Someone on Reddit posted the transcription below. I have not seen a transcription of the entire webcast.
12/14/CC with Kelly Basket Trials, Ray on mTNBC, Brain Mets, Recknor Long Haulers, NASH
25:05 Nader: For the next task of 2022, Cancer Basket Trial. 22 indications. We have lots of patients who talk to Dr. Kelly. Dr. Kelly is involved with a lot of patients who want to get on Leronlimab. Dr. Kelly, tell us a little bit about why we are excited about the Basket Trials.
25: 25 Kelly: We are excited about the Basket Trials. I'll start by saying I just presented at San Antonio Conference December 10th. That was in results wrt mTNBC in combination with carboplatin, CCR5 positive, mTNBC and I tell you, the reason why we are excited about the Basket Trial is that they think that there is a growing acceptance that the Tumor Micro Environment is the next Frontier for Immunotherapy. And I mean this amongst practicing physicians, the academic world, probably as well as big pharma, and I think we are more advanced than this. We've been looking at the mechanism of action in the tumor micro environment and see Leronlimabs impact across multiple different oncologic indications and we also think that we can pair this with a check point inhibitor, chemo, radiation, antibody zero conjugates, as well as maybe even a potential monotherapy in certain patients that don't qualify for other treatments. We think the MOA, with T-Regs. When T-Regs come in, they turn off the immune system. We know that they have a high prevalence of CCR5. We can block that. We can actually maybe leverage the immune system. If we look at macrophage re-polarization, that's another potential opportunity. Our animal studies showed a significant reduction in angiogenesis. I think it was 62% in total vessillary and 80% reduction in small vessel area. But, we know that tumors need a blood supply to grow and if we can help limit that, then we think we can have benefit for patients. And last, we know that normal cells, CCR5 is only present on an immune cell, but we know that when cells under go malignant transformation, that they start sprouting up CCR5, and we believe that is a contributor to metastasis. So we have multiple different mechanisms of action and we continue to find more as we go along that we will be evaluating.
27:15 Nader: Yeah, and BTD that we will be filing, Dr. Nitya Ray did a fantastic job on that. There were some patients with brain metastases. Dr. Ray, explain to us, for a breakthrough designation strategy, are we going to file for brain metastases and perhaps later on, if we do get BTD on the original submissions, maybe we want to ask for Basket Trial data, but tell us about the Basket Trial please.
27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases. They are all mTNBC patients. So we have submitted all of the results, including all of the patients with brain metastases, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and see that forward with brain metastases. Now, these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases.
29:40 Nader: Cancer BTD that we filed, we should hear hopefully soon and this is going to happen in 2022, if the BTD is there, we will be doing, if there is a need for Phase 3 or what ever we need to move forward for approval. If we don't get BTD, we still will immediately do a trial with the magnitude to hit a p value. ??-mab had a Phase 1-2, their data was strong. Hopefully our data is strong enough to impress the FDA and get a BTD, but we will know soon.
30:45 Nader: So the Critically Ill population in Brazil, we now have 20 sites, am I right Scott Dr. Kelly? Kelly: That's correct. and we're adding more. Nader: And I think they said we will have up to 40 in the 2 months after December, but by end of December, we should have 20-25, and if those sites are in place, enrolling 50 or 51 patients, b/c 40% of 126 is 50.4, so 50 patients, whatever, that's not going to be a problem if there is a spike in covid 19 cases. Now, people keep saying, why did you reduce it to 50 patients and now you're not going to hit primary endpoint. We explained our endpoints that we have are different and that we based this study on the very powerful CD12 data. But if we do an interim analysis at 51 patients, and we don't hit our primary endpoint, so we continue, as a matter of fact, we may do more than 126 patients, we might do 200, whatever it is. So this is not shooting ourselves in the foot in any way shape or form. And severe population will go forward, will always get the latest data and always update the shareholders with what we have. And the last thing that we have is for Critically Ill population in the US population that we just submitted to the FDA. We are excited to start that because unfortunately, there are states in the US where their ICUs are getting packed again. We want to pin down those states and open sites there immediately and perhaps do our study. We will be working with CROs, currently with PPD. Where are we Dr. Recknor with those PPD?
32:50 Recknor: We are progressing nicely. Nader: Great.
Kelly: Nader, I'll add, it's interesting. We believe Omicron is gonna be the dominant strain. We believe it's gonna be more contagious. We don't know if it's gonna cause more severe disease. We just don't know that. but if you look, I think it's already in 32 states, (probably 50 by now), this is how quickly this goes, so ultimately, it will overcome delta and become the most dominant strain, we just don't know if it's gonna cause severe disease and that's something that time will tell.
Nader: Yeah and England's prime minister indicated that there already was one dead from Omicron. and CDC said this am that 3% of the cases in the US are now from Omicron.
Kelly: So its gonna spread exponentially as we know. And the other thing I would add is that we don't know how thats gonna affect the Long Haulers. Obviously, you have a more contagious virus, there is a possibility that Long Haulers might get even more than 10-30% that people say that out there. If you look, they are starting at 271,000,000 cases of covid, so you're looking at well over 27,000,000 patients that will eventually be affected by Long Haulers.
