Stepped Up Clinical Efforts Targeting Breast Cancer Therapies and Treatments Leading to Opportunistic Options

Palm Beach, FL –August 26, 2020 – Although various market revenue projections may differ in the total dollar figures, the reports in the triple negative breast cancer (TNBC) treatment market all predict a sustainable growth oner the next several years to come. A previous report from Mind Aspire Market Research was trumped by another report from Future Wise Research. The Mind Aspire report estimated the global triple-negative breast cancer treatment market revenue is projected to reach US$727 Million by the end of 2026 and grow at a CAGR of 4.9% during the forecast period, while the Future Wise report projected a higher figure, forecasting a value of over US$ 820 million by 2027 end and register a CAGR of over 4.5% from 2020 to 2027. The Future report said it relied upon the rising advancements in research related to cancer, that have led to new drugs being introduced to diagnose and treat cancer. The entrance of new drugs and treatments are aimed at improving the treatment rate against triple-negative breast cancer. Latest clinical efforts are being targeted towards molecular characterization stage of triple-negative breast cancer across rising remedial targets like androgen receptors, PARP1, and non- receptor & receptor tyrosine kinases.     Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Orchard Therapeutics (NASDAQ: ORTX), Heat Biologics, Inc. (NASDAQ:HTBX), Sarepta Therapeutics, Inc. (NASDAQ: SRPT), Bristol Myers Squibb (NYSE:BMY).


The report added: “These latest actions are expected to boost the growth of the triple-negative breast cancer treatment market. Development of generics remains a lucrative area for the market. The growing need for effective cancer management and more efficient drugs is expanding the size of the market. The availability of biosimilars in developing regions is proving to be an efficient drug which has resulted in the growth of the market. The rising number of clinical trials for the combined therapies is boosting the growth of the market as well. New drug formulations are currently in the processing stages of different phases of clinical development and this has augured the growth of the market.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® Doses First Patient in Phase 2 IRENE Study Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast Cancer – Oncolytics Biotech® today announced the first patient has been dosed in the Company’s investigator-sponsored phase 2 study of pelareorep-anti-PD-1 combination therapy in unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). The study, known as IRENE, is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte. Participants in the multi-center study receive pelareorep in combination with Incyte’s anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012).


The recently announced IRENE study builds on prior clinical data showing pelareorep-induced priming of an adaptive immune response in multiple breast cancer subtypes. In addition to investigating the safety and efficacy of pelareorep-anti-PD-1 combination treatment in TNBC patients, the study will also evaluate changes in PD-L1 expression and correlations between treatment outcomes and peripheral T cell clonality, a previously identified biomarker of pelareorep response that may enable the success of future registrational trials by facilitating study design and patient selection. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center.


Principal investigator Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey and Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, commented, “The paucity of treatment options in metastatic triple-negative breast cancer combined with its aggressive clinical behavior results in a poorer prognosis when compared to other subtypes of breast cancer. This is an exciting study to evaluate the role of immunomodulation in the tumor microenvironment as a treatment option. I’m looking forward to getting this study underway to potentially make an impact in the lives of patients affected with metastatic triple-negative breast cancer.”    Read this full press release and more news for ONCY at:    


Other recent developments in the biotech industry include:

Orchard Therapeutics (NASDAQ: ORTX), a global gene therapy leader, recently announced presentations at the upcoming 46th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT), taking place virtually from August 29 – September 1, 2020. New interim data from OTL-203, an investigational gene therapy for the treatment of mucopolysaccharidosis type I (MPS-I), will be shared as part of an invited oral presentation titled ‘Gene Therapy in Leucodystrophies and Other Metabolic Disorders’.


The presentations are listed below and the full preliminary program is available online at the EBMT Annual Meeting website. Presentations will be available to registered attendees for virtual viewing throughout the duration of the live meeting and content will be accessible online following the close of the meeting.


Heat Biologics, Inc. (NASDAQ:HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine, recently reported preclinical data for Heat’s gp96-based COVID-19. The data, generated at the University of Miami Miller School of Medicine, shows robust T cell mediated immune response directed against the spike protein of SARS-CoV-2.


Heat Biologics’ COVID-19 vaccine induced the expansion of both “killer” CD8+ T cells that destroy virus infected cells, as well as “helper” CD4+ T cells that assist in producing highly specific antibodies. Both T cell subsets were shown to release cytokines that amplify the anti-viral immune response and, upon vaccination, memory CD8+ T cells migrated to the lungs and airways-the tissue-specific site of interest for SARS-CoV-2 infection. These lung and airway tissue resident memory CD8+ T cells are crucial in mounting an effective response to respiratory viruses.


Sarepta Therapeutics, Inc. (NASDAQ: SRPT), the leader in precision genetic medicine for rare diseases, recently announced the U.S. Food and Drug Administration (FDA) has accepted the Company’s New Drug Application (NDA) seeking accelerated approval for casimersen (SRP-4045) and provided a regulatory action date of February 25, 2021. The FDA has indicated it does not currently plan to hold an advisory committee to discuss the application. In addition, the Company has received conditional approval of AMONDYS 45 as the brand name for casimersen. Casimersen, a phosphorodiamidate morpholino oligomer (PMO), is engineered to treat patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the dystrophin gene.


The Company submitted its NDA filing in June 2020 and requested priority review, which the FDA granted. The NDA included data from the casimersen arm of the ESSENCE study (also known as Study 4045-301), a global, randomized, double-blind, placebo-controlled Phase 3 study evaluating the efficacy and safety of casimersen in patients amenable to skipping exons 45. An interim analysis from ESSENCE demonstrated a statistically significant increase in dystrophin production as measured by western blot in patients who received casimersen compared to baseline and placebo. The study is ongoing and remains blinded to collect additional efficacy and safety data.


Bristol Myers Squibb (NYSE:BMY) recently announced that the Phase 3 IDHENTIFY study evaluating IDHIFA® (enasidenib) plus best supportive care (BSC) versus conventional care regimens, which include best supportive care (BSC) only, azacitidine plus BSC, low-dose cytarabine plus BSC or intermediate-dose cytarabine plus BSC, did not meet the primary endpoint of overall survival (OS) in patients with relapsed or refractory acute myeloid leukemia (R/R AML) with an isocitrate dehydrogenase-2 (IDH2) mutation. The safety profile of IDHIFA was consistent with previously reported findings. The company will complete a full evaluation of the IDHENTIFY data and work with investigators to present detailed results at a future medical meeting.


“While we are disappointed by the outcome of the IDHENTIFY study, we remain confident in IDHIFA’s established role as a treatment option for patients with relapsed or refractory AML with an IDH2 mutation and are grateful to all those who participated in the study,” said Noah Berkowitz, M.D., Ph.D., senior vice president, Global Clinical Development, Hematology, Bristol Myers Squibb. “AML is one of the most difficult-to-treat blood cancers, and we’re committed to furthering our research and improving on the standards of care for patients living with this aggressive disease.”


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