Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced the presentation of new preclinical data from the company’s CLD-201 (SuperNova) allogeneic stem cell-based platform and announces readiness for clinical trial launch in 2024 at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. The meeting is taking place in San Diego from November 1-5, 2023.
CLD-201 builds on decades of stem cell and oncolytic virus research and is a novel allogeneic solution with potential advantages over an autologous approach including enhanced potency, improved manufacturing reproducibility, lower cost, and the ability to treat multiple cancer types. CLD-201 consists of allogeneic mesenchymal stem cells loaded with the oncolytic vaccinia virus CAL1, which has the potential to target a variety of solid tumors.
The poster presentation details the evaluation of CLD-201 in in vitro and animal models in the presence of complement and neutralizing antibodies, and the assessment of immune cell infiltration in treated and untreated tumors. Tumor growth inhibition and induction of anti-tumor immunity were compared in mice treated with unprotected CAL1 virus and CLD-201. Additionally, the poster presents the readiness of the product and plans to launch clinical trial in 2024.
“This new CLD-201 data further supports the potential of our stem-cell based platform to effectively target a variety of solid tumors while exhibiting promising anti-tumor effects in multiple animal models,” said Antonio F. Santidrian, PharmD, Ph.D., Chief Scientific Officer of Calidi Biotherapeutics. “We believe that CLD-201 is a very promising immunotherapy platform, based on its observed inhibition of tumor growth in multiple tumor types and its powerful anti-tumor immune effects, as well as its superiority to existing autologous therapies as an allogeneic alternative. We look forward to initiating a Phase 1 clinical trial in 2024 and generating additional data on the potential of CLD-201 to treat advanced solid tumors.”
Key highlights from the poster presentation are below:
- Multiple allogeneic adipose tissue-derived mesenchymal stem cell banks were generated, and one was selected for GMP manufacturing and loaded with the oncolytic vaccinia virus CAL1, creating CLD-201.
- CLD-201 demonstrated greater resistance to inactivation by the humoral immune system compared to the unprotected CAL1 virus.
- CLD-201 significantly inhibited the growth of the tumors even at the very low dose of 1.5×103 cells containing 1.6×104 viral plaque forming units (PFU).
- CLD-201 has been successfully GMP manufactured, and its safety profile has been analyzed in both immunocompetent and immunocompromised pre-clinical models.
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