Biointron的动态

Congratulations to Araris Biotech AG and Chugai Pharmaceutical Co., Ltd. on their licensing agreement in developing next-generation ADCs! This reflects a new addition to the wave of ADC licensing deals announced prior to the coming JPM conference. Araris Biotech AG ("Araris"), a Swiss oncology biotech company developing next-generation antibody drug conjugates (ADCs), today announced they have entered a Research Collaboration and Option to License Agreement (“RCO”) under which Araris will use its proprietary linker-conjugation platform, AraLinQ?, to generate novel ADCs using antibodies against undisclosed targets provided by Chugai Pharmaceutical Co., Ltd. ("Chugai"). Araris is to receive an upfront fee and milestone payments potentially totalling USD 780 million plus royalties on net product sales. By the way, Araris is one of several ADC companies to watch in the world selected in June 2024 by Clarivate. Chinese Antibody Society is an independent non-profit, non-government global professional organization with focus upon antibody-based therapeutics. Our society’s official journal, Antibody Therapeutics is an international peer-reviewed, open access journal published by Oxford University Press, and is indexed by ESCI, PubMed and Scopus (2023 CiteScore: 8.7). You are welcome to visit the official website of the journal (see link below) and submit your therapeutic antibody related manuscripts to our journal by June 30, 2025 to enjoy 50% APC (Article Processing Charge/publication fee) discount. . https://lnkd.in/gsTu_U2 #antibodies #antibody #antibodytherapeutics #mabs #mab #antibodydiscovery #antibodydevelopment #biologics #adc #adcs #antibodydrugconjugates #antibodydrugconjugate

?????????????? ???? ?????????????????? ???????????????? #biotech ?????????? in the second half of December 2024 ?? ?? BioArctic announces massive $1.35B Alzheimer's drug deal with Bristol Myers Squibb. https://lnkd.in/dgKwm4S3 ?? Ottimo Pharma raises $140M series A to ready PD1/VEGFR2 cancer antibody for clinic. https://lnkd.in/dBGcWAtx ?? RAPT Therapeutics and Shanghai Jemincare Pharmaceutical announce license agreement for novel anti-IgE antibody for potential $672.5M. https://lnkd.in/eDpcUSFU ?? Candid Therapeutics and EpimAb Biotherapeutics, Inc. to collaborate on development of novel T-cell engagers for autoimmune indications. https://lnkd.in/ePRzy-mt ?? Angitia Biopharmaceuticals announces $120M Series C financing to develop bispecific antibodies for musculoskeletal diseases. https://lnkd.in/gKawUQrE ?? TuHURA Biosciences, Inc. enters into merger agreement to acquire Kineta, including the rights to novel KVA12123 antibody. https://lnkd.in/enQPQUTM ?? Ikena Oncology and Inmagene Biopharmaceuticals announce agreement for merger and private placement for $175M. https://lnkd.in/eDdnvCJt ?? TigaTx gets up to $35.5M in funding from Advanced Research Projects Agency for Health (ARPA-H) and The National Institutes of Health awards to advance IgA mAb. https://lnkd.in/e-2EgrsM ?? NGM Biopharmaceuticals will receive up to $608M from license agreement for NGM313, a Phase 2-ready FGFR1c/β-Klotho receptor complex agonistic antibody with KdT Ventures. https://lnkd.in/gt4m4zv4 ?? Scailyte and Visterra Inc. partner to advance autoimmune disease research with AI and antibody therapies. https://lnkd.in/e49vHXZP ?? Orion Corporation and Abilita Therapeutics, Inc. partner to develop innovative antibody therapeutics. https://lnkd.in/etricnZX #Biointron #Antibodies #Immunotherapy #PharmaNews #Healthcare #DrugDevelopment #DrugDiscovery #Oncology #Innovation #Networking

