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15
2024-03

Biotheus Expanded Their Partnership with Hansoh Pharma for Developing EGFR/cMET Bispecific Antibody-Drug Conjugates

Time of issue: : 2024-03--15
ZHUHAI, China, March 15, 2024 /PRNewswire/ -- On March 14, 2024, Biotheus Inc. (Biotheus), a clinical-stage biotech company focusing on the discovery and development of biologics for oncology and inflammatory diseases, and Hansoh Pharmaceutical Group Co., Ltd. (Hansoh Pharma,03692.HK), China's leading innovation-driven pharmaceutical company, jointly announced that the two parties will further expand their strategic collaboration, following their current partnership since 2022. Biotheus will grant Hansoh Pharma a license to use the proprietary anti-EGFR/cMet bispecific antibody PM1080/HS-20117 independently developed by Biotheus for the development of antibody-drug conjugates products (ADC Product). Under the terms of the agreement, Hansoh Pharma will obtain exclusive worldwide rights from Biotheus to use PM1080/HS-20117 for the development, production, and commercialization of ADC Product, with the right of sublicense. Biotheus will be eligible to receive up to 5 billion RMB in upfront and success-based milestones for ADC Product, as well as tiered royalties based on global net sales from Hansoh Pharma. PM1080/HS-20117 is a 1+1 heterodimeric structure of EGFR/cMet bispecific antibody, which can inhibit the growth and survival of tumors by specifically targeting the tumor antigens EGFR and cMet, and is currently in phase I clinical trials. "This is the second collaboration between Hansoh and Biotheus. We really appreciate Hansoh's confidence in the potential of PM1080", said Mr. Xiaolin Liu, Co-founder, Chairman and Chief Executive Officer of Biotheus. "Bispecific ADCs have a potential advantage for better tumor enrichment, overall efficacy and safety. Hansoh develops an outstanding ADC platform, and this collaboration will facilitate the synergy between Hansoh's ADC expertise and Biotheus' antibody capabilities. Through this collaboration, we hope to develop a novel EGFR/cMet bispecific ADC with better efficacy and safety for cancer patients worldwide."  "We are delighted to expand our partnership with Biotheus." Said Ms Eliza Sun, Executive Director of the Board at Hansoh. "This collaboration combines Hansoh's proprietary ADC Platform technology with Biotheus' novel bispecific antibody. We hope this new approach will further increase the clinical benefit in patients with NSCLC or other solid tumors. We are confident in our ability to offer transformative treatment options to cancer patients in China and worldwide. This is made possible through our extensive experience in clinical development, exceptional commercialization efforts, and external partnerships." About Biotheus Inc. Biotheus is a clinical-stage biotech company dedicated to the discovery, development, and delivery of novel antibodies to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established several innovative platforms for antibody discovery. With an experienced R&D team, Biotheus has built a differentiated product pipeline with programs at various stages. For more information, please visit www.biotheus.com . About Hansoh Pharma Hansoh Pharma is a leading pharmaceutical company in Greater China driven by innovation. It is committed to the treatment of major diseases in the areas of oncology, anti-infections, CNS diseases, metabolic diseases, as well as autoimmune diseases, and is dedicated to improving human health through continuous innovation. Hansoh Pharma has been ranked among the top 100 global pharmaceutical companies and the top 3 best industrial enterprises in China in terms of pharmaceutical R&D pipeline for several years, and is a national key high-tech enterprise and a national technology innovation demonstration enterprise. Hansoh Pharma was listed on the Stock Exchange of Hong Kong in June, 2019 (stock code: 03692.HK). For more information, please visit www.hspharm.com .
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06
2023-11

Biotheus Enters Into Strategic Partnership with BioNTech to Develop and Commercialize Bispecific Antibody Candidate Targeting PD-L1 and VEGF in Multiple Solid Tumor Indications

