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Biocytogen
Innovative technologie drives the R&D of new drugs
Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMiceTM HiTS Platform).We aspire to accelerate innovation through external partnerships.
Pipeline
kr To streamline the entire drug development process
kr We are committed to working with global partners to develop innovative antibody drugs to benefit patients as soon as possible.
YH003
Phase ll
CD40 mAb- YH003
PD-1+ chemo
Pancreatic ductal adenocarcinoma (1L&2L)
YH003은 면역세포 표면의 TNF receptor superfamily중 하나인 CD40을 타겟으로 하는 새로운 인간화 항체입니다. 이는 CD40 수용체의 신호통로를 특이적으로 활성화시켜, 수지상세포등의 선천적인 면역 세포를 활성화하고, 항종양 T세포의 효력과 활성을 증대시킵니다. 저희 바이오사이토젠은 이전까지의 in vitro 약효 스크리닝 모델의 극복할 수 없는 단점을 고려하여, YH003 개발 프로젝트에서는 규모화된 in vivo 약효 스크리닝과 체내 독성 분석 모델을 채용하여 후보물질을 선별하는 전략을 사용하였습니다.
YH001
Phase l
CTLA-4 mAb- YHO01
Tracon
Sarcoma
YH001은 CTLA-4을 타겟으로 하는 단일클론항체로서, 암세포에 대한 신체의 면역응답성을 높이고, 종양미세환경 중에서의 Treg세포의 감소를 이끌어내어, 다양한 종양치료의 목적을 달성할 수 있도록 합니다. 체내의 항종양 활성을 억제하는 신호를 차단하여, 환자의 종양에 대한 면역응답성을 개선하는 치료법은 현재 가장 유망한 면역요법으로서 인식되고 있습니다.
YH002
Phase l
OX40 mAb- YHO02
YH001
Solid tumors
전임상 연구 데이터에서 나타나듯이, OX40를 타겟으로 하여 활성화시키는 YH002 단일클론항체는 OX40L과 경쟁적으로 OX40에 결합하여, OX40/OX40L 및 연관된 신호 통로를 활성화시켜, T세포의 증식과 활성화를 촉진합니다. YH002는 또한 독특한 항원결합부위를 갖고 있어, 높은 면역활성화 작용과 안전성을 가지고 있습니다.
YH004
Phase l
4-1BB - YH004
Mono
Solid tumor + Hematological malignancy
YH004은 면역세포 표면의 TNF receptor superfamily중 하나인 4-1BB를 타겟으로 하는 새로운 인간화 항체로서 독특하게도 IgG1 isotype을 베이스로 하고 있습니다. 4-1BB는 주로 T세포, 수지상세포, 단핵세포, B세포, 비만세포, NK세포와 호중성 과립구에서 발현됩니다.
YH008
Phase l
PD1 x CD40
Mono
Solid tumors
YH008 is an anti-PD-1 x CD40 bispecific antibody for the treatment of solid tumors. YH008 activates CD40 while simultaneously inhibiting PD-1. The results of in vitro and in vivo experiments show that the activation of the CD40 pathway by YH008 depends on the cross-linking effect of PD-1, avoiding non-specific activation outside the tumor microenvironment.
