- Morphogenesis Inc and CohBar Inc (NASDAQ:CWBR) announced initial results from an exploratory analysis of anti-tumor responses to rechallenge with an ICI following protocol-directed IFx-Hu2.0 therapy for Advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) patients who exhibited primary resistance to ICIs.
- Related: CohBar Stock Doubles: Company Agrees To Merge With Morphogenesis To Advance Late-Stage Oncology Candidates
- IFx-Hu2.0 is Morphogenesis' lead personalized cancer vaccine candidate designed to overcome primary resistance to checkpoint inhibitors.
- The ongoing Phase 1b study evaluates IFx-Hu2.0 in a two-stage study design to assess the safety and to examine the effects of repeated weekly dosing for up to 3 weeks on the magnitude of the ensuing systemic immune response to determine the optimal dose and schedule for a planned Phase 2/3 registration directed trial.
- Four of 5 (80%) patients with advanced MCC and 1 of 2 (50%) patients with cSCC, or 5 of 7 total (71%), experienced objective anti-tumor responses to ICI rechallenge in this setting, with a duration of response ongoing in 4 patients and one response lasting 23 months.
- Based on the positive preliminary results, an additional 11 patients are planned for enrollment in the expansion stage of the Phase 1b study using the weekly x 3 dosing schedule.
- Additional exploratory/biomarker analyses are planned.
- Price Action: CWBR shares are down 1.37% at $2.77 on the last check Monday.
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