Here is the text of the presentation of the application (CLIN1-10999) from Poseida Therapeutics, Inc., to directors of the California stem cell agency.
The presentation was made by Shyam Patel, associate director for portfolio development and review at the stem cell agency. The directors did not discuss the application and gave it the go-ahead July 19, 2018,on a 14-0 vote.
The application was approved sometime prior to that date by the agency’s grant reviewers in a closed-door session, as is the practice for handling all applications. The agency’s governing board routinely rubber stamps the decisions of reviewers in virtually all cases.
The grant was designed to fund work leading up to the trial in question. The award was closed before the trial began.
Here is what Patel had to say, based on the CIRM transcript of the meeting.
“This is a late stage preclinical therapy study for a therapy for prostate cancer. The therapy itself is CAR-T cells, and these are stem memory T cells that compose this particular product.
"The indication is for patients with metastatic castrate resistant prostate cancer. This is the most advanced form of this particular disease. The goal for this particular project is to conduct product manufacturing, conduct the preclinical safety and efficacy studies, as well as prepare and submit the IND. And they're requesting roughly $4 million for CIRM funding, and they're going to be co-funding $1 million.
"To give you an idea about this particular project, we've prepared a few items. First of all, the potential impact for this therapy. There are 165,000 new cases of prostate cancer submitted for this particular year, and roughly 30,000 prostate cancer deaths for 2018 as estimated by the NIH.
"Now, the particular disease indication that this product is going for, which is the metastatic castrate resistant prostate cancer population, that represents a very small percentage of the overall prostate cancer population, but an overwhelming majority of the deaths for this particular disease. If successful, this particular therapy would target that most needy, highest risk patient population.
"In terms of the value proposition, over the last decade or so, there has been a steady improvement in the standard of care for prostate cancer. Currently available therapies for prostate cancer for metastatic castrate resistant prostate cancer includes hormone therapy, chemotherapy, as well as an autologous T-cell product, which is an activated T-cell product, all of which have shown modest survival benefit in clinical trials.
"The proposed therapy has a potential to induce long-term remission with possibly a single treatment. In terms of why this is a stem cell project, as I mentioned earlier, this particular product is composed of memory stem T-cells.
"To give you a brief overview of the current portfolio for CIRM with respect to related projects, we are not currently funding any prostate cancer-directed projects, but we do have some solid tumor projects, including therapies including therapies of cell-derived therapies as well as small molecule antibody-based therapies, all in early phase or IND-enabling studies. This particular applicant has received CIRM funding before.
"They are currently conducting a phase 1 trial for a CAR-T based therapy for multiple myeloma, which is funded by CIRM. Lastly, the GWG (grant review group) reviewed this application and unanimously gave it a tier one recommendation. There were 12 scores for tier one, zero scores for tier two, and zero scores for tier three. The CIRM team recommendation follows the GWG recommendation for the award amount of $3,992,090."
