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 availability
of oral and poster presentations at the American Society of
Clinical Oncology’s (ASCO) ASCO20 Virtual Scientific Program taking
place from May 29 - May 31, 2020.
“A comprehensive body of evidence was presented today at ASCO
2020 that continues to validate our approach to conditional
antibody activation and therapeutic target engagement with the
Probody platform,” said Amy Peterson, M.D., chief development
officer of CytomX Therapeutics. “The seven presentations
collectively highlight the potential of the Probody platform to
enable successful engagement of previously undruggable targets,
like CD71 and CD166, and create next generation immune-checkpoint
inhibitors such as the anti-PD-L1 Probody therapeutic, CX-072, and
BMS-986249, a Probody version of ipilimumab. The findings underpin
the advancement of all four drug candidates into Phase 2 and our
commitment to bringing meaningful advances to patients living with
cancer.”
CX-2029: Validating CD71 As A First-in-Class Oncology
Target
In the oral abstract 3502, Dr. Melissa Johnson of the Sarah
Cannon Research Institute at Tennessee Oncology, presented
preliminary clinical data from the first-in-human, dose-escalation,
monotherapy Phase 1 study of CX-2029, a Probody drug conjugate
(PDC) targeting CD71 (transferrin receptor). CX-2029 is
conjugated to the cytotoxic payload MMAE and is being developed by
CytomX in partnership with AbbVie. As of an April 20, 2020 data
cutoff, 45 patients with advanced solid tumors were enrolled into 8
escalating dose cohorts between 0.1 mg/kg – 5 mg/kg CX-2029
administered intravenously every three weeks.
- Evidence of target lesion reduction was seen, principally in
patients with tumors of squamous histology. (Figure
1)° 3 confirmed partial responses were observed in 17
response-evaluable patients treated at doses ≥2 mg/kg of CX-2029, 2
in patients with squamous non-small cell lung cancer (SqNSCLC) and
1 in a patient with head and neck squamous cell cancer
(HNSCC).° 2 of the partial responses (both at the 3
mg/kg dose) were confirmed after the April 20th cutoff date.
CX-2029 Waterfall Plot (Doses
2–5 mg/kg)
Figure 1 is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/51129ea3-a850-4d2f-9c41-4da88807669f
Safety Profile Supports Recommended Phase 2 Dose of 3
mg/kg, Every Three Weeks
- CX-2029 was generally well tolerated at doses up to 3
mg/kg.
- At doses of 0.25 – 5 mg/kg, CX-2029 circulated predominantly as
the intact species (>90%).
- The most common treatment related adverse events (TRAE) were
infusion related reactions, anemia, and neutropenia/leukopenia.
° Infusion related reactions were mostly Grade 1/2,
occurred at the first dose, were not dose dependent and resolved
upon initiation of supportive care.° Hematologic TRAEs Grade
≥ 3 were dose dependent. • Anemia
and neutropenia are commonly observed with the MMAE payload.
• Anemia was managed with transfusions and
supportive care.
- No CX-2029 treatment related deaths were reported and late
onset Grade 3/4 TRAEs were predominately anemia and
neutropenia.
- The etiology of anemia is under investigation and is likely
multifactorial, including MMAE-related and CD71 expression on red
blood cell precursors.
- CytomX is preparing to advance the dose of 3 mg/kg of CX-2029
administered every 3 weeks into 4 dose-expansion cohorts: HNSCC,
SqNSCLC, esophageal carcinoma and diffuse large B cell
lymphoma.
“Targeting CD71 with this novel approach has the potential to
address areas of unmet medical need in difficult to treat tumor
types, improving patient benefit,” said Melissa L. Johnson, M.D.,
CX-2029 principal study investigator and associate director of lung
cancer research at Sarah Cannon Research Institute at Tennessee
Oncology. "This first-in-human data of CX-2029 establishes the
transferrin receptor as a high potential anticancer target
addressable with CytomX’s Probody technology.”
CX-2009: Encouraging Clinical Activity Supports
Advancement in HER2 Negative Breast Cancer In Poster 18,
Dr. Valentina Boni of START Madrid-CIOCC, presented updated data on
CX-2009, a PDC targeting CD166 and conjugated to the cytotoxic
payload DM4. As of an April 20, 2020 data cutoff, 96 patients were
enrolled into the dose escalation Phase 1 study and received
CX-2009 at escalating doses of 0.25 - 10 mg/kg every 3 weeks (86
patients) or 4 - 6 mg/kg every 2 weeks (10 patients).
