Checkpoint Therapeutics Inc’s Post

In regulatory affairs news, Checkpoint Therapeutics Inc announced it has reached alignment with the Food and Drug Administration on its biologics license application (BLA) resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. Cosibelimab is a human IgG1 monoclonal antibody that directly binds to programmed death-ligand 1 (PD-L1) and blocks its interactions with the PD-1 and B7.1 receptors. https://lnkd.in/eydHXwXx

Coming off a $50 million series B financing round, radiopharmaceutical developer Ratio Therapeutics has expanded its partnership with Florida-based CDMO PharmaLogic. About Ratio’s Technology Platforms Ratio Therapeutics’ 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. Trillium™ technology is a proprietary and innovative platform that incorporates a tunable, structural motif enabling our compounds to reversibly bind to albumin, thereby modulating their pharmacokinetics (PK) and improving drug availability, tumor delivery, and tumor loading, while simultaneously reducing the side effects commonly observed with other radiotherapies.   Ratio’s Macropa™ technology reflects a proprietary chelator that is used to attach the alpha emitting radionuclide actinium-225 to Trillium™ and other compounds. Its unique chemistry enables ease of manufacture and improves in vivo stability of the resulting compound. The news: https://lnkd.in/gGtQ9sen Ratio therapeutics: https://lnkd.in/gMuBGxPR

So much potential with this therapy to help patients with solid tumors. Will be a great benefit to patients across the country to have access to #Amtagvi moving forward in 2024.

Priority Review Granted in the US for Enhertu in Metastatic HER2-Positive Solid Tumors AstraZeneca and Daiichi Sankyo's application for their cancer drug Enhertu has been accepted and granted Priority Review by the FDA. The drug is being reviewed for the treatment of adult patients with unresectable or metastatic HER2-positive solid tumors who have received prior treatment or have no other treatment options. The application is based on data from a Phase II trial where Enhertu showed promising results in previously treated patients across various types of HER2-expressing metastatic solid tumors. If approved, Enhertu would be the first tumor-agnostic HER2-targeted medicine. For more details please click the link! https://lnkd.in/dK2gkpvT #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Huge deal in Feb 2024 1. https://lnkd.in/gQr-WJsM Bristol Myer Squibb acquire Rayzebio for $4.1Bn Rayzebio is late-stage clinical pharmaceutical company, leading radiopharmaceutical therapy. One of leading pipeline is RYZ101, which targets somatostatin receptor (SSTR)2 in gastroenter pancreatic neuroendocrine tumors(GEP-NETs) and extensive small cell lung cancer(ES-SCLC) 2. https://lnkd.in/gW-9rA5c Novo's Acquisition of Catalent with $16.5Bn huge demand at Wegovy and Ozempic triggers the M&A of Catalent

Congratulations to Biond Biologics Ltd.! The company announced that the first patient has been dosed in a first-in-human clinical trial testing BND-35, a humanized ILT3/LILRB4 antagonist antibody. BND-35 binds ILT3/LILRB4 with high affinity and blocks its interaction with ligands present in the tumor microenvironment. BND-35-induced immune activity enhancement was demonstrated in a unique system of patient-derived tumoroids. In vivo, blocking ILT3/LILRB4 activity with BND-35, as monotherapy or in combination therapy, resulted in decreased tumor growth and induced a pro-inflammatory phenotype in tumor-resident T cells and myeloid cell populations. Further information about the trial is available in https://lnkd.in/dKm5Q6Fr (Trial Identifier: NCT06274437). https://lnkd.in/dgSZGVTV

Roche Terminates Collaboration with Repare Therapeutics for ATR Inhibitor Camonsertib Development Roche and Repare Therapeutics have ended their collaboration agreement for the development of camonsertib, a cancer therapy. Repare will now take over the development of camonsertib and is optimistic about its potential. The collaboration between Roche and Repare involved a significant upfront payment and had the potential to reach up to $1.2 billion based on various milestones. Recent milestones include Repare achieving a $40 million payment upon the initiation of a Phase II trial. Roche has terminated the agreement for camonsertib's development and commercialization, citing a review of its pipeline and external factors. Repare remains committed to the development of camonsertib and expects to meet its obligations under the agreement. For more details please click the link! https://lnkd.in/d_MqC7f9 #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical

Uncovering the potential of #ADCs to target tumours 👇 European Pharmaceutical Review discusses how #ADCs are set to play a pivotal role in the future of oncology, thanks to their potential to offer targeted treatments with a lower risk of side effects. Click the link below to read the article 🔗 https://lnkd.in/eNPmy5kg

AbbVie Submits Biologics License Application for Telisotuzumab Vedotin in NSCLC AbbVie has submitted a Biologics License Application to the U.S. FDA for Telisotuzumab Vedotin (Teliso-V), an investigational antibody-drug conjugate targeting c-Met overexpressing non-small cell lung cancer. Supported by positive data from the Phase 2 LUMINOSITY trial and a Breakthrough Therapy Designation granted by the FDA in 2021, Teliso-V aims to provide a first-in-class treatment option for patients with limited options. Dr. Roopal Thakkar, AbbVie's Executive Vice President of Research and Development, expressed optimism about Teliso-V’s potential to improve outcomes for these high-need patients. The ongoing Phase 3 TeliMET NSCLC-01 trial continues to evaluate its efficacy. For more details please click the link! https://lnkd.in/d_-HrWgU #marketaccess #reimbursement #pricing #hta #heor #healtheconomics #medicaldevices #pharmaceutical 

Aprea Therapeutics begins patient dosing in ACESOT-1051 phase 1 trial evaluating oral WEE1 inhibitor APR-1051