Antibody Discovery Platforms
Using its proprietary RenMice® platforms
Based on the RenMice (RenMab, RenLite and RenNano) platforms, Biocytogen has established six fully human antibody technology platforms to meet multiple targets and multiple proprietary forms of antibody drug development
kr Collaborations
kr Leveraging strengths offering flexibilities pursuing win-win
50therapeutic antibody co-development/out-licensing/transfer agreements kr
42target-nominated RenMiceTM licensing projects
Biocytogen Enters into Antibody Evaluation, Option and License Agreement with Myricx for ADC Development
Beijing, China, September 7, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, today announces an antibody evaluation, option and license agreement with Myricx Bio (‘Myricx’), a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs). Under the terms of the agreement, Myricx will provide its proprietary linker and payload and Biocytogen will conjugate them with its RenMice®-derived fully human antibodies to make ADCs. Biocytogen will carry out feasibility tests for these ADCs as CRO services, and upon option exercise, Myricx will be responsible for further development and commercialization. Biocytogen will receive an upfront payment and, subject to exercise Biocytogen will be eligible to receive ongoing development and commercialisation milestone payments, as well as single-digit royalties on net sales.In this project, the antibodies developed by Biocytogen were not only screened by its high specificity, cross-species reactivity, high affinity and good developabilities, but also by its high internalization activity specifically for ADC uses.NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is developing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types."Thanks to Myricx recognition of our antibody assets, preclinical discovery expertise and CMC capabilities,” said by Dr. Yuelei Shen, President and CEO of Biocytogen. “Myricx is a leading expert in NMTi payloads and we believe that the combination of both companies’ strengths will result in ADC drugs with first-in-class and best-in-class potential.”Myricx CEO Dr Robin Carr said: “We are delighted to have reached this agreement with Biocytogen with ground-breaking technology to develop novel antibodies for use in drug development. We believe that the combination of its antibody with our novel NMTi-based selective cytotoxic payloads will enable us to develop best-in-class ADCs to meet significant clinical needs in oncology. NMT inhibitors represent a novel class of ADC payloads that can be exploited as targeted therapies in cancer. Based on our positive proof of concept data we believe that ADC-NMTi offers huge potential for selective cancer cell killing via its unique mechanism of action.”About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab®/RenLite®/RenNano® mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMice® HiTS Platform). As of June 30, 2023, 50 therapeutic antibody co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. 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 Myricx Bio - www.myricxbio.com Myricx Bio (“Myricx”) is a UK biotech company focused on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs), based on inhibitors of N-myristoyltransferases (NMT) for the treatment of cancer.NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is advancing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types.Based in London, Myricx is a spin out from Imperial College London and the Francis Crick Institute with investment from Sofinnova Partners and Brandon Capital Partners.Myricx Bio is the trading name of Myricx Pharma Limited.Follow us on LinkedInBiocytogen Contacts Antibody assets and platforms: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
Eucure and Syncromune Establish Technology Transfer Agreement for YH002 (OX40 Antibody) and Multiple Other Clinical-Stage Antibodies
BEIJING, China, August. 30, 2023 – Eucure (Beijing) Biopharma Co., Ltd. (“Eucure”), a wholly owned subsidiary of Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”), announced today that the company has entered into a technology transfer agreement with Syncromune, Inc. (“Syncromune”), a US-based clinical-stage biopharmaceutical company focused on the development of SYNC-T™, a platform technology designed to synchronize in situ neoantigen T cell education and immunostimulation, for the development and clinical supply of certain compounds. This agreement is an expansion to the license agreement executed in 2022 where Biocytogen/Eucure licensed worldwide rights for YH002 (anti-OX40 antibody) and other active ingredients to Syncromune for the exclusive development and commercialization of intratumoral immunotherapy based on SYNC-T™ technology. Under the newly signed agreement, Syncromune will be granted an option right and upon option-exercise, Eucure will transfer technology to Syncromune for the manufacture of YH002 and other clinical-stage antibodies currently being evaluated for intratumoral immunotherapy based on SYNC-T™ technology. Under the newly signed agreement, Syncromune will pay Eucure an upfront fee and, upon option-exercise, Eucure is entitled to receive milestone fees.Currently, Syncromune’s SYNC-T investigational therapy is being used in Phase 1 investigator initiated trials and has produced preliminary clinical data supporting further development of the candidates.