CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated, localized biologics, today announced its
2024 company priorities and anticipated milestones for its
wholly-owned and partnered pipeline.
“With INDs recently filed for wholly-owned programs, CX-2051 and
CX-801, and continued progress in dose escalation with our Probody®
T-Cell engager, CX-904, CytomX is well positioned as we enter 2024.
Our current lead programs build on more than a decade of Probody
platform experience at CytomX and integrate key design elements
that leverage previously validated oncology targets, potent
effector mechanisms and tailored masking strategies,” said Sean
McCarthy, D.Phil., chief executive officer and chairman of CytomX
Therapeutics. “We believe our multi-modality Probody therapeutic
pipeline will address major unmet medical needs in the treatment of
cancer. CytomX is entering a potentially milestone-rich period in
2024 and 2025 during which we aim to generate proof of concept
clinical data across our lead programs that point the way to future
registrational studies.”
“CytomX’s multi-modality pipeline is highly relevant at this
moment in time in oncology R&D. CX-904 is a potentially
differentiated EGFR-CD3 T-cell engager in an ongoing Phase 1
clinical trial and, with both CX-2051 and CX-801 also expected to
enter the clinic in 2024, we have a broad opportunity to make a
meaningful difference in the treatment of cancer,” said Wayne Chu,
M.D., chief medical officer of CytomX Therapeutics. Continued Dr.
Chu, “CX-2051 is an ADC designed to truly unlock EpCAM as an
anti-cancer target and we believe the topoisomerase-1 inhibitor
payload may be an ideal effector mechanism for multiple EpCAM
expressing tumors. CX-801 is a powerful immune-stimulating agent
with potential to mitigate historical clinical limitations of
cytokine therapies due to toxicity. Our vision is for CX-801 to
become a cornerstone of combination regimens for a wide range of
tumor types including those that have either stopped responding to,
or have failed to respond to, prior immunotherapy. CytomX’s lead
therapeutic candidates have the potential for significant impact
and we will be working tirelessly to bring these therapies forward
for the benefit of patients.”
CX-904, EGFRxCD3 T-cell
Engager
CX-904 is a conditionally activated Probody
T-cell engager designed to target the epidermal growth factor
receptor (EGFR) on cancer cells and the CD3 receptor on T cells
within the tumor microenvironment. CX-904 is partnered with Amgen
in a global co-development alliance and is being evaluated in an
ongoing Phase 1 study in patients with advanced solid tumors that
have known EGFR expression. Backfilling of certain dose escalation
cohorts has been initiated and dose ranging continues. Initial
Phase 1a dose escalation data is anticipated in the second half of
2024. The Phase 1a data will inform a potential decision during
2024 to initiate Phase 1b expansion cohorts in specific EGFR
positive tumor types. The decision to potentially initiate Phase 1b
expansion cohorts will be taken in conjunction with Amgen.
CX-2051, Antibody Drug Conjugate (ADC)
targeting EpCAM
EpCAM is a high potential oncology target that
has been clinically validated by locally administered, previously
approved cancer therapies. However, efforts to generate
systemically administered anti-EpCAM therapeutics have, to date,
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 epithelial 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. An IND
application has been filed for this program and clinical initiation
in EpCAM expressing solid tumors is expected in the first half of
2024.
CX-801, Interferon-alpha 2b
(IFNα2b)
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. An IND application has been filed for this
program. Phase 1 initiation for CX-801 as a monotherapy and in
combination with checkpoint inhibition is expected in the first
half of 2024.
BMS-986288, Non-fucosylated
CTLA-4-targeting Probody Therapeutic
Bristol Myers Squibb continues to make progress evaluating the
next-generation CTLA-4 program, BMS-986288, a non-fucosylated
CTLA-4 targeting Probody therapeutic. In 2023, Bristol Myers Squibb
prioritized the BMS-986288 Probody® therapeutic program as its lead
next-generation CTLA-4 program and advanced the program to Phase 2
clinical studies. BMS-986288 is designed to be more potent than
ipilimumab (YERVOY®) and to leverage CytomX’s Probody therapeutic
technology to potentially localize clinical activity to tumors
while reducing systemic toxicity. The ongoing Phase 2 clinical
evaluation of BMS-986288 includes proof of concept studies for
microsatellite stable (MSS) colorectal cancer (CRC) and non-small
cell lung cancer (NSCLC). Bristol Myers Squibb anticipates data
from the study will be available in 20241. CytomX and Bristol Myers
Squibb also continue to collaborate on multiple preclinical
research programs.
Research and Development
Partnerships
CytomX has multiple active research and
development partnerships with major biotechnology and
pharmaceutical companies (Amgen, Astellas, Bristol Myers Squibb,
Moderna, Regeneron). Throughout 2023, CytomX made substantial
progress across its research partnerships including the
commencement of programs under its new alliances with Regeneron and
Moderna. In January 2023, CytomX earned a $5 million milestone for
the first T-cell engager clinical candidate nominated in the
Astellas collaboration. CytomX has a consistent track record of
forming new strategic research and development alliances and
achieving preclinical research and clinical milestones. Partnering
is expected to remain an important part of the Company’s strategy
in 2024 and beyond.
2024 PRIORITIES AND KEY MILESTONES
CytomX enters 2024 in a strong strategic
position and with significant momentum in its pipeline. The
company’s key pipeline programs are progressing towards clinical
proof of concept and key milestones in 2024 including:
- CX-904 (EGFRxCD3):
Continued enrollment into Phase 1a dose escalation. Phase 1a
initial dose escalation data are expected in the second half of
2024. These data are expected to inform a potential decision, to be
taken with Amgen, to initiate Phase 1b expansion cohorts in
specific EGFR positive tumor types in 2024.
- CX-2051 (EpCAM):
Initiation of Phase 1 dose escalation in solid tumors with known
EpCAM expression including metastatic colorectal cancer as one
priority indication is expected in the first half of 2024.
- CX-801 (IFNα2b):
Initiation of Phase 1 dose escalation in solid tumors including
melanoma, renal, and head and neck squamous cell carcinoma is
expected in the first half of 2024.
- Next-Generation CTLA-4
Program: Continued clinical progress for BMS-986288
including proof-of-concept studies in MSS CRC and NSCLC. Bristol
Myers Squibb anticipates data from the study will be available in
2024.
- Collaborations:
Continuation of drug discovery and development activities with
Bristol Myers Squibb, Amgen, Astellas, Regeneron, and Moderna with
potential pre-clinical and clinical milestones possible in 2024 and
and beyond.
- Financial: CytomX
ended the third quarter of 2023 with $194 million of cash and cash
equivalents. Cash runway is projected to the second half of 2025,
excluding any potential milestones from existing collaborations or
new business development.
About CytomX
TherapeuticsCytomX 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 that has broad potential applicability in
traditionally immuno-oncology sensitive as well as insensitive
(cold) 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
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, 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,
BMS-986288, CX-904, and CX-801, 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.
Investor Contact:Chris
OgdenSVP, Finance and Accountingcogden@cytomx.comDirect: (317)
767-4764
Investor and Media
Contact:Stern Investor RelationsStephanie
Ascherstephanie.ascher@sternir.com212-362-1200
_____________________________
1 Bristol Myers Squibb 2023 R&D Day, September 14, 2023
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