Cartesian Therapeutics will present updated Phase 2b trial data for Descartes-08 at an upcoming cell therapy summit.
Quiver AI Summary
Cartesian Therapeutics, Inc. announced that it will present updated efficacy and safety data from its Phase 2b trial of Descartes-08, an mRNA cell therapy for generalized myasthenia gravis, at the 2nd Annual Cell Therapy for Autoimmune Disease Summit in Philadelphia from December 2-4, 2024. Dr. Miloš Miljković, the company’s Chief Medical Officer, will lead the presentation on December 3, followed by a conference call and webcast to discuss the findings and details of a planned Phase 3 trial, also on December 3. Descartes-08 is a promising therapeutic candidate that has received various designations from the FDA, and Cartesian Therapeutics is focused on developing mRNA cell therapies for autoimmune diseases.
Potential Positives
- Updated efficacy and safety data from the Phase 2b trial of Descartes-08, targeting generalized myasthenia gravis, will be presented at a notable summit, highlighting the company's commitment to addressing significant autoimmune diseases.
- The presentation and subsequent conference call will feature key opinion leaders, enhancing the credibility and visibility of Cartesian Therapeutics in the medical community.
- Descartes-08 has received multiple designations from the FDA, including Orphan Drug and Regenerative Medicine Advanced Therapy designations, indicating its potential significance in treating rare diseases.
Potential Negatives
- Potential delays in regulatory approvals may hinder the advancement of their therapies, impacting their market presence and investor confidence.
- The statement about challenges and uncertainties in clinical trials could raise concerns about the reliability of their product development and timelines.
- The company’s reliance on third parties for conducting clinical trials poses risks that could affect the integrity and outcome of their trials.
FAQ
What is Descartes-08 and its significance?
Descartes-08 is an mRNA CAR-T therapy targeting B-cell maturation antigen, in development for autoimmune diseases like myasthenia gravis.
When will Cartesian Therapeutics present updated trial data?
Updated efficacy and safety data will be presented on December 3, 2024, at the Cell Therapy for Autoimmune Disease Summit.
How can I access the conference call for updates?
The conference call can be accessed by dialing 1-800-715-9871 or through a live audio webcast on Cartesian's website.
What designations has Descartes-08 received from the FDA?
Descartes-08 has received Orphan Drug Designation, Regenerative Medicine Advanced Therapy Designation, and Rare Pediatric Disease Designation from the FDA.
Who will present at the upcoming summit?
Miloš Miljković, M.D., Chief Medical Officer of Cartesian Therapeutics, will present at the summit on December 3, 2024.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$RNAC Insider Trading Activity
$RNAC insiders have traded $RNAC stock on the open market 27 times in the past 6 months. Of those trades, 17 have been purchases and 10 have been sales.
Here’s a breakdown of recent trading of $RNAC stock by insiders over the last 6 months:
- METIN KURTOGLU (Chief Technology Officer) has traded it 5 times. They made 0 purchases and 5 sales, selling 82,368 shares.
- TIMOTHY A SPRINGER has traded it 16 times. They made 16 purchases, buying 645,677 shares and 0 sales.
- MILOS MILJKOVIC (Chief Medical Officer) has traded it 2 times. They made 0 purchases and 2 sales, selling 55,000 shares.
- CHRISTOPHER M JEWELL (Chief Scientific Officer) has traded it 3 times. They made 0 purchases and 3 sales, selling 52,115 shares.
- TIMOTHY C BARABE purchased 7,500 shares.
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Full Release
FREDERICK, Md., Nov. 21, 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 updated efficacy and safety data from the Phase 2b trial of Descartes-08 in patients with generalized myasthenia gravis will be presented at the 2 nd Annual Cell Therapy for Autoimmune Disease Summit, being held December 2-4, 2024 in Philadelphia.
Details of the presentation are as follows:
- Title: Perspectives on Bringing Cell Therapies to the Autoimmune Space: From Concept to Clinic
- Session Name: Diving into Challenges & Successes in the Autoimmune Space to Direct Future Outcomes
- Presenter: Miloš Miljković, M.D., M.Sc., Chief Medical Officer, Cartesian Therapeutics
- Session Date/Time: Tuesday, December 3, 2024, 9:30-10:00 a.m. ET
Conference Call and Webcast
The Company will host a conference call and webcast to discuss the updated data, as well as details regarding the design of its planned Phase 3 trial, on Tuesday, December 3, 2024, at 7:30 a.m. ET. Joining members of the Cartesian management team will be key opinion leader James F. Howard Jr., M.D., Professor of Neurology, Medicine, and Allied Health at the University of North Carolina School of Medicine.
To access the conference call, please dial 1-800-715-9871 (toll-free) or 1-646-307-1963 (international) at least 10 minutes prior to the start time and ask to be joined into the Cartesian Therapeutics call. The live audio webcast, along with accompanying slides, can be accessed on the Events & Presentations section of Cartesian’s website at https://ir.cartesiantherapeutics.com/news-and-events/events-presentations . A replay of the webcast will be available for a limited time following the event on Cartesian’s website.
About Descartes-08
Descartes-08, Cartesian’s lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy (mRNA CAR-T) product targeting B-cell maturation antigen (BCMA) in clinical development for generalized myasthenia gravis (MG) and systemic lupus erythematosus. In contrast to conventional DNA-based CAR T-cell therapies, mRNA CAR-T administration is designed to not require preconditioning chemotherapy, can be administered in the outpatient setting, and does not carry the risk of genomic integration associated with cancerous transformation. Descartes-08 has been granted Orphan Drug Designation and Regenerative Medicine Advanced Therapy Designation by the U.S. Food and Drug Administration for the treatment of MG, and Rare Pediatric Disease Designation for the treatment of juvenile dermatomyositis.
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 an mRNA CAR-T in Phase 2b clinical development for patients with generalized myasthenia gravis and Phase 2 development for systemic 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 observations and data from the myasthenia gravis Phase 2b trial, the ability of the Company’s product candidates to be administered in an outpatient setting or without the need for preconditioning lymphodepleting chemotherapy, the potential of Descartes-08, Descartes-15, or any of the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, juvenile dermatomyositis, 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 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 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
Blaine Davis
Chief Financial Officer
[email protected]
Media Contact
David Rosen
Argot Partners
[email protected]