RAPT Therapeutics Inc.

• RAPT Therapeutics Inc.
• Health-Care

RAPT

We are a clinical-stage immunology-based biopharmaceutical company focused on discovering, developing and commercializing oral small molecule therapies for patients with significant unmet needs in oncology and inflammatory diseases. Utilizing our proprietary drug discovery and development engine, we are developing highly selective small molecules designed to modulate the critical immune responses underlying these diseases. In our first four years since inception, we have discovered and advanced two unique drug candidates each targeting C-C motif chemokine receptor 4 (“CCR4”).

Our lead oncology drug candidate, FLX475, reached the clinic in just two and a half years and we expect our lead inflammation drug candidate, RPT193, to enter the clinic in the second half of 2019. We are also pursuing a range of targets, including general control nonderepressible 2 (“GCN2”) and hematopoietic progenitor kinase 1 (“HPK1”), that are in the discovery stage of development.

Our lead oncology drug candidate, FLX475, selectively inhibits the migration of immunosuppressive regulatory T cells (“Treg”) into tumors. In a Phase 1 clinical trial in 104 healthy volunteers, FLX475 was well tolerated and demonstrated favorable drug-like properties with a level of target engagement that, in our preclinical studies, corresponded with 90% inhibition of in vitro Treg migration and the highest level of inhibition of in vivo Treg migration and antitumor activity. FLX475 has also demonstrated robust single agent and combination activity in preclinical tumor models by selectively inhibiting Treg migration into the tumor.

We are currently conducting a Phase 1/2 clinical trial investigating FLX475 as a single agent and in combination with pembrolizumab (marketed as Keytruda) in patients with “charged” tumors who we believe have the greatest probability of clinical benefit, in order to study the safety and potential clinical activity of FLX475 in patients with advanced cancer. We anticipate results from the Phase 2 portion of the trial could provide clinical proof-of-concept (“PoC”) data in the first half of 2020.

Our lead inflammation drug candidate, RPT193, is designed to selectively inhibit the migration of type 2 T helper cells (“Th2 cells”), into allergically-inflamed tissues. Th2 cells are clinically validated drivers of allergic diseases along the “atopic march” such as atopic dermatitis (“AD”), asthma, chronic urticaria (skin rash), allergic conjunctivitis, chronic rhinosinusitis and eosinophilic esophagitis (inflammation of the esophagus). Our preclinical pharmacology and toxicology results for RPT193 showed activity in clinically validated pathways in allergic inflammatory disease models to a degree we believe, if confirmed in clinical trials, would be competitive with currently marketed injectable biologics and show a safety profile that suggests chronic dosing in humans should be well tolerated.

We believe the preclinical toxicology and activity results, combined with the convenience of once-daily oral dosing, suggest a profile competitive with standard of care and emerging clinical-stage drug candidates. We expect to initiate a seamless Phase 1 trial of RPT193 comprised initially of Phase 1a single and multiple dose escalation cohorts of healthy volunteers in the second half of 2019, followed by placebo-controlled Phase 1b testing in patients with moderate to severe AD. We submitted a Clinical Trial Application (“CTA”) in Europe in June 2019 and plan to submit an Investigational New Drug application (“IND”) in the United States in the third quarter of 2019 for this Phase 1 trial. We anticipate PoC clinical results from the Phase 1b portion of this study by mid-2020. Thereafter, we intend to expand clinical development into additional Th2-driven allergic indications.

In addition, we are identifying lead compounds that inhibit GCN2, which we believe is a fundamental regulator of antitumor immunity and tumor cell survival. Preclinical studies have demonstrated that a potential inhibitor of GCN2 (an “RPT-GCN2i”), has the ability to restore in vitro T cell proliferation and function in nutrient-deprived conditions, enhance tumor cell death and elicit antitumor responses in preclinical tumor models. We are developing an RPT-GCN2i with the intent of filing an IND with the FDA in 2020. 

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