BioNTech announces positive topline phase 2 results for mRNA immunotherapy candidate BNT111 in patients with advanced melanoma
- Phase 2 trial met primary endpoint, showing significant improvement in overall response rate (ORR) for BNT111 combined with cemiplimab.
- BNT111 program received Fast Track and Orphan Drug designations from the FDA in 2021.
- The trial will continue to assess secondary endpoints, with data to be presented at an upcoming medical conference.
- BNT111 is based on BioNTech’s FixVac platform and uridine mRNA-LPX technology.
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IMUNON to report topline results from the Phase 2 OVATION 2 study with IMNN-001 in advanced ovarian cancer tomorrow
- IMUNON will announce topline results from the Phase 2 OVATION 2 Study with IMNN-001 in advanced ovarian cancer on July 30 at 8:00 a.m. Eastern time.
- A conference call to discuss the results will follow at 8:30 a.m. Eastern time.
- IMNN-001 is an interleukin-12 (IL-12) immunotherapy based on IMUNON's TheraPlas technology.
- The call will be archived for replay through August 13, 2024, and a webcast will be available for 90 days.
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Verastem Oncology receives FDA orphan drug designation for avutometinib and defactinib for the treatment of pancreatic cancer
- The FDA granted Orphan Drug Designation to avutometinib, a RAF/MEK clamp, in combination with defactinib, a selective FAK inhibitor, for treating pancreatic cancer.
- Initial interim results from the ongoing RAMP 205 trial showed promising safety and efficacy for the combination in first-line metastatic pancreatic cancer.
- In the dose level 1 cohort, 83% of patients achieved a confirmed partial response with more than six months of follow-up.
- Orphan Drug Designation provides benefits like tax credits, FDA user fee exemptions, and potential seven years of market exclusivity upon approval.
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