Advancements in Breast Cancer Research & Clinical Studies Producing Optimism for New Treatments

PALM BEACH, Florida, June 25, 2020 /PRNewswire/ -- The triple negative breast cancer (TNBC) treatment market to grow at stellar CAGR through 2026. A recent report from Cole Market Research has stated that the ongoing advancements in cancer research continue to lead to the introduction of newer and better treatment options including drug therapies. The provision of newer drugs and treatments is expected to improve the diagnostic and treatment rate for triple-negative breast cancer. The report said: "Some of the recent clinical efforts are being targeted at the molecular level characterization of triple-negative breast cancer across emerging therapeutic targets such as epigenetic proteins, PARP1, androgen receptors, receptor and non-receptor tyrosine kinases, and immune checkpoints. These initiatives are anticipated to boost revenue growth of the triple-negative breast cancer treatment market. In a new research study, Persistence Market Research estimates the global triple-negative breast cancer treatment market revenue to cross US$ 720 Mn by 2026 from an estimated valuation of just under US$ 505 Mn in 2018. This is indicative of a CAGR of 4.7%during the period 2018 to 2026." Active biotech and pharma companies in the markets this week include Eli Lilly and Company (NYSE: LLY), Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC), Genprex, Inc. (NASDAQ: GNPX), Cardiff Oncology, Inc. (NASDAQ: CRDF), Merck & Co., Inc. (NYSE: MRK). 

It continued saying: "One of the biggest trends being observed in the global market for triple-negative breast cancer treatment is the shift towards combination therapy. Companies in the global triple-negative breast cancer treatment market are conducting clinical trials for combination therapies by collaborating with other players in the market. Combination therapies are the latest innovation in the field of oncology and the combination of therapeutic drugs with chemotherapy is said to be an effective protocol for the treatment of triple-negative breast cancer. Another huge trend in the triple-negative breast cancer treatment market is the emergence of nanotechnology as an efficient tool in the clinical management of critical diseases such as triple-negative breast cancer. It has been observed that the combination of gold nanoparticles and folic acid results in higher cell entry rate in both in-vitro and in-vivo models, indicative of the fact that folate receptors are effective targeted therapies for the treatment of triple-negative breast cancer."

Oncolytics Biotech^® Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech^® Announces Investigator Sponsored Phase 2 Trial Evaluating Pelareorep-anti-PD-1 Combination Treatment in Triple-Negative Breast Cancer - Oncolytics Biotech^® today announced a new investigator-sponsored triple-negative breast cancer (TNBC) study to be managed by Rutgers Cancer Institute of New Jersey The phase 2 trial, known as IRENE, will investigate the use of pelareorep in combination with Incyte's anti-PD-1 checkpoint inhibitor retifanlimab (INCMGA00012) in patients with unresectable locally advanced or metastatic TNBC.

"We are very excited to evaluate pelareorep in TNBC, as prior clinical data show it has the potential to address a pressing unmet need in this challenging indication," said 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. "Checkpoint inhibitors targeting interactions between PD-L1 and PD-1, while commercially successful, are ineffective in up to 80% of TNBC patients. This is often due to an immunosuppressive tumor microenvironment.  Checkpoint inhibitors are beneficial in patients who have upregulation of PD-L1 expression in the tumor environment.  Clinical data show that systemic pelareorep administration can upregulate PD-L1 expression in tumors across multiple breast cancer subtypes, highlighting its potential to substantially increase the percentage of patients who respond to checkpoint inhibitor therapy. Through the IRENE study, we aim to explore how pelareorep-induced adaptive immune responses synergistically interact with PD-1 inhibition to improve patient outcomes in TNBC."

The newly announced IRENE study represents an expansion of Oncolytics' lead breast cancer program into a new disease subtype (TNBC). 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 pivotal studies by facilitating the patient selection process. The trial will take place at the Rutgers Cancer Institute of New Jersey and The Ohio State University Comprehensive Cancer Center, and is co-sponsored by Oncolytics, the Rutgers Cancer Institute of New Jersey, and Incyte.    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:

Genprex, Inc. (NASDAQ: GNPX) a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, recently announced that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex™ immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron"). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company's manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.

Genprex's upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso®) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda®) in NSCLC is also planned.

Cardiff Oncology, Inc. (NASDAQ: CRDF)  a clinical-stage oncology therapeutics company developing drugs to treat cancers with the greatest medical need for new treatment options, including KRAS-mutated colorectal cancer, Zytiga®-resistant prostate cancer and leukemia, recently announced presentation of final results of its Phase 1b study, and preliminary positive data from its Phase 2 study, in relapsed or refractory acute myeloid leukemia (AML). The data was presented as a virtual poster presentation at the European Hematology Association (EHA) annual conference.

The presentation highlighted the efficacy, durability of response, favorable safety and tolerability profile, as well as correlative biomarker data. Anti-leukemic activity was observed at a wide range of onvansertib doses (27 to 90 mg/m²), indicating a large therapeutic window.

Merck & Co., Inc. (NYSE: MRK) known as MSD outside the United States and Canada, recently announced that KEYTRUDA, Merck's anti-PD-1 therapy, has been approved by the National Medical Products Administration (NMPA) in China as monotherapy for the treatment of patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by a fully validated test, following failure of one prior line of systemic therapy. This new indication was granted full approval based on the overall survival (OS) findings from the global Phase 3 KEYNOTE-181 trial, including data from an extension of the global study in Chinese patients. With this new approval, KEYTRUDA is now approved for five indications across three different types of cancer in China, including as a first-line treatment for appropriate patients with advanced non-small cell lung cancer (monotherapy and in combination with chemotherapy) and as a second-line treatment for advanced melanoma. The U.S. Food and Drug Administration approval in July 2019 was based upon the global KEYNOTE-181 trial.

In an article published by Zacks.com, Eli Lilly and Company's (NYSE: LLY) CDK4 & 6 inhibitor, Verzenio, significantly reduced the risk of cancer returning in a large late-stage study in patients with high risk HR+, HER2- early breast cancer. Verzenio is approved to treat advanced breast cancer and is not approved for an early stage breast cancer indication.

The phase III monarchE study (n= 5,637) met its primary endpoint of invasive disease-free survival (iDFS) by showing that Verzenio in combination with standard adjuvant endocrine therapy (ET) significantly decreased the risk of breast cancer recurrence or death compared to standard adjuvant ET alone. The data was presented from a pre-planned interim analysis of the study.

The positive data led the company's stock up around 16% on Tuesday as the study data could be a game changer in treating breast cancer. Lilly's shares have risen 24.6% this year so far against a decrease of 5.3% for the industry.

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