Maria Fardis, PhD, MBA

11 Antibody & 4 VHH full-platform transfers (Bayer, Bonum, Sanofi, Scholar Rock, Servier-Symphogen, UCB, EpiBiologics and others undisclosed). Now able to disclose Abbvie. Our libraries are popular. Jeff's talk explains why: high affinities, excellent developability, great diversities.

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Astellas Pharma's subsidiary, Xyphos Biosciences, is partnering with Poseida Therapeutics, Inc. Therapeutics to develop two "convertible" CAR-T therapy candidates for solid tumors. The goal of this collaboration is to create a safer option compared to traditional cell therapies. Xyphos' platform and Poseida's genetic editing technology will be combined to make more effective solid tumor cell therapies. Astellas will pay Poseida $50 million upfront and another $550 million in potential milestone payments, with low double-digit royalties if a therapy is commercialized. #advancedtherapies #cart #therapies #celltherapy #cellandgenetherapy #regenerativemedicine #solidtumors #cancer #oncology #milestones #royalties #collaboration #biotech #biotechnology #pharma #pharmaceuticals #lifesciences #therapeutics Kristin Yarema, Ph.D. Gary Starling

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Elevation Oncology Partners with Synaffix BV in $368M Deal to Advance HER3 ADC Development Synaffix announces that it has entered into a licensing agreement with Elevation Oncology to develop EO-1022, a HER3-targeting Antibody-Drug Conjugate (ADC) leveraging Synaffix’s advanced platform technologies. This collaboration aims to create a highly effective and safer therapy for HER3-positive solid tumors. With up to $368 million in milestone payments, this partnership highlights the transformative potential of ADCs in precision oncology and patient care. Cutting-Edge Technology Integration Synaffix provides Elevation Oncology with global access to its clinical-stage, site-specific ADC technology platform, including GlycoConnect® antibody conjugation, HydraSpace® polar spacer, and the toxSYN® linker-payload SYNstatin E™. These advanced technologies enable the creation of a differentiated HER3 ADC candidate with enhanced efficacy and tolerability, holding the potential to set a new benchmark in oncology therapeutics. Strategic and Financial Framework Under the agreement terms, Synaffix will receive up to $368 million, contingent on achieving specific clinical, regulatory, and commercial milestones. Additionally, Elevation Oncology will handle research, development, and commercialization, while Synaffix will manage manufacturing components tied to its proprietary platform. https://lnkd.in/em89DTzB

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🚀 $MIRA MIRA Pharmaceuticals Announces Key Milestone in Ketamir-2 Clinical Development! We're thrilled to share an exciting update as MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) accelerates its journey toward becoming a clinical-stage company! 🔬 Clinical Trial Site Selected: We've chosen The Centre for Human Drug Research (CHDR) in Leiden, The Netherlands, as the site for our Phase I/IIa trial for Ketamir-2, our novel oral ketamine analog. Recruitment begins in Q1 2025, and initial safety and efficacy data is expected in the second half of 2025. 💡 Why CHDR? Their cutting-edge PainCart® technology will allow us to assess early signs of Ketamir-2’s efficacy in healthy subjects during Phase I—a groundbreaking approach to pain management. 📋 Innovative Study Design: Our trial will include: Phase I: Focused on safety, tolerability, and early efficacy in healthy subjects. Phase IIa: Targeting diabetic neuropathy patients, with initial efficacy data anticipated in the first half of 2026. 🏆 Advancing Breakthroughs: Ketamir-2 has shown superior efficacy compared to existing drugs like pregabalin and gabapentin, offering a potential non-addictive, safe, and effective solution for pain and depression. 💪 Strong Financial Position: With a healthy balance sheet, MIRA is well-equipped to achieve these milestones without unfavorable financing deals. 📈 Looking Ahead: As we transition into a clinical-stage company, we remain dedicated to building strategic partnerships, advancing Ketamir-2, and exploring its potential across additional indications. 🔗 Visit our website to learn more: https://lnkd.in/eZNZzHR7 Together, we're redefining possibilities in pain and depression treatment. 🚀 #Pharmaceuticals #ClinicalTrials #Innovation #PainManagement #DepressionTreatment #Biotech #FDA

