Continuation from Bio and Hoops shared information, thanks again !!!....
How realistic is it to be able to balance the needs of everyone involved, or do you have to bend to one party to move things along?
Lalezari: There's a difference between developing a drug and giving the best patient care — and I've had to navigate that. For example, in the CRC study, because of the breast cancer data, the higher dose looked much better. I really wrestled with whether to even include the lower dose because I thought it might be suboptimal. It turns out that lower dose is demonstrating encouraging activity in CRC, and it's unclear whether the higher dose is going to be better. So even if you think you know, you might not.
In the end, we know that the patients, the FDA, the investors, and CytoDyn want the same thing. We want solid data showing the drug works, as quickly as possible.
It's a competitive landscape. How do you differentiate yourself when talking to a prospective principal investigator or even patients?
Lalezari: Two ways. One, again, that safety profile: 1,600 patients treated in the CRC study. These are third-line, really fragile patients. There has been no serious adverse event related to leronlimab. There's been no dose adjustment or treatment limitation due to an adverse event with leronlimab. So, having a drug in oncology that is not causing adverse effect, that separates us.
The ctDNA data that we've generated is preliminary, but no one has ever seen anything quite like it in terms of a 70% decrease in at week 2. It's not enough for the FDA. And it's not quite enough yet for a partnership, but every oncologist I show that data seems pretty impressed. We now have quite a few academic oncologists come to us now proposing their own investigator initiated studies. When you add this early evidence of biologic activity with a benign safety profile and potential relevance throughout solid tumor oncology, you have a rather amazing story. And now I really don’t have to spend my time persuading anyone; the data has helped generate significant interest among investigators and potential collaborators. And we saw it in the enrollment, too. The study enrolled over a period of just a few months.
Robert E. Hoffman: Sadly, the bar is pretty low on colorectal cancer. The current standard of care, bevacizumab and LONSURF, saw an overall response rate of 6% and then no complete responses in the data in their study. Real-world data suggests it's maybe 3%. These patients are in dire need of anything at this point. Unfortunately, colorectal cancer is one of the fastest-rising cancers in patients under 50 in the U.S. There's just a huge unmet medical need, and it's a big market, too.
How realistic is it to be able to balance the needs of everyone involved, or do you have to bend to one party to move things along?
Lalezari: There's a difference between developing a drug and giving the best patient care — and I've had to navigate that. For example, in the CRC study, because of the breast cancer data, the higher dose looked much better. I really wrestled with whether to even include the lower dose because I thought it might be suboptimal. It turns out that lower dose is demonstrating encouraging activity in CRC, and it's unclear whether the higher dose is going to be better. So even if you think you know, you might not.
In the end, we know that the patients, the FDA, the investors, and CytoDyn want the same thing. We want solid data showing the drug works, as quickly as possible.
It's a competitive landscape. How do you differentiate yourself when talking to a prospective principal investigator or even patients?
Lalezari: Two ways. One, again, that safety profile: 1,600 patients treated in the CRC study. These are third-line, really fragile patients. There has been no serious adverse event related to leronlimab. There's been no dose adjustment or treatment limitation due to an adverse event with leronlimab. So, having a drug in oncology that is not causing adverse effect, that separates us.
The ctDNA data that we've generated is preliminary, but no one has ever seen anything quite like it in terms of a 70% decrease in at week 2. It's not enough for the FDA. And it's not quite enough yet for a partnership, but every oncologist I show that data seems pretty impressed. We now have quite a few academic oncologists come to us now proposing their own investigator initiated studies. When you add this early evidence of biologic activity with a benign safety profile and potential relevance throughout solid tumor oncology, you have a rather amazing story. And now I really don’t have to spend my time persuading anyone; the data has helped generate significant interest among investigators and potential collaborators. And we saw it in the enrollment, too. The study enrolled over a period of just a few months.
Robert E. Hoffman: Sadly, the bar is pretty low on colorectal cancer. The current standard of care, bevacizumab and LONSURF, saw an overall response rate of 6% and then no complete responses in the data in their study. Real-world data suggests it's maybe 3%. These patients are in dire need of anything at this point. Unfortunately, colorectal cancer is one of the fastest-rising cancers in patients under 50 in the U.S. There's just a huge unmet medical need, and it's a big market, too.
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