Oncternal Expands Leadership Team with Appointment of Frank Hsu, M.D., as Chief Medical Officer, & Rajesh Krishnan, Ph.D., as...
August 28 2019 - 4:01PM
Business Wire
Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage
biotechnology company developing potential first-in-class product
candidates for cancers with critical unmet medical needs, today
announced the appointment of Frank Hsu, M.D., as Chief Medical
Officer, and Rajesh Krishnan, Ph.D., as Senior Vice President,
Chemistry, Manufacturing and Controls (CMC) and Manufacturing.
Dr. Hsu brings to Oncternal extensive experience in cancer drug
development, most recently from Immune Design Corporation, where he
served as Vice President and Head of Oncology, responsible for
development and execution of the company’s clinical programs,
supporting preclinical and business efforts. Dr. Krishnan brings a
wealth of experience in manufacturing, process development,
technology transfer and technical operations, most recently from
Dynavax Technologies Corporation, where he served as Vice
President, Process Development and Manufacturing Sciences.
“I am very excited to announce these two key executive
appointments. Frank Hsu’s arrival reflects the growing importance
of clinical drug development at Oncternal,” said James Breitmeyer,
M.D., Ph.D., Oncternal’s President and CEO. “We believe that
Frank’s wealth of expertise in oncology drug development and
regulatory approval, his deep academic oncology background and
proven ability to collaborate and lead teams make him an ideal fit
for Oncternal as we advance our pipeline of potential
first-in-class targeted therapies. Raj Krishnan’s appointment also
reflects Oncternal’s commitment to advancing its diverse targeted
therapeutic candidates. Raj has extensive experience and a proven
track record of innovation and success in cross-functional CMC
programs involving biologic and small molecule product candidates.
We believe that the addition of these two outstanding professionals
to the Oncternal executive team will be instrumental as we continue
to advance our lead clinical product candidate, cirmtuzumab, along
with our clinical TK216 product candidate and our preclinical ROR1
targeted CAR-T program.”
Dr. Hsu stated, “This is an exciting time at Oncternal, with its
diversified clinical pipeline targeting emerging cancer biology and
multiple indications, including both hematological and solid tumor
programs. I look forward to working with the talented individuals
at Oncternal to execute the Company’s clinical development
programs.”
“I am delighted to have the opportunity to bring my extensive
experience with process development and manufacturing of both
biologic and small molecule product candidates to Oncternal,” said
Dr. Krishnan.
Dr. Hsu has held positions of increasing responsibility in both
biotech and academic settings. From 2013 through 2018, he served as
Vice President and Head of Oncology at Immune Design Corporation
prior to its acquisition by Merck Co., Inc., where he was
responsible for development of several immuno-oncology programs.
From 2012 until 2013, Dr. Hsu served as Chief Medical Officer at
Zyngenia, Inc., where he was responsible for development of its
multivalent protein therapeutics. From 2002 through 2012, he served
as Senior Medical Director at Genzyme Corporation prior to its
acquisition by Sanofi, S.A. Previously, Dr. Hsu was a faculty
member at Yale University, serving as an Assistant Professor of
Medicine in the Section of Oncology and co-Director/Director of the
Immunology Research Program of the Yale Cancer Center. Dr. Hsu
holds a B.S. degree in biology from Stanford University, and an
M.D. degree from Harvard Medical School and the Health Science and
Technology Program at the Massachusetts Institute of Technology. He
completed his internship/residency in Internal Medicine at the
University of California, San Francisco and his oncology training
at Stanford University.
Dr. Krishnan has experience across a range of CMC and
manufacturing technologies for U.S. and international manufacturing
sites, involving both internal and partnered programs. From 2018
until 2019, he served as Vice President, Process Development and
Manufacturing Sciences at Dynavax Technologies Corporation, where
he led manufacturing, drug process development, process validation
and technology transfer efforts for commercial and clinical
development programs. From 2012 through 2017, Dr. Krishnan served
in several positions at Gilead Sciences, Inc., most recently as
Head, Biologics Drug Substance Process Development. Previously, he
served in positions of increasing responsibility at Merck &
Co., Inc., Amgen Inc. and Pfizer from 2000 through 2012. Dr.
Krishnan holds a B.S.E. degree in chemical engineering from
Princeton University, an M.S. degree in chemical engineering from
the University of California, Davis, and a Ph.D. degree in
Biochemical Engineering from the University of California,
Davis.
About Oncternal Therapeutics
Oncternal Therapeutics is a clinical-stage biopharmaceutical
company focused on developing a diverse pipeline of product
candidates for the treatment of cancers with critical unmet medical
need. Oncternal focuses drug development on promising yet untapped
biological pathways implicated in cancer generation and
progression. The pipeline includes its lead clinical program,
cirmtuzumab, a monoclonal antibody designed to inhibit the ROR1
receptor that is being evaluated in a Phase 1/2 clinical trial in
combination with ibrutinib for the treatment of chronic lymphocytic
leukemia (CLL) and mantle cell lymphoma (MCL), and TK216, a
small-molecule compound that is designed to inhibit E26
transformation specific (ETS) family oncoproteins, which is being
evaluated in a Phase 1 clinical trial alone and in combination with
vincristine as a treatment for Ewing sarcoma, a rare pediatric
cancer. In addition, Oncternal has a CAR-T program targeting ROR1,
which is currently in preclinical development as a potential
treatment for hematologic cancers and solid tumors. More
information is available at www.oncternal.com.
