Source – Poseida Therapeutics
Japanese pharmaceutical company Astellas is making a strategic move by investing $50 million to acquire an 8.8% stake in Poseida Therapeutics. This investment grants Astellas a prime opportunity to secure access to Poseida’s promising solid tumor CAR-T cell therapy. While Poseida faces certain pipeline setbacks and strategic adjustments, this collaboration marks a significant step forward.
The focal point of the agreement revolves around P-MUC1C-ALLO1, an allogeneic CAR-T cell therapy developed by Poseida for treating solid tumors. Astellas is keen on obtaining preferential partnering options for this therapeutic innovation.
The deal structure encompasses a $25 million investment for 8,333,333 shares of Poseida’s common stock at a price of $3 per share, facilitated through a private placement. Additionally, Astellas will make a one-time payment of $25 million for exclusive first negotiation rights for P-MUC1C-ALLO1. As part of the arrangement, Astellas will also secure a board observer seat and certain rights concerning any potential changes in control at Poseida.
“We are excited to announce a strategic investment by Astellas, a premier global pharmaceutical company that shares our strategic vision for the future of genetic engineering and cell and gene therapies. This investment further validates our technology and approach and also reflects our broad strategic options in progressing the business. Based on this investment and cost control measures implemented in the business, we are extending our cash runway guidance as we remain focused on being good stewards of capital. As we look towards the future, we are taking recent learnings from our allogeneic programs and implementing improvements across our clinical trials. Based on these findings, we are adjusting guidance on data updates and look forward to sharing clinical data highlighting some of these enhancements at a medical meeting later this year, with plans for a more robust clinical update to follow in mid-2024.”
– Mark Gergen, Poseida’s Chief Executive Officer
Solid tumors represent a challenging terrain for CAR-T therapies, contrasting with their success in blood cancers. Poseida, however, is pioneering a distinct approach by developing off-the-shelf treatments derived from healthy donors. This strategy aims to avoid adverse immune reactions and expedite treatment timelines. The ongoing phase 1 trial for P-MUC1C-ALLO1 is anticipated to involve 100 participants, with primary study completion slated for 2026.
This collaboration arrives at a pivotal juncture for Poseida. The termination of a gene therapy partnership with Takeda, announced in July, has prompted Poseida to reevaluate its gene therapy program. The focus now is on determining the prioritization of internal programs and exploring potential avenues for future gene therapy development through business partnerships.
“We are continuing to advance the Phase I trials for both P-BCMA-ALLO1 and P-MUC1C-ALLO1 and the data we have generated has led us to find improvements that we believe have the potential to greatly benefit our allogeneic portfolio. We have implemented a number of these already in our clinical-stage programs, as we continue steady progress in dose-ranging and explore approaches such as raising conditioning lymphodepletion to emerging industry norms and exploring additional dosing and administration options. We are also improving our manufacturing process in ways that will further increase product yield, and are encouraged by the early signals we are seeing in this area also. Overall, we remain highly excited about the potential of our allogeneic platform and our ongoing opportunities for continuous improvement.”
– Kristin Yarema, Ph.D., President of Cell Therapy at Poseida
Investors responded positively to news of Astellas’ investment, propelling Poseida’s shares up by 23% to reach $2, a notable increase from the previous closing price of $1.63.
While challenges lie ahead, the Astellas partnership provides Poseida with extended financial runway until early 2025. In May, the company reported cash and equivalents totaling $247.2 million, sufficient to sustain operations until mid-2024.
“The strategic investment by Astellas, together with our disciplined capital expenditure, cost control initiatives and expected payments and milestones from the Roche collaboration, put us on a firm financial foundation. With these updates we have extended our cash runway based upon current plans into early 2025. In addition, we believe that further upside from our Roche collaboration as well as potential business development opportunities provide additional confidence as we enter the second half of 2023.”
– Johanna Mylet, Chief Financial Officer of Poseida
Notably, Poseida is also engaged in a collaboration with Roche involving the allogeneic CAR-T therapy P-BCMA-ALLO1, which is currently in Phase I testing for relapsed/refractory multiple myeloma. Anticipated clinical updates are expected this year, with a more comprehensive update planned for mid-2024 due to the implementation of a new dosing regimen. Furthermore, Poseida and Roche are working together on P-CD19CD20-ALLO1, a therapy targeting B-cell malignancies, which recently received clearance for human testing in June. Site initiation is underway, with dosing projected to commence in early 2024.
