Oncolytics Biotech® Doses First Patient in Study of Pelareorep/FOLFIRINOX Combination Therapy in Pancreatic Cancer
Oncolytics Biotech has dosed the first patient in the GOBLET study cohort, which assesses the combination of pelareorep and modified FOLFIRINOX (mFOLFIRINOX) with or without atezolizumab in newly diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) patients. The study, funded by a US$5 million grant from PanCAN’s Therapeutic Accelerator Award, aims to evaluate the objective response rate (ORR) and safety of this combination therapy. This collaboration involves AIO-Studien-gGmbH and is part of a larger Phase 1/2 multiple indication study for gastrointestinal cancers. The outcomes could potentially lead to the development of new pancreatic cancer treatment regimens.
- Dosing of first patient in the new GOBLET study cohort.
- US$5 million funding from PanCAN's Therapeutic Accelerator Award.
- Potential expansion of pelareorep-based therapies for pancreatic cancer.
- Collaboration with AIO-Studien-gGmbH as part of a larger Phase 1/2 study.
- Objective response rate (ORR) and safety are primary endpoints.
- None.
Insights
The initiation of the dosing for the new cohort in the GOBLET study is a promising advancement. Pancreatic ductal adenocarcinoma (PDAC) is one of the most aggressive cancers with limited treatment options. The combination therapy involving pelareorep and modified FOLFIRINOX, with or without atezolizumab, aims to improve the objective response rate (ORR) and safety profile in newly diagnosed metastatic PDAC patients. The previous combination of pelareorep and atezolizumab showed a significant increase in tumor response rates compared to chemotherapy alone, suggesting a potential improvement in patient outcomes.
The fact that the study is supported by a
For retail investors, it is noteworthy that this trial could pave the way for additional registration programs, thus potentially enhancing the company’s product pipeline and market position in oncology treatments.
From a financial perspective, the news underscores Oncolytics Biotech Inc.'s strategic direction and potential for future growth. The dosing of the first patient in this new cohort signifies progress in the company's clinical trials, which could lead to new marketable treatments. The
Investors should note that successful trial outcomes could result in the expansion of Oncolytics’ marketable drug portfolio, enhancing revenue streams. Additionally, the potential FDA Fast Track Designation and collaboration with the Global Coalition for Adaptive Research (GCAR) may expedite the approval process, reducing the time to market for new treatments. This could positively impact the company's financial health and stock valuation in the long term.
Short-term fluctuations in stock price may occur depending on interim trial results and market reactions. Therefore, while the news is optimistic, investors should remain cautious and monitor the trial's progress closely.
The clinical trial's focus on combining pelareorep with mFOLFIRINOX, with or without atezolizumab, is innovative as it aims to exploit potential synergistic effects. Synergy in drug combinations can substantially improve therapeutic outcomes, especially in a tough-to-treat cancer like metastatic PDAC. The study's design, which includes both objective response rate (ORR) and safety as co-primary endpoints, is meticulously crafted to provide a comprehensive evaluation of the therapy's efficacy and tolerability.
Pelareorep, an oncolytic virus, works by selectively infecting and destroying cancer cells while stimulating the immune system. Modified FOLFIRINOX, a potent chemotherapeutic regimen, is considered the best option for many PDAC patients. Adding atezolizumab, an immune checkpoint inhibitor, can potentially enhance the overall immune response against cancer. This combination could address multiple mechanisms of tumor growth and resistance, potentially leading to significant clinical benefits.
For investors, understanding the scientific rationale and innovative approach of this trial can offer insights into the potential of Oncolytics' pipeline. Successful results could not only benefit patients but also position the company as a leader in the field of oncolytic virus-based immunotherapies.
Demonstrating pelareorep's synergy with modified FOLFIRINOX +/- atezolizumab in pancreatic cancer could expand the number of patients it may benefit
Funding for the study comes from the
"Initiation of dosing in the mFOLFIRINOX cohort of the GOBLET study is an important milestone for Oncolytics, and we're excited to begin evaluating another pelareorep combination therapy that could result in a second pancreatic cancer registration program for the company," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "The combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer patients more than doubled tumor response rates compared to earlier trials of chemotherapy alone. That combination received Fast Track Designation from the FDA and is expected to be evaluated in an adaptive registration-enabling trial through the Global Coalition for Adaptive Research (GCAR). If the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, we could have two pancreatic cancer treatment regimens on the path to registration. I want to highlight PanCAN's important support for this program with gratitude. The
Anna Berkenblit, MD, MMSc, Chief Scientific and Medical Officer at PanCAN said, "Working toward our vision to create a world in which all patients with pancreatic cancer will thrive, PanCAN launched the Therapeutic Accelerator Award to speed the drug development process and bring new options to patients faster. Dosing the first patient in this new cohort of the GOBLET study is an important step toward further evaluation of this investigational immunotherapeutic approach."
