Imfinzi granted priority review and breakthrough therapy designation for limited-stage small cell lung cancer in the US
- AstraZeneca's sBLA for Imfinzi, based on ADRIATIC Phase III trial results, has been accepted and granted Priority Review by the FDA.
- The FDA action date for the regulatory decision is anticipated during Q4 2024.
- Imfinzi also received Breakthrough Therapy Designation for limited-stage small cell lung cancer (LS-SCLC).
- The ADRIATIC trial showed Imfinzi reduced the risk of death by 27% and disease progression or death by 24% compared to placebo.
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Incyte and Syndax announce U.S. FDA approval of Niktimvo for chronic GVHD
- The FDA has approved Niktimvo (axatilimab-csfr) for chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
- Approval based on AGAVE-201 study, which showed a 75% overall response rate within the first six months of treatment.
- Niktimvo demonstrated durable responses across all organs studied and patient subgroups.
- Incyte and Syndax will co-commercialize Niktimvo in the U.S., with plans to launch smaller vial sizes by early 2025.
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Verrica Pharmaceuticals announces positive preliminary topline results from part 2 of phase 2 clinical study of VP-315
- VP-315 was well tolerated with no reported treatment-related serious adverse events.
- All patients treated with VP-315 had a reduction in tumor size, with an overall reduction of approximately 86%.
- Approximately 51% of lesions treated in Part 2 achieved complete histological clearance.
- The company plans to request an End-of-Phase 2 meeting with the FDA in the first half of 2025.
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Genprex announces positive clinical study updates from Acclaim-1 and Acclaim-3 phase 1/2 clinical trials in lung cancer
- Acclaim-1 trial shows prolonged progression-free survival (PFS) in two patients with NSCLC treated with Reqorsa and Tagrisso.
- Acclaim-3 trial reports partial remission (PR) in the first patient treated with Reqorsa and Tecentriq for SCLC.
- FDA granted Fast Track Designation for both Acclaim-1 and Acclaim-3 trials, with Orphan Drug Designation for Acclaim-3.
- Genprex to re-focus oncology clinical development, ceasing enrollment in Acclaim-2 trial and limiting Acclaim-1 to patients previously treated only with Tagrisso.
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Accutar Biotechnology receives FDA fast track designation for AC699 in ER+ / HER2- breast cancer
- Accutar Biotechnology's AC699 has been granted Fast Track designation by the FDA for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
- AC699 is an investigational orally bioavailable, chimeric degrader of estrogen receptor (ER) α, currently in a Phase 1 trial.
- The Fast Track designation facilitates more frequent meetings and communications with the FDA, potentially leading to accelerated approval and priority review.
- The ongoing Phase 1 trial has shown a 50% objective response rate (ORR) in patients with an ESR1 mutation.
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Kiromic BioPharma’s Deltacel receives FDA fast track designation
- The FDA granted Fast Track designation to Deltacel (KB-GDT-01) for treating metastatic non-small cell lung cancer (NSCLC).
- Deltacel is being evaluated in the Deltacel-01 Phase 1 study for patients with stage 4 NSCLC who have failed standard therapies.
- The Fast Track designation allows for more frequent communication with the FDA, potential priority review, and rolling submission of applications.
- Recent data from the Deltacel-01 trial showed a favorable safety profile and preliminary clinical efficacy in NSCLC patients.
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Ivonescimab received priority review from China's NMPA for first-line treatment of PD-L1 positive NSCLC
- Ivonescimab, a PD-1/VEGF bi-specific antibody, received priority review from China's NMPA for first-line treatment of PD-L1 positive NSCLC.
- The application is based on the HARMONi-2 (AK112-303) study, showing significant improvement in PFS compared to pembrolizumab.
- Ivonescimab is already approved for EGFR-mutant non-squamous NSCLC that has progressed after EGFR-TKI therapy.
- Akeso is conducting multiple Phase III trials and clinical trials for ivonescimab covering 16 indications.
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Panavance Therapeutics announces foundational publication of misetionamide in ovarian cancer
- Misetionamide (GP-2250) shows significant single-agent activity and synergy with PARP inhibitors and bevacizumab in preclinical studies.
- The drug inhibits key enzymes in cancer cell metabolism, leading to oxidative, metabolic, and hypoxic stress within the cancer cells.
- Misetionamide also impairs cancer cell viability by inhibiting key transcription factors like NFkB.
- Panavance plans to initiate a Phase 1/2 proof of concept study in platinum-resistant ovarian cancer following a pre-IND meeting with the FDA.
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CV6 Therapeutics initiates patient dosing in Phase 1a trial for CV6-168
- The Phase 1a trial will evaluate the safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity of CV6-168 in multiple solid cancers.
- CV6-168 is a first-in-class dUTPase-specific DNA Uracilation agent targeting Uracil-DNA metabolism.
- The study is a multicenter, open-label, dose-escalation trial involving patients with advanced metastatic solid tumors refractory to standard treatments.
- Primary objectives include determining the safety profile, optimal biologically relevant doses, maximum tolerated dose, and anti-tumor activity of CV6-168.
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TransCode Therapeutics announces phase 1 clinical trial initiation
- TransCode Therapeutics has initiated a Phase 1 multicenter, open-label clinical study of TTX-MC138.
- Two clinical trial sites have been activated, with patient enrollment expected this quarter.
- The trial will evaluate the safety and preliminary anti-tumor activity of TTX-MC138 in metastatic solid cancers.
- The study includes a dose-escalation phase followed by a dose-expansion phase to further assess safety, tolerability, and anti-tumor activity.
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