Oncolytics Biotech Inc. (ONCY:NASDAQ; ONC:TSX) may be shifting priority focus for its proprietary oncolytic reovirus formulation pelareorep to pancreatic cancer from breast cancer, based on "several lines of evidence," reported Dr. Douglas Loe, managing director and analyst at Leede Financial Inc., in a July 9 research note.
"Consolidated pancreatic cancer survival data support our view that [pancreatic cancer] could/should be Oncolytics' lead indication," Loe wrote.
Along with breast and pancreatic, pelareorep is being tested in several Phase 2 cancer trials, including multiple myeloma.
283% Return Implied
Leede Financial reiterated its CA$5.25 per share one-year price target on the Canadian biotech firm, trading at about CA$1.37 per share at the time of Loe's report, noted the analyst. From this price, the return to target is 283%.
Oncolytics is a Speculative Buy.
Compelling Survival Data
The Alberta-headquartered biotech released a summary of its survival data from some published Phase 1/2 clinical studies evaluating pelareorep in pancreatic cancer, reported Loe. According to the results, use of pelareorep in combination with other standard-of-care therapies such as paclitaxel, "was associated with a survival benefit that, if replicated in a controlled pivotal Phase 3 advanced pancreatic study, would have a nontrivial chance of clinical and regulatory success," the analyst wrote.
Oncolytics pointed out that median progression-free survival for patients treated with a pelareorep-paclitaxel combination was 12.1 months versus 6.4 months for paclitaxel alone. In contrast, median progression-free survival was lowest at 5.8 months for pelareorep-paclitaxel when combined with Bavencio.
In his report, Loe presented other positive pelareorep survival clinical trial data:
1) Data from the ongoing, 55-patient pancreatic cancer cohort of the GOBLET trial showed a 62% overall response rate, an 85% disease control rate and a 45% one-year survival rate, in 13 evaluable subjects.
2) Data from a Phase 2 trial published in 2023 in the British Medical Journal reported a clinical benefit rate of 42% (one partial responder, four other patients with stable disease) when pelareorep was combined Keytruda.
3) Data from an 11-patient Phase 1b trial published in 2020 in Clinical Cancer Research showed disease control in three of 10 evaluable subjects, with one partial response lasting for 17.4 months, for patients treated with a combination of pelareorep, Keytruda and one or more small-molecule anti-cancer agents often used in pancreatic cancer therapy (5-fluorouracil, gemcitabine or irinotecan).
4) Data from a 34-patient Phase 2 trial published in 2018 in Cancers demonstrated that pelareorep, used in combination with gemcitabine, Abraxane or FOLFIRINOX (leucovirin, 5-fluorouracil, irinotecan and oxaliplatin), resulted in a median overall survival of 10.2 months, with a one- and two-year survival rate of 45% and 24%, respectively.
5) Data from a 73-patient Phase 2 advanced pancreatic cancer trial published in 2016 in Molecular Therapy showed no differences in progression-free survival in patients treated with paclitaxel-carboplatin chemotherapy and in patients treated with paclitaxel-carboplatin plus pelareorep (4.9 months versus 5.2). However, one- and two-year overall survival rates were more impressive for pelareorep-treated patients at 34% and 20%, respectively, compared to control patients (28% and 6%).
Breast Cancer Indication
Loe reported that just as for pancreatic cancer, Phase 2 data from the evaluation of pelareorep as a treatment for breast cancer were positive. In fact, Phase 2 breast cancer data from Oncolytics' 48-patient BRACELET-I trial, published just this month in Clinical Cancer Research, again showed that combination pelareorep-paclitaxel positively affected breast cancer survival in a reproducible way, unlike other pelareorep-containing chemotherapy regimens. As such, Oncolytics likely will test pelareorep-paclitaxel in at least one study arm in a future metastatic breast cancer Phase 2/3 trial.
Despite the positive data, the analyst noted, the breast cancer arena already is well-populated by small molecule cyclin-dependent kinase inhibitors, including Ibrance, and other drugs with a similar mechanism of action, making it a less attractive primary indication.
Look at Revised Model
Leede Financial revised its model on Oncolytics to reflect advanced pancreatic cancer as Oncolytics' lead indication for pelareorep, and this only minimally affects the financial services firm's estimated timelines to approval by the U.S. Food and Drug Administration (FDA), reported Loe. In the model, Phase 2/3 testing in pancreatic cancer is completed by year-end 2028, and FDA approval and commercial launch by future partners follow in H2/29.
The model still has Oncolytics receiving royalty payments from future partners at a royalty rate of 23% and still has a single course of therapy costing US$20,000, which is conservative, Loe noted.
Leede Financial's model assumes that Oncolytics will explore HER2-negative/hormone receptor-positive metastatic breast cancer as a secondary pelareorep indication, the analyst wrote.
"Phase 2 performance of pelareorep-paclitaxel has been sufficiently positive in our view to justify advanced testing in this indication, but we expect Oncolytics to proceed more cautiously on this indication at least until cash-contributing codevelopment partners can be identified," added Loe.
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