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%).
[NLINSERT]
Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
