RAPT Therapeutics Announces Poster Presentation at the American Society of Clinical Oncology Virtual Scientific Program
May 29 2020 - 8:00AM
RAPT Therapeutics, Inc. (Nasdaq: RAPT), 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, today announced the presentation of a Trials
in Progress poster for the ongoing seamless Phase 1/2 clinical
trial of FLX475, a small molecule CCR4 antagonist in development
for multiple tumor types. The poster was presented at the American
Society of Clinical Oncology (ASCO) 2020.
The poster presentation detailed previously reported initial
Phase 1 healthy volunteer data for FLX475 that demonstrated
excellent safety, pharmacokinetics (PK) and target engagement.
FLX475 is designed to block regulatory T cells from migrating to
tumor sites, where they suppress immune system responses to cancer
cells, without depleting regulatory T cells in the rest of the body
nor immune cells required for an anti-tumor response. A robust
pharmacodynamic (PD) assay measuring receptor occupancy on
circulating regulatory T cells demonstrated that FLX475 achieved
exposure levels over the targeted 75%, predicting maximal
inhibition of regulatory T cell recruitment into tumors via CCR4
signaling. In addition, levels of FLX475 increased in a
dose-proportional manner, with a strong PK/PD correlation observed
between drug levels and receptor occupancy.
Building on these data, RAPT initiated a seamless Phase 1/2
study of FLX475. The Phase 1 portion of the trial was a standard
dose escalation study in patients with many types of cancer, and
the Phase 2 portion is evaluating FLX475 both as monotherapy and in
combination with a checkpoint inhibitor in patients with “charged”
tumors, which are tumors that express high levels of CCR4 ligands
(CCL17 and CCL22), and have a high presence of regulatory T cells
and CD8+ effector T cells. RAPT is currently enrolling the Phase 2
portion of the trial in patients with charged tumors, including
non-small cell lung cancer, triple negative breast cancer, head and
neck squamous cell carcinoma, cervical cancer as well as
EBV-positive nasopharyngeal cancer and lymphomas.
“We are pleased with our continued progress in clinical
evaluation of FLX475 and remain encouraged by our early
observations,” said Brian Wong, M.D., Ph.D., President and CEO of
RAPT Therapeutics. “The previously reported checkpoint
inhibitor-refractory patient with non-small cell lung cancer with a
confirmed partial response in the Phase 1 part of this study
continues to respond to FLX475 plus Keytruda, and is approaching
the 1-year mark of study treatment. Our sites in the U.S.,
Australia and Asia continue to enroll patients and we remain on
track to report results for both the Phase 1 and initial Phase 2
expansion cohorts in the second half of 2020.”
The poster presented at ASCO can be viewed on the RAPT website
under the Events and Presentation tab of the Investor Relations
section here.
About FLX475FLX475 is a small molecule CCR4
antagonist designed to block the migration of regulatory T cells
(Treg) specifically into tumors, but not healthy tissues.
Treg represent a dominant pathway for downregulating the
immune response, and may limit the effectiveness of currently
available therapies such as checkpoint inhibitors. RAPT is
developing FLX475 for the treatment of a broad range of “charged”
tumors, which represent cancer types the company believes are most
likely to respond to FLX475, where a large quantity of
Treg cells are likely to be the cause of immune suppression
within the tumor. FLX475 blocks the migration of Treg to the
tumor, which may restore naturally occurring antitumor immunity and
synergizing with a variety of both conventional and immune-based
therapies, such as radiation, chemotherapy, checkpoint inhibitors,
immune stimulators and adoptive T cell therapy.
About RAPT Therapeutics, Inc.RAPT
Therapeutics is 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 its proprietary
discovery and development engine, the Company is developing highly
selective small molecules designed to modulate the critical immune
drivers underlying these diseases. RAPT has discovered and advanced
two unique drug candidates, FLX475 and RPT193, each targeting C-C
motif chemokine receptor 4 (CCR4), for the treatment of cancer and
inflammation, respectively. The Company is also pursuing a range of
targets, including hematopoietic progenitor kinase 1 (HPK1) and
general control nonderepressible 2 (GCN2), that are in the
discovery stage of development.
Forward-Looking StatementsThis press release
contains forward-looking statements. These statements relate to
future events and involve known and unknown risks, uncertainties
and other factors that may cause our actual results, performance or
achievements to be materially different from any future
performances or achievements expressed or implied by the
forward-looking statements. Each of these statements is based only
on current information, assumptions and expectations that are
inherently subject to change and involve a number of risks and
uncertainties. Forward-looking statements include, but are not
limited to, statements about the clinical development of FLX475,
the interpretation of preliminary observations from the Phase 1
cohort in FLX475 and the continued progress and timing of results
from clinical trials of FLX475. Detailed information regarding risk
factors that may cause actual results to differ materially from the
results expressed or implied by statements in this press release
may be found in RAPT’s Form 10-Q filed with the Securities and
Exchange Commission on May 14, 2020 and subsequent filings made by
RAPT with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof. RAPT
disclaims any obligation to update these forward-looking
statements.
RAPT Media Contact:Angela
Bittingmedia@rapt.com(925) 202-6211
RAPT Investor Contact:Sylvia
Wheelerswheeler@wheelhouselsa.com
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