Epacadostat

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

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Wednesday, May 18, 2022
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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.

Key Points: 
  • 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.
  • Engaging additional clinical sites is consistent with our strategy of increasing patient access to our novel treatments and should speed up the enrollment schedule for our clinical trial.
  • Hoag is a nonprofit, regional health care delivery network in Orange County, California, that treats more than 30,000 inpatients and 460,000 outpatients annually.
  • NCI designation further expands Sylvesters ability to provide access to novel therapies through more clinical trials and collaboration with other designated centers.

BriaCell Receives FDA Fast Track Approval for Targeted Breast Cancer Immunotherapy

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Wednesday, April 13, 2022
NDA, Drug development, News, Nature, Breast cancer, EDGAR, Biotechnology, Fast track (FDA), Clinical trial, Judgement, U.S. Securities and Exchange Commission, Biologics license application, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Immunotherapy, Acceleration, Toronto Stock Exchange, Food, GLOBE, Risk, Patient, Review, Nasdaq, Company, Food and Drug Administration, Communication, White Light Rock & Roll Review, Epacadostat, Forward-looking statement, Incyte, TSX, Safety, Hope, Fast Track, Plasma protein binding, HLA, FDA, Accelerated approval (FDA), BLA, SEDAR, Breast, New Drug Application, Therapy, Priority review, Cancer, Survival, BCT, Pharmaceutical industry, Medical imaging, Medical device

U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCells lead candidate, Bria-IMT, for the treatment of metastatic breast cancer.

Key Points: 
  • U.S. Food and Drug Administration (FDA) has granted Fast Track status to BriaCells 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.
  • PHILADELPHIA and VANCOUVER, British Columbia, April 13, 2022 (GLOBE NEWSWIRE) -- 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 BriaCells lead candidate, Bria-IMT, for the treatment of metastatic breast cancer (breast cancer that has spread beyond the breast).

BriaCell advances preparatory work for new Bria-OTS™ breast cancer clinical trial

Retrieved on: 
Thursday, April 7, 2022
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BriaCell and National Cancer Institute collaborating on Bria-OTS, BriaCells off-the-shelf personalized immunotherapy, as a treatment for cancer.

Key Points: 
  • BriaCell and National Cancer Institute collaborating on Bria-OTS, BriaCells off-the-shelf personalized immunotherapy, as a treatment for cancer.
  • 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 goal is to develop novel therapeutics for future clinical collaborations, allowing cancer patients to potentially benefit from potent and personalized cancer immunotherapy in the future.
  • BriaCell has two advanced breast cancer immunotherapy programs in different stages of clinical development:
    Bria-IMT: BriaCell is actively enrolling and dosing advanced breast cancer patients in the Phase I/IIa combination study with Incytes checkpoint inhibitor, retifanlimab, and its immunomodulator, epacadostat.

BriaCell Adds Two Clinical Trial Sites to Accelerate Patient Enrollment

Retrieved on: 
Monday, February 28, 2022
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The additional clinical sites include the following: 1) Atlantic Health System, Morristown, New Jersey, and 2) Tranquil Clinical Research, Webster, Texas.

Key Points: 
  • The additional clinical sites include the following: 1) Atlantic Health System, Morristown, New Jersey, and 2) Tranquil Clinical Research, Webster, Texas.
  • BriaCells clinical sites work closely with Cancer Insight, LLC to manage the clinical and regulatory aspects of the Phase I/IIa clinical trial in advanced breast cancer on behalf of BriaCell.
  • With over 30 years of experience, Tranquil Clinical Research, has been providing novel treatments to patients in Webster, Texas.
  • Its focus has been on excellence in the clinical trial process and bringing trustworthy products to patients.

Drug Combinations and New Approvals Delivering Optimistic Results in Oncology Stocks

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Wednesday, December 8, 2021
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Over the past decade, cancer drug revenues increased 70%, according to a retrospective analysis .

Key Points: 
  • Over the past decade, cancer drug revenues increased 70%, according to a retrospective analysis .
  • "These milestones include the reporting of new clinical biomarker data from our AWARE-1 breast cancer study, which we are pleased to be announcing today.
  • It also indicates that changes in peripheral blood T cell populations may be predictive of patient response.
  • We look forward to working with her team in our advanced breast cancer clinical trial to accelerate patient recruitment."

Drug Combinations and New Approvals Delivering Optimistic Results in Oncology Stocks

Retrieved on: 
Wednesday, December 8, 2021
Merck, Oncolytics Biotech, Merck Group, Tafasitamab, Lung cancer, News, Self-signed certificate, Breast cancer, Therapy, CEO, TSX, National Institute, Eli Lilly and Company, 2021 Essex County Council election, Hematology, Lenalidomide, Oncology, Epacadostat, IRENE, Pfizer, NICE, Gilead Sciences, Cancer Drugs Fund, Lymphoma, Ponatinib, Patient, National Institute for Health and Care Excellence, NYSE, GILD, Immunotherapy, Phase, CDF, ONC, Cancer, Pelareorep, Principal investigator, TACSTD2, Neoplasm, Sacituzumab govitecan, ASH, Bristol Myers Squibb, Congress, Principal, TNBC, LLY, Safety, Internal medicine, Science, CAGR, MD, RET, Clinical trial, Survival, NASDAQ, Doctor of Philosophy, NSCLC, Pharmaceutical industry

VANCOUVER, BC, Dec. 8, 2021 /PRNewswire/ -- USA News Group  -  Growing at a healthy CAGR of 14.1%, the Cancer Immunotherapy Market is being projected to hit nearly $310 billion by 2030, according to Allied Analytics. Over the past decade, cancer drug revenues increased 70%, according to a retrospective analysis. Last December, biotechs working on breast cancer treatments saw their shares soar. This year has continued that momentum, with multiple biotech companies driving progress in the fight against cancer, including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Incyte Corporation (NASDAQ:INCY), BriaCell Therapeutics Corp. (NASDAQ:BCTX), Gilead Sciences, Inc. (NASDAQ:GILD), and Eli Lilly and Company (NYSE:LLY).

