IMV T cell therapy demonstrates 86% objective response rate in combination with Merck’s Keytruda® in PD-L1 positive patients with r / r DLBCL
DARTMOUTH, Nova Scotia – (COMMERCIAL THREAD) – IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical-stage biopharmaceutical company pioneering a new class of immunotherapies, today announced that the Company’s T-cell therapy demonstrates a rate of 86% objective response in combination with Keytruda from Merck® (pembrolizumab) in patients with relapsed / refractory diffuse large B cell lymphoma program positive for Death Ligand 1 (PD-L1) (r / r DLBCL). Detailed results will be presented at the Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting, which will be held virtually November 9-14, 2020, and a webcast hosted by IMV on November 12, 2020.
“Biomarkers are essential for the development of precision medicine in oncology. Not only can they improve the outcome of cancer patients receiving treatment, but they can also significantly reduce the risk inherent in advanced clinical trials and make it easier to bring new treatments such as our new T cell therapy to market, ”said Joanne Schindler. , Chief physician of IMV. “LDGCB is the most common form of non-Hodgkin lymphoma and relapsed / refractory patients need more accessible and better treatment options. Identifying a predictive biomarker of response for these patients was an important goal of our clinical plan and our path to approval.
All clinical responses are associated with the expression of the PD-L1 biomarker
All clinical responses observed so far in the study have been observed in PD-L1 positive subjects defined as a percentage of PD-L1 + cells labeled in the tumor region of 10% or more. No benefit was observed in the PD-L1 negative population (n = 11) where all subjects presented with progressive disease (PD) (n = 9) or stable disease (SD) (n = 2).
The difference between the two populations is statistically significant and indicates that PD-L1 has the potential to become a predictive biomarker and a companion diagnostic for the treatment of LDGCB with the combination, in order to identify and recruit the patients most likely to reply.
At the data cut-off date for submission to SITC, 18 pre-treatment samples from patients included in the SPiReL study were available for biomarker analysis. Thirty-nine percent (7/18) of subjects demonstrated positive PD-L1 tumor expression prior to treatment. Key findings for this population include:
100% of subjects with a disease control rate (DCR) defined as stable disease (SD) or complete or partial response (CR or PR)
86% (6/7) of subjects with an objective response rate (ORR) (3 CR and 3 PR)
The PD-L1 pathway regulates T cell responses allowing tumors to escape detection by the immune system. PD-L1 expression has been extensively studied in relation to the prognosis of various cancers and is approved in several tumor types as a predictive biomarker for treatment with checkpoint inhibitors targeting the PD-1 / PD pathway. -L1. In DLBCL, PD-L1 has been shown to be expressed in 26-75% of patients and is generally associated with a poor prognosis and shorter survival.1.2.
Checkpoint inhibitors such as Keytruda® and Opdivo® are not approved in LDGCB and have demonstrated limited activity, including in PD-L1 positive patients.1.3
Poster presentation details
Baseline PD-L1 expression and tumor immune infiltration are associated with a clinical response in patients with r / r DLBCL treated with DPX-Survivac, low dose cyclophosphamide and pembrolizumab
Presenter: Neil Berinstein, MD, FRCPC, ABIM
Hematologist at Sunnybrook Health Science Center, Toronto.
The poster has been available on the company’s website and on the SITC conference platform since November 9 at 8:00 a.m. EST. The final poster presentation will include additional data collected between the abstract submission date and the presentation itself. The poster is available under Scientific publications and posters section on IMV’s website.
The company will discuss the data during a live webcast on November 12 at 8:00 a.m. EST with a presentation of the results by Neil Berinstein, MD, FRCPC, ABIM, principal investigator of the SPiReL study. Registration for the webcast will be available under “Events, webcasts and presentationsIn the Investors section of the IMV website. The video recording will be available for replay shortly after.
