Calidi Biotherapeutics Updates on CLD-101 Trial and Highlights RTNova, CLD-201 at 2024 ASCO Meeting

Calidi Biotherapeutics Inc., a clinical-stage biotechnology company known for its innovative immunotherapy treatments, presented three significant abstracts during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. These presentations, showcased in a poster session on June 1, 2024, included updates on the NeuroNova (CLD-101) Phase 1 trial, and preclinical data on the RTNova (CLD-400) and SuperNova (CLD-201) platforms.

NeuroNova (CLD-101) Phase 1 Trial

The NeuroNova program's CLD-101, which utilizes tumor-targeting neural stem cells (NSCs) to deliver an oncolytic adenovirus (CRAd-S-pk7) directly to tumor sites, is a promising candidate for treating recurrent high-grade gliomas. The primary focus of this Phase 1 study is to assess the safety and feasibility of administering up to four weekly intracerebral doses of CRAd-S-pk7. The treatment involves a standardized dose of 1.50 x 10^8 NSCs and 1.875 x 10^11 viral particles, established as the maximum feasible dose in initial human studies.

Secondary objectives include evaluating the biological activity, biodistribution, immunogenicity, safety, and preliminary clinical efficacy of CRAd-S-pk7. Since the trial's inception in May 2023, three patients have been safely treated under Treatment Schedules 2 and 3. Currently, patient enrollment for Treatment Schedule 4 is ongoing, reflecting steady progress.

RTNova (CLD-400) Preclinical Data

Calidi's RTNova (CLD-400) platform represents a groundbreaking approach to systemic antitumor virotherapy. This platform employs a specially designed tumor-selective vaccinia virus strain capable of producing enveloped vaccinia viruses (envRTs) that resist humoral immunity. This allows the therapy to systemically target and destroy tumor cells while modifying the tumor microenvironment by expressing desired proteins within the tumor.

Preclinical studies in murine models demonstrated that envRT-01 could inhibit tumor growth across multiple types with just a single systemic injection of 4.5e6 PFU env-RT-01. Notable changes were observed in the immune microenvironment of lung cancer and metastatic sites, indicating the platform's potential for widespread tumor targeting and treatment.

SuperNova (CLD-201) Preclinical Data

SuperNova (CLD-201) is another promising candidate in Calidi’s pipeline, designed for treating multiple solid tumors. Preclinical results showed no adverse toxicity at the maximum tolerated dose of 2e6 PU/animal, and a notable reduction in tumor volume compared to control groups. Furthermore, CLD-201 was cleared from the lungs within two weeks post-treatment, and in-vitro models indicated potent cytolysis across various cancer types.

The platform's ability to induce significant local and systemic immune cell infiltration upon local administration positions it as a powerful tool in immunotherapy. Calidi is preparing to launch a Phase 1 non-randomized trial to evaluate the safety and initial anti-tumor effects of intra-tumorally administered CLD-201.

Summary and Future Directions

Calidi Biotherapeutics remains at the forefront of developing novel immunotherapies that harness the power of stem cells and oncolytic viruses. The data presented at ASCO underscore the company's progress and potential in advancing cancer treatment. With ongoing clinical trials and promising preclinical results, Calidi aims to bring these innovative therapies closer to clinical application, potentially offering new hope for patients with high-grade gliomas and other solid tumors. The company continues to drive its research forward, with anticipation of future clinical trials and regulatory filings.

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