Cartesian Therapeutics (RNAC) licenses in vivo CAR-T delivery tech from WestGene
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Cartesian Therapeutics entered a strategic licensing agreement with WestGene Biopharma to develop novel in vivo CAR-T therapies for autoimmune diseases. The collaboration combines Cartesian’s mRNA payload from Descartes-08 with WestGene’s targeted lipid nanoparticle platform.
WestGene’s in vivo mRNA CAR-T platform has early clinical data showing favorable safety, including repeated dosing of up to 14 infusions in a single patient with only one Grade 1 cytokine release syndrome event reported. The partners plan a Phase 1 dose-escalation study in generalized myasthenia gravis using mRNA from Descartes-08 delivered via WestGene’s nanoparticles, with trial initiation expected in the second half of 2026 and first clinical data expected in the first half of 2027.
Positive
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Negative
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8-K Event Classification
2 items: 7.01, 9.01
2 items
Item 7.01
Regulation FD Disclosure
Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Repeated doses: up to 14 doses
Clinical trial start: 2H 2026
First clinical data: 1H 2027
+2 more
5 metrics
Repeated doses
up to 14 doses
Repeated administration in a single patient with WestGene’s platform
Clinical trial start
2H 2026
Expected initiation of Phase 1 in generalized myasthenia gravis
First clinical data
1H 2027
Expected initial in-human data from in vivo CAR-T program
Adverse events
one Grade 1 CRS
Only Grade 1 cytokine release syndrome case reported in WestGene studies
Descartes-08 stage
Phase 3, Phase 2, Phase 1/2
Ongoing trials in MG, myositis and pediatric autoimmune diseases
Key Terms
in vivo chimeric antigen receptor T-cell (CAR-T) therapies, targeted lipid nanoparticle (tLNP) platform, Bayesian Optimal Interval (BOIN) adaptive design, cytokine release syndrome (CRS), +1 more
5 terms
in vivo chimeric antigen receptor T-cell (CAR-T) therapies medical
"to advance the development of novel in vivo chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases"
targeted lipid nanoparticle (tLNP) platform technical
"using mRNA CAR‑T constructs delivered via its targeted lipid nanoparticle (tLNP) platform"
Bayesian Optimal Interval (BOIN) adaptive design technical
"using a Bayesian Optimal Interval (BOIN) adaptive design with a comprehensive translational assessment package"
cytokine release syndrome (CRS) medical
"Only one subject experienced Grade 1 cytokine release syndrome (CRS)"
An excessive immune reaction in which the body’s defense system releases large amounts of inflammatory signals (cytokines) all at once, like an overactive alarm system that triggers too many responders and causes collateral damage. It matters to investors because this side effect can halt clinical trials, prompt safety warnings or recalls, and increase development costs and regulatory scrutiny for drugs or therapies, affecting a company’s valuation and future revenue prospects.
BCMA-directed T-cell engager (TCE) medical
"and a BCMA-directed T-cell engager (TCE) as part of its expanding mRNA payload portfolio"
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): June 9, 2026
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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(Address of principal executive offices)(Zip Code)
(301 ) 348-8698
Registrant’s telephone number, including area code
N/A
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the
following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Securities registered pursuant to Section 12(b) of the Act:
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Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new
or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 7.01 |
Regulation FD Disclosure.
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On June 9, 2026, Cartesian Therapeutics, Inc. (the “Company”) issued a press release announcing its entry into a strategic licensing
agreement with WestGene Biopharma Co. (“WestGene”) to advance the development of novel in vivo chimeric antigen receptor T-cell (“CAR-T”) therapies in autoimmune diseases. A copy of the press release is attached as Exhibit 99.1 to this Current
Report on Form 8-K.
The information in Item 7.01 of this Form 8-K, including Exhibit 99.1 attached hereto, shall not be deemed “filed” for purposes of
Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as
amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1, except as required by law.
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Financial Statements and Exhibits.
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(d) Exhibits
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Exhibit No.
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Exhibit Description
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99.1
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Press release of
Cartesian Therapeutics, Inc. issued on June 9, 2026.
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104
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Cover Page Interactive Data File (embedded within the Inline XBRL document)
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its
behalf by the undersigned hereunto duly authorized.
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CARTESIAN THERAPEUTICS
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Date: June 9, 2026
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By:
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/s/ Carsten Brunn, Ph.D.
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Carsten Brunn, Ph.D.