Time of issue: : 2023-11--06
Bispecific Antibody Candidate PM8002 demonstrated encouraging data at this year's ASCO Annual Meeting (abstract #2536 & #e13091) and ESMO Congress (abstract #1992P) BioNTech will hold exclusive licenses to develop and commercialize PM8002 globally excluding Greater China   ZHUHAI, China, Nov. 6, 2023 /PRNewswire/ -- Biotheus Inc. ("Biotheus"), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, today announced that the company has entered into an exclusive global license and collaboration agreement under which BioNTech will be developing, manufacturing and commercializing PM8002 globally ex-Greater China, whereas Biotheus retains the rights to exploit PM8002 in Greater China. PM8002 is currently being tested in Phase 2 studies in China to evaluate the efficacy and safety of the candidate as a monotherapy or in combination with chemotherapy in patients with advanced solid tumors. Under the terms of the agreement, Biotheus will receive an upfront payment of $55 million, and is eligible to receive additional development, regulatory and sales milestone payments potentially totalling over $1 billion as well as tiered royalties on potential future product sales. The transaction is expected to close in Q4 2023, subject to customary closing conditions, including clearance under the Hart-Scott-Rodino ("HSR") Antitrust Improvements Act, and regulatory clearances. PM8002 is a bispecific antibody candidate with humanized anti-PD-L1 single heavy-chain variable (VHH) domains fused to an anti-VEGF-A IgG1 antibody containing Fc-silencing mutations. PM8002 has demonstrated a positive safety profile and encouraging antitumor activity presumably through reduced systemic toxicity by enriching anti-VEGF activity into the tumor microenvironment at this year's ASCO Annual Meeting and ESMO Congress 2023. "Biotheus' innovative platform has the capability to expedite preclinical research, bolstering our impressive innovative pipeline of products with encouraging efficacy and safety including PM8002. Collaborating with industry trailblazer BioNTech, we hope to advance PM8002 through multi-regional clinical trials with the aim to be able to provide it to patients worldwide," stated Xiaolin Liu, Co-founder, Chairman, and CEO of Biotheus. About Biotheus Biotheus Inc. is a clinical-stage biotech company dedicated to the discovery, development, and delivery of novel antibodies to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established several innovative platforms for antibody discovery. With an experienced development team, Biotheus has built a robust pipeline of ten programs at various stages of clinical development. For more information about Biotheus, please visit www.biotheus.com. About BioNTech Biopharmaceutical New Technologies (BioNTech) is a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. The Company exploits a wide array of computational discovery and therapeutic drug platforms for the rapid development of novel biopharmaceuticals. Its broad portfolio of oncology product candidates includes individualized and off-the-shelf mRNA-based therapies, innovative chimeric antigen receptor (CAR) T cells, several protein-based therapeutics, including bispecific immune checkpoint modulators, targeted cancer antibodies and antibody-drug conjugate (ADC) therapeutics, as well as small molecules. Based on its deep expertise in mRNA vaccine development and in-house manufacturing capabilities, BioNTech and its collaborators are developing multiple mRNA vaccine candidates for a range of infectious diseases alongside its diverse oncology pipeline. BioNTech has established a broad set of relationships with multiple global pharmaceutical collaborators, including Duality Biologics, Fosun Pharma, Genentech, a member of the Roche Group, Genevant, Genmab, OncoC4, Regeneron, Sanofi, and Pfizer. For more information, please visit www.BioNTech.com
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20
2023-07

Biotheus Announces Strategic Research Collaboration and Worldwide License Agreement with BioNTech

Time of issue: : 2023-07--20
ZHUHAI, China, July 19, 2023 /PRNewswire/ -- Biotheus Inc. ("Biotheus"), a clinical-stage biotech company dedicated to the discovery and development of biologics for oncology and inflammatory diseases, announced today that it has entered into a strategic research collaboration, option and worldwide license agreement with BioNTech SE ("BioNTech"), a next generation immunotherapy company pioneering novel therapies for cancer and other serious diseases. Under the terms of the agreement, Biotheus will grant BioNTech worldwide, exclusive options to a preclinical-stage bispecific antibody and a clinical-stage monoclonal antibody for cancer therapy. In addition, Biotheus will grant BioNTech exclusive licenses to existing panels of VHH binders against multiple targets along with options to request Biotheus to generate new panels of VHH binders against targets nominated by BioNTech. In exchange, BioNTech will provide Biotheus with an upfront payment and following option exercise on Biotheus' preclinical-stage bispecific antibody, Biotheus will also be eligible for clinical, regulatory, and commercial milestone payments and tiered single digit royalties. "Biotheus is deeply committed to leveraging advanced technologies to address unmet medical needs. Partnering with BioNTech, a pioneering leader in novel therapies, significantly furthers our mission. Through this collaboration, we can combine our expertise to discover innovative, potentially transformative therapies for patients worldwide," said Xiaolin Liu, Co-founder, Chairman, and Chief Executive Officer of Biotheus. About Biotheus Biotheus Inc. is a clinical-stage biotech company dedicated to the discovery, development, and delivery of novel antibodies to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established several innovative platforms for antibody discovery. With an experienced development team, Biotheus has built a robust pipeline of ten programs at various stages of clinical development. For more information about Biotheus, please visit www.biotheus.com.
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15
2022-11

