Latest news with #BCMAxCD3
Yahoo
03-07-2025
- Business
- Yahoo
Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma
Regeneron has won US Food and Drug Administration (FDA) approval for Lynozyfic (linvoseltamab-gcpt), marking the entry of another BCMAxCD3 bispecific drug in the multiple myeloma (MM) treatment space. Via an accelerated approval, Lynozyfic is indicated to treat adult patients with relapsed or refractory multiple myeloma (r/r MM) who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti‑CD38 monoclonal antibody. Regeneron's drug joins two fellow BCMAxCD3 bispecific antibodies already at market in the US – Johnson & Johnson's (J&J) Tecvayli and Pfizer's Elrexfio. Despite playing catch-up with its rivals, Regeneron's product offers a dosing advantage. Lynozyfic, which stimulates T-cells to recognise and destroy cancer cells, can be administered monthly after 24 weeks of therapy, depending on how well the patient responds. Meanwhile, J&J's Tecvayli can be given every two weeks in patients who show a good response after at least six months, and Elrexfio has the same dosing interval from week 25 onward. Lynozyfic also has a fortnightly dosing schedule for patients starting from week 14. Regeneron's Phase I/II Linker-MM1 trial (NCT03761108) with Lynozyfic demonstrated an objective response rate of 70% in 80 patients with MM. Tecvayli and Elrexfio had response rates of 63% and 56% in their respective trials, though direct comparisons are difficult to draw without a head-to-head study. Boxed warnings are common for T-cell directing drugs, and Lynozyfic is no different. It comes with one for cytokine release syndrome (CRS) and neurologic toxicity – including immune effector cell-associated neurotoxicity syndrome – in addition to warnings and precautions for infections, neutropenia, hepatotoxicity and embryo-foetal toxicity. It is unclear how Regeneron will challenge J&J and Pfizer in MM, who both reached the market first but have less convenient dosing options. Justin Holko, Regeneron's senior vice-president for global oncology/haematology commercial business, told Pharmaceutical Technology: 'We don't comment on sales figures or market share, but believe Lynozyfic has the potential to provide significant benefit to multiple myeloma patients, society and the healthcare system.' Tecvayli generated $549m in 2024 while Elrexfio secured $133m. MM is the second most common blood cancer, and revenue for these drugs is expected to skyrocket. Tecvayli, for example, is forecast to reach nearly $4.5bn in annual sales by 2031, according to GlobalData's Pharma Intelligence Center. Similar analysis predicts Lynozyfic will generate $707m in sales by that year, a lower figure primarily due to Regeneron's later market entry. International Myeloma Foundation's interim CEO Diane Moran said: '[Lynozyfic] provides appropriate multiple myeloma patients and their care teams with a novel patient-centric treatment option that includes a dosing schedule that can be adapted based on patient response. We appreciate Regeneron's continued research to further advance treatment for this community.' "Regeneron nabs dosing edge with Lynozyfic's FDA approval in multiple myeloma" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Associated Press
23-06-2025
- Business
- Associated Press
Harbour BioMed Enters Global Strategic Collaboration with Otsuka to Advance BCMAxCD3 Bispecific T-Cell Engagers
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 22, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ('Otsuka') to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area. 'We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs,' said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. 'This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice® and HBICE® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients' lives worldwide.' Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, 'Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients.' About HBM7020 HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed's fully human HBICE® bispecific technology and Harbour Mice® platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit . About Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit View original content to download multimedia: SOURCE Harbour BioMed
Yahoo
23-06-2025
- Business
- Yahoo
Harbour BioMed Enters Global Strategic Collaboration with Otsuka to Advance BCMAxCD3 Bispecific T-Cell Engagers
CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SHANGHAI, June 22, 2025 /PRNewswire/ -- Harbour BioMed (HKEX: 02142), a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology, today announced a global strategic collaboration with Otsuka Pharmaceutical Co., Ltd. ("Otsuka") to advance BCMAxCD3 bispecific T-cell engagers for the treatment of autoimmune diseases. Under the terms of the agreement, Otsuka is granted an exclusive license to develop, manufacture, and commercialize HBM7020, a BCMAxCD3 bispecific T-cell engager globally, excluding Greater China (Mainland China, Hong Kong, Macau and Taiwan). In return, Harbour BioMed will receive a total of $47 million in upfront and near-term payments. The company is also eligible for additional payments of up to $623 million upon the achievement of specified development and commercial milestones, as well as tiered royalties on future net sales. This strategic collaboration establishes a foundation for potential future partnerships between the two companies in the T-cell engager area. "We are delighted to collaborate with Otsuka, a global healthcare leader renowned for its innovative approach to addressing unmet medical needs," said Dr. Jingsong Wang, Founder, Chairman, and CEO of Harbour BioMed. "This collaboration underscores the strength of Harbour BioMed's proprietary Harbour Mice® and HBICE® technology platforms, which enable the rapid development of fully human bispecific antibodies with optimized safety and efficacy profiles. By leveraging our unique capabilities, we are well-positioned to advance next-generation biotherapeutics that can make a meaningful difference in patients' lives worldwide." Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, noted, "Otsuka is expanding our development pipeline in the autoimmune disease field by leveraging the antibody drug platform of our subsidiary Visterra, and the small molecule drug discovery platform of our subsidiary Jnana. HBM7020 is expected to demonstrate efficacy in a broad range of autoimmune diseases in which B cells play a major role in disease pathogenesis, and we hope to contribute further to the field of specialized autoimmune diseases and thereby benefit patients." About HBM7020 HBM7020 is a BCMAxCD3 bispecific antibody generated using Harbour BioMed's fully human HBICE® bispecific technology and Harbour Mice® platform. It is designed to crosslink target cells and T cells by binding to BCMA and CD3 on the cell surface, leading to potent T cell activation and targeted cell elimination. By incorporating dual anti-BCMA binding sites for enhanced cell targeting and monovalent-optimized CD3 activity to minimize cytokine release syndrome (CRS), HBM7020 has demonstrated potent cytotoxicity with broad therapeutic potential in both immunological and oncological diseases. In August 2023, HBM7020 obtained IND clearance from the National Medical Products Administration (NMPA) to commence a Phase I trial for cancer in China. About Harbour BioMed Harbour BioMed (HKEX: 02142) is a global biopharmaceutical company committed to the discovery and development of novel antibody therapeutics in immunology and oncology. The company is building a robust and differentiated pipeline through internal R&D capabilities, strategic global collaborations in co-discovery and co-development, and selective acquisitions. Harbour BioMed's proprietary antibody technology platform, Harbour Mice®, generates fully human monoclonal antibodies in both the conventional two heavy and two light chain (H2L2) format and the heavy chain-only (HCAb) format. Building upon HCAb antibodies, the HCAb-based immune cell engagers (HBICE®) bispecific antibody technology enables tumor-killing effects that traditional combination therapies cannot achieve. Additionally, the HCAb-based bispecific immune cell antagonist (HBICATM) technology empowers the development of innovative biologics for immunological and inflammatory diseases. By integrating Harbour Mice®, HBICE®, and HBICATM with a single B-cell cloning platform, Harbour BioMed has built a highly efficient and distinctive antibody discovery engine for developing next-generation therapeutic antibodies. For more information, please visit About Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical Co., Ltd. is a total healthcare company that focuses on each individual's potential to enhance their well-being. Our medical-related business provides treatments and diagnostics for both physical and mental health. Our nutraceutical business supports daily health maintenance and improvement. Otsuka's unique products and services are based on scientific evidence, under the guidance of our corporate philosophy: Otsuka-people creating new products for better health worldwide. For further information, please visit View original content to download multimedia: SOURCE Harbour BioMed Sign in to access your portfolio
Yahoo
04-06-2025
- Business
- Yahoo
Cullinan Therapeutics Licenses Rights to Velinotamig, a Clinical-Stage BCMA-Directed Bispecific T Cell Engager, from Genrix Bio for Development in Autoimmune Diseases
Advances Cullinan's leadership in T cell engager (TCE) development for autoimmune diseases with both a CD19 TCE and BCMA TCE in its pipeline Strengthens Cullinan portfolio of autoimmune programs with the opportunity to address a broader range of diseases while maintaining cash runway into 2028 Company to host conference call today at 4:30 pm ET CAMBRIDGE, Mass., June 04, 2025 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; 'Cullinan'), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced that it has entered into an agreement with Genrix Bio for a global (ex-Greater China), all indication, exclusive license to velinotamig, a BCMAxCD3 bispecific T cell engager. Velinotamig has demonstrated potential best-in-class efficacy at the Phase 2 target dose in nearly 50 patients with relapsed/refractory (r/r) multiple myeloma (MM). Cullinan will develop velinotamig in autoimmune diseases. 'We believe T cell engagers represent the next wave of innovation in autoimmune diseases, and we are excited to build upon our core T cell engager expertise and extensive KOL relationships to develop another potential best-in-class, clinical-stage program. Accumulated data supports BCMA as a promising target in autoimmune diseases, offering a precise and potentially disease-modifying approach by eliminating the entirety of the self-reactive plasma cells that result in certain autoimmune diseases, especially those diseases driven by long-lived plasma cells,' said Nadim Ahmed, Chief Executive Officer of Cullinan Therapeutics. 'Adding a BCMAxCD3 bispecific T cell engager to our pipeline complements our rapid global clinical development of CLN-978, enabling us to address the needs of more patients across a broader range of autoimmune diseases than with either molecule alone.' Genrix plans to initiate a Phase 1 study in China by the end of this year in patients with autoimmune diseases. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases. 'With our planned Phase 1 study of velinotamig in autoimmune diseases, we will be able to quickly leverage our experience in autoimmune diseases to complete the study in China expeditiously,' said Dr. Liu Zhigang, Chairman, Chief Executive Officer, and Chief Science Officer of Genrix Biopharmaceutical 'Cullinan is a proven leader in developing T cell engagers and we are confident in the company's ability to carry the program forward to address the needs of patients with autoimmune diseases.' Under the agreement, Cullinan will pay Genrix Bio an upfront license fee of $20 million for exclusive rights to develop and commercialize velinotamig in all disease areas globally outside of Greater China. In the future, Genrix will also be eligible to receive up to $292 million in development and regulatory milestones plus up to an additional $400M in sales-based milestones, as well as tiered royalties from mid-single digits up to the mid- teens on potential ex-Greater China net sales. Importantly, with refinement of the clinical oncology pipeline, Cullinan reiterates its existing guidance to have cash resources into 2028 based on its current operating plan. Cullinan Therapeutics Conference Call Information Cullinan Therapeutics will host a conference call today, June 4, at 4:30 pm ET. Investors, analysts and the general public are invited to listen to a live webcast of the call. A link to join the call and to find related materials will be available under the Events and Presentations section of the Company's investor relations website at About Velinotamig Velinotamig is a bispecific antibody that can simultaneously bind to the BCMA and CD3 antigens, redirecting cytotoxic T cells to target BCMA-expressing cells. Velinotamig has high affinity for BCMA and lower affinity for CD3. Affinity for BCMA is two orders of magnitude higher than for CD3, ensuring that the bispecific antibody recruits and activates T cells while minimizing non-specific T cell activation and reducing the toxicity mediated by the CD3 antibody. Genrix Bio received approval from the National Medical Products Administration (NMPA) in January 2022 to conduct clinical trials for the indication of multiple myeloma. Velinotamig received Breakthrough Therapy Designation by the Center for Drug Evaluation (CDE) for the treatment of relapsed and refractory multiple myeloma. About Cullinan Therapeutics Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company dedicated to creating new standards of care for patients. Cullinan has strategically built a diversified portfolio of clinical-stage assets that inhibit key drivers of disease or harness the immune system to eliminate diseased cells in both autoimmune diseases and cancer. Cullinan's portfolio encompasses a wide range of modalities, each with the potential to be best and/or first in class. Anchored in a deep understanding of oncology, immunology, and translational medicine, we create differentiated ideas, identify the most appropriate targets, and select the optimal modality to develop transformative therapeutics across a wide variety of autoimmune and cancer indications. We push conventional boundaries from candidate selection to differentiated therapeutic, applying rigorous go/no go criteria at each stage of development to fast-track only the most promising molecules to the clinic and, ultimately, commercialization. With deep scientific expertise, our teams exercise creativity and urgency to deliver on our promise to bring new therapeutic solutions to patients. Learn more about Cullinan at and follow us on LinkedIn and X. About Genrix Bio Genrix Bio (Stock Code: 688443), founded in 2015, is an innovative biopharmaceutical company driven by advanced antibody drug discovery technology to address critical clinical needs. With antibody drug R&D centers in Beijing, Shanghai, and Chongqing, we are committed to the development of monoclonal and bispecific antibodies for autoimmune diseases, infectious diseases, and oncology. Our capabilities span across antibody molecular discovery, process development and quality research, clinical trials, and large-scale commercialization. Upholding the philosophy of "to deliver affordable and reliable new medicines for patients," we strive to address the clinical needs of a wider population. Learn more about Genrix Bio at Forward Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding Cullinan's beliefs and expectations regarding the potential benefits of, and plans relating to, the license agreement between Cullinan and Genrix Bio, including anticipated milestone payments under the license agreement, as well as royalties on net sales; the therapeutic potential of velinotamig; the timing of planned clinical development of velinotamig; our expectations regarding our cash resources; and other statements that are not historical facts. The words 'anticipate,' 'believe,' 'continue,' 'could,' 'estimate,' 'expect,' 'hope,' 'intend,' 'may,' 'plan,' 'potential,' 'predict,' 'project,' 'target,' 'should,' 'would,' and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management's current expectations and beliefs of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: uncertainty regarding the timing and results of regulatory submissions; the success of our clinical trials and preclinical studies; risks related to our ability to protect and maintain our intellectual property position; risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption 'Risk Factors' in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither Cullinan nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Contacts: InvestorsNick Smith+1 401.241.3516nsmith@ Media Rose Weldon+1 215.801.7644rweldon@
