bioSeedin

𝐌𝐞𝐞𝐭 𝐭𝐡𝐞 𝐄𝐱𝐩𝐞𝐫𝐭𝐬: 𝐒𝐞𝐜𝐮𝐫𝐞 𝐘𝐨𝐮𝐫 𝐒𝐞𝐚𝐭 𝐚𝐭 𝐎𝐮𝐫 𝐕𝐢𝐫𝐭𝐮𝐚𝐥 𝐑𝐨𝐚𝐝𝐬𝐡𝐨𝐰 ☀ bioSeedin Presents: InnoXpo Seasonal Roadshow! ☀ 📅 Date: August 28, 2024 🎤 APPLY TO PRESENT! 🚀 What is InnoXpo Seasonal Roadshow? Discover groundbreaking innovations at the bioSeedin Innovative Therapeutic Roadshow! We’re on a mission to export cutting-edge ideas to the global market. Join us as we unite biotech visionaries, pharma leaders, and investors. Get ready to witness the future of pharmaceutics through our promising pipeline developments. 🌐 Why choose bioSeedin? Collaboration with 8000  Global Biopharmaceutical Partners Forge Enduring Partnerships with TOP Pharmaceutical Firms in the US, EU, and APAC Unlock Industry Insights and Make Global Connections ✍ How to apply? 1. Click the following link to explore our detailed event page. 2. Hit the "Be Our Speaker" button in the banner. 3. Fill in your basic information and company description. 4. Click "Submit" and get ready for an exhilarating roadshow experience! 👉 Apply Now! https://lnkd.in/gQH9sUK6 #SeasonalRoadshow #GlobalRoadshow

𝐍𝐞𝐰 𝐏𝐡𝐚𝐬𝐞 𝟑 𝐒𝐭𝐮𝐝𝐲 𝐇𝐢𝐠𝐡𝐥𝐢𝐠𝐡𝐭𝐬 𝐄𝐟𝐟𝐢𝐜𝐚𝐜𝐲 𝐨𝐟 𝐀𝐋𝐓𝐔𝐕𝐈𝐈𝐈𝐎 𝐢𝐧 𝐂𝐡𝐢𝐥𝐝𝐫𝐞𝐧 𝐰𝐢𝐭𝐡 𝐇𝐞𝐦𝐨𝐩𝐡𝐢𝐥𝐢𝐚 𝐀 Full results from the XTEND-Kids Phase 3 study, published in The New England Journal of Medicine (NEJM), highlight the efficacy, safety, and pharmacokinetic profile of ALTUVIIIO [Antihemophilic Factor (Recombinant), Fc-VWF-XTEN Fusion Protein]. ALTUVIIIO (efanesoctocog alfa) is a first-in-class, high-sustained factor VIII replacement therapy approved for adults and children with hemophilia A for routine prophylaxis, on-demand treatment, and perioperative management. Dr. Lynn Malec Lynn Malec, Medical Director of Comprehensive Center for Bleeding Disorders, said, “Children represent a population for which it has been historically difficult to achieve effective bleed prevention, and these published results demonstrate an important breakthrough as we strive to optimize the standard of care.” The XTEND-Kids study shows ALTUVIIIO met primary and secondary endpoints, including the occurrence of factor VIII inhibitors and annualized bleed rates (ABRs). No inhibitor development to factor VIII was detected (0%), and the median ABR was 0.00. Eighty-two percent of children treated with once-weekly ALTUVIIIO had zero joint bleeds, highlighting its potential to provide long-term joint health preservation. Dr. Dietmar Berger Dietmar Berger, Global Head of Development and Chief Medical Officer at Sanofi, commented, “The XTEND-Kids data validate the connection between high-sustained factor activity levels and improved health outcomes. Offering a treatment option that emphasizes effective bleed protection can give families increased peace of mind.” ALTUVIIIO was well-tolerated in children, with no adverse events leading to treatment discontinuation. The most common treatment-emergent adverse events were SARS-CoV-2 test positive, upper respiratory tract infection, and fever. No serious allergic reactions, anaphylaxis, or embolic or thrombotic events were reported. #Hemophilia #ALTUVIIIO #XTENDKidsStudy #Sanofi #BleedingDisorders #PediatricCare #MedicalResearch

