Below are quotes in chronological order from the March 3, 2023 conference call. Coffey, Heineman, and de Guttadauro are all speaking from up-to-date data from the BRACELET-1 trial since the trial is open label (https://clinicaltrials.gov/ct2/show/NCT04215146)
. Open label means that all the parties involved in the trial know what treatment each patient is receiving. As a financier of and collaborator in the trial ONC will be staying informed of patient results in real-time.
From these comments I think we can draw the following points:
- Based on what they are seeing in real time (as of one month ago) ONC anticipates positive results from BRACELET-1.
- Positive results in one or two pela arms would represent a second randomized trial validating IND213. Matt emphasized this point in his Mar. 7th podcast as well.
- A second validation of pela in HR+HER2- breast cancer de-risks pela. Likewise, the Adlai Norte results and the known mechanism of action from AWARE-1 also validate plea’s safety and efficacy. The fact of a strong signal that pela works in pancreatic cancer as well as mBC also validates (and further de-risks) pela. The positive pre-clinical results of pela with other immuno-therapeutic regimes like CAR-T further undergirds the broad applicability of pela.
- The BRACELET-1 results as they mature are key. ORR and especially PFS typically give a strong signal in mBC, but increased OS is the ultimate goal. As of March 3rd there continue to be patients who have not progressed and who are therefore still receiving therapy. As the data matures the ultimate OS comes more and more into focus. ONC has repeatedly given the H2 readout at an important oncology meeting (ASCO June 2-6) as a key moment. This suggests ONC expects that by June the data will be sufficiently mature to give a compelling signal on which to base a partnership (or buyout) and initiate registration trials. I personally hypothesize that while ONC is now conversing and sharing data with multiple BPs under confidentiality agreements it will not be until they deem the data sufficiently optimal that ONC will initiate an active bidding process for ONC. Until then I believe all parties with confidentiality agreements will do their utmost to honour those agreements. I don’t expect news of a deal until a deal is officially announced.
- ONC will not “sell themselves short” by rushing a deal. They will wait until the maturing data is optimally compelling. It is not a good look to be anxious and panicking, nor is it strategically smart. A calm, deliberative, and methodical approach is the way to go and the way that ONC is implementing.
Quotes from the March 3, 2023 Year-end Conference Call
Matt Coffey:
Last year, we completed enrollment in the program’s second randomized Phase 2 trial, BRACELET-1, which is approaching a crucial data readout that we anticipate sharing at a major medical meeting next quarter. We expect this readout, which Tom and Andrew will discuss in more detail to provide key data that will validate the program’s prior positive results and help inform the design of subsequent registrational trial.
With all these data in place, we believe a successful outcome from BRACELET-1 would represent a key inflection point for our breast cancer program as it would clear the way for pela’s advancement into a registrational study and bolster our business development activities.
Thomas Heineman:
At a medical meeting next quarter, we anticipate reporting progression-free survival and tumor response results from this trial, which was designed to enroll a total of 48 patients. While enrollment into BRACELET-1 is complete, it should be noted that many patients continue to be followed for critical endpoints. Accordingly, some key results of the study, including overall survival will only come into focus as the data mature.
A successful result from the trial would therefore be one or both of the cohorts that include pela numerically outperformed the paclitaxel monotherapy arm. Achieving this result would result in a second randomized dataset supporting pela’s ability to deliver meaningful clinical benefit to HR-positive HER2-negative breast cancer patients further derisking our program as we move towards a registrational study.
Andrew de Guttadauro:
That said, I’ll again note that our ongoing interactions with prospective partners have indicated that showing meaningful data from BRACELET-1 would be a critical step towards reaching a deal. This is not surprising as a successful outcome from BRACELET-1 together with IND-213’s statistically significant results would give us two randomized data sets demonstrating pela’s ability to drive clinical benefit in HR-positive HER2-negative metastatic breast cancer patients.
As we look toward BRACELET-1’s anticipated readout next quarter, I should emphasize that we will continue to advance in a deliberate manner as the overall survival Tom mentioned matures.
With several patients still receiving treatment, there is an opportunity for a truly impressive endpoint that we could sell ourselves short if we rush into a deal prematurely based on data that could improve over time. With industry leaders such as Pfizer, Roche, Merck Serono, Bristol-Myers Squibb and Insight already familiar with pela thanks to collaborative clinical trials, we intend to run a methodical and competitive process that ensures we reach the best possible outcome for our shareholders.
Many of the key pieces needed to achieve our BD goals already in place, thanks to our current data and breast of pancreatic cancer, and we expect that the continued execution of our clinical regulatory strategy will bring us to a successful outcome.
Matt Coffey:
In our HR-positive, HER2-negative breast cancer program, the continued advancement of BRACELET-1 has us closing in on a critical data readout that if positive will bolster our BD prospects and accelerate pela’s path into a registrational study in this indication.
Andrew de Guttadauro:
Pfizer has a period of review where they can review the data before it can be shared with anybody else under confidentiality. That period is over. But that doesn’t mean that Pfizer isn’t still looking at the data because the data is still maturing as Tom mentioned. So, we are now outside that period, so we can under confidentiality agreement, also share the data with other parties besides Pfizer.
And I think it’s the fact that you have two shots on goal actually strengthens both your credibility of the data overall, but also allows you to basically drive more interest. So, there are certainly certain companies that are breast or in GI cancers that have more of a bias towards one or the other. But I would say anybody who is interested in one is also asking about the other. I have yet to see anybody who just wants to review panc or breast.