Zai Lab and Novocure Announce Positive Topline Results from Phase 3 PANOVA-3 Trial for Pancreatic Cancer, Dec 2, 2024
Zai Lab and Novocure announced that the Phase 3 PANOVA-3 trial of Tumor Treating Fields (TTFields) therapy in combination with chemotherapy for pancreatic adenocarcinoma met its primary endpoint. The trial demonstrated a statistically significant improvement in median overall survival (mOS) with TTFields therapy, showing 16.20 months mOS compared to 14.16 months with chemotherapy alone (HR=0.819; P=0.039). TTFields therapy was well-tolerated and offers a promising new treatment option for patients with unresectable, locally advanced pancreatic cancer. Global and China regulatory filings are planned for this indication.
Full Article: Zai Lab and Novocure PANOVA-3 Trial Results
Senti Bio Announces Positive Initial Clinical Data in Phase 1 Trial of SENTI-202 for AML, Dec 2, 2024
Senti Biosciences reported promising early data from its Phase 1 trial of SENTI-202, an off-the-shelf CAR-NK cell therapy for relapsed/refractory AML. Of the three patients treated at the lowest dose, two achieved complete remission (CR) with minimal residual disease (MRD) negativity, maintaining remission for over 3 and 4 months, respectively. SENTI-202 was well-tolerated, with no dose-limiting toxicities. These results highlight its potential to address a critical unmet need in relapsed/refractory AML. Further data and dose escalation results are anticipated in 2025.
Full Article: Senti Bio Phase 1 Trial Data
Alligator Bioscience Announces Workforce Reduction to Focus on Mitazalimab Development, Dec 2, 2024
Alligator Bioscience has announced a workforce reduction of 70% as part of a strategic restructuring to focus on advancing mitazalimab, a CD40-targeting antibody for metastatic cancers. The decision comes after promising Phase 2 results in pancreatic cancer, showing an overall response rate (ORR) of 40.4%. The cost-saving measures, which are expected to save $6 million annually, will also reduce early-stage R&D efforts, allowing the company to focus on preparing mitazalimab for Phase 3 trials. CEO Søren Bregenholt emphasized that this restructuring will enhance the asset's partnership potential and help secure funding through 2025.
Full Article: Alligator Bioscience Workforce Reduction
TRIO Pharmaceuticals Completes $3.1 Million Financing Round to Advance Cancer Therapeutics, Dec 3, 2024
TRIO Pharmaceuticals has closed a $3.1 million pre-Series A financing round led by Friedman Bioventure Fund, with additional support from the Myeloma Investment Fund and other investors. The funds will support the advancement of its bispecific antibody platforms, TRAILBody™ and TIE-ADC™, designed to target high-mortality cancers like multiple myeloma and acute myeloid leukemia (AML). The financing will accelerate preclinical activities and bring TRIO closer to its clinical trials. CEO Dr. Reiner Laus highlighted the transformative potential of the company’s therapies to address critical patient needs in oncology.
Full Article: TRIO Pharmaceuticals Financing Round
Gilead Sciences Partners with Tubulis in $415M Deal to Develop ADCs, Dec 3, 2024
Gilead Sciences has entered a $20M upfront partnership with Tubulis to develop advanced antibody-drug conjugates (ADCs) for solid tumors, with the potential for up to $415M in milestone payments. The collaboration will utilize Tubulis' Tubutecan platform, aiming to improve ADC stability and reduce toxicities. This partnership marks Gilead’s strategic re-entry into the ADC space, following previous setbacks with Trodelvy in bladder and lung cancers.
Full Article: Gilead and Tubulis ADC Partnership
Antag Therapeutics Announces €80 Million Series A Financing for Obesity Treatment, Dec 4, 2024
Antag Therapeutics raised €80 million in Series A funding, led by Versant Ventures and Novo Holdings, to advance its obesity treatment, AT-7687. This once-weekly GIPR antagonist is designed to complement GLP-1 therapies, offering improved tolerability and efficacy while delivering superior weight loss and metabolic benefits. With FDA approval of its IND application, clinical trials for AT-7687 will begin next year, both as a monotherapy and in combination with GLP-1 receptor agonists. The funding will also support the expansion of Antag's pipeline for monthly injectable therapies.
Full Article: Antag Therapeutics Series A Financing
Thermosome Initiates Final Dose Level in Phase I Trial of THE001 for Soft Tissue Sarcoma, Dec 4, 2024
Thermosome has advanced its Phase I trial of THE001, a targeted therapy for soft tissue sarcoma (STS), to dose level 3 (DL3), following confirmation of safety at dose level 2 (DL2) by the DSMB. THE001, in combination with regional hyperthermia, has shown a favorable safety profile with no dose-limiting toxicities or serious unexpected adverse events reported. Early signs of efficacy and encouraging pharmacokinetic data support its potential as an innovative and tolerable treatment option for heavily pre-treated STS patients.
Full Article: Thermosome Phase I Trial Data
Elicio Therapeutics Completes Enrollment for Phase 2 AMPLIFY-7P Study, Dec 4, 2024
Elicio Therapeutics has completed enrollment for its Phase 2 AMPLIFY-7P study, which evaluates ELI-002 7P, a novel immunotherapy targeting mutant KRAS-driven pancreatic ductal adenocarcinoma (PDAC) in patients at high risk of relapse post-surgery. With 135 patients enrolled, the study’s primary endpoint is disease-free survival (DFS). Interim results, including DFS analysis, are expected in the first half of 2025, and will help assess the potential of ELI-002 as a transformative cancer vaccine.
Full Article: Elicio Therapeutics AMPLIFY-7P Enrollment
Protara Therapeutics Reports Positive Phase 2 Results for TARA-002 in NMIBC, Dec 5, 2024
Protara Therapeutics announced positive results from its Phase 2 ADVANCED-2 trial evaluating TARA-002, an investigational cell-based therapy, in high-risk non-muscle invasive bladder cancer (NMIBC). The trial demonstrated a 72% complete response (CR) rate at six months across BCG-exposed patients, with no Grade 2 or higher treatment-related adverse events. TARA-002 activates immune cells and induces antitumor responses, offering a promising potential as a treatment option for NMIBC patients. Initial data from 12-month evaluable patients is expected by mid-2025.
Full Article: Protara Therapeutics Phase 2 Results
Nektar Therapeutics Announces Positive Phase 2 Results for NKTR-255 in Combination with CD19 CAR-T Therapy, Dec 7, 2024
Nektar Therapeutics presented promising Phase 2 results for NKTR-255, an IL-15 agonist, as an adjuvant to CD19-directed CAR-T therapy in relapsed/refractory large B-cell lymphoma (LBCL) at the 66th ASH Annual Meeting. NKTR-255 improved the complete response rate to 73% at six months compared to 50% for placebo, with two patients achieving complete responses from stable or partial disease. The treatment was well-tolerated and may significantly enhance CAR-T durability and progression-free survival.
Full Article: Nektar Therapeutics NKTR-255 Results
Incyte Announces Positive Phase 3 Trial Results for Retifanlimab in Combination with Chemotherapy in NSCLC, Dec 7, 2024
Incyte announced positive results from the Phase 3 POD1UM-304 trial, showing that retifanlimab (Zynyz), a PD-1 inhibitor, in combination with chemotherapy significantly improved overall survival (18.1 months vs. 13.4 months), progression-free survival, and response rates in patients with metastatic non-small cell lung cancer (NSCLC). The treatment was well-tolerated, with no new safety concerns, and the company plans to submit a supplemental Biologics License Application to the FDA next year.
Full Article: Incyte Retifanlimab Trial Results
