On January 7, 2025 Orion’s collaboration partner Bayer reported it has submitted an application to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) for the oral androgen receptor inhibitor (ARi) darolutamide (Press release, Orion, JAN 7, 2025, View Source [SID1234649443]). Bayer is seeking approval for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC). The submission is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC.

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The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets around the world, including China. The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries around the world, including China. Darolutamide is developed jointly by Orion and Bayer.

On January 6, 2025 Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company focused on developing life-changing therapies for patients with cancer and diabetes, reported that members from its executive leadership team will be attending and participating in investor, industry and business development meetings at the 43rd Annual J.P. Morgan Healthcare Conference, taking place Jan. 13-16, 2025 in San Francisco, California (Press release, Genprex, JAN 6, 2025, View Source [SID1234649484]).

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In attendance will be Ryan Confer, President, Chief Executive Officer and Chief Financial Officer; Mark Berger, MD, Chief Medical Officer; and Thomas Gallagher, Senior Vice President of Intellectual Property and Licensing. Throughout the duration of the conference, Genprex executives will be available to conduct one-on-one meetings with industry and investor groups to provide an overview of the Company’s gene therapies for cancer and diabetes.

For those interested in meeting Genprex management during the conference, please request a meeting through Investor Relations at [email protected].

On Jan. 6, 2025 Akeso, Inc. (9926.HK) ("Akeso" or the "Company") reported its participation in the upcoming 43rd Annual J.P. Morgan Healthcare Conference, taking place on January 13, 2025, in San Francisco, California (Press release, Akeso Biopharma, JAN 6, 2025, View Source [SID1234649483]). The company’s founder, chairwoman, president, and CEO, Dr. Michelle Xia will share the latest developments and plans for its globally leading programs, including ivonescimab (PD-1/VEGF bispecific antibody), cadonilimab (PD-1/CTLA-4 bispecific antibody), and ligufalimab (CD47 monoclonal antibody), as well as more cutting-edge multispecific antibody pipeline assets.

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Time：SF local time 2:15-2:55pm, Jan. 15, 2025

On January 7, 2025 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing next-generation oncology therapies, and Duality Biotherapeutics ("DualityBio"), a clinical-stage biotech company focusing on the discovery and development of next-generation antibody-drug conjugate (ADC) therapeutics, reported that they have entered into an exclusive license agreement, pursuant to which Avenzo will develop, manufacture and commercialize AVZO-1418/DB-1418, a potential best-in-class EGFR/HER3 bispecific ADC, globally (excluding Greater China) (Press release, Avenzo Therapeutics, JAN 6, 2025, View Source [SID1234649459]).

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"DualityBio has a strong track record of developing and advancing a pipeline of differentiated ADCs that target a broad range of indications," said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo Therapeutics. "By targeting both EGFR and HER3 with its differentiated design, AVZO-1418/DB-1418 has the potential to provide clinical benefit across multiple solid tumor types. We are excited to add this drug candidate to our clinical pipeline and look forward to collaborating with DualityBio to quickly progress this program into clinical studies."

Under the terms of the agreement, DualityBio will receive an upfront payment of $50 million and will be eligible to receive up to approximately $1.15 billion in development, regulatory and commercial milestone payments. In addition, DualityBio is eligible to receive tiered royalties on sales in Avenzo’s territory.

"DualityBio and Avenzo share a common purpose in developing the next generation of oncology therapies that address underserved therapeutic areas," said John Zhu, Ph.D., Founder and CEO of DualityBio. "Based on preclinical studies, we believe AVZO-1418/DB-1418 has the potential to offer enhanced therapeutic benefits over other therapies. We look forward to partnering with the Avenzo team to accelerate the development of this program and provide a potential new treatment option to cancer patients."

IND-enabling studies are ongoing with plans to advance AVZO-1418/DB-1418 into a first-in-human clinical study this year.

About AVZO-1418/DB-1418
AVZO-1418/DB-1418 is an EGFR/HER3 dual targeting, topoisomerase-1 inhibitor-based ADC built from DualityBio’s proprietary Duality Innovative Bispecific Antibody Conjugate (DIBAC) platform. In preclinical studies, AVZO-1418/DB-1418 has exhibited higher binding affinity to tumor cells and has demonstrated its efficacy potential across various solid tumors, including those that are EGFR-resistant, EGFR-low or HER3-resistant.

On January 6, 2025 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported that Chief Executive Officer, Madan Jagasia, M.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference, on Wednesday, January 15, at 8:00 am PST (11:00 am EST) (Press release, Obsidian Therapeutics, JAN 6, 2025, View Source [SID1234649450]).

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