Cartesian Therapeutics Establishes New Corporate Headquarters and State-of-the-Art mRNA Cell Therapy cGMP Manufacturing Facility in Frederick, Maryland
- Cartesian Therapeutics is transitioning its corporate headquarters to Frederick, Maryland.
- The new facility will support expanded cGMP manufacturing of mRNA cell therapies for autoimmune diseases.
- The facility has clinical and commercial manufacturing scale capabilities to support the company's pipeline of innovative mRNA cell therapies.
- The move will allow Cartesian to scale its in-house cGMP manufacturing capabilities for late-stage clinical and commercial supply.
- Cartesian's mRNA cell therapies are designed for convenient and safe administration in an outpatient setting without chemotherapy.
- Topline data from the Phase 2b study of Descartes-08 in myasthenia gravis is expected in mid-2024.
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The announcement by Cartesian Therapeutics regarding the transition to a new cGMP compliant facility is a strategic move that could have significant financial implications. The facility's increased capacity for clinical and commercial manufacturing of mRNA cell therapies positions the company to meet anticipated demand, which can lead to increased revenue streams upon successful product launches. The location within the I-270 Biotech Corridor could provide access to a rich talent pool and potential collaborations, potentially driving down research and development costs while accelerating innovation.
Investors should note the timing of this expansion aligns with the expected release of topline data from the Phase 2b study of Descartes-08 in myasthenia gravis. Positive results could lead to an uptick in investor confidence and stock valuation, while negative outcomes may have the opposite effect. The ability to scale manufacturing in-house is a critical factor in maintaining control over production costs and product quality, which can directly impact the company's gross margins and long-term profitability.
Cartesian's focus on mRNA cell therapies for autoimmune diseases represents a cutting-edge approach in the biotech industry. The transition to a new facility signifies an advancement from early to late-stage clinical development, which is a pivotal moment for biotech companies. The in-house cGMP manufacturing capabilities are essential for ensuring the quality and consistency of therapies, which is particularly important in the highly regulated pharmaceutical industry.
As the first randomized placebo-controlled trial of cell therapy in autoimmunity, the Descartes-08 study in myasthenia gravis holds considerable scientific interest. Should the study yield positive results, it could establish a new treatment paradigm in autoimmunity, potentially disrupting current standards of care. This could significantly expand the market potential for Cartesian's therapies, given the unmet medical needs in autoimmune diseases.
The expansion of Cartesian's manufacturing capabilities is a proactive measure to anticipate the needs of a growing market for autoimmune disease treatments. The autoimmune disease therapeutics market is expanding, with a growing prevalence of autoimmune disorders and an increasing demand for biologics. Cartesian's strategic investment in infrastructure could position the company favorably against competitors, especially in the niche area of mRNA cell therapies.
Understanding the competitive landscape, the move to a cGMP facility may offer Cartesian a competitive edge in terms of speed to market and cost-efficiency. The biotech sector is highly competitive and companies that can streamline their operations to rapidly produce and deliver high-quality products at a lower cost are more likely to succeed. Additionally, the company's location in the I-270 Biotech Corridor could facilitate partnerships and collaborations that may enhance its market position and visibility.
New facility expected to support expanded cGMP manufacturing of clinical and commercial supply of Company’s pipeline of mRNA cell therapies for the treatment of autoimmune diseases
GAITHERSBURG, Md., March 05, 2024 (GLOBE NEWSWIRE) -- Cartesian Therapeutics, Inc. (NASDAQ: RNAC), a clinical-stage biotechnology company pioneering mRNA cell therapy for autoimmune diseases, today announced its plans to transition its corporate headquarters to Frederick, Maryland. The approximately 20,000 square foot state-of-the-art current good manufacturing practice (cGMP) compliant facility has clinical and commercial manufacturing scale capabilities designed to support the Company's maturing pipeline of innovative mRNA cell therapies for the treatment of autoimmune diseases.
“Our new headquarters and manufacturing facility will provide us with the infrastructure to support our next phase of growth while allowing us to remain in the vibrant I-270 Biotech Corridor community,” said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “Importantly, we believe the new facility will allow us to scale our wholly-owned, in-house cGMP manufacturing capabilities for late-stage clinical and commercial supply of our mRNA cell therapy product candidates, while continuing to maintain control over product quality and production. We look forward to relocating to Frederick as we continue to work toward our mission of expanding the reach of cell therapy to patients with autoimmune diseases.”
Cartesian’s internally manufactured portfolio of mRNA cell therapies is purposefully designed to expand the reach of cell therapy to autoimmunity with product candidates that have the potential to be administered conveniently and safely in an outpatient setting without lymphodepletion chemotherapy. Topline data from the Phase 2b study of Descartes-08 in myasthenia gravis (MG) is expected in mid-2024. This is the first randomized placebo-controlled trial of cell therapy in autoimmunity.
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. Additional Phase 2 studies are planned in systemic lupus erythematosus under an allowed IND, as well as basket trials 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 Company’s headquarters relocation, the Company’s manufacturing capabilities and ability to supply necessary quantities of its product candidates for clinical trials and potential commercialization, the Company’s ability to maintain control over its product quality and production, the potential of Descartes-08 and Descartes-15 and the Company’s other product candidates to treat myasthenia gravis, systemic lupus erythematosus, 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, 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 RNA Armory® 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 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.
Contact Information:
Investor Relations:
Melissa Forst
Argot Partners
cartesian@argotpartners.com
Media:
David Rosen
Argot Partners
david.rosen@argotpartners.com
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