Technology News

BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT Combination in Advanced Metastatic Breast Cancer

BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT Combination in Advanced Metastatic Breast Cancer

  • BriaCell has received agreement and positive feedback from its End of Phase II meeting with the FDA for lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor, in advanced metastatic breast cancer.
  • After reviewing BriaCell's Fast Track designated Phase I / IIa data, the FDA has agreed on the primary end point, the essential elements of the pivotal registration study design, and type of patients to be included.
  • Registration study success could lead to a Biologics License Application (BLA) submission and commercialization approvals for BriaCell's novel immunotherapy approach.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce that it has received agreement and positive feedback from its End of Phase II meeting with the FDA regarding BriaCell's lead clinical candidate, Bria-IMT™ in combination with a checkpoint inhibitor (under Fast Track designation), in advanced metastatic breast cancer.

BriaCell and the FDA have agreed on the primary end point, the essential elements of the study design, and the type of patients to be enrolled in BriaCell's upcoming pivotal clinical study. This pivotal registration study will be enrolling advanced metastatic breast cancer patients for whom no approved treatment options exist.

Registration study success could lead to a Biologics License Application (BLA) submission for the approval of the combination regimen for commercialization in advanced metastatic breast cancer.

"The importance of this milestone speaks for itself and is yet another major step towards our goal to become one of the leading immuno-oncology companies," stated Dr. William V. Williams, BriaCell's President and CEO. "Jumping directly into a pivotal study shortly after receiving Fast Track status has greatly advanced our lead clinical program timetable with the ultimate goal of commercializing our novel immunotherapy approach for women with no approved treatment options."

About BriaCell Therapeutics Corp.

BriaCell is an immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer. More information is available at https://briacell.com/ .

Safe Harbor

This press release contains "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Examples of forward-looking statements in this news release include statements that the Company makes regarding to the Company upcoming pivotal clinical study and the potential for the Company to make a Biologics License Application for the approval of the combination regimen. Forward-looking statements are based on BriaCell's current expectations and are subject to inherent uncertainties, risks, and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully under the heading "Risks and Uncertainties" in the Company's most recent Management's Discussion and Analysis, under the heading "Risk Factors" in the Company's most recent Annual Information Form, and under "Risks and Uncertainties" in the Company's other filings with the Canadian securities regulatory authorities and the U.S. Securities and Exchange Commission, all of which are available under the Company's profiles on SEDAR at www.sedar.com and on EDGAR at www.sec.gov . Forward-looking statements contained in this announcement are made as of this date, and BriaCell Therapeutics Corp. undertakes no duty to update such information except as required under applicable law.

Neither the Toronto Stock Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Toronto Stock Exchange) accepts responsibility for the adequacy or accuracy of this release.

Contact Information

Company Contact:
William V. Williams, MD
President & CEO
1-888-485-6340
info@briacell.com

Media Relations:
Jules Abraham
Director of Public Relations
CORE IR
917-885-7378
julesa@coreir.com

Investor Relations Contact:
CORE IR
investors@briacell.com


Primary Logo

News Provided by GlobeNewswire via QuoteMedia

BCT:CA
BriaCell CEO Letter to Shareholders

BriaCell CEO Letter to Shareholders

  • Positive FDA feedback on our pivotal study for lead clinical candidate Bria-IMT™ in combination with a checkpoint inhibitor could greatly accelerate the path to commercialization.
  • Successful completion of the pivotal study could be followed by a Biologics License Application submission and commercialization.
  • Pivotal study's primary endpoint to be linked to survival improvement.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, today issues a letter to shareholders from Dr. William V. Williams, BriaCell's President and CEO.

Dear BriaCell Shareholders,

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell to Investigate Alleged Illegal Trading of Public Securities

BriaCell to Investigate Alleged Illegal Trading of Public Securities

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announced today that it has approved measures to address alleged illegal trading activity of its publicly traded securities. The Company believes that certain individuals andor companies may have engaged in manipulative andor suspected illegal trading practices that may have artificially depressed its share price. As a result, BriaCell is implementing a plan to address this issue which may include legal action.