Key Points: 
  • Over the past decade, cancer drug revenues increased 70%, according to a retrospective analysis .
  • "These milestones include the reporting of new clinical biomarker data from our AWARE-1 breast cancer study, which we are pleased to be announcing today.
  • It also indicates that changes in peripheral blood T cell populations may be predictive of patient response.
  • We look forward to working with her team in our advanced breast cancer clinical trial to accelerate patient recruitment."

BriaCell Adds Mary Crowley Cancer Research Center as a Clinical Trial Site for its Phase I/IIa Breast Cancer Study

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Thursday, November 18, 2021
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Dr. Barve will work closely with Cancer Insight, LLC to manage the clinical and regulatory aspects of the Phase I/IIa clinical trial in advanced breast cancer on behalf of BriaCell.

Key Points: 
  • Dr. Barve will work closely with Cancer Insight, LLC to manage the clinical and regulatory aspects of the Phase I/IIa clinical trial in advanced breast cancer on behalf of BriaCell.
  • In addition to Mary Crowley Cancer Research center, the clinical sites at St. Joseph Health-Sonoma County, Santa Rosa, Calif. and the Cancer Center of Kansas, Wichita, Kan. are open and actively enrolling patients for BriaCells Phase I/IIa advanced breast cancer clinical trial.
  • We are delighted to add Mary Crowley Cancer Research center with Dr. Barve as Principal Investigators to our team.
  • BriaCell anticipates the addition of the Mary Crowley Cancer Research center clinical sites may accelerate patient enrolment to build on our existing patient data.

BriaCell Phase I/IIa Clinical Trial Combination Study in Advanced Breast Cancer Patients Open for Enrollment

Retrieved on: 
Wednesday, July 14, 2021
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The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.

Key Points: 
  • The Phase I/IIa combination study is designed to evaluate BriaCells lead candidate, Bria-IMT, with Incytes checkpoint inhibitor, retifanlimab, and IDO1 inhibitor, epacadostat, for the treatment of advanced breast cancer.
  • The BriaCell and Incyte clinical program is a non-exclusive clinical trial collaboration to evaluate the effects of combinations of novel clinical candidates.
  • Under the agreement, Incyte is providing compounds from its development portfolio, including retifanlimab, an anti-PD-1 monoclonal antibody, and epacadostat, an IDO1 inhibitor, for use in combination studies with Bria-IMT, in advanced breast cancer patients.
  • BriaCell and Incyte had previously treated two patients under this Phase I/IIa combination study subsequent to the corporate collaboration commencement in April 2019 .

DGAP-News: Newly published data in Cancer Immunology, Immunotherapy support the potential of Secarna Pharmaceuticals' LNA-modified ASOs to effectively block important immunosuppressive pathway

Retrieved on: 
Thursday, March 26, 2020
Amino acids, Branches of biology, Medicine, Immune system, Indoleamine 2,3-dioxygenase, Oncology, Cancer treatments, Signal transduction, Cancer immunology, Epacadostat, Immunotherapy, MTOR, Secarna's proprietary drug discovery platform, LNAplusTM, Secarna Pharmaceuticals GmbH & Co. KG

DGAP-News: Secarna Pharmaceuticals GmbH & Co. KG / Key word(s): Scientific publication

Key Points: 
  • DGAP-News: Secarna Pharmaceuticals GmbH & Co. KG / Key word(s): Scientific publication
    Newly published data in Cancer Immunology, Immunotherapy support the potential of Secarna Pharmaceuticals' LNA-modified ASOs to effectively block important immunosuppressive pathway
    The issuer is solely responsible for the content of this announcement.
  • Both targets are catalytic enzymes that play a key role in an important immunosuppressive pathway - the degradation of tryptophan into kynurenine.
  • Secarna's approach also was shown to be synergistic with one of the clinically most advanced IDO1-specific small molecule inhibitors (epacadostat).
  • The published data show that treatment of cancer cells with LNAplusTM-modified ASOs specific for IDO1 and TDO2 lead to potent target knockdown in vitro.

BriaCell Doses First Patient in Phase I/IIa Study Evaluating Bria-IMT™ in Combination with INCMGA00012 and Epacadostat in Patients with Advanced Breast Cancer

Retrieved on: 
Monday, October 7, 2019
Chemical compounds, Breast cancer, Epacadostat, Oxadiazoles, Incyte, Metastatic breast cancer, Organic compounds, Clinical medicine

Patient dosing has begun in the Phase I/IIa study evaluating the anti-tumor effects of BriaCells lead candidate, Bria-IMT in combination with Incytes INCMGA00012 and epacadostat in patients with advanced breast cancer.

Key Points: 
  • Patient dosing has begun in the Phase I/IIa study evaluating the anti-tumor effects of BriaCells lead candidate, Bria-IMT in combination with Incytes INCMGA00012 and epacadostat in patients with advanced breast cancer.
  • A subsequent group of patients will be treated with the triple combination of the Bria-IMT with INCMGA00012 and epacadostat.
  • The starting dose of epacadostat has been established to be safe when given in combination with INCMGA00012 in patients with cancer.
  • Phase I/IIa clinical trial is an open-label, multi-center study to evaluate the safety and efficacy of Bria-IMT in combination with INCMGA00012, and epacadostat in patients with advanced breast cancer.