Autoimmune diseases such as multiple sclerosis (MS) are thought to occur partly due to unusual immune responses to common infections. Early MS symptoms, including dizziness, spasms, and fatigue, often resemble other conditions, complicating diagnosis, which heavily relies on detailed brain MRI evaluations. MS can severely impair motor control, but advancements in treatment can slow down its progression and help maintain functions such as walking. Notably, around 10% of MS patients begin producing a distinctive set of antibodies against their own proteins years before symptoms appear. These autoantibodies have been found to bind to both human cells and common pathogens, possibly explaining why immune attacks on the brain and spinal cord occur in MS. Now, researchers have identified a unique autoantibody signature in about 10% of MS patients that appears years before the onset of clinical symptoms, raising hopes for early detection via a simple blood test and earlier treatment initiation. ...
Diagonal Therapeutics develops agonist antibodies to treat rare cardiovascular conditions. Using artificial intelligence, the startup’s technology sorts through billions of antibody/receptor combinations to identify the ones that reactivate signaling pathways lost to disease.In a drug discovery career spanning more than two decades, Alex Lugovskoy has seen a lot of antibodies come and go. The vast majority of them work by inhibiting a cellular function. Lugovskoy, now the CEO of startup Diagonal Therapeutics, said he long hoped someone would come up with a way to develop antibodies that activate their targets. With each passing year, no one did. So he took up the challenge himself. Diagonal uses computational and experimental techniques to understand what happens when an antibody binds to a receptor and which binding combinations will yield the desired effect. After developing its platform for the past two years, the startup this past week pulled back the curtain on its ...
ROCKVILLE, Md. and SUZHOU, China, March 27, 2024 /PRNewswire/ — Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of oncology, metabolic, autoimmune, ophthalmology and other major diseases, announces that the first participant has been successfully dosed with IBI310 (anti-CTLA-4 monoclonal antibody) in combination with sintilimab (PD-1 inhibitor) in a randomized, controlled, multicenter Phase 3 clinical trial (Neoshot), for resectable MSI-H/dMMR[1] colon cancer (stage cT4 or cN+) neoadjuvant therapy. Neoshot is the first Phase 3 clinical trial (NCT05890742) in China to investigate MSI-H/dMMR colon cancer neoadjuvant immunotherapy. The study will evaluate the safety and efficacy of IBI310 combined with sintilimab for neoadjuvant therapy, compared with adjuvant chemotherapy after radical surgery for MSI-H/dMMR colon cancer. The primary endpoints are pathologic complete response (pCR) rate and event-free survival (EFS). Previously, in a randomized, controlled, multicenter Phase 1b study for neoadjuvant ...
At the high-profile European Lung Cancer Conference (ELCC) 2024, Akesobio and its partner Summit Therapeutics (Summit) jointly released the PD-1/VEGF dual antibody Ivonescimab(AK112/SMT112) combined with chemotherapy for the first-line treatment of advanced non-cancer lung cancer. Updated data from Cohort 1 (EGFR/ALK wild type) of the Phase II small cell lung cancer (NSCLC) clinical study (AK112-201). Previous research results have been published at the 2023 ASCO Annual Meeting and eClinical Medicine, a subsidiary of the top international medical journal “The Lancet”. Cohort 1 included a total of 135 patients with EGFR/ALK wild-type NSCLC who received Ivonescimab combined with chemotherapy, including 63 patients with squamous cell carcinoma and 72 patients with non-squamous cell carcinoma. As of October 2023, the median follow-up time has been further extended to 21.3 months. As the follow-up time is extended, the clinical advantages of Ivosib in the first-line treatment of advanced or metastatic NSCLC become more obvious. ...
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 ...
The agreement outlines the potential for Merus to earn up to $1.5bn payments from Gilead. Merus will head the early-stage research works for two programmes, with the option to expand to a third asset. Credit: aslysun / Shutterstock.com. Gilead Sciences has entered a research partnership, option and licence agreement with Merus for the discovery of dual tumour-associated antigens targeting trispecific antibodies. The partnership will leverage Merus’ Triclonics technology and Gilead’s capabilities in the oncology field. The aim is to advance multiple preclinical research programmes that could potentially transform cancer treatment. Merus focuses on the development of full-length, multispecific antibodies named Biclonics and Triclonics, referred to collectively as Multiclonics. These antibodies are created by a common light chain technology. The Triclonics trispecific platform creates antibodies that can target three different antigens simultaneously. Merus will spearhead the early-stage research works for two programmes, with the option to expand to a third asset. ...