Biotheus has entered into a license and collaboration agreement with Hansoh Pharma for its EGFR/MET bispecific antibody in the Greater China territory

Time of issue: : 2022-11--15
Zhuhai, China, November 14, 2022 (PR NEWSWIRE) --- Biotheus Inc., a clinical-stage biotech company focused on the discovery and development of biologics for oncology and inflammatory diseases, announced today that they have entered into a collaboration agreement with Hansoh Pharmaceuticals, for Biotheus’ EGFR/MET bispecific antibody (also known as PM1080) in Greater China, including Mainland China, Hong Kong, Macao and Taiwan. Under the terms of the agreement, Hansoh will be granted by Biotheus the exclusive rights to develop, commercialize and manufacture PM1080 for the treatment of cancer, and shall assume all the costs accordingly in the territory. In return, Biotheus will receive 50 million CNY and is entitled to receive up to ~1.4 billion CNY for future development, regulatory and commercialization milestones, plus tiered royalty payments based on net sales. “We are delighted to enter into a partnership with Biotheus.” Said Ms. Yun Sun, Managing Director of the Board at Hansoh. “EGFR/MET bispecific antibodies are an instrumental therapeutic option for non-small cell lung cancer and other cancer indications; PM1080, based on its outstanding efficacy, safety and PK profiles in preclinical studies, has best-in-class potential for treating cancer, either alone or in combination with Hansoh’s almonertinib. Through this partnership, we believe that we will bring forth rapidly a better therapeutic option to Chinese cancer patients, by utilizing our rich experience and capabilities in the development and commercialization of oncological drugs.” “We really appreciate Hansoh’s trust and confidence in us.”, said Xiaolin Liu, Co-founder, Chairman and Chief Executive Officer of Biotheus. “Hansoh is one of the leading oncology pharmaceutical companies in China and this collaboration spurs the synergy between Hansoh’s strong development and commercialization capabilities with our rich R&D expertise at Biotheus. The partnership will expedite the development and commercialization of PM1080 in Greater China. Biotheus has robust R&D platforms with 10 programs currently undergoing phase I or II clinical development. We are proud of our current accomplishments within four years of founding Biotheus and will continue our commitment to discover innovative drugs to benefit patients.” About PM1080 PM1080 is an EGFR/MET bispecific antibody under development at Biotheus, who owns global rights to the asset. PM1080 is currently undergoing GLP toxicity studies. Previous preclinical data has shown that PM1080 is safe and efficacious, either alone or in combination with other anti-cancer agents, including EGFR TKIs. About Biotheus Inc. Biotheus Inc. is a clinical-stage biotech company established in 2018 and is committed to the development and commercialization of novel antibodies, to address the unmet medical needs of patients with oncology and inflammatory diseases worldwide. Since its inception, Biotheus has established multiple top-caliber platforms for antibody discovery. With a well-seasoned development team, Biotheus has built up a robust pipeline inclusive of 10 programs at different stages of clinical development. For more information about Biotheus, please visit: www.biotheus.com. About Hansoh Pharmaceuticals Hansoh Pharma (3692.HK), one of the largest biopharmaceutical companies in Greater China and in China, is committed to discovering and developing life-changing medicines to help patients conquer serious diseases and disorders. Hansoh Pharma is supported by over 10,000 dedicated employees in China and the United States. Founded in 1995, Hansoh has fully integrated research and development, manufacturing, and commercial capabilities, supporting leading positions in oncology, central nervous system (CNS) disorders, infectious diseases, gastrointestinal disorders, diabetes, autoimmune diseases, and other main therapeutic areas in China. With the support of over 1,400 highly skilled R&D professionals, Hansoh has successfully developed multiple internally discovered drug candidates into NMPA-approved innovative medicines, including Morinidazole (Mailingda, 迈灵达), a third-generation nitroimidazole antibiotic; PEG-Loxenatide (Fulaimei, 孚来美), the first once-weekly long-acting GLP-1 analogue discovered and developed in China for the treatment of diabetes; Flumatinib (Xinfu, 昕福), a second-generation BCR-ABL inhibitor for frontline treatment of chronic myeloid leukemia (CML); Almonertinib (Ameile, 阿美乐), a third-generation EGFR inhibitor for the treatment of NSCLC with EGFR mutations; and Tenofovir Amibufenamide (恒沐), the first second-generation oral anti-HBV drug developed in China. Through collaboration and partnership, NMPA has granted approval to Inebilizumab (Xinyue, 昕越), a humanized anti-CD19 monoclonal antibody, as a treatment for patients with neuromyelitis optica spectrum disorder (NMOSD). For more information, please visit: www.hspharm.com
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15
2022-04

