First Patient Dosed in Phase 1 Clinical Trial Evaluating Neoepitopes Formulated in IMV’s DPX Delivery Platform in Ovarian Cancer Patients
DARTMOUTH, Nova Scotia, Jan. 17, 2019 (GLOBE NEWSWIRE) — IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, today announced that the first patient has been treated in the Phase 1 trial evaluating neoepitopes formulated in the Company’s proprietary DPX delivery platform in patients with ovarian cancer. The study is part of the Company’s DPX-NEO program, which is an ongoing collaboration between UConn Health and IMV to develop neoepitope-based anti-cancer therapies.
“Expanding our DPX-based clinical immunotherapy program beyond DPX-Survivac is an important milestone for IMV, and we are pleased to be able to do so with this type of cutting-edge program in which the novel mechanism of action underscoring all DPX-based candidates plays a critical role,” said Frederic Ors, Chief Executive Officer at IMV. “We believe that the potential of neoepitope-based therapies could be a significant advance in the way physicians treat patients with ovarian cancer who today face a high unmet medical need. We look forward to working with UConn Healthto advance this program as IMV is committed to developing an immunotherapy option for women affected by this disease.”
Investigators will assess the safety and efficacy of using patient-specific neoepitopes discovered at UConn Health and formulated in IMV’s proprietary DPX-based delivery technology in women with ovarian cancer. Investigators plan to enroll up to 15 patients in the Phase 1 study. UConn Health is funding the trial with IMV providing materials and counsel.
Epitopes are the part of the biological molecule that is the target of an immune response. Neoepitopes are the mutated proteins produced by a patient’s own tumors. Neoepitope immunotherapies target these patient-specific proteins and have been referred to as ‘the next immunotherapy frontier.’ (1)“The first immunization of the first ovarian cancer patient with our personalized, patient-specific neoepitopes developed at the University of Connecticut using our proprietary technology, formulated in IMV’s excellent immunomodulatory DPX delivery platform, is a major milestone for us,” said Study Investigator Pramod K Srivastava, PhD, MD, Director of the Neag Comprehensive Cancer Center at the University of Connecticut School of Medicine. About the DPX-NEO Program
The DPX-NEO program is an ongoing collaboration evaluating the anti-cancer activity of proprietary patient-specific epitopes developed at UConn Health and formulated in IMV’s DPX-based novel immunotherapeutic delivery technology. IMV had previously announced the results from preclinical research in which researchers at UConn found that neoepitopes formulated in DPX-based formulations demonstrated superior immunogenic activity over comparators in mouse tumor models. In addition, IMV also previously announced a breakthrough in formulating multiple peptides in DPX formulations. The Company has patented the technology, which allows for both a larger number and a broader potential range of peptides into a single formulation as compared to standard formulation technologies.
IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the programming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell-activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently assessing DPX-Survivac as a monotherapy in advanced ovarian cancer, as well as a combination therapy in multiple clinical studies with Incyte and Merck. Connect at www.imv-inc.com.
IMV Forward-Looking Statements
This press release contains forward-looking information under applicable securities law. All information that addresses 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 on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Corporation, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. IMV Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law. These forward-looking statements involve known and unknown risks and uncertainties and those risks and uncertainties include, but are not limited to, our ability to access capital, the successful and timely completion of clinical trials, the receipt of all regulatory approvals and other risks detailed from time to time in our ongoing quarterly filings and 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 audited annual consolidated financial statements which are available on SEDAR at www.sedar.com and on EDGAR at www.sec.gov/edgar.Contacts for IMV: MEDIA Andrea Cohen, Sam Brown Inc. T: (917) 209-7163 E: AndreaCohen@sambrown.com INVESTOR RELATIONS Marc Jasmin, IMV Senior Director, Investor Relations T: (902) 492-1819 E: email@example.com Patti Bank, Managing Director, Westwicke Partners O: (415) 513-1284 T: (415) 515-4572 E: firstname.lastname@example.org REFERENCES 1 Neoepitope Vaccines, Next Immunotherapy Frontier Cancer Discovery Published Online First December 28, 2015; doi:10.1158/2159-8290.CD-NB2015-179 Source: IMV Inc.
DARTMOUTH, Nova Scotia, Sept. 04, 2018 (GLOBE NEWSWIRE) — IMV Inc. (Nasdaq: IMV; TSX: IMV), a clinical stage immuno-oncology corporation, celebrated its grand opening today of its new facilities in Dartmouth, Nova Scotia. Frederic Ors, IMV’s Chief Executive Officer, and Andrew Sheldon, IMV’s Chairman of the Board, opened today’s event with remarks about the company’s milestones and successes. Other speakers included federal MP Darren Fisher, the Honourable Randy Delorey, Minister of Health and Wellness, and Dartmouth Centre Councillor Sam Austin. Emilie Chiasson, the Atlantic Regional Director of Ovarian Cancer Canada, served as the event’s Master of Ceremonies.
