Ziv Kirshner

👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟐𝟐𝐧𝐝 𝐎𝐜𝐭𝐨𝐛𝐞𝐫 𝟐𝟎𝟐𝟒 👩‍🔬💬 🦠 Cellipont Bioservices and Mongoose Bio Inc. have partnered for the technology transfer, process development, and cGMP manufacturing of Mongoose Bio’s autologous MGB-001 TCR-T cell therapy. MGB-001 targets highly immunogenic and widely expressed solid tumors, leveraging epigenetic T cell reprogramming and advanced antigen discovery powered by Generative AI. 🧬 Papillon Therapeutics received Rare Pediatric Disease designation from the FDA for PPL-002, an experimental gene therapy for Danon disease. PPL-002 is a gene-modified hematopoietic stem cell therapy designed to express functional Lamp-2 protein, addressing the underlying cause of Danon disease. Preclinical studies show promising improvements in affected tissues. Danon disease is a rare, life-threatening genetic disorder that primarily affects the heart and muscles, with severe complications in adolescence. 🦠 Nona Biosciences has entered a strategic collaboration with OverT Bio to develop next-generation cell therapies for solid tumors. The partnership will leverage Nona's fully human heavy chain-only antibodies (HCAbs) from its Harbour Mice® platform and innovative CAR-function screening platform, NonaCarFxTM. These HCAbs, with reduced immunogenicity and enhanced CAR design versatility, aim to improve the safety and efficacy of cell therapies. 🧬 Editas Medicine has entered a $238 million deal with Genevant Sciences to combine Genevant’s LNP technology with Editas’ CRISPR Cas12a gene editing system. The collaboration aims to develop in vivo gene editing therapies targeting two undisclosed conditions. Genevant will receive an upfront fee, milestone payments, and tiered royalties if the therapies reach the market. Editas is also progressing toward clinical trials for its lead therapy for sickle cell disease. 🦠 Immusoft’s Phase I trial of ISP-001, an engineered B-cell therapy for mucopolysaccharidosis type I (MPS I), showed promising early results. The first patient experienced reduced urinary glycosaminoglycans, improved quality of life, and functional gains beyond enzyme replacement therapy. ISP-001 was well tolerated without preconditioning. Immusoft plans to explore higher doses and extend its platform to other diseases like MPS II, obesity, and diabetes. 🧬 Genespire raised €46.6 million in a Series B round to advance GENE202, an off-the-shelf pediatric gene therapy for Methylmalonic Acidemia (MMA), into Phase I/II clinical trials. MMA is a severe genetic disorder with no current disease-modifying treatments. Genespire’s innovative Immune Shielded Lentiviral Vector platform, developed at SR-Tiget, enables lifelong therapy production from the patient’s liver. The financing will also expand Genespire's pipeline targeting other genetic diseases. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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Lipid Nanoparticles (#LNPs) have gained popularity as carriers for gene therapies due to their high tolerance, limited side-effects and low toxicity, making them prime candidates for difficult to reach tissues for diseases such as #autoimmune, #cancer and infectious diseases. 🦠 With an increase in popularity for gene therapies the space is due to grow massively over the next 3 years and I am working with some of the best companies in the market, who work in this space. 🧬 They are looking for experts in the Gene Therapy space, with extensive experience in LNP, particularly in their #CMC , #analyticaldevelopment teams to join their California location 🦠 You will be part of the growth of an exciting, innovative space, where you will have direct impact to helping push companies through the clinic to commercialization. 🧬 If you are interested in working for highly invested, growing #Biotechnology companies in the #Gene #Therapy space, specializing in #LNP and #AAV modalities, then I would love to speak with you! 🦠 ✉️ kelly.mccarthy@epmscientific.com ☎️  +1 415 -228 -7032 #genetherapy #LNPs #AAV #nonviral #viralvector #california #californiajobs #hiring #losangeleshiring #sandiegohiring #celltherapy #autoimmune #Research #development #drugsubstance #drugproduct #lipidnanoparticles #recruitment #executiveheadhunting #exectuivehiring #cancertreatement #tissuetreatment

