Celltelligence’s Post

GT Biopharma, Inc., a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company's proprietary natural killer (NK) cell engager, TriKE® platform, announced the US Food and Drug Administration has cleared its IND application for GTB-3650, allowing the company to proceed with a Phase 1 clinical trial, which is anticipated to start in second half of 2024. GTB-3650 is being developed for the treatment of CD33 positive leukemias, including AML and MDS. GTB-3650 TriKE is the first TriKE product candidate under development that utilizes camelid nanobody technology. GTB-3650 TriKE is a tri-specific molecule composed of a camelid nanobody that binds the CD16 receptor on NK cells, a single chain variable fragment that recognizes CD33 on tumor cells, and human IL-15. #mabs https://lnkd.in/esQGMPGP

Drug Discovery News Roundup from May 2024 | https://lnkd.in/gKF2UZVX In May, we saw transactions worth millions and billions of dollars to advance next-generation neuroplastogens from AbbVie and Gilgamesh Pharmaceuticals, KRAS G12C inhibitors from BridgeBio Oncology Therapeutics, a potential Pompe disease treatment from Shionogi & Co., Ltd and Maze Therapeutics and molecular glues from Takeda and Degron Therapeutics. We also highlight positive clinical readouts for hot targets such as TTR stabilizers, Hedgehog pathway inhibitors, plasma kallikrein inhibitors, DPP-1 inhibitors, and PCSK9 inhibitors. Did you miss any key updates? Here's a recap of May's most notable drug discovery news highlights! Link | https://lnkd.in/gKF2UZVX

🚀 Presenting ADC Digest for April 2024!🔬💊 This week, the landscape of Antibody Drug Conjugates (ADCs) is ablaze with remarkable advancements! 🔬 💊ADC Therapeutics Accelerates R&D with Genedata Biologics 💊BiVictriX Therapeutics AML treatment granted Orphan Drug status by FDA 💊ProPhase Labs unveils Project ZenQ-AI Stay tuned for more updates and breakthroughs in the world of Antibody-Drug Conjugates!  #ADC #orphandrug #Innovation #ADCnews #CIScientists #Antibodydrugconjugate

(Benefit-Risk Management / Bladder Cancer Treatments / (Revised) US FDA Draft Guidance) If you're in the clinical cancer space (and possibly not in bladder CA area), I would still recommend reviewing this guidance as the latest pulse on FDA's onc considerations during drug development and net-benefit assessments for bringing a product to market. Start w/table of contents. Drug or biologic, both inclusive. #fda #cder #cber #drugs #biologics #bladdercancer #cancerdrugs #clinicalstudies #clinicalresearch #clinicaltrials

#ACROHighlights [Featured Product] 📣 Exciting news! Pfizer's Class 1 new drug, PF-06940434 injection, has been approved for clinical trials in China. This Integrin αv/β8 antagonist shows promising potential against tumors. By selectively binding and blocking the Integrin αv/β8 receptor, it prevents the activation of TGF-β1, enhancing anti-tumor immunity in the tumor microenvironment and promoting tumor cell death. Discover more about Integrin therapeutic drug development and explore our comprehensive range of high-quality Integrin recombinant proteins, covering all 24 subtypes! 🔬 💥Visit our official website: https://smpl.is/8ercr #Pfizer #clinicaltrial #IntegrinAntagonist #AntiTumorActivity #Immunotherapy #TumorMicroenvironment #ResearchandDevelopment #BioPharma #ACROBiosystems

The topic of ADCs is gaining traction in multiple Phorums within BioPhorum, representing a burgeoning sector in oncology therapeutics. Many BioPhorum members have an ADC candidate in their pipeline. Global harmonization challenges impacting speed to patients have prompted our members to collaborate. Together, we aim to enhance global acceptability, providing regulatory professionals with confidence and clarity on the path forward. #BioPhorum #ADCs https://lnkd.in/ePuQK6k5

