Palm Beach, FL –November 9, 2020 – Much time and money has been allocated in the global breast cancer drug market, and multiple reports project continued growth in the sector. Early detection, increase in awareness, and incidence of breast cancer are some of the key trends stoking market growth. One such report from Market Reports World projected that the global Breast Cancer Drugs market, which is valued at $14.56 billion in 2020 is expected to reach $23.82 billion by the end of 2026, growing at a CAGR of 7.2% during 2021-2026. Another report had even loftier expectations. Grand View Research said that the global breast cancer drug market size is expected to reach $38.4 billion by 2025, and it is projected to expand at a CAGR of 10.7% during the forecast period. It added: “Global breast cancer drugs market is expected to grow lucratively as many players focus majorly on R&D of innovative treatments. They engage in extensive research to develop novel drugs for the treatment of the disease to gain a higher market share. There exists a growing pressure and need for novel therapies and treatment due to rapidly accelerating prevalence of diseases. The strong pipeline is expected to provide new and effective treatment options and improved outcomes than existing therapies.” Active biotech and pharma companies in the markets this week include Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), Aptevo Therapeutics Inc. (NASDAQ: APVO), Cardiff Oncology, Inc. (NASDAQ: CRDF), Halozyme Therapeutics, Inc. (NASDAQ: HALO), Merck (NYSE: MRK).
Yet another report from Market Research added: “Early detection of breast cancer is key to effective treatment of the disease. Also, early exposure of disease can lead to better outcomes including a number of treatment options, improved survival rate, and changed quality of life. There exist a rising pressure and demand for novel therapies or treatment owing to the rapidly growing prevalence of diseases. The strong pipeline is projected to provide effective and new treatment options and upgraded outcomes than already existing therapies… The growing prevalence of the disease coupled with emerging and better novel therapies are some factors likely to fuel the global market growth. Global breast cancer drugs market is estimated to grow lucratively attributable to many major players are focusing on Research & Development of new and innovative treatments. They involve extensive research in order to develop novel drugs for the treatment of this disease to gain a higher market share. Various target and specific therapies have been designed and customized along with various advancements in drug delivery systems.”
Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech® and SOLTI Present Clinical Breast Cancer Data Highlighting Pelareorep-Induced Anti-Tumor T Cell Responses at The Society for Immunotherapy of Cancer Annual Meeting – Oncolytics Biotech® and SOLTI-Innovative Breast Cancer Research today announced the publication of an electronic poster with clinical data from the AWARE-1 window-of-opportunity breast cancer study at The Society for Immunotherapy of Cancer (SITC) 35th Anniversary Annual Meeting.
The AWARE-1 study, a collaboration between Oncolytics Biotech and SOLTI, combines the appropriate intervention for each patient’s breast cancer sub-type, plus pelareorep, with or without atezolizumab (Tecentriq®), followed by surgery in early-stage breast cancer patients. Data presented in the electronic poster were from the ten HR+/HER2- breast cancer patients that make up the study’s first cohort. These data demonstrate the ability of pelareorep to promote a pro-inflammatory tumor microenvironment (TME) and provide a basis for the findings of a prior successful phase 2 trial (IND-213) that showed a near doubling of overall survival with pelareorep treatment in HR+/HER2- breast cancer patients (link to PR, link to poster).
“AWARE-1’s elegant paired-biopsy design allows us to assess the impact of pelareorep on each patient’s tumor immune environment, and the results to date have been very promising,” said Dr. Aleix Prat, M.D., PhD., Translational Investigator of the Study, SOLTI President and Head of the Medical Oncology Department at Hospital Clinic in Barcelona. “These data continue to support pelareorep’s ability to train the immune system to target cancer and highlight its potential to address a critical unmet need by increasing the number of patients responding to checkpoint inhibitor therapies. Data presented at SITC showing pelareorep-induced generation and expansion of anti-tumor and anti-viral T cell clones are also noteworthy, as they suggest the induction of a durable anti-cancer immune memory effect. These data, together with previously reported AWARE-1 results, provide strong support for the observed survival benefit in a prior randomized phase 2 study evaluating pelareorep in metastatic breast cancer patients.”