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👨‍🔬💬 𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐡𝐞𝐫𝐚𝐩𝐲 𝐍𝐞𝐰𝐬: 𝟗𝐭𝐡 𝐉𝐮𝐥𝐲 𝟐𝟎𝟐𝟒 👩‍🔬💬 🦠 Adicet Bio, Inc received Fast Track Designation from the FDA for ADI-270 for the potential treatment of patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC) who have been treated with an immune checkpoint inhibitor and a vascular endothelial growth factor inhibitor. ADI-270 is an armored allogeneic “off-the-shelf” gamma delta CAR T cell therapy candidate targeting CD70-positive cancers. CD70 is a compelling target due to its high expression in both solid and hematological malignancies. 🦠 Obsidian Therapeutics received Fast Track Designation from the FDA for OBX-115, a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15, for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors. 🧬 Jaguar Gene Therapy announced the receipt of FDA responses from a Type C meeting regarding the Phase I clinical trial for JAG201, a gene replacement therapy that targets a genetic form of autism spectrum disorder (ASD) where a SHANK3 mutation or deletion is present, and Phelan-McDermid syndrome. Jaguar Gene Therapy plans to dose the first pediatric patient in Q1 of 2025 with expansion into adults following the pediatric cohort. 🦠 Interius BioTherapeutics has received approval from the Australian Therapeutic Goods Administration to begin a Phase I trial of INT2104, an investigational in vivo CAR gene therapy for B-cell malignancies. The trial, starting in Q4 2024, will assess the safety of a single infusion of INT2104 in adult patients with refractory/relapsing B cell malignancies. 🦠 Cartesian Therapeutics announced a $130 million PIPE financing deal, expected to close by July 3, 2024. Proceeds will fund pipeline programs and general corporate purposes. Cartesian also dosed the first patient in a Phase 2 trial for Descartes-08, an mRNA CAR-T therapy targeting B-cell maturation antigen, in systemic lupus erythematosus (SLE). The study aims to evaluate outpatient administration without chemotherapy for SLE patients refractory to standard therapies. 🧬 Charles River Laboratories and AAVantgarde Bio announced a CDMO agreement to produce GMP plasmid DNA. AAVantgarde has two proprietary AAV-based large gene delivery platforms, both of which aim to enable efficient delivery of large genes to tissue and cells in vivo. Charles River will develop the plasmid DNA for AAVantgarde’s Stargardt’s disease program (AAVB-039), using their AAV-intein platform, which has demonstrated a very efficient recombination to deliver therapeutically meaningful protein levels. 🛎 My aim is to be the messenger when it comes to your CGT news. Follow #mCGT to stay updated! #celltherapy #genetherapy #ATMP

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🚨 Register Now for FREE at the Oligonucleotide Therapeutics Xchange - Maryland 2024! 🚨 Don’t miss the Poster Presentation on “Untargeted Mass Spectrometry for Precision Oligo Analytics” happening on October 30th, 2024, from 15:15 - 15:45 on the Manufacturing Track! 🔗 Secure your spot today! https://lnkd.in/ek6Mjb7V 🔬 Why attend? This session will dive into the powerful role of untargeted mass spectrometry in enhancing the accuracy and quality of oligonucleotide production. You’ll gain insights into: 🟠 How this technique helps identify key molecular components and impurities 🟠 The role it plays in streamlining manufacturing processes 🟠 Its impact on ensuring precision and consistency in oligonucleotide-based research and development 🟠 Best practices for improving quality control in oligo manufacturing 💡 Meet the Expert Joseph Fraone, Business Development Manager at Bachem brings over a decade of experience in biopharma and biotech, with a strong background in aptamer discovery and pharmaceutical solutions. **Agenda Subject To Change. 💊 Only available for Senior Scientists and above, from Bio and Pharma companies with a drug pipeline. #OligonucleotideTherapeutics #MassSpectrometry #PrecisionAnalytics #Biotech #Manufacturing #OligoR&D #Bachem #LifeSciences #Pharma #Oligonucleotides #Biopharma #DrugDiscovery #RND #Pharmaceuticals #QualityControl #UntargetedMassSpec #OligonucleotideManufacturing #Therapeutics #BioTechIndustry #hubXchange #Xchanges #Roundtable #FreePass #RegisterNow #ComplimentaryPass

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Demonstrating the technical leadership of SK pharmteco! 🧬 Catch up with our team at ASGCT to discuss how SKPT can support your #cellandgene development!

