Calidi Biotherapeutics Presents CLD-101 Phase 1 Trial Update and Preclinical Data Highlighting RTNova and CLD-201 at 2024 ASCO Annual Meeting

Rhea-AI Summary

Calidi Biotherapeutics presented significant updates at the 2024 ASCO Annual Meeting, focusing on their NeuroNova (CLD-101), RTNova (CLD-400), and SuperNova (CLD-201) programs. CLD-101's Phase 1 trial is progressing, with safety and feasibility confirmed for up to four weekly doses in patients with high-grade gliomas. Preclinical data on RTNova showed its ability to target and reach tumors systemically, while SuperNova (CLD-201) demonstrated promising non-clinical results, with no adverse toxicity and effective tumor volume reduction. These findings underscore Calidi's innovative approach to antitumor virotherapy and reinforce their commitment to advancing targeted immunotherapies.

Positive

• CLD-101 Phase 1 trial shows safety and feasibility with up to four weekly doses.
• Enrollment progress in the fourth cohort of CLD-101 study.
• RTNova (CLD-400) demonstrated ability to target multiple tumor types systemically in preclinical models.
• SuperNova (CLD-201) showed no adverse toxicity and effective tumor volume reduction in non-clinical studies.
• CLD-201 induced robust local and systemic immune cell infiltration in animal models.
• Upcoming Phase 1 trial for CLD-201 to assess safety and anti-tumor effects.

Negative

• CLD-101's trial is still in early Phase 1, limiting immediate clinical applications.
• Preclinical data, while promising, do not guarantee similar results in human trials.

Insights

Medical Research Analyst

The updates presented by Calidi Biotherapeutics offer significant insights into the progress of their clinical-stage biotechnology programs. The Phase 1 trial of CLD-101 showcases promising early results regarding the safety and feasibility of their oncolytic virotherapy. The use of neural stem cells (NSCs) to deliver an oncolytic adenovirus specifically to tumor sites marks a novel approach in treating high-grade gliomas. This could potentially revolutionize the treatment of such aggressive tumors if the safety and efficacy are further validated in subsequent phases of clinical trials. For retail investors, understanding the importance of safety and feasibility in early-stage trials is crucial. These factors determine whether the treatment is viable for further development, which could eventually lead to FDA approval and commercialization.

In the preclinical studies of the RTNova (CLD-400) platform, the data indicates that the treatment can effectively target all tumor sites systemically. This is particularly important as it suggests a broader application across different cancer types. The ability to modify the tumor microenvironment and induce changes that inhibit tumor growth can make RTNova a versatile tool in cancer therapy. However, investors should be mindful that preclinical results, while promising, need to be validated in human trials to confirm efficacy and safety.

Financial Analyst

Calidi Biotherapeutics' presentation at the ASCO Annual Meeting is a important event for the company, affecting both short-term and long-term investor sentiment. The enrollment progress and safety data from the Phase 1 trial of CLD-101 could provide a positive signal to the market. Early-stage biotechnology companies often see share price movements in response to trial updates, especially when the news is favorable. The company's focus on high-grade gliomas, a condition with a high unmet medical need, could attract significant attention and investment if future trials continue to show positive results.

The preclinical data for RTNova (CLD-400) and SuperNova (CLD-201) also play a important role in shaping investor expectations. These platforms' potential to treat a range of solid tumors suggests a diverse and robust pipeline. However, investors should weigh these developments against the inherent risks of biotechnological innovations, including the long and uncertain path to market approval and potential competition from other emerging therapies. The fact that Calidi is preparing for an IND application and initiation of a Phase 1 trial for CLD-201 shows a forward momentum, but it's essential to remain cautious and consider the company's overall financial health and ability to sustain long-term R&D efforts.

- NeuroNova (CLD-101) Phase 1 update highlights enrollment progress, safety and feasibility in delivering up to four weekly doses of CLD-101

- Showcased preclinical data on RTNova (CLD-400) platform’s ability to survive bloodstream and reach all tumors systemically

- Non-clinical data supporting the upcoming SuperNova (CLD-201) clinical trial

SAN DIEGO--(BUSINESS WIRE)-- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These posters, presented on June 1, 2024, include an update from the City of Hope-led Phase 1 study of Calidi's CLD-101 program, and preclinical data surrounding Calidi’s RTNova (CLD-400) and CLD-201 platforms.

“We are thrilled by the opportunity to present at ASCO and showcase the progress we have made across our various programs. Calidi’s cutting edge approach to antitumor virotherapy is evident through the entirety of our pipeline, and these data updates are reflective of the tireless work from our scientific team and collaborators” said Allan Camaisa, CEO and Chairman of the Board at Calidi Biotherapeutics. “In our CLD-101 program, NeuroNova’s safety and tolerability observed in the patients dosed thus far, reaffirms our belief in the combination of neural stem cells and antitumor viruses as a potentially transformative therapy for high-grade glioma patients. We are encouraged by the initial safety profile of cohorts 2 and 3, enabling the ongoing recruitment and dosing of the fourth cohort. Along with our clinical progress, we continue to be excited by our novel preclinical programs, RTNova (CLD-400), and look forward to filing our IND application with the FDA on Supernova (CLD-201) for a future phase 1 clinical trial, with their potential ability to treat a diverse set of solid tumors.”