Key data and conclusions from the electronic poster include:
- Tumor-cell specific pelareorep replication was observed in all cohort-1 patients following systemic pelareorep administration
- 70% of cohort 1 patients saw an increase in CelTIL, the study’s primary endpoint and a measure of tumor-associated cellularity and tumor-infiltrating lymphocytes that is associated with favorable clinical outcomes
- On average, there was a 14-fold increase in intratumoral CD8+ T cells from baseline (pre-pelareorep administration) to surgery (21-days post-administration), with increases observed in all cohort-1 patients
- Pelareorep administration led to the generation and expansion of new T cell clones in the tumor and periphery, which included both anti-tumor and anti-viral clones
Thomas Heineman, M.D., Ph.D., Global Head of Clinical Development and Operations at Oncolytics, commented, “These newly announced AWARE-1 results add to the promising clinical dataset supporting pelareorep’s immunotherapeutic mechanism of action and to the proposed registration pathway in our lead metastatic breast cancer program. The observed 70% CelTIL response rate in cohort-1 patients is highly encouraging, as CelTIL is associated with favorable patient outcomes, and this response rate was achieved despite the absence of checkpoint blockade therapy. Further, previously announced data have shown that CelTIL scores correlate with high peripheral T cell clonality, underscoring T cell clonality’s potential as a predictive biomarker that may facilitate the design of future registrational trials and improve their chances of success. We look forward to presenting additional AWARE-1 data later this year and to the continued progress of the trial, which will be key as we move our lead breast cancer program towards a registrational study.” Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/
Other recent developments in the biotech industry include:
Aptevo Therapeutics Inc. (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ platform, recently provided an update on its ongoing APVO436 Phase 1 clinical trial.
APVO436 is a novel anti-CD123 x anti-CD3 targeted investigational bispecific antibody therapy being evaluated for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS), in a Phase 1/1b open-label, dose-escalation study evaluating the safety and pharmacokinetic profile.
Aptevo is pleased to announce that, based on preliminary data, a patient in cohort 6 of the clinical trial has shown complete remission.
Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, castration-resistant prostate cancer and leukemia, recently announced company highlights and financial results for the third quarter ended September 30, 2020. The Company is issuing this press release in lieu of conducting a conference call.
“Cardiff Oncology has seen robust growth over the past few months, which has been driven primarily by clinical data sets demonstrating safety and efficacy of onvansertib in solid tumor indications,” said Dr. Mark Erlander, chief executive officer of Cardiff Oncology. “Data from our lead KRAS-mutated metastatic colorectal cancer (mCRC) program presented at the European Society for Medical Oncology (ESMO) conference, shows that the addition of onvansertib to standard-of-care therapy has led to durable responses and a significant improvement in the objective response rate (ORR) versus historical ORR’s of standard-of-care alone, highlighting onvansertib’s ability to address a critical unmet need in second-line treatment. We have also seen progress in our metastatic castration-resistant prostate cancer (mCRPC) program, presenting positive biomarker and efficacy data demonstrating onvansertib’s ability to overcome Zytiga® resistance across known androgen receptor resistance mechanisms, at the Prostate Cancer Foundation (PCF) Scientific Retreat.”
Halozyme Therapeutics, Inc. (NASDAQ: HALO) recently announced that studies sponsored by Janssen Research & Development, LLC (Janssen) evaluating subcutaneous (SC) daratumumab utilizing ENHANZE® will be the subject of presentations at the upcoming American Society of Hematology (ASH) Annual Meeting and Exposition taking place virtually December 5-8, 2020.
Primary data from the Phase 3 APOLLO study of SC daratumumab in combination with pomalidomide and dexamethasone (D-Pd) in patients with multiple myeloma who have received one or more prior lines of therapy (Abstract #412) will be the subject of an oral presentation and official ASH Press Program (Sunday, December 6 3:00 p.m. ET).
Merck (NYSE: MRK), known as MSD outside the United States and Canada, and AstraZeneca recently announced that LYNPARZA has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic) who have progressed following a prior therapy that included a new hormonal agent.
The approval by the European Commission was based on a subgroup analysis from the Phase 3 PROfound trial showing LYNPARZA demonstrated an improvement in radiographic progression-free survival (rPFS) and overall survival (OS) versus enzalutamide or abiraterone in men with BRCA1/2 mutations. It follows the recommendation for approval by the Committee for Medicinal Products for Human Use of the European Medicines Agency in September 2020.
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