GAITHERSBURG, Md. – Cartesian Therapeutics, a biotechnology firm listed on NASDAQ: RNAC, has initiated a Phase 2 clinical trial for its mRNA CAR-T cell therapy, Descartes-08, targeting systemic lupus erythematosus (SLE). The company announced today that the first patient has been dosed in the trial, which is investigating the safety and efficacy of the therapy in adults with moderate to severe SLE refractory to standard treatments.
Descartes-08 is an autologous therapy, meaning it is derived from the patient's own cells, and is designed to target the B-cell maturation antigen (BCMA). Unlike traditional DNA-based CAR-T therapies that require preconditioning chemotherapy, Descartes-08 is administered without such chemotherapy and is intended to avoid the risk of genomic integration and potential cancerous transformation.
The ongoing trial, which expects to enroll up to 30 patients, aims to provide a new outpatient treatment option for SLE, a chronic autoimmune disease affecting around 1.5 million people in the United States. Symptoms of SLE can be severe and life-threatening, impacting multiple organ systems.
The Phase 2 trial follows previous studies of Descartes-08 in treating myasthenia gravis (MG), where it exhibited a favorable safety profile suitable for outpatient administration. Dr. Carsten Brunn, President and CEO of Cartesian, expressed optimism for the therapy's potential to address the limitations of existing CAR-T cell therapies for autoimmune diseases.
Susan Manzi, M.D., M.P.H., Chair of the Medicine Institute at Allegheny Health Network (LON:NETW) and Medical Director for the Lupus Foundation of America, highlighted the significance of this milestone for the lupus community, given the limited effectiveness of current treatments.
Cartesian Therapeutics specializes in mRNA cell therapies for autoimmune diseases and has a pipeline that includes Descartes-15, another mRNA CAR-T therapy.
This article is based on a press release statement from Cartesian Therapeutics.
In other recent news, biotech firm Cartesian Therapeutics has secured a private investment in a public equity (PIPE) deal, expected to yield approximately $130 million. The financing round, which includes new and existing investors such as HBM Healthcare Investments and Invus, will advance the company's pipeline programs.
In another development, Cartesian Therapeutics reported positive outcomes from its Phase 2b trial of Descartes-08, a treatment for myasthenia gravis. The trial revealed a clinically meaningful improvement in 71% of patients treated with Descartes-08. The company plans to hold an End-of-Phase 2 meeting with the FDA by the end of 2024.
Mizuho Securities has resumed coverage on Cartesian Therapeutics shares, assigning a Buy rating and emphasizing the potential of its mRNA-based CAR-T technology in treating autoimmune diseases. Mizuho highlights the broad applicability of Cartesian's RNA cell therapy platform, which could extend to a range of autoimmune diseases.
These are among the recent developments for Cartesian Therapeutics.
InvestingPro Insights
As Cartesian Therapeutics advances its clinical trials for Descartes-08, the financial health and market performance of the company, trading under NASDAQ: RNAC, offer critical insights for investors. According to recent data from InvestingPro, Cartesian holds a market capitalization of $431.91 million, indicative of its size and market value within the biotechnology sector. The company's financial metrics reflect challenges, with a negative price-to-earnings (P/E) ratio of -0.45, suggesting that investors are currently facing losses relative to the company's earnings.
InvestingPro Tips for Cartesian reveal a mixed outlook. On the positive side, the company holds more cash than debt, providing a buffer for operational flexibility. Additionally, liquid assets exceed short-term obligations, which could be crucial in funding ongoing research and trials without immediate liquidity concerns. However, analysts anticipate a sales decline in the current year and do not expect the company to be profitable within this timeframe. Moreover, Cartesian suffers from weak gross profit margins, which could impact its ability to fund future projects or expand its pipeline effectively.
Investors tracking Cartesian's stock performance will note that while the stock has fared poorly over the last month with a -30.1% return, it has shown a strong return over the last three months at 52.61%. This volatility might reflect market reactions to developments within the company and the biotech industry at large. It's also noteworthy that Cartesian does not pay dividends, which could influence investment decisions for those seeking regular income streams from their stock holdings.
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