Shares of Fate Therapeutics traded higher after the firm reported it has treated the first patient in a first-in-human trial of FT596 for patients with B-cell malignancies and chronic lymphocytic leukemia.
Clinical-stage biopharmaceutical company Fate Therapeutics Inc. (FATE:NASDAQ), which is focused on the development of programmed cellular immunotherapies for cancer and immune disorders, yesterday announced that "the first patient has been treated in the company's first-in-human Phase 1 clinical trial evaluating FT596, the first cell therapy product candidate engineered with three active anti-tumor modalities, in patients with B-cell malignancies and chronic lymphocytic leukemia."
The company described FT596 as "an off-the-shelf chimeric antigen receptor (CAR) natural killer (NK) cell cancer immunotherapy derived from a clonal master induced pluripotent stem cell (iPSC) line engineered to express a proprietary CD19-targeting CAR, a novel high-affinity 158V, non-cleavable CD16 (hnCD16) Fc receptor, and a unique interleukin-15 receptor fusion (IL-15RF)."
The company's President and CEO Scott Wolchko commented, "We are pleased to have worked with the Masonic Cancer Center, University of Minnesota to treat the first patient with FT596...The COVID-19 pandemic presents unprecedented challenges for clinical trial conduct worldwide, and we anticipate there will be delays across our studies. We are committed to the health and safety of our employees and partners, and have implemented a remote work program to the greatest extent possible while continuing certain activities that can only be completed on-site. We are also working closely with our clinical sites and principal investigators so that we are well positioned to accelerate clinical trial execution when pressures on the health system ease."
The company also used the opportunity to provide an operational update on its response to the global COVID-19 pandemic. The firm stated that it has taken steps commensurate with CDC and the State of California guidelines to protect the health and safety of its employees and the community. The company added that it has implemented a work from home policy, and restricted on-site activities to certain manufacturing and necessary laboratory and support activities.
The company noted that it remains committed to its clinical programs and development plans though it does expect that the timelines of its ongoing clinical trials will be impacted somewhat by potential delays or disruptions due to the COVID-19 situation.
The firm indicated that "it continues to engage the U.S. Food and Drug Administration (FDA) and remains on-track to submit Investigational New Drug applications to the FDA for FT538, its off-the-shelf, iPSC-derived NK cell product candidate for multiple myeloma and for FT819, the company's first off-the-shelf, iPSC-derived CAR T-cell product candidate for B-cell malignancies in Q2/20."
The company explained that its proprietary induced pluripotent stem cell (iPSC) product platform, which is supported by more than 300 issued and 150 pending patents, "enables mass production of off-the-shelf, engineered, homogeneous cell products that can be administered with multiple doses to deliver more effective pharmacologic activity, including in combination with cycles of other cancer treatments." The firm stated in the report that "human iPSCs possess the unique dual properties of unlimited self-renewal and differentiation potential into all cell types of the body."
Fate Therapeutics is a clinical-stage biopharmaceutical company headquartered in San Diego, Calif., that specializes in developing cellular immunotherapies for cancer and immune disorders utilizing its using its proprietary induced pluripotent stem cell (iPSC) product platform. The company's listed that its immuno-oncology product candidates include natural killer (NK) cell and T-cell cancer immunotherapies and its immuno-regulatory product candidates include ProTmune™ that is currently being evaluated in a Phase 2 clinical trial for the prevention of graft-versus-host disease.
Fate Therapeutics has a market capitalization of around $1.8 billion with approximately 75.94 million shares outstanding and a short interest of about 13.7%. FATE shares opened 18% higher today at $24.90 (+$3.83, +18.189%) over yesterday's $21.07 closing price. The stock has traded today between $22.89 and $25.00 per share and is currently trading at $23.10 (+$2.03, +9.63%).
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 interview or the decision to write an article until three business days after the publication of the interview or 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.