On June 3, 2024 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reported the presentation of three abstracts in a poster session during the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Calidi Biotherapeutics, JUN 3, 2024, View Source [SID1234644066]). 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.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We are thrilled by the opportunity to present at ASCO (Free ASCO Whitepaper) 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 (Free ASCO Whitepaper) 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.