“We are pleased to expand what has been a fruitful collaboration, to date, with Syncromune” said Yuelei Shen, Ph.D., President and CEO of Biocytogen. “As we continue identifying novel therapeutic antibodies suitable for development into tumor vaccine and other modalities, we look forward to establishing more strategic partnerships to advance the field of immunotherapy.”“We are excited that SYNC-T has shown initial anti-tumor activity based on the preliminary Phase 1 clinical data,” said Eamonn Hobbs, President and Chief Executive Officer of Syncromune. “We believe this technology transfer agreement may help accelerate our FDA IND filling process, and we are optimistic that our proprietary SYNC-T investigational therapy may have the potential to provide a treatment benefit to cancer patients.”About YH002 YH002 is a recombinant anti-OX40 humanized IgG1 agonistic antibody. The specificity, safety, and anti-cancer efficacy of YH002 have been evaluated in a comprehensive panel of pre-clinical studies. A first-in-human (FIH), multicenter, open-label, Phase 1 dose-escalation study is currently underway in Australia to evaluate the safety, tolerability, and pharmacokinetics and determine the MTD/RP2D of YH002 in adult subjects with advanced solid malignancies.About SYNC-T™ Syncromune® is developing SYNC-T™, a disruptive personalized in situ platform drug immunotherapy designed to educate T cells and stimulate the immune system to treat metastatic solid tumors where other therapies have failed. SYNC-T utilizes a combination approach of tumor activation and targeted delivery, aiming to synchronize the timing and location of tumor antigen release with the functional activation of immune cells. To achieve tumor activation, a portion of a target tumor is lysed to generate immunogenic cell death and the release of Damage Associated Molecular Patterns (DAMPs) and tumor antigens, changing the tumor microenvironment by creating an in situ vaccine. The second component of the platform, targeted delivery, involves the intratumoral infusion of a proprietary fixed-dose combination drug with 4 active ingredients into the lysed portion of the tumor. This is designed to activate the immune system and combat immune suppression, which may result in patient-specific T cell education. The expansion of anti-cancer specific T cells can enable the immune system to recognize and destroy cancer in the treated tumor as well as in metastases throughout the body.About Eucure As a wholly owned subsidiary of Biocytogen, Eucure Biopharma undertakes the mission of clinical development for Biocytogen’s R&D pipelines. Relying on a strong clinical development team and extensive clinical development experience, Eucure Biopharma focuses on antibody drug therapy for oncology and other indications. The company has established a product pipeline for more than 10 targets, with 1 asset in Phase 2 MRCTs, 3 assets in Phase 1 clinical trials and 1 asset having received IND approvals. For more information, please visit www.eucure.com.About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab®/RenLite®/RenNano® mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMice® HiTS Platform). As of June 30, 2023, 50 therapeutic antibody co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. 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 Syncromune Syncromune is a privately held, clinical-stage biopharmaceutical company dedicated to the development of an in situ platform drug technology optimized for solid tumor cancers that aims to achieve the CAR T like efficacy demonstrated in liquid tumors.  The company is currently developing SYNC-T™, a novel platform technology that uses a drug/device combination approach. The platform is designed to achieve personalized T cell education and to enable the immune system to recognize and attack cancer throughout the body.  The first 2 candidates, SV-101 and SV-102 are currently in Phase 1 trials. Syncromune is headquartered in Fort Lauderdale, FL, USA. For more information, please visit www.syncromune.com.Biocytogen and Eucure Contacts: Antibody assets and platforms: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn Syncromune Contact: Danielle HobbsEVP, Corporate Communicationsmedia@syncromune.com
Biocytogen Pharmaceuticals Enters Into License Agreement With Pheon Therapeutics
