Oncolytics Biotech Inc T.ONC

ONCY's bought deal to support 2 Phase 3 studies

[Noteable]

... upon the commencement of the Phase 3 study in metastatic breast cancer with pelareorep + paclitaxel a pre-negotiated payment of US$ 85 million will flow to ONCY as part of the deal with Adlai Nortye that gave AN exclusive rights to pelareorep in China and certain Chinese territories .


The announced US$15 million raise will give ONCY the firepower to initiate 2 Phase 3 studies in pancreatic and metastatic breast cancer.

Adlai Nortye has already received approval from the Chinese regulators to run a Phase 3 involving pelareorep and paclitaxel in mBC. 

A Phase 3 in mBC will give ONCY the second trial in ER+/Her2-  mBC that the FDA has sought to validate ONCY's first study that showed pelareorep + paclitaxel doubled patient survival nd which would accelerate the FDA's approval of pelareorep as a single agent in the treatment of this cancer that has an unmet medical treatment need.

The second Phase 3 study involves PanCan who intends to rapidly achieve approval for pelareorep in combination with atezolizumab + gemcitabine + chemotherapy for the treatment of early stage pancreatic cancer

[Noteable]

An Accelerated Approval of the doublet of pelareorep + paclitaxel in the treatment of ER+/Her2- mBC would be based on the already demonstrated surrogate endpoints /  biomarkers of mPFS and mOS that the FDA had directed ONCY to achieve. I have already posted on how this developed and the direction that the FDA is taking in support of the use of surrogate endpoints in accelerating the approval

[westcoast1000]

Well said, Noteable.

[Noteable]

Adlai Nortye's US$85 million payment to ONCY is part of the negotiated licensing agreement  for pelareorep in China and is triggered on the enrollment and treatment of the 50th patient in a Phase 3 breast cancer study.  Since the FDA will permit the patient data from the Phase 2 BRACELET-1 to be rolled into an adaptive ER+/Her2- mBC Phase 3 study, ONCY can roll data from 31 Bracelet

[Noteable]

There is no weakness of any kind, particularly since this cash raise provides a direct pathway to an Accelerated Approval of pelareorep + paclitaxel in mBC along with Adlai Nortye's US$85 million payment to ONCY in the exclusive licensing of pelareorep in China.

[Noteable]

With ONCY undertaking 2 Phase 3 clinical trials and the prospect of rapidly gaining 2 Accelerated Approvals on its own,  helped by the fast changing regulatory environment which is shifting to favor biological I/O companies like ONCY, and with ONCY achieving these approvals on its own, and without a reliance on a Big Pharma, ONCY's acquisition value will ultimately result in a value that

[Noteable]

So having ONCY move forward on conducting 2 Phase 3 clinical trials and then achieving 2 Accelerated Approvals on its own, only adds further value to ONCY as a fully operationally I/O bio-platform company,  with 2 approved indications arising from its platform technology in pelareorep. Such a scenario would make highly valued and sought after by the same Big Pharma companies that we have been