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President, Chief Executive Officer and Chairman of the Board
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Exhibit 99.1
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Cartesian Therapeutics Announces Strategic Licensing Agreement with WestGene Biopharma to Accelerate the Development of In Vivo CAR-T Platform
in Autoimmune Diseases
WestGene’s established targeted LNP platform combined with Cartesian’s mRNA payload from Descartes-08 integrates two independently, clinically
tested technologies for rapid clinical translation
Plans to advance multiple Cartesian-owned, internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed TCE as part of
expanding mRNA payload portfolio
Clinical trial expected to initiate in 2H 2026 using mRNA payload from Descartes-08 combined with WestGene’s LNP
platform in patients with MG; Clinical data expected in 1H 2027
FREDERICK, MD, June 9, 2026 (GLOBE NEWSWIRE) – Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (the “Company” or “Cartesian”), a late clinical-stage biotechnology
company pioneering cell therapy for autoimmune diseases, today announced a strategic licensing agreement with WestGene Biopharma Co., Ltd. (“WestGene”) to advance the
development of novel in vivo chimeric antigen receptor T-cell (CAR-T) therapies in autoimmune diseases.
“Building on our leadership in autologous cell therapy in autoimmune disease, we are partnering with WestGene to extend our mRNA payloads into in vivo delivery,”
said Carsten Brunn, Ph.D., President and Chief Executive Officer of Cartesian. “We believe that the potential for in vivo to further enhance the delivery of cell therapies in the field of autoimmune disease provides a compelling commitment to
scientific innovation. This partnership provides an accelerated and efficient path to human clinical data with expected proof-of-concept being evaluated in patients with myasthenia gravis. With positive clinical data, we intend to advance
programs across multiple autoimmune diseases into U.S. clinical development. We believe this collaboration has the potential to further transform the treatment paradigm for cell therapy in autoimmune diseases.”
WestGene has previously conducted clinical studies in the fields of oncology and autoimmune diseases using mRNA CAR‑T constructs delivered via its targeted lipid nanoparticle (tLNP) platform, establishing early proof of concept for its in vivo approach. Across multiple dosing regimens, including repeated administration of up
to 14 doses in a single patient, the therapy demonstrated a favorable safety and tolerability profile, with no dose-limiting toxicities (DLTs), serious adverse events (SAEs), immune effector cell-associated neurotoxicity syndrome (ICANS), or
infusion-related reactions (IRRs) reported. Only one subject experienced Grade 1 cytokine release syndrome (CRS). Clinical data demonstrated robust in vivo CAR-T generation following administration, including high levels of circulating CD8⁺
CAR-T cells and rapid, sustained B-cell depletion. Importantly, CAR expression and biological activity were maintained following repeat dosing, supporting the potential for long-term, multi-cycle administration without evidence of diminished
pharmacologic activity. The underlying ionizable lipid technology has shown preferential uptake in CD8⁺ T cells in vivo and a consistent tolerability profile, collectively reinforcing the potential of WestGene’s platform to deliver consistent
biologic activity and serving as a validated vehicle for advancing additional programs, including Cartesian’s anti‑BCMA approach.
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Cartesian is partnering with WestGene to conduct a Phase 1 dose-escalation study of the mRNA used in Descartes-08 delivered via WestGene’s proprietary targeted
lipid nanoparticles (tLNPs) in patients with generalized myasthenia gravis. IV infusions will be administered across multiple dose levels using a Bayesian Optimal Interval (BOIN) adaptive design with a comprehensive translational assessment
package including clinical response measures. The program represents a novel in vivo approach to BCMA-directed T-cell engineering that, if successful, could eliminate the ex vivo manufacturing step.
In addition to Descartes-08, Cartesian’s tested CAR construct with the potential to be evaluated initially with the WestGene LNP delivery platform, Cartesian is
also planning to advance multiple internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed T-cell engager (TCE) as part of its expanding mRNA payload portfolio. The WestGene partnership is designed to provide an
efficient framework to move additional Cartesian payloads into human trials, extending the platform’s potential to generate clinical proof-of-concept data across multiple programs in several disease states.
“We are thrilled to partner with Cartesian, which we believe to be the most clinically advanced mRNA CAR-T company, whose validated payloads complement
WestGene’s targeted LNP delivery platform,” said Xiangrong Song, Ph.D., Co-Founder and CEO of WestGene. “WestGene brings the early clinical infrastructure to rapidly evaluate Cartesian’s constructs in vivo, and we
believe this collaboration has the potential to meaningfully advance the treatment of autoimmune diseases.”
Under the terms of the agreement, WestGene will receive an upfront payment and is eligible to receive potential development and commercial based milestone
payments. This clinical study is expected to initiate in 2H 2026 with in-human data expected in 1H 2027.
This strategic collaboration between Cartesian and WestGene was facilitated by Uni-Pioneers, BioMed., Inc. (“Uni-Pioneers”), a Chapel Hill-based firm
specializing in strategic partnership, cross-border venture creation, deal-making, and alliance building. Leveraging its expertise, Uni-Pioneers worked closely with both Cartesian and WestGene to structure a partnership that has the potential
to accelerate the path to clinical proof of concept of in vivo CAR-T and TCE therapies in autoimmune diseases.