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Why Gilead Sciences and Arcellx Anito-cel's data shows Promise in Multiple Myeloma Therapy Innovative Safety Profile: Early clinical data suggest anito-cel offers a reassuring safety advantage, with no reported cases of Parkinsonism, cranial nerve palsies, or Guillain-Barré syndrome—potentially addressing critical quality-of-life concerns. Encouraging Efficacy: With a 97% response rate and a median progression-free survival of 30.2 months in Phase 1, anito-cel demonstrates strong potential as an effective treatment option in heavily pretreated multiple myeloma patients. Cutting-Edge Technology: Anito-cel’s unique D-Domain binding technology may contribute to its promising safety and efficacy, reflecting innovation in CAR-T therapy design. #CellTherapy #MultipleMyeloma #InnovationInHealthcare #CAR_T #advancedtherapies #biotech #biotechnology #lifesciences #Data #ASH2024 https://lnkd.in/eCmJ_vP3

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𝐀𝐒𝐇 𝟐𝟎𝟐𝟒: Nurix Therapeutics CEO Arthur T. Sands, M.D., Ph.D. talks BTK degradation vs inhibition and the company's broader pipeline of degraders. He discusses Nurix's clinical data set that was presented at #ASH24. Plus, the company's pipeline, including in the autoimmune space, and degrader-antibody conjugates. Full video: https://lnkd.in/gU5gsPzW BiotechTV is brought to you by: Mispro | Breakthrough Properties | HSBC Innovation Banking | NYSE | Allucent | Klein Hersh

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#ICYMI: Nurix’s President and CEO, Arthur T. Sands, M.D., Ph.D., caught up with Brad Loncar of BiotechTV at #ASH2024 to discuss new clinical data from Nurix’s BTK degrader NX-5948 and what’s next for Nurix as we advance our pipeline of targeted protein modulation therapeutics. Watch the full interview here: https://lnkd.in/gU5gsPzW

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🌟 Live from the 19th BioPharma Drug Discovery Nexus Conference! Join Lars Nieba CEO at Engimmune Therapeutics, as he unveils groundbreaking insights on coupling protein engineering with AI to develop multi-specific, soluble TCR-based cell engagers for oncology and auto-immune diseases. Don't miss this enlightening session! #BioPharma #DrugDiscovery #Innovation #NexusConference #Switzerland #Proteinengineering #AI #Cell #TCR #ImmuneDiseases #ProcurementDirect #LiveUpdate #ConferenceLive #DiscoveryConference #EuropeEvent

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Acurx Pharmaceuticals, Inc. (Nasdaq: ACXP) Announces $2.5 Million Registered Direct Offering Priced At-the-Market Under Nasdaq Rules   Acurx Pharmaceuticals, Inc. (#NASDAQ: #ACXP), a late-stage #biopharmaceutical company developing a new class of #antibiotics for difficult-to-treat #bacterial #infections, announced that it has entered into a definitive agreement for the purchase and sale of an aggregate of 2,463,058 shares of its common stock at a purchase price of $1.015 per share in a registered direct offering priced at-the-market under Nasdaq rules. In addition, in a concurrent private placement, the Company will issue unregistered warrants to purchase up to 2,463,058 shares of common stock. The warrants will have an exercise price of $0.90 per share, will be exercisable upon issuance and expire five years following the date of issuance. The closing of the offering is expected to occur on or about January 7, 2025, subject to the satisfaction of customary closing conditions.   https://lnkd.in/eAKy4iSM #nasdaq #acxp #antibiotics #acurx

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𝐒𝐅 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐖𝐞𝐞𝐤: Verve Therapeutics' CEO Sekar (Sek) Kathiresan on the company's two clinical programs, and more in the pipeline. He provides an update on the company's PCSK9 and ANGPTL3 clinical programs, as well for the preclinical LPA program. Full video: https://lnkd.in/gScui7Fg BiotechTV's coverage of SF Healthcare week is brought to you by: HSBC Innovation Banking. BiotechTV is brought to you by: Mispro | Breakthrough Properties | HSBC Innovation Banking | Allucent | NYSE | Savills

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Ratio’s fully integrated proprietary R&D platforms, Trillium™ and Macropa™, harness the tumor-killing power of the alpha emitting radionuclide actinium-225 to selectively destroy #cancer cells. Ratio’s Trillium™ technology is a proprietary and innovative platform that modulates drug pharmacokinetics (PK) and improves drug availability, tumor delivery, and tumor loading, while simultaneously reducing the side effects commonly observed with other radiotherapies. Learn more: https://lnkd.in/e--KTJiH #radiopharmaceuticals #theranostics