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RAPT Therapeutics Therapeutics and Shanghai Jemincare Pharmaceutical Announce Exclusive License Agreement for Novel Long-Acting anti-IgE Antibody SOUTH SAN FRANCISCO, Calif., Dec. 23, 2024 (GLOBE NEWSWIRE) -- RAPT Therapeutics, Inc. (Nasdaq: RAPT), a clinical-stage, immunology-based biopharmaceutical company focused on discovering, developing and commercializing novel therapies for patients with significant unmet needs in inflammatory diseases, and Shanghai Jemincare Pharmaceutical Co., Ltd (“Jemincare”), a subsidiary of Jiangxi Jemincare Group, a leading pharmaceutical company in China, today announced they have entered into an exclusive license agreement for JYB1904 (RAPT designation RPT904), a clinical-stage, half-life extended anti-immunoglobulin E (IgE) monoclonal antibody. Under the terms of the license agreement, RAPT is granted worldwide rights excluding mainland China, Hong Kong, Macau and Taiwan (together, the “Jemincare Territory”) to develop and commercialize RPT904. As consideration for the license, Jemincare receives a $35 million upfront license fee, up to $672.5 million in additional payments upon the achievement of various regulatory and commercial milestones, and royalties on future sales of RPT904 outside the Jemincare Territory. RPT904 is being developed to offer patients a potentially improved therapeutic option compared to omalizumab (marketed as Xolair®), an anti-IgE monoclonal antibody approved for several allergic disorders, including asthma, chronic spontaneous urticaria (CSU), chronic rhinosinusitis with nasal polyps and, most recently, food allergy. RAPT plans to pursue development of RPT904 initially in food allergy. Separately, Jemincare is conducting Phase 2 clinical trials of JYB1904 in China in asthma and CSU. “We’re delighted to partner with Jemincare and excited by RPT904 and its potential to be a novel best-in-class treatment option for patients with food allergy. Omalizumab’s rapid uptake in food allergy since its approval earlier this year confirms the high unmet need and large opportunity in this growing market,” commented Brian Wong M.D., Ph.D., President and CEO of RAPT. “RPT904 targets the same clinically validated epitope as omalizumab and combined with extended half-life, gives this molecule a best-in-class profile. We plan to initiate a Phase 2b clinical trial of RPT904 in food allergy in the second half of 2025.” https://lnkd.in/e92YkAmT

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Tissue cross-reactivity for antibody specificity testing is an old, outdated technology. FDA guidance documents* state, “appropriate newer technologies should be employed as they become available and validated.” Get better data faster with the Membrane Proteome Array: https://bit.ly/4eKOdPy * Points to consider in the manufacture and testing of monoclonal antibody products for human use, 1997 (p. 30)

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Sagesse Bio is an early stage pharmaceutical company utilizing RNAi technology to accelerate the clinical development of novel solutions to destroy or remodel undesirable pockets of fat. The company's lead compound, SGY-101, is IND-enabled and currently in Phase II clinical trials for other indications. Sagesse Bio will promptly begin clinical evaluation of SGY-101 with comprehensive scientific and technical support from Sirnaomics which specializes in the development of RNAi technology. Initial indications of interest include body contouring and fat reduction. The strategic goal of Sagesse Bio is to become the leading provider of therapeutic solutions for targeted fat reduction in both medical dermatology and aesthetic medicine. 

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Abzena’s poster from #wadc:

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AGC Biologics meets diverse viral vector demands in gene therapy through standardized platform processes like ProntoLVV™ and BravoAAV™, supporting scalable production up to 2,000 L. Dr. Martina Brunati iterates why adaptability and rapid response are critical in meeting developer needs, emphasizing how a platform approach enhances efficiency and quality. Through this templated yet adaptable approach, our cell and gene experts have created robust, GMP-compliant processes from development to commercialization in advanced gene therapies. Read our latest blog, find the link in the comments below! #biotech #pharma #Biopharma #pharmaceuticals #LifeScience #Biotechnology #biologics #Biopharmaceuticals #AGCBio #CDMO

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The W. L. Gore & Associates Protein A membrane device, integrated with AGC Biologics' platform, offers a fully single-use, scalable solution for antibody production. It ensures faster cycling, higher productivity, and cost efficiency, making it ideal for all stages from discovery to GMP-level manufacturing of next-gen therapies. Read more about it in our new blog post: https://lnkd.in/grRC_U5i #biotech #pharmaceuticals #LifeScience #Biotechnology #biologics #Biopharmaceuticals #biopharma #pharma #mammalian #AGCBio #CDMO #YourfriendlyCDMOexpert

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For anyone building diagnostics: Very cool approach to gain valuable insights into FDA decision summaries. Brendan O'Leary scraped the FDA’s decision summaries and provided some simple R code for anyone to get up and running in no time to prod and probe those summaries. Very nice work!

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🚀 Ginkgo Bioworks, Inc. Bioworks Sets Date for Q2 2024 Results Presentation 🚀 📅 Presentation Date: Thursday, August 8, 2024, at 5:30 PM ET. Ginkgo Bioworks Holdings, Inc. (NYSE: DNA) has announced a presentation and Q&A session to review its business performance for the second quarter ended June 30, 2024. The session will be held post-market on August 8, 2024. About Ginkgo Bioworks: Ginkgo Bioworks is a leader in cell programming and biosecurity, offering end-to-end services for various markets, including food, agriculture, pharmaceuticals, and specialty chemicals. Their biosecurity division focuses on developing infrastructure and technologies to predict and respond to biological threats. #GinkgoBioworks #Q2Results #InvestorUpdate #Biotech #Biosecurity #CellProgramming #Innovation #GinkgoResults

