On April 7, 2021 IMV Inc. (Nasdaq: IMV; TSX: IMV) ("IMV" or the "Company"), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies, reported that, following feedback from the U.S. Food & Drug Administration (FDA), the company has entered into an agreement with Merck to initiate a Phase 2B clinical trial to evaluate its lead compound, maveropepimut-S (DPX-Survivac) in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, in patients with recurrent/refractory diffuse large B cell lymphoma (r/rDLBCL) (Press release, IMV, APR 7, 2021, View Source [SID1234577686]). The contribution of low dose cyclophosphamide (CPA) as an activator of immune response will also be evaluated in this trial.
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"We are proud to continue working with Merck to deepen the relationship that was built during our basket trial and the prior "SPiReL" study in r/rDLBCL", said Andrew Hall, Chief Business Officer at IMV. "This new agreement continues to leverage our common vision to save and improve lives by delivering better treatments to patients with unmet medical needs. In this collaboration we look forward to collaborating with Merck, beyond the provision of Keytruda, to ensure clinical and regulatory alignment, thus optimizing our probability of success."
In a press release issued on March 17, 2021, the Company announced that the FDA provided valuable feedback on the clinical trial design and the study is expected to begin in Q2 2021.
Frederic Ors, Chief Executive Officer at IMV stated "The guidance from the FDA is an important milestone for the Company and we believe it provides us regulatory clarity and confidence to advance our development strategy for our lead immunotherapy in this difficult-to-treat patient population. We intend to initiate this trial rapidly and will seek to confirm the promising results obtained in the SPiReL study."
The three-arm Phase 2B trial is a randomized, parallel group, Simon two-stage study 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 with r/r DLBCL 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 (ORR), centrally evaluated per Lugano (2014) and measured by the number of subjects per arm achieving a best response of Partial or Complete Response (PR+CR) during the 2-year treatment period. All subjects will be evaluated for their baseline PD-L1 expression with the goal to validate the SPiReL data that highlighted PD-L1 as a possible predictive biomarker for the combination therapy.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.
About Maveropepimut-S
Maveropepimut-S is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Treatments with Maveropepimut-S in association with CPA have demonstrated a favorable safety profile across all clinical studies.
Maveropepimut-S, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX) which is designed to generate a sustained cytotoxic T cell response against cancer cells presenting survivin peptides on their surface.
Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to chemotherapies. IMV has identified over 20 cancer indications in which survivin can be targeted by maveropepimut-S.
Maveropepimut-S has received Fast Track designation from the FDA as maintenance therapy in advanced ovarian cancer, as well as Orphan Drug designation status from the FDA and the European Medicines Agency (EMA) in the ovarian cancer indication.