About the SPiReL study
“SPiReL” is a phase 2 non-randomized, open-label efficacy and safety study of a new combination of immunotherapy with DPX-Survivac and pembrolizumab. Low dose intermittent cyclophosphamide is given as an immune modulator. Subjects with incurable r / r DLBCL and survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria for combination therapy. Secondary goals include safety, duration of response, and time to next treatment. Exploratory endpoints include T cell response, tumor immune cell infiltration, and biomarker analysis. To date, 24 subjects have been enrolled.
DPX-Survivac is the lead candidate for IMV’s new class of immunotherapy that generates targeted and long-lasting cancer cell killing capabilities in vivo. Treatments with DPX-Survivac T cell therapy have demonstrated a favorable safety profile in all clinical studies.
IMV’s T-cell therapy, DPX-Survivac, consists of survivin-based peptides formulated in IMV’s proprietary delivery platform (DPX). The main compound of IMV is designed to generate a sustained cytotoxic cellular response against cancer cells with survivin peptides on their surface.
Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor associated antigen, is widely overexpressed in most types of cancer and plays a critical role in antagonizing cell death, supporting angiogenesis associated with tumors and the promotion of resistance to chemotherapy. . IMV has identified over 20 cancer indications in which survivin can be targeted by DPX-Survivac.
DPX-Survivac has received US Food and Drug Administration (FDA) Fast Track designation as maintenance therapy in advanced ovarian cancer, as well as orphan drug status from the US FDA. United and the European Medicines Agency (EMA) in the indication of ovarian cancer. .
IMV Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more widely applicable, and more widely accessible to people facing cancer and other serious illnesses. IMV is pioneering a new class of cancer immunotherapies and vaccines based on the Company’s proprietary delivery platform (DPX). This patented technology exploits a new mechanism of action that allows the activation of immune cells in vivo, which aim to generate new powerful synthetic therapeutic capacities. IMV’s lead candidate, DPX-Survivac, is a T cell activating immunotherapy that combines the utility of the platform with a novel cancer target: survivin. IMV is currently evaluating DPX-Survivac in advanced ovarian cancer, as well as a combination therapy in several clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight COVID-19. Visit www.imv-inc.com and connect with us on Twitter and LinkedIn.
IMV’s forward-looking statements
This press release contains forward-looking information under applicable securities laws. All information that deals with activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management as of the date the statements are made. In the press release, these forward-looking statements include, without limitation, the potential impacts of biomarkers in the treatment of cancer; the potential for using DPX-Survivac to treat different types of cancer; and the results and timing of expected results of the Company’s various studies of DPX-Survivac. However, they should not be taken as a representation that any of the plans will be realized. Actual results may differ materially from those presented in this press release due to risks affecting the Company, including access to capital, successful design and completion of clinical trials, and timely receipt and receipt of all regulatory approvals. IMV Inc. assumes no responsibility for updating any forward-looking statements in this press release, except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and these risks and uncertainties include, without limitation, our ability to access capital, the successful and timely completion of clinical trials and studies, the receipt of all the risk approvals detailed from time to time in our quarterly filings and our annual information form. Investors are cautioned not to rely on these forward-looking statements and are encouraged to read IMV’s continuous disclosure documents, including its current annual information form, as well as its consolidated financial statements available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar
1 Xu-Monette, Zijun Y et al. “PD-1 expression and clinical PD-1 blockade in B-cell lymphomas” Blood vol. 131.1 (2018): 68-83. doi: 10.1182 / sang-2017-07-740993
2 Suzuki Y, Kohno K, Matsue K, et al. Expression of PD-L1 (SP142) in neoplastic cells predicts a poor prognosis for patients with intravascular large B-cell lymphoma treated with rituximab-based multi-agent chemotherapy. Cancer Med. 2020; 9 (13): 4768-4776. doi: 10.1002 / cam4.3104
3 Ansell SM, et al. Nivolumab for relapsed / refractory diffuse large B-cell lymphoma in ineligible or failed autologous patients: a phase II single-arm study. J Clin Oncol. 2019 Feb 20; 37 (6): 481-489. doi: 10.1200 / JCO.18.00766