Robert Kernstock

The #FDA has cleared the IND application for TYRA-300, an oral FGFR3-selective inhibitor, for use in low-grade, intermediate-risk #NMIBC. This regulatory decision paves the way for a phase 2 clinical trial of TYRA-300 in this patient population. #blcsm https://lnkd.in/eDHSH_Zh

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📢 In March 2024, the #FDA officially released the finalized version of the "Clinical Pharmacology Considerations for Antibody-Drug Conjugates Guidance for Industry." Initially published in February 2022, this guidance outlines the FDA's latest concepts in clinical pharmacology and provides specific, professional recommendations on bioanalytical methods, dosing strategies, dose and exposure-response analysis, intrinsic factors, QTc assessments, immunogenicity, and DDIs. Our Quantitative Clinical Pharmacology team at Amador has prepared a detailed summary of this guidance to help you navigate and apply these recommendations in your drug clinical development projects.💡 🔗 https://hubs.la/Q02zByMW0 #ClinicalPharmacology #ADCs #DrugDevelopment #Bioanalytics #Pharmacokinetics #RegulatoryGuidance #Innovation #Immunogenicity

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Delve into a discussion with experts from FDA and industry about MIDD Strategies in RNA-Based Oligonucleotide Drug Development in this upcoming #ASCPTwebinar. 4/24 at 12 pm ET: https://bit.ly/49MdUxw

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The FDA recently released a draft guidance offering best practices for common questions received by the Office of Therapeutic Products (OTP). Read the summary by Cencora's Louis Cicchini and Cori Gorman in @DrugDiscoveryDev here: https://ow.ly/nnBG50UnO7y

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FDA Guidance on CGT Products: A New Era for Regulatory Clarity? The FDA’s draft guidance on CGT products is a critical resource for sponsors. It offers clear expectations for IND submissions, expedited pathways, and product characterization. Our team sees this as an opportunity for sponsors to take a more proactive approach with regulators - especially through early meetings like INTERACT and pre-IND. But we know the execution isn’t always straightforward. What are your thoughts on the guidance? Are you seeing clearer pathways, or do the hurdles remain? 👉 Access the guidance here: https://lnkd.in/eQbNpvJK #FDA #CGT #CellTherapy #GeneTherapy #INTERACT #preIND

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Bristol Myers Squibb has queued a Phase 1 study of Orum Therapeutics’ ORM-6151 (BMS-986497), a first-in-class, anti-CD33 antibody-enabled GSPT1 degrader for the treatment of patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. The study will enroll an estimated 35 patients and is due to start in late May 2024. Orum Therapeutics has developed a new class of ADC payloads, called neoDegraders, to specifically degrade intracellular target proteins within cancer cells via the E3 ubiquitin ligase pathway. Conjugated to antibodies, neoDegraders are designed to be delivered specifically to cancer cells and degrade the intracellular target protein and cause tumor cell death. https://lnkd.in/edTcDRFj

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Dr. Nina E. Weisser, Director of Preclinical, Multispecific Antibody Therapeutics, recently authored an article published in Drug Target Review discussing the development of trispecific T cell engagers (TriTCEs) with integrated CD28 costimulation. TriTCEs are designed to address the limitations of conventional bispecific TCEs in treating solid tumors by providing balanced T cell activation, leading to potentially more sustainable anti-tumor responses. This innovative approach could significantly advance immunotherapy for patients with difficult-to-treat solid tumors. Access the article: https://lnkd.in/ewRJvPA9

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CRS3123 is a small molecule protein synthesis inhibitor that acts on the novel target methionyl-tRNA synthetase (MetRS). CRS3123 has numerous potential advantages over current CDI therapies.

