IMV’s Lead Immunotherapy to be Investigated in Breast Cancer

On May 10, 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 its lead compound, maveropepimut-S (DPX-Survivac) will be investigated in patients with hormone receptor positive/HER2-negative (HR+/HER2-) breast cancer. HR+/HER2- tumors represent an unmet clinical need with relatively poor responses to neoadjuvant endocrine treatment1 (Press release, IMV, MAY 10, 2021, View Source [SID1234579602]). This investigator-initiated clinical study will be conducted at the Providence Cancer Institute in Portland, Oregon, and is expected to begin during summer 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to launch the next clinical proof of concept study of maveropepimut-S, which has already demonstrated positive clinical benefit in other cancer indications," said Frederic Ors, Chief Executive Officer at IMV. "Through targeted T-cell therapy, we believe maveropepimut-S presents a compelling option for the treatment of breast cancer. Our lead compound has demonstrated to enhance the innate tumor-fighting response which has resulted in efficacy in solid and liquid tumors without significant toxicity."

Kristina H. Young, M.D., Ph.D., Assistant Member, Tumor Microenvironment Lab in the Earle A. Chiles Research Institute, a division of Providence, commented, "Survivin upregulation is strongly associated with a subpopulation of breast cancer patients that are resistant to aromatase inhibitors. We believe that IMV’s survivin-targeted T cell therapy may improve the sensitivity to neoadjuvant aromatase inhibitors and, therefore, holds the potential to overcome resistance to treatment."

This three-arm Phase 1B trial is designed to assess the combination of maveropepimut-S and aromatase inhibitor with/without radiotherapy or cyclophosphamide (CPA) prior to surgery. Across the three arms of this study, IMV’s lead compound will be evaluated in 18 subjects with resectable, non-metastatic HR+/HER2- breast cancer.

The primary objective is to evaluate the safety of neoadjuvant combination of maveropepimut-S with the aromatase inhibitor and with/without radiation, or CPA and immunogenicity in each arm. Survivin-specific T cells in the resected tumor will be evaluated as a secondary objective. Extensive translational studies will be conducted as exploratory analyses to characterize maveropepimut-S’ mechanism of action in the tumor and the tumor’s immune environment.

"Understanding how HR+HER2- breast cancer responds to immunotherapy, particularly prior to surgery, remains an active area of investigation across the world," said Sasha E. Stanton, M.D., Ph.D., Assistant Member, Cancer Immunoprevention Lab at Providence. "Examining the role of this immune therapy targeting Survivin with the aromatase inhibitor letrozole, as well as the addition of radiation and low dose immune modulating chemotherapy, is important to improve neoadjuvant therapy response in these women."

About Maveropepimut-S (DPX-Survivac)

Maveropepimut-S is the lead candidate in IMV’s new class of immunotherapy that generates targeted and sustained cancer cell killing capabilities in vivo. Maveropepimut-S is evaluated in three phase 2 trials: in association with low dose cyclophosphamide (CPA) in advanced, recurrent ovarian cancer, and in combination with Merck’s Keytruda and low dose CPA in hematological and solid cancers (DLBCL, bladder, hepatocellular and MSI-high tumor cancers). Treatment 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.