BriaCell is working to build one of the leading immuno-oncology companies in the biotech sector with a singular focus on commercializing our novel immunotherapy approach for cancer patients. While our clinical team remains dedicated to developing these desperately needed therapies, the Company recognizes that recent milestones have been achieved with the support of loyal investors who are instrumental in the ongoing development of our assets. By taking action to protect the interests of our shareholders, we are also protecting the interests of the Company and the tens of thousands of cancer patients in need of effective treatment options. To this end, BriaCell is pursuing avenues to address alleged illegal activities carried out by various parties potentially working collusively with the intent of depressing the Company's share price while undermining the interest of our shareholders.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Announces New Patent Issuance, Bria-OTS IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment

BriaCell Announces New Patent Issuance, Bria-OTS IND Timing Guidance, and Additional Clinical Sites to Boost Enrolment

  • BriaCell's new patent protects its novel personalized off-the-shelf cell-based technology for breast cancer and multiple other cancer indications until 2040.
  • BriaCell expects to initiate its Bria-OTS™ clinical study under an Investigational New Drug Application (IND) in the first half of 2023, in accordance with FDA guidance.
  • Two additional clinical sites are now active in Phase II Bria-IMT™ study to broaden patient access: Carle Cancer Institute in Urbana, Illinois and the American Oncology Network, LLC (AON) in Baltimore, Maryland.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, is pleased to announce that it has received an Issue Notification from the United States Patent and Trademark Office for the composition of matter and method of use of its personalized off-the-shelf cell-based immunotherapy for cancer. The patent will issue on January 24, 2023 as US Patent No. 11,559,574 with the term extending to May 25, 2040. Additionally, BriaCell was awarded an Australian patent (Patent No. 2017224232, extends to February 27, 2037) covering composition of matter and method of use for its whole-cell cancer immunotherapy technology in Australia.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
BriaCell Announces Positive Clinical and Quality of Life Data in Advanced Metastatic Breast Cancer at 2022 San Antonio Breast Cancer Symposium®

BriaCell Announces Positive Clinical and Quality of Life Data in Advanced Metastatic Breast Cancer at 2022 San Antonio Breast Cancer Symposium®

  • Positive clinical data reported includes tumor shrinkage, disease control, progression free survival, and potential long term survival benefit in advanced metastatic breast cancer patients treated with the Bria-IMT™ combination regimen.
  • "Better quality of life" and "less pain" reported by many gravely ill advanced metastatic breast cancer patients treated with the Bria-IMT™ combination regimen.
  • Notably, many patients remained in our study longer than other prior therapies, suggesting excellent tolerability and clinical effectiveness of the Bria-IMT™ combination regimen.
  • More positive data is expected as patients remain on the study.
  • Treatment remained well-tolerated with no dose-limiting toxicities.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, presented positive safetytolerability and efficacy data from its lead product candidate, Bria-IMT™, summarized in three poster sessions during the 2022 San Antonio Breast Cancer Symposium ® (SABCS).

Mayo Clinic Professor and Principal Clinical Investigator, Saranya Chumsri, M.D., stated in an audio summary of the poster: "First, this is a heavily pretreated group of end-stage metastatic breast cancer ("MBC") patients. For many of these patients, other therapies don't exist or cannot be tolerated. Bria-IMT™ does not have any theoretical cross-resistance or overlapping toxicity with other MBC treatments, which is why it is so encouraging to see responses across all MBC subtypes and a very manageable adverse event experience."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
IPA's Subsidiary BioStrand and BriaCell Announce Artificial Intelligence Collaboration and License Agreement to Discover and Develop Anti-Cancer Antibodies

IPA's Subsidiary BioStrand and BriaCell Announce Artificial Intelligence Collaboration and License Agreement to Discover and Develop Anti-Cancer Antibodies

IPA (IMMUNOPRECISE ANTIBODIES LTD.) ( "IPA") (NASDAQ: IPA), an advanced biotherapeutic research and technology company, today announced that BioStrand BV ("BioStrand"), an AI in silico discovery subsidiary of IPA, has entered into a research collaboration and license agreement (the "Agreement") with BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) ("BriaCell"), a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20221130005423/en/

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Alkaline Fuel Cell Power Corp. Announces AGM Results

Alkaline Fuel Cell Power Corp. Announces AGM Results

Alkaline Fuel Cell Power Corp. (NEO: PWWR) (OTCQB:ALKFF) (Frankfurt: 77R, WKN: A3CTYF) ("AFCP" or the "Company") a diversified investment platform developing affordable, renewable, and reliable energy assets and cleantech, is pleased to announce the results of voting at its annual general meeting (" AGM ") of shareholders which was held on January 25, 2023 in person in Vancouver, British Columbia and by conference call (the " Meeting "). There were 19 shareholders represented in person or by proxy at the Meeting holding 2,423,369 common shares, representing 1.39% of the Company's total issued and outstanding common shares as at the record date for the Meeting. The voting results for each matter presented at the Meeting is set out below:

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Alkaline Fuel Cell Power Announces Resignation of Director

Alkaline Fuel Cell Power Announces Resignation of Director

Alkaline Fuel Cell Power Corp. (NEO: PWWR) (OTCQB:ALKFF) (Frankfurt: 77R, WKN: A3CTYF) ("AFCP" or the "Company") a diversified investment platform developing affordable, renewable, and reliable energy assets and cleantech, announces the resignation of Joel Dumaresq as director, effective January 12, 2023. Mr. Dumaresq will remain as the Chief Financial Officer of the Company while the Company seeks a suitable replacement.

