Pennsylvania NY NJ Biotech Networks’ Post

Gene&Cell Therapy >> Yuhan, Ubix ink licensing deal; Xenpozyme's royalty deal: Plus, news about Ipsen, Exelixis, Innovent, Codexis, Crosswalk Therapeutics and J&J: Yuhan licenses prostate cancer drug: The biotech will pay Seoul-based Ubix Therapeutics $3.6 million upfront and up to $105 million in biobucks for a preclinical androgen receptor degrader known as UBX-103. — Kyle LaHucik DRI Healthcare Trust expands royalty deal for Xenpozyme: The company will pay $13.25 million upfront and up to $32.5 million in milestones to HLS Therapeutics. The drug, which is used to treat patients with acid sphingomyelinase deficiency, is marketed by Sanofi. DRI first inked a royalty deal for Xenpozyme in 2022. — Jaimy Lee Ipsen, Exelixis expand deal: The biotechs broadened their nearly decade-old collaboration on cancer drug Cabometyx. Updated financial terms were not disclosed. — Kyle LaHucik Innovent touts Ph1 data for anti-Claudin drug: The company’s 6 mg dose of IBI343 achieved a 47.1% overall response rate and 88.2% disease control rate in patients with advanced gastric or gastroesophageal junction adenocarcinoma. The antibody-drug conjugate targets CLDN18.2, which is expressed in up to 80% of patients with gastric cancer. — Ayisha Sharma Codexis sells gene therapy assets: The California biotech agreed to offload its Fabry and Pompe disease compounds to Crosswalk Therapeutics. — Kyle LaHucik Johnson & Johnson talc settlement challenge fails: A judge last week rejected an attempt by a group of claimants to derail J&J’s talc bankruptcy settlement plan and denied a motion that would have prevented the company from filing for bankruptcy outside of New Jersey. J&J continues to pursue a $6.5 billion plan that would settle tens of thousands of ovarian cancer suits. — Nicole DeFeudis #lucidquest #genetherapy #celltherapy

FDA Guidance for #CARTcellTherapy published and available for download - which I highly recommend. And there's an upcoming webinar that will answer additional questions. #CellTherapyManufacturing #CellTherapy #Apheresis #Cryopreservation

Great news for #genetherapy! Excited about the final FDA guidance on CAR T cell products. This will boost safe & effective development of these game-changing cancer treatments. Join the FDA webinar on March 7th to learn more! #CBEROTP #cellandgenetherapy

Major milestone in demonstrating the impact of organ-on-a-chip biology in drug development.

Biosimilar regulatory framework is changing towards tailored development starting from smaller and “simpler” biologics and so on....

On the heels of last week's Scrip article on top 10 biggest drug launches expected in 2024, In Vivo highlights five high-value unpartnered assets (and three honorable mentions) in biotech pipelines that may draw strong interest this year. Not surprisingly, assets related to CAR-T cell therapy and NASH are represented on the list. NPV, predicted launch date, MoA, as well as background information about the asset owner, is included for each highlighted asset and provides highly relevant context. Keep an eye out for these assets as the year progresses. The analysis is powered by Evaluate proprietary data derived from consensus forecasts.

Ligand binding assays provide higher sensitivity than LC-MS for quantitation of oligo therapeutics in preclinical and clinical PK and biodistribution studies. Learn how these assays are automated and miniaturized on the CD-based Gyrolab platform in a 3-part feature including a podcast, video, and infographic! #oligo #gyrolab #PK #pharmacokinetics #genetherapy https://hubs.ly/Q02wNN5g0

The time for allogeneic cell therapy is coming!? What’s the concern of FDA? How to generate the appropriate safety tests for these allogeneic cell-based medical products ? Last month, April 2024, FDA announced a Draft Guidance about the “Safety Testing of Human Allogeneic Cells Expanded Safety Testing of Human Allogeneic Cells Expanded for Use in Cell-Based Medical Products” to provid recommendations for determining the appropriate cell safety testing to support an IND or a BLA. The guidance was issued by CBER and supplements the following two final guidances: 1. “Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs); Guidance for Industry,” dated January 2020 , and 2. “Guidance for FDA Reviewers and Sponsors: Content and Review of Chemistry, Manufacturing, and Control (CMC) Information for Human Somatic Cell Therapy Investigational New Drug Applications (INDs),” dated April 2008 #allogeneic #celltherapy https://lnkd.in/gXF-Pwfb

Register for this Endpoints News webinar on September 26 with experts from Sanofi who will discuss: - An overview of how to quickly go from protein to structure - Key examples of multi-specific drugs and the structural insights of a CEACAM5-targeting antibody drug conjugate (ADC) - How the adoption of #cryoEM has significantly increased the number of the targets that can be identified for clinical trials in both #biopharma and #biotech #SBDD #DrugDesign

Learn about in silico models for translating data from rat studies to human contexts to improve your understanding of psoriasis drug development and its potential applications. Join Frederico Martins for his presentation at the 55th Brazilian Congress of Pharmacology and Experimental Therapeutics. https://lnkd.in/gHEtHwp2 #psoriasis #pharmacology #drugdevelopment