Cartesian Therapeutics Announces First Patient Dosed in First-In-Human Phase 1 Trial of Next-Generation mRNA CAR-T Cell Therapy Descartes-15

Rhea-AI Summary

Cartesian Therapeutics (NASDAQ: RNAC) has dosed the first patient in a Phase 1 trial of Descartes-15, its next-generation autologous anti-BCMA mRNA CAR-T cell therapy. Designed for outpatient administration without preconditioning chemotherapy, Descartes-15 showed a ten-fold increase in CAR expression and target-specific killing compared to Descartes-08 in preclinical studies. The trial (NCT06304636) will evaluate safety and tolerability in multiple myeloma patients. CEO Carsten Brunn highlighted the therapy's potential for autoimmune diseases with high unmet need. Descartes-15 features enhanced CAR stability and predictable pharmacokinetics, positioning it as a potentially potent next-generation cell therapy.

Positive

• First patient dosed in Phase 1 trial of Descartes-15, advancing the mRNA CAR-T program
• Descartes-15 showed ten-fold increase in CAR expression and target-specific killing in preclinical studies
• Designed for outpatient administration without preconditioning chemotherapy, potentially improving patient experience
• Potential application in autoimmune diseases with high unmet need

Negative

• Early-stage clinical trial (Phase 1) with no efficacy data in humans yet
• Potential competition in the CAR-T and autoimmune disease treatment markets

Biotechnology Research Analyst

The initiation of the Phase 1 trial for Descartes-15 marks a significant milestone in Cartesian Therapeutics' mRNA CAR-T cell therapy development. The ten-fold increase in CAR expression and target-specific killing observed in preclinical studies is particularly noteworthy, potentially indicating enhanced efficacy compared to its predecessor, Descartes-08.

Key advantages of Descartes-15 include its outpatient administration without preconditioning chemotherapy, which could significantly improve patient experience and reduce healthcare costs. The therapy's predictable pharmacokinetics and enhanced CAR stability may lead to improved safety profiles and more consistent treatment outcomes.

While initially targeting multiple myeloma, the company's plan to expand into autoimmune indications represents a strategic move to address high unmet medical needs and potentially broaden the market opportunity for this technology platform.

Financial Analyst

This clinical milestone could have positive implications for Cartesian Therapeutics' financial outlook. The advancement of Descartes-15 into human trials diversifies the company's pipeline and potentially de-risks its overall portfolio. If successful, the therapy's outpatient administration could lead to cost efficiencies and improved market adoption, potentially translating to higher profit margins.

Investors should note the potential for expanded market opportunities in both oncology and autoimmune diseases. This dual-market strategy could significantly increase the addressable patient population and, consequently, the therapy's commercial potential. However, it's important to remember that early-stage clinical trials carry inherent risks and success is not guaranteed.

The company's NASDAQ listing (RNAC) provides liquidity for investors and could facilitate future capital raises to support ongoing research and development efforts.

Medical Research Analyst

The development of Descartes-15 represents a significant advancement in mRNA CAR-T cell therapy. The reported ten-fold increase in CAR expression and selective target-specific killing in preclinical studies is remarkable and could potentially translate to improved clinical outcomes for patients.

The ability to administer the therapy without preconditioning chemotherapy is a major advantage, as it could reduce treatment-related toxicities and improve patient quality of life. Additionally, the enhanced CAR stability in the presence of target-driven suppression addresses a key challenge in CAR-T cell therapy, potentially leading to more durable responses.

The planned expansion into autoimmune indications is particularly intriguing, as it could open new frontiers in the treatment of chronic diseases that currently lack effective therapies. However, careful monitoring of safety profiles in these new indications will be crucial.

Descartes-15 observed to achieve an approximately ten-fold increase relative to Descartes-08 in CAR expression and selective target-specific killing in preclinical studies

GAITHERSBURG, Md., Sept. 03, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company”), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced that the first patient has been dosed in its first-in-human Phase 1 trial of Descartes-15, the Company’s next-generation autologous anti-B cell maturation antigen (BCMA) mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T).

“Advancement of Descartes-15 into the clinic marks an important step forward in our mission to deliver innovative mRNA cell therapies to patients with autoimmune diseases,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We believe that Descartes-15, which was designed leveraging our novel mRNA platform, could serve as a highly potent next-generation cell therapy with the ability to be dosed in the outpatient setting without preconditioning chemotherapy. We look forward to advancing this important program into development for autoimmune indications with high unmet need.”