Dirk Arnold, M.D., Ph.D., Director of Asklepios Tumorzentrum Hamburg and primary investigator of the GOBLET trial commented, "I have been pleased to observe the strength of the clinical response data for pelareorep in multiple cohorts of the GOBLET gastrointestinal study, especially in pancreatic and anal cancer. mFOLFIRINOX is currently considered the best treatment option for many pancreatic cancer patients. Therefore, the evaluation of pelareorep and mFOLFIRINOX, with or without atezolizumab, presents an important opportunity to identify a novel therapeutic approach that may broaden the population of metastatic pancreatic cancer patients who could benefit from pelareorep-based therapies."
"Oncolytics is in a favorable position as we prepare to advance multiple pelareorep programs toward registration track studies and continue to expand pelareorep's potential as a backbone immunotherapy that can impact various tumor types. The collaboration with GCAR on a registration-enabling study for the combination of pelareorep, atezolizumab, gemcitabine, and nab-paclitaxel in pancreatic cancer, meeting with the FDA to align on next steps for our breast cancer program, expanded enrollment in the GOBLET anal cancer cohort, and now the initiation of dosing in the mFOLFIRINOX cohort of GOBLET, announced today, are all important elements of our corporate plan," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics. "The ability to improve the lives of cancer patients is something that motivates everyone at Oncolytics, and beginning to treat pancreatic cancer patients in the mFOLFIRINOX cohort of GOBLET is hopefully yet another step towards that goal."
About GOBLET cohort 5
The mFOLFIRINOX cohort of the Phase 1/2 GOBLET study is designed to evaluate newly diagnosed PDAC patients treated with pelareorep + mFOLFIRINOX with or without atezolizumab. There will be a three-patient safety run-in to evaluate the tolerability of each treatment arm: pelareorep + mFOLFIRINOX + atezolizumab and pelareorep + mFOLFIRINOX. A total of fifteen evaluable patients will be randomized to each arm in Stage 1 of this Simon two-stage study. The co-primary endpoints are objective response rate and safety. If Stage 1 success criteria are met, one or both treatment arms may be expanded to Stage 2 in which 17 additional evaluable patients per arm will be enrolled. Blood and tumor samples will also be collected for translational evaluations.
About GOBLET
The GOBLET (Gastrointestinal tumOrs exploring the treatment comBinations with the oncolytic reovirus peLarEorep and anTi-PD-L1) study is a phase 1/2 multiple indication study in advanced or metastatic gastrointestinal tumors. The study is being conducted at 17 centers in
- Pelareorep in combination with atezolizumab, gemcitabine, and nab-paclitaxel in 1st line advanced/metastatic pancreatic cancer patients;
- Pelareorep in combination with atezolizumab in 1st line MSI (microsatellite instability)-high metastatic colorectal cancer patients;
- Pelareorep in combination with atezolizumab and TAS-102 in 3rd line metastatic colorectal cancer patients
- Pelareorep in combination with atezolizumab in 2nd line advanced and unresectable anal cancer patients; and
- Pelareorep in combination with mFOLFIRINOX with and without atezolizumab in newly diagnosed metastatic PDAC patients.
Any cohort meeting pre-specified efficacy criteria in Stage 1 may be advanced to Stage 2 and enroll additional patients.
About AIO
AIO-Studien-gGmbH (AIO) emerged from the study center of the medical oncology working group within the German Cancer Society (DKG). AIO operates with a non-profit purpose of promoting science and research with a focus on medical oncology. Since its foundation, AIO has become a successful sponsor and study management company and has established itself both nationally and internationally.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing 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 multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as "forward-looking statements"). Forward-looking statements contained in this press release include Oncolytics' belief as to the potential, mechanism of action and benefits of pelareorep as a cancer therapeutic; the design, intent and potential benefits of the mFOLFIRINOX cohort of the GOBLET study; our belief that if the combination of pelareorep and mFOLFIRINOX also demonstrates a promising efficacy signal, the Company could have two pancreatic cancer treatment regimens on the path to registration; our corporate plan; the potential for expansion to Stage 2 if Stage 1 success criteria are met; our plans to advance towards registrational studies in metastatic breast cancer and pancreatic cancer; and other statements related to anticipated developments in Oncolytics' business and technologies. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. Such forward-looking statements involve known and unknown risks and uncertainties, which could cause Oncolytics' actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of pelareorep as a cancer treatment, the success and timely completion of clinical studies and trials, Oncolytics' ability to successfully commercialize pelareorep, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. In particular, we may be impacted by business interruptions resulting from COVID-19 coronavirus, including operating, manufacturing supply chain, clinical trial and project development delays and disruptions, labour shortages, travel and shipping disruption, and shutdowns (including as a result of government regulation and prevention measures). We may incur expenses or delays relating to such events outside of our control, which could have a material adverse impact on our business, operating results and financial condition. Investors should consult Oncolytics' quarterly and annual filings with the Canadian and
Company Contact Jon Patton Director of IR & Communication jpatton@oncolytics.ca | Investor Relations for Oncolytics Timothy McCarthy LifeSci Advisors +1-917-679-9282 tim@lifesciadvisors.com |
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SOURCE Oncolytics Biotech® Inc.
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