HALIFAX, Nova Scotia, May 31, 2018 (GLOBE NEWSWIRE) — IMV Inc. (“IMV” or the “Corporation”) (TSX:IMV) (OTCQX:IMMVD), a clinical stage immunotherapy company, today announced that its common shares have been approved for listing on the Nasdaq Capital Marketunder the symbol “IMV.” Trading will commence as early as Friday, June 1, 2018. The Corporation will retain its listing on the Toronto Stock Exchange under the symbol “IMV” and the company’s common shares will continue to trade on the OTCQX under the symbol “IMMVD” until trading on the Nasdaq commences.
Frederic Ors, IMV Chief Executive Officer, commented, “On the heels of recent progress we have made in positioning and validating IMV’s unique value proposition in immuno-oncology, listing on Nasdaq affords us the opportunity to attract more institutional investors, broaden our shareholder base, and improve liquidity. We celebrate this milestone and look forward to continuing our track record of clinical progress and corporate advancement.”
IMV Inc. is a clinical stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and other serious diseases. IMV is pioneering a new class of immunotherapies based on the Company’s proprietary drug delivery platform. This patented technology leverages a novel mechanism of action that enables the reprogramming of immune cells in vivo, which are aimed at generating powerful new synthetic therapeutic capabilities. IMV’s lead candidate, DPX-Survivac, is a T cell activating immunotherapy that combines the utility of the platform with a target: survivin. IMV is currently conducting three Phase 2 studies with Incyte and Merck assessing DPX-Survivac as a combination therapy in ovarian cancer and diffuse large B-cell lymphoma. Connect at www.imv-inc.com.
IMV Forward-Looking Statements
This press release contains forward-looking information under applicable Canadian and U.S. securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Although the Corporation believes the forward-looking statements in this press release are reasonable, it can give no assurance that the expectations and assumptions in such statements will prove to be correct. The Corporation cautions investors that any forward-looking statements by the Corporation are not guarantees of future results or performance, and that actual results may differ materially from those in forward-looking statements as a result of various factors, including, but not limited to, the matters discussed under “Risk Factors and Uncertainties” in IMV’s Annual Information Form filed on March 20, 2018. IMV Inc.assumes no responsibility to update forward-looking statements in this press release except as required by law.
Contacts for IMV:
MEDIA Mike Beyer, Sam Brown Inc. T: (312) 961-2502 E: email@example.com
INVESTOR RELATIONS Pierre Labbé, Chief Financial Officer T: (902) 492-1819 E: firstname.lastname@example.org
Patti Bank, Managing Director, Westwicke Partners O: (415) 513-1284 T: (415) 515-4572 E: email@example.com]]>
View original release HALIFAX, Nova Scotia, July 12, 2017 (GLOBE NEWSWIRE) — Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage immuno-oncology company, today announced a significant achievement in its personalized cancer medicines program. Immunovaccine scientists have successfully formulated 14 neoepitope cancer peptides into one single DepoVax formulation. In preclinical testing, the resulting personalized cancer vaccine demonstrated the ability to generate specific killer T cell responses against cancer peptides. Immunovaccine has filed a patent application covering this novel DepoVax-based rapid formulation process. The supporting data for the patent includes what the Company believes to be one of the first documented reports of 14 different neoepitope peptides synthesized into a single formulation. “We believe that the ability to effectively combine a high number of diverse peptides without manufacturing limitations represents an important milestone in the deployment of personalized neoepitope immunotherapies,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “Being able to do it so quickly and efficiently should provide an opportunity to develop truly personalized therapies on a scale that could, in our opinion, truly impact the way in which bespoke medicines are used in today’s treatment landscape.” This breakthrough evolved as part of the Company’s DPX-NEO program, which aims to develop patient-specific immunotherapies targeting neoepitopes (the mutated proteins, and potential targets of an immune response, produced by a patient’s own tumors.) The methodology under this patent application can include peptides with a wide range of physical and chemical characteristics—including those that are insoluble. Immunovaccine believes that this novel process combines the ease and speed of manufacturing with other advantages inherent in DepoVax formulations, including long-term formulation stability, as well as the potential to elicit a strong and specific T cell response maintained for a year or more. Neoepitope vaccines have demonstrated significant potential in the realm of personalized medicinesi,ii. However, the complexity and potential expense of advancing these patient-specific vaccines includes substantial challenges for development and large-scale deployment. Intensive work is required to identify patient-specific peptide epitopes, and synthesize them rapidly into a single formulation. In addition, when the neoepitope peptides are selected from patients, investigators have not always been able to include many optimal candidates due to manufacturing limitations of the technology required to synthesize a single formulation. Immunovaccine believes that the DepoVax-based