USA News Group – Breast cancer rates are increasing this year, with nearly 300,000 new cases of invasive breast cancer diagnosed in women and 2,800 new cases in men. While breast cancer survival rates have improved in recent years, 1 in 8 women will still receive a diagnosis in their lifetime. Thankfully, there’s plenty of optimism coming from the biotech sector, including from Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC), AstraZeneca PLC (NASDAQ:AZN, Daiichi Sankyo Company, Limited (OTC:DSNKY), Gilead Sciences, Inc. (NASDAQ:GILD) and Accuray Incorporated (NASDAQ:ARAY).
At this year’s Society for Immunotherapy of Cancer (SITC) 2023, Oncolytics Biotech Inc. (NASDAQ:ONCY) (TSX:ONC) shared positive updates from its previously completed Phase 1/2 AWARE-1 breast cancer study involving its flagship drug pelareorep. This time, using novel imaging mass cytometry (IMC) technology, Oncolytics has been enabled to take a closer look at tumor microenvironment post-pelareorep/letrozole/atezolizumab treatment.
“Using the novel IMC technology to conduct further translational data analysis from the AWARE-1 study in early-stage breast cancer patients has confirmed and expanded our understanding of pelareorep’s mechanism of action in the tumor microenvironment,” said Dr. Matt Coffey, President and CEO of Oncolytics. “We look forward to incorporating these important translational learnings into our registrational program for HR+/HER2- metastatic breast cancer. These findings likely also have implications for other indications where we have seen signals of efficacy with atezolizumab/pelareorep combinations, including pancreatic cancer in the GOBLET study focused on gastrointestinal cancers.”
After using the pelareorep combination, Oncolytics saw more PD-L1 positive cells in the tumors, which is beneficial because these types of cells can make it easier for the immune system to recognize and attack cancer. As well, more immune system cells (T cells) were observed entering the tumors, which is another good sign that the immune system was getting more active in fighting the cancer. Overall, these changes suggest that the tumor environment becomes more “friendly” for the body to attack the cancer cells.
“Previously published analyses from AWARE-1 patient samples showed that in the first three days after dosing, pelareorep upregulated tumor PD-L1 expression in the tumors, induced the generation and expansion of T cell clones, and promoted the tumor infiltration of CD8+ T cells,” said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. “It also led to an increase in the CelTIL score in most patients, which is a measure of tumor cellularity and immune infiltration that is associated with favorable clinical outcomes. The new IMC data presented today show an increase in cytotoxic T cells and PD-L1 expression in tumors by three days following treatment and demonstrate pela’s ability to induce an enhanced immune state within tumors. This supports pelareorep’s ability to modify the tumor microenvironment and enhance the responsiveness of cancers to checkpoint inhibitor therapy.”
The market responded positively when AstraZeneca PLC (NASDAQ:AZN and Daiichi Sankyo Company, Limited (OTC:DSNKY) saw their breast cancer treatment outperform chemotherapy with statistically significant and clinically meaningful progression-free survival benefit in a Phase 3 study.
The duo followed this up in October, announcing their datopotamab deruxtecan reduced the risk of disease progression or death by 37%, providing a 2-month median progression-free survival (PFS) benefit.
"These statistically significant and clinically meaningful results from the TROPION-Breast01 trial support datopotamab deruxtecan as a new potential standard of care for patients with advanced HR-positive, HER2-low or negative breast cancer in the post-endocrine therapy setting,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “The results further validate the portability of Daiichi Sankyo's DXd antibody drug conjugate technology to additional targets such as TROP2, and we look forward to potentially bringing our second antibody drug conjugate to patients with breast cancer."
The joint effort from AstraZeneca and Daiichi Sankyo is seemingly on pace to challenge Gilead Sciences, Inc. (NASDAQ:GILD), as the duo plans to file for approval of datopotamab deruxtecan (Dato-DXd) after linking their antibody-drug conjugate (ADC) to improved outcomes.
Back in February, the FDA approved Gilead’s Trodelvy in pre-treated HR+/HER2- metastatic breast cancer. The treatment is now also recommended as a Category 1, preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network (NCC) as defined in the Clinical Practice Guidelines in Oncology.
“We are pleased that Trodelvy could now provide new hope for people living with pre-treated HR+/HER2- metastatic breast cancer, building on the transformative role that Trodelvy is already playing for people with metastatic triple-negative breast cancer,” said Daniel O'Day, Chairman and CEO, Gilead Sciences. “We thank the physicians, patients and their families who put their trust in the TROPiCS-02 study and helped make this milestone possible.”
The momentum for Trodelvy in 2023 has been a boost for Gilead, as the drug went on to gain approval from the European Commission (EC) over the summer, and helped to deliver a 64% revenue jump in Q2 2023 for the company.
Late in the summer, Accuray Incorporated (NASDAQ:ARAY) received clearance from both the FDA and the EC for its VitalHold breast package on the Radixact System. The treatment facilitates deep inspiration breath hold (DIBH) treatments using the Radixact System’s fixed beam angle delivery mode.
"Our goal in introducing VitalHold for the Radixact System is to provide clinicians with additional choice and flexibility when treating the full spectrum of breast cancer cases they see daily in their practice," said Suzanne Winter, President and CEO of Accuray. “Now, Accuray can offer our customers the widest range of radiation treatment delivery techniques in one device, the Radixact System. This industry-leading approach demonstrates how our relentless focus on innovation has enabled Accuray to make an already great system even better, providing clinicians with tools that help ensure precise, truly personalized treatments are achievable for more patients.”
Article Source: https://usanewsgroup.com/2023/10/02/the-most-undervalued-oncolytics-company-on-the-nasdaq/
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