Oncolytics Biotech Inc T.ONC

RE:Oncolytics Biotech Announces Key Progress & Upcoming Studies

[Noteable]

Thomas Heineman confirmed that the upcoming (next) Phase 2 mBC and pancreatic cancer registrational clinical trials will also pursue the early approval  Accelerated Approval pathway.

Heineman stated that : " After discussions with key opinion leaders, our biopharma collaborators and the FDA, we have identified an approach that can generate primary endpoint results within two years of the start of patient enrollment accordingly our next planned breast cancer study is anticipated to be a registration enabling large phase two study of around 180 HR positive or two negative metastatic breast cancer patients.

We would use progression free survival as a primary endpoint, and would power the study to achieve a phase three level of success if the expected clinical benefit is achieved as Pela based therapy demonstrates a progression free survival benefit comparable to that seen with [Bracelet-1] we anticipate seeking licensure, potentially through the accelerated approval pathway.

This approach has been used to achieve the initial approvals of other breast cancer treatments, including Pfizer's Ibrance and [Daichii Sanyo's Enhertu]. We believe this is a cost effective and efficient strategy for the development of pellet and breast cancer."

Heineman stated in the Q3 2024 Conference Call: " Our main priorities are to advance our planned registrational studies in breast and pancreatic cancer." ...." our next planned breast cancer study is anticipated to be a registration enabling large phase two study of around 180 HR positive/ HER2 negative metastatic breast cancer patients."

Thomas Heineman continued -- "I would now like to move to the Goblet study and our opportunity in gastrointestinal cancers. So far, we have evaluated Pela based therapies in first line metastatic pancreatic ductal adenocarcinoma or PDAC, third line metastatic colorectal cancer and second line, or later anal cancer.

Despite the difficulty of treating these specific cancers, Pela based combination therapy met the initial predefined efficacy success criteria for each of these indications.

Our highest priority in GI cancer is pancreatic cancer. We've seen exciting efficacy signals in previous studies, and the objective response rates were reported in the pancreatic cancer cohort of the goblet study was more than double historical objective conference.

The strength of these results attracted the attention of multiple potential partners. One of these collaborators is the global global coalition for adaptive research, or GCAR, which specializes in the design and conduct of cost effective, innovative, adaptive clinical trials intended to support licensure.

We are currently collaborating with GCAR to develop an adaptive registration and labeling study to evaluate Pela based combination therapy and metastatic PDAC, and we expect to seek with  GCAR FDA guidance on study design.

We look forward to continuing our collaboration with GCAR on this exciting opportunity, and we will provide an update in this program advances. As a compliment to our work with GCAR, we also received a $5 million grant from the Pancreatic Cancer Action Network, also known as Pan Can to evaluate a different Pela based combination therapy in PDAC Historically, the two most common standards of care in metastatic pancreatic cancer are the chemotherapy regimens of gemcitabine nappaclitaxel or modified folfirinox. The gemcitabine nab-paclitaxel regimen is the focus of our work with GCAR, while the PAN CAN  grant is funding the evaluation of pela combined with modified folfirinox. This is an attractive opportunity, because as pela based therapy demonstrates benefits when combined with both commonly used chemotherapy regimens, it may lead to improved therapeutic options for nearly all metastatic pancreatic cancer patients.

Earlier this year, we announced the dosing of the first patient in the new goblet cohort evaluating Pella combined with modified folfirinox.Enrollment into this cohort of the GOBLET study is ongoing, and we will provide additional updates when they become available."

 

Registrational enabling effectively means a drug is completely ready for filing for full approval.

Accelerated Approval provides for a drug to receive a conditional FDA marketing approval based on surrogate endpoints that have demonstrated a clinical benefit, An Accelerated Approval is granted well before a Registrational BLA is filed, and an AA requires the sponsor to run a confirmatory clinical trial on which the FDA decides to grant full marketing approval. The FDA's full marketing approval follows the sponsor registering (filing) a Biological Licensing Application (BLA) on the final results of the confirmatory / registration enabling clinical trial.

Registration Enabling Clinical Trial means (a) a hyman clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amemded, and is intended to (i) establish that the productis safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associate with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory authorities in a country other than the United States.