Onconova Therapeutics, Inc. (NASDAQ:ONTX) Q2 2023 Earnings Call Transcript

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Dr. Steve Fruchtman: So this is — we have two international sites as ISTs participating in this trial. One at Thomas Jefferson in Philadelphia, where one of the world’s experts in RDEB squamous cell resides, Dr. Andrew South and also Dr. Johann Bauer in Austria. Those are two primary sites. Since the results of these trials have been presented, we now have requests to treat patients in Israel, in Chile and Paris, France, and we are doing it on a compassionate use approach. And in discussions with the agency — with the agency specifically, they asked us and we will transition the trials to an Onconova sponsored trial, and again, because these patients may appear anyway, we may have to do it as once a patient is identified anywhere in the world, because these are ultra-rare patients then we would open up a site or perhaps a patient can travel to one of the major medical centers that are expert in RDEB squamous cell.

So the responses have been reported at a major medical meeting. We have what we think is very impressive cutaneous complete remissions, a number of patients since those presentations are now also on the trial in the compassionate use approach. I believe there’s another patient more recently put on a trial at Thomas Jefferson, but those patients are too early for efficacy evaluation, but they continue on either oral or intravenous rigosertib and we look forward that the continuation of rigosertib see an efficacy signal in a larger number of patients. In the interim, we plan, as Victor said, to create a protocol to go back to the agency and get their buy-in on an Onconova sponsored trial, potentially in RDEB squamous cell carcinoma.

Unidentified Analyst: Thanks for clarifying, Steve, and thank you for the updates.

Dr. Steve Fruchtman: Pleasure, Surendar.

Operator: Our next question comes from Robert LeBoyer from Noble Capital Markets.

Robert LeBoyer: Good afternoon. And my question has to do with the melanoma trial going on at Vanderbilt. And I was wondering if you could give any additional details as to the number of patients or the progress that’s been made or any particular data points that might be ahead?

Dr. Steve Fruchtman: So we have not publicly stated how many patients are on that trial. I will mention that in the first cohort is enrolling and that first cohort is, I believe, almost completed. Maybe a little bit too early to evaluate efficacy, so it’s up to three patients at the next cohort. So far, there’s been no safety concerns and the next cohort, obviously, would be at a higher dose of rigosertib, but that trial in the malignant melanoma is quite early in its progress.

Robert LeBoyer: Okay. Thank you very much.

Operator: I am showing no further questions in the queue. At this time, I’d like to turn the call back to Steve for any closing remarks.

Dr. Steve Fruchtman: Thank you again, Operator, and thank all of you for participating in today’s call. We are pleased to be approaching important milestones as we mentioned, across our pipeline and look forward to providing additional updates as they are achieved. Thanks again for participating and for your excellent questions and have a wonderful evening. Thank you again.

Operator: Thank you all for participating in today’s call. This concludes today’s event. You may now disconnect.

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