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Nucleus Biologics Launches QuickStart Media™: A Suite of Optimized Media Formulations That Provide a Head Start on Your Therapy Optimization - https://lnkd.in/gYKezEBS Nucleus Biologics, The Cell Performance Company™, a leading provider of custom cell culture media and buffers for the cell and gene therapy industry, announces the launch of a novel platform to expedite the formulation and manufacture of custom media. This platform, called QuickStart Media™, is a groundbreaking addition to its comprehensive line of cell culture products and solutions and further demonstrates Nucleus Biologics’ expertise and dedication to the delivery of custom cell culture media, buffers, reagents, and services simpler and faster. As the name implies, QuickStart Media was developed to provide scientists with a head start in the development of a high performing, custom media. The formulations that carry the QuickStart Media brand have all been developed for high performance for specific cell types or functions but allow full customization of components and final packaging enabling researchers to tailor their product to fit their exact process or critical quality attributes (CQAs). This offering stands alone in the cell culture market by providing researchers with both the convenience of off-the-shelf and the flexibility of custom media. This process offers transparency through licensing that can both enhance performance and supply chain consistency. “Nucleus Biologics is committed to empowering scientists with the tools they need to drive innovation and discovery,” said David Sheehan, President and CEO of Nucleus Biologics. “QuickStart Media represents the first platform of proven formulations that can be optimized and licensed to allow unprecedented transparency. This flexibility not only accelerates the research process, but also speeds the time for therapy developers to get into the clinic. As a critical component of a therapy, the industry needs to shift its thinking and allow scientists to know what is in their media and optimize their therapy. Ultimately, this is about faster cures.” #cellculture #celltherapy #genetherapy #custommedia David De Leonardis Brad Taylor

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BrightPath Bio and Cellistic Announce Process Development and Manufacturing Collaboration for Phase 1 Clinical Trial of iPSC-derived BCMA CAR-iNKT cell - https://lnkd.in/eUv2kfKq Brightpath Biotherapeutics (Tokyo Stock Exchange Growth 4594, “BrightPath”), a pioneer in iPS cell-derived Natural Killer T (“NKT”) cell therapy, and Cellistic, a leader in advanced iPS cell therapy manufacturing, today announced a process development and manufacturing agreement to advance BrightPath’s novel allogeneic CAR-T cell therapy platform, utilizing iPSC-derived NKT cells for clinical trials. The strategic collaboration includes the use of Cellistic’s innovative 3D bioreactor-based manufacturing platform, Echo, to enable GMP-compliant, clinical-scale manufacturing of iPSC-derived BCMA-targeting CAR-NKT cells for Phase 1 multiple myeloma trial; establishing BrightPath as a first mover in this emerging field. “The use of NKT cells as effectors in allogeneic CAR-T therapy represents a promising strategy, offering not only direct cytotoxicity but also indirect anti-tumor activity through the priming of host CD8+ T cells—a mechanism expected to evade host immune rejection and to enhance the durability of clinical responses. However, achieving clinical- scale manufacturing of such a rare subset of T cells while preserving their original functionality has conventionally been a significant challenge. Induced pluripotent stem (iPS) cell technology has overcome this barrier, making large-scale production feasible.“ stated Ken Nagai, CEO of BrightPath. “We are excited to partner with BrightPath in the development of their revolutionary iPSC-derived cell therapy,” said Gustavo Mahler, CEO of Cellistic. “Our Echo manufacturing platform is designed to meet the unique challenges of cell therapy production, ensuring scalability, quality, and regulatory compliance. Together, we can advance the therapeutic potential of BCMA CAR-NKT cells and help BrightPath to bring innovative solutions to patients in need.” #ipscells #tcells #advancedtherapies Laetitia Avanzini

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💡 Feature Article 💡 In our latest #BioTuesdays feature, Adi Zuloff-Shani, Ph.D., CEO of Clearmind Medicine (NASDAQ: CMND; FSE: CWY0), discusses how their novel molecule, MEAI, is disrupting binge behaviors by targeting key neural pathways to treat alcohol use disorder (AUD). With FDA-approved clinical trials underway and innovative products like an MEAI-based beverage, Clearmind is poised to revolutionize treatments for AUD and beyond. 🔗 https://lnkd.in/gi4SfYKb Kilmer Lucas Inc.

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#BigPharma's growing interest in the #cellandgenetherapy space has the potential to reshape the industry's future. At this year's Cell & Gene #MeetingontheMesa, industry leaders highlighted that large pharma companies' significant resources and expertise are uniquely positioned to address the complex challenges of developing and commercializing these therapies. From high #manufacturing costs to navigating #regulatory hurdles, Big Pharma is playing an essential role in scaling innovations that smaller biotechs often struggle to bring to market. Their partnerships will prove critical to bringing life saving treatments to patients who need them most. As the sector continues to evolve, collaboration between Big Pharma and biotech can help shape the future of cell and gene therapies.

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