CytomX Therapeutics Announces FDA Clearance of Investigational New Drug Application for CX-904 for the Treatment of Advanced Solid Tumors
19 Enero 2022 - 7:00AM
CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated therapeutics, today announced that the U.S.
Food and Drug Administration (FDA) has cleared the company’s
Investigational New Drug (IND) application for CX-904, an EGFRxCD3
T-cell-engaging bispecific antibody being co-developed by CytomX
and Amgen.
“The impressive innovation of CX-904’s design
and its advancement into the clinical setting underscores our
commitment to destroying cancer differently. The CX-904 IND also
marks the sixth therapeutic candidate and the third treatment
modality overall to enter the clinic from our versatile and tunable
Probody platform, reinforcing our leadership in the field of
conditional activation of biologic therapeutics,” said Sean
McCarthy, D.Phil., president, chief executive officer and chairman
of CytomX Therapeutics. “Our masked Probody T-cell engagers are
designed to harness the power of this highly potent modality. We
are eager to initiate the Phase 1 dose-escalation study for CX-904
as the leading edge of our broad efforts to bring conditionally
activated bispecifics to patients with advanced solid tumors.”
T-cell-engaging bispecific antibodies have
tremendous potential for the treatment of solid tumors by directing
T cells against tumor antigens, including the epidermal growth
factor receptor (EGFR). However, the extraordinarily high potency
of these agents can narrow their therapeutic window significantly
when their target is present on normal tissues. CX-904 is a
conditionally activated T-cell bispecific antibody designed to bind
to both EGFR on cancer cells and to the CD3 receptor on T cells
selectively in the tumor microenvironment. In preclinical studies,
CytomX's conditionally activated Probody EGFRxCD3 bispecific
therapeutics demonstrated potent anti-tumor activity and strong
improvement in safety versus EGFRxCD3 bispecifics without Probody
masking.1
About CytomX Therapeutics,
Inc.CytomX is a clinical-stage, oncology-focused
biopharmaceutical company dedicated to destroying cancer
differently. By pioneering a novel class of conditionally activated
biologics, powered by its Probody® technology platform, CytomX’s
goal is to transcend the limits of current cancer treatments and
successfully leverage therapeutic targets that were once thought to
be inaccessible. CytomX’s robust and differentiated pipeline
includes the wholly-owned praluzatamab ravtansine (CX-2009), an
investigational conditionally activated antibody-drug conjugate
(ADC) directed toward CD166, and CX-2029, an investigational
conditionally activated ADC directed toward CD71 co-developed with
AbbVie. These two programs are currently being evaluated in Phase 2
studies, targeting a variety of late-stage, difficult-to-treat
cancer types, including breast cancer for praluzatamab ravtansine,
and squamous non-small cell lung cancer, and head and neck squamous
cell carcinoma for CX-2029. CytomX’s clinical pipeline also
includes cancer immunotherapeutic candidates against validated
targets such as the CTLA-4-targeting Probody therapeutics,
BMS-986249 and BMS-986288, partnered with Bristol Myers Squibb, and
our wholly-owned conditionally activated anti-PD-L1 antibody,
pacmilimab (CX-072), as well as the Amgen-partnered CX-904, a
conditionally activated T-cell-engaging bispecific antibody against
the epidermal growth factor receptor on tumor cells and the CD3
receptor on T cells. In addition, CytomX has a diverse preclinical
portfolio and strategic collaborations with other leaders in
oncology, including AbbVie, Amgen, Astellas, and Bristol Myers
Squibb. For more information about CytomX and how it is working to
make conditionally activated treatments the new standard-of-care in
the fight against cancer, visit www.cytomx.com and follow us on
LinkedIn and Twitter.
CytomX Therapeutics Forward-Looking
StatementsThis press release includes forward-looking
statements. 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, including
those relating to the potential benefits, safety and efficacy or
progress of CytomX’s or any of its collaborative partners’ product
candidates, including CX-904, the potential benefits or
applications of CytomX’s Probody platform technology, CytomX’s
ability to develop and advance product candidates into and
successfully complete clinical trials, including the ongoing and
planned clinical trials of praluzatamab ravtansine, CX-2029,
BMS-986249, BMS-986288, pacmilimab, and CX-904, and the timing of
the commencement of clinical trials, initial data, investigational
new drug applications and other development milestones. Risks and
uncertainties that contribute to the uncertain nature of the
forward-looking statements include: the unproven nature of CytomX’s
novel Probody Platform technology; CytomX’s clinical trial product
candidates, including CX-904, are in the initial stages of clinical
development and its other product candidates are currently in
preclinical development, and the process by which preclinical and
clinical development could potentially lead to an approved product
is long and subject to significant risks and uncertainties,
including the risk that the COVID-19 worldwide pandemic may
continue to negatively impact the business, research and clinical
operations of CytomX or its partners, including the development of
preclinical drug candidates due to delays in and disruption of
research activities and the development of clinical drug candidates
due to delays in or disruption of clinical trials, including
impacts on the enrollment of patients in clinical trials or other
clinical trial disruptions; the possibility that the results of
early clinical trials may not be predictive of future results; the
possibility that CytomX’s clinical trials will not be successful;
the possibility that current preclinical research may not result in
additional product candidates; CytomX’s dependence on the success
of praluzatamab ravtansine, CX-2029, BMS-986249, BMS-986288,
pacmilimab, and CX-904; CytomX’s reliance on third parties for the
manufacture of the Company’s product candidates; and possible
regulatory developments in the United States and foreign
countries. Additional applicable risks and uncertainties include
those relating to our preclinical research and development,
clinical development, and other risks identified under the heading
"Risk Factors" included in CytomX’s Quarterly Report on Form 10-Q
filed with the SEC on November 4, 2021. 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.
Probody is a U.S. registered trademark of CytomX
Therapeutics, Inc.
Reference:
- Boustany L, La Porte S, Wong L, et
al. EGFR-CD3 Bispecific Probody™ Therapeutic Induces Tumor
Regressions and Increases Maximum Tolerated Dose > 60 fold in
Preclinical Studies. Poster presented at: AACR-NCI-EORTC
International Conference on Molecular Targets; 2017 Oct. 26-30;
Philadelphia, PA.
https://cytomx.com/wp-content/uploads/CytomX-PbTCB_AACR_NCI_EORTC_2017_FINAL.pdf
Investor Contact:Chau Cheng,
PhD MBAVP, Investor Relations & Corp.
Communicationsccheng@cytomx.comDirect: (650) 273-4999
Media Contact:Bret
CoonsDirector, Corporate Communicationsbcoons@cytomx.comDirect:
(650) 528 2929
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