Calidi Biotherapeutics Presented New CLD-401 Data and In Situ TCE Platform Advances at the ESMO Congress 2026, Including Highlighting the Potential of its RedTail Gene Medicine Platform to Turn Tumors into Localized TCE Biofactories
The mouse studies extend RedTail data to two delivery routes and localized production of T-cell engagers.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Calidi Biotherapeutics (CLDI) presented preclinical data showing complete tumor eradication in 80% of mice treated with CLD-401 in a breast cancer model. The EMT6 model control arm had no complete tumor eradication. Presented on October 24 at ESMO Congress 2026, additional results showed antitumor activity with intravenous or direct tumor administration in an MB49 bladder cancer model.
Data on CLD-501 and CLD-502, candidates designed to produce T-cell engagers—proteins that redirect T cells toward tumors—showed antigen-dependent, dose-responsive tumor-cell killing. The EpCAM-targeted construct generated approximately 10 ng/mL of T-cell engager within tumors after intravenous delivery. Calidi is pursuing partnerships to accelerate clinical development.
Positive
- Minor pointCLD-401 achieved complete tumor eradication in 80% of EMT6 breast tumor-bearing mice versus 0% in controls.
- Minor pointCLD-401 retained antitumor activity with intravenous or direct tumor administration in the MB49 bladder cancer model.
- Minor pointTROP-2- and EpCAM-targeted T-cell engagers showed antigen-dependent, dose-responsive T cell-mediated killing in preclinical studies.
- Minor pointEpCAM-targeted construct generated approximately 10 ng/mL of T-cell engager within tumors following intravenous delivery.
- Minor pointAdded T-cell engager payload did not reduce co-encoded IL-15 SA expression in reported laboratory or animal studies.
- Minor point. Forward-looking: it has not happened yet and may not happen.Calidi is pursuing partnerships to accelerate clinical development and expand the RedTail platform's impact.
Negative
- None.
Details
Market Reaction – CLDI
On Oct 27, the day this news came out, the latest delayed price for CLDI is 1.56% below the previous close. Argus tracked a peak move of +4.6% during the session. Our momentum scanner has recorded 5 alerts for this stock so far that day. The latest delayed price is $0.63.
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Key Figures
- Complete tumor eradication
- 80% vs. 0% in control
- CLD-401 in EMT6 breast cancer tumor-bearing mice
- EpCAM-targeted TCE concentration
- approximately 10 ng/mL
- Generated directly within tumors following IV delivery
Historical Context
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Previewed CLD-401 mouse findings and in situ TCE data subsequently reported at ESMO.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
t-cell engager medical
epcam medical
il-15 superagonist medical
oncolytic virus medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
Single-dose CLD-401 induced tumor regression and complete response in
Building on the growing clinical evidence supporting T-cell engagers in solid tumors, data showed the platform generated approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors following IV delivery, without systemic administration of the TCE protein itself, turning the tumor into a localized TCE biofactory
SAN DIEGO, Oct. 27, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic medicines, announced that it presented two posters at the European Society for Medical Oncology (ESMO) Congress 2026 last week in Madrid. The presentations showcased new data from the Company’s RedTail platform, a systemically delivered virotherapy platform engineered to selectively target tumors, remodel the tumor microenvironment, and enable high-level expression of therapeutic genetic payloads directly within tumors.
Together, the presentations demonstrated the RedTail platform's expanding flexibility, from CLD-401-mediated tumor immune priming to dual-payload candidates designed for localized T-cell redirection. The Company continues to expand the functionality of the RedTail platform and is pursuing strategic partnerships to accelerate clinical development and broaden its impact.
On October 24, 2026, the Company presented preclinical data on its lead program, CLD-401, showing complete tumor eradication in
Also on October 24, 2026, the Company presented preclinical data on CLD-501, the lead compound from its in situ T-cell engager (“TCE”) platform, including its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate. Data from the EpCAM-targeted construct also showed that incorporation of an additional TCE payload did not reduce expression of the co-encoded IL-15 SA payload in the reported in vitro or in vivo studies.
Both candidates are systemically delivered RedTail virotherapies designed to selectively target tumors and enable localized co-expression of a tumor-targeted TCE and IL-15 SA. The presentation showed antigen-dependent, dose-responsive T cell-mediated cytotoxicity for TROP-2- and EpCAM-targeted TCEs. By converting tumors into localized biofactories expressing TCEs and T cell-activating payloads, generating approximately 10 ng/mL of EpCAM-targeted TCE directly within tumors following IV delivery, the In Situ TCE platform addresses the toxicity, tumor-exposure, and immunosuppressive TME barriers associated with systemically administered TCEs in solid tumors. A link to the poster can be found here.
About Calidi
Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The Company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.
CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, is being developed for metastatic non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform with its novel In Situ T-cell engager approach for solid tumors, including CLD-501, its TROP-2-targeted candidate, and CLD-502, its EpCAM-targeted candidate.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here.
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
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FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Calidi's CLD-401 breast cancer mouse study show at ESMO 2026?
A single dose of CLD-401 induced tumor regression and complete response in 80% of mice in the EMT6 breast tumor model. Complete tumor eradication was 0% in the control arm. These were preclinical animal results.
Did Calidi's added T-cell engager payload affect IL-15 SA expression?
Adding the T-cell engager payload to the EpCAM-targeted construct did not reduce expression of the co-encoded IL-15 SA payload in the reported laboratory or animal studies. IL-15 SA activates T cells and natural killer cells.