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HER2-Targeted Therapies Introduced Early in Breast Cancer Treatment Offering Hope for Patients

Palm Beach, FL – May 4, 2022 – News Commentary – Globally, the R&D on breast cancer in all its forms has been steadily growing at a significant pace over the last several years and will continue in the years to come. Breast cancer is the second most common cancer in the world and the most common cancer in women worldwide. Human epidermal growth factor receptor 2-positive (HER2+) breast cancer constitutes approximately 20% of breast cancer cases and was historically associated with poor prognosis in the absence of effective treatments. The realization that introducing HER2-targeted therapies earlier into the disease management strategy could improve disease-free survival (DFS) has created a large market for HER2-directed therapies. Today, HER2+ breast cancer patients are living longer with their disease, thanks to established disease management strategies using regimens. According to Stats Market Research the HER2+ market is forecast to grow to $12.1B by 2030, at a Compound Annual Growth Rate (CAGR) of 1.5%.  A report from Mordor Intelligence added that the breast cancer therapy market is expected to grow at a CAGR of 8.3% over the forecast period, 2022-2027.  The report said: “Due to the outbreak of COVID-19, the market has faced a slight setback owing to the delay in diagnosis, drug shortages, and unavailability of healthcare professionals. For instance, according to an article published in the JAMA Network in August 2020, there was a significant decline in breast cancer diagnoses (by as much as 51.8%) in the United States from March 1, 2020, to April 18, 2020. Hence, the delay in diagnosis of breast cancer has impacted the treatment of the same. Thus, the COVID-19 pandemic has negatively impacted the breast cancer therapy market in its initial phase. However, the market is expected to gain traction over the coming years as the treatments are resumed worldwide.”  Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Clovis Oncology, Inc. (NASDAQ: CLVS), Belite Bio Inc (NASDAQ: BLTE), Endo International plc (NASDAQ: ENDP), Pfizer Inc. (NYSE: PFE).


Stats Market Research continued: “Further, the major factors fueling the market’s growth are the high incidence and prevalence rate of breast cancer worldwide, increasing investment in research and development, and advancements in cancer biology and pharmacology promoting drug development.  The high incidence and prevalence rate of breast cancer worldwide is a major factor driving the market’s growth.  Within North America, the United States is expected to dominate the overall market throughout the forecast period. The major factors fueling the market growth are the increasing burden of breast cancer in the country and rising awareness pertaining to breast cancer as well as rising product launches.”


Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS:  Oncolytics Biotech® and SOLTI Present New Clinical Biomarker Data Demonstrating Pelareorep’s Potential to Improve the Prognosis of Breast Cancer Patients at the ESMO Breast Cancer Meeting Oncolytics Biotech® and SOLTI-Innovative Cancer Research today announced new clinical biomarker data demonstrating pelareorep’s immunotherapeutic effects, synergy with checkpoint inhibition, and potential to improve the outlook for patients with HR+/HER2- breast cancer. The data, which are featured in a poster presentation at the 2022 European Society for Medical Oncology (ESMO) Breast Cancer Meeting, are from cohorts 1 and 2 of the AWARE-1 window-of-opportunity study in early-stage breast cancer patients.


Patients in AWARE-1’s first two cohorts were treated with pelareorep and the aromatase inhibitor letrozole without (cohort 1), or with (cohort 2), the PD-L1 checkpoint inhibitor atezolizumab approximately 21 days prior to the surgical resection of their tumors. Cohorts 1 and 2 of AWARE-1 exclusively enrolled patients with HR+/HER2- disease, the breast cancer subtype that Oncolytics intends to examine in a future registrational study. Previously reported results showed AWARE-1 met its primary translational endpoint, with cohort 2 achieving the pre-specified success criteria for treatment-induced increases in CelTIL score (link to the PR). CelTIL score is a metric for tumor inflammation and cellularity and is associated with improved clinical outcomes in breast cancer patients.


“The latest data from AWARE-1 further demonstrate pelareorep’s potential to improve clinical outcomes in breast cancer patients through its ability to activate T cells and remodel the tumor microenvironment,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer of Oncolytics. “Notably, pelareorep treatment increased markers of tumor cell death and, perhaps even more impressive, 100% of evaluable pelareorep-treated patients had a favorable Risk of Recurrence Score (ROR-S) compared to 55% at baseline. Together, these latest AWARE-1 results further establish pelareorep’s ability to attack tumors through multiple mechanisms.”


