Fate Therapeutics, Inc. FATE presented encouraging initial clinical and translational data from the first patient treated in its early-stage study on experimental pipeline candidate  FT819.

Data showed that the first patient suffering from active lupus nephritis (LN) and treated with FT819 had favorable clinical experience, achieved drug-free clinical remission and continued on-study free of all immunosuppressive therapy.

Shares gained 12.38% on the news data.

Shares of Fate have lost 42.8% year to date compared with the industry’s decline of 11.1%.

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FATE’s Six-Month Follow-up Data on FT819

FT819 is FATE’s off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8αβ+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking.

The ongoing multi-center phase I  study for patients with moderate-to-severe systemic lupus erythematosus (SLE) is designed to evaluate the safety, pharmacokinetics and anti-B cell activity of FT819 (NCT06308978).

The first three patients, all of whom presented with active LN despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning consisting of either cyclophosphamide alone or bendamustine alone, followed by a single dose of FT819 at 360 million cells.

Among these, a 27-year-old African American-Asian woman diagnosed with LN over ten years ago achieved DORIS (definition of remission in SLE) clinical remission and LLDAS (low lupus disease activity state) at follow-up after six months. The patient also experienced a resolution of fatigue, something that rheumatologists struggle to improve with other treatments.

This woman continues to be on study, in clinical remission, and free of all immunosuppressive therapies as of a data cutoff date of Nov. 11, 2024.

As of the same date, the patient did not experience any serious event or events of any grade of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome, or graft-versus-host disease.

The initial results are promising, and FATE believes this differentiated therapeutic approach has the potential to transform outcomes for patients with autoimmune diseases without requiring patient apheresis, discontinuation of maintenance therapy, intense conditioning chemotherapy and extended hospitalization.

FATE is also enrolling a second treatment arm under the FT819 phase I autoimmunity study to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. This new arm is being conducted with the study’s conditioning arm.

FATE’s Promising Pipeline

FATE is focused on developing and manufacturing universal, off-the-shelf cell products using its proprietary induced pluripotent stem cell product platform. Its immuno-oncology pipeline includes iPSC-derived natural killer cells and T-cell product candidates.

Fate is co-developing FT825/ONO-8250, a multiplexed-engineered, iPSC-derived CAR T-cell product candidate, with ONO Pharmaceutical. The company is conducting a multi-center, phase I study to assess the safety, pharmacokinetics and activity of FT825/ONO-8250 in patients with advanced solid tumors.

A phase I study of FT522 in patients with relapsed/refractory B-cell lymphoma is ongoing.

Zacks Rank & Stocks to Consider

FATE currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech sector are Immunocore Holdings plc IMCR,  Spero Therapeutics SPRO and Castle Biosciences, Inc. CSTL, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Immunocore’s 2024 loss per share have narrowed from $1.79 to 94 cents. Loss per share estimates for 2025 have narrowed from $2.35 to $1.57 during the same time frame. Year to date, shares of IMCR have lost 54.6%.

IMCR’s earnings beat estimates in two of the trailing four quarters and missed the same in the other two, the average surprise being 25.57%.

In the past 60 days, estimates for Spero Therapeutics’ 2024 loss per share have narrowed from $1.59 to $1.31. Estimates for 2025 loss per share have narrowed from $1.54 to $1.16. Year to date, shares of Spero Therapeutics have lost 20.4%.

Spero Therapeutics’ earnings beat estimates in two of the trailing four quarters and missed the mark on the other two occasions, delivering an average surprise of 94.42%.

In the past 60 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from 58 cents to 8 cents. Loss per share estimates for 2025 have narrowed from $2.13 to $1.88 during the same time frame. Year to date, shares of CSTL have surged 29.3%.

CSTL’s earnings beat estimates in each of the trailing four quarters, the average surprise being 172.72%.


 

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