Biotheus Shares Latest Research & Development Updates on Multiple Programs During AACR, 2022 and SITC, 2021

Time of issue: : 2022-04--15
Biotheus Inc., participated at the 113th Annual Meeting of the American Association of Cancer Research, 2022, sharing six posters including four bispecifics: PM1022 (PD-L1 x TIGIT), PM1009 (TIGIT x PVRIG), PM4008 (CEACAM5&6 x CD3) and PM1032 (CLDN18.2 x 4-1BB); and two other monoclonal antibodies: PM1038 (CD39) and PM1015 (CD73). Biotheus also previously presented at the Annual SITC meeting in 2021 on programs PM1003 (PD-L1/4-1BB) . Details of these programs are below.   AACR2022 PM1022 (PD-L1 x TIGIT): https://www.abstractsonline.com/pp8/#!/10517/presentation/17744 PM1009 (TIGIT x PVRIG): https://www.abstractsonline.com/pp8/#!/10517/presentation/17746 PM4008 (CEACAM5&6 x CD3): https://www.abstractsonline.com/pp8/#!/10517/presentation/17774 PM1032 (CLDN18.2 x 4-1BB): https://www.abstractsonline.com/pp8/#!/10517/presentation/17775 PM1015 (CD73): https://www.abstractsonline.com/pp8/#!/10517/presentation/18034 PM1038 (CD39): https://www.abstractsonline.com/pp8/#!/10517/presentation/17747 SITC2021 PM1003: http://dx.doi.org/10.1136/jitc-2021-SITC2021.895   BD enquiries and supplemental material requests Please contact du.yl@biotheus.com or tsun.a@biotheus.com for partnering opportunities and high-resolution PDFs of these posters.   About Biotheus Founded in 2018, Biotheus focuses on the research and development of next generation multispecific antibodies for oncology and inflammatory diseases. As a clinical-stage biotech company, Biotheus currently has two programs at phase II clinical development and a further six programs at phase I. For more information, please visit www.biotheus.com.   PM1022 (PD-L1 x TIGIT): AACR2022 Abstract #5525 BACKGROUND: TIGIT (T-cell immunoglobulin and ITIM domain), which is primarily expressed on activated and 'exhausted' T and NK cells, is one of the most promising 'next generation' immune checkpoint target. Engagement of TIGIT to its ligands (i.e., PVR and PVRL2) leads to inhibitory signaling in T cells and promotes the functional exhaustion of tumor-infiltrating T lymphocytes. Anti-TIGIT monoclonal antibodies have shown clinical benefit when combined with anti-PD-L1 agents in NSCLC. Here, we describe our novel anti-PD-L1 × TIGIT bispecific antibody (PD-L1 × TIGIT biAb) that blocks both the PD-L1/PD-1 and TIGIT/PVR/PVRL2 pathways and has the potential to exhibit equal clinical benefit compared to current combination therapies. RESULTS: The PD-L1 × TIGIT biAb binds with high affinity to the extracellular domain of human TIGIT and PD-L1 and can bind to TIGIT and PD-L1 simultaneously. In a competition assay, the PD-L1 × TIGIT biAb efficiently blocked the interaction between TIGIT and PVR/PVRRL2, and likewise PD-L1 to PD-1. The PD-L1 × TIGIT biAb induced higher luciferase signals than the anti-TIGIT or anti-PD-L1 mAbs alone in a luciferase reporter-based cell system and enhanced IFN-γ production in an MLR assay. In vivo, the PD-L1 × TIGIT biAb demonstrates similar anti-tumor efficacy to the combination of anti-TIGIT and anti-PD-L1 mAbs, which is stronger than the single-agents alone. We have also completed GLP-toxicity studies that have shown excellent safety. CONCLUSIONS: We have discovered a novel PD-L1 × TIGIT biAb, which induces strong immune responses in vitro and in vivo, supporting its clinical development for the treatment of human cancers. Clinical trials shall be initiating in early 2022. PM1009 (TIGIT x PVRIG): AACR2022 Abstract #5527 BACKGROUND: TIGIT (T-cell immunoglobulin and ITIM domain), which is primarily expressed on activated and 'exhausted' T and NK cells, is one of the promising 'next generation' immune checkpoint molecules. Engagement of TIGIT to its ligands (i.e., PVR and PVRL2) leads to inhibitory signaling in T cells, promoting functional exhaustion of tumor-infiltrating T lymphocytes. Anti-TIGIT monoclonal antibodies have shown clinical benefit when combined with anti-PD-L1 agents in NSCLC. However, the single-agent efficacy of anti-TIGIT therapies have been limited. PVRIG (PVR-related immunoglobulin domain containing), which is another coinhibitory receptor of the DNAM/TIGIT/CD96 nectin family, binds with high affinity to PVRL2 and suppresses T-cell function, and shows nonredundant inhibitory effects alongside the TIGIT/PVR/PVRL2 axis. Here, we report a fully-human anti-TIGIT × PVRIG bispecific antibody (anti-TIGIT × PVRIG biAb), which blocks both the PVRIG/PVRL2 and TIGIT/PVR/PVRL2 pathways, that maintains the efficacy of the combination of the two mono-agents. The anti-TIGIT × PVRIG biAb is also highly efficacious when combined with PD1/PD-L1 inhibitors in mouse tumor models. RESULTS: The anti-TIGIT × PVRIG biAb binds with high affinity to the extracellular domain of human TIGIT/PVRIG and can bind to TIGIT and PVRIG simultaneously. In a competition assay, the anti-TIGIT × PVRIG biAb efficiently blocked the interaction between TIGIT and PVR/PVRRL2, and PVRIG with PVRL2. In a luciferase reporter cell system, the anti-TIGIT × PVRIG bi
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03
2021-12