Durable Clinical Activity Observed in HER2 Negative
(HER2-) Breast Cancer
- Evidence of target lesion reduction was observed at doses or
dose equivalents of ≥4 mg/kg every 3 weeks across 68 evaluable
patients including those with HER2- breast cancer, ovarian cancer,
NSCLC and HNSCC.° HER2- breast cancer patients were heavily
pretreated with a median of 7 prior lines of therapy.
- 26 patients with HER2– breast cancer who received ≥4 mg/kg of
CX-2009 were response-evaluable: ° 2 confirmed partial
responses were observed, both in patients with hormone receptor
positive (HR+) breast cancer. ° 3 unconfirmed responses were
observed in patients with triple negative breast cancer (TNBC).
° Clinical benefit rates of 39% and 35% were observed
at 16 and 24 weeks (CBR16 and CBR24, respectively).
• All 4 TNBC patients who achieved CBR16 also achieved
CBR24.
CX-2009 Waterfall Plot and Spider Plot:
HER2- Breast Cancer (≥4 mg/kg Every 3 Weeks)
Figure 2 is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/3d8523cb-3517-4ae7-b428-19700c46a749
Safety Profile Supports Recommended Phase 2 Dose of
7mg/kg, Every 3 Weeks
- CX-2009 was generally well tolerated at doses up to 7 mg/kg
administered every three weeks.
- No dose limiting toxicities (DLTs) were reported at doses up to
7 mg/kg.
- DM4-related toxicities, including ocular, neuropathic, and
hepatic were higher in frequency at dose equivalents greater than 7
mg/kg dosed at every three weeks compared to 7 mg/kg or lower.
° Occurrence and severity of ocular adverse events were dose
dependent: One Grade 3+ event was observed in a patient treated at
5 mg/kg, none at 7 mg/kg. ° 20% of patients dosed at ≥8 mg/kg
experienced Grade 3+ ocular adverse events.
- Preliminary pharmacokinetic (PK) data showed that CX-2009
circulates predominantly intact at all doses and PK is not strongly
influenced by target-mediated drug disposition or anti-drug
antibodies (ADAs). (Poster 329)
In December 2019, CytomX announced the initiation of a Phase 2
expansion study of CX-2009 monotherapy at 7 mg/kg administered
every three weeks in up to 40 patients with hormone receptor (ER,
PR) positive, HER2 negative breast cancer. In March 2020, CytomX
announced the decision to temporarily pause new patient enrollment
and new site activation in this study due to the impact of the
COVID-19 pandemic. CytomX continues to closely monitor emerging
Health Authority guidance and IRB/Ethics Committee recommendations
and intends to resume the CX-2009 clinical program as soon as
practicable.
“Patients with advanced breast cancer continue to need treatment
options, this is especially true for patients with hormone receptor
positive and HER2 negative breast cancer that is refractory to
hormonal based therapies,” said Alison L. Hannah, M.D., chief
medical officer of CytomX Therapeutics. “We believe that targeting
CD166, previously considered undruggable as an oncology target,
using our Probody drug conjugate platform, may provide a unique
treatment opportunity for this patient population. The data in
patients with triple negative breast cancer are equally interesting
and support the advancement of CX-2009 monotherapy into Phase 2
where we will also evaluate CX-2009 in combination with CX-072, our
Probody therapeutic directed against PD-L1.”
CX-072: Anti-PD-L1 Probody Checkpoint Inhibitor
In the oral presentation of Abstract 3005 by Dr. Fiona
Thistlethwaite of The Christie NHS Foundation Trust at the
University of Manchester, updated data were presented from the
Phase 1/2 trial of PROCLAIM-CX-072 monotherapy and CX-072 in
combination with ipilimumab with a focus on patients who received
long-term treatment, defined as ≥ 6 months of treatment. The CX-072
10 mg/kg monotherapy expansion arm enrolled 114 patients in seven
tumor types.
