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 Gunnar Kaufmann, Ph.D., as Chief
Scientific Officer and Igor Bilinsky, Ph.D., as Chief Business
Officer.
“Dr. Kaufmann brings to Oncternal significant expertise in
advancing preclinical programs from concept to the clinic and
successfully initiating and executing collaborations with corporate
partners, and Dr. Bilinsky has extensive experience in business
strategy, corporate development and strategic partnering,” said
James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. “We
believe that the addition of these two industry veterans to our
executive team will be key in helping us achieve our ambitious
goals of advancing our three oncology drug programs.”
Dr. Kaufmann, who has extensive experience in discovery and
preclinical development of both biotherapeutics and small molecule
drug product candidates, will focus on progressing Oncternal’s
preclinical product development programs and exploring
opportunities to expand the Company’s product development pipeline.
Prior to joining Oncternal, Dr. Kaufmann served as Senior Vice
President, Immunotherapy, Head of Research and Global Partnerships
at Sorrento Therapeutics, Inc. Dr. Kaufmann was previously a
faculty member at The Scripps Research Institute and still serves
as Adjunct Assistant Professor in the Departments of Chemistry and
Immunology and Microbial Science. Dr. Kaufmann holds a B.S. in
human biology from Phillips University Marburg, an M.S. in human
biology from Ernst-Moritz-Arndt University Greifswald, and a Ph.D.
from The Scripps Research Institute’s Biology Program.
Dr. Bilinsky, who has more than 20 years of experience as a
senior executive and consultant to the biotechnology industry, will
be responsible for strategic planning and advancing corporate and
business development initiatives at Oncternal. Dr. Bilinsky
formerly served as Chief Operating Officer of AmpliPhi Biosciences
Corporation, a biotechnology company developing targeted therapies
for patients with life-threatening bacterial infections.
Previously, Dr. Bilinsky was General Manager, Immuno-Oncology, and
Senior Vice President, Special Operations and Research Operations,
at Ignyta, Inc., a biotechnology company focused on precision
medicine in oncology that was acquired by Roche. Prior to joining
Ignyta, Dr. Bilinsky was Senior Vice President, Corporate
Development at Vical Inc., Vice President, Business Development and
Special Operations at Halozyme Therapeutics, Inc., and Chief
Executive Officer of Androclus Therapeutics, Inc. Dr. Bilinsky was
previously a principal in the healthcare practice of the Boston
Consulting Group, Inc., where he advised companies in the
biotechnology and pharmaceutical industries on business strategy,
operational performance, and mergers and acquisitions. Dr. Bilinsky
received his B.S. in physics from the Moscow Institute of Physics
and Technology and his Ph.D. in physics from the Massachusetts
Institute of Technology.
About Cirmtuzumab
Cirmtuzumab is an investigational, potentially first-in-class
monoclonal antibody targeting ROR1, or Receptor tyrosine
kinase-like Orphan Receptor 1. Cirmtuzumab is currently in a Phase
1/2 clinical trial in combination with ibrutinib for the treatment
of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma
(MCL), in a collaboration with the University of California San
Diego School of Medicine and the California Institute for
Regenerative Medicine. In addition, an investigator-initiated Phase
1 clinical trial of cirmtuzumab in combination with paclitaxel for
women with metastatic breast cancer is being conducted at the UC
San Diego School of Medicine. CIRM has also provided funding to
support development programs for cirmtuzumab and a CAR-T product
candidate that targets ROR1, which is currently in preclinical
development as a potential treatment for hematologic cancers and
solid tumors.
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 June 2019 ASCO meeting that six
patients with mantle cell lymphoma (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.
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 CLL and 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.
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 three oncology drug programs.
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 its 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 Oncternal’s 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 its 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/20190909005267/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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