New NASDAQ Alert [Inside]

AwesomeStocks Hello! New Alert: BriaCell Therapeutics Corp. (NASDAQ: BCTX) BCTX is a NASDAQ listed “immuno-oncology-focused biotechnology company developing targeted and effective approaches for the management of cancer”. Immunotherapies use the body’s own immune system to “destroy cancer cells while offering the potential for higher levels of safety and efficacy than chemotherapy; and may also prevent cancer recurrence”. The company’s “lead product candidate, Bria-IMT™” was recently “Awarded Fast Track status by the U.S. Food and Drug Administration (FDA)”. “Bria-IMT™ (SV-BR-1-GM) is a targeted immunotherapy being developed for the treatment of advanced breast cancer (i.e. breast cancer that has spread from the breast or armpit to other areas of the body including the bones, lungs, liver or sometimes the brain).” Sadly, “breast cancer is currently the most common cancer globally, accounting for 12.5% of all new annual cancer cases worldwide”. “Breast cancer accounts for about 30% of all new cancer cases in women each year in the United States”. “Bria-IMT™ is a genetically engineered human breast cancer cell line with features of immune cells. It is clinically used as a targeted immunotherapy.” BCTX believes that “Bria-IMT™ both indirectly and directly stimulates the body’s own cancer-fighting cells to attack and destroy breast cancer tumors”. In addition, as the company mentioned recently, “With BriaCell’s newly issued patent, protecting the composition of matter and method of use of BriaCell’s personalized off-the-shelf whole-cell immunotherapies, BriaCell expects to begin dosing advanced metastatic breast cancer patients in its Bria-OTS™ Phase I/IIa clinical study in the first half of 2023.” Here is a little more from the company on “Bria-OTS™: Off-the-Shelf Personalized Immunotherapy”: “This novel treatment approach came about when we found that the HLA type of our previously disclosed top responders matched with the Bria-IMT™ cell-line HLA type.” “The treatment will be “personalized” because the cell therapy will match the HLA type of the patient, even though it is pre-manufactured.” Furthermore, BCTX “has developed Bria-OTS2.0 or Bria-APTC, the next generation (enhanced version) of Bria-OTS™, BriaCell’s off-the-shelf personalized immunotherapy for advanced metastatic breast cancer”. BCTX “currently holds multiple issued patents and pending patent applications to cover its whole-cell immunotherapy’s composition of matter and method of use worldwide.” Since the start of the year, the company has announced multiple accomplishments. Earlier this year, the company announced: “BriaCell Announces Positive End of Phase II Meeting with the FDA for Bria-IMT™ Combination in Advanced Metastatic Breast Cancer” Here are the company’s highlights from this press release: - “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.” Here are the company’s comments from this press release: “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.” In February, the company announced: “BriaCell Reports Positive Survival Data in Advanced Metastatic Breast Cancer” Here are some of the company’s comments from this press release: “This is working, and it’s working well. We had high hopes going into this clinical read-out, and the survival numbers have even exceeded our expectations. With 9 of 11 women still alive, this has a material impact for the patients and their loved ones, especially since some patients may have had only weeks or months to live prior to our treatment,” stated Dr. William V. Williams, BriaCell’s President and CEO. “This survival update bodes well for our upcoming pivotal trial, since the FDA has agreed to survival benefits as the primary endpoint.” In March, the company announced: “BriaCell Announces Intention to Spin-Out Certain Pre-Clinical Assets into a Newly Created “SpinCo” Entity whereby Shareholders to Receive One New Share of “SpinCo” in Addition to Each Current Share of BriaCell Already Held” Here are the company’s highlights from this press release: - “SpinCo Assets (SpinCo) includes Bria-TILsRx™, and protein kinase C delta (PKCδ) inhibitors for multiple indications including cancer.” - “SpinCo’s goal is to potentially accelerate the development of its assets, and to create value.” As the company further explained: “BriaCell believes that the Transaction will increase shareholder value by allowing capital markets to ascribe value to the SpinCo Assets independently of BriaCell’s core immunotherapy assets. SpinCo will provide an opportunity for SpinCo Assets to be funded and developed on their own.” Here is a little “About the SpinCo Assets”: - “PKCδ Inhibitor: Therapeutics for multiple disease indications including cancer” - “PKCδ, also called novel PKC, has been associated with a number of diseases including cancer.” - “Selective inhibitors of PKCδ, have been shown to be effective treatments for several animal models of cancer and other diseases. SpinCo’s novel and highly selective PKCδ inhibitors may be developed as candidates for multiple disease indications including several tumor types.” - “Bria-TILsRx™: Multi-Specific Binding Reagents - Immunotherapies for Cancer” - “Developed as potential immunotherapies for cancer, SpinCo’s two novel Bria-TILsRx™s are multi-specific binding reagents designed to act as potent immune cell activators and/or immune checkpoint inhibitors. They are expected to selectively target and destroy cancer cells without harming normal (non-cancerous) cells. This may mean less severe side effects for the treated cancer patients compared with those of alternative therapies.” Here are some of the company’s comments from this press release: “Dr. William V. Williams, BriaCell’s President and CEO stated, “Housing the SpinCo Assets in a new corporate structure would be beneficial to both BriaCell shareholders and SpinCo shareholders as we believe there is significant independent value to be had from these assets. Developing them under a separate entity allows us to unlock the development potential of the SpinCo Assets as novel treatments for multiple diseases under a separate balance sheet, allowing for maximizing both entities to maintain their focus, while providing our shareholders the opportunity to own shares in both companies.”” Most recently, the company announced: “BriaCell Presents Positive Data Demonstrating Survival and Clinical Benefits in Advanced Metastatic Breast Cancer at the 2023 AACR” Here are the highlights from this press release: - “15 of 18 patients remain alive of those recruited since the study reopened in 2021.” - “Longer than expected patient survival data highlights tolerability and clinical effectiveness of BriaCell’s combination treatment.” - “The Bria-IMT™ combination regimen activated the immune system even in anergic patients with very weak immune systems.” - “Continued positive clinical data suggests more meaningful survival and clinical benefits in advanced metastatic breast cancer.” As the company further explained in this press release: “Our data highlights the potential clinical value of the Bria-MT™ regimen in patients with advanced metastatic breast cancer after receiving multiple prior therapies,” said Carmen Calfa, M.D., of the Sylvester Comprehensive Cancer Center at the University of Miami, Associate Professor of Clinical Medicine, Principal Clinical Investigator, and co-author of the study of Bria-IMT™ in combination with PD-1 inhibitors pembrolizumab and retifanlimab. “These results are promising and the fact that patients have had a great quality of life thus far is remarkable. We are hopeful that this novel immunotherapy proves to be an effective therapy for our patients.” BCTX has multiple potential catalysts in its favor to experience increased growth. Make sure to do your own due diligence. Sources: [Presentation]( [BC]( [PR1]( [PR2]( [PR3]( [PR4]( [PR5]( [PR6]( [PR7]( [Website]( [Chart]( Happy Trading! AwesomeStocks Note: We encourage all traders and investors to develop personal trading rules that you can follow and that work for you. Always protect your downside and note that we alert extremely volatile short-term opportunities. Before investing in securities, you should always consult with your financial, tax and legal advisor and never invest money you cannot afford to lose. DISCLAIMER You should read and understand this disclaimer in its entirety before joining the website or email/blog list of AwesomeStocks.com (the “Publisher”). 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