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> Pharmaceutical Technology talks with Brittany L. Hayes, Ph.D. after #AAPSPharmSci on challenges in developing peptide-based OSD drugs: https://lnkd.in/e-U4HMDB The development of oral peptide-based drugs presents unique challenges, specifies Brittany Hayes, PhD, Highly Potent & Oncology Platform Director at CordenPharma, due to the harsh environment of the gastrointestinal tract, highly acidic stomach, and enzymes that degrade peptides. “New manufacturing technologies and formulation techniques have shown to increase bioavailability by a few percentage points,” says Hayes. “But there's a lot of variability here, including variability from one patient to the next and also in the same patient from one day to the next day. One of the big ones that's been out there is permeation enhancers.” Analytics is an important factor for the development of peptide-based drugs, highlights Hayes, because degradation products may be difficult to detect and quantify. “And then, with the use of these permeation enhancers, there needs to be simultaneous dissolution of the permeation enhancer and the peptide,” she says. “So, there may be some challenges here with analytical methods.” Learn more about CordenPharma's offerings for: OSD Clinical to Commercial Manufacturing: https://lnkd.in/eRF8Aekf Bioavailability Enhancement: https://lnkd.in/e-Q5nWQZ #CordenPharma #cmdo #osd #peptidedrugs #peptides #bioavailability #drugformulation #pharmaceuticals #permeationenhancers #hpapis #oncology #pharmamanufacturing #technology

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As experts in evaluating immunogenicity risks for complex generic peptides, ProImmune was honored to participate as subject matter experts (Drs. Jeremy Fry & Emilee Knowlton, Ph.D.) in the recent workshop co-hosted by the US FDA and the Center for Research on Complex Generics. The workshop addressed key topics such as best practices for assessing adaptive immunogenicity related to product impurities, using orthogonal methods like in vitro MHC binding and functional T cell proliferation assays. It also covered strategies for incorporating innate immune response modulating impurities (IIRMIs) as suitability controls in cytokine release assays to demonstrate assay sensitivity. The importance of filing a DMF with the FDA, including detailed assay protocols and validation data, was also highlighted. ProImmune leads the industry with the fastest turnaround times, ensuring we enable our clients to meet critical submission deadlines. Furthermore, our ProStorm® Cytokine Release Assay and ProMap® T Cell Assay methods have been successfully filed with the FDA. To learn more about our cutting-edge technologies designed to assess the immunogenicity risks of your complex generic peptides and support regulatory submissions, please reach out to us. Full presentations from this workshop are freely available on the CRCG website via the link below: https://lnkd.in/gpPu_jsf

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Bristol Myers Squibb has posted details for a Phase 3 study (NCT06646276) of BMS-986489 (BMS-986012+nivolumab fixed dose combination) in combination with carboplatin plus etoposide vs atezolizumab in combination with carboplatin plus etoposide as first-line therapy in participants with extensive-stage small cell lung cancer. BMS-986012 is a novel, nonfucosylated, human IgG1 antibody that binds specifically to Fucosyl-GM1, which is a monosialoganglioside with limited expression in healthy tissues and high expression on SCLC cells. Due to start in January 2025, the study will enroll an estimated 530 participants. #mabs https://lnkd.in/epK644TA

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📑 Sifting through lengthy research papers and articles can slow down discovery. Open Targets now uses LLM-powered summaries to tackle this challenge—helping researchers quickly uncover key insights about drug targets and therapeutic opportunities. Discover how this feature accelerates your research! ⚡https://lnkd.in/eY7pSfAH #OpenTargets #DrugDiscovery #BiomedicalResearch #LLMs #LifeSciences #AIPowered #ScientificInnovation

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Join us at #ACSDenver to interact with international chemists! 𝗘𝗻𝗴𝗮𝗴𝗶𝗻𝗴 𝘄𝗶𝘁𝗵 𝘁𝗵𝗲 𝗔𝗖𝗦: 𝗧𝗵𝗿𝗼𝘂𝗴𝗵 𝘁𝗵𝗲 𝗘𝘆𝗲𝘀 𝗼𝗳 𝗜𝗻𝘁𝗲𝗿𝗻𝗮𝘁𝗶𝗼𝗻𝗮𝗹 𝗖𝗵𝗲𝗺𝗶𝘀𝘁𝘀 Want a new perspective on engagement in the ACS? Catch our presenters at this poster session!

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LAST CHANCE! Therapeutic Antibody Discovery: Selecting Effective Candidates for Emerging Viral Threats In this webinar TODAY, Robert Carnahan and Lauren Williamson, from Vanderbilt University Medical Center, describe recent advancements in therapeutic antibody discovery, enabled by the Bruker Beacon® Platform, that can support a rapid response to novel viruses. Register now to join us for this free webinar sponsored by Bruker: https://hubs.li/Q02R6zZq0 Vincent Pai #Antibodies

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