Exclusive License Agreement for an Oncological Target Antibody to Develop Best-In-Class ADC Beijing, China and London, UK, July 5, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, today announces an antibody license agreement with Pheon Therapeutics (Pheon), a leading Antibody-Drug Conjugate (ADC) specialist developing next generation ADCs for a wide range of hard-to-treat cancers. Under the terms of the agreement, Pheon will develop and commercialize an antibody developed using Biocytogen’s proprietary RenMiceTM platforms. Biocytogen will receive an upfront payment and is eligible for development and commercial milestone payments, as well as single-digit royalties on net sales. Biocytogen’s proprietary RenMiceTM platforms feature the complete replacement of human antibody variable genes in situ. The platforms together with target knock-out strategy empower the generation of fully human antibodies with low immunogenicity, great diversity, species cross-reactivity, high affinity and good developability. RenMice platforms and derived antibodies have been recognized by many renowned biotech and biopharmaceutical companies.The new agreement expands Pheon’s ADC pipeline which boasts first-in-class and best-in-class ADCs to meet significant unmet clinical needs in oncology. Pheon launched in March 2022 with a $68 million Series A financing led by a strong leadership team of specialists in targeted oncology therapies and ADCs.Dr. Yuelei Shen, President and CEO of Biocytogen, said: "We are glad to collaborate with Pheon Therapeutics. Using RenMiceTM, we have launched Project Integrum which aims to develop fully human therapeutic antibody molecules for 1000+ targets for the development of drugs in different modalities. The combination of our strengths in fully human antibody discovery with Pheon’s strengths in ADC technologies may accelerate the generation of differentiated novel therapeutics that can bring benefits to patients.”Bertrand Damour, Chief Executive Officer of Pheon Therapeutics, said: "This license agreement represents a significant expansion of Pheon’s pipeline, and it enhances our ability to successfully develop the next generation of ADCs. Biocytogen is a fantastic partner with groundbreaking technology that is well suited to our needs. We look forward to working with them and helping to find powerful therapies that can address the significant unmet patient need in solid tumours across a broad range of hard-to-treat cancers.” Biocytogen’s Contacts Antibody assets and antibody discovery platforms: BD-Licensing@biocytogen.comMedia: pr@bbctg.com.cnPheon’s Optimum Strategic Communications Nick Bastin, Hana Malik, Zoe Bolt, Elena BatesTel: +44 (0) 203 882 9621Email: Pheon@optimumcomms.comAbout Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMabTM/RenLite®/RenNanoTM mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMiceTM HiTS Platform). As of May 31, 2023, 46 therapeutic antibody co-development/out-licensing/transfer agreements and 20 RenMiceTM licensing agreements have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. 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 Pheon Therapeutics Pheon Therapeutics is an Antibody Drug Conjugate (ADC) specialist developing a pipeline of monotherapies for novel targets and/or with novel payloads. ADCs offer the potential to treat solid tumors and liquid cancers that have not responded to other treatments. Pheon’s lead program is a first-in-class ADC against a novel target that is highly expressed in solid tumors across a broad range of hard-to-treat cancer types. Pheon is backed by specialist healthcare investors Atlas Venture, Brandon Capital, Forbion and Research Corporation Technologies (RCT). Pheon has a world class, proven leadership team that brings together the best of ADC engineering, clinical and managerial expertise and track record. For further information, please visit www.pheontx.com
Biocytogen News
Biocytogen Officially Launches RenMice Series
Fully Human Antibody and TCR Mouse Models Showcase Biocytogen's Capabilities to Innovate the Discovery of Novel Biologic Drugs Beijing, China, September 15, 2023 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315) officially announces the RenMice® series, which includes a collection of independently developed, fully human antibody mice and TCR mice with proprietary intellectual property. The term "Ren", defined as “human”, is derived from the Chinese pinyin for "人" (rén), which integrates Eastern cultural elements and represents Biocytogen's commitment to developing innovative technologies that advance the discovery, development and delivery of novel therapeutics, ultimately benefiting human health. The RenMice® series encompasses five strains of fully human antibody/TCR mice: RenMab®, RenLite®, RenNano®, RenTCR™, and RenTCR-mimic™. These mice provide robust support for the discovery of fully human monoclonal antibodies, bispecific antibodies, bispecific antibody-drug conjugates (BsADCs), nanobodies, fully