- In August 2019, Oncternal announced it has opened for
enrollment its randomized Phase 2 study of cirmtuzumab, a
ROR1-targeted monoclonal antibody, combined with ibrutinib in
patients with CLL. The decision to open the Phase 2 portion of the
Company’s ongoing Phase 1/2 CIRLL (Cirmtuzumab and Ibrutinib
targeting ROR1 for Leukemia and Lymphoma) clinical trial was
triggered by favorable outcomes from the Part 1 dose-finding and
Part 2 dose-confirming cohorts of the clinical trial, including an
observed interim objective response rate (ORR) of 100% for the
first nine CLL patients with evaluable data receiving the
recommended dosing regimen who have completed 12 weeks of
cirmtuzumab plus ibrutinib treatment in Part 2. The Company
continues to see a well-tolerated safety profile consistent with
that seen with ibrutinib treatment alone.
- In June 2019, Oncternal presented interim data from its ongoing
Phase 1/2 study of cirmtuzumab in combination with ibrutinib at the
2019 American Society of Clinical Oncology (ASCO) Annual Meeting –
the largest oncology conference of the year. Results from the first
12 patients with CLL treated in the Part 1 dose-finding portion of
the Phase 1 study showed an observed interim ORR of 91.7% for the
combination of cirmtuzumab plus ibrutinib, including three patients
with clinical or confirmed complete responses, and a well-tolerated
safety profile consistent with that seen for ibrutinib treatment
alone.
- Oncternal also disclosed at the ASCO meeting that six patients
with MCL had been treated in a separate cohort of the CIRLL study.
One patient with MCL who had relapsed following an allogeneic stem
cell transplant experienced a confirmed complete response (CR)
after 3 months of cirmtuzumab plus ibrutinib treatment, including
complete resolution of a large mediastinal mass. This CR appears to
be durable, and has been confirmed after 6, 9 and 11 months of
cirmtuzumab plus ibrutinib treatment.
Forward-Looking Information
Oncternal cautions you that statements included in this press
release that are not a description of historical facts are
forward-looking statements. In some cases, you can identify
forward-looking statements by terms such as “may,” “will,”
“should,” “expect,” “plan,” “anticipate,” “could,” “intend,”
“target,” “project,” “contemplates,” “believes,” “estimates,”
“predicts,” “potential” or “continue” or the negatives of these
terms or other similar expressions. These statements are based on
the Company’s current beliefs and expectations. Forward-looking
statements include statements regarding Oncternal’s expectations
regarding its ability to advance its lead clinical product
candidate, cirmtuzumab, along with its TK216 clinical product
candidate and preclinical ROR1 targeted CAR-T program. The
inclusion of forward-looking statements should not be regarded as a
representation by Oncternal that any of its plans will be achieved.
Actual results may differ from those set forth in this release due
to the risks and uncertainties inherent in Oncternal’s business,
including, without limitation: uncertainties inherent in the
clinical development process and in obtaining regulatory approval
of cirmtuzumab, TK216 and Oncternal’s other product candidates,
including potential delays in the commencement, enrollment and
completion of clinical trials; Oncternal’s dependence on the
success of cirmtuzumab, TK216 and its other product development
programs; the risk that interim results of a clinical trial do not
necessarily predict future or final results and that one or more of
the clinical outcomes may materially change as patient enrollment
continues, following more comprehensive reviews of the data, and as
more patient data become available; the risk that unforeseen
adverse reactions or side effects may occur in the course of
developing and testing product candidates such as cirmtuzumab,
TK216 and Oncternal’s other product candidates; the Company’s
reliance on third parties for the manufacture of its product
candidates and the risk that sufficient quantities of such product
candidates may not be available to perform clinical studies or at
an acceptable cost, which could delay, prevent or impair
Oncternal’s development efforts; Oncternal’s limited operating
history and the fact that it has incurred significant losses, and
expects to continue to incur significant losses for the foreseeable
future; risks related to the inability of Oncternal to obtain
sufficient additional capital to continue to advance the
development of cirmtuzumab, TK216 and its other product candidates;
and other risks described in Oncternal’s prior press releases as
well as in public periodic filings with the U.S. Securities &
Exchange Commission. All forward-looking statements in this press
release are current only as of the date hereof and, except as
required by applicable law, Oncternal undertakes no obligation to
revise or update any forward-looking statement, or to make any
other forward-looking statements, whether as a result of new
information, future events or otherwise. All forward-looking
statements are qualified in their entirety by this cautionary
statement. This caution is made under the safe harbor provisions of
the Private Securities Litigation Reform Act of 1995.
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version on businesswire.com: https://www.businesswire.com/news/home/20190828005725/en/
Oncternal Contacts: Investors Richard Vincent
858-434-1113 rvincent@oncternal.com
Media Jason Spark 619-849-6005 jason@canalecomm.com
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