AlfaDAX | Assessment results of 6 public drug molecules AlfaDAX online system (https://lnkd.in/gnAcAJq5) offers global users efficient and convenient biopharmaceutical #molecule #druggability assessment services, helping customers mitigate risks through molecular modification and expedite new drug development. Tremelimumab and Ipilimumab are both marketed #antibodies against CTLA4. AlfaDAX predicts that Tremelimumab is prone to aggregation, while Ipilimumab is not, which is consistent with the actual situation [1]. Accordingly, Ipilimumab is more widely used than Tremelimumab. On March 25, 2011, the US FDA approved Ipilimumab (trade name Yervoy) for the treatment of advanced melanoma. The administration method is intravenous injection. It is suitable for patients with unresectable or metastatic melanoma, intermediate-risk or low-risk advanced renal cell carcinoma, and certain types of metastatic colorectal cancer. Tremelimumab is mostly used in metastatic melanoma research and needs to be used in combination with Durvalumab to treat solid cancers such as liver cancer and lung cancer. Infliximab and Adalimumab are both marketed antibodies against TNFA, but Infliximab has a higher viscosity [2]. The maximum recommended concentration of infliximab is 4mg/ml [3], which greatly limits its efficacy, while the maximum recommended concentration of Adalimumab can reach 100mg/ml [4]. This is one of the main reasons why Adalimumab can continue to be the best-selling antibody drug of the year, while Infliximab cannot. Although fully humanized Adalimumab can be widely used, like mouse-derived Infliximab, it still has serious immunogenicity problems. About 28% of patients will develop drug-resistant antibodies within three years after injection of Adalimumab, which affects efficacy and causes safety problems [5]. The reason is just as predicted by the AlfaDAX online system. Adalimumab is easy to attract each other through electrostatic force and aggregate. Under pressure such as oxidation and stirring, it is extremely easy to produce small aggregated particles of varying degrees. These small aggregated particles of varying degrees are the main reason for causing different degrees of immunogenicity [5]. Bococizumab and Alirocumab are both PSCK9 antibodies. Bococizumab was halted in Phase III clinical trials, while Alirocumab was successfully launched on the market. Through AlfaDAX online system analysis, we found that Bococilizumab has a strong nonspecific binding tendency, which affects efficacy and produces toxic side effects [6]. #GreatBayBio #GBB #AlfaDAX

?? Breaking news: a $1B licensing deal in trispecific antibody! ?? AbbVie and Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group (HKEX: 2096) today announced an option to license agreement to develop SIM0500, an investigational new drug candidate. SIM0500 is currently in Phase 1 clinical trials in patients with relapsed or refractory multiple myeloma (MM), in both China and the U.S. SIM0500 is a humanized trispecific antibody that targets GPRC5D, BCMA, and CD3, developed independently by Simcere Zaiming using their T-cell engager polyspecific antibody technology platform. This molecule features a low affinity/high target-activating CD3 engaging arm and binding sites for the two tumor antigens: G-Protein-coupled receptor class 5 member D (GPRC5D) and B-cell maturation antigen (BCMA). SIM0500 has shown strong T cell cytotoxicity against multiple myeloma (MM) cells by leveraging a combination of various antitumor effects. Simcere Zaiming will receive an upfront payment from AbbVie and is eligible to receive option fees and milestone payments of up to $1.055B, as well as tiered royalties on net sales outside of the Greater China territory. AbbVie is eligible to receive tiered royalties on net sales in the Greater China territory. Chinese Antibody Society is an independent non-profit, non-government global professional organization with focus upon antibody-based therapeutics. Our society’s official journal, Antibody Therapeutics is an international peer-reviewed, open access journal published by Oxford University Press, and is indexed by ESCI, PubMed and Scopus (2023 CiteScore: 8.7). You are welcome to visit the official website of the journal (see link below) and submit your therapeutic antibody related manuscripts to our journal by June 30, 2025 to enjoy 50% APC (Article Processing Charge/publication fee) discount. https://lnkd.in/gsTu_U2 #antibodies #antibody #antibodytherapeutics #mabs #mab #antibodydiscovery #antibodydevelopment #biologics #trispecific #trispecificantibody #trispecificantibodies #licensing #deal

Everything you missed in #Pharma & #Biotech ???? ? Approvals BeiGene's Tevimbra approved in US for gastric and metastatic esophageal cancer Innovent Biologics's ROS1 inhibitor?Dovbleron approved by China's NMPA for advanced NSCLC Amgen's antibody bispecific Imdylltra approved for small cell lung cancer in UK Vertex Pharmaceuticals’ Alyftrek approved by FDA as a once-daily triple combination therapy for cystic fibrosis patients aged 6+ FDA expands Vertex Pharmaceuticals’ Trikafta label to include more cystic fibrosis mutations Novo Nordisk gains FDA approval for Alhemo, a new hemophilia treatment ? ?? Deals Roche signs $1B deal with Innovent Biologics for IBI3009, an ADC targeting DLL3 in small-cell lung cancer Marinus Pharma sells seizure med Ztalmy to Immedica Pharma AB for $151M, securing rare disease revenue and U.S. capabilities Regeneron strengthens ocular portfolio by acquiring Oxular’s polymeric eye-delivery technology Ikena Oncology merges with Inmagene Biopharmaceuticals to form InmageneBio ??Late-stage developments Axsome Therapeutics, Inc. reports mixed results in Alzheimer’s agitation; filing expected in 2H2025 ?? To watch Verastem Oncology’s avutometinib + defactinib combo for KRAS-mutant recurrent LGSOC gains FDA Priority Review Novo Nordisk files citizen petition to block compounded versions of Victoza ?? Access CVS Pharmacy implements the CVS CostVantage reimbursement model across all commercial prescriptions, aiming to enhance transparency in retail pharmacy services Draft legislation integrates EU joint clinical assessment (JCA) into Germany’s AMNOG process with flexible timelines, allowing German benefit assessments to proceed independently if JCA reports face delays or procedural flaws France's HAS establishes S2E economic evaluation service to enhance health economic evaluations, focused on cost-effectiveness and budget impact assessments for healthcare technologies amid rising innovation costs and public spending constraints Sweden introduces a "staircase" drug pricing model linking costs to disease rarity, allowing higher prices for ultra-orphan drugs while imposing lower prices or volume-related agreements for high-budget-impact treatments ?? Other The FDA releases suite of new guidelines aimed at advancing and modernizing drug development across key areas, including accelerated approvals, AI in clinical trials, clinical trial design, patient-focused drug development, decentralized trials, and improving trial diversity Evidence grows for GLP-1 receptor agonists in heart disease, highlighting expanded use cases beyond diabetes and weight loss FDA announces end of tirzepatide shortage; Eli Lilly and Company joins Novo Nordisk's lawsuit aimed at stopping compounding pharmacies from producing lower-cost versions of their drugs, including tirzepatide (Mounjaro, Zepbound) and semaglutide (Ozempic, Wegovy) ?? What’s your favorite industry news? #pharma #biotech #pulsenews #curiousminds Hannah Kurth

