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The Company is issuing a clarification news release at the request of IIROC.
Vancouver, British Columbia--(Newsfile Corp. - May 18, 2022) - Defence Therapeutics Inc. (CSE: DTC) (FSE: DTC) (OTC Pink: DTCFF) ("Defence" or the "Company"), a Canadian biopharmaceuticals company primarily focused on the development of novel immune-oncology vaccines and drug delivery technologies, is pleased to announce the development of novel dual-acting AccumTM-linked protein vaccine, AccuVAC-PTE7, dedicated to protect from cervical cancer (prophylactic vaccine) or to treat (therapeutic vaccine) patients with pre-established cervical tumors.
The protection from cervical cancer can currently only be achieved with the use of Gardasil-9 or Cervarix, two vaccines directed against the L1 proteins of HPV. However, there is currently no cure for patients with established cervical cancer and the clinical trials conducted previously with other companies with both the E6 and E7 proteins were highly disappointing.
Since the AccumTM molecule was previously shown to significantly enhance the immunogenicity of various proteins, as shown notably in our press releases dated of January 26th, 2022 and November 3rd, 2021, the Defence team engineered a novel protein-based vaccine targeting the oncogenic protein E7 normally used by HPV to transform healthy cells into an outgrowing tumor. Pre-clinical studies conducted on this new vaccine, AccuVAC-PTE7, not only provide a 100% protection from cervical cancer if delivered prophylactically (e.g. before tumor growth), but also show potent anti-tumoral effects against established tumors when combined with various immune-checkpoint blockers such as anti-PD-1, anti-CTLA4 or anti-CD47.
"The idea of having a dual-acting vaccine targeting cervical cancer capable of both protecting and treating patients from cervical cancer is a giant step in the field of cancer vaccines. In addition, this vaccine contains a single protein, the E7, which makes it easier to manufacture and use compared to a mix of 9 proteins as provided by the Gardasil-9 product," says Mr. Plouffe, the CEO of Defence Therapeutics.
According to Fortune Business Insights, the global HPV vaccine market size was valued at $3.80 Bn in 2019 & is projected to reach $12.69 Bn by 2027, with a CAGR of 16.3%. https://www.fortunebusinessinsights.com/human-papillomavirus-hpv-vaccines-market-101962.
The preclinical studies have been complete at Dr. Moutih Rafei's lab at the Universite de Montreal. Dr. Rafei is Defence's vice-president - research and development, and he has led, reviewed and approved the scientific disclosure contained in this press release. Dr. Rafei has a PhD in experimental medicine from McGill University and received his postdoctoral training at the Universite de Montreal. He is an immune-oncologist who specializes in the fields of T-cell development, stem cell biology, cancer immunotherapy and autoimmune diseases.
The program on ACCUVAC-PTE7 vaccine began in early 2022 followed by the in vivo studies on mice led by Dr. Rafei. A GLP study is scheduled for this summer 2022 by an independent CRO and the results will be announced when received later this year. Defence's plan is to prepare and present an FDA package in the fall of 2022 to get ready to do a Phase I clinical trial in the USA in Q2 of 2023.
Defence Therapeutics is a publicly-traded biotechnology company working on engineering the next generation vaccines and ADC products using its proprietary platform. The core of Defence Therapeutics platform is the ACCUMTM technology, which enables precision delivery of vaccine antigens or ADCs in their intact form to target cells. As a result, increased efficacy and potency can be reached against catastrophic illness such as cancer and infectious diseases.
Cautionary Statement Regarding "Forward-Looking" Information
This release includes certain statements that may be deemed "forward-looking statements." All statements in this release, other than statements of historical facts, that address events or developments that the Company expects to occur, are forward-looking statements. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the words "expects", "plans", "anticipates", "believes", "intends", "estimates", "projects", "potential" and similar expressions, or that events or conditions "will", "would", "may", "could" or "should" occur. Although the Company believes the expectations expressed in such forward-looking statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results may differ materially from those in the forward-looking statements. Factors that could cause the actual results to differ materially from those in forward-looking statements include regulatory actions, market prices, and continued availability of capital and financing, and general economic, market or business conditions. Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Forward-looking statements are based on the beliefs, estimates and opinions of the Company's management on the date the statements are made. Except as required by applicable securities laws, the Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.
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To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124517