Apros Therapeutics to Present Interim Clinical Data from a Phase 1 Study Evaluating APR003 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting and World Vaccine & Immunotherapy Congress (WVIC) West Coast

SAN DIEGO--(BUSINESS WIRE)--Apros Therapeutics, Inc., a clinical stage biotechnology company focused on tissue-targeted Toll-Like Receptor 7 (TLR7) agonists for the treatment of advanced cancers and infectious diseases, today announced that they will present interim pharmacokinetic and pharmacodynamic Phase 1 clinical data for APR003 at the 2022 Society for Immunotherapy of Cancer (SITC) Annual Meeting to be held November 8-12^th in Boston, MA. Data will also be presented at the World Vaccine & Immunotherapy Congress, West Coast November 28^th - December 1^st in San Diego, CA. APR003 is a first-in-class orally-administered gastrointestinal (GI)- and liver-targeted TLR7 agonist and is currently being evaluated in an ongoing Phase 1 dose escalation trial (NCT04645797) in relapsed/refractory colorectal cancer (CRC) patients with hepatic metastasis.

APR003 was safely administered and rapidly absorbed with a pulsatile PK profile. Pharmacodynamic analysis revealed that upon weekly dosing, APR003 elicited robust Interferon-alpha, Interferon-gamma inducible protein 10 (IP-10), and Interferon Stimulated Gene 15 (ISG15) responses, suggesting strong immune priming. In addition, APR003 achieved a similar or greater IP-10 response compared to other (non-targeted) agents of the same class, indicating that tissue-targeted approach may have an increased safety window. These data support further clinical investigation of APR003 in other GI and Liver malignancies and metastatic disease as a single agent and in combination with checkpoint inhibitor or complementary therapies.

PRESENTATION DETAILS:

Meeting: 2022 Society for the Immunotherapy of Cancer (SITC)
Title: APR003, an oral liver- and GI-targeted TLR7 agonist, elicits a robust type I interferon response in advanced colorectal cancer patients
Presenting Author: Andrew T. Miller, Ph.D.
Abstract Number: 1167
Date and Time: November 10-11^th, 9:00am - 9:00pm
Location: Boston Convention & Exhibition Center, Hall C, Boston, MA

Meeting: World Vaccine & Immunotherapy Congress (WVIC) West Coast 2022
Title: Developing oral tissue-targeted TLR7 agonists for cancer immunotherapy
Presenting Author: Andrew T. Miller, Ph.D.
Date and Time: December 1^st, 11:40am
Location: Loews Coronado Bay Resort, San Diego, CA

Full abstracts will be made available online and will be included in the Journal for ImmunoTherapy of Cancer (JITC) supplement on November 7. Posters will also be available on the Apros website at www.aprostx.com following the presentations.

ABOUT APR003

APR003 is a first-in-class, orally-administered, TLR7 agonist designed specifically to localize to the gastrointestinal tract and liver to promote local immune activation in these targeted tissues and drive tumor eradication. Given the immune-activating capacity of this class of drugs, the tissue-targeted approach with APR003 is predicted to exhibit an improved tolerability profile compared to other non-tissue-targeted approaches that possess side effects associated with systemic immune activation and inflammation. TLR7 activation in the gastrointestinal tract and liver of patients with advanced cancers in these tissues may lead to innate immune priming, release of cytokines and, ultimately, enhanced anti-tumor immune responses by turning cold tumors into hot tumors. The first-in-human trial will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics in patients with advanced unresectable colorectal cancers. Upon identification of the optimal dose, APR003 will be expanded to other gastrointestinal and liver malignancies for evaluation of safety and efficacy.

ABOUT APROS THERAPEUTICS

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 variety of proprietary approaches with the aim of restricting drug distribution, controlling half-life and inducing immune inactivation 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. For more information, please visit www.aprostx.com.

Forward-Looking Statements –

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 Apros’s plans for developing APR003 for the treatment of CRC and the potential benefits of APR003 for CRC. Risks that contribute to the uncertain nature of the forward-looking statements include uncertainties related to the impact of certain translational research, completion of clinical trials and whether the results from clinical trials will validate and support the safety and efficacy of APR003 for CRC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Apros undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Stephen Keane
Chief Business Officer
Stephen_Keane@aprostx.com
(858) 345-6638
www.aprostx.com