differentiated therapeutics to patients in need," said Amanda Wagner, Chief Executive Officer of Immunitas. "The timing is ideal for adding James Wooldridge, M.D., to our Clinical Advisory Board. Jim has extensive immuno-oncology development expertise and brings important clinical insight to our pipeline. We are excited to be working with him and look forward to the continued enrollment and dosing of patients in this inaugural trial of IMT-009."

Dr. Wooldridge has more than 20 years of experience in clinical oncology research and drug development, spanning the biotechnology, pharmaceutical, and academic sectors. He previously served as the Chief Medical Officer at Checkmate Pharmaceuticals before the company’s acquisition by Regeneron. He also held the role of Chief Medical Officer at Aeglea BioTherapeutics, where he oversaw development of enzyme-based treatments for rare genetic diseases. Prior to his work as a biotech executive, Dr. Wooldridge spent nearly 11 years heading cancer therapeutic development through various roles at Eli Lilly, most recently serving as Chief Scientific Officer, Immuno-oncology Clinical Development. Dr. Wooldridge also previously conducted clinical and translational cancer research as a faculty member at the University of Iowa and the University of Missouri. He earned his M.D. at the Tulane University School of Medicine and completed post-graduate training in internal medicine and medical oncology at the University of Iowa.

About IMT-009
IMT-009 is a fully human, Fc-attenuated IgG1 monoclonal antibody that binds to CD161 and blocks its interaction with its ligand, CLEC2D. Preclinical data confirm that CD161 blockade with IMT-009 results in enhanced anti-tumor activity. IMT-009 is under evaluation in a Phase 1/2a clinical trial for use as a monotherapy and combination treatment for solid tumor and hematological malignancies. The Phase 1 study is designed to evaluate the safety, tolerability, pharmacodynamic biomarkers, and preliminary efficacy of IMT-009 as well as identify the Recommended Phase 2 Dose (RP2D). The trial will then transition into Phase 2 with multiple expansion cohorts to assess the safety and efficacy of IMT-009 alone or in combination with another antineoplastic agent.

On January 4, 2023 Aktis Oncology, a biotechnology company discovering and developing novel classes of targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, reported that the company will present at the upcoming 41st Annual J.P. Morgan Healthcare Conference, taking place in San Francisco, CA, Jan. 9 – 12. Matthew Roden, PhD, President and Chief Executive Officer, will deliver a corporate presentation on Monday, Jan. 9, 2023 at 3:30 p.m. PT (Press release, Aktis Oncology, JAN 4, 2023, View Source [SID1234625835]).

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On January 4, 2023 Nektar Therapeutics’ (Nasdaq: NKTR) President and Chief Executive Officer, Howard Robin, reported that it is scheduled to present at the upcoming 41st Annual J.P. Morgan Healthcare Conference in San Francisco on Wednesday, January 11, 2023 at 8:15 a.m. Pacific Time (Press release, Nektar Therapeutics, JAN 4, 2023, View Source [SID1234625833]). The presentation and Q&A session will be accessible via a Webcast through a link posted on the Investor Events Calendar section of the Nektar website: View Source This webcast will be available for replay until February 11, 2023.

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