- Company achieves positive proof of concept in Phase IIa study of its lead product candidate, Bria-IMT, in advanced breast cancer patients
- Efficacy data comparable to that of other approved breast cancer therapies in a similar stage of development
- Combination study with immune checkpoint inhibitors in the works, enrollment already open
BriaCell Therapeutics Corp. (OTCQB: BCTXF) (TSX.V: BCT), a clinical-stage biotechnology company focused on the development of proprietary targeted immunotherapy for advanced breast cancer, has achieved proof of concept and reported promising results from a Phase IIa study of its lead clinical candidate, Bria-IMT.
Study data indicates promising anti-tumor activity for Bria-IMT in heavily pre-treated advanced breast cancer patients, according to a company press release (http://ibn.fm/fXxxL). Additionally, results highlight the outstanding safety and tolerability of BriaCell Therapeutics’ lead product candidate, with efficacy data similar or superior to other approved breast cancer drugs that are in a similar stage of development.
“This top-line data compares very well with data from existing breast cancer therapies which have a sizable market share when they were at a similar stage of clinical development, as well as with other promising breast cancer treatments currently under study,” BriaCell CEO and President Dr. Bill Williams stated in a news release.
A total of 31 patients with advanced stage breast cancer were enrolled in the Phase II Bria-IMT monotherapy study. The proof of concept and mechanism of action work is based on the results observed in the first 20 patients, while assessment of the remaining 11 patients is still in progress.
The preliminary data seems to confirm the company’s HLA Matching Hypothesis and support its strategy for the development of Bria-OTS, the first off-the-shelf personalized immunotherapy for advanced breast cancer, designed to provide treatment without the high costs and difficult manufacturing generally associated with personalized therapies. The technology is applicable to other types of cancer, as well.
“Bria-IMT appears to be most effective in patients who match with Bria-IMT at 2 HLA loci (types) further supporting BriaCell’s HLA Matching Hypothesis, and the development of Bria-OTS to cover 90% of the patient population,” Williams added. “We are delighted with these positive clinical findings that confirm our HLA Matching Hypothesis in the Phase I/IIa trial in advanced breast cancer showing significant tumor shrinkage without serious side effects.”
The company has launched a Phase IIa combination study of Bria- IMT with pembrolizumab – marketed as Keytruda and manufactured by Merck & Co., Inc. (NYSE: MRK) – or as ipilimumab – marketed as Yervoy and manufactured by Bristol-Myers Squibb Company (NYSE: BMY) – in advanced breast cancer. The combination study is listed on ClinicalTrials.gov as NCT03328026.
These checkpoint inhibitors, pembrolizumab (anti-PD-1) and ipilimumab (anti-CTLA-4), have come to the forefront in the fight against cancer with substantial benefits for some patients. Most recently, the significance of immune checkpoints was recognized by the Nobel committee, which awarded Drs. Honjo (PD-1) and Allison (CTLA-4) with the 2018 Nobel Prize in Physiology or Medicine.
“In our view, the combination of Bria-IMT with Keytruda or Yervoy has the potential to provide a new therapeutic option and substantial clinical benefit in heavily pre-treated advanced breast cancer patients where there remains a significant unmet need,” Williams explained.
With the global cancer immunotherapy market expected to reach nearly $120 billion by 2021 (http://ibn.fm/WVGZ0) and with more than 266,000 new cases of invasive breast cancer expected to be diagnosed in the U.S. this year (http://ibn.fm/qkuk8), BriaCell believes that it can leverage its proprietary technology to address the needs of the breast cancer medication market and also develop immunotherapies for other cancer indications in the near future.
For more information, visit the company’s website at www.BriaCell.com
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