formulations demonstrate the ability to address these limitations as they do not limit the target peptides to highly soluble peptides. This flexibility should enable investigators to optimize the choices of immunogenic targets access a broader range of candidates. “Developing a suitably immunogenic delivery system that can accommodate multiple potential targets is one of the most significant challenges faced by this type of therapy, and while we are thrilled to have found a potential solution to this limitation, we believe that the implications of this formulation process can go well beyond the neoepitope space,” said Marianne Stanford, Vice President, Research, at Immunovaccine. “We see future applications of the DepoVax multiple peptide formulation using a high number of tumor-associated antigens in one immuno-oncology agent, or multiple targets for an infectious disease within one vaccine. We are excited to explore the potential applications of this technology.” About DepoVax Technology The technology underlying DepoVax formulations suspends vaccine components in an oil diluent that prevents their release at the site of injection. This process forces immune cells to take up these components in an active process, delivering them directly to immune organs such as the lymph nodes. DepoVax formulations have undergone extensive testing in more than 60 preclinical and seven clinical studies. In clinical trials, these formulations have consistently demonstrated the ability to generate robust T and B cell responses, and durable immune responses. Immunovaccine had previously announced a DPX-NEO collaboration with UConn Health, and is in active discussions with additional industry partners to expand the program.]]>
Immunovaccine Announces Dosing of First Patient in Investigator-Sponsored Phase 1b/2 Clinical Trial Evaluating Immuno-Oncology Candidate Targeting Incurable HPV-Related Cancers
See original release here 100 Percent of Healthy Older Adult Volunteers Who Responded to Vaccine Achieved a Sustained Antigen-Specific Immune Response that Remains at Peak One Year Post-Vaccination with DPX-RSV; This Level of Response with a Low-dose Volume of a Small Peptide is Groundbreaking and Highlights Potential of DepoVax™ Platform Halifax, Nova Scotia; April 12, 2017 – Immunovaccine Inc. (TSX: IMV; OTCQX: IMMVF), a clinical stage immuno-oncology company, today announced updated data on its investigator-sponsored Phase 1 clinical trial testing the safety and immunogenicity of its DepoVax™-based, small B-cell epitope peptide vaccine candidate for respiratory syncytial virus (RSV). In the 25 µg dose cohort, which was the only dose tested out to one year, 100 percent of older adults (7/7 immune responders) vaccinated with DPX-RSV maintained the antigen-specific immune responses one year after receiving the booster dose. At one year, the antibody levels measured were still at peak with no sign of decrease. The 25 µg dose was delivered in a volume of 50 microliters. A standard flu vaccine is typically 60 µg delivered in 10 times this volume. “The persistence of antigen-specific, circulating immune response at such a high level at six months was intriguing enough to warrant an assessment at the one year time point,” said Joanne Langley, BA, MD, MSc, FRCPC, of the Canadian Center for Vaccinology (CCfV) based at Dalhousie University, and the trial’s principal investigator. “The persistence of immunogenicity at one year to this peptide vaccine presented in a novel adjuvanting platform suggests that it is possible to create an immune response that lasts for at least an entire RSV season.” “We believe that the strength and duration of this immune response, particularly from a peptide epitope vaccine, is truly groundbreaking,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “We have long since maintained that, to effectively deal with complex diseases such as RSV, we need to pursue a novel target and a delivery formulation that is reliable and impactful. We believe that this DPX-RSV data validates this approach, and are hopeful that our vaccine candidate may offer those who suffer from RSV an option that goes beyond what can be accomplished with other vaccines in development.” “It is encouraging to observe such a prolonged serum antibody response against this membrane protein of RSV after DPX-RSV vaccination,” said Xavier Saelens, group leader of the VIB-UGent Centre for Medical Biotechnology (VIB and Ghent University, Belgium). “We have analyzed the year-one samples blinded and in a different way compared to the measurements performed by Immunovaccine. The results obtained in the two labs align clearly and show the longevity of the antibody response,” said Bert Schepens, staff scientist in the Saelens group, which has been performing confirmatory testing of the clinical trial samples. Last year, Immunovaccine reported positive top-line results from the Phase 1 dose-escalation trial evaluating the safety and immunogenicity of DPX-RSV in 40 healthy older adults six months after vaccination. In a further follow-up, antigen-specific immune responses were detected at least six months after the last vaccination in 93 percent (15/16) of patients receiving DPX-RSV, in both low-dose (8/8 participants) and high-dose (7/8 participants) cohorts. The new data reported today are based on the high-dose cohort, which was the only dose tested out to one year. The trial was conducted at the Canadian Center for Vaccinology (CCfV), based at Dalhousie University; the IWK Health Centre; and the Nova Scotia Health Authority; and funded in an industry-academic collaboration by the Canadian Institutes of Health Research and Immunovaccine. About RSV