On February 28, 2010, AbbVie and OSE Immunotherapeutics, an immunotherapeutics company, announced a strategic partnership to develop OSE-230, a monoclonal antibody designed to address serious chronic inflammatory diseases, which is currently in preclinical studies. OSE-230 is a first-of-its-kind monoclonal antibody designed to activate the G protein-coupled receptor (GPCR) target ChemR23, which may provide a novel mechanism for relieving chronic inflammation by regulating macrophage and neutrophil function. Dr. Jonathon Sedgwick, Senior Vice President and Global Head of Discovery Research at AbbVie, said: “This collaboration underscores our commitment to expanding our immunology portfolio, with the ultimate goal of raising the standard of care for patients suffering from inflammatory diseases worldwide. We look forward to applying our expertise in immunology drug development to advance the development of OSE-230. Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, said: “We are pleased to partner with AbbVie, a global leader in the development and commercialization of ...
Today (1st March), the official website of the Center for Drug Evaluation (CDE) of the NMPA announced that the PM8002 injection applied by Biotheus is planned to be included in the breakthrough therapy category, and the indication is the first-line treatment of inoperable locally advanced/recurrent metastatic triple-negative breast cancer with albumin-bound paclitaxel for combined injection. Public information shows that PM8002 is an anti-PD-L1/VEGF bispecific antibody independently developed by Biotheus. BioNTech has reached a cooperation agreement of more than US$1 billion with Biotheus to obtain the development, production and commercialization rights of this product worldwide (except Greater China). PM8002 is a bispecific antibody drug candidate consisting of a humanized anti-PD-L1 mono-antibody (VHH) fused to an anti-VEGF-A IgG1 antibody containing an Fc-silent mutation. This design can enrich PM8002 molecules into the tumor environment and reduce the systemic side effects caused by systemic VEGF blockade. According to an earlier press release fromBiotheus, PM8002 ...
According to the CDE official website, AstraZeneca’s Class 1 therapeutic biological product AZD0486 has obtained implicit approval for clinical trials and is intended to be used to treat relapsed or refractory B-cell acute lymphoblastic leukemia. AZD0486 (TNB-486) is a new, fully human CD19xCD3 IgG4 bispecific antibody, originally developed by TeneoTwo. In 2022, AstraZeneca acquired TeneoTwo for US$1.265 billion and also obtained its clinical-stage drug TNB-486. According to public information, AZD0486 can bind to CD19 on the surface of B lymphocytes and CD3 receptors on the surface of T lymphocytes, thereby initiating the immune response of T lymphocytes. A Phase I clinical study (NCT04594642) published in the journal “OncLive” in August 2023 showed that AZD0486 has a durable tumor inhibitory effect on relapsed/refractory follicular lymphoma, regardless of the expression level of CD20, and it is also independent of the type and dosage of existing drugs. Currently, AZD0486 has entered the Phase ...
ROCKVILLIE, MD. and SUZHOU, China, February 20, 2024— Innovent Biologics, Inc. (“Innovent”) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, today announced that the primary endpoint has been achieved in the Phase 3 registrational study (RESTORE-1) of IBI311, a recombinant anti-insulin-like growth factor 1 receptor (IGF-1R) antibody in Chinese subjects with Thyroid Eye Disease (TED). Innovent plans to submit the new drug application (NDA) for IBI311 in the treatment of TED to the Center for Drug Evaluation (CDE) of the National Drug Administration (NMPA). RESTORE-1 (CTR20223393) is a multicenter, randomized, double-masked, placebo-controlled Phase 2/3 clinical trial to evaluate the efficacy and safety of IBI311 in subjects with TED. The Phase 3 results of RESTORE-1 showed that the primary endpoint was successfully met: at Week 24, the proptosis responder rate in the study eye ...
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