Descartes-15 is designed to have predictable and controllable pharmacokinetics, including technological advances that enhance CAR stability even in the presence of target-driven suppression of CAR. Similar to Descartes-08, the Company’s lead product candidate, Descartes-15 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors. Relative to Descartes-08, Descartes-15 has been observed to achieve an approximately ten-fold increase in CAR expression and selective target-specific killing in preclinical studies.

The Phase 1 dose escalation trial (NCT06304636) will assess the safety and tolerability of outpatient Descartes-15 administration in patients with multiple myeloma. Following the Phase 1 dose escalation trial, the Company expects to subsequently assess Descartes-15 in autoimmune indications.

About Cartesian Therapeutics

Cartesian Therapeutics is a clinical-stage company pioneering mRNA cell therapies for the treatment of autoimmune diseases. The Company’s lead asset, Descartes-08, is a potential first-in-class mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systematic lupus erythematosus, with a Phase 2 basket trial planned in additional autoimmune indications. The Company’s clinical-stage pipeline also includes Descartes-15, a next-generation, autologous anti-BCMA mRNA CAR-T. For more information, please visit www.cartesiantherapeutics.com or follow the Company on LinkedIn or X, formerly known as Twitter.

Forward Looking Statements

Any statements in this press release about the future expectations, plans and prospects of the Company, including without limitation, statements regarding the ability of Descartes-15 and Descartes-08 to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the Company’s in-house manufacturing capabilities, the potential of the Company’s technology to enable precision control and optimization of engineered cells for diverse cell therapies leveraging multiple modalities, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, multiple myeloma, or any other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, the Company’s ability to conduct its clinical trials and preclinical studies, the timing or making of any regulatory filings, the anticipated timing or outcome of selection of developmental product candidates, the ability of the Company to consummate any expected agreements and licenses and to realize the anticipated benefits thereof, the novelty of treatment paradigms that the Company is able to develop, the potential of any therapies developed by the Company to fulfill unmet medical needs, and enrollment in the Company’s clinical trials and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “hypothesize,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including, but not limited to, the following: the uncertainties inherent in the initiation, completion and cost of clinical trials including proof of concept trials, including uncertain outcomes, the availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a particular clinical trial will be predictive of the final results of that trial and whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, the ability to predict results of studies performed on human beings based on results of studies performed on non-human subjects, the unproven approach of the Company’s technology, potential delays in enrollment of patients, undesirable side effects of the Company’s product candidates, its reliance on third parties to conduct its clinical trials, the Company’s inability to maintain its existing or future collaborations, licenses or contractual relationships, its inability to protect its proprietary technology and intellectual property, potential delays in regulatory approvals, the availability of funding sufficient for its foreseeable and unforeseeable operating expenses and capital expenditure requirements, the Company’s recurring losses from operations and negative cash flows, substantial fluctuation in the price of the Company’s common stock, risks related to geopolitical conflicts and pandemics and other important factors discussed in the “Risk Factors” section of the Company’s most recent Annual Report on Form 10-K and subsequently filed Quarterly Reports on Form 10-Q, and in other filings that the Company makes with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent the Company’s views only as of the date of its publication and should not be relied upon as representing its views as of any subsequent date. The Company specifically disclaims any intention to update any forward-looking statements included in this press release, except as required by law.

Investor Contact
Melisssa Forst
Argot Partners
cartesian@argotpartners.com 

Media Contact
David Rosen
Argot Partners
david.rosen@argotpartners.com 

FAQ

What is Descartes-15 and how does it differ from Descartes-08?

Descartes-15 is Cartesian Therapeutics' next-generation autologous anti-BCMA mRNA CAR-T cell therapy. It showed a ten-fold increase in CAR expression and target-specific killing compared to Descartes-08 in preclinical studies. Both are designed for outpatient administration without preconditioning chemotherapy.

What is the current stage of clinical development for Descartes-15 (RNAC)?

Cartesian Therapeutics has just dosed the first patient in a Phase 1 clinical trial (NCT06304636) for Descartes-15. The trial will assess safety and tolerability in multiple myeloma patients.

What are the potential applications of Descartes-15 beyond multiple myeloma?

Following the Phase 1 trial in multiple myeloma, Cartesian Therapeutics plans to assess Descartes-15 for autoimmune indications with high unmet medical needs.

What are the key features of Descartes-15 that make it potentially advantageous?

Descartes-15 is designed for outpatient administration without preconditioning chemotherapy, has enhanced CAR stability, and showed increased CAR expression and target-specific killing in preclinical studies. It also has predictable and controllable pharmacokinetics.