TROP2xHER2 BsADC (OBI Pharma)

BEIJING, China & BOSTON, MA, USA I January 08, 2024 I Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, today announces that it has entered into an Exclusive Option and License Agreement with Radiance Biopharma Inc. (“Radiance”), a biotechnology company specializing in developing next generation Antibody Drug Conjugates. The agreement grants Radiance an option to license from Biocytogen a first-in-class fully human anti-HER2/TROP2 bispecific antibody-drug conjugate (BsADC) for therapeutic product development, manufacturing and commercialization for all human indications worldwide. HER2 and TROP2 are two tumor-associated antigens (TAAs) that have been found to be commonly expressed and co-expressed by multiple tumor types, including breast, gastric, colorectal, bladder, pancreatic, and non-small-cell lung cancer. Under the terms of the agreement, upon the option exercised, Biocytogen will be entitled to receive an option fee, licensing fee, development and commercialization milestone payments, as well as single-digit royalties on net sales. In addition, Biocytogen has the right to collect the sharing of sublicensing fee, if any, between Radiance and third party. Dr. Yuelei Shen, President and CEO of Biocytogen, said : “We are excited to collaborate with Radiance, a strong team with extensive experience in drug development, to develop a leading proprietary fully human bispecfic antibody drug conjugate. We are optimistic that the combination of our strength in BsADC discovery and the extensive experience of Radiance’s team will help expedite the commercialization of this dual-targeting BsADC”: Marc Lippman, MD, Chairman of the Board of Radiance said : “We are excited to enter into this Exclusive Option and License Agreement with Biocytogen for a novel human anti- HER2 and Trop2 Bispecific Antibody Drug Conjugate. Preclinical data from in vitro and in vivo assays of this BsADC shows promising high potency of anti-tumor activities in leading tumor indications. We are eager to work with Biocytogen to move the product to the clinic to benefit patients.” About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Founded on gene editing technology, Biocytogen leverages genetically engineered proprietary RenMice ® (RenMab TM /RenLite ® /RenNano ® /RenTCR-mimic TM ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established an off-the-shelf library of over 400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2023, 50 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 42 target-nominated RenMice ® licensing projects have been established around the globe, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen pioneered the generation of drug target knock-in humanized models for preclinical research, and currently provides a few thousand off-the-shelf animal and cell models under the company’s sub-brand, BioMice TM , along with preclinical pharmacology and gene-editing services for clients worldwide. Headquartered in Beijing, Biocytogen has branches in China (Haimen Jiangsu, Shanghai), USA (Boston, San Francisco), and Germany (Heidelberg). For more information, please visit http://en.biocytogen.com.cn . About Radiance Biopharma Radiance is focused on developing a pipeline of antibody-based cancer therapeutics including mono and bispecific Antibody Drug Conjugates (ADCs) for the treatment of cancer and to address other unmet medical needs. Marc Lippman, MD, a co-founder and Chairman of the Board of Radiance is a renowned oncologist and former founding board member of Seagen, a leader in the field of ADCs, recently acquired by Pfizer. Based in Boston, Massachusetts, Radiance has a world class, proven leadership team that brings together the best of ADC engineering, clinical, managerial expertise and track record. Radiance is an affiliated company to Alphageneron Pharmaceuticals Inc., a clinical-stage biotechnology company developing unique targeted cell and gene therapies for treating cancer and other unmet medical needs. For more information, please visit www.radiancebiopharma.com . SOURCE: Biocytogen

TAIPEI, Taiwan, Jan. 03, 2024 (GLOBE NEWSWIRE) -- OBI Pharma, a clinical stage oncology company (4174.TWO), today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for OBI-992, to conduct a Phase 1/2 study of its novel antibody - drug conjugate (ADC) cancer therapy targeting TROP2. OBI plans to enroll patients with advanced solid tumors, including non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), and gastric cancer (GC), although several other cancers are also potential targets. OBI Pharma's Chief Medical Officer, Wayne Saville, M.D., noted, “The clinical trial intends to evaluate the safety, pharmacokinetics, and preliminary efficacy of OBI-992, a novel TROP2 ADC with best-in-class potential. We look forward to dosing the first patient in our Phase 1/2 clinical study of OBI-992, which is expected to begin in early 2024.” Heidi Wang, Ph.D., OBI Pharma’s Chief Executive Officer, added, “OBI-992 is a novel TROP2 ADC designed and engineered by OBI. It demonstrates outstanding preclinical efficacy, favorable safety, and high stability in numerous in-vivo studies compared to other TROP2 ADCs. We are excited to commence the first-in-human clinical trial of OBI-992. OBI Pharma strives to advance our promising therapeutics to the clinic for cancer patients.” About OBI-992 OBI-992 is a TROP2-targeted antibody-drug conjugate (ADC) that carries a potent topoisomerase I inhibitor payload to kill tumor cells. TROP2 is highly expressed in a variety of solid tumors such as lung, breast, ovarian, and gastric cancer, rendering it an ideal target for cancer therapy. OBI-992 uses a unique hydrophilic, enzyme-cleavable linker that is stable in circulation but releases the cytotoxic payload inside tumor cells. OBI-992 demonstrates remarkable antitumor efficacy, improved pharmacokinetic characteristics, and a favorable safety pro animal models. The TROP2 targeting antibody was in-licensed from Biosion, Inc. , in December 2021. OBI Pharma owns ex-China commercial rights for OBI-992. About OBI Pharma OBI Pharma, Inc., is a clinical stage oncology company that is headquartered in Taiwan and established in 2002. Its mission is to develop novel cancer therapeutic agents for patients with high unmet medical needs. The company’s novel first-in-class immuno-oncology portfolio targeting Globo H includes: two Globo H active immunotherapy vaccines, Adagloxad Simolenin (formerly OBI-822) and OBI 833. Using the company’s unique ADC platforms, including GlycOBI™, OBI created its novel ADC pipelines, OBI-992, OBI-902, OBI-904, and OBI-905, targeting TROP2, Nectin4, and HER2, respectively. OBI’s pipeline also includes the first-in-class AKR1C3-targeted small-molecule prodrug OBI-3424, which selectively releases a potent DNA-alkylating antitumor agent in the presence of the aldo-keto reductase 1C3 (AKR1C3) enzyme. Additional information can be found at . Forward-Looking Statements Statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, statements about future clinical trials, results and the timing of such trials and results. Such risk factors are identified and discussed from time to time in OBI Pharma’s reports and presentations, including OBI Pharma’s filings with the Taiwan Securities and Futures Bureau. COMPANY CONTACT: Kevin Poulos OBI Pharma, Inc. 1.619.537.7698 Ext. 102 kpoulos@obipharmausa.com