Recknor: To that point as well, many of the Long Haulers are those who have gotten covid more than once time, with different variants. We are starting to see that there may be a cumulative effect with multiple exposures in these patients.
Kelly: And again, we don't know how these patients are going to respond to the vaccinations. We just don't know.
36:10 Recknor: I did Nader, One thing, in keeping with the reduction in fibrosis that we are seeing, these Long Hauler patients, and perhaps, this is the signal of all post viral syndromes, have a lot of Fatty Deposition in the Liver and in the Pancreas. Also, there is cardiac involvement as well. And so we are incorporating, with this signal that we are seeing, with reduction of fibrosis, we think that we will be able to do this systemically. And we are incorporating that in evaluation of our trials as well. and I think its important to not only have a subjective patient reported outcome, but also objective measures, in terms of cognitive testing, MRIs, etc.
37:10 Kelly: I would like to mention, I just recently presented at the World antiviral conference on November 30th. we covered a lot of ground in that. HIV mono, HIV prep, HIV cure project, combo therapy, covid 19 critical, LH, NASH and oncology and I think there is a growing interest in LL as a platform molecule across multiple indications and I think what that is going to do for us is that in terms of partnerships, we just brought back Dr. Brendan Rey who worked with us in the past and now that we have data, Brendan is an attorney with virology experience and we are going to be looking at partnership opportunities not only with domestic, but also China, Argentina, Taiwan, South East Asia, Mexico, Turkey, Korea. We are looking at multiple different things like oncology, HIV, NAFLD, NASH, so I think it's really exciting where we are going going into this new year.
38:05 Nader: Absolutely, and the last, if the NASH trial is as strong as what we believe, when we unblind it, let's just say, that with the open label, we hit our primary endpoint and secondary endpoint, we will immediately file those results with MHRA UK, Health Canada, Brazil and Philippines, cause they have pharmaceuticals over there that we are working with. So this is going to go to a whole new level if we have a primary and secondary endpoint hit in either the open arm or the unblinded, but we will be reporting on that hopefully very soon.
12/14/CC with Kelly Basket Trials, Ray on mTNBC, Brain Mets, Recknor Long Haulers, NASH
25:05 Nader: For the next task of 2022, Cancer Basket Trial. 22 indications. We have lots of patients who talk to Dr. Kelly. Dr. Kelly is involved with a lot of patients who want to get on Leronlimab. Dr. Kelly, tell us a little bit about why we are excited about the Basket Trials.
25: 25 Kelly: We are excited about the Basket Trials. I'll start by saying I just presented at San Antonio Conference December 10th. That was in results wrt mTNBC in combination with carboplatin, CCR5 positive, mTNBC and I tell you, the reason why we are excited about the Basket Trial is that they think that there is a growing acceptance that the Tumor Micro Environment is the next Frontier for Immunotherapy. And I mean this amongst practicing physicians, the academic world, probably as well as big pharma, and I think we are more advanced than this. We've been looking at the mechanism of action in the tumor micro environment and see Leronlimabs impact across multiple different oncologic indications and we also think that we can pair this with a check point inhibitor, chemo, radiation, antibody zero conjugates, as well as maybe even a potential monotherapy in certain patients that don't qualify for other treatments. We think the MOA, with T-Regs. When T-Regs come in, they turn off the immune system. We know that they have a high prevalence of CCR5. We can block that. We can actually maybe leverage the immune system. If we look at macrophage re-polarization, that's another potential opportunity. Our animal studies showed a significant reduction in angiogenesis. I think it was 62% in total vessillary and 80% reduction in small vessel area. But, we know that tumors need a blood supply to grow and if we can help limit that, then we think we can have benefit for patients. And last, we know that normal cells, CCR5 is only present on an immune cell, but we know that when cells under go malignant transformation, that they start sprouting up CCR5, and we believe that is a contributor to metastasis. So we have multiple different mechanisms of action and we continue to find more as we go along that we will be evaluating.
27:15 Nader: Yeah, and BTD that we will be filing, Dr. Nitya Ray did a fantastic job on that. There were some patients with brain metastases. Dr. Ray, explain to us, for a breakthrough designation strategy, are we going to file for brain metastases and perhaps later on, if we do get BTD on the original submissions, maybe we want to ask for Basket Trial data, but tell us about the Basket Trial please.
27:60 Nitya Ray: The BTD application that is submitted is 28 patients from 3 different trials. And out of the 28, 6 had brain metastases. They are all mTNBC patients. So we have submitted all of the results, including all of the patients with brain metastases, now with the FDA and FDA is reviewing it and we are waiting for FDA to respond for BTD application and we expect to hear from them in about 2 weeks. 2-3 weeks. Our CTA application I believe was submitted on November 5. So by January 5, we should hear from FDA. and then we are going to discuss with FDA and see that forward with brain metastases. Now, these are not the only patients with brain metastases because these are mTNBC patients. But, we have other patients in the Basket Trial and not mTNBC, with brain metastases. And so we are very excited about what is happening with these patients. And so we are going to discuss this with the FDA and we do plan, after we receive the response from the FDA on the BTD application that is submitted, we are going to plan for perhaps another BTD just focusing on the brain metastases.
