ONCY Stock Up on Regulatory Update From Breast Cancer Program
Shares of Oncolytics Biotech ONCY rallied 18.2% on Friday after the company announced that it is seeking an accelerated pathway for the approval of its lead developmental candidate, pelareorep, for the metastatic breast cancer (mBC) indication. The stock is also gaining today.
Pelareorep follows a unique mechanism of action, different from currently available therapeutics for this indication. It selectively targets cancer cells, triggering a cascade of inflammatory responses (which include PD-L1 upregulation and enhanced T-cell infiltration) that help the immune system eliminate the tumor while leaving healthy tissue unharmed.
Recent Update From ONCY’s Breast Cancer Study of Pelareorep
Last month, Oncolytics reported positive data from its phase II BRACELET-1 study, which evaluated the combination regimen of pelareorep and standard-of-care chemotherapy (paclitaxel) compared with paclitaxel monotherapy in patients with HR+/HER2- mBC.
Per the data readout from the BRACELET-1 study, pelareorep significantly improved outcomes for advanced mBC patients. While the median overall survival for the paclitaxel control group was 18.2 months, the same was “Not Reached” for the pelareorep arm, as more than half of the patients receiving the candidate were still alive at the final analysis.
Oncolytics stated that the conservative estimate of median overall survival for the pelareorep group is 32.1 months, indicating that the combination of pelareorep and paclitaxel provides a survival benefit of more than 12 months compared with paclitaxel alone. Additionally, 64% of patients on pelareorep combo therapy survived at least two years compared with 33% in the control group. The study also reported a longer progression-free survival of 12.1 months upon treatment with the investigational combo therapy compared with 6.4 months for paclitaxel alone, which represents a benefit of 5.7 months.
Year to date, shares of Oncolytics have plunged 18.5% compared with the industry’s 2.8% decline.
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ONCY’s Plans for the Future Development of mBC Candidate
Based on the strong efficacy data from the phase II BRACELET-1 study, Oncolyticsplans to conduct another “large” phase II study to support the accelerated approval of pelareorep/paclitaxel combo to treat HR+/HER2- mBC.
Per the company, the impending registrational study will enroll approximately 180 patients with HR+/HER2- mBC who have progressed on antibody-drug conjugates (ADCs) like AstraZeneca AZN and Daiichi Sankyo’s Enhertu, who are not eligible for ADCs, or who cannot tolerate ADCs. This patient population represents approximately 55,000 mBC patients in the United States.
Oncolytics is currently gearing up to submit the planned phase II study design of the pelareorep/paclitaxel combo for the mBC indication to the FDA in early 2025. The company anticipates beginning enrollment in the registrational study in the first half of 2025.
Enhertu, a specifically engineered HER2-directed ADC is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Enhertu is presently approved for advanced or metastatic HER2-positive gastric cancer, previously treated HER2-mutant metastatic non-small cell lung cancer and metastatic HER2-positive and HER2-low breast cancer and solid tumors. Daiichi Sankyo recognizes the U.S. sales of Enhertu, while AstraZeneca records its share of gross profit margin from Enhertu sales under Alliance revenues. In the first six months of 2024, Enhertu generated $683 million in alliance revenues for AstraZeneca.
ONCY’s Pelareorep Studies for Other Cancer Indications
Oncolytics is simultaneously evaluating pelareorep in various cohorts of its GOBLET study, spanning across different stages of development to treat gastrointestinal cancer indications like pancreatic and anal cancers. Upcoming milestones include updated efficacy data from cohort 4 of the GOBLET study, investigating pelareorep and Roche’s RHHBY Tecentriq (atezolizumab) for second-line or later anal cancer, in the first half of 2025.
The company also anticipates reporting initial efficacy results from cohort 5 of the GOBLET study, investigating pelareorep and modified FOLFIRINOX chemotherapy, with or without Roche’s Tecentriq, for newly diagnosed pancreatic cancer, in the second half of 2025. Per Oncolytics, positive results from this cohort could potentially provide an additional registrational opportunity.
Roche’s blockbuster immuno-oncology drug, Tecentriq, is currently approved in the United States, EU and several other countries to treat some of the most aggressive and difficult-to-treat forms of cancer, including advanced lung cancer, urothelial cancer and breast cancer.
Roche’s extensive development program for Tecentriq includes multiple ongoing and planned phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynecological and head and neck cancers.
Oncolytics Biotech Inc. Price and Consensus
Oncolytics Biotech Inc. price-consensus-chart | Oncolytics Biotech Inc. Quote
ONCY’s Zacks Rank and Stock to Consider
Oncolytics currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is ANI Pharmaceuticals ANIP, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 earnings per share have moved up from $4.53 to $4.81. Earnings per share estimates for 2025 have improved from $5.38 to $5.86. Year to date, shares of ANIP have gained 4.9%.
ANIP’s earnings beat estimates in each of the trailing four quarters, the average surprise being 31.32%.
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