In business news, Araris Biotech AG, a Swiss oncology biotech company developing next-generation antibody drug conjugates (ADCs), announced they have entered a Research Collaboration and Option to License Agreement (“RCO”) under which Araris will use its proprietary linker-conjugation platform, AraLinQTM, to generate novel ADCs using antibodies against undisclosed targets provided by Chugai Pharmaceutical Co., Ltd. Under the terms of the RCO Agreement, Chugai will pay an upfront fee, fund all research activities and after exercising the option be solely responsible for the development, manufacturing and global commercialization activities. Upon achievement of certain development, regulatory and commercial milestones by Chugai after exercising the option, Araris will be eligible for potential milestone payments of approximately USD 780 million, plus royalties on net sales of products. https://lnkd.in/e6iyUAGk

Today, the following news was released: https://lnkd.in/gbyU7GF4 "AbbVie (NYSE: ABBV) and FutureGen Biopharmaceutical (Beijing) Co., Ltd. have announced a license agreement to develop FG-M701, a next-generation TL1A antibody for the treatment of IBD currently in preclinical development. FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential best-in-class functional characteristics compared to first-generation TL1A antibodies, aiming to achieve greater efficacy and less frequent dosing as a therapy for IBD." This second-generation antibody, compared to the first generation, is engineered for “less frequent dosing”, which is particularly important for treating chronic diseases that require frequent doses. To achieve the goal of “less frequent dosing” for a therapeutic antibody, both Fc and Fv engineering play a role. ABS has unique technology to design pH-dependent antibodies that can dissociate from the antigen in low pH lysosomes, thus escaping protein decay and recycling back. This technology could enable the antibody with pro-longed half life, thus reduce dosing frequency. We look forward to supporting our partners with this technology. ??

??Covalent Biologics: A New Frontier for Antibody Therapeutics?? ??Enlaza Therapeutics is a pioneer in developing covalent antibody drug conjugates (ADCs) focused on treating cancer. ADCs are composed of an antibody, a chemotherapy drug, and a linker molecule, which release the drug directly into cancer cells. Enlaza's innovative approach incorporates covalent bonds, creating a permanent link between the drug and its target, enhancing drug efficacy by preventing its quick clearance from the body. Covalent biologics, a relatively new concept, are particularly advantageous for small protein drugs, which typically clear quickly, reducing their effectiveness. ??These covalent biologics offer better tumor penetration due to their smaller size, compared to traditional antibodies, thus potentially providing better efficacy and safety. Enlaza’s strategy involves using non-natural amino acids in antibodies that become reactive only upon binding to the target, ensuring the drug remains at the intended site, improving clearance and reducing unwanted exposure. ????Enlaza's pipeline, though not fully disclosed, focuses on cancer treatment with plans to expand into other therapeutic areas. Having secured $161 million in funding, the company is poised to bring its covalent biologics into clinical stages. Despite promising preclinical results, challenges such as ensuring tumor penetration and minimizing side effects remain. Enlaza is leading the way in this innovative approach to drug development. #pharmaceuticals?#cdmo?#researchanddevelopment?#pharmaceuticalmanufacturing?#apidevelopment?#pharmaindustry #drugdiscovery?#smallmolecule?#cmcs?#chemistrythatmatters?#PharmaCDMO?#drugdevelopment?#contractmanufacturing?#CMOservices?#pharmasupplychain

