SAN DIEGO - Poseida Therapeutics, Inc. (NASDAQ:PSTX), a biopharmaceutical company, announced new interim clinical data from its Phase 1 trial of P-BCMA-ALLO1, an investigational CAR-T therapy for relapsed/refractory multiple myeloma (RRMM). The trial reported a 91% overall response rate (ORR) in the optimized lymphodepletion arm, including a 100% ORR in BCMA-naïve patients.
The data, presented at the 21st International Myeloma Society Annual Meeting, also showed the therapy's safety profile, with no dose-limiting toxicities and low rates of cytokine release syndrome (CRS) and immune effector cell neurotoxicity syndrome (ICANS), both Grade 2 or less. There were no cases of graft vs. host disease or Parkinsonism.
P-BCMA-ALLO1, developed in collaboration with Roche, is a non-viral, allogeneic CAR-T cell therapy utilizing a T stem cell memory (TSCM)-rich platform. The therapy was granted Regenerative Medicine Advanced Therapy (RMAT) designation by the FDA.
The Phase 1/1b trial enrolled 72 patients, requiring at least three prior lines of therapy, including exposure to a proteasome inhibitor, immunomodulatory drug, and anti-CD38 monoclonal antibody. A significant proportion of participants had received prior BCMA-targeting therapy.
In the optimized lymphodepletion arm C, patients received cyclophosphamide and fludarabine followed by P-BCMA-ALLO1. Results showed a 91% ORR, with a 22% complete response rate. No patients required bridging therapy, and the median time from enrollment to treatment was one day.
The trial's primary objective is to assess the safety and maximum tolerated dose of P-BCMA-ALLO1, with its anti-myeloma activity as a secondary objective. The ongoing Phase 1/1b trial is enrolling new patients using the Arm C lymphodepletion regimen.
Poseida will host a webcast and conference call with multiple myeloma experts to discuss the data and provide business updates. This announcement is based on a press release statement.
In other recent news, Poseida Therapeutics, a clinical-stage biopharmaceutical company, has been granted Regenerative Medicine Advanced Therapy (RMAT) status by the U.S. Food and Drug Administration (FDA) for its investigational therapy P-BCMA-ALLO1. This therapy, which targets B-cell maturation antigen (BCMA), is currently undergoing Phase 1/1b clinical development for the treatment of relapsed/refractory multiple myeloma. The RMAT designation is part of the 21st Century Cures Act and is intended to expedite the development and review of regenerative medicine therapies for serious or life-threatening diseases.
Poseida's therapy has shown potential efficacy and safety in early clinical data, contributing to the FDA's decision. The company's approach uses stem cell memory T cells (TSCM) to potentially provide a more effective and durable response. In addition to the RMAT designation, Poseida has also secured Orphan Drug designation for P-BCMA-ALLO1, signaling its potential to address an unmet medical need in the multiple myeloma patient population.
New clinical data from the ongoing Phase 1 study of P-BCMA-ALLO1 will be presented at an upcoming international meeting, with further updates on clinical development expected in the latter half of the year. The RMAT designation opens the possibility of accelerated approval based on surrogate or intermediate endpoints that may predict long-term benefits. These are recent developments in Poseida Therapeutics' mission to advance allogeneic cell therapies and genetic medicines to treat cancer and rare diseases.
InvestingPro Insights
Poseida Therapeutics' promising clinical data for its CAR-T therapy comes at a crucial time for the company, as reflected in recent financial metrics and analyst opinions. According to InvestingPro data, Poseida's market capitalization stands at $281.65 million, indicating its current valuation in the biotech sector.
The company's revenue for the last twelve months as of Q2 2023 was $88.46 million, with a quarterly revenue growth of 29.78% in Q2 2023. This growth aligns with the positive clinical results and could potentially drive future financial performance. However, it's important to note that Poseida is not yet profitable, with a negative gross profit of $68.32 million over the same period.
InvestingPro Tips highlight some key aspects of Poseida's financial situation. The company holds more cash than debt on its balance sheet, which could provide financial flexibility as it continues its clinical trials and product development. Additionally, Poseida's liquid assets exceed short-term obligations, suggesting a stable short-term financial position.
Despite the positive clinical data, InvestingPro Tips indicate that two analysts have revised their earnings downwards for the upcoming period. This, coupled with the fact that analysts do not anticipate the company to be profitable this year, underscores the challenges faced by early-stage biotech companies in translating clinical success into financial returns.
Investors should also be aware that Poseida's stock has taken a significant hit over the last week, with a 1-week price total return of -11.87%. This volatility is not uncommon in the biotech sector, especially around clinical data announcements.
For those interested in a deeper analysis, InvestingPro offers 8 additional tips for Poseida Therapeutics, providing a more comprehensive view of the company's financial health and market position.
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