I think we have 2 things going for ZIOP in this regard. SB was inefficient in the past. If you listened on the call they said that they would be using IL-15 in the future. I think the CD-19 trial will be what shows everyone that ZIOP has the goods. The key is to allow SB to persist in the body for a longer period of time. Allowing it to continue to fight the tumor longer. The CD-19 trial will be starting in the next 1 - 6 months. Hopefully only a month or 2 from now but we need to wait and see what the company has to say. They are close to meeting the FDA guidelines of 70% viability. When this happens the T-cells will be allowed to grow and persist in the body for a much longer period of time. Our treatment may not be as potent as the viral approach but it won't matter because SB will continue fighting for an extended period. It will likely be an advantage because it might limit the cytokine storm issues. Doctors can grow the cells in the body as fast as they choose and they will grow slower while the viral approach infuses large numbers creating the cytokine storm issues we have seen.
This will likely happen in TCRs as well. Until then Dr. Rosenberg is using peripheral blood that will allow the t-cells to be younger and keep fighting longer. He mentioned on the call that they may need a second infusion. I was thrilled to hear that. I thought that about prior trials in CD-19. I don't know why they didn't infuse and then 2-3 months later infuse again allowing the treatment to remain in the body for an extending period fighting the cancer. But this issue is goign to be mute if the SB new system with IL-15 works. I was hoping that the NCI would add membrane bound IL-15 to their treatment. They would then have younger blood and IL-15 to keep the cells growing and fighting for an extended period. That will likely come later.
On the call they were asked when they would have a readout of the trial. They didn't really answer but the analyst interpreted what they said as no results would be released until later in 2020. But they basically said it was up to Rosenberg. We know that if the trials are doing well Dr. Rosenberg will start talking about the results prior to presenting the results at a scientific conference. The trial is likely to end in 2020 but we could hear results in late 2019 or early 2020. It will take a month or 2 prior to the first infusion and then a few months to see results. My question that was not answered is will they be infusing both the individual and the hotspot patient parallel to each other. Is this like 2 separate trials. I personally feel that results could be forthcoming at ASH in December if the trial is going well. If the trial is not seeing miracle complete Remissions it could be 2020 before we see results. One thing is sure to me. Shorts are taking a major risk if they are expecting results to be discussed for the first time in mid to late 2020.
We really have no idea if this is going to work but it is clear that this approach has the potential to treat all solid tumors and cure cancer. I am excited about the future and it will only take a few months before we will know if this approach will work. Long term shareholders have been waiting for this for 3-4 years. That is when Dr. Cooper started discussing TCRs and telling us it was coming. I think he talked too much. When you discuss TCRs and nothing happens investors start seeing the company as one that will never move forward. Finally the trial is actually preparing to begin. We are within a month or 2 of infusing the first patient. Nothing is standing in our way now. I am very excited about this approach and as the trial is moving forward Wall Street will begin to jump on board.
Think about the progress the last year.
Freed ourselves from XON forever. No more preferred shares and no delays from the XON partnership.
IL-12 ended the mono therapy trial and is enrolling the final phase 1 combo patient this month.
IL-12 combo phase 2 begins in the next week. approximately 2 weeks ago the company saif the phase 2 would be starting in a couple weeks. I would anticipate a PR on the start of the phase 2 in the very near future.
Got the NCI patents that will allow for us to move the TCR trial forward
Received approval by the FDA to begin the TCR phase 1 trial. (HUGE)
Told by the company last week that the CD-19 trial on hold is still on schedule for the 2nd half of 2019. Based on Dr. Coopers comments it looks like they have likely met the 70% requirement and are validating the data prior to submitting it to the FDA. If they haven't met the 70% requirement they are very confident that they will be there soon.
So everything is on schedule and drugs are really moving forward with an opportunity to be commercially viable products. When have we been able to say that. Thank you Dr. Mauney and Dr. Cooper. You are doing a great job.