HIGH IMPACT – Poseida announced in its Q3 press release that it will end its P-BCMA-101 autologous CAR-T program and prioritize its allogeneic CAR-T P-BCMA-ALLO1.
- “While we believe the P-BCMA-101 autologous program has competitive advantages and would be approvable, one long-term strategic benefit of that program has been to inform our highly-differentiated allogeneic approach. With the P-BCMA-ALLO1 clinical program now underway and with very high confidence in our allogeneic platform, we will begin a planned wind down of P-BCMA-101.” – CEO Eric Ostertag
- Clinical data on P-BCMA-101, and how it has informed the P-BCMA-ALLO1 allogeneic CAR-T program, will be presented at ASH in poster form (#3858) on December 13.
- Poseida did not hold an earnings call.
inThought first confirmed that Posieda would be canceling its autologous BCMA CAR-T program in favor of its allogeneic version during a one-on-one management meeting at the William Blair conference in July. At that time, management stated the company wanted to have the allogeneic product in the clinic before pulling the plug on the autologous program and have consistently communicated this to their investors. That same day the P-BCMA-ALLO1 trial (NCT04960579) was posted on ClinicalTrials.gov followed by FDA IND clearance in August. The trial record has a study start date of October 2021 but still indicates “not yet recruiting.”
P-BCMA-101 was at one time a high competitor threat, with the first encouraging release of data at ASH 2018 that coincided with company plans to file not so far in the future. Since then, while Poseida has been an active company at medical and investor conferences, there were minimal data updates on the program. In 2020 Poseida finally released interim data in a small number of patients to highlight its nanoplasmid technology and optimized manufacturing progress, but since then the clear focus has shifted to its allogeneic asset. We likely won’t see any clinical data from P-BCMA-ALLO1 until at least 2023. Poseida is working with Takeda to develop a non-viral method to build in vivo gene therapies in six indications, that may be incorporated into its CAR-T programs.
Source: Poseida Q3 2021 Earnings