Our Products
We are focused on developing first-in-class, broadly applicable product candidates designed to activate a patient’s immune system against their own cancer from within. Leveraging our proprietary retroviral replicating vector (RRV) technology platform, our lead product candidate, Toca 511 & Toca FC, is being investigated for the treatment of patients with brain cancer, bladder cancer and other advanced cancers with significant unmet medical needs. Additional RRV product candidates are in preclinical development.
Tocagen Pipeline
Candidate
Toca 511 & Toca FC
| Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 |
TOCA 5
Recurrent high grade glioma
NRG-BN006
Newly diagnosed glioblastoma (in collaboration with NRG Oncology)
TOCA 6
Advanced solid tumors (CRC, pancreatic, sarcoma & lung)
TOCA 8
Recurrent high grade non-muscle invasive bladder cancer
Candidate
Gene Therapies
| Discovery | Preclinical | Phase 1 | Phase 2 | Phase 3 |
Oncology TBD
*NRG Oncology is the study sponsor; Funded by the National Cancer Institute.
Toca 511 & Toca FC
1
Toca 511 is administered to patient
2
Toca 511 selectively infects and spreads through tumor
3
Toca 511 delivers a gene to cancer cells called cytosine deaminase (CD)
4
Patients take cycles of oral tablet called Toca FC
5
CD enzyme converts Toca FC into anticancer drug, 5-FU within infected cancer cells
6
5-FU kills cancer cells and immune system is activated leading to clearance of the tumor
Toca 511 & Toca FC is under investigation in a Phase 3 trial (Toca 5) in patients with recurrent high grade glioma and a Phase 1b trial in patients with advanced cancers (Toca 6). We are also planning to conduct a clinical trial in patients with newly diagnosed glioblastoma (NRG-BN006) in collaboration with NRG Oncology and a Phase 1 trial in patients with recurrent high grade non-muscle invasive bladder cancer (Toca 8).
Toca 511 (vocimagene amiretrorepvec) is an investigational injectable retroviral replicating vector (RRV) that encodes a prodrug activator enzyme, cytosine deaminase (CD). CD is derived from yeast, and humans do not naturally have this gene. Its selective delivery to cancer cells means that the infected cancer cells selectively carry the CD gene and produce CD protein.
Toca FC is an investigational, orally administered, extended-release formulation of 5-fluorocytosine (5-FC). 5-FC is a prodrug that is inactive as an anti-cancer drug. In humans, the orally administered Toca FC is absorbed and carried through the bloodstream, crosses the blood-brain barrier and diffuses into the cancer cells. In animal models, Tocagen has shown that 5-FC is converted into the active anticancer drug, 5-FU, at high concentrations in Toca 511-infected cancer cells that are producing CD protein. 5-FU is a well-established anti-cancer agent used in many conventional chemotherapy settings.
Toca 511 & Toca FC has a dual mechanism of action within the tumor microenvironment: In addition to the direct killing of Toca 511-infected cancer cells, 5-FU can kill neighboring uninfected cancer cells and immune-suppressive myeloid cells, including myeloid-derived suppressor cells, or MDSCs, as well as tumor associated macrophages, or TAMs. Cancer cell death releases damage-associated molecular patterns, or DAMPs, pathogen-associated molecular patterns, or PAMPs, and cancer associated antigens, resulting in antigen presentation and activation of T cells. Such cancer cell killing leads to the release of cancer associated antigens and local inflammatory DAMPs and PAMPs, which stimulate the antigen-presenting cells in the tumor micro-environment to present the cancer associated-antigens to the CD4 (helper) and CD8 (killer) T cells of the immune system. This results in further induction and harnessing of these cells against the cancer associated antigens to kill more cancer cells and provide durable control of the cancer, a process called acquired immunity. This approach is designed to selectively destroy cancer cells within the body, while leaving healthy cells unharmed.
Based on preclinical data, we believe Toca 511 & Toca FC may have therapeutic benefit in multiple solid tumor cancers. Because Toca 511 & Toca FC has been well tolerated in clinical trials to date, Tocagen believes it could be added to established cancer treatments without additional toxicity.
We’re hiring. Tocagen is looking for the best and the brightest to join our team. Can you help further our goal to fight cancer? We offer competitive benefits and an invigorating work environment.