Life Science News

  • Based on clinical data with Bria-IMT™, BriaCell has developed Bria-OTS™, an off-the-shelf (i.e. pre-manufactured) personalized immunotherapy.
  • Bria-OTS™ will be used to treat patients with advanced breast cancer, providing patients with readily available personalized treatment.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, presented the development details of its novel off-the-shelf (OTS) personalized immunotherapy, Bria-OTS™, summarized in a poster session held at the American Association for Cancer Research (AACR) Annual Meeting 2022 in New Orleans, Louisiana.

"Excitement is taking root within BriaCell as we progress towards our upcoming Bria-OTS™ clinical trial, where we will be matching our immunotherapy to each patient's HLA type with the goal of increasing the likelihood of clinical benefit," remarked Dr. Miguel A. Lopez-Lago, Senior Director, R&D. "We intend to treat each patient with a personalized formulation, based on a simple saliva test that determines each patient's HLA types."

Poster presentation details are summarized below:

Poster Title: Toward a Personalized Off-the-Shelf Cellular Immunotherapy for Cancer

Summary:

  • BriaCell's lead candidate, the Bria-IMT™ regimen, has produced a safe and effective immune response and disease control in heavily pre-treated advanced breast cancer patients. These patients had failed multiple prior regimens.
  • Patients that match the Bria-IMT™ immunotherapy treatment at least at 1 HLA type were more likely to experience clinical benefit.
  • Therefore, BriaCell generated genetically modified Bria-IMT™ cell lines that expressed an extended repertoire of HLA types to be able to match the majority of patients with the therapy and increase the likelihood of response. This new cellular therapy has been termed Bria-OTS™.
  • The Bria-OTS™ novel approach produces a personalized cancer immunotherapy treatment that is off-the-shelf (i.e. pre-manufactured and ready for use); thus, avoiding treatment delays and bypassing the complex manufacturing process of some other personalized immunotherapies.
  • Once administered to patients, Bria-OTS™ immunotherapies are postulated to activate the patient's immune system to recognize and eliminate cancerous cells by both activating tumor-directed T cells, and potentially antibody responses. A schematic video showing the proposed mechanism is available here: https://briacell.com/moa/ .
  • The AACR poster discloses the specific alleles selected and the strategy for performing the genetic engineering. BriaCell anticipates treating each patient with the appropriate pre-manufactured Bria-OTS™ formulation based on each patient's HLA-type. This off-the-shelf process would forego the complex, expensive and demanding manufacturing procedures associated with other personalized immunotherapies.

Bria-OTS™ immunotherapy design

Patients that match Bria-IMT™ cell line at least at 1 HLA allele are more likely to derive clinical benefit. Therefore, BriaCell has genetically modified the Bria-IMT™ cell line to match more patients. Based on population analysis, BriaCell has genetically engineered the Bria-IMT™ parent cell line to express 8 Class I and 7 Class II HLA types. The Class I and Class II regions refer to the genes coding for molecules HLA-A, -B, -C, and HLA-DR, -DQ, –DP, respectively. Four cell lines have been developed, each engineered to express four HLA alleles: two HLA-A alleles and two HLA-DRB alleles. The new cell therapy would be able to match >99% of the population at least at one HLA type.

Manufacturing of Bria-OTS™ immunotherapies for upcoming clinical trial

  • Bria-OTS™ cell lines developed at BriaCell facilities have been transferred to a cGMP facility for testing and clinical production in preparation for the upcoming clinical trial in advance breast cancer.
  • BriaCell is currently conducting extensive testing on the Bria-OTS™ immunotherapy products in compliance with the most recent guidelines of the Center for Biologics Evaluation and Research (CBER) division of the FDA— to ensure patient safety.
  • BriaCell expects Bria-OTS™ to enter an open-label Phase I/IIa clinical trial designed to evaluate its safety and efficacy in patients with advanced breast cancer. The clinical trial will be managed by Cancer Insight, LLC.

A copy of the poster has been posted at the following: https://briacell.com/scientific-publications/ .

