CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of
conditionally activated therapeutics, today announced preliminary
Phase 2 results in patients with either advanced squamous non-small
cell lung cancer (sqNSCLC) or head and neck squamous cell carcinoma
(HNSCC), who were treated with CX-2029 – a CD71-directed
conditionally activated antibody-drug conjugate (ADC) being
co-developed by CytomX and AbbVie.
“We are pleased to report these first results
from the ongoing Phase 2 expansion study of CX-2029, a novel ADC
developed with the CytomX Probody Therapeutic platform. We are
encouraged that the response rate in heavily-pretreated and
unselected sqNSCLC patients at this recent data cut off is trending
with our stated target of 20% and enrollment in this tumor type
continues towards our goal of 25 efficacy-evaluable patients. No
new safety signals were observed and we are also encouraged by the
low discontinuation rate due to adverse events. These preliminary
results corroborate our previous Phase 1 observations and open a
potential sqNSCLC commercial opportunity in the growing
post-checkpoint inhibitor setting where there are limited treatment
options,” said Sean McCarthy, D.Phil., president, chief executive
officer and chairman of CytomX Therapeutics. “We continue to work
closely with our partner, AbbVie, and look forward to completing
the expansion phase of the CX-2029 development program and
providing further data updates in 2022.”
As of the data cutoff on October 29, 2021, 23
patients with sqNSCLC and 29 patients with HNSCC had received at
least one dose of CX-2029 at 3 mg/kg (safety population), of whom
16 sqNSCLC patients and 25 HNSCC patients had at least one post
baseline assessment (efficacy-evaluable population), including, per
protocol, 5 patients (2 sqNSCLC and 3 HNSCC) enrolled in the
previously reported Part B (tumor biopsy cohorts). The median
follow-up time was 3.8 months (range, 0.2-20.1). In the 16 efficacy
evaluable patients with sqNSCLC, objective response rate (ORR) by
local investigator was 18.8 percent, including two confirmed
partial responses (PRs) and one unconfirmed PR that confirmed seven
days after the data cutoff. Two of these responses were ongoing and
the third had a response duration of 5.6 months. The disease
control rate (DCR), which includes patients with a complete
response, PR or stable disease, was 87.5 percent. In the 25
efficacy evaluable patients with HNSCC, there was one confirmed PR
(ORR 4.0%) and a DCR of 56.0 percent, including one unconfirmed PR.
Below is a summary table.
|
sqNSCLC |
HNSCC |
|
Safety Evaluable |
Efficacy Evaluable |
Confirmed PR |
Safety Evaluable |
Efficacy Evaluable |
Confirmed PR |
Part B |
2 |
2 |
1 |
3 |
3 |
1 |
Part C |
21 |
14 |
2* |
26 |
22 |
0** |
Total |
23 |
16 |
3 |
29 |
25 |
1 |
ORR |
|
|
18.8% |
|
|
4.0% |
*Includes one unconfirmed PR that confirmed
after the data cutoff. **One unconfirmed PR was observed (will not
confirm).
Safety analysis was conducted on all sqNSCLC and
HNSCC patients who received at least one dose of CX-2029 at 3 mg/kg
(N=52), either in Part B (N=5), or in the expansion cohorts (N=47).
The median number of prior therapies in the metastatic setting was
two (range, 1-5) for sqNSCLC and three (range, 1-9) for HNSCC. All
patients with sqNSCLC had received prior platinum and prior
checkpoint inhibition; in HNSCC, all but one patient received prior
platinum and all but two, prior checkpoint inhibition.
The safety profile was consistent with previous
Phase 1 observations, with no new safety signals identified. The
most common treatment-related adverse events (TRAEs) in 10% or more
of patients (All Grade, Grade 3) were anemia (78.8%, 67.3%),
infusion related reactions (69.2%, 3.8%), fatigue (19.2%, 1.9%),
and nausea (13.5%, 0.0%), and decreased neutrophil count (13.6%,
9.6% (plus one Grade 4 event 1.9%)). The most common reason for
treatment discontinuation was disease progression (44.2%), three
patients (5.8%) discontinued for a treatment-related adverse event
(anemia; 2 Grade 2, 1 Grade 3). TRAEs leading to dose interruption
or reduction were 40.4% and 34.6%, respectively. Thirteen patients,
eight with sqNSCLC and five with HNSCC, were still on treatment as
of the data cut off.
Conference Call &
WebcastCytomX management will host a conference call and a
simultaneous webcast today at 5 p.m. ET (2 p.m. PT) to discuss
these results. To join the conference call, please dial (877)
809-6037 (domestic) or (615) 247-0221 (international) and reference
the conference ID 8065625. A live webcast of the call can be
accessed via the Events and Presentations page of CytomX's website
at https://ir.cytomx.com/events-and-presentations. A replay of the
webcast will also be available for 30 days following the call.
About CX-2029Co-developed by
CytomX and AbbVie, CX-2029 is a conditionally activated
antibody-drug conjugate (ADC) comprised of a CD71-directed
humanized monoclonal antibody conjugated via a cleavable linker to
the microtubule inhibitor, monomethyl auristatin E (MMAE), with a
drug-to-antibody ratio (DAR) of 2. A key feature of CX-2029 is its
masking peptide, which covers and blocks the cellular binding
region of the antibody. Tethered to the antibody via a
protease-cleavable linker, the masking peptide is designed to be
removed in a protease-rich tumor microenvironment, enabling the
then unmasked ADC to engage its target and deliver the toxic
payload inside tumor cells. The goal is to have CX-2029 remain
inert while in circulation, with the intent of limiting binding in
healthy tissues until it is activated by tumor-associated
proteases. CX-2029 is being evaluated as monotherapy in a Phase 2
expansion study (NCT03543813) designed to enroll patients in four
cohorts; squamous non-small cell lung cancer, squamous head and
neck cancer, esophageal and gastroesophageal junction cancers (both
adenocarcinoma and squamous histologies), and diffuse large B-cell
lymphoma.
About CytomX
TherapeuticsCytomX 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). 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-2029, 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 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, and
pacmilimab; 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.
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
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