CytomX Therapeutics, Inc. (Nasdaq: CTMX), a clinical-stage
oncology-focused biopharmaceutical company pioneering a novel class
of investigational antibody therapeutics based on its Probody®
therapeutic technology platform, today announced the achievement of
a clinical milestone in conjunction with the CX-2029 program,
triggering a $40 million payment from AbbVie to CytomX. The company
also provided an update on its lead wholly owned clinical programs.
“CytomX has made excellent progress during 2020,
including the establishment of a major new strategic alliance with
Astellas, the initiation of a randomized Phase 2 study by our
partner, Bristol Myers Squibb, evaluating the anti-CTLA-4 Probody,
BMS-986249, in front line melanoma, and today the achievement of a
significant clinical and financial milestone within our AbbVie
alliance. This progress underscores the increasing validation of
our Probody platform and illustrates how our partnering strategy
continues to contribute meaningfully to the advancement of our
pipeline,” said Sean McCarthy, D.Phil., president, chief executive
officer and chairman of CytomX Therapeutics. “From our
position of strength, against the pressures that the COVID-19
pandemic backdrop is placing on the healthcare system and clinical
trial enrollment across the biopharma sector, we are today
announcing steps to reprioritize our clinical portfolio and
optimize resource allocation with the goal of maximizing long-term
value. These steps will afford an increased emphasis on our work on
undruggable targets such as CD166 and CD71 and the continued
advancement of additional potential first-in-class programs towards
future IND filings.”
Achievement of $40 Million Phase 1 Dose
Escalation Milestone in CX-2029 AbbVie Partnership
In April 2016, AbbVie and CytomX entered into a
Co-Development and Licensing Agreement under which the two
companies are co-developing CX-2029, a Probody drug conjugate
against CD71. CD71, also known as the transferrin receptor 1
(“TfR1”), is a cell surface protein essential for iron uptake in
dividing cells. CD71 is highly expressed in a number of solid and
hematologic cancers and has attractive molecular properties for
efficient delivery of cytotoxic payloads to tumor cells. CD71 has
high potential as an anti-cancer target but is widely considered
undruggable due to its presence on most dividing healthy
cells. CX-2029 is designed to potentially create a
therapeutic window for this novel target.
Under the agreement, CytomX is responsible for
clinical development up to initial clinical proof of concept.
AbbVie will lead late-stage clinical development and global
commercial activities with CytomX eligible to receive a profit
share in the U.S. and tiered double-digit royalties on net product
sales outside of the U.S. CytomX retains an option to
co-promote in the United States. The $40 million milestone
announced today was reached by CytomX through the achievement of
pre-specified criteria for the dose escalation phase of the ongoing
Phase 1/2 clinical trial, PROCLAIM-CX-2029 (NCT003543813).
CytomX and AbbVie are finalizing plans for the advancement of
CX-2029 to Phase 2 expansion cohorts in select tumor types.
Preliminary clinical data from the Phase 1 dose escalation phase of
PROCLAIM-CX-2029 is expected to be presented in 2020.
“We are encouraged by the progress of CX-2029 in
the dose escalation studies executed by CytomX and look forward to
seeing the data emerge from the expansion cohort phase,” said Mohit
Trikha, Ph.D., vice president and head of oncology early
development and Bay Area Site Head, AbbVie.
Clinical Pipeline Update
CytomX is conducting multiple clinical trials
worldwide and is committed to protecting the safety of its study
participants and the physicians and staff that operate these
clinical studies.
In assessing the evolving COVID-19 pandemic, and
the emerging challenges for clinical trial execution within our
studies and across the industry, CytomX has made the decision to
temporarily pause new patient enrollment and new site activation in
the PROCLAIM-CX-2009-001 study evaluating the CD166-targeting
Probody drug conjugate CX-2009. This study includes the Phase 2
expansion study evaluating CX-2009 as monotherapy in patients with
hormone receptor (ER, PR) positive, HER2 negative breast cancer.
