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

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Poseida Therapeutics (Nasdaq: PSTX) has announced the nomination of a new development candidate under its collaboration with Roche, triggering a $15 million milestone payment. The candidate is an allogeneic, dual CAR-T therapy targeting hematologic malignancies, including multiple myeloma. This nomination builds on their collaboration with Roche, showcasing Poseida's non-viral genetic engineering toolkit to create TSCM-rich allogeneic CAR-T therapies.

The company now has three programs under their collaboration with Roche, including P-BCMA-ALLO1 and P-CD19CD20-ALLO1. Poseida plans to host a Cell Therapy R&D Day on November 14th, 2024, to highlight progress across its pipeline. With this milestone payment, Poseida expects its cash position to be sufficient to fund operations into early 2026.

Positive
  • Nomination of new development candidate triggers $15 million milestone payment from Roche
  • Collaboration with Roche now includes three programs in development
  • Lead program P-BCMA-ALLO1 has received RMAT designation for relapsed/refractory multiple myeloma
  • Cash runway extended into early 2026 with the new milestone payment
Negative
  • None.

Insights

The nomination of a new CAR-T development candidate by Poseida Therapeutics under its collaboration with Roche is a significant positive development. This triggers a $15 million milestone payment, extending Poseida's cash runway into early 2026. The company's cash position as of June 30, 2024, was $237.8 million and this additional influx strengthens their financial stability.

The collaboration with Roche, a major pharmaceutical player, adds credibility to Poseida's technology platform. With three programs now under this partnership, including the lead P-BCMA-ALLO1 in Phase 1b trials, Poseida is well-positioned in the competitive CAR-T therapy space. The RMAT designation for P-BCMA-ALLO1 could potentially expedite its path to market.

Investors should note the potential for additional milestone payments and the possibility of further business development deals, which could extend the cash runway even further. The upcoming Cell Therapy R&D Day on November 14th may provide more insights into the company's pipeline and future prospects, potentially impacting investor sentiment.

The nomination of a new allogeneic, dual CAR-T therapy candidate for hematologic malignancies, including multiple myeloma, is a noteworthy advancement in the field. This approach, targeting multiple antigens, could potentially address some of the limitations of current CAR-T therapies, such as antigen escape and relapse.

Poseida's non-viral transposon-based DNA delivery system, which allows for the insertion of two full-length CARs into T stem cell memory cells (TSCM), is a unique technological approach. TSCM cells are known for their long-term persistence and self-renewal capacity, which could translate to more durable responses in patients.

The focus on multiple myeloma, an incurable blood cancer, addresses a significant unmet medical need. If successful, this therapy could expand treatment options across different lines of therapy and care settings. The preclinical data supporting this dual CAR-T approach is promising, but it's important to see how it translates to clinical outcomes.

Allogeneic, TSCM-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 (TSCM).

"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, TSCM-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 14th, 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.

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SOURCE Poseida Therapeutics, Inc.

FAQ

What is the new development candidate announced by Poseida Therapeutics (PSTX)?

Poseida Therapeutics announced an allogeneic, dual CAR-T therapy targeting known antigens expressed in hematologic malignancies, including multiple myeloma.

How much is the milestone payment triggered by the nomination of the new candidate for PSTX?

The nomination triggered a $15 million milestone payment from Roche to Poseida Therapeutics.

When is Poseida Therapeutics (PSTX) hosting its Cell Therapy R&D Day?

Poseida Therapeutics is hosting its Cell Therapy R&D Day on November 14th, 2024.

How many programs does Poseida Therapeutics (PSTX) now have under its collaboration with Roche?

Poseida Therapeutics now has three programs under its collaboration with Roche.

Poseida Therapeutics, Inc.

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Biotechnology
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SAN DIEGO