𝐌𝐞𝐢𝐭𝐡𝐞𝐚𝐥 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 𝐀𝐜𝐪𝐮𝐢𝐫𝐞𝐬 𝐍𝐨𝐫𝐭𝐡 𝐀𝐦𝐞𝐫𝐢𝐜𝐚𝐧 𝐑𝐢𝐠𝐡𝐭𝐬 𝐭𝐨 𝐂𝐎𝐍𝐓𝐄𝐏𝐎™ (𝐅𝐨𝐬𝐟𝐨𝐦𝐲𝐜𝐢𝐧 𝐟𝐨𝐫 𝐈𝐧𝐣𝐞𝐜𝐭𝐢𝐨𝐧) Meitheal Pharmaceuticals, Inc. Meitheal Pharmaceuticals, Inc., a Chicago-based biopharmaceutical company specializing in generic injectables, fertility, biologic, and branded products, has acquired North American rights to CONTEPO™ from Nabriva Therapeutics. CONTEPO™ is a novel intravenous broad-spectrum antibiotic effective against multi-drug resistant strains causing complicated urinary tract infections (cUTI). “The addition of CONTEPO™ enhances our portfolio with a therapeutic addressing the significant unmet need due to increasing antibiotic resistance,” said Tom Shea Tom Shea, CEO of Meitheal. “We are well-positioned to advance CONTEPO™ through the final regulatory stages and ensure a consistent supply to patients needing innovative treatment for drug-resistant UTIs.” Meitheal gains North American rights, including development results, regulatory activities, and all intellectual property related to CONTEPO™, in exchange for a payment upon closing and a royalty on net U.S. sales. CONTEPO™ is already marketed outside the U.S. for nine indications, including cUTI. It uses a new dosing approach for optimized efficacy and met the primary endpoint in the pivotal ZEUS™ trial for cUTI. “The U.S. treatment paradigm for complicated infections is fragmented, with many traditional options rendered obsolete by antibiotic resistance,” said Brett Novak Brett Novak, Senior VP of Commercial Operations at Meitheal. “CONTEPO™ offers a differentiated mechanism of action and efficacy against most multi-drug resistant strains, potentially becoming the antibiotic treatment of choice for appropriate patients.” Nabriva submitted the NDA for CONTEPO™ to the FDA for treating cUTI, with a decision expected later this year. Meitheal is preparing for the commercial launch with a marketing and sales organization and a medical science liaison team. Meitheal’s parent company, Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd. (NKF), has invested over $300 million in recent years to support sustainable product supply across its focus areas. #MeithealPharma #CONTEPO #Antibiotics #Biopharma #HealthcareInnovation #UTI #AntibioticResistance

𝟒𝐃 𝐌𝐨𝐥𝐞𝐜𝐮𝐥𝐚𝐫 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈 𝐃𝐚𝐭𝐚 𝐟𝐨𝐫 𝐖𝐞𝐭 𝐀𝐌𝐃 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐚𝐭 𝐀𝐒𝐑𝐒 𝐌𝐞𝐞𝐭𝐢𝐧𝐠 4D Molecular Therapeutics (4DMT) 4D Molecular Therapeutics revealed positive Phase II data for its wet age-related macular degeneration (AMD) candidate, 4D-150, at the ASRS annual meeting. The Phase II PRISM study shows 4D-150 to be safe and well-tolerated, with no serious adverse events. The trial aims to reduce the frequency of Regeneron's Eylea injections, typically given every four or eight weeks. Impressively, 77% of 4D-150-treated patients were injection-free after 24 weeks, and 93% required zero or only one additional injection. At the planned Phase III dosage (3E10 vg/eye), there was an improvement of 4.2 letters in best-corrected visual acuity from baseline at week 24, with sustained anatomic control. 4D-150 utilizes 4DMT’s R100 intravitreal vector and a transgene cassette. The candidate showed a solid safety profile with no significant anterior chamber or vitreous inflammation at 3E10 vg/eye. Analysts have noted that safety is crucial for wet AMD treatments, particularly gene therapies, due to the risk of blindness from intraocular inflammation. Safety is considered one of 4D-150’s key differentiators. Following the announcement, 4DMT’s stock price rose over 9% premarket. This follows positive data in February, where 4D-150 reduced annual Eylea injections by 85% and 89% at low and high doses, respectively. “The data on 4D-150 show its promise as a potentially safe, routine, one-time intravitreal treatment aimed at preserving vision for millions of wet AMD patients,” said 4DMT Chief Medical Officer Robert Kim Robert Kim. Additional data from the SPECTRA study of 4D-150 in diabetic macular edema is expected in Q4, 2024. Phase III trial alignments with the FDA and EMA are ongoing, with the final design expected in Sept. 2024. The trial is slated to begin in Q1, 2025. #4DMT #GeneTherapy #WetAMD #ClinicalTrials #Biotech #ASRS2024 #Ophthalmology #PharmaNews

