Poseida Therapeutics Announces Nomination of New CAR-T Development Candidate Under Collaboration with Roche

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Oct 17, 2024, 08:00 ET

Allogeneic, T_SCM-rich dual CAR-T for the treatment of hematologic malignancies, including multiple myeloma

Nomination triggers $15 million milestone payment to Poseida, extending cash runway into early 2026

Poseida Cell Therapy R&D Day to take place on Thursday, November 14 at 7 am PT / 10 am ET

SAN DIEGO, Oct. 17, 2024 /PRNewswire/ -- Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune, and rare diseases, today announced the nomination of a new development candidate under its collaboration with Roche. The nomination triggered a $15 million milestone payment from Roche to Poseida.

The new candidate is an allogeneic, dual CAR-T therapy targeting known antigens expressed in hematologic malignancies, including multiple myeloma. The large capacity of Poseida's non-viral transposon-based DNA delivery system enables the insertion of genes for two full length chimeric antigen receptors (CARs) into T stem cell memory cells (T_SCM).

"The nomination of a new development candidate builds on our collaboration with Roche and highlights the unique potential of our proprietary non-viral genetic engineering toolkit to create differentiated, T_SCM-rich allogeneic CAR-T therapies targeting one or more antigens," said Kristin Yarema, Ph.D., president and chief executive officer of Poseida Therapeutics. "Multiple myeloma is a common and incurable blood cancer with significant room for potent, safe and accessible novel agents to expand use across lines of therapy and sites of care. With compelling preclinical data supporting the target combination of this dual CAR-T, we look forward to advancing this program towards the clinic as a part of the collaboration. We also look forward to providing updates on our CAR-T programs and earlier-stage pipeline at Poseida's upcoming Cell Therapy R&D Day."

Poseida and Roche now have three programs under their collaboration, which was established in August 2022 to develop allogeneic CAR-T therapies directed to hematologic malignancies. The lead collaboration program, P-BCMA-ALLO1, is an allogeneic CAR-T therapy targeting BCMA that has received Regenerative Medicine Advanced Therapy (RMAT) designation for adult patients with relapsed/refractory multiple myeloma after three or more prior lines of therapies. Poseida is currently enrolling patients in a Phase 1b portion of the clinical trial. The second program, P-CD19CD20-ALLO1, is an allogeneic dual CAR-T candidate in Phase 1 development for B-cell malignancies.

Dr. Yarema added, "Based on P-BCMA-ALLO1's promising differentiated safety and efficacy results established with the recent interim Phase 1 data presented at the IMS Annual Meeting in September and in collaboration with Roche, we look forward to continued patient enrollment in the Phase 1b trial. The new allogeneic dual CAR-T therapy candidate announced today will leverage the same proprietary Poseida GMP manufacturing platform that was used to create and advance P-BCMA-ALLO1."

Poseida Cell Therapy R&D Day
The Company plans to host its Cell Therapy R&D Day on November 14^th, 2024, featuring presentations from management and top scientists. The event will highlight the Company's progress across its clinical-stage and earlier-stage pipeline of differentiated allogeneic CAR-T therapies in oncology and autoimmune disease.

The virtual event and access to the live webcast will be available through the following registration link: https://wsw.com/webcast/cc/pstx7/1467684. Registration for this virtual event and access to a replay of the live webcast will also be available on the Investors & Media section of www.poseida.com. A replay of the webcast will be available for approximately 90 days following the presentation.

Cash Position
As of June 30, 2024, the Company's cash, cash equivalents and short-term investments balance was $237.8 million. With the $15 million milestone from Roche's nomination of a new development candidate, the Company expects that its cash, cash equivalents and short-term investments together with other remaining near-term milestones and other payments from Roche will be sufficient to fund operations into early 2026. Potential additional anticipated progress and payments under the Roche Collaboration Agreement and/or potential additional business development could further extend the cash runway.

About Poseida Therapeutics, Inc.

Poseida Therapeutics is a clinical-stage biopharmaceutical company advancing differentiated allogeneic cell therapies and genetic medicines with the capacity to cure. The Company's pipeline includes investigational allogeneic CAR-T cell therapies for hematologic cancers, autoimmune diseases, and solid tumors, as well as investigational in vivo genetic medicines that address patient populations with high unmet medical need. The Company's approach is based on its proprietary genetic editing platforms, including its non-viral transposon-based DNA Delivery System, Cas-CLOVER™ Site-Specific Gene Editing System, Booster Molecule and nanoparticle gene delivery technologies, as well as in-house GMP cell therapy manufacturing. The Company has formed strategic collaborations with Roche and Astellas to unlock the promise of cell therapies for cancer patients. Learn more at www.poseida.com and connect with Poseida on X and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, expected plans with respect to clinical trials, including timing of clinical data updates; anticipated timelines and milestones with respect to the Company's development programs and manufacturing activities and capabilities; the potential capabilities and benefits of the Company's technology platforms and product candidates; the quotes from Dr. Yarema; and the Company's plans and strategy with respect to developing its technologies and product candidates. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon the Company's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the fact that interim data from the Company's clinical trials may change as more patient data become available and remain subject to audit and verification procedures that could result in material differences from the final data; the Company's reliance on third parties for various aspects of its business; risks and uncertainties associated with development and regulatory approval of novel product candidates in the biopharmaceutical industry; the Company's ability to retain key scientific or management personnel; the Company's ongoing and planned clinical trials; whether any of the Company's product candidates will be shown to be effective or safe; the Company's ability to finance continued operations; the fact that the Company will have limited control over the efforts and resources that Roche devotes to advancing development programs under its collaboration agreement with Roche; the fact that the Company may not receive the potential fees, reimbursements and payments under its collaboration agreement with Roche; the ability of Roche to early terminate the collaboration, such that the Company may not fully realize the benefits of the collaboration; and the other risks and uncertainties described in the Risk Factors section of the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 5, 2024, and in other filings the Company makes with the SEC from time to time. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

SOURCE Poseida Therapeutics, Inc.