- Following feedback from the FDA, IMV Inc IMV has inked an agreement with Merck & Co MRK to initiate a Phase 2B trial evaluating IMV's lead compound, maveropepimut-S (DPX-Survivac), in combination with Merck's Keytruda (pembrolizumab) in patients with recurrent/refractory diffuse large B cell lymphoma (r/rDLBCL).
- The contribution of low-dose cyclophosphamide (CPA) as an activator of immune response will also be evaluated in this trial.
- In a press release issued on March 17, the company announced that the FDA provided feedback on the clinical trial design. The study is expected to begin in Q2 2021.
- The three-arm Phase 2B trial is designed to assess the combination of maveropepimut-S and Keytruda with or without CPA. A third arm will evaluate maveropepimut-S as a single agent.
- Across the three arms of this study, IMV's lead compound will be evaluated in up to 150 subjects who have received at least two prior lines of systemic therapy and who are ineligible or have failed autologous stem cell transplant (ASCT) or CAR-T therapy.
- The primary endpoint is Objective Response Rate.
- Maveropepimut-S consists of survivin-based peptides designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.
- Price Action: MRK shares are up 0.3% at $76, while IMV shares are down 1.25% at $3.15 in the premarket session on the last check Wednesday.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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