CytomX continues to closely monitor emerging Health Authority
guidance and IRB/Ethics Committee recommendations. CytomX intends
to resume the CX-2009 clinical program as soon as practicable.
CytomX has also made the strategic decision to
terminate the PROCLAIM-CX-072-002 study (NCT03993379) evaluating
the anti-PD-L1 Probody CX-072 in combination with Yervoy®
(ipilimumab) in melanoma. This decision comes following a
re-evaluation of the evolving clinical, competitive and commercial
landscapes in immuno-oncology, taken together with impact of the
COVID-19 pandemic. This decision allows for resources to be
redirected towards CytomX’s potential first-in-class assets,
including a combination of CX-072 and CX-2009, and to the
generation of additional clinical candidates for advancement to IND
filing and clinical trials.
Teleconference Scheduled Today at 6:00 p.m. ET
Conference Call/Webcast Information
CytomX management will host a conference call today at 6:00 p.m.
ET. Interested parties may access the live audio webcast of
the teleconference through the “Investor & News” section of
CytomX's website at http://ir.cytomx.com or by dialing
1-877-809-6037 (U.S. and Canada) or 1-615-247-0221 (International)
and using the passcode 7169589. An archive of the webcast will be
available on the CytomX website from March 30, 2020, until April 6,
2020.
About CytomX Therapeutics
CytomX is a clinical-stage, oncology-focused
biopharmaceutical company with a vision of transforming lives with
safer, more effective therapies. We are developing a novel class of
investigational antibody therapeutics, based on our Probody®
technology platform, for the treatment of cancer.
Probody therapeutics are designed to remain
inactive until they are activated by proteases in the tumor
microenvironment. As a result, Probody therapeutics are intended to
bind selectively to tumors and decrease binding to healthy tissue,
to minimize toxicity and potentially create safer, more effective
therapies. As leaders in the field, our innovative technology is
designed to turn previously undruggable targets into druggable
targets and to enable more effective combination therapies. CytomX
and its partners, comprised of leading biotechnology and
pharmaceutical companies, have developed a robust pipeline of
potential best-in-class immunotherapeutic candidates against
clinically validated targets and potential first-in-class
therapeutic candidates against novel, difficult to drug targets.
Five novel drug-candidates utilizing our Probody technology are in
the clinic, with three advancing into Phase 2 studies and one in
Phase 1 studies. These clinical programs include cancer
immunotherapeutic candidates against validated targets such as two
CTLA-4-targeting Probody therapeutics partnered with Bristol Myers
Squibb (BMS-986249) and (BMS-986288). The CytomX clinical stage
pipeline also includes first-in-class Probody drug conjugate
product candidates against previously undruggable targets,
including a CD166-targeting Probody drug conjugate wholly owned by
CytomX (CX-2009) and a CD71-targeting Probody drug conjugate
partnered with AbbVie (CX-2029). CD166 and CD71 are among cancer
targets that are considered to be inaccessible to conventional
antibody drug conjugates due to their presence on many healthy
tissues. In addition to its wholly owned programs, CytomX has
strategic collaborations with AbbVie, Amgen, Astellas and Bristol
Myers Squibb. For additional information about CytomX Therapeutics,
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. Accordingly, you should
not rely on any of these forward-looking statements, including
those relating to the potential benefits, safety and efficacy of
CytomX’s or any of its collaborative partners’ product candidates,
administered separately or in combination, 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 CX-2009 and CX-2029. 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 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 development of preclinical and clinical drug
candidates, including delaying or disrupting the enrollment of
patients in clinical trials; 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 pre-clinical research may not result
in additional product candidates; CytomX’s dependence on the
success of CX-2009, CX-2029, BMS-986249 and BMS-986288; 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
Annual Report on Form 10-K filed with the SEC on February 27, 2020.
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.
Yervoy is a registered trademark of Bristol
Myers Squibb.
Contact:
Investors and Media:
Christopher Keenan VP, Investor Relations and Corporate
Communications ckeenan@cytomx.com 650-383-0823
CytomX Therapeutics (NASDAQ:CTMX)
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