Biocytogen and Acepodia Join Forces to Advance Bispecific Antibody and Dual-Payload ADCs for Treating Complex Tumors

Collaboration initiates development of dual-payload bispecific antibody-drug conjugates (BsAD2Cs)Biocytogen’s RenLite® meets Acepodia’s AD2C for precision oncology solutions BEIJING, ALAMEDA, Calif. and TAIPEI, January 7 – Biocytogen (HKEX: 02315) and Acepodia (6976:TT), today announced a groundbreaking strategic partnership to jointly assess a dual-payload bispecific antibody-drug conjugate (BsAD2C) program.This collaboration combines Biocytogen’s RenLite® platform with Acepodia’s Antibody-Dual-Drugs Conjugation (AD2C) technology to tackle some of the toughest challenges in oncology—tumor heterogeneity and drug resistance. This novel approach aims to address these complexities by utilizing dual-payloads that target multiple therapeutic or disease pathways. These payloads are delivered with bispecific antibodies that enable enhanced precision and functionality.As part of the strategic partnership, Biocytogen will provide a bispecific antibody derived from its proprietary RenLite® platform, which is designed to produce fully human bispecific antibodies with unique binding properties. To this antibody, Acepodia will integrate two different payloads using its Antibody-Dual-Drugs Conjugation (AD2C) platform. This platform enables site-selective conjugation of multiple payloads to an antibody using bio-orthogonal click chemistry with no required antibody engineering, maintaining antibody integrity and binding capacity, and allowing strategic and precise control over the Drug-to-Antibody Ratio (DAR) for optimal potency and safety.“We are thrilled to partner with the Acepodia team who brings deep expertise in bio-orthogonal click chemistry and the unique opportunity to combine our RenLite® bispecific antibodies with site-selective dual-payload conjugates,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “We look forward to bridging our platforms to explore the therapeutic potential of highly potent BsADCs.”“Biocytogen’s superior bispecific antibodies and highly collaborative team make them an ideal partner for advancing our AD2C payload platform,” said Sonny Hsiao, Ph.D., Co-Founder and CEO of Acepodia. “This partnership redefines the possibilities of ADC design, with the potential to deliver breakthrough therapies to patients in desperate need of new options.”  This strategic partnership underscores the commitment of both companies to addressing the critical unmet needs in ADC drug development for solid tumors, paving the way for innovative therapies that improve patient outcomesAbout 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™/ RenLite®/ RenNano®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2024, approximately 150 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and nearly 50 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™, 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 Acepodia Acepodia is transforming cancer and autoimmune disease treatment with first-in-class immune cell engagers that deliver enhanced and targeted potency through multiple conjugation platforms. Leveraging a family of bio-orthogonal click chemistry approaches originating from Nobel Prize laureate Carolyn Bertozzi’s lab, Acepodia’s platforms are designed to improve safety and offer broad applicability across hematologic and solid tumor cancers, as well as autoimmune diseases. By combining innovative science with a patient-centric vision, Acepodia aims to bring powerful, next-generation therapies to patients underserved by today’s treatments. For more information, please visit https://www.acepodia.com/.Forward-Looking Statements This press release contains forward-looking statements regarding the potential therapeutic benefits, evaluation outcomes, and future development strategies for the dual-payload BsAD2C program. Such statements are subject to risks and uncertainties that may cause actual results to differ materially. Neither Biocytogen nor Acepodia undertakes any obligation to update these forward-looking statements, whether as a result of new information, future events, or otherwise.

Biocytogen Announces IDEAYA’s Nomination of Development Candidate IDE034, a Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC and Option Exercise