29:40 Nader: Cancer BTD that we filed, we should hear hopefully soon and this is going to happen in 2022, if the BTD is there, we will be doing, if there is a need for Phase 3 or what ever we need to move forward for approval. If we don't get BTD, we still will immediately do a trial with the magnitude to hit a p value. ??-mab had a Phase 1-2, their data was strong. Hopefully our data is strong enough to impress the FDA and get a BTD, but we will know soon.
30:45 Nader: So the Critically Ill population in Brazil, we now have 20 sites, am I right Scott Dr. Kelly? Kelly: That's correct. and we're adding more. Nader: And I think they said we will have up to 40 in the 2 months after December, but by end of December, we should have 20-25, and if those sites are in place, enrolling 50 or 51 patients, b/c 40% of 126 is 50.4, so 50 patients, whatever, that's not going to be a problem if there is a spike in covid 19 cases. Now, people keep saying, why did you reduce it to 50 patients and now you're not going to hit primary endpoint. We explained our endpoints that we have are different and that we based this study on the very powerful CD12 data. But if we do an interim analysis at 51 patients, and we don't hit our primary endpoint, so we continue, as a matter of fact, we may do more than 126 patients, we might do 200, whatever it is. So this is not shooting ourselves in the foot in any way shape or form. And severe population will go forward, will always get the latest data and always update the shareholders with what we have. And the last thing that we have is for Critically Ill population in the US population that we just submitted to the FDA. We are excited to start that because unfortunately, there are states in the US where their ICUs are getting packed again. We want to pin down those states and open sites there immediately and perhaps do our study. We will be working with CROs, currently with PPD. Where are we Dr. Recknor with those PPD?
32:50 Recknor: We are progressing nicely. Nader: Great.
Kelly: Nader, I'll add, it's interesting. We believe Omicron is gonna be the dominant strain. We believe it's gonna be more contagious. We don't know if it's gonna cause more severe disease. We just don't know that. but if you look, I think it's already in 32 states, (probably 50 by now), this is how quickly this goes, so ultimately, it will overcome delta and become the most dominant strain, we just don't know if it's gonna cause severe disease and that's something that time will tell.
Nader: Yeah and England's prime minister indicated that there already was one dead from Omicron. and CDC said this am that 3% of the cases in the US are now from Omicron.
Kelly: So its gonna spread exponentially as we know. And the other thing I would add is that we don't know how thats gonna affect the Long Haulers. Obviously, you have a more contagious virus, there is a possibility that Long Haulers might get even more than 10-30% that people say that out there. If you look, they are starting at 271,000,000 cases of covid, so you're looking at well over 27,000,000 patients that will eventually be affected by Long Haulers.
Recknor: To that point as well, many of the Long Haulers are those who have gotten covid more than once time, with different variants. We are starting to see that there may be a cumulative effect with multiple exposures in these patients.
Kelly: And again, we don't know how these patients are going to respond to the vaccinations. We just don't know.
36:10 Recknor: I did Nader, One thing, in keeping with the reduction in fibrosis that we are seeing, these Long Hauler patients, and perhaps, this is the signal of all post viral syndromes, have a lot of Fatty Deposition in the Liver and in the Pancreas. Also, there is cardiac involvement as well. And so we are incorporating, with this signal that we are seeing, with reduction of fibrosis, we think that we will be able to do this systemically. And we are incorporating that in evaluation of our trials as well. and I think its important to not only have a subjective patient reported outcome, but also objective measures, in terms of cognitive testing, MRIs, etc.
37:10 Kelly: I would like to mention, I just recently presented at the World antiviral conference on November 30th. we covered a lot of ground in that. HIV mono, HIV prep, HIV cure project, combo therapy, covid 19 critical, LH, NASH and oncology and I think there is a growing interest in LL as a platform molecule across multiple indications and I think what that is going to do for us is that in terms of partnerships, we just brought back Dr. Brendan Rey who worked with us in the past and now that we have data, Brendan is an attorney with virology experience and we are going to be looking at partnership opportunities not only with domestic, but also China, Argentina, Taiwan, South East Asia, Mexico, Turkey, Korea. We are looking at multiple different things like oncology, HIV, NAFLD, NASH, so I think it's really exciting where we are going going into this new year.
38:05 Nader: Absolutely, and the last, if the NASH trial is as strong as what we believe, when we unblind it, let's just say, that with the open label, we hit our primary endpoint and secondary endpoint, we will immediately file those results with MHRA UK, Health Canada, Brazil and Philippines, cause they have pharmaceuticals over there that we are working with. So this is going to go to a whole new level if we have a primary and secondary endpoint hit in either the open arm or the unblinded, but we will be reporting on that hopefully very soon.
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