Personalized breast cancer treatment using Bria-OTS™

To increase the likelihood of therapeutic response, BriaCell will treat each patient with the optimized premanufactured Bria-OTS™ formulation, based on individual specific HLA type. A simple saliva test that determines HLA types will be used to categorize patients. In BriaCell's current and active Bria-IMT™ Phase I/IIa clinical trial, BriaCell had previously reported average overall survival benefit of 13.4 months in patients with 2+ HLA matches (average of 5 prior regimens) 1 versus 7.2-9.8 months in historical comparison treatment trials (2 prior regimens) 2 .

(1) BriaCell treats severely sick patients, as indicated by the "prior regimens" figures, indicating the number of therapies these patients had failed prior to treatment with Bria-IMT™.
(2) Overall survival of 7.2-9.8 months was reported in similar patients with metastatic breast cancer who have failed 2 prior therapy attempts (third line setting); Kazmi S, et al. Breast Cancer Res Treat. 2020 Aug 17. To more accurately present survival data, BriaCell has included only those women able to mount an immune response.

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, among others, statements the Company makes regarding: (i) the outcome of the testing and clinical production of the Bria-OTS™ cell lines, (ii) the safety and efficacy of any potential treatment regime with Bria-OTS™, and (iii) when and whether Bria-OTS™ will enter an open-label Phase I/IIa clinical trial. 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 our 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 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


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BCT:CA
BriaCell Adds Additional Clinical Sites to Broaden Patient Access and Further Boost Enrollment

BriaCell Adds Additional Clinical Sites to Broaden Patient Access and Further Boost Enrollment

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announces that it has activated Hoag Memorial Hospital Presbyterian ("Hoag") and re-engaged Sylvester Comprehensive Cancer Center, part of UHealth the University of Miami Health System, as two additional clinical sites for the screening and enrollment of advanced breast cancer patients in the Phase IIIa combination study of BriaCell's lead candidate, Bria-IMT™, with Incyte's checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat.

"While we continue to steadily accrue patients in our ongoing clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors, the addition of these clinical sites should help further accelerate patient enrollment in the clinical trial. We look forward to discussing our safety and efficacy data with the FDA, now with Fast Track status , to plan our pivotal registration study and remain on track to achieve this major milestone in 2022," stated Dr. Bill Williams, BriaCell's President & CEO.

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BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy

BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy

  • U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell's lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer.
  • Fast Track improves the speed and frequency of communication with FDA, potentially leading to earlier drug approval and access by patients.
  • BriaCell is currently enrolling and dosing advanced breast cancer patients in a Phase I/IIa study, now with Fast Track designation.

BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company") a clinical-stage biotechnology company specializing in targeted immunotherapies for cancer, announces that the U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCell's lead candidate, Bria-IMT™, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the breast).

The Fast Track designation will apply to patients with metastatic breast cancer. BriaCell is developing Bria-IMT™ in combination with immune checkpoint inhibitors in a clinical trial listed in ClinicalTrials.gov as NCT03328026 . BriaCell is currently enrolling and dosing advanced breast cancer patients in its Phase I/IIa combination study of Bria-IMT™ with Incyte's checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat under corporate collaboration with Incyte.

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TSXV:BCT

BriaCell Presents Clinical and Scientific Findings at the Annual Symposium of Society of Surgical Oncology 2020

Preliminary safety and efficacy data are being presented today from the clinical trials of Bria-IMT™ in combination with immune checkpoint (PD-1) inhibitors in advanced breast cancer patients.

  • Clinical responses and disease control—without serious side effects—in heavily pre-treated patients with metastatic breast cancer seen with lead candidate, Bria-IMT™, in combination with pembrolizumab (KEYTRUDA®; manufactured by Merck & Co., Inc.), a PD-1 inhibitor.
  • Higher levels of immune system activation were directly related to higher incidences of tumor reduction and higher rates of disease control and clinical benefit in patients with advanced breast cancer.

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is announcing the results of clinical studies with its lead product candidate, Bria-IMT™, summarized in a poster session during the SSO 2020 International Conference on Surgical Cancer Care™, a virtual event held in the evenings of August 17-18, 2020. The patient data summarized and discussed belong to previously-disclosed patients (i.e., no incremental numbers enrolled).