human T-cell receptors (TCRs), and TCR-mimic antibodies. Biocytogen is also generating more strains of fully human RenMice for MHC cluster genes, NK cell cluster genes, and other gene clusters for diverse drug development purposes, which will be integrated into the RenMice portfolio upon successful development.Since their successive release in 2019, Biocytogen’s RenMice series has received global recognition in the biopharmaceutical and biotechnology field. As of June 30, 2023, Biocytogen has entered into RenMice licensing agreements with 20 biopharmaceutical/biotechnology companies worldwide; 42 target-nominated antibody development projects have been initiated. Additionally, 50 antibody drug co-development/out-licensing/transfer agreements have been established with partners worldwide. As Biocytogen’s Project Integrum has completed 900+ target-specific antibody discovery projects and identified 400,000-500,000 antibody molecules, the number of external therapeutic antibody co-development/out-licensing/transfer agreements are expected to increase significantly. The successful development of new RenMice platforms will further enhance Biocytogen's technical capabilities in novel drug discovery and accelerate the development of new therapeutics in collaboration with global partners. RenMice Series and Their Drug Discovery ApplicationsRenMab Mice: A Leading Model for Fully Human Monoclonal Antibody Discovery Biocytogen developed RenMab mice using its proprietary Size-Unlimited Precise Chromosome Engineering (SUPCE) technology, which allowed for replacement of the murine antibody heavy and light chain variable region genes with the corresponding human counterparts in situ. Thus, RenMab is one of the few mouse models available that has the complete repertoire of human antibody variable region genes. Following immunization, RenMab mice generate diverse fully human monoclonal antibody sequences targeting various epitopes with affinity similar to wild-type mice. Importantly, these antibodies possess excellent specificity and physicochemical properties and do not require additional in vitro humanization, leading to substantial time and cost savings in downstream development, and an elevated likelihood of successful clinical translation. As a fully human antibody mouse model developed independently in China, RenMab received Chinese patent authorization in 2023.RenLite Mice: A Common Light Chain Model for the Discovery of Fully Human Bispecific Antibodies and Bispecific ADCs Similar to RenMab mice, RenLite mice feature the complete in situ replacement of human antibody heavy chain variable region genes. Unlike RenMab mice, RenLite mice possess a single human antibody light chain variable region gene. As a result, antibodies generated by RenLite mice share a common light chain, effectively reducing heavy and light chain mismatching when assembled into bispecific antibodies (BsAbs). By incorporating Knobs-into-Holes (KIH) technology, the mismatch rate of heavy-heavy chain is also significantly reduced, collectively resulting in an assembly success rate of over 95%, significantly reducing the complexity of the CMC process. BsAbs assembled from RenLite-derived antibodies resemble monoclonal antibodies and exhibit favorable physicochemical properties, and can be further developed into bispecific ADCs.RenNano Mice: A Fully Human Heavy Chain-Only Model for Nanobody Discovery RenNano mice were developed via genetic modification of the antibody constant region in RenMab mice. Following immunization, RenNano mice produce fully human heavy-chain-only antibodies (HCAbs) that can bind to antigens without a light chain. RenNano-derived HCAbs possess diverse CDR3 sequences and can recognize a variety of epitopes with excellent specificity and affinity. HCAbs derived from RenNano mice demonstrate robust biological function both in vitro and in vivo, making them suitable for various drug modalities, including bispecific antibodies, multispecific antibodies, and cell therapies. Using RenNano mice, Biocytogen initiated the "Nano 100 Project" in February 2023 to discover fully human therapeutic nanobodies against over 100 different targets.RenTCR Mice: A Novel Fully Human TCR Discovery Platform Developed using SUPCE technology, RenTCR mice can directly produce fully human TCR sequences after immunization. These mice lack tolerance to foreign antigens, such as those from humans or viruses, enabling the generation of high-affinity TCRs targeting human TAAs and viral antigens. These TCRs use human genes to avoid immunogenicity concerns. Furthermore, they do not require further mutagenesis to improve binding affinity, reducing the risk of introducing off-target toxicity. Using RenTCR mice for human TCR discovery does not require patient samples, unlike traditional tumor-infiltrating lymphocyte (TIL) therapy, and can generate a more diverse range of TCR sequences than TILs. The