BriaCell Announces Successful Completion of Phase I Portion

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  • BriaCell has efficiently accomplished its Phase I security and tolerability analysis of Bria-IMT™ together with Incyte’s retifanlimab in superior breast most cancers.
  • The mixture therapy confirmed a good security profile in 12 sufferers.
  • Phase II efficacy portion of the research, beneath FDA’s quick observe designation, now underway with survival knowledge and scientific profit being compiled.

PHILADELPHIA and VANCOUVER, British Columbia, Oct. 21, 2022 (GLOBE NEWSWIRE) — BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) (“BriaCell” or the “Company”), a clinical-stage biotechnology firm specializing in focused immunotherapies for most cancers, is happy to announce the completion of the Phase I half of the scientific trial of its lead candidate, Bria-IMT™, together with Incyte’s PD-1 inhibitor, retifanlimab, in superior breast most cancers. The efficacy and survival knowledge of the handled sufferers is being evaluated within the Phase II half of the research which was lately awarded the FDA’s quick observe designation. Under an FDA accepted protocol, one other arm has lately been added to the Phase II research to guage the results of dosing schedules for sufferers within the research.

“We are very impressed by the clinical data showing a favorable safety profile for our treatment in advanced breast cancer patients who have failed other therapies,” commented Dr. Del Priore, BriaCell’s Chief Medical Officer. “We look forward to further advancing this program and sharing the data in the coming months.”

The Phase I portion of the trial, with the first purpose of assessing security and tolerability of the mixture, enrolled 12 topics who had beforehand failed no less than two prior strains of remedy, characterised as a difficult-to-treat affected person inhabitants. The mixture therapy had a good security profile and appeared well-tolerated with no dose-limiting toxicities.

Now progressing by the Phase II half of the scientific trial, a randomized managed design might be used to permit comparability of the effectiveness of the therapy regimens between the 2 arms of the research with completely different dosing schedules.

BriaCell is on schedule to satisfy with the FDA later this yr to debate the design of a key registration research.

About BriaCell Therapeutics Corp.

BriaCell is an immuno-oncology-focused biotechnology firm growing focused and efficient approaches for the administration of most cancers. More data is accessible at https://briacell.com/.

Safe Harbor

This press launch incorporates “forward-looking statements” which can be topic to substantial dangers and uncertainties. All statements, apart from statements of historic truth, contained on this press launch are forward-looking statements. Forward-looking statements contained on this press launch could also be recognized by the use of phrases equivalent to “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the destructive of these phrases or different comparable expressions, though not all forward-looking statements comprise these phrases. Examples of forward-looking statements on this information launch embody statements that the Company makes concerning the completion of the Phase II portion of the research; the potential success of the Bria-IMT™ program; the impact(s) of Bria-IMT™ on sufferers;; the flexibility of the Company to additional advance its scientific research; and the character and frequency of communications with the FDA. Forward-looking statements are based mostly on BriaCell’s present expectations and are topic to inherent uncertainties, dangers and assumptions which can be troublesome to foretell. Further, sure forward-looking statements are based mostly on assumptions as to future occasions that won’t show to be correct. These and different dangers and uncertainties are described extra totally beneath the heading “Risks and Uncertainties” within the Company’s most up-to-date Management’s Discussion and Analysis, beneath the heading “Risk Factors” within the Company’s most up-to-date Annual Information Form, and beneath “Risks and Uncertainties” within the Company’s different filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which can be found beneath the Company’s profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov. Forward-looking statements contained on this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no obligation to replace such data besides as required beneath relevant regulation.

Neither Toronto Stock Exchange nor its Regulation Services Provider (as that time period is outlined within the insurance policies of the Toronto Stock Exchange) accepts accountability for the adequacy or accuracy of this launch.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
[email protected] 

Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
[email protected]

Investor Relations Contact:
CORE IR
[email protected]

 



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