Key data and conclusions from the ESMO Breast Cancer poster include:


  • Gene expression analyses showed 100% of evaluable patients had a Risk of Recurrence Score (ROR-S) classified as “low” at surgery vs. 55% with a “low” ROR-S at baseline (information pertaining to prognostic testing of gene signature assays in breast cancer can be found by clicking here)
  • Treatment with pelareorep with (cohort 2) or without (cohort1) atezolizumab led to the conversion of tumors from the more aggressive luminal B to the luminal A subtype, which is associated with improved clinical outcomes
    • 100% of evaluable cohort 2 tumors were luminal A at surgery (21 days post-treatment) vs. 70% at baseline (pre-treatment)
    • 70% of evaluable cohort 1 patients had luminal A tumors at surgery vs. 40% at baseline
  • Pooled analysis of tumors from cohorts 1 and 2 shows a statistically significant 4-fold post-treatment increase in the average expression of caspase 3, which is a marker of apoptotic cell death
  • Pooled analysis across cohorts 1 and 2 shows statistically significant increases in markers of T cell activation and no significant changes in markers of T cell exhaustion from baseline to surgery


Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc., commented, “AWARE-1’s results continue to exceed our expectations. With each new dataset, we gain additional clarity on how pelareorep’s immunologic mechanism of action synergistically combines with checkpoint inhibition. The study has also identified changes in blood T cell populations as a potential biomarker to predict patient response. We are now working to confirm these promising findings with efficacy data and additional biomarker analyses from our ongoing BRACELET-1 trial. If positive, we expect BRACELET-1’s results to inform the design of a registrational study in HR+/HER2- breast cancer and validate our broader strategy of developing pelareorep in combination with leading anti-cancer agents.”  CONTINUED Read this full press release and more news for ONCY at:    


Other recent developments in the biotech industry of note include:


Belite Bio Inc (NASDAQ: BLTE) recently announced that LBS-008, an orally administered tablet, has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the treatment of STGD1. This decision was based upon FDA’s review of non-clinical data and preliminary clinical data from studies of LBS-008.


“We are delighted that LBS-008 has received FDA Fast Track Designation. STGD1 is a terrible retinal disease with the potential to severely affect the vision of afflicted patients and there are currently no approved treatments,” said Dr. Tom Lin, the Company’s Chairman and CEO. “At present, we are conducting a Phase 3 clinical trial in order to bring to market a treatment that will halt or slow the progression of STGD1. Additionally, we are evaluating our plan to launch a Phase 2/3 trial in Dry AMD in 2022. Dry AMD is a disease which shares a similar underlying pathophysiology with STGD1 and is a leading cause of central vision loss in people over 50.”


Endo International plc (NASDAQ: ENDP) recently announced that its subsidiary Endo Ventures Limited (EVL) acquired six development-stage, ready-to-use injectable product candidates from Nevakar Injectables Inc., a subsidiary of Nevakar, Inc.


“These six product candidates that would be used in critical care settings meaningfully expand Endo’s ready-to-use injectable product pipeline,” said Scott Sims, Senior Vice President and General Manager, Injectable Solutions & Generics at Endo. “We look forward to further developing and bringing these durable and differentiated products to market—and to the healthcare providers and patients who need them.”


Clovis Oncology, Inc. (NASDAQ: CLVS) recently announced that seven abstracts from the company’s pipeline, including late-breaking data from the ATHENA-MONO Phase 3 clinical trial evaluating Rubraca monotherapy versus placebo and imaging of solid tumors using FAP-2286, will be presented in oral and poster sessions during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting held June 3-7, 2022, in Chicago. Three additional retrospective analyses evaluating Rubraca and PARP inhibitors will be published online during the meeting.


“The wealth of data being presented during ASCO, including more detailed analyses of the positive results from the ATHENA-MONO study of Rubraca monotherapy versus placebo in first-line maintenance treatment for ovarian cancer, adds to the breadth of knowledge demonstrating that Rubraca is an important part of treatment for patients regardless of biomarker status,” said Patrick J. Mahaffy, President and CEO of Clovis Oncology. “Additionally, we look forward to new imaging data of FAP-2286 in solid tumors, an important component in understanding the solid tumor types where FAP-2286 may offer clinical benefit for patients.”


Pfizer Inc. (NYSE: PFE) recently reported strong financial results for first-quarter 2022 and updated certain components of 2022 financial guidance. Pfizer reaffirmed its previous 2022 revenue guidance, including its guidance for Comirnaty, the Pfizer-BioNTech SE (BioNTech) COVID-19 vaccine, and for Paxlovid, its oral COVID-19 treatment, despite unfavorable impacts from foreign exchange.


The first-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer’s R&D pipeline can be found on the Pfizer website.  Dr. Albert Bourla, Chairman and Chief Executive Officer, stated: “I am very proud of our performance this quarter, both from a financial perspective and from the standpoint of trying to be a force for good in the world. We continue to supply the world with Comirnaty, which remains a critical tool for helping patients and societies avoid the worst impacts of the COVID-19 pandemic, and we are on track to fulfill our commitment to deliver at least 2 billion doses to low- and middle-income countries in 2021 and 2022, including at least 1 billion doses this year. In addition, we are delivering on our production commitments for Paxlovid, which is already having a profound impact on the lives of patients. In response to the devastating war in Ukraine, and as a company that is dedicated to promoting human health, we have chosen to continue to supply the people of Russia with the medications they need, and are donating all profits from our Russian subsidiary to humanitarian efforts in Ukraine. We will continue to do all we can to support the health of all people, which is in line with our purpose: Breakthroughs that change patients’ lives.”


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