Scienza e Tecnologia
Oncolytics Biotech® Reports Third Quarter 2022 Financial Results and Recent Operational Highlights
SAN DIEGO and CALGARY, AB , Nov. 7, 2022 /PRNewswire/ -- Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) today announced recent operational highlights and financial results for the third quarter ended September 30, 2022 . All dollar amounts are expressed in Canadian currency unless otherwise noted.
"Our continued progress in breast cancer and the highly-promising pancreatic cancer data we reported earlier today have pelareorep moving confidently towards pivotal trials in both of these indications for which new treatment options are needed," said Dr. Matt Coffey , President and Chief Executive Officer of Oncolytics Biotech Inc. "In breast cancer, we remain on track to report an expansive dataset from our randomized BRACELET-1 trial in the first half of next year. This phase 2 trial was carefully designed to validate the statistically significant survival benefit provided by pelareorep in a prior phase 2 study, and its results are expected to inform the optimal design of a subsequent registrational trial. In pancreatic cancer, we plan to discuss our new data with regulators to enable the program's expeditious advancement into a pivotal study. With these core programs each representing a potential registration opportunity and distinct avenue for value creation, we believe we are entering a new phase in Oncolytics' evolution."
An abstract published as part of the SITC Meeting, and highlighted in a separate press release issued earlier today, features data from the phase 1/2 GOBLET trial's cohort in first-line advanced/metastatic pancreatic ductal adenocarcinoma, one of the most difficult-to-treat human cancers. As of the abstract's data cutoff date ( July 28, 2022 ), seven of ten evaluable patients had achieved a partial response following treatment with pelareorep in combination with atezolizumab and the chemotherapeutic agents gemcitabine and nab-paclitaxel. An additional two patients achieved stable disease, leading to an ORR and clinical benefit rate of 70% and 90%, respectively. The 70% ORR reported as of the cutoff date is nearly triple the average ORR of approximately 25% reported in historical control trials evaluating the combination of gemcitabine and nab-paclitaxel in pancreatic cancer . Together with data from prior clinical studies, these results suggest pelareorep synergizes with checkpoint inhibition and chemotherapy in pancreatic cancer and support Oncolytics' plan to advance into a registrational pancreatic cancer study pending discussions with regulatory authorities.
An abstract published earlier today as part of the Society for Immunotherapy of Cancer (SITC) 37 Annual Meeting features new data on the twenty HR+/HER2- breast cancer patients comprising the first two cohorts of the AWARE-1 study. Patients in these cohorts were treated with pelareorep and letrozole without (cohort 1) or with (cohort 2) Roche's anti-PD-L1 checkpoint inhibitor atezolizumab. Flow cytometry analyses of blood samples from these patients showed a statistically significant increase in anti-cancer NK cells on day 21 post-treatment in cohort 2 compared to cohort 1. In addition, cohort 2 patients showed higher levels of HLA-DR expression (a marker of T cell activation) in anti-cancer CD8+ T cells, and better maintained low levels of T cell exhaustion markers on day 21 compared to cohort 1 patients. Together with prior clinical data, these results further demonstrate pelareorep's immunologic mechanism of action and its potential to synergistically combine with a variety of drug classes.
Mr. Rigby has over thirty years of pharmaceutical and biotechnology industry experience. He is currently the Group Chief Executive Officer of Revolo Biotherapeutics and previously co-founded Zogenix, Inc., a CNS-focused specialty pharmaceutical company that was acquired by UCB earlier this year in a transaction valued at up to approximately U.S. $1.9 billion .
Issued: September 30, 2022 – 58,706,442
December 31, 2021 – 55,043,789
Management will host a conference call for analysts and institutional investors at 8:30 a.m. ET today, November 7, 2022 . To access the call, please dial (888) 664-6383 ( North America ) or (416) 764-8650 (International) and, if needed, provide confirmation number 4240-6541. 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: 406-541#.
1. Von Hoff D et al. N Engl J Med 2013; 369:1691-1703 DOI: 10.1056/NEJMoa1304369
2. O'Reilly et al. Eur J Cancer. 2020 June; 132: 112–121. DOI:10.1016/j.ejca.2020.03.005
3. Karasic et al. JAMA Oncol. 2019 Jul 1 ; 5(7):993-998. DOI: 10.1001/jamaoncol.2019.0684
4. Tempero et al. Ann Oncol. 2021 May; 32(5):600-608. DOI: 10.1016/j.annonc.2021.01.070
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.
Director of IR & Communication
+1-858-886-7813
jpatton@oncolytics.ca
LifeSci Advisors
+1 - 917-679-9282
tim@lifesciadvisors.com
View original content:https://www.prnewswire.co.uk/news-releases/oncolytics-biotech-reports-third-quarter-2022-financial-results-and-recent-operational-highlights-301669591.html