Merck Announces 100% Complete Response Rate with Zilovertamab Vedotin in Phase 2 waveLINE-007 Trial for Diffuse Large B-Cell Lymphoma, Dec 8, 2024
Merck announced positive results from the Phase 2 waveLINE-007 trial, demonstrating that zilovertamab vedotin, an investigational antibody-drug conjugate targeting ROR1, achieved a 100% complete response (CR) rate in untreated diffuse large B-cell lymphoma (DLBCL) patients when combined with R-CHP chemotherapy. The trial established 1.75 mg/kg as the recommended dose, with promising efficacy and manageable safety, including a 93.5% 12-month duration of response. Merck plans to advance this ROR1-directed ADC in multiple hematologic malignancies.
Full Article: Merck Zilovertamab Vedotin Trial Results
Affimed Announces Positive Results for AFM13 in Combination with AlloNK for Relapsed/Refractory Classical Hodgkin Lymphoma, Dec 8, 2024
Affimed presented promising results at the 66th ASH Annual Meeting, showcasing the combination of acimtamig (AFM13) and Artiva Biotherapeutics’ AlloNK in patients with relapsed/refractory classical Hodgkin lymphoma (R/R cHL). The combination demonstrated an overall response rate of 86%, with a complete response (CR) rate of 55%, with no unexpected safety signals. This data supports the potential of this combination in heavily pretreated patients with R/R cHL.
Full Article: Affimed AFM13 Combination Trial Results
Monte Rosa Therapeutics Provides Development Progress Update for MRT-2359 in MYC-driven Solid Tumors, Dec 9, 2024
Monte Rosa Therapeutics shared interim results from its Phase 1/2 trial of MRT-2359, a GSPT1-directed molecular glue degrader, in patients with MYC-driven solid tumors. The study selected a 0.5 mg dose on a 21 days on/7 days off schedule as the recommended Phase 2 dose. MRT-2359 demonstrated 60% GSPT1 degradation in tumor biopsies with favorable safety. Ongoing combination studies with enzalutamide and fulvestrant are planned for further clinical updates in Q1 2025.
Full Article: Monte Rosa MRT-2359 Trial Update
Innovent Presents Phase 1 Data for IBI343 in Advanced Pancreatic Cancer, Dec 9, 2024
Innovent Biologics presented updated data from its Phase 1 study of IBI343, an anti-CLDN18.2 antibody-drug conjugate (ADC), in patients with advanced pancreatic ductal adenocarcinoma (PDAC). The treatment achieved a 32.6% objective response rate and an 81.4% disease control rate in CLDN18.2-positive patients, with a median progression-free survival of 5.3 months. IBI343 has been granted FDA Fast Track designation, marking significant progress for patients with this hard-to-treat cancer.
Full Article: Innovent IBI343 Phase 1 Data
Carisma Therapeutics Announces Strategic Restructuring to Focus on Core Pipeline, Dec 9, 2024
Carisma Therapeutics announced a strategic restructuring to refocus on its in vivo macrophage engineering platform for fibrosis, oncology, and autoimmune diseases. This decision includes halting the development of CT-0525 and reducing its workforce by 34%. The company aims to prioritize high-potential programs, including its CAR-M therapies in collaboration with Moderna, to better address unmet medical needs.
Full Article: Carisma Therapeutics Restructuring Announcement
Opna Bio Presents Interim Data from Phase 1 Study of OPN-2853 in Advanced Myelofibrosis, Dec 9, 2024
Opna Bio shared interim results from its Phase 1 study of OPN-2853, a BET inhibitor, in combination with ruxolitinib for patients with advanced myelofibrosis. The combination showed a 50% spleen reduction in evaluable patients, demonstrating good tolerability. Additionally, preclinical data for OPN-6602 showed 100% tumor regression in multiple myeloma models, highlighting the potential for overcoming resistance mechanisms in oncology.
Full Article: Opna Bio OPN-2853 Trial Results
Tasca Therapeutics Launches with $52M Series A Financing to Develop Small Molecule Inhibitors for Multiple Oncology Indications, Dec 10, 2024
Tasca Therapeutics announced the closing of a $52 million Series A financing co-led by Regeneron Ventures and Cure Ventures, with additional support from Invus Group. The funding will advance the company’s drug discovery platform and support clinical development of its lead candidate, CP-383, a first-in-class anti-cancer molecule. The company plans to progress CP-383 into Phase 1/2 studies and expand its pipeline, targeting unique protein modifications to unlock novel therapeutic opportunities across various cancer types.
Full Article: Tasca Therapeutics Series A Financing
Lava Therapeutics Discontinues Phase 1 Program for LAVA-1207, Redirects Focus to Other Pipeline Candidates, Dec 10, 2024
Lava Therapeutics has announced the discontinuation of its Phase 1 clinical program for LAVA-1207, a bispecific gamma delta T-cell engager targeting metastatic castration-resistant prostate cancer. Despite some clinical signals, including PSA reductions and extended treatment durations, the drug did not meet internal benchmarks. Lava will now shift resources to further develop other pipeline candidates, including LAVA-1266, targeting acute myeloid leukemia and myelodysplastic syndrome. The decision is unrelated to safety concerns, with LAVA-1207 showing a favorable safety profile.
