We recently announced the clearance of an IND application with the U.S. FDA for CDR404, our lead program in development as the first of its kind precision immunotherapy for solid tumors. CDR404 is an antibody-based, bivalent and bispecific MAGE-A4 T-cell engager (TCE) based on our unique M-gager® technology for targeting intracellular tumor antigens through the major histocompatibility complex (MHC). As we look ahead to initiating Ph 1 trial enrollment of CDR404 in the coming months, we are continuing to advance several additional programs leveraging our M-gager technology against promising intracellular cancer targets with the goal of improving patient lives. Stay tuned to learn what’s next from CDR-Life! Learn more here: https://lnkd.in/e2ME_tDq
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Moderna and Merck today announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk #melanoma (stage III/IV) following complete resection. The companies have initiated Phase 3 studies in the adjuvant setting in patients with high-risk melanoma and non-small cell lung #cancer and plan to rapidly expand to additional tumor types. Learn more: https://lnkd.in/dW4eZiQi
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Moderna mRNA cancer treatment breakthough Significant progress in the application of mRNA technology to treat melanoma, with Moderna and MSD announcing follow-up data from the phase 2B trial of their mRNA-based individualised neoantigen therapy delivered in combination with KEYTRUDA Over three years, melanoma patients who received the mRNA treatment in combination with KEYTRUDA saw the risk of recurrence or death cut by 49% and metastasis cut by 62% compared to patients who received only KEYTRUDA Moderna and MSD are now initiating Phase 3 studies for patients with both high-risk melanoma and small-cell lung cancer, with plans to rapidly expand the treatment to other tumour types #melanoma #cancertherapy #mrna #mrnavaccines
Moderna and Merck today announced follow-up data from the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study, a clinical trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with KEYTRUDA, Merck's anti-PD-1 therapy, in patients with resected high-risk #melanoma (stage III/IV) following complete resection. The companies have initiated Phase 3 studies in the adjuvant setting in patients with high-risk melanoma and non-small cell lung #cancer and plan to rapidly expand to additional tumor types. Learn more: https://lnkd.in/dW4eZiQi
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Immutep Limited is pleased to announce we have received positive feedback from the FDA regarding our planned TACTI-004 Phase III trial of efti in combination with KEYTRUDA®, MSD's anti-PD-1 therapy, and histology-based platinum doublet chemotherapy for the treatment of first-line metastatic non-small cell lung cancer (1L NSCLC), regardless of PD-L1 expression. The TACTI-004 Phase III trial, which will enrol ~750 patients, is based on the positive efficacy and safety data in 1L NSCLC generated from the TACTI-002 Phase II and INSIGHT-003 trials. Read the announcement: https://bit.ly/3WvCBK9 #LAG3 #biotechnology
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Clinical trial update! We are thrilled to report that our VET3-TGI novel oncolytic immunotherapy is ready for Phase 1/1b testing in incurable advanced solid tumors. VET3-TGI specifically targets and preferentially kills tumor cells directly while stimulating anti-cancer immunity by expressing its therapeutic payload consisting of the transgenes for interleukin-12 and a TGFbeta inhibitor. The study will evaluate the safety profile and efficacy of VET3-TGI when administered as a monotherapy and in combination with checkpoint inhibitor therapy. https://bit.ly/3xF6jmu
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Incyclix Bio announces FDA clearance of investigational new drug application for INX-315 in patients with advanced or metastatic cancer. INX-315 is a novel, potent and selective inhibitor of Cyclin-dependent kinase 2 (CDK2) with compelling pre-clinical efficacy and safety data. CDK2 is thought to play an important role in driving proliferation of certain cancers, including those harboring CCNE1 amplification and breast cancers that have acquired resistance to CDK4/6 inhibitors (CDK4/6i). Chemenu has been working to develop more compounds for drug discovery. Here comes the building blocks we can provide: https://lnkd.in/gfrVcWYE #INX-315 #Cyclin #kinase #CDK2 #cancer #buildingblocks
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Merck’s Keytruda claims digital marketing crown, holding off challenges from AstraZeneca, BMS Merck’s dominance of the PD-1/L1 checkpoint inhibitor space extends to the digital realm. | Merck’s dominance of the PD-1/L1 checkpoint inhibitor space extends to the digital realm. That is the topline finding of a study of digital marketing trends, which found Merck has the highest traffic to patient and unbranded U.S. sites about non-small cell lung cancer (NSCLC). https://lnkd.in/da_U-VyC
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R&D, Drug Development & Medical Affairs, Market Access Global Clinical Studies and Product Lifecycle Management, RA, Board of Directors, International Speaker, Development Programs, Strategic Leadership.
