Calidi Biotherapeutics Announces Partnership with Avance Clinical to Facilitate Australian Regulatory Approval and Accelerate Initiation of CLD-401 Clinical Trials
Rhea-AI Summary
Calidi Biotherapeutics (NYSE: CLDI) announced a partnership with Avance Clinical to expedite Australian regulatory approval and rapidly initiate a first-in-human Phase I trial of CLD-401. The company said it will pursue an IND filing with the FDA in 2026 while conducting IND-enabling studies.
CLD-401 is a tumor-replicating vaccinia engineered to express an IL-15 superagonist, intended as systemic monotherapy for patients with refractory solid tumors.
Positive
- Partnership with Avance to accelerate Australian regulatory approval and trial start
- Planned FDA IND filing in 2026 to enable U.S. clinical development
- CLD-401 designated as lead candidate from RedTail platform expressing IL-15 superagonist
- Ongoing IND-enabling studies supporting first-in-human Phase I initiation
Negative
- Planned Phase I is first-in-human, so clinical safety and efficacy are unproven
- FDA IND is planned but not yet filed, so U.S. trial timing remains uncertain
Key Figures
Market Reality Check
Peers on Argus
CLDI gained 4.24% while tracked peers were mixed; momentum scanner shows GNPX moving down 2.62%, suggesting today’s move is stock-specific rather than sector-driven.
Previous Partnership Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 03 | CLD-401 partnership | Positive | -0.7% | Strategic CDMO partnership to advance CLD-401 toward IND filing. |
Prior partnership news for CLD-401 saw a small negative move despite constructive development progress.
Recent history around CLD-401 has focused on building the path to the clinic. A prior partnership on Nov 3, 2025 with Matica Bio aimed to advance CLD-401 toward an IND through analytical development, process development, and GMP manufacturing support, yet the stock moved -0.65%. Today’s Avance Clinical collaboration similarly targets regulatory and trial initiation steps for CLD-401, extending that partnership-driven execution theme.
Historical Comparison
In the past, CLDI’s partnership news (e.g., Matica Bio for CLD-401) led to an average -0.65% move, so any strong positive reaction to this Avance Clinical deal would mark a departure from that pattern.
Partnerships have progressively supported CLD-401, from GMP manufacturing and IND preparation with Matica Bio toward regulatory approval and first-in-human trials with Avance Clinical.
Market Pulse Summary
This announcement highlights a new partnership to support Australian regulatory approval and a first-in-human Phase I trial of CLD-401, alongside an intended FDA IND filing in 2026. It builds on earlier CLD-401 development work and platform expansion efforts. Investors may track progress on IND-enabling studies, timing of trial initiation, and subsequent safety and pharmacodynamic data as key markers of execution on the RedTail platform strategy.
Key Terms
il-15 superagonist medical
tumor microenvironment medical
pharmacodynamics medical
monotherapy medical
solid tumors medical
AI-generated analysis. Not financial advice.
SAN DIEGO, March 24, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announced a partnership with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. In parallel, the Company will pursue an IND filing with the FDA in 2026.
CLD-401 is a genetically modified form of vaccinia virus that is systemically delivered, replicates only in tumor cells, and expresses high levels of IL-15 superagonist (IL-15 SA), an activator of innate and adaptive immune response, in the tumor microenvironment. The planned phase I will investigate the safety, pharmacodynamics, and efficacy of CLD-401 given as monotherapy in patients with solid tumors that have exhausted all other therapeutic options.
“We believe CLD-401 represents a unique mechanism of action in oncology,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “We are excited to work with Avance Clinical to initiate clinical studies as quickly as possible and bring this potential treatment option to patients whose disease is resistant to current therapies.”
Calidi is currently conducting IND-enabling studies with CLD-401, the first lead candidate from its RedTail platform. 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 T-cell engagers 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
FAQ
What did Calidi (CLDI) announce on March 24, 2026 about CLD-401 clinical plans?
How will the Avance Clinical partnership affect CLDI's timeline for CLD-401 trials?
What is CLD-401 and how does it work as described by Calidi (CLDI)?
When does Calidi plan to file an IND for CLD-401 with the FDA (CLDI)?
What will Calidi's planned Phase I trial for CLD-401 evaluate (CLDI)?
Does Calidi (CLDI) have other RedTail platform activities alongside CLD-401 development?
