IMV Inc IMVIF

RE:RE:New Trial in Breast Cancer

[qwerty22]

https://link.springer.com/article/10.1007/s10549-008-0164-5

qwerty22 wrote:

Interesting. What can you say about this? Ph1, Investigator lead, so early and IMV have no control over it. A bunch of clinical scientists see the potential of dpx as a treatment in a different role to how it's mostly already been tested. Sounds like in the first instance it's going to be heavily focused on the science rather than a rapid clinical development path.

Neo-adjuvant therapy.
https://www.cancercenter.com/community/blog/2019/01/whats-the-difference-adjuvant-and-neoadjuvant-therapies

I think a lot of the data and KOL feedback so far really points to DPX as a good candidate for neo-adjuvant and adjuvant treatment so it's good to see it investigated but this requires a very different type of trial and dataset for approval than the trials they've already done and this study is really going way back to the start of the clinical trial process.

 

 

Breakthorough wrote: IMVs Lead Immunotherapy to be Investigated in Breast Cancer Study will evaluate maveropepimut-S (formerly known as DPX-Survivac) with an aromatase inhibitor, with/without radiotherapy or cyclophosphamide prior to surgery Analysis of tumor tissue in this study will provide key insights for the therapeutic potential of maveropepimut-S in tumors expressing survivin May 10, 2021 07:05 AM Eastern Daylight Time DARTMOUTH, Nova Scotia--(BUSINESS WIRE)--IMV Inc. (Nasdaq: IMV; TSX: IMV) (IMV or the Company), a clinical-stage biopharmaceutical company pioneering a novel class of cancer immunotherapies, today announced 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. This investigator-initiated clinical study will be conducted at the Providence Cancer Institute in Portland, Oregon, and is expected to begin during summer 2021. 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. Tweet this 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 IMVs 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, IMVs 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 tumors 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.