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Even after enormous investments of time and resources, 𝟵 𝗼𝘂𝘁 𝗼𝗳 𝟭𝟬 𝗱𝗿𝘂𝗴𝘀 𝗳𝗮𝗶𝗹 the first time they contact a human. Why? Because many drug discovery programs lack models that truly predict 𝗲𝗳𝗳𝗶𝗰𝗮𝗰𝘆 𝗮𝗻𝗱 𝘁𝗼𝘅𝗶𝗰𝗶𝘁𝘆. Unlike commonly used immortalized lines and animal models, iPSC-based models incorporate 𝗺𝗼𝗿𝗲 𝗿𝗲𝗹𝗲𝘃𝗮𝗻𝘁 𝗵𝘂𝗺𝗮𝗻 𝗯𝗶𝗼𝗹𝗼𝗴𝘆 earlier in drug discovery. Curious to see how? Comment "drug discovery" below, and I'll share an outline of Ncardia's iPSC platform, allowing you to mimic drug interactions with the human body from hit identification to lead optimization ⬇ #drugdiscovery #clinicaltrials #biotechnology

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Struggling to find qualified histotechnologists for your lab? You’re not alone. I just wrapped up a conversation with a laboratory director from the West Coast, and he shared some real challenges his lab is facing. Like many, he’s dealing with a shortage of histotechnologists. His lab currently relies on travelers, which creates significant issues: 1.) These travelers are expensive. 2.) They often lead to quality problems. There’s a lack of local talent; the pipeline just isn’t there. So, what's the solution? International recruitment. Here’s how it can transform their pathology department. Build Your Own Pipeline: Instead of waiting for new histotechnologist to relocate to the this city you can take control and bring your own. Imagine bringing in 3 to 4 motivated histotechnologists from the Philippines who are ready to contribute to your lab. Quick Turnaround: The process can move fast. As a nonprofit, this lab can get new staff in about six months. That’s efficient and effective. Cost Efficiency: By hiring international candidates, they can eliminate the need for temporary workers, reducing costs and training time. Plus, these new hires can stay for up to six years, providing stability and continuity. In summary, now you know you can utilize International recruitment not just for medical laboratory scientist but histotechnologist as well.

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💥 𝗧𝗵𝗲 $𝟯𝟬𝟬𝗕 𝗣𝗵𝗮𝗿𝗺𝗮 𝗦𝗵𝗮𝗸𝗲-𝗨𝗽: 𝗪𝗵𝗼 𝗪𝗶𝗹𝗹 𝗗𝗼𝗺𝗶𝗻𝗮𝘁𝗲 𝗼𝗿 𝗗𝗶𝘀𝗮𝗽𝗽𝗲𝗮𝗿? 🚨 Nearly 𝟮𝟬𝟬 𝗱𝗿𝘂𝗴𝘀 are losing patent protection—including 𝟲𝟵 𝗯𝗹𝗼𝗰𝗸𝗯𝘂𝘀𝘁𝗲𝗿𝘀. This time it’s biologics-heavy, and biosimilars are the game-changer. 🔮 𝗪𝗵𝗮𝘁’𝘀 𝗰𝗼𝗺𝗶𝗻𝗴? 💸 𝘼 𝙬𝙖𝙫𝙚 𝙤𝙛 𝙈&𝘼: Smaller biotechs with innovative pipelines will become billion-dollar battlegrounds as Big Pharma scrambles for survival. ⚗️ 𝘼 𝙣𝙚𝙬 𝙚𝙧𝙖 𝙤𝙛 𝙞𝙣𝙣𝙤𝙫𝙖𝙩𝙞𝙤𝙣: Pharma giants must disrupt or be disrupted. 🌍 𝙄𝙣𝙘𝙧𝙚𝙖𝙨𝙚𝙙 𝙥𝙖𝙩𝙞𝙚𝙣𝙩 𝙖𝙘𝙘𝙚𝙨𝙨: Biosimilars could reshape global healthcare. This could mean a shuffling of the deck. The industry is entering a $300B showdown, where only the bold and the strategic will shape the next era and thrive. 👀 𝗛𝗼𝘄 𝗱𝗼 𝘆𝗼𝘂 𝗲𝘅𝗽𝗲𝗰𝘁 𝘁𝗵𝗲 𝗳𝗶𝗲𝗹𝗱 𝘁𝗼 𝗲𝘃𝗼𝗹𝘃𝗲 𝗮𝗳𝘁𝗲𝗿 𝘁𝗵𝗶𝘀 𝘀𝗵𝗮𝗸𝗲-𝘂𝗽?

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