𝐀𝐭𝐚𝐫𝐚 𝐁𝐢𝐨𝐭𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐅𝐃𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐁𝐋𝐀 𝐟𝐨𝐫 𝐓𝐚𝐛𝐞𝐥𝐞𝐜𝐥𝐞𝐮𝐜𝐞𝐥 (𝐭𝐚𝐛-𝐜𝐞𝐥®) 𝐟𝐨𝐫 𝐄𝐁𝐕 𝐏𝐓𝐋𝐃 Atara Biotherapeutics, Inc. (Nasdaq: ATRA) Atara Biotherapeutics, a leader in T-cell immunotherapy, announced that the FDA has accepted its Biologics License Application (BLA) for tabelecleucel (tab-cel®) as monotherapy for adults and pediatric patients (two years and older) with Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless inappropriate. There are no FDA-approved therapies for this condition. The BLA has been granted Priority Review with a Prescription Drug User Fee Act (PDUFA) target date of January 15, 2025. “The acceptance of the tab-cel BLA is a significant milestone towards making this first-of-its-kind treatment available to patients in the U.S.,” said Pascal Touchon Pascal Touchon, President and CEO of Atara. “The FDA’s priority review highlights the high unmet need in EBV PTLD, a devastating disease with limited treatment options and poor survival rates. We are preparing for a potential U.S. launch in early 2025, alongside the Phase 2 EBVision trial for potential label expansion.” Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy targeting EBV-infected cells. The BLA is supported by data from over 430 patients, including pivotal ALLELE study data showing a 48.8% Objective Response Rate (ORR) and a favorable safety profile. Tab-cel has received Breakthrough Therapy and orphan drug designations from the FDA. In December 2023, Atara expanded its global partnership with Pierre Fabre Laboratories, covering the U.S. and other global markets. Upon BLA acceptance, Atara will receive a $20 million milestone payment, with an additional $60 million contingent on FDA approval. Pierre Fabre is also reimbursing Atara for global development costs and purchasing inventory through the manufacturing transfer date. Atara is eligible for sales milestones and tiered royalties on net sales globally. Tab-cel, branded as Ebvallo™, received marketing authorization in Europe in December 2022, the UK in May 2023, and Switzerland in May 2024 for treating relapsed or refractory EBV PTLD. Ebvallo was awarded the 2024 Prix Galien International Award for “Best Product for Orphan/Rare Diseases.” #AtaraBiotherapeutics #TabCel #FDA #PriorityReview #Immunotherapy #EBVPTLD #Biotech #PharmaNews

𝐁𝐚𝐲𝐞𝐫 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐍𝐔𝐁𝐄𝐐𝐀® 𝐢𝐧 𝐏𝐡𝐚𝐬𝐞 𝐈𝐈𝐈 𝐀𝐑𝐀𝐍𝐎𝐓𝐄 𝐓𝐫𝐢𝐚𝐥 𝐟𝐨𝐫 𝐌𝐞𝐭𝐚𝐬𝐭𝐚𝐭𝐢𝐜 𝐇𝐨𝐫𝐦𝐨𝐧𝐞-𝐒𝐞𝐧𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐫𝐨𝐬𝐭𝐚𝐭𝐞 𝐂𝐚𝐧𝐜𝐞𝐫 Bayer Bayer reports that the Phase III ARANOTE trial of NUBEQA® (darolutamide) plus androgen deprivation therapy (ADT) met its primary endpoint of radiological progression-free survival (rPFS) in metastatic hormone-sensitive prostate cancer (mHSPC). NUBEQA plus ADT significantly increased rPFS compared to placebo plus ADT, with no new safety signals observed. Christian Rommel, Ph.D. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division, stated, "Today's results build on the established efficacy and tolerability profile of NUBEQA. We look forward to sharing detailed results at an upcoming scientific congress and discussing regulatory approval with the FDA." The ARANOTE trial (NCT04736199) involved 669 patients and assessed the efficacy and safety of NUBEQA plus ADT in mHSPC patients. NUBEQA is already indicated in the U.S. for mHSPC in combination with docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC). #Bayer #NUBEQA #ProstateCancer #ClinicalTrials #Oncology #PharmaNews #FDA #MedicalResearch

