Oncolytics Biotech Inc ONCY

Observations from Adlai Nortye Press Release

[Proboscises]

Observations from the Adlai Nortye Press Release

 

 

1. These are very positive results.  Better than I expected to hear at this point.  The PFS and OS data will likely improve over time.  That seems to be the expectation of the President and CMO of Adlai Nortye.  He is quoted as saying expectantly, “We look forward to further characterizing the efficacy and durability of the studied combination as data from the trial mature and to continuing our collaboration with Oncolytics”.
2. These were all second-line advanced/metastatic HR+/HER2- breast cancer patients.   As of the data cut-off date the evolving (meaning, if I’m not mistaken, it can only get better) median progression free survival was 9.1 months.  It would be useful to know what the typical PFS is for second line advanced/metastatic HR+/HER2- breast cancer patients.  Does anyone have that information?
3. Both the Adlai Nortye President and Matt Coffey emphasized the durability of the therapy response.  Adlai Nortye President: “There are also promising signs of pelareorep-paclitaxel combination therapy driving durable clinical benefit, with one patient notably still on study for nearly a year while maintaining a PR.”  Matt Coffey: “We believe Adlai Nortye's latest data significantly de-risk this upcoming readout as they validate IND-213's positive results by confirming the ability of pelareorep plus paclitaxel to drive durable clinical responses in HR+/HER2- breast cancer patients.” Quotes in press releases are always very limited and presumably emphasize the most important things.  In this case both Adlai Nortye and Oncolytics emphasize the durability of the therapy response.  I believe in many cancer indications improved PFS does not necessarily result in improved OS (I.e. durability), however, with pelareorep used in both HR+/HER2- breast cancer patients and pancreatic cancer patients the results seem to indicate improved durability.  Ultimately, improved OS/durability is the most hoped for consequence of a successful cancer therapy.  Thomas Heineman in the pancreatic press release of November 10th also emphasized durability of response.  “We were particularly excited to see a partial response deepen into a confirmed complete response as of the latest data cut, since this further indicates potentially durable anti-cancer effects from the combination therapy."
4. In the press release both IND-213 and BRACELET-1 are mentioned in the context of improving OS.  BRACELET-1 in particular is highlighted in the final two paragraphs of this press release.  Matt wants to draw attention to this trial because though it is randomized it is not blinded and therefore ONC and Pfizer both know the real-time results.  The strong expectation is that the BRACELET-1 trial will show strong OS results, presumably because ONC is seeing this in real time and lengthening the time of the overall data release to June 2023 will give more opportunity for the OS to show itself.  I personally think the ASCO Annual Meeting in Chicago from June 2-6 is the most likely time for ONC to release the data as this is the largest and most prestigious of all clinical oncology meetings.  Pfizer will know the results prior to the ASCO meeting and on that knowledge may be inclined to make a partnership/buy-out offer prior to ASCO (perhaps much earlier).  Likewise Roche has the Pancreatic results using their check-point inhibitor in combination with chemo and Pela and they may want to make a partnership/buyout bid earlier than Pfizer.  We can’t know how this will play out in the context of dynamic negotiations with one or two or more potential partners/purchasers, but the competitive tension is there to work in favour of ONC/Y making a good deal.  I suggest sticking to the big picture and what we know and not sweating the small stuff.
5. A final comment from the end of the press release: “A copy of the SABCS poster (P3-07-04), entitled, A Multicenter, Single-Arm, Open-Label Phase I Study of AN1004 (Pelareorep) Oncolytic Virus Plus Paclitaxel in Chinese Patients with Hormone Receptor-Positive and HER2-Negative Advanced/Metastatic Breast Cancer (REO 026-1), will be available on the Posters & Publications page of Oncolytics' website (LINK) following the conclusion of the symposium.”  It appears likely to me that policy of the conference is to not permit the public release of posters until the end of the conference.  If so, this would apply to the AWARE-1 poster as well.  So the angst of some regarding the non-release of the poster was unnecessary.  Happily ONC/Y did the same trick in this conference as in the SITC conference where they published a photo in twitter of their staff at the conference with the poster in the background.
6. Stay calm and carry on.