bioSeedin

𝐌𝐞𝐞𝐭 𝐛𝐢𝐨𝐒𝐞𝐞𝐝𝐢𝐧 𝐚𝐭 𝐁𝐢𝐨 𝐉𝐚𝐩𝐚𝐧 𝟐𝟎𝟐𝟒 📅 Date: October 9–11, 2024 📍 Location: Pacifico, Yokohama, Japan bioSeedin is excited to attend Bio Japan 2024, one of Asia's leading partnering events for the global biotechnology industry. Join us in Yokohama this October to explore cutting-edge innovations and collaborate with industry leaders across biotech, pharma, and life sciences. Bio Japan 2024 is the ideal platform to network with leading companies, investors, and experts in the field, providing opportunities for strategic partnerships and business development. Don’t miss out on this chance to drive new collaborations and stay at the forefront of industry trends. 🔗 Let's connect and innovate together! For more details, please click this link: https://lnkd.in/gkB2h4Cx

𝐔𝐍𝐈𝐎𝐍 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝟐𝐛 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐎𝐫𝐢𝐬𝐦𝐢𝐥𝐚𝐬𝐭 𝐢𝐧 𝐀𝐭𝐨𝐩𝐢𝐜 𝐃𝐞𝐫𝐦𝐚𝐭𝐢𝐭𝐢𝐬 UNION Therapeutics A/S UNION therapeutics A/S has shared results from the Phase 2b ADESOS study of orismilast in adults with moderate to severe atopic dermatitis, presented by Prof. Dr. Eric Simpson at the EADV Congress 2024. The study involved 233 patients, showing significantly more achieving Investigator Global Assessment (IGA) 0/1 responses at Week 16 with orismilast doses of 20 mg (26.3%), 30 mg (24.3%), and 40 mg (30.9%) compared to placebo (9.5%; all p < 0.05). These results were further supported by reductions in TARC skin levels, a key biomarker for atopic dermatitis. At Week 16, mean percentage changes in Eczema Area and Severity Index (EASI) were -55.1%, -52.2%, -61.4%, and -50.4% for the 20 mg, 30 mg, 40 mg, and placebo groups, respectively. Notably, active arms showed significant reductions in itch as early as Week 2, enhancing patient quality of life. Kim Kjøller Kim Domela Kjøller, Co-CEO of UNION, stated, "The ADESOS study results confirm the potential of orismilast as a safe oral treatment option across immunology." No new safety signals were identified, with common side effects including diarrhea, nausea, and headache, mostly mild. UNION plans to advance orismilast to Phase 3 development in atopic dermatitis. #AtopicDermatitis #Orismilast #ClinicalTrials #Immunology #Phase2b #UnionTherapeutics #EADV2024 #Biotech #Pharmaceuticals

𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐂𝐨𝐛𝐞𝐧𝐟𝐲 𝐟𝐨𝐫 𝐒𝐜𝐡𝐢𝐳𝐨𝐩𝐡𝐫𝐞𝐧𝐢𝐚: 𝐀 𝐌𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐟𝐨𝐫 𝐏𝐮𝐫𝐞𝐓𝐞𝐜𝐡 𝐇𝐞𝐚𝐥𝐭𝐡 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) PureTech Health today announced that KarXT (xanomeline and trospium chloride), developed by PureTech PureTech, has received FDA approval for the treatment of schizophrenia in adults. This approval triggers milestone payments totaling $29 million from Royalty Pharma and Karuna Therapeutics, which was acquired by Bristol Myers Squibb (BMS) in March 2024. KarXT, now marketed as Cobenfy, combines xanomeline and trospium chloride to address tolerability issues in treating neuropsychiatric conditions. Eric Elenko Eric Elenko, Co-founder and President of PureTech, noted that this approval is a significant milestone in transforming the lives of patients with schizophrenia. This achievement validates PureTech’s innovative model, generating approximately $1.1 billion to date, and supports the advancement of other programs, including LYT-100 for idiopathic pulmonary fibrosis. Bharatt Chowrira Bharatt Chowrira, CEO of PureTech, emphasized the importance of this milestone and the ongoing focus on unmet medical needs in their pipeline. #FDAApproval #Cobenfy #Schizophrenia #PureTechHealth #BiotechInnovation #Neuropsychiatry #KarunaTherapeutics #BristolMyersSquibb #HealthcareInnovation

