Scienza e Tecnologia
Oncolytics Biotech® Reports First Quarter 2023 Financial Results and Operational Highlights
SAN DIEGO, Calif. and CALGARY, AB , May 5, 2023 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the first quarter ended March 31, 2023 . All dollar amounts are expressed in Canadian currency unless otherwise noted.
"Our core programs in breast and pancreatic cancer are moving towards registrational studies with compelling clinical data and important milestones expected this year," said Dr. Matt Coffey , President and Chief Executive Officer. "The first of these milestones will come later this month when we report data from BRACELET-1, a randomized phase 2 trial expected to inform the design of a subsequent pivotal registrational study in HR+/HER2- metastatic breast cancer. Stakeholders across the breast cancer community have demonstrated a keen interest in this readout, which will add to a dataset that already includes statistically significant phase 2 results showing pelareorep's ability to drive a robust overall survival benefit in this indication. Notably, the BRACELET-1 abstract was selected for an oral presentation at the upcoming ASCO meeting, providing a highly prestigious venue to discuss the results with potential partners and the clinical community."
Dr. Coffey continued, "Looking into the second half of 2023, we expect to report updated results from GOBLET's first-line pancreatic cancer cohort and provide guidance on the optimal registration paths for our breast and pancreatic cancer programs. With these programs both targeting large markets with significant clinical unmet needs and supported by robust clinical proof-of-concept data, we believe confirming their paths towards approval will represent important value-creating events and substantially de-risk and maintain pelareorep's development pathway."
BRACELET-1 is designed to confirm and expand upon Oncolytics' prior positive clinical results for pelareorep in HR+/HER2- metastatic breast cancer and inform the design of a subsequent registrational study. These prior data include phase 1 results demonstrating pelareorep's single-agent activity, as well as randomized phase 2 data that showed a statistically significant near doubling of median overall survival in patients treated with pelareorep combined with paclitaxel compared to those treated with paclitaxel monotherapy. Additionally, data from early-stage HR+/HER2- breast cancer patients demonstrated pelareorep's ability to stimulate anti-tumor immunity, remodel tumor microenvironments, and potentially improve patient prognosis by decreasing the risk of cancer recurrence score.
BRACELET-1 includes cohorts evaluating paclitaxel monotherapy, paclitaxel plus pelareorep, and paclitaxel plus pelareorep in combination with avelumab in HR+/HER2- metastatic breast cancer. The trial was designed to enroll a total of 48 patients and is not powered to detect statistical significance. An abstract corresponding to the upcoming oral presentation will be published by ASCO on May 25, 2023 , at 5:00 p.m. ET . The oral presentation will take place on June 3, 2023 , during a session being held from 2:15 p.m. – 3:45 p.m. ET .
The poster, titled "Efficacy of function-enhanced, re-activatable, dual-specific CAR T cells pre-loaded with oncolytic virus for immunotherapy of high-grade glioma," will be presented in Poster Hall A from 2:15 p.m. – 5:15 p.m. ET on June 3, 2023 . The corresponding abstract will be published prior to the ASCO meeting, on May 25, 2023 , at 5:00 p.m. ET .
The data to be presented at the ASCO meeting follow preclinical results published in ( ), which showed pelareorep synergistically enhancing the efficacy of CAR T cell therapy in murine solid tumor models (link to PR, link to the paper). Oncolytics is currently advancing preclinical research collaborations evaluating pelareorep-CAR T cell combination therapies, one of which has generated results with a potential partner's own CAR T constructs that are in-line with those published in the publication.
Oncolytics will host a key opinion leader (KOL) webinar on June 5, 2023 at 8 a.m. ET , where KOLs and the Oncolytics management team will discuss recent data from the BRACELET-1 study. A live question and answer session will follow the formal presentation.
To register for the webinar, please click here.
Management will host a conference call for analysts and investors at 8:30 a.m. ET today, May 5, 2023 . To access the call, please dial (888) 664-6383 ( North America ) or (416) 764-8650 (International) and, if needed, provide confirmation number 3550-3191. To join the conference call without operator assistance, please click here. A live webcast of the call will also be available by clicking here or on the Investor Relations page of Oncolytics' website (LINK) and will be archived for three months. A dial in replay will be available for one week and can be accessed by dialing (888) 390-0541 ( North America ) or (416) 764-8677 (International) and using replay code: 503-191#.
(in thousands of Canadian dollars, except share amounts)
Issued: March 31, 2023 – 63,990,950
December 31, 2022 – 61,327,914
(in thousands of Canadian dollars, except share amounts)
(in thousands of Canadian dollars)
(in thousands of Canadian dollars)
Oncolytics is a biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. This compound induces anti-cancer immune responses and promotes an inflamed tumor phenotype -- turning "cold" tumors "hot" -- through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with immune checkpoint inhibitors and may also be synergistic with other approved oncology treatments. Oncolytics is currently conducting and planning clinical trials evaluating pelareorep in combination with checkpoint inhibitors and targeted therapies in solid and hematological malignancies as it advances towards registration studies in metastatic breast cancer and pancreatic cancer. For further information, please visit: www.oncolyticsbiotech.com.
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Director of IR & Communication
+1-858-886-7813
jpatton@oncolytics.ca
LifeSci Advisors
+1 - 917-679-9282
tim@lifesciadvisors.com
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