About Cartesian Therapeutics
Cartesian Therapeutics is a late clinical-stage company pioneering cell therapy for the treatment of autoimmune diseases. The Company’s
lead asset, Descartes-08, is a CAR-T in Phase 3 clinical development for patients with generalized myasthenia gravis, Phase 2 clinical development in myositis, specifically dermatomyositis and antisynthetase syndrome, and in Phase 1/2
clinical development for pediatric autoimmune diseases, including juvenile dermatomyositis. For more information, please visit www.cartesiantherapeutics.com or follow the
Company on LinkedIn or X.
About WestGene Biopharma
WestGene Biopharma is a clinical-stage biotechnology company focused on nano-delivery (LNP/tLNP) and next-generation mRNA therapeutics. The company has developed
proprietary LNP delivery platforms and RNA engineering technologies to enable applications across oncology, autoimmune diseases, infectious diseases, metabolic disorders, and in vivo cell therapies. The Company’s nano-adjuvant WGa0401 has
launched under EUA. The lead mRNA asset, WGc-043, is a tumor vaccine in Phase 1 clinical development for patients with Epstein-Barr virus associated tumors including solid tumors and hematologic malignancies. For
more information, please visit www.westgenepharma.com or follow the Company on LinkedIn.
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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
partnership and strategic licensing agreement between the Company and WestGene and the ability of the Company and WestGene to develop therapies, treat disease, extend mRNA payloads into in vivo delivery, the integration and complementary
nature of the Company’s product candidates and WestGene’s LNP platform, the speed and efficiency of the development pathway for collaboration products between the Company and WestGene, the ability of the Company and its partnership with
WestGene to generate clinical proof-of-concept data across multiple programs in several disease states, the ability of the Company and its partnership with WestGene to advance multiple internally developed next-generation anti-BCMA CAR
constructs and a BCMA-directed T-cell engager (TCE) and the speed at which these constructs and TCE are developed, statements regarding the Company’s expected cash resources and cash runway, 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, or any of the Company’s other product candidates to treat MG, juvenile MG, myositis, JDM, or any
other disease, the anticipated timing or the outcome of ongoing and planned clinical trials, studies and data readouts, including the ongoing Phase 3 AURORA trial of Descartes-08 in MG, the ongoing Phase 2 TRITON trial of Descartes-08 in
myositis, and the ongoing Phase 1/2 HELIOS pediatric trial of Descartes-08 in autoimmune diseases, including JDM, the anticipated timing or the outcome of the FDA’s review of the Company’s regulatory filings, including the number of trials
that may be necessary in order to obtain marketing approval, the potential for in-vivo delivery of the Company’s product candidates, 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 enter into and maintain potential collaborations or partnerships, 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, political uncertainty, the Company’s 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, pandemics, and
macroeconomic impacts, 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.
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# # #
Contact Information:
Investor Contact:
Megan LeDuc
Associate Director, Investor Relations
megan.leduc@cartesiantx.com
Media Contact:
David Rosen
Argot Partners
david.rosen@argotpartners.com
FAQ
What agreement did Cartesian Therapeutics (RNAC) announce with WestGene Biopharma?
Cartesian announced a strategic licensing agreement with WestGene to develop in vivo CAR-T therapies for autoimmune diseases. The deal combines Cartesian’s Descartes-08 mRNA payloads with WestGene’s targeted lipid nanoparticle delivery platform to accelerate clinical development.
How will Cartesian Therapeutics (RNAC) and WestGene use Descartes-08 in this collaboration?
The collaboration uses the mRNA payload from Descartes-08, Cartesian’s CAR-T asset, delivered via WestGene’s targeted lipid nanoparticles. This in vivo approach aims to engineer BCMA-directed T cells without ex vivo manufacturing, starting in generalized myasthenia gravis patients.
What prior clinical experience does WestGene bring to its partnership with Cartesian Therapeutics (RNAC)?
WestGene has conducted clinical studies using mRNA CAR-T constructs delivered by its targeted lipid nanoparticle platform in oncology and autoimmune diseases. Across multiple regimens and up to 14 doses in one patient, it reported favorable safety and robust in vivo CAR-T generation.
Which additional programs could benefit from the Cartesian Therapeutics (RNAC) and WestGene collaboration?
Beyond Descartes-08, Cartesian plans to advance internally developed next-generation anti-BCMA CAR constructs and a BCMA-directed T-cell engager. The WestGene partnership is structured to move multiple mRNA payloads into human trials across several autoimmune disease indications.
How does this deal relate to Cartesian Therapeutics (RNAC) ongoing Descartes-08 trials?
Descartes-08 remains in Phase 3 for generalized myasthenia gravis, Phase 2 in myositis, and Phase 1/2 in pediatric autoimmune diseases. The WestGene agreement focuses on using Descartes-08 mRNA in an in vivo format, expanding the therapeutic platform beyond autologous cell therapy.