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: firstname.lastname@example.org Patti Bank, Managing Director, Westwicke Partners O: (415) 513-1284 T: (415) 515-4572 E: email@example.com 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.
Extensive facility renovation, new equipment, assists life sciences firm in creating jobs, growing regional economy
April 12, 2018 – Windsor, NS – Atlantic Canada Opportunities Agency
Canada is a country of innovators. Curiosity, creativity and a collaborative spirit are what lead to the kinds of innovations and technologies that improve our daily lives and drive our economy, and our country, forward. That is why the Government of Canada is investing $5,000,000 in BioVectra Inc. to help the Charlottetown-based biotechnology and pharmaceutical ingredient manufacturing company expand its operations to Nova Scotia. This will enable the firm to grow, create additional highly skilled positions and help build sustained economic prosperity in Atlantic Canada.
The funding was announced today by the Honourable Scott Brison, Secretary of the Treasury Board and Member of Parliament for Kings-Hants, on behalf of the Honourable Navdeep Bains, Minister of Innovation, Science and Economic Development and Minister responsible for the Atlantic Canada Opportunities Agency(ACOA). The repayable contribution is being made through ACOA’s Business Development Program, which helps small and medium-sized enterprises expand and modernize to improve competitiveness.
BioVectra will use the assistance to complete major renovations at its Windsor facility and to purchase new equipment. This will allow the company to increase its capacity to develop and manufacture biologic drug substances for global pharmaceutical and biotechnology companies. These materials are used in the creation of products to treat cancer, autoimmune disorders, diabetes, arthritis, and many other serious illnesses.
The project will create 28 full-time positions, and by 2020, when the plant is fully operational, it is expected that more than double that number of people will be employed there.
This investment builds on commitments made by the Government of Canada and the four Atlantic Provinces to drive economic growth in the region through the Atlantic Growth Strategy, which supports strategic investments in initiatives that build on the region’s competitive advantages, such as its strong export potential, growing innovation network, and skilled workforce.
About Keryx Biopharmaceuticals, Inc. Keryx Biopharmaceuticals, Inc., with headquarters in Boston, Massachusetts, is focused on the development and commercialization of innovative medicines that provide unique and meaningful advantages to people with kidney disease. The Keryx team consists of approximately 200 committed people working with passion to advance the care of people with this complex disease. This dedication has resulted in two FDA-approved indications for Keryx’s first medicine, Auryxia® (ferric citrate) tablets. For more information about Keryx, please visit www.keryx.com. About BioVectra BioVectra is a CDMO that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients. An innovative and reliable service partner with a strong regulatory history, BioVectra has over 45 years of experience specializing in: GMP Microbial Fermentation & Purification Complex Chemistry Process & Analytical Development For more information about BioVectra, please visit www.biovectra.com. Media Contact Jordan MacGregor Marketing and Communications Manager firstname.lastname@example.org 902-566-9116 ext. 6376 www.biovectra.com]]>
See original article here Halifax-based DGI Clinical takes a two-pronged approach to boosting health care: the group gives patients a voice and allows pharmaceutical companies to better understand their clinical trial data. DGI Clinical has developed systems that allow patients to state and communicate their health care priorities. Established in 2001 by Dalhousie-based Alzheimer’s expert Dr. Kenneth Rockwood, DGI has created patient-focused SymptomGuides. The Alzheimer’s and dementia SymptomGuide is available online. It allows sufferers to name the symptoms that most concern them. This information can be shared with family and health professionals. Both patients and caregivers can enter data and track symptoms. It’s important that patients state the symptoms that trouble them, said Chère Chapman, the company’s CEO. “Gone are the days when patients say, ‘Tell me what to do and I’ll do it,’” Chapman said. “The SymptomGuide allows patients to set goals for their treatment … One patient with dementia, for example, may wish to increase their social activity. Another may wish to decrease repetition of asking the same questions.” Chapman said between 4,000 and 5,000 people and their caregivers use the Alzheimer’s and dementia SymptomGuide. Other Symptom Guides have been created for clinical trials and clinic settings, including a recently developed hemophilia Symptom Guide. The company has also built bespoke Alzheimer’s and dementia tools for clinical trials and clinic use. “A company may want to develop a compound to reduce agitation. SymptomGuide will reveal how many of our users are concerned about agitation,” Chapman said. SymptomGuide can reveal details such as the disease stage or stages where agitation bothers patients, whether respondents are already diagnosed, and what therapies they may be on. DGI Clinical is now looking at working in the areas of HIV, cardiovascular disease and renal failure. “Our tools are applicable to chronic diseases, and our scientific team has already done a lot of research in these areas,” said Chapman. She said DGI Clinical’s tools allow pharmaceutical clients to fully understand their data. “The typical phase two drug trial looks at primary and secondary outcomes, including quality of life measures, but these are typically analyzed as if they are unrelated,” she said. “We allow pharmaceutical companies to see how the outcomes interact with each other to produce treatment effects.” She said that drug companies usually try to exclude frail people from drug trials, but people of different levels of frailty do get onto the trials. DGI offers a Frailty Index, which was developed at Dalhousie by Ken Rockwood and Arnold Mitnitski, both DGI scientists. It has been adapted for clinical trial data and provides pharmaceutical companies with greater information about the frailty of their clinical trial subjects. “The Frailty Index reveals the impact of the drug on frail people, resulting in more clinically meaningful information,” Chapman said. She said that deep analysis of data is especially useful when drug trial results are unclear. “It could be a $100-million decision to take a drug to the next level, so digging deeper into the data is worthwhile.” Chapman, a New Brunswick native with a background in health research and business management, had worked around the world before joining DGI a year ago, becoming CEO in December. She said the company is growing steadily, funding its own growth, and focusing on R&D and hiring staff. Halifax is an excellent base as the city’s universities produce great scientists. She said she is not aware of any direct competitors. “Our biggest issue is the education of potential clients,” she said. “We have to get people to change the ways they do things.” So far, the company has no Canadian clients. All clients are U.S. or European pharmaceutical companies or other groups with a health intervention to test. “We are not in a huge rush to grow,” Chapman said. “Science is complicated. It takes time for staff to understand all the science behind what we do, however bright they are.”]]>