Tocagen to Present Updated Data from Clinical and Preclinical Studies at Three Scientific and Medical Conferences
The clinical data includes details of immunologic trends seen in responding patients with recurrent high grade glioma (HGG) from a Phase 1 study of Toca 511 (vocimagene amiretrorepvec) & Toca FC (5-fluorocytosine, extended-release). Additionally, new preclinical data will be presented demonstrating the enhanced efficacy of Toca 511 & Toca FC regimen when combined with metronomic cyclophosphamide.
Summaries are provided below; full posters or presentations will be placed on
Details of the
Presentation Type: Poster (Abstract: P620)
Title: Enhanced Efficacy and Combinability of Low Dose Toca 511 and 5-FC with Metronomic Chemotherapy in Preclinical Models
Presenter: Sophie Viaud, Ph.D.
Date and Time:
- This study aimed to determine if the addition of metronomic cyclophosphamide would provide therapeutic benefit when combined with Toca 511 and 5-FC (5- fluorocytosine) in a preclinical, subcutaneous glioma model.
- The addition of metronomic cyclophosphamide improved tumor control and survival.
- Regulatory T cells were significantly reduced in the peripheral blood with the combination with metronomic cyclophosphamide and CD8+ T cells were significantly increased.
- Results support the further evaluation of Toca 511 & Toca FC with metronomic dosing of cyclophosphamide and potentially other chemotherapeutics.
Details of the CADDDC presentation are as follows:
Presentation Type: Oral Presentation (Abstract: 0023)
Title: PD-L1 Checkpoint Blockade Using a Single-Chain Variable Fragment Targeting PD-L1 Delivered by Retroviral Replicating Vector (Toca 521) Enhances Anti-Tumor Effect in Cancer Models
Date and Time:
- Toca 521, a retroviral replicating vector (RRV) expressing a single-chain variable fragment (scFv) targeting PD-L1, was developed using
Tocagen'sproprietary cancer-selective gene therapy platform technology.
- Preclinical results demonstrated Toca 521 reversed PD-1/PD-L1 mediated immune suppression in a human in vitro cell culture system, and conferred robust, durable and highly selective anti-tumor activity compared to systemically administered anti-PD-1 or anti-PD-L1 monoclonal antibodies.
- Plasma levels of scFv PD-L1 were equivalent to negative control levels and hence very low compared to reported levels in humans given systemic anti-PD1/PD-L1 therapy.
- These results warrant further development of Toca 521 to investigate the potential for improved safety and efficacy profiles compared to systemic monoclonal antibodies against the same checkpoint target. Toca 521 could also be useful in combination with other agents, including immuno-oncology therapies.
Details of the SNO presentation are as follows:
Presentation Type: Poster (Abstract: ATIM-26)
Title: Immunologic trends associated with recurrent high grade glioma patient outcomes in a Phase 1 clinical trial of Toca 511 and Toca FC
Date and Time:
- Human immune monitoring results from a Phase 1 clinical trial of Toca 511 & Toca FC support an immune-related mechanism of action for the regimen.
- Preliminary analyses identified immunologic biomarkers that can potentially predict, with high sensitivity and selectivity, patient outcomes following treatment with Toca 511 & Toca FC.
- These results indicate the value of evaluating potential biomarkers of patient outcomes in the ongoing randomized Toca 5 Phase 3 trial in patients with recurrent HGG.
About Toca 511 & Toca FC
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial (Toca 5) for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration awarded
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives, our plans to present data at upcoming scientific and medical conferences, and our plans regarding further development of our product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the success, cost and timing of our product candidate development activities including ongoing clinical trials; the ability to replicate outcomes from early-stage clinical trials in later-stage trials; our ability to execute on our strategy; regulatory developments in the
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