Calidi Biotherapeutics Presents Data on its New Approach to Bispecific T-Cell Engagers (BiTEs) Using its RedTail Platform at the 2026 AACR-IO Conference
Calidi Biotherapeutics (NYSE American: CLDI) presented preclinical data at the 2026 AACR Immuno-Oncology conference on its systemically delivered RedTail virotherapy platform.
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Rhea-AI Summary
Calidi Biotherapeutics (NYSE American: CLDI) presented preclinical data at the 2026 AACR Immuno-Oncology conference on its systemically delivered RedTail virotherapy platform. Data show RedTail can express a tumor-localized BiTE and high levels of IL-15 superagonist within the tumor microenvironment, potentially enabling T-cell activation in solid tumors. Calidi is conducting IND-enabling studies for CLD-401 and plans to submit an IND by the end of 2026 while pursuing strategic partnerships.
Details
News Market Reaction – CLDI
On Feb 20, the day this news came out, CLDI closed 7.97% above the previous close.
Data tracked by StockTitan Argus for the Feb 20 session.
Key Figures
- IND timing target
- end of 2026
- Planned Investigational New Drug application for CLD-401
- Conference year
- 2026
- AACR-IO Immuno-Oncology conference featuring RedTail/BiTE data
Historical Context
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Announcement of late-breaking AACR-IO abstract on RedTail BiTE approach and CLD-401.
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Corporate update outlining 2026 value drivers centered on RedTail and CLD-401 IND plan.
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Announcement of investor webinar to review RedTail data, IND progress, and Q3 2025 results.
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Q3 2025 financial results plus RedTail data, capital raises, and balance sheet discussion.
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New SITC 2025 preclinical data on CLD-401 systemic delivery and IL-15 superagonist expression.
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Key Terms
bispecific t-cell engagers (bite) medical
virotherapy medical
tumor microenvironment (tme) medical
il‑15 superagonist (il-15 sa) medical
cytokines medical
investigational new drug (ind) regulatory
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SAN DIEGO, Feb. 20, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today presented data on its novel approach to the use of BiTEs in solid tumors by utilizing its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference being held in Los Angeles, California. A link to the poster is available here and on the company’s website.
RedTail is Calidi’s systemically delivered virotherapy platform designed to selectively target tumors, remodel the tumor microenvironment (TME), and enable high-level expression of therapeutic genetic payloads directly within the tumor. CLD-401, the lead candidate derived from the RedTail platform, is engineered to express high levels of IL‑15 superagonist (IL-15 SA), a known T-cell activator, in the TME.
In data presented at the meeting, Calidi demonstrated RedTail viruses that could express both a functional BiTE, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous alteration of the TME and T-cell activation and introduction into the TME of a solid-tumor targeting BiTE. BiTEs have shown exceptional efficacy in hematological malignancies but have failed to show clinical benefit in solid tumors where the TME inhibits T-cell activity. By remodeling the TME and driving T-cell activation while expressing a tumor-localized BiTE, RedTail may overcome the historical limitations of BiTEs in solid tumors.
“The RedTail platform allows for the systemic and targeted delivery of genetic payloads to distal sites of disease,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “Once at the target, RedTail can induce high levels of expression of one or more genetic payloads, representing a major advance in the delivery of genetic medicines.”
“The data presented today highlight the ability of the RedTail platform to functionally overexpress complex biologics likes BiTEs and cytokines directly within the tumor microenvironment,” said Antonio F. Santidrian, PhD, Chief Scientific Officer and Head of Technical Operations at Calidi. “Simultaneous tumor-localized expression of a T-cell activator and BiTE via RedTail can remodel the TME to allow for T-cell engagement precisely where it is needed.”
Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026. The Company continues to expand the functionality of the RedTail platform and is also actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform.
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, targets 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 including its novel approach to incorporate BiTEs in solid tumors.
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 31, 2025, 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.
For Investors:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com
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