Needham Conference Highlights
Thanks to several on the Yahoo private board (matdu in particular) for posting highlights of this conference. There were several very interesting comments by CEO Brad Thompson of Oncolytics Biotech.
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Some have posted a few of the highlights on the public board, I am trying to add a few that I think are important to the list:
- More than 500 pts treated so far, with the NCI enrollment approaching 200.
- H&N phase III stage A data read-out should be coming in the near future.
- Some time this quarter, they should be able to come up with a decision on the NSCLC or squamous lung trial to see which one to take into a randomized study.
- Squamous lung trial enrollment is slower than expected, while the panc trials are enrolling faster than thought. Highly indication dependent.
- This quarter: should be able to decide whether to advance the colon trial into a randomized trial.
- H&N phase III : currently registered 13 countries with 12 enrolling. Total centers is 85, going to reach 100. Enrolling rate is expected to reach peak level about now. If they need to enroll 200 more patients in stage b, could accomplish that by the end of the year.
- H&N: PFS is generally a good indicator for OS if the time frame is less than 6 months. It should serve as a good tracking end point for the H&N trial.
- The NCI ovarian trial should complete enrollment by the end of the year, with data coming in Q2 or Q3 next year.
- Prostate trial should complete enrollment by the end of the year.
- Only safety concern with reolysin combo trial is with gemzar, especially with the higher (25%) European dosage.
- Has obtained composition of matter patents for reolysin that expire in 2028. Big pharmas have couple patent challenges but were defended successully by ONCY. My question is were those challenges for reolysin or for other viruses like herpes and vaccinia. It would be even more interesting if these were for non-reo viruses because it could mean that ONCY might have claims on the use of these other viruses for cancer treatment. That could further enhance the value of the company.
- A question on partnership: Bt said he still expects some kind of partnership before launch, but he did mention all these other M&A schemes done in other industries are becoming common in the biotech/pharma field.
- There are 11 bps differences between what ONCY uses in the trials compared to the wt strain.
- Reo appears to evade the immune system by attaching to red
blood cells
- In regards to manufacturing Brad said they can currently put out 100,000 doses per week (in a facility that was specifically build for them). He mentioned that the virus they are producing in these ongoing trial/confirmation runs would be usable for commercial release.