- As of an April 20, 2020 data cutoff, CX-072 monotherapy
continued to demonstrate durable anti-tumor activity in patients
with IO sensitive tumors such as TNBC, anal squamous cell carcinoma
(aSCC), cutaneous squamous cell carcinoma (cSCC) and tumors with
high mutational burden (hTMB).
- As of the same data cutoff, CX-072 in combination with
ipilimumab had been administered to 27 patients with advanced solid
tumors. Durable anti-cancer activity was observed including one
complete response in a patient with aSCC who remains on study more
than two years after first dose.
- Of the 141 patients across the monotherapy and combination
arms: 34 patients received long term treatment in the monotherapy
arm (median 11.3 months), and 6 patients received long term
treatment in the combination arm (median 21.3 months).
- Grade 3/4 TRAEs were 10% and 5.9% for who received monotherapy
< 6 months and ≥ 6 months, respectively, and 33% in each group
in the combination arm.
- Long term patients experienced fewer irAEs and had no grade 3+
irAEs suggesting that tolerability early on can impact duration of
treatment.
- Preliminary clinical PK data (Poster 332) and translational
analyses of pre- and on-treatment biopsies (Poster 172) were
supportive of the Probody mechanism of action.
CX-072 Monotherapy Waterfall Plots and
Spider Plots (10 mg/kg)
Figure 3 is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/daf244be-f486-43cc-9cf1-b50b60a8dce9
Continued Dr. Hannah “Our ASCO20 clinical, translational, and
pharmacokinetic presentations on CX-072 reinforce previously
presented data and show clear evidence of anti-cancer activity and
favorable tolerability for this unique checkpoint inhibitor. These
integrated data support a differentiated profile for CX-072 that we
believe can be of potential utility as a unique combination partner
for other anti-cancer agents, including CX-2009.”
BMS-986249: Anti-CTLA-4 Probody Demonstrates Encouraging
Safety Profile in Phase 1 Trial
Bristol Myers Squibb presented dose escalation data from their
Phase 1/2 trial of BMS-986249, a Probody version of the anti-CTLA-4
antibody ipilimumab in Abstract 3508. This trial assessed the
safety, pharmacokinetics and pharmacodynamics of escalating doses
of BMS-986249 as monotherapy or in combination with the anti PD-1
antibody nivolumab in patients with advanced cancers. The doses of
BMS-986249 ranged from 240 mg to 2400 mg (approximately 3 - 30
mg/kg). BMS-986249 was generally well tolerated as monotherapy and
in combination with nivolumab. Bristol Myers Squibb has initiated a
randomized clinical trial to explore various doses of BMS-986249 in
combination with nivolumab in patients with advanced
melanoma. ASCO20 Virtual Scientific Program - Posters
and Presentations
Copies of the ASCO20 presentations and posters are available
under the Scientific Publications section of the CytomX website at
www.CytomX.com.
Conference Call and Webcast
CytomX senior management will host a conference call and live
webcast with slides today, Friday, May 29, 2020, from 5:00 p.m. –
6:00 p.m. ET/ 2:00 p.m. – 3:00 p.m. PT to discuss these
presentations. This event can be accessed in three ways:
- From the CytomX website:
http://ir.cytomx.com/events-and-presentations. Please access the
website 15 minutes prior to the start of the call to download and
install any necessary audio software.
- By telephone: Participants can access the call by dialing
1-877-809-6037 (United States) or 1-615-247-0221 (International)
referencing Conference ID 4267278.
- By replay: A replay of the webcast will be located under the
Investor Relations section of CytomX’s website approximately two
hours after the conclusion of the live call and will be available
for 30 days following the call.
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 first-in-class therapeutic candidates against novel,
difficult to drug targets and potential best-in-class
immunotherapeutic candidates against clinically validated targets.
The CytomX clinical stage pipeline includes first-in-class 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. The
CytomX clinical stage 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. CytomX has strategic drug
discovery and development 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 or progress of CytomX’s
or any of its collaborative partners’ product candidates, the
potential benefits or applications of CytomX’s Probody platform
technology, and 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 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 pre-clinical research may not result
in additional product candidates; CytomX’s dependence on the
success of CX-2009, CX-2029, BMS-986249, BMS-986288, and CX-072;
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 May 7,
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. Investor and Media Contact: Christopher Keenan
VP, Investor Relations and Corporate Communications
ckeenan@cytomx.com 650-383-0823
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