𝐓𝐉 𝐁𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 𝐏𝐚𝐫𝐭𝐧𝐞𝐫𝐬 𝐰𝐢𝐭𝐡 𝐒𝐚𝐧𝐨𝐟𝐢 𝐟𝐨𝐫 𝐔𝐥𝐢𝐥𝐞𝐝𝐥𝐢𝐦𝐚𝐛 𝐃𝐞𝐯𝐞𝐥𝐨𝐩𝐦𝐞𝐧𝐭 𝐢𝐧 𝐆𝐫𝐞𝐚𝐭𝐞𝐫 𝐂𝐡𝐢𝐧𝐚 On September 25, TJ Biopharma announced a strategic collaboration with Sanofi Sanofi for the development, production, and commercialization of its innovative CD73 antibody, uliledlimab, in Greater China. Uliledlimab enhances immune responses against cancer cells by modulating the tumor microenvironment. It is currently being studied in combination with toripalimab for advanced non-small cell lung cancer (NSCLC). Recent data from clinical trials showed a 31% response rate in first-line NSCLC patients and a 63% response rate in patients with high CD73 expression and PD-L1 positivity. Under the agreement, Sanofi will receive exclusive rights to uliledlimab in mainland China, Hong Kong, Macau, and Taiwan. TJ Biopharma will lead clinical development and supply while receiving an upfront payment of €32 million (approximately RMB 250 million) and potential milestone payments, totaling up to €213 million (approximately RMB 1.7 billion). This partnership aims to provide breakthrough therapies for patients with autoimmune diseases and cancers. #TJBiopharma #Sanofi #Uliledlimab #CancerResearch #Oncology #Partnership #ClinicalTrials #Innovation #PharmaNews #Healthcare

𝐊𝐲𝐨𝐰𝐚 𝐊𝐢𝐫𝐢𝐧 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐑𝐨𝐜𝐚𝐭𝐢𝐧𝐥𝐢𝐦𝐚𝐛 𝐢𝐧 𝐀𝐭𝐨𝐩𝐢𝐜 𝐃𝐞𝐫𝐦𝐚𝐭𝐢𝐭𝐢𝐬 Kyowa Kirin Co., Ltd. Kyowa Kirin, Inc.- U.S. announced top-line results from the Phase 3 ROCKET HORIZON trial of rocatinlimab, an investigational therapy targeting the OX40 receptor. The trial met its co-primary endpoints: a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-ADTM) score of 0 or 1 (19.3% rocatinlimab vs. 6.6% placebo, p<0.001) and a ≥ 75% reduction in Eczema Area and Severity Index score (EASI-75) (32.8% rocatinlimab vs. 13.7% placebo, p<0.001), both at week 24. Statistically significant results were also achieved for all key secondary endpoints, including skin clearance and quality of life measures. “Achieving these results is a significant step forward for patients with moderate to severe atopic dermatitis,” said Takeyoshi Yamashita, Ph.D. Takeyoshi Yamashita, Chief Medical Officer at Kyowa Kirin. Detailed results will be shared at an upcoming medical congress, with ongoing discussions planned with global regulatory authorities. #AtopicDermatitis #ClinicalTrials #Rocatinlimab #KyowaKirin #InnovationInHealth #Biopharma

𝐆𝐞𝐧𝐞𝐧𝐭𝐞𝐜𝐡 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐆𝐚𝐳𝐲𝐯𝐚® 𝐢𝐧 𝐋𝐮𝐩𝐮𝐬 𝐍𝐞𝐩𝐡𝐫𝐢𝐭𝐢𝐬 Genentech Genentech, a member of the Roche Group Roche, reported positive topline results from the Phase III REGENCY study of Gazyva® (obinutuzumab) in active lupus nephritis. Patients treated with Gazyva plus standard therapy showed a higher complete renal response (CRR) at 76 weeks compared to standard therapy alone. Safety was consistent with Gazyva's profile, with no new safety signals. Dr. Levi Garraway Levi Garraway noted that Gazyva’s results could significantly impact long-term kidney function and delay end-stage kidney disease, while Dr. Brad H. Rovin emphasized Gazyva as a compelling new option for lupus management. The study met its primary endpoint, and key secondary endpoints showed meaningful benefits, indicating better disease control. Data will be submitted to health authorities for approval, aiming to provide a new treatment option for the approximately 1.7 million people affected by lupus nephritis globally. #Gazyva #LupusNephritis #ClinicalTrials #Genentech #Roche #KidneyHealth #AutoimmuneDisease

𝐏𝐟𝐢𝐳𝐞𝐫 𝐖𝐢𝐭𝐡𝐝𝐫𝐚𝐰𝐬 𝐎𝐗𝐁𝐑𝐘𝐓𝐀® 𝐟𝐨𝐫 𝐒𝐢𝐜𝐤𝐥𝐞 𝐂𝐞𝐥𝐥 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 Pfizer Inc. (NYSE: PFE) Pfizer has announced the voluntary withdrawal of all lots of OXBRYTA® (voxelotor) for sickle cell disease (SCD) across all approved markets. The company is also discontinuing all active voxelotor clinical trials and expanded access programs globally. This decision comes after new clinical data indicated that the overall benefit of OXBRYTA no longer outweighs the risks for the approved patient population, revealing an imbalance in vaso-occlusive crises and fatal events that require further assessment. Pfizer has notified regulatory authorities of these findings. “The safety and well-being of patients is our utmost priority,” said Aida Habtezion Aida Habtezion, Chief Medical Officer at Pfizer. “We advise patients to consult their physicians for alternative treatments while we investigate these findings.” For further inquiries, patients and healthcare professionals can contact Pfizer Medical Information at 1-800-438-1985. The company will keep stakeholders informed about next steps for OXBRYTA. Pfizer does not anticipate an impact on its full-year 2024 financial guidance. #Pfizer #SickleCellDisease #OXBRYTA #PatientSafety #HealthcareUpdates #ClinicalTrials

𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐀𝐪𝐧𝐞𝐮𝐫𝐬𝐚 𝐟𝐨𝐫 𝐍𝐢𝐞𝐦𝐚𝐧𝐧-𝐏𝐢𝐜𝐤 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 𝐓𝐲𝐩𝐞 𝐂 📢 The U.S. FDA has approved Aqneursa (levacetylleucine) for treating neurological symptoms associated with Niemann-Pick disease type C (NPC) in adults and pediatric patients weighing at least 15 kg. This marks the second approval for NPC in just one week, highlighting the FDA's commitment to advancing treatments for rare diseases. NPC is a rare genetic disorder leading to progressive neurological symptoms and organ dysfunction, typically resulting in a life expectancy of about 13 years. The approval was based on a 24-week randomized, double-blind, placebo-controlled study involving 60 patients, demonstrating improved outcomes in the modified Scale for the Assessment and Rating of Ataxia (fSARA). Common side effects include abdominal pain, difficulty swallowing, upper respiratory infections, and vomiting. Aqneursa should be taken orally up to three times daily, with dosing based on body weight. The FDA granted Aqneursa multiple designations, including Priority Review and Orphan Drug status. Approval was awarded to IntraBio Inc.IntraBio Inc. #FDAApproval #NiemannPickDisease #RareDiseases #Neurology #Biotech #Aqneursa #OrphanDrug #Innovation

𝐛𝐢𝐨𝐒𝐞𝐞𝐝𝐢𝐧 𝐍𝐄𝐖 𝐜𝐨𝐥𝐮𝐦𝐧, 𝐭𝐨 𝐬𝐡𝐚𝐫𝐞 𝐰𝐢𝐭𝐡 𝐲𝐨𝐮 𝐭𝐡𝐞 𝐯𝐢𝐬𝐢𝐨𝐧 𝐚𝐧𝐝 𝐭𝐫𝐞𝐧𝐝 𝐨𝐧 𝐭𝐡𝐞 𝐛𝐢𝐨𝐩𝐡𝐚𝐫𝐦𝐚 𝐦𝐚𝐫𝐤𝐞𝐭. 𝐓𝐢𝐭𝐥𝐞 𝐟𝐨𝐫 𝐭𝐨𝐝𝐚𝐲’𝐬 𝐚𝐫𝐭𝐢𝐜𝐥𝐞: CD (Suzhou) Biopharma Announces FDA Clearance for Phase I Clinical Trial of CD-001 Suzhou, China – September20, 2024 – CD(Suzhou) Biopharma has received clearance from the U.S. Food andDrug Administration (FDA) for its Investigational New Drug (IND)application of CD-001, entering a Phase I first-in-human trial.     CD-001, the company's leadingclinical candidate, is built on its proprietary Bispecific FusionProtein (BsFP) platform. This potential therapy, designed to targetPD-1 positive CD8 T cells using an anti-PD-1 antibody and engineeredIL-21 mutant, aims to address unmet medical needs in oncology andviral infections. For full article, please see the link: https://lnkd.in/gkTvSsFY

𝐈𝐦𝐦𝐮𝐬𝐨𝐟𝐭'𝐬 𝐈𝐒𝐏-𝟎𝟎𝟏 𝐓𝐫𝐢𝐚𝐥 𝐒𝐡𝐨𝐰𝐬 𝐏𝐫𝐨𝐦𝐢𝐬𝐢𝐧𝐠 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐌𝐏𝐒 𝐈 🚀 Metsera, Inc. Metsera has announced positive topline results from its Phase 1 clinical trial of MET-097, an ultra-long-acting GLP-1 receptor agonist for obesity and metabolic diseases. The trial demonstrated significant and durable weight loss, supporting a potential once-monthly dosing regimen. Dr. Steve Marso, CMO, stated, “These results position MET-097 as a potent and well-tolerated GLP-1 drug candidate. The initial efficacy shows weight loss that matches or exceeds current and investigational GLP-1 therapies, with the potential for no titration required.” Key trial highlights: Dose-linear pharmacokinetics with a half-life of 380 hours, 2-3 times longer than existing NuSH products. Mild, transient gastrointestinal adverse events, with no severe treatment-related issues. Weight loss of 7.5% at the 1.2 mg dose by day 36, and cumulative weight loss of 8.1% by day 57, indicating a durable effect. Dr. Brian Hubbard, CSO, noted that the results validate their HALO™ technology and set the stage for a series of NuSH analogs with extended half-lives. Metsera plans to initiate a Phase 2b trial of MET-097 in Q4 2024, with data expected in the first half of 2025. #Biopharma #ClinicalTrial #Obesity #MetabolicDiseases #Innovation