BERKELEY, Calif. and VANCOUVER, British Columbia, May 21, 2018 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (“BriaCell”) (TSX-V:BCT) (OTCQB:BCTXF), an immuno-oncology focused biotechnology company with a proprietary targeted immunotherapy technology, is pleased to announce the publication of the novel mechanism of action of BriaCell’s lead product candidate, Bria-IMT™ in the journal of Frontiers in Immunology, the 5th most cited journal in Immunology.
“The publication of BriaCell’s findings in such a prestigious peer-reviewed journal further validates our hypothesis that Bria-IMT™’s unique mechanism of action may be associated with a substantial tumor reduction in patients who match HLA Class II molecules with Bria-IMT™,” stated Dr. Williams, BriaCell’s President & CEO. “The findings outlined in this publication are the cornerstones of our pipeline of cell-based cancer therapeutics, referred to as Bria-OTS™, our off-the-shelf personalized immunotherapy for advanced breast cancer. This strategy will allow us to cover over 90% of the patients with advanced breast cancer as we work tirelessly to improve patient outcomes in the fight with this deadly disease,” Dr. Williams noted.
The Company is currently conducting a Phase IIa trial (NCT03066947) with Bria-IMT™, and a rollover trial (NCT03328026) with Bria-IMT™ in combination with other immunotherapies. For further information on the Phase IIa trials, please visit https://clinicaltrials.gov/ct2/show/NCT03066947.
The novel mechanism of action of Bria-IMT™, also referred to as SV-BR-1-GM, may explain the impressive early clinical data including tumor shrinkage observed in some patients with advanced metastatic breast cancer. As summarized in the peer-reviewed publication, a body of evidence suggests novel immune-stimulating actions of Bria-IMT™ which we believe are unique to Bria-IMT™ compared with other similar approaches. Specifically, Bria-IMT™ contains several factors including HLA-Class II molecules, molecules which typically are involved in starting an immune response. These molecules directly activate CD4+ “Helper” T cells, a key component of the immune system, which can produce a strong immune response against tumor cells resulting in tumor size reduction also known as clinical regression. Complete or even partial regressions are difficult to achieve in advanced breast cancer patients who have failed the standard of care. BriaCell has previously reported such responses in patients with advanced metastatic breast cancer, not only in soft tissue and visceral areas, but even in the brain, a difficult to treat site.
The details of the publication are the following:
Journal: Frontiers in Immunology
Section: Cancer Immunity and Immunotherapy
Title: SV-BR-1-GM, a Clinically Effective GM-CSF-Secreting Breast Cancer Cell Line, Expresses an Immune Signature and Directly Activates CD4+ T Lymphocytes
The manuscript of the publication can be accessed via the following link: http://journal.frontiersin.org/article/10.3389/fimmu.2018.00776/full?&utm_source=Email_to_authors_&utm_medium=Email&utm_content=T1_11.5e1_author&utm_campaign=Email_publication&field=&journalName=Frontiers_in_Immunology&id=297974.
In a related matter, BriaCell also had an abstract accepted for publication in the proceedings for the American Society of Clinical Oncology (ASCO) national meeting. The abstract discusses the clinical data on 6 patients dosed with Bria-IMT™ in 2017. The abstract notes that 2 of 6 heavily pre-treated patients showed tumor regression. An excellent safety profile was noted as well as additional support for our companion diagnostic, BriaDX™. This abstract can be accessed at this link: http://abstracts.asco.org/214/AbstView_214_229215.html.
BriaCell is an immuno-oncology focused biotechnology company developing targeted and safe approaches for the management of cancer. Immunotherapy has come to the forefront in the fight against cancer because it uses the body’s own immune system in recognizing and selectively destroying cancer cells while leaving normal cells intact. In addition, immunotherapy is also considered to be a more potent approach than chemotherapy, and has the potential to prevent cancer recurrence.
Bria-IMT™ (SV-BR-1-GM), the Company’s lead product candidate, is derived from a specific breast cancer cell line. It is genetically engineered to release granulocyte-macrophage colony-stimulating factor (GM-CSF), a substance that activates the immune system. BriaCell believes that Bria-IMT™ helps the body to recognize and kill tumor cells by activating both T cells that directly attack tumor cells, and B cells that produce anti-tumor antibodies.
The results of two previous proof-of-concept clinical trials (one with the precursor cell line not genetically engineered to produce GM-CSF and one with Bria-IMT™) produced encouraging results in patients with advanced breast cancer. Most notably, one patient with breast cancer that had spread to other sites (metastatic cancer) responded to Bria-IMT™ with a substantial reduction in tumor size and volume in these sites, including sites in the breast, the lung, soft tissues, and even the brain. BriaCell is currently conducting a Phase I/IIa clinical trial of Bria-IMT™ in patients with advanced breast cancer. In this trial, to date, Bria-IMT™ treatment has been safe with instances of tumor reduction observed. 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, to be able to predict the patients who will likely benefit the most from Bria-IMT™ treatments. Additionally, the FDA recently approved a rollover combination study of Bria-IMT™ with pembrolizumab [Keytruda®; manufactured by Merck & Co., Inc.] or ipilimumab [Yervoy®; manufactured by Bristol-Myers Squibb Company]. This study permits continuation of the Bria-IMT™ treatment for patients in the ongoing Phase I/IIa trials who stop responding to the treatment. The rollover trial is listed in ClinicalTrials.gov as NCT03328026.
