Oncolytics Biotech Inc T.ONC

Adlai Nortye Phase 2 Pela/Pax study could lead to US BLA

[Noteable]

What Adlai Nortye may be acheiving in conducting the Phase 2/3 Pelareorep - Paclitaxel cross over 'bridging' mBC study in China is the enrollment of sufficiently enough patients that satisfies the FDA SPA which ONCY gained several years ago.

The FDA SPA pointed  to ONCY being able to file an FDA regulatory BLA for marketing approval if a set number of patients were studied in the metastatic breast cancer indication.

It would appear that Adlai Nortye's efforts in China with the Pelareorep-Paclitaxel Phase 2/3 'bridging' study will meet the FDA's guidance for product registration filing in the US, especially now that US regulators are "willing to accept Chinese data if it meets global quality standards". The FDA standard appears to be being met with the Pelareorep-Paclitaxel study.   

In a recent Clinical Leader report it was specifically noted that "In addition to decreasing approval timelines in China, U.S. regulators are willing to accept Chinese data if it meets global quality standards. Drug developers will increasingly pursue simultaneous pre-IND meetings with both the U.S. FDA and China NMPA."

https://www.clinicalleader.com/doc/report-reflects-huge-growth-of-clinical-trials-in-china-0001  

A biologics license application (BLA) must include sufficinet material and data for the Food and Drug Administration (FDA) to determine that the biological product is safe and effective for each proposed indication and this requirement is being met by the Adlai Nortye study in China.

Adlai Nortye communicated their Phase 3 intention of the Pelareorep study in its March 2019 press release entitled 'Adlai Nortye Receives NMPA Approval for Pelareorep Phase III Clinical Trials' which stated that : "In the presentation of pelareorep clinical data, additional randomized phase II data in (meta)static breast cancer demonstrates doubling (21.8 months vs. 10.8 months) of overall survival in Hormone Receptor Positive (ER+PR+)/HER2- patients. Pelareorep has received Fast Track designation and Special Protocol Assessment Agreement for Phase III Clinical Trial from FDA for the treatment of (meta)static breast cancer."

[Noteable]

What this all means is that Adlai Nortye's Phase 2/3 'bridging' Pelareorep-Paclitaxel study in metastatic breast cancer could directly lead to the simultaneous regulatory BLA filing with the FDA and China's NMPA for the marketing approval of Pelareorep and this filing could occur in advance of the conclusion of this Adlai Nortye study since the FDA accepts a rolling submission as

[westcoast1000]

Good work in diggning this info out and reminding us all of where we are going and the significance of the Adlai trial. Thanks.

[Normandt1965]

I love it.

[lonc17]

Too bad many of the interesting numbers have been redacted.   https://www.sec.gov/Archives/edgar/data/1129928/000112992818000028/ex444regionallicensingagre.htm I think that this Adlai thing has not been correctly priced into ONC's SP.  Hopefully the market will catch up and recognize that Adlia is moving along swiftly. 

[Noteable]

The FDA provides for the filing of Biological Licensing Applications (BLAs) for USFDA marketing approval based solely on foreign data. The FDA's Code of Federal Regulations Title 21, Vol, 5 (314) (D) (Sec 314.106)(b) states the following: PART 314 -- APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Subpart D - FDA Action on Applications and Abbreviated Applications Sec