Fenebrutinib: A Potent, Selective, and Noncovalent BTK Inhibitor Author&Editor: Lisha Wang Several covalent and noncovalent Bruton's tyrosine kinase (BTK) inhibitors have been approved for the treatment of various cancers, including ibrutinib, acalabrutinib, zanubrutinib, and pirtobrutinib. Fenebrutinib, a potent and selective noncovalent BTK inhibitor, distinguishes itself from these approved BTK drugs. It is currently undergoing Phase III clinical development at Roche, in collaboration with its subsidiary Genentech, for the treatment of primary progressive multiple sclerosis (PPMS) and relapsing-remitting multiple sclerosis (RRMS). Roche has recently released 48-week data from the FENopta open-label extension (OLE) study (NCT05119569). The results indicate that 96% of patients treated with fenebrutinib were relapse-free at one year, with an annualized relapse rate (ARR) of 0.04. Additionally, there was no change in disability over 48 weeks, as measured by the Expanded Disability Status Scale (EDSS). Fenebrutinib was developed from a previous clinical candidate GDC-0834 by modifying it to prevent rapid amide bond hydrolysis in humans. Reference : (1) https://lnkd.in/dVanqq_E (2)  James J. Crawford ; et al. J. Med. Chem. 2018, 61, 2227-2245. Product.pharmablock.com PharmaBlock Group; PharmaBlock (USA), Inc. #DrugDiscovery #Innovation #Biotech

ORIC-533 is a potential best-in-class, oral inhibitor of CD73 developed by ORIC Pharmaceuticals which is currently in a Ph. Ib trial for the treatment of relapsed/refractory multiple myeloma (MM). It inhibits the CD73-mediated conversion of AMP to adenosine which generates an immunosuppressive tumor microenvironment and has the potential to be a next-generation immunotherapy. The in-depth use of co-crystal structures led the team to discover a novel set of phosphonate bioisosteres which were able to achieve bioavailability for a highly polar scaffold. The structure and discovery story of ORIC-533 were recently presented at the ACS Spring 2024 Meeting in New Orleans. Chemenu has been working to develop more compounds for drug discovery. Here come the building blocks we can provide: https://lnkd.in/g9Y68VZP #ORIC-533 #CD73 #MultipleMyeloma #AMP #Chemenu #buildingblocks

The FDA has issued a final guidance on the clinical pharmacology aspects of antibody-drug conjugates (ADCs), a promising class of targeted cancer therapies that combine an antibody, a linker, and a cytotoxic drug. The guidance provides recommendations on the design and analysis of clinical studies to evaluate the pharmacokinetics, pharmacodynamics, drug interactions, and immunogenicity of ADCs. The guidance also addresses the challenges and opportunities of applying model-informed drug development approaches to ADCs. This guidance is expected to facilitate the development and approval of safe and effective ADCs for patients with cancer. FDA announces a final guidance on clinical pharmacology considerations and recommendations for antibody-drug conjugates development programs. #shenclinicalservices #fda #fdaregulations https://lnkd.in/d-asxqj2.

Obe-cel, an investigational therapy utilizing CD19 CAR T cells, aims to address the limitations in clinical effectiveness and safety observed with existing CD19 CAR T cell treatments. Autolus Therapeutics presents extended follow-up results and further data analysis from the key Phase Ib/II FELIX study of obecabtagene autoleucel (obe-cel) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia, at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Benefit from Expert Insights and Extensive Analysis with DelveInsight Business Research LLP's ASCO 2024 Exclusive Coverage! https://lnkd.in/gE3gUFyM #ASCO24 #CancerTreatment #ASCO2024 #LungCancer #NSCLC #PharmaInnovation #MedicalResearch #OncologyAdvancements #ClinicalOncology #Pharmaceuticals #HealthcareConference #CancerResearch #ClinicalPractice #MedicalBreakthroughs #CancerCare #PharmaLeaders