Synlogic Forges Clinical Collaboration to Evaluate SYNB1891 in Combination with PD-L1 Checkpoint Inhibitor in Patients with Advanced Solid Tumors.
(C)2019 M2 COMMUNICATIONS
- US-based clinical stage company Synlogic, Inc., (NASDAQ: SYBX) has forged a new clinical collaboration with Swiss healthcare company Roche (SIX: RO), to explore Synlogic's Synthetic Biotic medicine, SYNB1891, a dual innate immune activator engineered to express a STING agonist, in combination with Roche's PD-L1-blocking checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced solid tumors, the company said.
Synlogic expects to file an Investigational New Drug application with the US Federal Drug Administration in the second half of 2019 for SYNB1891 to enable the company to begin an open-label Phase 1 clinical trial to evaluate the candidate as a monotherapy and a combination treatment with atezolizumab.
Tumors have developed mechanisms to subvert natural processes to suppress and evade immune control.
While the use of CPIs has greatly improved outcomes for patients with certain types of cancers, a percentage of patients still do not respond to these therapies.
Engagement of both the innate and adaptive arms of the immune system has been shown to be critical in generating an efficacious antitumor immune response.
SYNB1891 is a non-pathogenic strain of E.coli that has been engineered to express a STING (STimulator of INterferon Genes) agonist and stimulate the innate immune system.
When the bacteria are engulfed by antigen presenting cells within the tumor, the STING pathway is activated within the cell resulting in a type I interferon response and the initiation and propagation of tumor-specific T-cell responses.
In addition, the bacterial chassis used in Synlogic's Synthetic Biotic approach is believed to stimulate the innate immune system by several other mechanisms, including via Toll-like receptors, potentially adding to the magnitude of the overall immune response.
In combination with atezolizumab, SYNB1891 has the potential to elicit both innate and adaptive arms of the immune system to drive tumor reduction.
With an active IND, Synlogic plans to initiate an open-label, multicenter Phase 1 clinical trial of SYNB1891 administered by intra-tumoral injection to patients with advanced/metastatic solid tumors.
The primary objective of the study is to evaluate the safety and tolerability of escalating doses of SYNB1891 to determine the single-agent maximum tolerated dose as monotherapy and the recommended Phase 2 dose in combination with atezolizumab.
In addition, the study will explore immune biomarkers, objective response rates, and time to progression for evaluated tumors.
Synlogic will be the sponsor of the study and Roche will provide clinical supply of atezolizumab.
Synlogic is in the development of a novel class of living medicines, Synthetic Biotic medicines, based on its proprietary drug development platform.
The company leverages the tools and principles of synthetic biology to genetically engineer beneficial microbes to perform or deliver critical functions missing or damaged due to disease.
Synthetic Biotic medicines are designed to act locally and have a systemic effect to address disease in patients. Synlogic's two lead programmes, SYNB1020 and SYNB1618, are orally administered and target hyperammonemia as a result of liver damage or genetic disease, and phenylketonuria, respectively.
Synlogic is also developing SYNB1891 as an intratumorally-administered Synthetic Biotic medicine for the treatment of cancer.
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|Date:||May 24, 2019|
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