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Poseida Shares Point Higher After FDA Clears NDA for Relapsed/Refractory Multiple Myeloma Treatment Candidate

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Shares of Poseida Therapeutics traded 10% higher after the company reported that the U.S. Food and Drug Administration granted clearance for its Investigational New Drug Application for P-BCMA-ALLO1, an allogeneic CAR-T candidate for use in treating relapsed/refractory multiple myeloma.

Clinical-stage biopharmaceutical company Poseida Therapeutics Inc. (PSTX:NASDAQ), which uses its proprietary genetic engineering platform and technological capabilities to create next generation cell and gene therapeutics, today announced that "the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for P-BCMA-ALLO1, the company's first fully allogeneic CAR-T product candidate for patients with relapsed/refractory multiple myeloma."

Poseida Therapeutics' CEO Eric Ostertag, M.D., Ph.D. commented, "We view a fully allogeneic CAR-T product candidate comprised of a high-percentage of desirable stem cell memory T cells (Tscm) as the 'holy grail' of cell therapy in oncology…P-BCMA-ALLO1 has a very high percentage of Tscm cells with the potential to demonstrate safety in line with our prior P-BCMA-101 autologous approach, allowing for fully outpatient dosing. The increase in Tscm and a switch to an improved binder also gives P-BCMA-ALLO1 the potential for even better efficacy."

"Notably, Poseida's proprietary booster molecule technology gives us the ability to produce up to hundreds of doses of P-BCMA-ALLO1 from a single manufacturing run, thereby dramatically reducing cost and further increasing accessibility for patients who desperately need better and safer cell therapies," Ostertag added.

The company mentioned that after receiving the go-ahead from the FDA, it is now focused on securing and opening clinical sites for a Phase 1 trial of P-BCMA-ALLO1 and plans to commence dosing later this year. The Phase 1 trial has been designed as a dose-escalating study across several cohorts of allogeneic T stem cell memory (Tscm) CAR-T cells in patients with relapsed/refractory multiple myeloma.

The company explained in the news release that "P-BCMA-ALLO1 is its first fully allogeneic product candidate targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma." The firm noted that in "in-vitro and in-vivo preclinical studies, P-BCMA-ALLO1 showed effective, targeted cancer cell killing and cytokine secretion, with similar or superior performance in anti-tumor efficacy compared to an autologous CAR-T therapy, P-BCMA-101."

Poseida Therapeutics is a clinical-stage biopharma firm based in San Diego, Calif. It has engineered a proprietary genetic technology platform to design and develop next generation cell and gene therapeutics for a variety of indications. The company listed that its platform offers a "non-viral piggyBac® deoxyribonucleic acid (DNA) modification system, Cas-CLOVER™ site-specific gene editing system, and nanoparticle- and AAV-based gene delivery technologies." Poseida advised that the platform can be deployed on either a standalone basis or in combination with other cell and gene therapeutic modalities.

The firm's drug development pipeline includes utilizing CAR-T for oncology in treating multiple myeloma. prostate cancer, B – cells, and solid tumors. The company is also investigating liver-directed gene therapies for ornithine transcarbamylase (OTC) deficiency, hemophilia A, and methylmalonic acidemia (MMA).

Poseida Therapeutics began the day with a market cap of around $617.2 million with approximately 62.34 million shares outstanding and a short interest of about 2.8%. PSTX shares opened unchanged today at $9.90 (+$0.00, +0.00%) from Friday's $9.90 closing price. The stock has traded today between $9.80 to $11.10 per share and is currently trading at $10.90 (+$1.00, +10.10%).


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