Transcription of The Stock Network Interview with Starpharma (ASX:SPL, US OTC:SPHRY:SPL), Chief Executive Officer, Cheryl Maley
Lel Smits: Starpharma is an innovative biotechnology company advancing dendrima technology from the lab to the patient. The company has recently achieved an important regulatory milestone, receiving positive feedback from the US FDA on the clinical development strategy and phase one first-in-human study design for its DepHer2 radiotherapy program. Starpharma’s CEO, Cheryl Malley, joins me today to discuss the transition from preclinical to clinical development and what comes next from here.
Cheryl, welcome back to the Stock Network.
Cheryl Maley: Thanks, Lel, thanks for having me again.
Lel Smits: Pleasure to have you on and congratulations.
Starpharma has just received FDA alignment on the DepHer2 first in human phase one study design and overall clinical strategy. Can you outline really here what the significance is of this announcement?
Cheryl Maley: Yes, look, Lel, this is a really important announcement for us because it shows that all of the work that we’re doing on our HER2 radio treatment is heading in the right direction to go from preclinical to clinical. And the FDA is in support of the study design that we have in place so that we can advance that.
And it’s really important for us for a few different reasons. One is that it shows that the program is progressing for those HER2 positive cancer patients that is a need. We’ve got a new treatment option that we are developing, but also from a Starpharma perspective, it shows that the work that we’re doing in the radio pharmaceutical space, that the application and the utilization of our dendrimer technology can play a really important role.
So with the FDA reviewing the data that we have generated so far and now taking it to humans, we see that as a good validation of that we’re heading in the right direction for the value of the dendrimer plus the HER2 asset that we’re developing.
Lel Smits: Absolutely. And as you mentioned with the FDA confirmation now of a clear development pathway in a high unmet need setting, DEP HER2 highlights really this potential of Starpharma’s dendrimer platform in targeted radio pharmaceuticals. What comes next from here?
Cheryl Maley: Yeah. So now when we have the FDA advice and alignment on the study, we can now move forward to finalize those, you know, the study preparations. We’ve selected sites and all of those things are completed, but there are elements and ethics approval that still need to be achieved.
So we will finalize all of those plans. And then once we get that, we can commence the study in the second half of this year and patient recruitment, all of those things will happen. And we’re excited that we can actually move to this next phase with the HER2 radio treatment.
Lel Smits: So with regulatory and site preparation underway and also a pathway to future US development, what upcoming catalyst should investors now be watching out for from Starpharma?
Cheryl Maley: Yes. In relation to this particular radio program, the next update would be in relation to that commencement of the trial. So yes, let’s keep looking out for that one, but more broadly for Starpharma catalyst, there’s, you know, we’re working very hard on our partnership programs with that we have with Genentech, Radio Pharm and Medici.
So updates relating to any of those programs, as well as new partners coming in or new licensing opportunities relating to our technology. So they’re the things that investors should be looking out for.
Lel Smits: Thank you, Cheryl, for the update from Starpharma and congratulations again on the milestone. Look forward to seeing how the year evolves.
Cheryl Maley: Thanks so much, Lel.
Ends