successful launch of RenTCR mice will accelerate collaborations with research institutions focused on therapeutic TCR molecules, including TCR-T cell therapy companies.RenTCR-mimic Mice: Models for Fully Human TCR-mimic Antibody Discovery RenTCR-mimic mice were developed via humanization of class I MHC molecules in RenMab and RenLite mice. Immunization of RenTCR-mimic mice with pHLA complexes yields TCR-mimic antibodies that specifically target pHLA without recognizing human HLA molecules. Unlike traditional antibodies that can only recognize cell surface or extracellular antigens, antibodies generated by RenTCR-mimic mice can target intracellular antigens by recognizing pMHC complex on the cell surface, significantly expanding the range of druggable targets. Combined with its high-throughput antibody screening platform, Biocytogen can rapidly identify highly specific and high-affinity TCR-mimic antibodies, overcoming limitations associated with low affinity and tumor immune escape caused by endogenous TCRs. Fully human TCR-mimic antibody sequences can be used in the development of T-cell engagers and CAR-T therapies. Currently, TCR-mimic antibodies against over 10 intracellular TAAs, CTAs, mutated antigens, and viral antigens have been developed.RenMice KO Mice: Specialized Discovery for Challenging Targets and Project Integrum Due to the presence of immune tolerance, it is difficult to use conventional mouse immunization methods to generate antibodies targeting antigens with high homology between human and mouse. Knocking out the target gene in RenMice can reduce immune tolerance to the antigen, making it possible to obtain high-affinity, highly specific fully human antibodies against both homologous and heterologous regions following immunization. This strategy can increase antibody diversity against challenging targets like GPCRs and highly homologous targets, thereby improving screening success rates. It also increases the chances of obtaining species cross-reactive antibodies, facilitating downstream multi-species in vivo efficacy and safety evaluation. Over the past three years, Biocytogen’s Project Integrum has been utilizing RenMice KO mice to develop fully human antibody drugs against over 1,000 different targets. This initiative has yielded numerous fully human antibodies capable of cross-species recognition and established an antibody library consisting of 400,000 to 500,000 antibody sequences, which can ultimately help partners significantly improve project predictability, reduce development time and cost, and increase the success rate of drug development.About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab®/RenLite®/RenNano® mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMice® HiTS Platform). As of June 30, 2023, 50 therapeutic antibody co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. 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.Biocytogen Contacts RenMice series and antibody assets: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
2023.09.15
Biocytogen Enters into Antibody Evaluation, Option and License Agreement with Myricx for ADC Development
Beijing, China, September 7, 2023 - Biocytogen Pharmaceuticals (Beijing) Co., Ltd. ("Biocytogen", HKEX: 02315), a global biotech company focusing on the discovery of novel antibody therapeutics, today announces an antibody evaluation, option and license agreement with Myricx Bio (‘Myricx’), a UK biotech company focusing on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs). Under the terms of the agreement, Myricx will provide its proprietary linker and payload and Biocytogen will conjugate them with its RenMice®-derived fully human antibodies to make ADCs. Biocytogen will carry out feasibility tests for these ADCs as CRO services, and upon option exercise, Myricx will be responsible for further development and commercialization. Biocytogen will receive an upfront payment and, subject to exercise Biocytogen will be eligible to receive ongoing development and commercialisation milestone payments, as well as single-digit royalties on net sales.In this project, the antibodies developed by Biocytogen were not only screened by its high specificity, cross-species reactivity, high affinity and good developabilities, but also by its high internalization activity specifically for ADC uses.NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is developing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types."Thanks to Myricx recognition of our antibody assets, preclinical discovery expertise and CMC capabilities,” said by Dr. Yuelei Shen, President and CEO of Biocytogen. “Myricx is a leading expert in NMTi payloads and we believe that the combination of both companies’ strengths will result in ADC drugs with first-in-class and best-in-class potential.”Myricx CEO Dr Robin Carr said: “We are delighted to have reached this agreement with Biocytogen with