First lupus patient in remission with novel CAR T-cell therapy

SAN DIEGO – Fate Therapeutics Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company, announced that a lupus nephritis patient has achieved clinical remission after treatment with its innovative CAR T-cell therapy, FT819. The 27-year-old patient, who has been battling the disease for over a decade, experienced remission without the need for ongoing immunosuppressive drugs.

The patient was part of a Phase 1 Autoimmunity study for systemic lupus erythematosus (SLE), receiving a single dose of FT819 following a fludarabine-free conditioning regimen. As of a November 11, 2024 data cutoff, the patient remains free from serious adverse events and immune-related complications such as cytokine release syndrome (CRS) and graft-versus-host disease (GvHD).

Dr. Jennifer Medlin, Principal Investigator at the University of Nebraska Medical (TASE:PMCN) Center, highlighted the remarkable resolution of fatigue and expressed optimism for the therapy's potential in treating severe lupus cases. The patient's clinical remission was assessed by DORIS (definition of remission in SLE) and low lupus disease activity state (LLDAS) criteria, with significant improvements observed in arthritis, urinary sediment, and proteinuria.

The treatment also resulted in a rapid depletion of aberrant B cells, with a reconstituted B cell compartment showing a healthy profile, suggesting an immune reset. These findings were presented at the American College of Rheumatology (ACR) Convergence in Washington, D.C.

Fate Therapeutics' ongoing Phase 1 trial (NCT06308978) is evaluating the safety, pharmacokinetics, and anti-B cell activity of FT819 in patients with moderate-to-severe SLE. The company has also initiated a second treatment arm to assess FT819 as an add-on to maintenance therapy without conditioning chemotherapy.

The company's proprietary induced pluripotent stem cell (iPSC) product platform has been instrumental in developing FT819. This platform enables the manufacture of uniform cell products that can be stored for off-the-shelf availability, potentially serving a broad patient population.

Further clinical and translational data from the initial patients are expected to be presented at the American Society of Hematology (ASH) Annual Meeting from December 7-10. This news is based on a press release statement from Fate Therapeutics.

In other recent news, Fate Therapeutics reported earnings results for the first quarter of 2024, revealing a net loss of $0.47 per share, closely aligning with the anticipated net loss of $0.46 per share. The company's collaboration revenue for the quarter was reported at $1.9 million, nearly double the forecasted $1.0 million. In addition to financial updates, Fate Therapeutics announced that initial data from its clinical trials will be presented at upcoming conferences. This includes data from three lupus nephritis patients treated with their FT819 product and a systemic lupus erythematosus patient.

BMO Capital Markets has adjusted its outlook on Fate Therapeutics, revising the price target downward to $5.00 from the previous $6.00, while maintaining a Market Perform rating. Piper Sandler upgraded the company's stock from Neutral to Overweight. These adjustments by analysts are based on recent developments within the company.

Fate Therapeutics has also made strides in its clinical trials, focusing on immunotherapies FT819 for systemic lupus erythematosus and FT825 for solid tumors. The company's FT522 program in blood cancer was highlighted for its strong proof of concept data. In governance news, Fate Therapeutics updated its indemnification agreements for directors and officers, enhancing clarity and specificity. The company also announced the appointment of Dr. Neely Mozaffarian, an experienced immunologist, to its Board of Directors. These are among the recent developments shaping the company's trajectory.

InvestingPro Insights

While Fate Therapeutics (NASDAQ:FATE) is making significant strides in clinical trials with its innovative CAR T-cell therapy, FT819, the company's financial health presents a mixed picture. According to InvestingPro data, Fate Therapeutics has a market capitalization of $230.07 million, reflecting investor interest in its potential breakthrough treatments.

However, the company faces financial challenges. An InvestingPro Tip indicates that Fate Therapeutics is "quickly burning through cash," which is not uncommon for clinical-stage biopharmaceutical companies investing heavily in research and development. This cash burn rate is particularly relevant given the ongoing clinical trials and the potential need for further funding to bring FT819 to market.

On a positive note, another InvestingPro Tip reveals that the company "holds more cash than debt on its balance sheet," which could provide some financial flexibility as it continues its clinical programs. This strong cash position may be crucial for supporting ongoing research and development efforts, including the expansion of the FT819 trials.

The stock's recent performance has been challenging, with InvestingPro data showing a 37.46% price decline over the past month and a 40.59% drop over the last three months. This volatility may reflect investor uncertainty about the company's path to profitability and the timeline for potential FDA approvals.

For investors seeking a more comprehensive analysis, InvestingPro offers 14 additional tips for Fate Therapeutics, providing a deeper understanding of the company's financial position and market performance.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.