Therapy Areas: Infectious Diseases
Apros Therapeutics Wins IND Clearance from US FDA to Initiate the Trial of APR003
10 September 2020 - - US-based drug discovery and development company Apros Therapeutics, Inc's Investigational New Drug application for a Phase 1 dose escalation trial of APR003, the company's first-in-class orally-administered gastrointestinal- and liver-targeted TLR7 agonist development candidate, was cleared by the FDA, the company said.

The Phase 1 trial aims to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and initial anti-tumor activity of APR003 in patients with advanced unresectable CRC with malignant liver lesions.

The trial will be conducted at multiple sites in the United States, and the company intends to report top-line results upon completion.

APR003 is a first-in-class, orally-administered, TLR7 agonist designed specifically to localize to the GI and liver to promote local immune activation in the targeted tissues and drive tumor eradication.

Given the immune-activating capacity of this class of drugs, the tissue-targeted approach taken with APR003 is predicted to exhibit an improved tolerability profile compared to other oral non-targeted approaches, which possess side effects associated with systemic immune activation and inflammation.

TLR7 activation in the liver of patients with malignancies that are metastatic to the liver may lead to innate immune priming, release of cytokines and, ultimately, enhanced anti-tumor immune responses.

Although APR003 may have applications in several GI and liver malignancies, Apros will focus the initial evaluation of APR003 in patients with unresectable CRC that is metastatic to the liver given the unique bio-distribution and mechanism of action of this first-in-human investigational agent.

CRC is the 3rd most common cancer in the world, and 50% of patients with advanced disease will develop liver metastasis.

While most patients with CRC are non-responsive to immunotherapies, largely due to the immune-quiescent nature of the disease, APR003 aims to turn these "cold" tumors into "hot" immune-permissive tumors.

Founded in 2016, and based in San Diego, CA, Apros Therapeutics is focused on the discovery and development of tissue-targeted TLR7 agonists for the immunotherapy of cancer and infectious diseases.

Apros Therapeutics has employed a chemistry-based platform to develop a portfolio of small molecule TLR7 agonists using a range of proprietary approaches with the aim of restricting drug distribution, controlling half-life and dose in specific tissues.

Each development candidate is engineered to exert precise spatiotemporal bio-distribution to target a tumor/tissue type, in order to uncouple efficacy from systemic toxicity.

This platform ultimately aims to widen the therapeutic window and extend the application of innate immune agonists to treat a broad range of cancer and infectious disease indications. Apros Therapeutics is currently advancing multiple candidates into clinical development.
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