Based on our observation of superior tumor shrinking responses in the patients who shared certain HLA types with Bria-IMT™, BriaCell is developing Bria-OTS™, an off-the-shelf personalized Immunotherapy, for advanced breast cancer. Bria-OTS™ includes a set of cell lines, each being similar to Bria-IMT™, which are being engineered to express various pre-manufactured HLA types. With only 15 different HLA types, Bria-OTS™ cell line combinations are expected to cover over 90% of the United States’ population. BriaCell expects to use BriaDX™ to determine the HLA types of patients, and subsequently select one or two Bria-OTS™ cell lines with matching alleles to be administered to the patient. This should produce a potent and selective immune response against the cancer of each patient while eliminating the time, expense, and complex manufacturing logistics currently used for other personalized immunotherapies. In essence, Bria-OTS™ should provide a personalized treatment without the need for personalized manufacturing.
BriaCell’s small molecule program includes the development of novel, selective protein kinase C delta (PKCδ) inhibitors which have shown potent activity in a number of pre-clinical models of several different cancer indications as well as fibrotic diseases.
For additional information on BriaCell, please visit our website: http://briacell.com.
BriaCell Expands its Investor and Media Outreach Platform
BriaCell has recently expanded its investor and media outreach efforts in order to enhance communication and increase investor awareness of the Company, its product candidates, and its clinical programs. The comprehensive program is expected to improve BriaCell’s dialogue with institutional and retail investors, industry analysts, as well as with the investing public. In addition to its existing public relations and investor relations consultants, BriaCell has recently engaged the following IR and PR groups. It is important to disclose that BriaCell is unrelated and unaffiliated with each of the following entities, but the following firms and their clients may have an interest, directly or indirectly, in the securities of BriaCell.
IR Plus: Based in N. Kingstown, RI, IR Plus is a corporate communications and investor relations firm with a focus on broadening market awareness and engagement with the institutional and retail investment communities in both Canada and the United States. As of May 1, 2018, BriaCell will pay IR Plus a fee of US$2,000 per month for the minimum of 3 months, terminable at any time by either party upon providing a written notice of 30 days. In addition, Mr. Raymond Mullaney, IR Plus’s President, will be eligible for receiving 250,000 stock options of BCT.V, subject to the TSX and Board approval vested at an exercise price 10% above the 5-day weighted average trading price of the shares for the last 5 days that the shares traded on the TSX prior to the day of grant, exercisable for a term of 60 months from the date of grant (or per a vesting schedule approved by the exchange). The options will be dispersed in four equal grants quarterly (beginning in July 2018).
SmallCapVoice.com, Inc.: Based in Cedar Park, TX, SmallCapVoice.com, Inc., is a leading online marketing and investor relations firm that specializes in providing investor communication services to small cap companies using online tools like SEO, social media, email campaigns, audio interviews, etc. It is known for its ability to help emerging growth companies build a following among retail and institutional investors in the United States and Canada. As of April 1, 2018, BriaCell has been paying SmallCap Voice, Inc. US$2,500 at the end of each month. The contract can be terminated after 3 months for any reason by either party.
RB Milestone Group LLC: Based in New York, NY, RB Milestone Group LLC (“RBMG”) is a capital markets consulting firm that provides advisory services in corporate strategy, investor awareness, business development, market intelligence and research to small and venture-stage companies. RBMG is known for its deep-rooted contacts amongst high net worth individuals, small funds, family offices, brokers and strategics within the United States. Staff specialists have diverse sector knowledge centered on capital markets. BriaCell has paid RBMG the retainer fee of US$65,000 on March 30, 2018 for investor relations consulting services for 6 months. The contract can be terminated upon receiving a written notice of 30 days prior to the automatic renewal of the agreement for any reason by either party.
JGRNT Capital Corp.: Based in Toronto, Canada, JGRNT Capital Corp. will be providing capital markets consulting services focusing on the Canadian investor community for a one-year term. In exchange there will be a monthly retainer fee of CAD$1,000 plus HST. The agreement can be terminated by either party with a written notice of 30 days.
Independent Trading Group Inc. (ITG): Based in Toronto, Canada, ITG will be providing market maintenance services to BriaCell in compliance with the policies and guidelines of the TSX Venture Exchange, and other applicable legislation. ITG will trade shares of BriaCell on the TSX Venture Exchange for the purposes of maintaining a reasonable market and improving the liquidity of BriaCell’s shares. BriaCell has agreed to pay ITG CAD$3,500 per month during the term. The agreement between ITG and BriaCell is for a minimum of three months, and it may be terminated by either party with a written notice of 30 days. The agreement is principally for the purposes of maintaining market stability and liquidity for BriaCell’s common shares and is not a formal market making agreement. There are no performance factors contained in the agreement between ITG and BriaCell, and ITG will not receive any shares or options from BriaCell as compensation for services it will render.
JV Public Relations: With decades of experience and a solid track record of successfully communicating the values of public and private companies in the healthcare space, JV Public Relations is specialized in reaching out to key players in financial and healthcare-focused media outlets. BriaCell pays JV Public Relations a defined monthly retainer fee of US$2,500. The existing contract is on a month to month basis and can be dissolved by either party at any time.
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.
For further information, please contact:
BriaCell Therapeutics Corp.:
Manager, Corporate Development