Biotech

BriaCell Therapeutics (NASDAQ:BCTX, BCTXW;TSX:BCT) is a clinical phase biotechnology company developing innovative immunotherapies for treating cancer.

With a recently-awarded Fast Track status from the FDA, BriaCell's lead candidate, Bria-IMT™, is an immunotherapy currently being developed to treat advanced breast cancer, which is the expected cause of over 43,000 deaths in the US in 2022. Bria-IMT™achieved positive proof of concept, showing outstanding safety and efficacy data. Importantly, preliminary efficacy data was similar, or superior to, those of other approved breast cancer drugs when they were at a similar stage of clinical development. After significant success, BriaCell received FDA Fast Track designation for this targeted immunotherapy approach.

Bria-IMT mechanism of actioninvestingnews.com

Company Highlights

  • April 2022: BriaCell receives FDA fast-track approval for targeted breast cancer immunotherapy.
  • February 2022: BriaCell appoints renowned oncologist, Dr. Giuseppe Del Priore as chief medical officer, appoints immunologist Dr. Alexander Kharazi to its advisory board, and adds two clinical trial sites to accelerate patient enrollment.
  • December 2021: BriaCell announces insiders' intention to purchase up to 10 percent of public market securities.
  • September 2021: BriaCell announces securities buyback to purchase up to 10 percent of common shares and up to 10 percent of listed warrants.
  • July 2021: BriaCell Phase I/IIa clinical trial combination study in advanced breast cancer patients opens for enrollment.
  • June 2021: BriaCell Therapeutics announces closing of US$27.2 million private placement
  • June 2021: BriaCell Reports 12.0 months overall survival benefit in advanced breast cancer; 100 percent resolution of ‘eye-bulging’ tumor
  • February 2021: BriaCell announces closing of US$25 million public offering and listing on NASDAQ.
This BriaCell Therapeutics company profile is part of a paid investor education campaitn.*
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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BriaCell Presents Development Details of Bria-OTS Platform Technology at the American Association for Cancer Research  Annual Meeting 2022

BriaCell Presents Development Details of Bria-OTS Platform Technology at the American Association for Cancer Research Annual Meeting 2022

  • 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."

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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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Gilead Reaches Number One Spot as Top Overall Philanthropic Funder of HIV-Related Programs, According to Funders Concerned About AIDS Report

Gilead Sciences, Inc. (Nasdaq: GILD) today was officially recognized as the number one philanthropic funder of HIV-related programs in a new tracking report released by Funders Concerned About AIDS (FCAA). The report, found at: https:www.fcaaids.orginformphilanthropic-support-to-address-hiv-aids is released annually and is widely regarded as the most comprehensive study of its kind. It analyzes 2020 funding data (the most recent year available) revealing that Gilead's philanthropic support wholly drove the increase of private HIV and AIDS philanthropic funding representing 38% of all HIV funding and driving a majority of the increases in funding across all issues, populations and geographies. Gilead is also recognized in the report as the number one funder in the U.S. and the number three funder internationally. The report indicates that, "Private HIV and AIDS philanthropic funding to the U.S. rose for the seventh year in a row, totaling over $321 million in 2020, a dramatic 52% ($109 million) increase from 2019."

In addition to being recognized as the number one funder both overall and in the U.S., Gilead was also recognized as the number one funder across a range of categories, including:

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The Gummy Project

Potent Ventures Announces New Distribution Partnership with Dean's Dairy and Specialty Foods in Preparation for Launch of the Gummy Project

Potent Ventures Inc. (CSE: POT) (FSE: 0OS) (OTCQB: POTVF) ("Potent" or the "Company") is pleased to announce that the Company has entered into a new distribution partnership with Dean's Dairy & Specialty Foods ("Dean's").

Dean's distributes premium all-natural & organic products to grocers, cafes, and eateries in Vancouver, the Lower Mainland, and Vancouver Island. Dean's supports a network of +500 unique customer locations across the current 37 retail brands, and delivers 6 days a week with trucks that are meticulously maintained to ensure the freshest on-time delivery.

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The Klein Law Firm Reminds Investors of Class Actions on Behalf of Shareholders of ABBV, NTRA and AXSM

The Klein Law Firm announces that class action complaints have been filed on behalf of shareholders of the following companies. There is no cost to participate in the suit. If you suffered a loss, you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff

ABBVie Inc. (NYSE:ABBV)
Class Period: April 30, 2021 - August 31, 2021
Lead Plaintiff Deadline: June 6, 2022

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ABBV DEADLINE REMINDER: Kessler Topaz Meltzer & Check, LLP - Important June 6, 2022 Deadline Reminder for AbbVie, Inc.

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

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/124414

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CLASS ACTION UPDATE for ABBV, NTRA and OSCR: Levi & Korsinsky, LLP Reminds Investors of Class Actions on Behalf of Shareholders

Levi & Korsinsky, LLP announces that class action lawsuits have commenced on behalf of shareholders of the following publicly-traded companies. Shareholders interested in serving as lead plaintiff have until the deadlines listed to petition the court. Further details about the cases can be found at the links provided. There is no cost or obligation to you

ABBV Shareholders Click Here: https://www.zlk.com/pslra-1/abbvie-inc-loss-submission-form?prid=27475&wire=1
NTRA Shareholders Click Here: https://www.zlk.com/pslra-1/natera-inc-loss-submission-form?prid=27475&wire=1
OSCR Shareholders Click Here: https://www.zlk.com/pslra-1/oscar-health-inc-loss-submission-form?prid=27475&wire=1

* ADDITIONAL INFORMATION BELOW *

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Cardiol Therapeutics Appoints Teri Loxam and Chris Waddick to its Board of Directors

Cardiol Therapeutics Appoints Teri Loxam and Chris Waddick to its Board of Directors

Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) ("Cardiol" or the "Company"), a clinical-stage life sciences company focused on the research and clinical development of anti-fibrotic and anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that its Board of Directors has appointed Teri Loxam and Chris Waddick to serve as directors, effective immediately.

Ms. Teri Loxam has over 25 years of experience in the pharmaceutical, life sciences, and entertainment industries with diverse roles spanning strategy, investor relations, finance, and communications.Ms. Loxam joined Kira Pharmaceuticals ("Kira") in November 2021 as Chief Operating Officer and Chief Financial Officer. In this role, she oversees finance, operations, and strategic functions for the company. Prior to joining Kira, Ms. Loxam served as Chief Financial Officer at SQZ Biotech ("SQZ") where she led the company's financial operations, investor relations and communications/public relations functions. While at SQZ, she was instrumental in helping the company raise over $200M in private and public funding, including taking the company public through an IPO on the NYSE in October 2020. Before joining SQZ, Ms. Loxam served as Sr. Vice President of Investor Relations and Global Communications at Merck. In this role, she led its investor relations and investment community interactions as well as its internal and external communications efforts globally. Prior to Merck, Ms. Loxam was Vice President, Investor Relations for IMAX Corporation, where she reshaped the entertainment company's investor strategy, helping to convert its investor base and helping the company go public in China with an IPO on the Hong Kong Exchange. Ms. Loxam also spent over a decade at Bristol-Myers Squibb in a variety of roles of increasing responsibility across Strategy, Treasury, and Investor Relations. She started her career as a marine biologist and worked at Sea World of San Diego before making a transition into business. Ms. Loxam is a member of the board of directors of Vaxcyte. She holds an MBA from the University of California, Irvine, and a Bachelor of Science degree in Biology from the University of Victoria, B.C. Canada.

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