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Vancouver, BC – January 12, 2022 – USA News Group – So far in 2022, there have already been some impressive developments in the battle against breast cancer, which over the last decade has been the leading killer of female cancer patients, according to a decade long analysis. In just the first half of January, the market witnessed the identification of MAPK4 as a potential target for triple-negative breast cancer (TNBC), and a lasting survival benefit in HER2+ metastatic breast cancer from adding tucatninib to treatment with trastuzumab and capecitabine. There are plenty more developments to come from biotech companies working into 2022 on new treatments for breast cancer including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), Illumina, Inc. (NASDAQ:ILMN), Zai Lab Limited (NASDAQ:ZLAB), Merus N.V. (NASDAQ:MRUS), and Veru Inc.(NASDAQ:VERU).
Updating the market on its flagship immunotherapeutic agent pelareorep, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) laid out its primary breast cancer achievements in 2021, as well as its 2022 program to come in its latest letter to shareholders.
For breast cancer patients treated with pelareorep Oncolytics has witnessed a more-than-doubling of overall survival in metastatic HR+/HER2- in IND-213—as seen from study results delivered in 2017.
Through a series of data analysis, Oncolytics chose to focus on the three achievable objectives put in place by regulators and the company’s pharma partners, representing important steps towards a registrational study. This included: 1. Confirming that pelareorep works through an immunotherapeutic mechanism of action; 2. Determining whether pelareorep synergizes with immune checkpoint inhibitors; and 3. Identifying a biomarker to select patients who are likely to have better clinical outcomes.
In the shareholders letter, Dr. Matt Coffey, President & CEO of Oncolytics Biotech, wrote: “I am pleased to report that we are well on our way to achieving these three objectives.”
Back in April 2021, Oncolytics presented cohort data from its AWARE-1 study, being conducted with Roche, showing that the first two objectives referenced above had been achieved.
By December at the 2021 San Antonio Breast Cancer Symposium (SABCS), Oncolytics presented a positive safety update from its IRENE Phase 2 Triple-Negative Breast Cancer Trial evaluating the safety and efficacy of pelareorep in combination with the anti-PD-1 checkpoint inhibitor retifanlimab from Incyte for second- or third-line treatment of patients with metastatic triple-negative breast cancer (TNBC).
“Prior clinical studies have shown that pelareorep upregulates tumor PD-L1 expression and reverses immunosuppressive TMEs,” said Mridula George, M.D., Medical Oncologist, Rutgers Cancer Institute of New Jersey, Assistant Professor of Medicine, Rutgers Robert Wood Johnson Medical School, and principal investigator of the trial. “These findings suggest that pelareorep can address a pressing unmet need in TNBC by synergizing with PD-1 inhibition to increase the proportion of patients responding to therapy. We look forward to evaluating this hypothesis through the IRENE study’s continued advancement and are pleased that the pelareorep-retifanlimab combination has been well-tolerated in each of the patients enrolled in the trial.”
Safety data from the trial showed the combination was well-tolerated, with no safety concerns noted in any of the patients enrolled in the trial at the time of reporting. The IRENE study remains ongoing and will continue to enroll patients at the Rutgers Cancer Institute of New Jersey and the Ohio State University Comprehensive Cancer Center.
Illumina, Inc. (NASDAQ:ILMN) recently announced a partnership with world-leading prevision oncology specialists Agendia N.V. to co-develop in vitro diagnostic tests for oncology testing. Together, they companies intend to advance the use of next-generation sequencing for decentralized oncology testing.
The partnership plans to develop new tests to enhance the care and management of breast cancer patients, utilizing the Illumina MiSeqtm Dx sequencing platform to expand the range of gene panels available for solid tumor analysis.
“We are pleased to partner with Agendia, with its deep expertise in genomic testing in breast cancer, to expand the reach of NGS-based genomic testing in cancer care,” said Joydeep Goswami, Chief Strategy and Corporate Development Officer of Illumina. “We believe enabling in-house clinical testing will strengthen the knowledge of the healthcare network, reduce turnaround times, and ultimately better support more patients with improved guidance on care pathways.”
In China, Zai Lab Limited (NASDAQ:ZLAB) announced the acceptance of a New Drug Application by the China National Medical Products Administration (NMPA) for its investigational, Fc-engineered monoclonal antibody margetuximab, which targets HER2. The margetuximab NDA is for the treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, in combination with chemotherapy.
“We still need to improve the prognosis for people diagnosed with HER2-positive metastatic breast cancer, and additional anti-HER2 targeted therapies are needed,” said Professor Zefei Jiang, Chairman of Chinese Society of Clinical Oncology (CSCO) Breast Cancer Expert Committee and Deputy Director of Department of Oncology, Chinese PLA General Hospital. “Zai Lab’s bridging study confirmed the clinical benefit of margetuximab in Chinese patients. We are excited to see this potential new treatment option for patients living with metastatic breast cancer in China.”
Back in December 2021, Merus N.V. (NASDAQ:MRUS) presented at the 2021 San Antonio Cancer Symposium an updated analysis on its lead candidate zenocutuzumab in combination with trastuzumab and vinorelbine in patients with HER2+ metastatic breast cancer.
“We are pleased to present the final analysis of the triplet Zeno combination which has demonstrated clinically meaningful activity in heavily pretreated patients with HER2+/amplified MBC,” said Andrew Joe, Chief Medical Officer at Merus. “We are encouraged by Zeno’s potential to be active in indications outside NRG1 fusion cancers, opening opportunities for potential collaborations in these areas.”
The combination was observed to be well-tolerated in the run-in cohort and the cohort was expanded.
Veru Inc.(NASDAQ:VERU) opened 2022 with the announcement that the FDA granted fast track designation for enobosarm in patients with AR+ ER+ HER2- metastatic breast cancer who have shown previous disease progression on a nonsteroidal AI, fulvestrant, and a CDK 4/6 inhibitor is currently enrolling.
“We are very pleased that enobosarm has received Fast Track designation from the FDA, a distinction that underscores the urgent need for new, novel, targeted therapies for this important patient population suffering from this aggressive disease,” said Mitchell Steiner, MD, Chairman, President and CEO of Veru. “We look forward to ongoing, productive regulatory interactions with the FDA, which are further enabled with this designation.”
For more information go to: https://usanewsgroup.com/2020/02/24/why-biotechnology-companies-are-so-important/
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