𝐎𝐫𝐮𝐦 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 $𝟏 𝐁𝐢𝐥𝐥𝐢𝐨𝐧 𝐋𝐢𝐜𝐞𝐧𝐬𝐢𝐧𝐠 𝐃𝐞𝐚𝐥 𝐰𝐢𝐭𝐡 𝐕𝐞𝐫𝐭𝐞𝐱 𝐏𝐡𝐚𝐫𝐦𝐚𝐜𝐞𝐮𝐭𝐢𝐜𝐚𝐥𝐬 Orum Therapeutics Orum Therapeutics, a clinical-stage biotech company pioneering degrader-antibody conjugates (DACs), announced a global, multi-target license and option agreement with Vertex Pharmaceuticals (Nasdaq: VRTX) Vertex Pharmaceuticals. This agreement grants Vertex rights to use Orum’s Dual-Precision Targeted Protein Degradation (TPD²®) technology for discovering novel targeted conditioning agents for gene editing. Vertex will have the option to obtain a worldwide, exclusive license to research, develop, manufacture, and commercialize DACs using Orum’s TPD² technology. Orum will receive an upfront payment of $15 million and is eligible for additional option payments and milestones of up to $310 million per target for up to three targets, plus tiered royalties on future global sales. Vertex will handle all research, development, and commercialization efforts. "Vertex, a leader in innovative medicines and the first to receive FDA approval for a CRISPR/Cas9 gene-edited therapy, has chosen Orum’s TPD² technology to discover novel targeted conditioning agents," said Sung Joo Lee, Ph.D. SJ Lee, CEO and founder of Orum Therapeutics. "This agreement offers potential treatments for patients in a novel indication space with our leading targeted protein degradation approach." #Biotech #ProteinDegradation #GeneEditing #DACs #InnovativeMedicine #HealthcareInnovation #VertexPharmaceuticals #OrumTherapeutics #ClinicalTrials

𝐈𝐨 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜𝐬 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞𝐬 𝐏𝐫𝐨𝐦𝐢𝐬𝐢𝐧𝐠 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐈𝐑𝐗𝟒𝟐𝟎𝟒 𝐢𝐧 𝐀𝐋𝐒 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Io Therapeutics, Inc. Io Therapeutics presented results from studies of IRX4204, a phase II clinical stage, highly selective RXR nuclear receptor agonist, at the ALS Nexus conference in Dallas, Texas. The presentation, titled “The RXR Nuclear Receptor Agonist Compound IRX4204 is a Potential New Treatment for Amyotrophic Lateral Sclerosis,” was delivered by Vidyasagar Vuligonda, Ph.D., Chief Science Officer, and Martin E. Sanders, M.D. Martin Sanders, CEO. ALS is a progressively debilitating and ultimately fatal neurodegenerative disease. Key findings in ALS pathology include autoimmune imbalance in the CNS, neuroinflammation, and demyelination. IRX4204 has shown promise by promoting Treg cell growth and inhibiting Th17 cell growth, restoring their balance, and inhibiting neurodegeneration. The compound demonstrated these effects in multiple animal models, showing 100% efficacy in inhibiting transfer of neuro-autoimmunity. IRX4204 inhibits pro-inflammatory cytokines IL-17 and IL-6 and promotes maturation of oligodendrocyte precursor cells into myelin-producing oligodendrocytes, thereby repairing damaged myelin. The compound has shown neuroprotective, myelin protective, and reparative effects in animal models of multiple sclerosis, Parkinson’s disease (PD), and Alzheimer’s disease. IRX4204 has demonstrated safety and tolerability in phase I and II trials involving 85 cancer patients and 15 PD patients for up to 20 months. It has shown brain penetrance and motor function improvement in PD patients. Dr. Vuligonda stated, “Our results identify a new approach to potentially treating ALS by inhibiting multiple pathophysiologic processes with IRX4204, including autoimmune neuroinflammation, demyelination, and neuronal death.” Dr. Sanders added, “IRX4204 has potential to slow disability progression and delay mortality in ALS patients. We plan to advance IRX4204 into clinical trials for ALS to evaluate its safety and efficacy.” #NeurodegenerativeDiseases #ALSResearch #Pharmaceuticals #ClinicalTrials #InnovativeMedicine #HealthcareInnovation #Neurology #AlzheimersDisease #ParkinsonsDisease

