Our pipeline targeting multiple cancer indications

In addition to the NeuroNova and SuperNova products, Calidi is advancing engineered oncolytic virus constructs and allogeneic cell-based platforms for systemic (intravenous) administration.

A person in blue gloves holding a bottle of liquid.

NeuroNova (NNV)

Composed of immortalized neural stem cells (NSC) loaded with oncolytic adenovirus, for the treatment of patients with glioblastoma (GBM), an aggressive cancer in the brain or spinal cord. An open-label, Phase 1, dose-escalation clinical trial in patients with newly diagnosed high-grade gliomas has been completed, establishing the safety and signals of efficacy in patients with newly diagnosed glioblastoma (GBM). Clinical trial results were published in the prestigious journal, The Lancet Oncology, in the article, “Neural stem cell delivery of an oncolytic adenovirus in newly diagnosed malignant glioma: a first-in-human, phase 1, dose-escalation trial, (Fares et al. June 2021).

SuperNova (SNV)

Composed of adipose-derived mesenchymal stem cells (AD-MSC) loaded with oncolytic vaccinia virus, for the treatment of patients with advanced solid tumors. A physician-sponsored Phase 1 clinical trial was completed using autologous adipose-derived stromal cells, documenting excellent safety, and signaling efficacy in 24 patients with advanced solid tumors and two patients with acute myeloid leukemia (AML). Clinical trial results were published in the Journal of Translational Medicine, in the article, “First‑in‑human study of TK‑positive oncolytic vaccinia virus delivered by adipose stromal vascular fraction cells,” (Minev et al. August 2019).

Our Pipeline

In addition to the NeuroNova and SuperNova products, Calidi is advancing engineered oncolytic virus constructs and allogeneic cell-based platforms for systemic (intravenous) administration.

Therapy
Indications
Discovery
Non-Clinical
Phase 1
Phase 2
Pivotal Trial
Partner
CLD-101
NeuroNova
  • Newly Diagnosed High Grade Glioma
Entering Phase 1b/2
The north western university logo and the national cancer institute logo.

Our lead self-amplifying vRNA immunotherapy program, ONCR-021, encodes an optimized genome of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

‍

  • Demonstrated safety and tolerability of virions after intravenous (IV) administration in patients
  • Ability of the genome to replicate in solid tumors, including lung tumors
  • Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying RNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21.

‍

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying RNA immunotherapy to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.

CLD-101
NeuroNova
  • Recurrent High Grade Glioma
Phase 1 started
City of hope and cirm logos.

Our lead self-amplifying vRNA immunotherapy program, ONCR-021, encodes an optimized genome of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

‍

  • Demonstrated safety and tolerability of virions after intravenous (IV) administration in patients
  • Ability of the genome to replicate in solid tumors, including lung tumors
  • Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying RNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21.

‍

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying RNA immunotherapy to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.

CLD-201
‍SuperNova
  • Advanced Solid Tumors (TNBC, Melanoma, Head and Neck)
FDA Pre-IND – Planned Phase 1
The logo for the california stem cell agency.

Our lead self-amplifying vRNA immunotherapy program, ONCR-021, encodes an optimized genome of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

‍

  • Demonstrated safety and tolerability of virions after intravenous (IV) administration in patients
  • Ability of the genome to replicate in solid tumors, including lung tumors
  • Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying RNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21.

‍

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying RNA immunotherapy to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.

CLD-202
SuperNova
  • Metastatic Solid Tumors
In Discovery
Calidi Biotherapeutics

Our lead self-amplifying vRNA immunotherapy program, ONCR-021, encodes an optimized genome of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

‍

  • Demonstrated safety and tolerability of virions after intravenous (IV) administration in patients
  • Ability of the genome to replicate in solid tumors, including lung tumors
  • Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying RNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21.

‍

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying RNA immunotherapy to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.

CLD-400
RTNova
  • Metastatic Solid Tumors & Lung cancer
In Discovery
Calidi Biotherapeutics

Our lead self-amplifying vRNA immunotherapy program, ONCR-021, encodes an optimized genome of the coxsackievirus A21 (CVA21). We selected to advance ONCR-021 based on a number of CVA21’s properties, including:

‍

  • Demonstrated safety and tolerability of virions after intravenous (IV) administration in patients
  • Ability of the genome to replicate in solid tumors, including lung tumors
  • Inability to insert into host chromosome, eliminating the potential of insertional mutagenesis

Learn more about our selectively self-amplifying RNA Platform, including our novel lipid nanoparticle (LNP) delivery strategy designed to overcome the challenges caused by neutralizing antibodies that have likely limited the efficacy of prior efforts to treat tumors utilizing IV administration of CVA21.

‍

Development Status

In preclinical models, we have demonstrated proof of concept that ONCR-021 when administered intravenously, is able to successfully deliver a selectively self-amplifying RNA immunotherapy to tumors, leading to production of replication-competent virions within tumors that causes tumor growth inhibition.