Berkeley, CA and Vancouver, BC – July 24, 2017 – BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV: BCT) (OTCQB: BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, is pleased to announce that it has entered into a definitive share exchange agreement (the “Share Exchange Agreement”) with its wholly-owned subsidiary, BriaCell Therapeutics Corp. (“BriaCell USA”), a Delaware corporation, Sapientia Pharmaceuticals, Inc. (“Sapientia”) and all the shareholders of Sapientia (the “Sapientia Shareholders”). Sapientia, a biotechnology company based in Havertown, PA, that is developing novel targeted therapeutics for multiple indications including several cancers and fibrotic diseases.
Pursuant to the terms of the Share Exchange Agreement, BriaCell USA has agreed to acquire from the Sapientia Shareholders all of the issued and outstanding shares in the capital of Sapientia as at the date hereof in consideration to the Sapientia Shareholders, pro rata, of an aggregate of 2,500,000 common shares in the capital of BriaCell (the “Transaction”). As part of the Transaction, BriaCell acquired all rights, including composition of matter patents, and preclinical study data to a novel therapeutic technology platform, known as protein kinase C delta (PKCδ) inhibitors, which represents a unique, highly-targeted approach to treat cancer and to boost the immune system.
There is growing evidence that PKCδ inhibitors may stop the growth of cancer cells by blocking the actions of mutant RAS. RAS regulates cell signaling pathways, cell growth, and apoptosis (cell death). RAS mutations are seen in approximately 30% of all cancer cases. Additionally, PKCδ blocks the Transforming Growth Factor beta (TGFβ) signaling pathway, hence boosting the immune response. Extensive preclinical studies by the scientific founders of Sapientia have shown the robust activity of PKCδ inhibitors against cancer stem cells, neuroendocrine tumors (e.g., carcinoid), melanoma, pancreatic, breast, lung, and prostate cancers. Activity has also been demonstrated in models of fibrotic diseases, such as systemic sclerosis (scleroderma). The newly acquired PKCδ inhibitors will synergistically expand BriaCell’s existing development pipeline.
Sapientia’s intellectual property includes two U.S. patents issued to the scientific founders, Douglas V. Faller, MD, PhD, and Robert M. Williams, PhD, who will continue to further develop the technology with BriaCell as scientific advisors.
Dr. D.V. Faller, a graduate of MIT and Harvard Medical School, is a Professor of Medicine, Pediatrics, Biochemistry, Microbiology, Pathology and Laboratory Medicine at the Boston University School of Medicine. He is also the Director of the Cancer Center, Grunebaum Professor of Cancer Research and Vice-Chairman, Division of Medicine at BU. Dr. Faller’s research focuses on the identification of novel pathways and proteins to serve as targets for directed therapeutics in cancer and blood diseases. These targets include oncogenes and non-oncogene dependent pathways and oncogenic viruses. Dr. Faller has founded three biotechnology companies including HemaQuest pharmaceuticals and Phoenicia Biosciences, Inc.
Dr. R.M. Williams is a University Distinguished Professor of Chemistry, Colorado State University. Dr. Williams received his Ph.D. from MIT and was a post-doctoral fellow at Harvard University. Dr. Williams’ research focuses on the interplay of synthetic organic chemistry, microbiology, biochemistry and molecular biology. His research interests have included the total synthesis of biologically active natural products, with an emphasis on anti-cancer agents, studies on drug-DNA interactions, design and synthesis of antibiotics and anti-tumor agents, and biosynthetic pathways. Dr. Williams has co-founded 5 biotechnology companies and has extensive experience in synthetic organic chemistry, medicinal chemistry, process chemistry and pharmaceutical drug formulations.
Dr. Douglas V. Faller commented, “We look forward to working with BriaCell and its expert team to further develop our innovative PKCδ inhibitors which have great potential to be a leading technology for the treatment of cancer and fibrotic diseases. Our work with BriaCell will build upon our dedication to being one of the leading experts in targeted cancer therapy and immunotherapy.” “Both BriaCell and Sapientia are highly dedicated to developing innovative targeted therapies for patients with complex chronic diseases, ” Dr. Robert M. Williams commented.
“We are very excited by the acquisition of the novel technology platform for the treatment of cancer and fibrotic diseases,” stated Dr. William V. Williams, President & CEO of BriaCell. “This strategic acquisition will allow us to be able to leverage our experience in drug discovery and clinical development of targeted cancer therapeutics, and to broaden our pipeline. Sapientia’s intellectual property in cancers and fibrotic diseases provides synergies and opportunities for BriaCell by allowing us to strategically expand our pipeline into multiple cancer and fibrotic disease indications. By adding a pipeline of other product candidates, we plan to strengthen BriaCell’s footprint in other markets – besides breast cancer, and plan organic growth opportunities in the evolving oncology landscape. The early stage drug discovery program, focused on innovative PKCδ inhibitors, provides excellent value for our pipeline with targeted expenditures,” Dr. Williams added.
The Transaction is considered a “related party transaction” within the meaning of the TSX Venture Exchange Policy 5.9 and Multilateral Instrument 61-101—Protection of Minority Security Holders in Special Transactions (“MI 61-101”) as Dr. William Williams, the President, CEO and director of the Company and Martin Schmieg, a director of the Company, are each shareholders of Sapientia. The Company is relying on an exemption available from the formal valuation requirements under Section 5.5(b) of MI 61-101 and an exemption available from minority approval requirements under Section 5.7(a) of MI 61-101 on the basis that the fair market value of the transactions with the insiders do not exceed 25% of the Company’s market capitalization.
The Transaction is subject to the final approval of the TSX Venture Exchange.
BriaCell is an immuno-oncology focused biotechnology company developing a more targeted, less toxic approach to cancer management. BriaCell’s mission is to serve late-stage cancer patients with no available treatment options.
Immunotherapy has come to the forefront of the fight against cancer, harnessing the body’s own immune system in recognizing and selectively destroying the cancer cells while sparing normal ones. Immunotherapy, in addition to generally being more targeted and less toxic than commonly used types of chemotherapy, is also thought to be a strong type of approach aimed at preventing cancer recurrence.
BriaVax™, the Company’s lead product candidate, is a genetically engineered whole-cell vaccine derived from a human breast tumor cell line. It is believed to activate the immune system to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses. The Company has already demonstrated encouraging clinical results, and is intent on building upon these results to further advance BriaVax™ through additional FDA-approved clinical trials in order to help cancer patients with limited therapeutic options. The results of two previous Phase I clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with BriaVax™) have been encouraging in patients with advanced breast cancer. Most notably, one patient with metastatic breast cancer responded to BriaVax™ with substantial reduction in tumor burden including lung and brain metastases.
For additional information on BriaCell, please visit our website: http://briacell.com/
Cautionary Note Regarding Forward-Looking Information
Except for the statements of historical fact, this news release contains “forward-looking information” within the meaning of the applicable Canadian securities legislation which involves known and unknown risks relevant to the Company in particular and to the biotechnology and pharmaceutical industries in general, uncertainties and other factors that may cause actual events to differ materially from current expectation. These risks are more fully described in the Company’s public filings available at www.sedar.com. Other forward-looking information in this news release includes but is not limited to the intended use of proceeds of the Offering and other terms of the Offering, the expected timing of completion of the Offering, the Company’s ability to satisfy the conditions to completion of the Offering and the need for additional financing.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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