𝐀𝐬𝐜𝐞𝐧𝐞𝐮𝐫𝐨𝐧 𝐒𝐀 𝐒𝐞𝐜𝐮𝐫𝐞𝐬 $𝟏𝟎𝟎 𝐌𝐢𝐥𝐥𝐢𝐨𝐧 𝐒𝐞𝐫𝐢𝐞𝐬 𝐂 𝐅𝐢𝐧𝐚𝐧𝐜𝐢𝐧𝐠 𝐭𝐨 𝐀𝐝𝐯𝐚𝐧𝐜𝐞 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫’𝐬 𝐃𝐢𝐬𝐞𝐚𝐬𝐞 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 Asceneuron SA Asceneuron SA, a clinical-stage biotech company focused on small molecules targeting tau protein aggregation in neurodegenerative diseases, has raised an oversubscribed $100 million Series C financing round. The funding, led by Novo Holdings Novo Holdings and joined by EQT Life Sciences EQT Life Sciences – LSP Dementia Fund, OrbiMed OrbiMed, SR One SR One Capital Management, and existing investors like M Ventures M Ventures and Sofinnova Partners Sofinnova Partners, will support the clinical development of Asceneuron's OGA inhibitors. The primary focus of this funding is to advance ASN51, an oral small molecule drug designed to inhibit OGA, into Phase 2 clinical trials for Alzheimer’s disease. ASN51 aims to prevent tau protein aggregation, a hallmark of Alzheimer’s, and has shown potential in treating other neurodegenerative diseases, including Parkinson’s and ALS. Five Phase 1 trials have confirmed ASN51's central nervous system uptake and high OGA enzyme occupancy. Barbara Angehrn Pavik Barbara Angehrn Pavik, CEO of Asceneuron, stated: "This financing validates our OGA inhibitor pipeline. We are excited to advance ASN51 into Phase 2, recognizing its potential to expand treatment options for Alzheimer’s patients." Naveed Siddiqi Naveed Siddiqi, MD of Novo Holdings, added: "Alzheimer’s is at a transformational point. Asceneuron’s innovative oral drug offers a potential paradigm shift in treatment." Hakan Goker Hakan Goker, PhD of M Ventures, remarked: "Asceneuron’s development of OGA inhibitors is highly promising for Alzheimer’s and other neurodegenerative diseases. We welcome the new investor group to support this significant development phase." New board members from the investor syndicate include Naveed Siddiqi (Novo Holdings), Philip Scheltens (EQT Life Sciences), and Dina Chaya (OrbiMed), joining existing directors from Sofinnova Partners and M Ventures. #Alzheimers #Biotech #HealthcareInnovation #NeurodegenerativeDiseases #InvestmentNews

🌟 Unafraid of Change and Comparison: Biologics Maintain Their Quality [𝐖𝐞𝐛𝐢𝐧𝐚𝐫 𝐍𝐨.𝟏𝟖𝟖] Topic: Unafraid of Change and Comparison: Biologics Maintain Their Quality Date: July 17, 2024 Time: 19:00-20:30【𝐁𝐉𝐓 (𝐔𝐓𝐂/𝐆𝐌𝐓 𝟎𝟖:𝟎𝟎)】. Agenda: 🕖 19:00-19:40 Comparability Studies for Process Changes in Antibody Drugs Speaker: Dr. Cao | Senior Director of Analytical Development, Altruist Biologics Altruist Biologics, Innovent Bio Innovent Biologics 1.Strategies and Principles for Comparability Studies 2.Application of Characterization and Stability Studies 3.Case Analysis 🕖19:40-19:45 Q&A 🕖 19:45-20:25 Key Points of Quality Similarity Studies for Biosimilars Speaker: Wanqiu Huang | Senior Researcher of Structural Characterization, Altruist Biologics Altruist Biologics, Innovent Bio Innovent Biologics 1.Regulatory Requirements for Pharmaceutical Similarity Evaluation 2.Key Points of Similarity Evaluation 3。Case Analysis 🕖 20:25-20:30 Q&A Join us for an insightful session on maintaining quality in biologics despite changes and comparisons. 🌐💡