DARTMOUTH, Nova Scotia – (Commercial wire(NASDAQ: IMV; TSX: IMV) (“IMV” or the “Company”), a clinical-stage bio-pharmaceutical company that is pioneering a new class of cancer immunotherapies and vaccines against infectious diseases, today announces that lasting clinical benefits are induced By combining treatment of IMV’s t cell therapy with Merck’s Keytruda® (Pembrolizumab) in subjects with PD-L1 positive recurrent / refractory diffuse large B cell lymphoma (R / R DBLCL) have been presented at the American Society of Hematology (Ash) annual meeting.
“Compared to currently approved therapies, this combination has demonstrated a promising duration of response with limited adverse events in this difficult-to-treat patient population,” said Drs. . The improved clinical response in this subset of patients with PD-L1 expression is an exciting scientific finding. .1 And is more likely caused by the complementary mechanisms of action of the two immunotherapies. ”
“These are exciting early data and the potential synergistic action of the two immunotherapists paves the way for a new treatment paradigm with combination therapies,” said Dr. Joanne Schindler, Chief Medical Officer at IMV. “We will also evaluate the combination therapy with Merck in other solid tumor indications and we look forward to exploring the potential of what we have seen in the SPiReL study. ”
In his presentation at the annual ASH conference, Dr. Neil Berinstein describes the results of the SPiReL study:
In the PD-L1 + population (n = 7), subjects
Have a higher median progression free survival (PFS) of 230 days, compared with the PD-L1 negative subjects (70 days) with a p-value of 0.007, suggested for a strong predictive biomarker for this treatment combination.
Demonstrated an objective response in six subjects, including three subjects who had completed one year of study treatment,
Demonstrated an ORR and a DCR at 85.7%.
Peripheral blood was assessed for Survivin-specific ELISpot responses in 15 subjects with available samples. All 3 subjects with a CR and 3 of 4 subjects with PR had positive ELISpot responses while only 1 subject with SD and 1 subject with PD demonstrated Survivin-specific ELISpot response, suggested of an association between the clinical responses with the mechanism of action of DPXs -Survivac.
Treatment is well tolerated. The majority of treatment-related adverse events are grade 1 and 2 severity. A majority of these are injection site reactions associated with the subcutaneous administration of DPX-Survivac.
The poster presentation of dr. Berinstein is available under the section for Scientific Publications & Posters on the IMV website and is also available on the ASH meeting platform.
Biomarkers related to clinical response were also discussed at a poster presentation at the Society for Immunotherapy of Cancer (CITC) 35th Anniversary Annual Meeting, and during a webcast hosted by IMV on 12 November 2020.
DPX-Survivac is the main candidate in IMV’s new class of immunotherapy that generates targeted and sustained capabilities in vivo. Treatments with DPX-Survivac T cell therapy have shown 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). IMV’s lead compound is designed to generate a sustained cytotoxic T cell response against cancer cells that present Survivin peptides on their surface.
Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is widely over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis and promoting resistance to chemoth. IMV has identified more than 20 cancer indications in which the DPX-Survivac can be targeted.
DPX-Survivac has received fast track designation from the US. It. Food and Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status of the US. It. FDA and the European Medicines Agency (EMA) in Ovarian Cancer.
About the SPiReL study
“SPiReL” is a phase 2 Non-randomized, open label, efficacy and safety study of a new immunotherapy combination with DPX-Survivac and Pembrolizumab. Intermittent low dose cyclophosphamide is given as an immune modulator. Subjects with R / R incurable DLCL and Survivin expression are eligible for participation. The primary outcome is to document the objective response rate using modified Cheson criteria for the combination treatment. Secondary objectives include safety, duration of response and time to further treatment. Exploratory endpoints include T cell response, tumor immune cell infiltration and biomarker analysis. To date, 24 subjects have been enrolled.
IMV Inc. Is a biopharmaceutical company clinical stage dedicated to making immunotherapy more effective, more widely applicable, and more widely available for people facing cancer and other serious diseases. IMV is pioneering a new brand of cancer-targeted immunotherapies and vaccines based on the proprietary delivery platform (DPX). The patented technology leverages a new mechanism of action that enables the activation of immune cells in vivo, Which are aimed at generating powerful new synthetic therapeutic capabilities. The main candidate of IMV, DPX-Survivac, is a T cell-activating immunotherapy that combines the use of the platform with a new cancer goal: Survivin IMV is currently assessing DPX-Survivac in advanced ovarian cancer, as well as a combination therapy Merkal clinical studies with Merck. IMV is also developing a DPX-based vaccine to fight COVID-19. Visit www.imv-inc.com and join us on Twitter And LinkedIn.
IMV forecast statements
The press release contains forecast information under applicable securities law. Any information that relates to activities or developments that we expect in the future, is forecast information. Forward-looking statements use such words as “will”, “may”, “potential”, “believe”, “expect”, “continue”, “anticipate” and other similar terminology. Forecast statements are based on the estimates and opinions of management on the date of the statements. In the press release, such forecast statements include, but are not limited to, statements regarding the FDA potentially granting accelerated regulatory approval of DPX-Survivac, the potential for synergistic action and results from the use of combined immunotherapies by the Company The company’s ability to reach an agreement with its collaboration partners and the timing of the expected results of other DPX Survivac studies with other tumor types. However, they should not be considered as a representation that any of these plans will be achieved. Actual results may differ from those shown in this press release due to risks affecting the Company, including access to capital, the successful design and completion of clinical trials and the timely receipt of all regulatory approvals to commence, and thereafter continue. , Clinical Studies. And trials and the receipt of all regulatory approvals to commercialize its products. IMV Inc. Assumes no responsibility to update forecast statements in this press release except as required by law. These forecast statements involve known and unknown risks and uncertainties, and the risks and uncertainties include, but are not limited to, the ability to access capital, the success and, in general, the timely completion of clinical trials and studies and the receipt of All. Regulatory approvals as well as other risks detailed from time to time in our ongoing quarterly filings and annual information form. Investors are cautioned not to rely on the forecast statements and are encouraged to read IMV’s ongoing disclosure documents, including the current annual information form, as well as the audited annual consolidated financial statements available on SEDAR on www.sedar.com and on EDGAR at www.sec.gov/edgar.
1Checkpoint inhibitors such as Keytruda® And OpDivo® Are not approved in DLBCl and have demonstrated limited activity included in PD-L1 positive patients: Xu-Monette, Ziun J. et al. “PD-1 expression and clinical PD-1 blockade in B-cell lymphomas” Blood vol. 131.1 (2018): 68-83. Doi: 10.1182 / blood-2017-07-740993; Suzuki Y, Kohno K, Matsue K, et al. PD-L1 (SP142) expression 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