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OTC:BCTXF

BriaCell Announces Presentation and Abstract Publication at 2020 American Society of Clinical Oncology (ASCO) Meeting

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, announces the publication of its abstract in the ASCO Meeting Library — available in the Journal of Clinical Oncology by May 26, 2020. The Company will present at the 2020 ASCO Annual Meeting, a virtual event held during the dates of the originally planned in-person Annual Meeting (May 29-June 2, 2020). The ASCO Annual Meeting represents the world’s largest gathering of oncology physicians, biotechnology executives, researchers, and investment analysts to discuss cutting-edge clinical research and therapeutics in oncology.

Dr. Bill Williams, BriaCell’s President & CEO, and Dr. Charles Wiseman, BriaCell’s Scientific Founder and Director, will present clinical data and pathological findings from the Phase I/IIa studies of Bria-IMT™ alone or in combination with checkpoint inhibitors in advanced breast cancer patients.

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OTC:BCTXF

BriaCell Continues Business and Clinical Operations During COVID-19 Pandemic

  • Phase I/IIa clinical study of BriaCell’s lead candidate, Bria-IMT™, for breast cancer treatment, with Incyte Corporation’s immune checkpoint inhibitor, INCMGA00012, is ongoing and recruiting patients amidst the COVID-19 pandemic.
  • BriaCell is currently evaluating a number of business strategies to develop its potential treatments for breast cancer on its own or in partnership.
  • Clinical and pathological findings of Bria-IMT™, alone or in combination with checkpoint inhibitors, KEYTRUDA® and INCMGA00012, in advanced breast cancer will be presented at upcoming conferences.

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT) (OTCQB:BCTXF), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, announces that the Phase I/IIa clinical study of Bria-IMT™, for breast cancer treatment, with Incyte Corporation’s immune checkpoint inhibitor, INCMGA00012, is ongoing and recruiting patients amidst the COVID-19 pandemic. Further, BriaCell is currently evaluating a number of business strategies to develop its potential treatments for breast cancer on its own or in partnership. BriaCell will be presenting the clinical and pathological findings of Bria-IMT™, alone or in combination with checkpoint inhibitors, KEYTRUDA® and INCMGA00012, in advanced breast cancer will be presented at upcoming conferences including 2020 American Society of Clinical Oncology (ASCO) Meeting (May 29-Jun 2, 2020), and American Association for Cancer Research (AACR) Annual Meeting in August 2020.

“We are committed to develop treatment solutions for advanced breast cancer patients with no effective treatment options and understand that continuation of our clinical studies during these unprecedented times is critical for our patients. We are grateful to our clinical team for having made the task possible,” said Dr. Bill Williams, BriaCell’s President & CEO.

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The Gross Law Firm Announces Class Actions on Behalf of Shareholders of VLTA, AUPH and PEGA

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

Volta Inc. (NYSE:VLTA)

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LAWSUITS FILED AGAINST LCID, AUPH and BKKT - Jakubowitz Law Pursues Shareholders Claims

Jakubowitz Law announces that securities fraud class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies who purchased shares within the class periods listed below. Shareholders interested in representing the class of wronged shareholders have until the lead plaintiff deadline to petition the court. Your ability to share in any recovery doesn't require that you serve as a lead plaintiff. For more details and to speak with our firm without cost or obligation, follow the links below

Lucid Group, Inc. (NASDAQ:LCID)

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The Gross Law Firm Announces Class Actions on Behalf of Shareholders of ABBV, IRNT and BKKT

The securities litigation law firm of The Gross Law Firm issues the following notice on behalf of shareholders in the following publicly traded companies. Shareholders who purchased shares in the following companies during the dates listed are encouraged to contact the firm regarding possible Lead Plaintiff appointment. Appointment as Lead Plaintiff is not required to partake in any recovery

ABBVie Inc. (NYSE:ABBV)

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SHAREHOLDER ALERT: AUPH LILM LICY: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH)

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Deadline Approaching: Kessler Topaz Meltzer & Check, LLP Reminds AbbVie, Inc. Investors of Deadline in Securities Fraud Class Action Lawsuit and Encourages Investors to Contact the Firm

The law firm of Kessler Topaz Meltzer & Check, LLP (www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE: ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THEFOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE:JUNE 6, 2022
CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:
James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/124773

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SHAREHOLDER ALERT: VRT VLTA ABBV: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

Vertiv Holdings Co (NYSE:VRT)

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