CytomX Therapeutics Announces FDA Clearance of IND Applications for CX-2051, a Probody® Antibody Drug Conjugate (ADC) Targeting EpCAM and CX-801, a Conditionally Activated Interferon Alpha-2b
24 Janeiro 2024 - 10:00AM
CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated, localized biologics, today announced that
it has received clearance from the U.S. Food and Drug
Administration (FDA) for its Investigational New Drug (IND)
applications for the conditionally activated Probody® therapeutics
CX-2051, an EpCAM-directed ADC, and CX-801, a dually-masked version
of interferon-alpha 2b. CX-2051 has been cleared for the initiation
of Phase 1 dose escalation in solid tumors with known EpCAM
expression and CX-801 has been cleared for the initiation of Phase
1 dose escalation in solid tumors including melanoma, renal, and
head and neck squamous cell carcinoma. Both programs are expected
to start Phase 1 studies in the first half of 2024.
“CX-2051 and CX-801 have the potential to address major unmet
needs in oncology and we are excited to advance these programs into
Phase 1 clinical studies. CX-2051 is an ADC conjugated to a
next-generation topoisomerase-1 inhibitor payload that we believe
is tailored to certain EpCAM-expressing tumors, including
colorectal cancer,” said Wayne Chu, M.D., chief medical officer of
CytomX Therapeutics. “CX-801 is designed to overcome previous
limitations of interferon-directed therapies due to systemic
toxicity and establish CX-801 as a cornerstone of combination
regimens, including with checkpoint inhibitors, across a wide range
of tumor types,” continued Dr. Chu.
“The parallel advancement of these programs toward the clinic
demonstrates the continued high productivity of the CytomX team and
the versatile, multi-modality nature of our Probody® platform. The
product design principles behind CX-2051 and CX-801 integrate over
a decade of continuous innovation and experience at CytomX,” said
Sean McCarthy, D.Phil., chief executive officer and chairman of
CytomX Therapeutics. “We look forward to the clinical initiation of
these programs as we enter a potentially milestone-rich period for
the company in 2024 and 2025.”
About CX-2051
EpCAM is a high potential oncology target that has been
clinically validated by locally administered, previously approved
cancer therapies. However, to date, efforts to generate
systemically administered anti-EpCAM therapeutics have not been
successful due to toxicities in certain epithelial tissues, notably
in the gastrointestinal tract. CX-2051, a conditionally activated
ADC, is tailored to optimize the therapeutic index for
EpCAM-expressing cancers. The cytotoxic payload utilized in CX-2051
is a derivative of camptothecin, a topoisomerase-1 inhibitor, a
class of drug that has shown potent clinical anti-cancer activity
in the ADC context for multiple targets. CX-2051 has demonstrated a
wide predicted therapeutic index and strong preclinical activity
and tolerability in multiple preclinical models, including
colorectal cancer. Phase 1 clinical initiation in EpCAM expressing
solid tumors is expected in the first half of 2024. Further details
on the design and preclinical optimization of CX-2051 can be found
here:
Link to 2023 World ADC Conference presentation
About CX-801
Interferon-alpha 2b is an immunotherapeutic cytokine that has
demonstrated clinical activity and gained regulatory approval
previously in multiple cancer types, including metastatic melanoma,
renal cancer and bladder cancer. IFNα2b provides a potentially
superior approach to activating anti-tumor immune responses
compared to other cytokines. CX-801 is a dually masked,
conditionally activated version of IFNα2b that has the potential to
become a cornerstone of combination therapy for a wide range of
tumor types, including in traditionally immuno-oncology sensitive
as well as insensitive (cold) tumors. Phase 1 initiation for CX-801
solid tumors including melanoma, renal, and head and neck squamous
cell carcinoma anticipated in the first half of 2024. Further
details on the design and preclinical optimization of CX-801 can be
found here:
Link to 2023 SITC poster
About CytomX
Therapeutics
CytomX is a clinical-stage, oncology-focused biopharmaceutical
company focused on developing novel conditionally activated
biologics designed to be localized to the tumor microenvironment.
By pioneering a novel pipeline of localized biologics, powered by
its Probody® therapeutic platform, CytomX’s vision is to create
safer, more effective therapies for the treatment of cancer.
CytomX’s robust and differentiated pipeline comprises therapeutic
candidates across multiple treatment modalities including
antibody-drug conjugates (“ADCs”), T-cell engagers, and immune
modulators such as cytokines and checkpoint inhibitors. CytomX’s
clinical pipeline includes the cancer immunotherapeutic candidates
CX-904 and BMS-986288. CX-904, partnered with Amgen, is a
conditionally activated T-cell-engaging antibody targeting the
epidermal growth factor receptor (EGFR) on tumor cells and the CD3
receptor on T cells. BMS-986288, partnered with Bristol Myers
Squibb, is a conditionally activated CTLA-4-targeting antibody that
is a non-fucosylated version of ipilimumab. In addition, CytomX has
a diverse, emerging portfolio of wholly-owned drug candidates
including CX-2051, a conditionally activated ADC directed toward
epithelial cell adhesion molecule, EpCAM, with potential
applicability across multiple EpCAM-expressing epithelial cancers,
and CX-801, an interferon alpha-2b Probody cytokine with broad
potential applicability in traditionally immuno-oncology sensitive
as well as insensitive tumors. CytomX has established strategic
collaborations with multiple leaders in oncology, including Amgen,
Astellas, Bristol Myers Squibb, Regeneron and Moderna. 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
Statements
This 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, including those related to
the future potential of partnerships or collaboration agreements.
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-2051,
CX-801, BMS-986288, and CX-904, the potential benefits or
applications of CytomX’s Probody therapeutic platform, CytomX’s or
its collaborative partners’ ability to develop and advance product
candidates into and successfully complete clinical trials,
including the ongoing and planned clinical trials of BMS-986288 and
CX-904, and the timing of the commencement of clinical trials or
initial and ongoing data availability for CX-801 and CX-2051, 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
therapeutic technology; CytomX’s clinical trial product candidates
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 possibility that
the results of preclinical research and 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 BMS-986288,
CX-904, CX-801, and CX-2051; CytomX’s reliance on third parties for
the manufacture of the Company’s product candidates; possible
regulatory developments in the United States and foreign countries;
and the risk that we may incur higher costs than expected for
research and development or unexpected costs and expenses.
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 7, 2023. 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.
CytomX Contact:Chris OgdenSVP,
Finance and Accounting cogden@cytomx.comDirect: (317) 767-4764
Investor and Media
Contact:Stern Investor RelationsStephanie
Ascherstephanie.ascher@sternir.com212-362-1200
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