Key highlights from the company’s three presentations at ASCO are below:

Poster Title: Phase 1 study of multiple intracerebral doses of a neural stem cell-based oncolytic virotherapy for treatment of recurrent high-grade gliomas

Abstract Number: TPS2102

Session Title: Central Nervous System Tumors

• CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites.
• The study focuses on the safety and feasibility of delivering up to four weekly intracerebral doses of CRAd-S-pk7 to patients with recurrent high-grade gliomas.
• All participants receive a uniform dose of 1.50 x 10⁸ NSCs and 1.875 x 10¹¹ viral particles, the maximum feasible dose from the initial human study.
• Secondary objectives for the study include assessing the biological activity, biodistribution, immunogenicity, safety, and preliminary clinical efficacy of CRAd-S-pk7.
• The initial patient began treatment in May 2023. Currently, three patients in Treatment Schedule 2 and three in Treatment Schedule 3 have been enrolled and treated safely.
• Calidi is currently enrolling patients in Treatment Schedule 4.

Poster Title: Transforming tumor immune microenvironments with a novel systemic enveloped oncolytic virotherapy targeting all tumor sites

Abstract Number: 2559

Session Title: Developmental Therapeutics – Immunotherapy

• Calidi’s RTNova (CLD-400) systemic antitumor virotherapy platform is a novel tumor-selective vaccinia virus strain, a program designed to target all tumor sites and capable of producing a high amount of enveloped vaccinia viruses (envRTs) resistant to humoral immunity.
• The technology allows the therapy to reach every tumor systemically, killing tumor cells, and expressing any desired protein within the tumor, thus modifying the tumor microenvironment.
• In preclinical murine models, envRT-01 targeted multiple tumor types and led to tumor growth inhibition with a single systemic injection of 4.5e⁶ PFU env-RT-01
• envRT-01 induced changes in tumor immune microenvironment, targeted lung cancer and metastatic sites, and induced dramatic changes in lung metastasis tumor microenvironments.

Poster Title: Non-clinical evidence supporting the upcoming SuperNova (CLD-201) clinical trial: Cell-based oncolytic virotherapy for multiple solid tumors

Abstract Number: 2553

Session Title: Developmental Therapeutics – Immunotherapy

• Animals treated with the maximum tolerated dose of 2e⁶ PU/animal showed no signs of adverse toxicity and exhibited a reduction in tumor volume compared to the control group.
• No toxicity findings were associated with CLD-201 in the disease-free model, and additionally, virus detection in the lungs was cleared within two weeks following the last CLD-201 treatment.
• CLD-201 induced potent cytolysis across multiple cancer types in in-vitro models.
• Local administration of CLD-201 induced both robust local and systemic immune cell infiltration.
• Calidi is expecting to initiate a Phase 1 non-randomized trial to assess the safety and initial anti-tumor effects of CLD-201 administered intratumorally.

Copies of the posters are available on the Publications section of Calidi’s website.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

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 upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), 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 Registration Statements filed with the SEC on Form S-4 filed on August 2, 2023, on Form S-1 filed on October 6, 2023, on Form S-1 filed on January 29, 2024, as amended on February 7, 2024, on Form 10-K filed on March 15, 2024, and Final Prospectus filed on April 17, 2024.

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For Investors:

Stephen Jasper

Gilmartin Group

stephen@gilmartinir.com

For Media:

Stephen Thesing

ir@calidibio.com

Source: Calidi Biotherapeutics, Inc.

FAQ

What progress has Calidi Biotherapeutics made in the CLD-101 Phase 1 trial?

The CLD-101 Phase 1 trial has confirmed safety and feasibility for up to four weekly doses, with progress in patient enrollment for the fourth cohort.

What were the key findings for RTNova (CLD-400) presented at ASCO 2024?

RTNova (CLD-400) showed the ability to survive in the bloodstream and target multiple tumor types systemically in preclinical models.

What are the preclinical results for SuperNova (CLD-201)?

SuperNova (CLD-201) showed no adverse toxicity and effective tumor volume reduction, with robust local and systemic immune cell infiltration in non-clinical studies.

When did the first patient begin treatment in the CLD-101 Phase 1 trial?

The first patient began treatment in May 2023.

What is the goal of the upcoming Phase 1 trial for CLD-201?

The Phase 1 trial for CLD-201 aims to assess the safety and initial anti-tumor effects of intratumoral administration.