IDEAYA has exercised the option for an exclusive worldwide license on Biocytogen’s potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody-drug conjugate (BsADC), BCG034 (IDE034)This milestone further validates Biocytogen’s proprietary RenLite® antibody discovery platform, demonstrating its potential to advance innovative therapies for patientsIND application for IDE034 expected in 2025 to enable first-in-human clinical evaluation of B7H3/PTK7 topo-I-payload BsADC programIDE034 has the potential to be developed as a monotherapy and in combination with IDEAYA's PARG inhibitor IDE161 BEIJING, China and South San Francisco, CA, November 11, 2024– Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, has exercised the option for an exclusive worldwide license for Biocytogen's B7H3/PTK7 BsADC program, IDE034, and has nominated it as a development candidate.“We are excited that IDEAYA has chosen to exercise their option to license the worldwide rights to our B7H3/PTK7 BsADC IDE034, which incorporates our proprietary topoisomerase linker-payload,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This important milestone in our collaboration further validates the capabilities of Biocytogen’s RenLite® platform, bringing us closer to impactful treatments for patients with solid tumors. We look forward to supporting IDEAYA as they advance this program to clinical stages.”Michael White, Ph.D., Chief Scientific Officer of IDEAYA Biosciences, commented, “We are pleased to nominate IDE034 as a development candidate. This promising, potential first-in-class B7H3/PTK7 topo-I-payload bispecific ADC has shown significant tumor regression in preclinical models. The high prevalence of B7H3/PTK7 co-expression in solid tumors such as lung, colorectal, and head and neck cancers underscore its potential as both a monotherapy and in combination with our PARG inhibitor, IDE161.”IDEAYA is targeting an Investigational New Drug (IND) submission to the U.S. FDA in 2025 for IDE034, pending the completion of ongoing preclinical and IND-enabling studies, to facilitate the initiation of first-in-human trials.Under the option and license agreement between Biocytogen and IDEAYA, Biocytogen will receive upfront and option exercise fees, along with additional development and regulatory milestone payments, commercial milestone payments, and royalties on net sales, totaling $406.5 million, including up to $100 million in development and regulatory milestone payments.Based on the Human Protein Atlas database, B7H3/PTK7 has been reported to be co-expressed in multiple solid tumor types, including in lung, colorectal, and head and neck cancers at approximately 30%, 46% and 27%, respectively.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™/ RenLite®/ RenNano®/ RenTCR-mimic™ ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologics™, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of June 30, 2024, approximately 150 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and nearly 50 target-nominated RenMice® licensing projects have been established with over 60 global pharmaceutical and biotech companies, 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™, 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 IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.Biocytogen Media Contacts Antibody assets and platforms:  BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn

Biocytogen Announces Option and License Agreement with IDEAYA Biosciences for Potential First-in-Class B7H3/PTK7 Topo-I-Payload Bispecific ADC Program

Biocytogen granted IDEAYA an option for an exclusive worldwide license for potential first-in-class B7H3/PTK7 topo-I-payload bispecific antibody drug conjugate (BsADC) programB7H3/PTK7 co-expression found in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancersRational combo opportunities with IDEAYA’s DNA Damage Repair (DDR) pipeline, including IDE161 (PARG)Targeting development candidate nomination in H2 2024 Beijing, China and South San Francisco, CA, July 31, 2024–Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (Biocytogen, HKEX: 02315), a global biotech company focusing on the discovery of novel antibody/ADC therapeutics, announced that it has entered into an option and license agreement for a potential first-in-class B7H3/PTK7 BsADC program with IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics.“We are thrilled to announce our collaboration with IDEAYA to explore the promising combination of our potential first-in-class ADC and IDEAYA’s DDR small molecules,” said Dr. Yuelei Shen, President and CEO of Biocytogen. “This partnership leverages our cutting-edge RenLite® platform and proprietary linker-payload technology to enhance the precision and potency of ADCs. IDEAYA's strong determination and rich experience in drug development make us confident that this therapy could be rapidly advanced to benefit patients.”“The potential first-in-class B7H3/PTK7 topo-I-payload BsADC program has the potential to be developed as a monotherapy agent in multiple solid tumor types, and advances IDEAYA’s broader corporate strategy to enable wholly-owned first-in-class rational combinations at the intersection of ADCs and small molecule DDR-based therapies to deliver greater benefit for patients,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences.The agreement grants IDEAYA an option for an exclusive worldwide license from Biocytogen for a potential first-in-class B7H3/PTK7 topo-I-payload BsADC program. B7H3/PTK7 has been found to be co-expressed in multiple solid tumor types, including double-digit percent prevalence in lung, colorectal, and head and neck cancers, among others.Under the terms of the agreement, Biocytogen will receive an upfront fee and upon an option exercise by IDEAYA, be entitled to receive an option exercise fee, development and regulatory milestones and commercial milestone payments, as well as single-digit royalties on net sales. Total potential upfront, option exercise and milestone payments equal an aggregate of $406.5 million, including development and regulatory milestones of $100.0 million.Based on preclinical data, the potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload BsADC program has the potential to be developed as a monotherapy agent and used in combination with multiple programs in IDEAYA’s pipeline targeting DDR-based therapies, including PARG inhibitor IDE161. A development candidate nomination for the B7H3/PTK7 topoisomerase-I-inhibitor payload BsADC program is targeted for the second half of 2024.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® (RenMabTM/ RenLite®/ RenNano®/ RenTCR-mimicTM ) platforms for fully human monoclonal/bispecific/multispecific antibody discovery, bispecific antibody-drug conjugate discovery, nanobody discovery and TCR-mimic antibody discovery, and has established a sub-brand, RenBiologicsTM, to explore global partnerships for an off-the-shelf library of >400,000 fully human antibody sequences against approximately 1000 targets for worldwide collaboration. As of December 31, 2023, 103 therapeutic antibody and multiple clinical asset co-development/out-licensing/transfer agreements and 47 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, BioMiceTM, 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 IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA’s approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.   Biocytogen Contacts Antibody assets and platforms:  BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn Investor and Media Contact IDEAYA BiosciencesAndres Ruiz BrisenoSVP, Head of Finance and Investor Relations  investor@ideayabio.com