Full Article: Lava Therapeutics LAVA-1207 Trial Discontinuation
Cellectar Biosciences Provides Strategic Update, Shifts Focus to Early-Stage Radiopharmaceuticals, Dec 10, 2024
Cellectar Biosciences announced a strategic update focusing on advancing its early-stage radiopharmaceutical programs while seeking partnerships or divestiture for its treatment iopofosine I 131 for Waldenstrom’s macroglobulinemia. This decision follows FDA guidance requiring additional studies for accelerated approval. The company will continue developing its phospholipid ether drug conjugates CLR-121225 and CLR-121125 for solid tumors. Cellectar also revealed a 60% workforce reduction, aiming to extend its cash runway into Q3 2025, reaffirming its commitment to impactful therapies.
Full Article: Cellectar Biosciences Strategic Update
IDEAYA Biosciences Doses First Patient in Phase 1 Trial of IDE161 in Combination with Keytruda for Endometrial Cancer, Dec 10, 2024
IDEAYA Biosciences has dosed the first patient in its Phase 1 clinical trial evaluating IDE161, a first-in-class PARG inhibitor, in combination with Merck’s KEYTRUDA (pembrolizumab) for patients with MSI-high and MSS endometrial cancer. The trial builds on IDE161’s robust preclinical anti-tumor activity and FDA Fast Track designations for BRCA-mutated cancers. This collaboration aims to explore IDE161’s potential as a novel precision oncology treatment, improving outcomes for patients with challenging cancer types.
Full Article: IDEAYA Biosciences IDE161 Trial
Genesis Therapeutics Expands Leadership Team with Key Appointments, Dec 11, 2024
Genesis Therapeutics strengthens its leadership team with key 2024 appointments, including Dr. Shifeng Pan as Chief Scientific Officer, Alla Ivanova as SVP of Engineering, and Dr. Paul A. Friedman as Chairman of the Board. With extensive expertise in drug discovery and AI, these leaders aim to advance Genesis’ GEMS AI platform, expand the therapeutic pipeline, and drive breakthroughs in addressing severe diseases.
Full Article: Genesis Therapeutics Leadership Appointments
Alessa Therapeutics Secures $15M Seed Funding to Advance Prostate Cancer Therapy, Dec 12, 2024
Alessa Therapeutics has raised $15M in seed funding to support the development of Enolen®, a localized prostate cancer therapy currently in first-in-human trials. The funding, led by Mission BioCapital and JJDC, will accelerate progress toward delivering a targeted, enzalutamide-eluting seed implant with minimal systemic side effects, providing a promising alternative to invasive procedures for low-risk prostate cancer patients.
Full Article: Alessa Therapeutics Seed Funding
iTeos Therapeutics Discontinues Development of Inupadenant, Dec 12, 2024
iTeos Therapeutics has decided to deprioritize inupadenant, an A2A receptor antagonist, despite presenting promising Phase 2 data at ESMO IO 2024. While the combination therapy showed a 63.9% overall response rate in metastatic NSCLC, it did not meet clinical benchmarks necessary to justify further investment. iTeos will focus on advancing its TIGIT program, partnered with GSK, with updates expected in 2025.
Full Article: iTeos Therapeutics Trial Update
Gilead Sciences Appoints Dietmar Berger as Chief Medical Officer, Dec 12, 2024
Gilead Sciences announced the appointment of Dietmar Berger, MD, PhD, as Chief Medical Officer, effective January 2, 2025. Dr. Berger brings over 25 years of experience in drug development, having led global programs at Sanofi, Genentech, Bayer, and Amgen. He will oversee Gilead’s Development and Medical Affairs organizations, focusing on virology, oncology, and inflammation portfolios.
Full Article: Gilead Sciences Appointment
Repare Therapeutics Announces Positive Results from MYTHIC Phase 1 Trial, Dec 12, 2024
Repare Therapeutics revealed promising results from the MYTHIC Phase 1 trial, evaluating the combination of Lunresertib and Camonsertib in patients with endometrial and platinum-resistant ovarian cancers. The combination therapy demonstrated durable clinical benefits, with response rates of 25.9% in endometrial cancer and 37.5% in PROC patients. Repare plans to initiate Phase 3 trials in 2025, aiming to establish this combination as a new standard of care for these underserved populations.
Full Article: Repare Therapeutics Trial Results
PDC*line Pharma Presents Phase III Results for PDClung01 Cancer Vaccine, Dec 12, 2024
PDC*line Pharma presented promising Phase I/II results for PDClung01, an off-the-shelf cancer vaccine, at ESMO-IO 2024. Combined with pembrolizumab, PDClung01 achieved a 55% objective response rate and improved progression-free survival by 36% in stage IV NSCLC patients with high PD-L1 expression. The vaccine showed a mild safety profile, with most adverse events being grade 1-2. A randomized Phase IIb trial is planned for 2026, highlighting the potential of PDClung01 in NSCLC immunotherapy.
Full Article: PDC*line Pharma Trial Results
Candel Therapeutics Announces Promising Phase 3 Results for CAN-2409 in Prostate Cancer, Dec 14, 2024
Candel Therapeutics revealed positive Phase 3 results for CAN-2409, a viral immunotherapy, in intermediate-to-high-risk localized prostate cancer. In combination with valacyclovir and radiation therapy, CAN-2409 significantly improved disease-free survival by 14.5% at 54 months, with a 30% reduction in progression or death risk compared to radiation alone. The therapy also achieved an 80.4% pathological complete response rate, showing strong potential as a transformative treatment for prostate cancer.
Full Article: Candel Therapeutics CAN-2409 Results
