NEW HAVEN, Conn., Feb. 6, 2020 /PRNewswire/ -- Kleo
Pharmaceuticals, Inc., an immuno-oncology company developing
next-generation, fully synthetic bispecific compounds designed to
emulate or enhance the activity of biologics, announced today that
it has received Investigational New Drug (IND) authorization to
proceed from the U.S. Food and Drug Administration (FDA) to
initiate a safety and tolerability clinical study combining KP1237,
a CD38-targeting antibody recruiting molecule (ARM™), with
patients' own Natural Killer (NK) cells to treat multiple myeloma
(MM) in post-transplant patients.
The single-arm study will be conducted in 25-30 patients with
exploratory endpoints that assess the MRD (minimal residual
disease) conversion rate at 90-100 days after transplantation.
Recent clinical trials have identified MRD negativity
post-transplant as a potential surrogate of long-term remission in
MM. The trial is expected to begin enrollment in the first half of
2020, and topline data are expected in the second half of 2021.
"We are excited to have clearance to initiate a clinical trial
in the US that addresses a significant unmet medical need in newly
diagnosed, post-transplant multiple myeloma patients," said Kleo
CEO Doug Manion, MD. "Approximately
30,000 individuals are diagnosed with multiple myeloma in
the United States each year, with
at least 1/3 of those patients undergoing autologous stem cell
transplants."
In this trial, KP1237 is being investigated as a "cell homing"
molecule to target the patient's activated NK cells to the
CD38-expressing tumor. Current anti-CD38 therapeutic antibodies
kill NK cells and are not approved for use in this clinical
settingi.
Nonclinical efficacy data presented at the 2019 American
Society of Hematology (ASH) Annual Meeting demonstrated that
CD38-ARMs are able to kill multiple myeloma cells by
antibody-dependent cellular cytotoxicity without depleting
CD38-expressing immune cells. Nonclinical data also demonstrated
that the CD38-ARM molecule did not induce complement-dependent
cytotoxicity (CDC) suggesting it is not likely to cause CDC in
humans. Kleo's 2019 ASH posters can be viewed here and
here.
About Kleo Pharmaceuticals, Inc.
Kleo Pharmaceuticals
is a unique immuno-oncology company developing next-generation
bispecific compounds designed to emulate or enhance the activity of
biologics based on the groundbreaking research of its scientific
founder Dr. David Spiegel at Yale
University. Similar to complex biologic drugs, Kleo's
compounds recruit the immune system to destroy cancer cells, with
the advantage of being smaller and more versatile, leading to
potentially improved safety and efficacy over biologics. They are
also much faster and less costly to design and produce,
particularly against novel targets. Kleo is advancing several drug
candidates based on its proprietary technology platforms, all of
which are modular in design and enable rapid generation of novel
immunotherapies that can be optimized against certain cancers, or
enhance the properties of existing immunotherapies. These include
Antibody Recruiting Molecules (ARMs), Synthetic Antibody Mimics
(SyAMs) and Monoclonal Antibody Therapy Enhancers (MATEs). Biohaven
Pharmaceutical Holding Company (NYSE:BHVN) and PeptiDream Inc.
(Nikkei:PPTDF) are investors in Kleo Pharmaceuticals. For
more information visit http://kleopharmaceuticals.com.
Forward-Looking Statements
This news release includes
forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These forward-looking
statements involve substantial risks and uncertainties, including
statements that are based on the current expectations and
assumptions of the Company's management. All statements, other than
statements of historical facts, included in this press release
regarding the Company's plans and objectives, expectations and
assumptions of management are forward-looking statements. The use
of certain words, including the words "estimate," "project,"
"intend," "expect," "believe," "anticipate," "will," "plan,"
"could," "may" and similar expressions are intended to identify
forward-looking statements. The forward-looking statements are made
as of this date and the Company does not undertake any obligation
to update any forward-looking statements, whether as a result of
new information, future events or otherwise.
CONTACT INFORMATION
Tiberend Strategic Advisors, Inc.
Maureen McEnroe, CFA (Investors)
212-375-2664
mmcenroe@tiberend.com
Ingrid Mezo (Media)
646-604-5150
imezo@tiberend.com
i DARZALEX® (daratumumab) injection [package insert
on the internet]. Horsham, PA:
Janssen Biotech, Inc.,
http://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/DARZALEX-pi.pdf
(2019, accessed 05 February
2020).
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SOURCE Kleo Pharmaceuticals, Inc.