Once more into the IgA fray. We just learned Jade Bio and Aerovate will merge to focus on developing a potential “best-in-class” treatment for IgA nephropathy. Jade is the fourth spinout of Paragon Therapeutics, Inc. to go public via a reverse merger and the third this year, following?Oruka Therapeutics?and?Crescent Biopharma. Paragon specializes in discovering promising new antibody drugs, which it then licenses to newly created companies to advance their development. In Jade’s case, JADE-001 targets a protein known as APRIL that’s thought to play a major role in the development of IgA nephropathy, which over time erodes kidney function. Jade aims to dose its drug every two months, compared to anti-APRIL antibodies being developed by Otsuka Pharmaceutical Companies (U.S.) and Novartis that are dosed once per month or once every two weeks. (Otsuka last week said its antibody,?sibeprenlimab, succeeded in a Phase 3 trial, while Novartis?expects data?for its drug, zigakibart, in 2026.) The combined company will be named Jade Biosciences and will be led by Tom Frohlich, Jade’s current Chief Executive Officer (CEO).?Jade’s existing Board of Directors will remain in place, chaired by Eric Dobmeier, former President and CEO of Chinook Therapeutics and current Venture Partner at Samsara BioCapital. Board members include Lawrence Klein, Ph.D., CEO of Oruka Therapeutics; Erin Lavelle, former Chief Operating Officer and Chief Financial Officer at ProfoundBio and Eliem Therapeutics; Chris Cain, Ph.D., Director of Research at Fairmount and Tomas Kiselak, Managing Member at Fairmount. IgAN has become a competitive area of drug development. ? Novartis acquired Chinook Therapeutics?last year ? Biogen?bought HI-Bio: A Biogen Company ? Vertex Pharmaceuticals?bought Alpine Immune Sciences, Inc. ? Travere Therapeutics received full FDA approval this year ? Calliditas Therapeutics's was first to market last fall There are 130,000 to 150,000 people who have IgAN in the U.S. Over time, their kidneys can no longer remove waste from the blood, leaving them at risk of progressing to end-stage renal disease (ESRD), which requires hemodialysis or kidney transplant. With the right focus on target therapies, patient access, physician engagement, and effective commercial strategies, we will see significant strides made in managing IgAN and improving outcomes for countless patients here in the U.S. and across the globe. *** What are you following in this space? What changes do you hope to see in the IgAN landscape over the next 3 to 5 years based on this flurry of positive results and investment? -- Sources: [1] Fierce: https://lnkd.in/eikyMsBs [2] Bio Dive: https://lnkd.in/ewDfgcJ3 [3] Jade PR: https://lnkd.in/eJ5xmesD [4] Novartis: https://lnkd.in/eYy72JzU [5] Otsuka: https://lnkd.in/ecQVvqku Photo: Jade Bio CEO Tom Frohlich Credit: Endpoints News

???????????????????? ????????????????: ???????? ?????????? ???????? ?????????? 5 ?????????? ?? ?? Apogee Therapeutics (Nasdaq: APGE) has begun dosing healthy volunteers in its first clinical trial for APG990, a novel, subcutaneous half-life extended monoclonal antibody targeting OX40L. This innovative treatment is being developed for those living with atopic dermatitis (AD) and has potential for broader applications in asthma, COPD, and other inflammatory and immunology conditions. ?? ?Monte Rosa Therapeutics, (Nasdaq: GLUE), a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, announced that the first participants have been dosed in a Phase 1, single ascending dose / multiple ascending dose (SAD/MAD), healthy volunteer study evaluating MRT-6160, a VAV1-directed MGD being developed for systemic and neurological autoimmune diseases. The Company expects to obtain initial data from the Phase 1 study in Q1 2025. ?? Tanvex Biopharma USA, Inc., a contract development and manufacturing organization (CDMO) for biologics and a biosimilars products company, announced that the U.S. Food and Drug Administration (FDA) approved NYPOZI? (filgrastim-txid), the Company’s biosimilar referencing Neupogen?,1, to treat chemotherapy-induced neutropenia in cancer patients. The approval marked an important regulatory milestone that was quickly complemented by the FDA’s acceptance of the Company’s Biologics License Application (BLA) for TX-05, an investigational antineoplastic biologic targeting HER2-positive breast and gastric cancer, a proposed biosimilar to Herceptin?,2 (trastuzumab). Both milestones further validate Tanvex’s expertise in biosimilars and contract biologics development and manufacturing using its U.S. based and FDA licensed manufacturing facility. ?? Cresilon snagged its second FDA clearance for human use. The FDA granted 510(k) clearance to Traumagel, the startup’s gel that can stop bleeding in just seconds, for temporary external use to control moderate to severe bleeding. ?? Arthrosi Therapeutics, Inc. has announced that the US Food and Drug Administration (FDA) has granted Fast Track Designation to its investigational drug AR882, aimed at treating gout patients with clinically visible tophi. #biotechnews #biotech #biopharma #biopharmanews #CDMO #CDMOnews