CytomX Announces U.S. FDA Clearance of Investigational New Drug Application for Phase 1/2 Clinical Study of Anti-PD-L1 Probod...
14 Diciembre 2016 - 7:00AM
CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical
company developing investigational Probody™ therapeutics for the
treatment of cancer, today announced that the U.S. Food and Drug
Administration (FDA) has cleared the company’s Investigational New
Drug (IND) application for its lead program, CX-072, a wholly-owned
PD-L1-targeting Probody therapeutic for the treatment of
cancer. The company plans to immediately initiate the study
and open clinical sites to support patient enrollment.
“Initiating the first clinical program emerging
from the Probody platform is a major milestone for CytomX,” said
Sean McCarthy, D.Phil., president and chief executive officer of
CytomX Therapeutics. “CX-072 has the potential to become a
differentiated centerpiece of combination cancer therapy by
targeting the tumor microenvironment, while sparing healthy
tissues. We are partnering with clinical trial sites to bring
this innovative treatment option to patients as quickly as
possible.”
About PROCLAIMPROCLAIM
(Probody Clinical
Assessment In
Man) is an international umbrella program designed
to evaluate CytomX Probody therapeutics. The first module to
be initiated is the PROCLAIM-072 clinical study, an open-label,
dose-finding phase 1/2 trial evaluating CX-072 as monotherapy and
in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib)
in patients with metastatic or locally advanced unresectable solid
tumors or lymphomas. CytomX aims to achieve three goals as part of
the PROCLAIM-072 clinical trial:
- Tolerability: Demonstrate that CX-072 is well tolerated in
patients and potentially improves safety, particularly in the
combination setting.
- Anti-cancer activity: Demonstrate initial evidence of CX-072’s
anti-cancer activity as monotherapy and in combination.
- Translational program and Probody platform proof-of-concept:
Explore mechanistic aspects of Probody activity in patients.
Clinical data from PROCLAIM-072 is expected to
begin to emerge in late 2017 and throughout 2018.
About CytomX TherapeuticsCytomX is
a clinical stage, oncology-focused biopharmaceutical company
pioneering a novel class of investigational antibody therapeutics
based on its Probody technology platform. The company uses the
platform to create proprietary cancer immunotherapies against
clinically-validated targets, as well as to develop first-in-class
investigational cancer therapeutics against novel targets. CytomX
believes that its Probody platform has the potential to improve the
combined efficacy and safety profile of monoclonal antibody
modalities, including cancer immunotherapies, antibody drug
conjugates and T-cell-recruiting bispecific antibodies. Probody
therapeutics are designed to take advantage of unique conditions in
the tumor microenvironment to enhance the tumor-targeting features
of an antibody and reduce drug activity in healthy tissues.
The company’s investigational Probody therapeutics address
clinically-validated cancer targets in immuno-oncology, such as
PD-L1, against which the clinical candidate CX-072 is directed, as
well as novel targets, such as CD-166, that are difficult to drug
without causing damage to healthy tissues. In addition to its
proprietary programs, CytomX is collaborating with strategic
partners including AbbVie, Bristol-Myers Squibb Company, Pfizer
Inc., MD Anderson Cancer Center, and ImmunoGen, Inc. For more
information, visit www.cytomx.com.
Forward-Looking StatementsThis
press release includes forward-looking statements, including
statements related to the development and advancement of the
company’s product candidates into, and the successful completion
of, clinical trials, including with respect to the timing of a
Phase 1 clinical trial for CX-072 and the availability of data from
such clinical trials. Such forward-looking statements involve known
and unknown risks, uncertainties and other important factors that
are difficult to predict, may be beyond our control, and may cause
the actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied in such statements. Accordingly, you should
not rely on any of these forward-looking statements. Our Probody
platform is in preclinical development, and the process by which a
preclinical technology could potentially lead to an approved
product is long and subject to significant risks and uncertainties.
Projected net cash utilization and capital resources are subject to
substantial risk of variance based on a wide variety of factors
that can be difficult to predict. Applicable risks and
uncertainties include those relating to our preclinical research
and development and other risks identified under the heading "Risk
Factors" included in our filings with the SEC. The forward-looking
statements contained in this press release are based on information
currently available to CytomX and speak only as of the date on
which they are made. CytomX does not undertake and specifically
disclaims any obligation to update any forward-looking statements,
whether as a result of any new information, future events, changed
circumstances or otherwise.
Corporate Communications Contact:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388
Investor Contact:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973
CytomX Therapeutics (NASDAQ:CTMX)
Gráfica de Acción Histórica
De Jun 2024 a Jul 2024
CytomX Therapeutics (NASDAQ:CTMX)
Gráfica de Acción Histórica
De Jul 2023 a Jul 2024