U.S. expanded access program (EAP) for Telix’s breakthrough investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). The patient was dosed at ARA Diagnostic Imaging - Austin Radiological Association in Austin (TX) ccRCC is the most common and aggressive form of kidney cancer, making up around 80% of the more than 76,000 kidney cancer diagnoses in the U.S. each year. This EAP follows the successful global Phase III ZIRCON study of TLX250-CDx which reported positive results, meeting its primary and secondary endpoints. #expandedaccess #renalcare #kidneycancer #PET #positron #imagingtechnologies #innovación
The first patient has been dosed in a U.S. expanded access program (EAP) for Telix’s breakthrough investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). The patient was dosed at ARA Diagnostic Imaging - Austin Radiological Association in Austin (TX) ccRCC is the most common and aggressive form of kidney cancer, making up around 80% of the more than 76,000 kidney cancer diagnoses in the U.S. each year. This EAP follows the successful global Phase III ZIRCON study of TLX250-CDx which reported positive results, meeting its primary and secondary endpoints. Ahead of regulatory approval, this program provides continued access to TLX250-CDx to address a clear unmet patient need. To learn more click here: https://bit.ly/3GANq50 TLX250-CDx has not received a marketing authorisation in any jurisdiction.
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The first patient has been dosed in a U.S. expanded access program (EAP) for Telix’s breakthrough investigational positron emission tomography (PET) imaging agent TLX250-CDx (89Zr-DFO-girentuximab) in clear cell renal cell carcinoma (ccRCC). The patient was dosed at ARA Diagnostic Imaging - Austin Radiological Association in Austin (TX) ccRCC is the most common and aggressive form of kidney cancer, making up around 80% of the more than 76,000 kidney cancer diagnoses in the U.S. each year. This EAP follows the successful global Phase III ZIRCON study of TLX250-CDx which reported positive results, meeting its primary and secondary endpoints. Ahead of regulatory approval, this program provides continued access to TLX250-CDx to address a clear unmet patient need. To learn more click here: https://bit.ly/3GANq50 TLX250-CDx has not received a marketing authorisation in any jurisdiction.
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Want to count cells like Iovance Biotherapeutics, Inc.? Use a NucleoCounter® An exciting cancer immunotherapy study by Iovance Biotherapeutics, Inc. https://okt.to/buI3K4 showed that their Gen 2 tumor-infiltrating lymphocyte (TIL) manufacturing process produces effective drug products for adoptive cell transfer (ACT) across five different solid tumor types 💉 The process currently used to produce Lifileucel for melanoma proved highly reproducible, as shown by the NucleoCounter® NC-200™. Key findings included: - Comparable manufacturing success rates across drug products - High purity TILs yielded by the Gen 2 processes for all indications - Robust IFN-γ response upon reactivation Want to elevate your processes? Book a NucleoCounter® NC-202™ demo: https://okt.to/C6BO3n 🤝
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Last week, Medigene AG secured a patent protecting its T cell receptor directed against NY-ESO-1, aligning with analogous patents previously approved in the United States, Japan, South Korea, Taiwan, and Australia. Read here the PR: https://lnkd.in/dHrZtMsJ NY-ESO-1 is a a well-recognized and validated cancer-testis antigen, which is expressed in multiple tumor types varies with higher prevalence in metastatic vs. primary tumors. This TCR, alongside the PD1-41BB costimulatory switch protein, are the main element of Medigene AG lead program MDG1015, which is advancing towards the clinic. More information on MDG1015: https://lnkd.in/d6k_fakE As initial clinical indications for MDG1015 the Company selected gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma. More information around indication selection here: https://lnkd.in/dT6W2sPS #Platform2Patient
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Passionate Life Sciences Entrepreneur, CEO at Shape Biopharmaceuticals
4moCongratulations for IND clearance! Wishing you good luck with the trial!