ground-breaking technology to develop novel antibodies for use in drug development. We believe that the combination of its antibody with our novel NMTi-based selective cytotoxic payloads will enable us to develop best-in-class ADCs to meet significant clinical needs in oncology. NMT inhibitors represent a novel class of ADC payloads that can be exploited as targeted therapies in cancer. Based on our positive proof of concept data we believe that ADC-NMTi offers huge potential for selective cancer cell killing via its unique mechanism of action.”About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab®/RenLite®/RenNano® mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMice® HiTS Platform). As of June 30, 2023, 50 therapeutic antibody co-development/out-licensing/transfer agreements and 42 target-nominated RenMice® licensing projects have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. 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 Myricx Bio - www.myricxbio.com Myricx Bio (“Myricx”) is a UK biotech company focused on the discovery and development of a completely novel class of selective cytotoxic payloads for antibody drug conjugates (ADCs), based on inhibitors of N-myristoyltransferases (NMT) for the treatment of cancer.NMT is an enzyme that adds a specific lipid modification to a number of protein targets key to cancer cell survival. Myricx is advancing a pipeline of ADCs to address serious unmet needs in oncology based on its NMT inhibitor (NMTi) payload chemistry platform and has demonstrated excellent preclinical efficacy and safety across multiple solid tumour associated antigens and cancer cell types.Based in London, Myricx is a spin out from Imperial College London and the Francis Crick Institute with investment from Sofinnova Partners and Brandon Capital Partners.Myricx Bio is the trading name of Myricx Pharma Limited.Follow us on LinkedInBiocytogen Contacts Antibody assets and platforms: BD-Licensing@biocytogen.com Media: pr@bbctg.com.cn
2023.09.07
Biocytogen Establishes Two Business Divisions To Distinguish Preclinical Models and Services (BioMice) from Antibody Drug R&D
Beijing, China, August 31, 2023 – Biocytogen Pharmaceuticals (Beijing) Co., Ltd. (“Biocytogen”, HKEX: 02315) today announces the official formation of two major business divisions to represent the company’s product, service, and asset portfolio. Over the last decade, Biocytogen has developed several technology platforms to streamline the entire drug development process, including generation of specialized (humanized) animal and cell model products, preclinical pharmacology evaluation, and most recently, fully human antibody discovery and clinical development. With the company’s expanding initiatives focused on antibody drug development, the company has officially established two business divisions, with one focusing on animal models and preclinical services, and the other focusing on the discovery and development of novel antibody-based drugs for out-licensing and partnerships. Biocytogen’s preclinical platforms include custom gene-editing services, generation of off-the-shelf humanized and/or immunodeficient animal and cell model products, and preclinical pharmacology services. These innovative products and services enable efficient evaluation of novel anti-human therapeutics, especially biologics. To better showcase these business lines, and to enhance the brand image of the company’s preclinical models and services, the company will integrate these major platforms under the “BioMiceTM” sub-brand. As one of the leaders in humanized animal model production, the establishment of the BioMice sub-brand for Biocytogen’s preclinical model and service division will enhance global awareness of the central role of the company’s animal model products in biologic drug discovery.Biocytogen’s other business division, which harnesses its proprietary fully human antibody RenMiceTM (RenMab®, RenLite®, RenNano®, RenTCRmTM, RenTCRTM) platforms to discover novel antibody therapeutics for out-licensing and/or co-development, will be announced at a later date.BioMice Introduction With these divisions in place, BioMice products and services will encompass the following:Gene editing services: Biocytogen’s gene targeting team provides quality gene-editing services to deliver custom BioMice strains to clients, using ESC/HR (ESC, Embryonic Stem Cell; HR, Homologous Recombination) and EGETM (Extreme Genome Editing) technologies. Several years ago, the company independently established stem cells on the C57BL/6 background and developed a culture system to keep them totipotent after nearly 100 passages, so that they could be more easily used to obtain adult mice. EGETM is a CRISPR/Cas9-based gene-editing technology that increases the efficiency of gene knock-in by nearly 20-fold after independent R&D and optimization. In addition, this technology enables the precise