Biotheus' Bifunctional Therapeutic PM8001 has been Approved by the USFDA to Enter Phase II Studies

Time of issue: : 2021-12--03
Biotheus Inc., has announced that its proprietary anti-PD-L1/TGF-β bifunctional therapeutic, named PM8001, has been approved by the USFDA (United States Food and Drug Administration) for conducting clinical phase II studies as part of an international multicenter clinical trial. PM8001 enhances anti-tumor immune responses by blocking PD-L1/PD-1-mediated checkpoint signals and neutralizes TGF-β in the tumor microenvironment. PM8001 has a smaller size than a conventional antibody (~110 kDa) that could potentially improve its tumor penetration efficiency and is also depleted of its Fc-related effector function to mitigate any potential off-target effects. PM8001 was approved for phase I clinical studies by the Chinese NMPA in March 2020. The results from this phase I study show that PM8001 is safe and well tolerated by patients. Tumor shrinkage has also been observed on a variety of advanced solid tumors. The current plans are to investigate these exciting observations further as a single agent and in combination studies. This positive phase I data was used for the subsequent application and approval of phase II clinical studies that will be conducted in China and the US. This is a critical development milestone for Biotheus, for the development of their proprietary assets, and to foster important collaborations with experts from around the world. Mr. Liu Xiaolin, Chairman and CEO of Biotheus, stated: "PM8001 is the first anti-tumor bifunctional therapeutic asset that we have invested substantial resources to advance forward. The successful approval from the (US)FDA is both a recognition and encouragement for our team's efforts and preliminary clinical data. Biotheus has started to implement a strategic pathway to globalize our product pipeline. We are excited for PM8001 and looking forward to promote our other upcoming assets on the global stage". About Biotheus Inc. Biotheus Inc. is a biotechnology company based in Zhuhai, Guangdong, China with multiple clinical-stage assets under clinical development. Biotheus' management team has broad experience from drug discovery to NDA filing in the US and China and is developing a broad me-better/novel target pipeline focused on immuno-oncology and inflammatory diseases. While aiming to develop their leading assets towards market authorization, Biotheus is actively looking for late-stage clinical and commercialization partners to deliver their next-generation therapeutics to patients worldwide.
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