ABOUT Alkaline Fuel Cell Power CORP.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Alkaline Fuel Cell Power Corp. Announces Grant of Restricted Share Units

Alkaline Fuel Cell Power Corp. Announces Grant of Restricted Share Units

Alkaline Fuel Cell Power Corp. (NEO: PWWR) (OTCQB:ALKFF) (Frankfurt: 77R, WKN: A3CTYF) (" AFCP " or the " Company "), a diversified investment platform developing affordable, renewable, and reliable energy assets and cleantech, is pleased to announce that the Company has granted an aggregate of 9,541,557 restricted share units (" RSUs ") to certain arm's-length consultants of the Company (each, a " Consultant ").

The RSUs will vest in accordance with the terms of each Consultant's RSU agreement and in accordance with the Company's 2021 RSU Plan. Upon vesting, each RSU entitles the holder thereof to receive one common share in the capital of the Company.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
REPEAT - Alkaline Fuel Cell Power Corp. Announces Prototype Launch of Jupiter 1.0, a Powerful Fuel Cell System for Homes and Small Buildings, and Management Update

REPEAT - Alkaline Fuel Cell Power Corp. Announces Prototype Launch of Jupiter 1.0, a Powerful Fuel Cell System for Homes and Small Buildings, and Management Update

Alkaline Fuel Cell Power Corp. (NEO: PWWR) (OTCQB:ALKFF) (Frankfurt: 77R, WKN: A3CTYF) (" PWWR " or the " Company "), a diversified investment platform developing affordable, renewable, and reliable energy assets and cleantech, is pleased to announce that its wholly owned Belgium subsidiary, Fuel Cell Power NV (" FCP NV "), has launched the prototype of its micro-combined heat and power (" CHP ") fuel cell, named Jupiter 1.0 .

"Alkaline Fuel Cell Power is proud to present the prototype of our fuel cell system for homes and small buildings - Jupiter 1.0," stated Frank Carnevale, Chief Executive Officer of PWWR. "The Jupiter 1.0 prototype will be piloted with select strategic partners to demonstrate the advantages of delivering green hydrogen to homes and small buildings, globally. We thank staff for their dedication and effort to complete this important milestone on time."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Nano One Provides Progress Update on the Successful Integration of Candiac LFP Operation

Nano One Provides Progress Update on the Successful Integration of Candiac LFP Operation

Highlights

  • One-Pot trials commencing and decommissioning of unused equipment progressing.
  • Functional re-org implemented to align innovation and commercialization centres.
  • Completed integration of Candiac team and facility, focus now on post-merger activities.
  • Focusing on meeting market demand while harnessing government support.

nano one® Materials Corp. ("nano one" or the "Company"), a clean technology company focused on the production of cathode materials used in lithium-ion batteries, is pleased to provide an update on the reorganization of the combined teams, and the transformation of the Candiac lithium iron phosphate ("LFP") facility to the One-Pot process, following completion of the acquisition previously announced on November 1, 2022

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Alkaline Fuel Cell Power Corp. Announces Prototype Launch of Jupiter 1.0, a Powerful Fuel Cell System for Homes and Small Buildings, and Management Update

Alkaline Fuel Cell Power Corp. Announces Prototype Launch of Jupiter 1.0, a Powerful Fuel Cell System for Homes and Small Buildings, and Management Update

Alkaline Fuel Cell Power Corp. (NEO: PWWR) (OTCQB:ALKFF) (Frankfurt: 77R, WKN: A3CTYF) (" PWWR " or the " Company "), a diversified investment platform developing affordable, renewable, and reliable energy assets and cleantech, is pleased to announce that its wholly owned Belgium subsidiary, Fuel Cell Power NV (" FCP NV "), has launched the prototype of its micro-combined heat and power (" CHP ") fuel cell, named Jupiter 1.0 .

"Alkaline Fuel Cell Power is proud to present the prototype of our fuel cell system for homes and small buildings - Jupiter 1.0," stated Frank Carnevale, Chief Executive Officer of PWWR. "The Jupiter 1.0 prototype will be piloted with select strategic partners to demonstrate the advantages of delivering green hydrogen to homes and small buildings, globally. We thank staff for their dedication and effort to complete this important milestone on time."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×