editing of DNA sequences at almost any genomic site. To date, approximately 4300 customized gene editing projects have been delivered to customers.Gene-edited animal and cell model R&D/production/sales: To date, more than 2900 gene-edited BioMice animal and cell models have been developed for preclinical drug discovery and pharmacology evaluation, and it is expected that 200-300 new models will enter the market each year. These models can be divided into 3 categories:1)Animal and cell models with humanized drug targets, including immune checkpoints (such as PD-1 and CD3E), cytokines and/or cytokine receptors (such as IL-4/IL-4R and IL-33), GPCRs (such as CCR8), TAAs (such as HER2 and TROP2), etc.2)Severely immunodeficient B-NDG® mice and second-generation B-NDG® models for human immune system reconstitution, including B-NDG B2m KO mice plus for prolonged experiments by delaying the onset of GvHD, B-NDG hIL15 mice for better human NK cell reconstitution, and B-NDG hTHPO mice that do not require radiation;3)Target gene knock-out mice, disease models, aged mice and other tool mice.Preclinical pharmacology services: Taking advantage of the company’s leading position in the generation of innovative animal models, Biocytogen established comprehensive in vivo and in vitro pharmacology platforms to perform drug efficacy evaluations, pharmacodynamic (PD) analysis, pharmacokinetic (PK) analysis, biomarker analysis, and pathology and toxicity analysis in large scale. The company’s pharmacology team has developed multiple disease models, including tumor models (syngeneic models, cell line-derived xenograft (CDX) and patient-derived xenograft (PDX) models, and spontaneous models), metabolic disease models (NASH, obesity and diabetes, atherosclerosis, chronic kidney disease, fibrosis, etc.), and inflammatory and autoimmune disease models (asthma, rheumatoid arthritis, atopic dermatitis, psoriasis, SLE, MS, IBD, etc.) for preclinical drug efficacy evaluations. So far, Biocytogen has become a long-term partner for more than 400 biotech and biopharmaceutical companies around the world; more than 2000 pharmacological evaluation projects have been completed.Animal facility: Biocytogen has a 55,000-sqm SPF facility in Haimen (Jiangsu), China, with smaller facilities in Daxing (Beijing), China and Boston (U.S.). The total capacity is more than 150,000 cages, including 30,000 cages in 300 isolators and 120,000 cages in IVCs. The maximum supply capacity of the facility is 800,000 genetically modified mice annually. Through implementing strict scientific and standard operating procedures, and a highly efficient facility management system, the animal centers adhere to strict standards for critical quality-control testing to identify microbial contamination. Haimen Animal Center has been AAALAC accredited since 2016, and Beijing Animal Center received AAALAC accreditation in 2021; the Boston satellite facility adheres to the same standards.With a wide range of animal strains, large-scale supply capabilities, and high-quality service capabilities, BioMice products and services have been recognized by many research institutes and biotech/biopharmaceutical companies globally. This includes almost all MNCs, leading biotech and biopharmaceutical companies in China, and many renowned research institutes, with models published in top-tier research journals. For more information about how BioMice products and services can support your research, please contact us at info@biocytogen.com.About Biocytogen Biocytogen (HKEX: 02315) is a global biotechnology company that drives the research and development of novel antibody-based drugs with innovative technologies. Using its proprietary RenMab®/RenLite®/RenNano® mice platforms for fully human monoclonal, bispecific/multispecific antibody and nanobody development, Biocytogen has integrated its in vivo drug efficacy screening platforms and strong clinical development expertise to streamline the entire drug development process. Biocytogen is undertaking a large-scale project to develop first-in-class and/or best-in-class antibody drugs for more than 1000 targets, known as Project Integrum (RenMiceTM HiTS Platform). As of June 30, 2023, 50 therapeutic antibody co-development/out-licensing/transfer agreements and 42 target-nominated RenMiceTM licensing projects have been established worldwide, including several partnerships with multinational pharmaceutical companies (MNCs). Biocytogen's pipeline is comprised of 10 core assets, with partnerships established for multiple clinical assets. The company’s sub-brand, BioMice, encompasses the generation and distribution of animal model products, as well as preclinical pharmacology and gene-editing services for clients around the globe. 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.Contacts BioMice Inquiries: info@biocytogen.com Antibody R&D Inquiries: BD-Licensing@biocytogen.com
2023.08.31