RAPT Therapeutics and Hanmi Pharmaceutical Announce Collaboration to Develop and Commercialize FLX475 in Asia
December 03 2019 - 04:05PM
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, and Hanmi Pharmaceutical Co., LTD today
announced a license and collaboration agreement for FLX475 in Asia.
FLX475 is an oral, small molecule CCR4 antagonist in development
for the treatment of multiple cancers.
“We are actively building our immuno-oncology portfolio, and see
FLX475 as a potential keystone in our effort to deliver new safe
and effective cancer therapeutics to patients who need them,” said
Hanmi CEO Se-Chang Kwon, Ph.D. “This compound complements our
current product portfolio and has the potential to address a large
and growing population of patients suffering from cancers that are
prevalent in Asian countries. We look forward to partnering with
RAPT to advance FLX475 through the clinic efficiently.”
Under the terms of the agreement, RAPT will receive $10 million
in an upfront payment and near-term milestone payment.
Additionally, RAPT will receive up to $48 million in success-based
development milestones and up to $60 million in potential sales
milestones, as well as double-digit royalties on any future sales
of FLX475 in the specified territories. In return, Hanmi will
receive an exclusive license to develop, in parallel with RAPT, and
commercialize FLX475 for the treatment of cancer in South Korea and
China, including Taiwan and Hong Kong. In addition to leveraging
its clinical trial infrastructure in Korea and China to augment
RAPT’s ongoing Phase 1/2 clinical study of FLX475, Hanmi will also
conduct a Phase 2 clinical trial in Korea and China to evaluate
FLX475 in patients with gastric cancer.
“FLX475 targets “charged” tumors including virally-associated
cancers, gastric cancer, non-small cell lung cancer, triple
negative breast cancer and head and neck cancers, which are
predicted to have high levels of CCR4 ligands, regulatory T cells
and CD8+ effector T cells,” said Yung-Jue Bang, M.D., Ph.D.,
professor of Medical Oncology at Seoul National University
Hospital. “I believe FLX475 has the potential to offer
patients a new therapeutic option that is desperately needed,
particularly in Korea, which has the highest rate of gastric cancer
in the world.”
“This collaboration with Hanmi can provide us an entry point
into the Asian market, allowing us to potentially expand our
geographic footprint in a region with high prevalence of patients
with “charged” tumors who we believe are most likely to respond to
FLX475,” said Brian Wong, M.D., Ph.D., president and CEO of RAPT
Therapeutics. “Hanmi, with its fully integrated R&D
infrastructure and nimble execution efficiency, has accumulated
clinical development experiences and an extensive network of key
opinion leaders. We believe Hanmi is a perfect partner for the
development of FLX475.”
FLX475 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.
RAPT is currently enrolling patients in a Phase 1/2 study of
FLX475 as a monotherapy, and in combination with pembrolizumab, in
patients with “charged” tumors and expect results from the Phase 2
portion of the trial in the first half of 2020.
About Hanmi Pharmaceutical Co., LTD Hanmi
Pharmaceutical is a Korea-based global pharmaceutical company
focused on the development and commercialization of new
pharmaceutical products. The Company is fully integrated from
R&D through manufacturing, marketing and sales with an
established presence in Korea as well as China. More information on
Hanmi is available at www.hanmipharm.com.
About RAPT Therapeutics, Inc.RAPT Therapeutics
(formerly FLX Bio) 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 responses underlying these diseases.
In its first four years since inception, RAPT has discovered and
advanced two unique drug candidates, each targeting C-C motif
chemokine receptor 4. The company’s lead oncology drug candidate,
FLX475, reached the clinic in just two and a half years and its
lead inflammation drug candidate, RPT193, is also in the clinic.
The company is also pursuing a range of targets, including general
control nonderepressible 2 and hematopoietic progenitor kinase 1,
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 which 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,
RAPT’s collaboration with Hanmi in regard to the Asian market in
the future, and the parties’ performance of the license and
collaboration agreement. Detailed information regarding 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 final prospectus filed with the Securities and
Exchange Commission on November 1, 2019. 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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