BriaCell Announces Advancement of its Small Molecule Program and Patent Allowance
BERKELEY, Calif. and VANCOUVER, British Columbia, Nov. 13, 2017 (GLOBE NEWSWIRE) -- BriaCell ("BriaCell" or the "Company") (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary vaccine technology, today disclosed the allowance by the US Patent and Trademark Office (USPTO) and also the European Patent Office (EPO) of two patent applications related to protein kinase C delta (PKCδ) inhibitor technology, titled “PKC Delta Inhibitors for use as Therapeutics”. In a related matter, BriaCell announced the advancement of its small molecule program based on its proprietary PKCδ inhibitor technology.
The PKCδ inhibitor technology, which includes the entire PKCδ inhibitor patent portfolio, was recently acquired by BriaCell from Sapientia Pharmaceuticals Incorporated (Sapientia). The technology, developed by Douglas V. Faller, MD, PhD, and Robert M. Williams, PhD, includes potent and selective small molecule inhibitors of PKCδ, an enzyme involved in the development of certain cancers. It has been shown that PKCδ inhibitors cause the breakdown of RAS proteins, involved in cancer cell growth, and hence cause the cancer cells to stop dividing and die. In addition, by boosting the immune system to recognize and kill cancer cells, PKCδ inhibitors may act as a type of immunotherapy.
“We are extremely pleased that both the US Patent and Trademark Office and the European Patent Office have allowed these claims on PKC Delta Inhibitors for use as Therapeutics,” stated Dr. Douglas V. Faller, co-inventor of the patent and BriaCell’s Scientific Advisory Board member. “This opens the door to the development of additional PKCδ inhibitors with better drug-like properties.”
“We are excited to advance the chemistry efforts on the PKCδ inhibitors, and anticipate rapid progress in developing small molecules suitable for clinical use,” stated Dr. William Williams, BriaCell’s President & CEO.
About PKCδ Inhibitor Technology
The excitement about the PKCδ inhibitors stems from PKCδ’s action on the ‘RAS master switch'. RAS proteins have a pivotal importance in gene expression, cell division and programmed cell death. A pharmaceutical that could block RAS in cancer cells would likely be a very potent anticancer medicine, but, despite enormous efforts by scientists around the world, finding such a drug has been a complete failure. The driving insight of the Sapientia scientists was based on creating a ‘sneak attack’ on RAS, by blocking PKCδ. Based on this hypothesis, PKCδ inhibitors may act as a targeted cancer therapy by specifically blocking the actions of RAS proteins, involved in the growth of cancer cells, and as a result, cause cancer cells to die. Additionally, PKCδ inhibitors may act as an immunotherapy by blocking Transforming Growth Factor beta (TGFβ) signaling pathways that lower immune activity, and hence boost the immune response to destroy cancer cells.
PKCδ inhibitors Pre-Clinical Data to Date
Extensive preclinical studies by Douglas V. Faller, MD, PhD, and Robert M. Williams, PhD, have shown robust activity of BriaCell’s proprietary PKCδ inhibitors against cancer stem cells, neuroendocrine tumors (e.g., carcinoid), melanoma, pancreatic, breast, lung, and prostate cancers. The activity of the PKCδ inhibitors has also been demonstrated in models of fibrotic diseases including systemic sclerosis (scleroderma).
The patent portfolio is believed to be quite broad and is directed to compounds, pharmaceutical compositions, methods of treatment, and methods of assessing patients related to PKCδ inhibitor technology and includes U.S. Patent No. 9,364,460 and U.S. Patent No. 9,572,793. BriaCell has now received allowance of additional claims for its PKCδ inhibitor technology, namely U.S. Patent Application Publication No. 2017/0252322 and also EPO Patent Application Publication No. 2897610. Both of these applications will issue very soon as US and EPO Patents. Additional applications are also pending in both the United States and Europe.
BriaCell plans to develop a platform of novel PKCδ inhibitors for both oncology and fibrotic diseases. These PKCδ inhibitors are potentially first-in-class and offer a novel approach to both targeted cancer therapies and immunotherapeutic drug candidates.
PKCδ inhibitors may also add to the anti-tumor activity of BriaVax™, a whole-cell cancer vaccine currently in clinical testing for advanced breast cancer.
BriaCell is an immuno-oncology focused biotechnology company developing a targeted and safe approach to the management of cancer. 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 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 potent approach with the potential to prevent cancer recurrence.
BriaVax™, the Company's lead product candidate, is a whole-cell breast cancer vaccine genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system by allowing the body to recognize and eliminate cancerous cells by inducing tumor-directed T cell and potentially antibody responses.
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 breast, lung, soft tissue and brain metastases. The company is currently conducting a Phase I/IIa clinical trial for BriaVax™ in patients with advanced breast cancer. This trial is listed in ClinicalTrials.gov as NCT03066947. The trial is being conducted along with the co-development of BriaDx™, the Company’s companion diagnostic test. The interim data for the first 10 patients is expected by the first quarter of 2018. Additionally, the FDA recently approved the roll-over combination study of BriaVax™ with pembrolizumab [Keytruda; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy; manufactured by Bristol-Myers Squibb Company] for patients previously treated with BriaVax™ in the Company’s ongoing Phase I/IIa clinical trial in advanced breast cancer. The roll-over trial is listed in ClinicalTrials.gov as NCT03328026.
BriaCell is also developing novel, selective protein kinase C delta (PKCδ) inhibitors. PKCδ inhibitors have shown activity in a number of pre-clinical models of RAS genes’ transformed cancers including breast, pancreatic, non-small cell lung cancer and neuroendocrine tumors (such as carcinoid tumors).
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.
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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Manager, Corporate Development