Compass Therapeutics Provides Corporate Update
05 Gennaio 2024 - 2:00PM
Compass Therapeutics, Inc. (Nasdaq: CMPX), a clinical-stage,
oncology-focused biopharmaceutical company developing proprietary
antibody-based therapeutics to treat multiple human diseases, today
reported a business update.
“We made significant progress in the fourth quarter of the year
across our portfolio, and we look forward to reporting top-line
data from COMPANION-003 by mid-year and COMPANION-002 in the second
half of the year. We are also excited to report additional
responses in our Phase 1b monotherapy study of CTX-471, including a
complete response in a patient with small cell lung cancer. We hope
to see additional efficacy signals in the second part of our Phase
1b study, where we are studying CTX-471 in combination with
KEYTRUDA® in patients with melanoma, NSCLC and SCLC,” said Vered
Bisker-Leib, PhD, incoming Chief Executive Officer of Compass.
“We are excited to have Vered Bisker-Leib elevated to the Chief
Executive Officer role recognizing many years of strong
performance. We are equally pleased that our founding CEO, Thomas
Schuetz, will continue to play a key role at the Company,” said
Carl Gordon, PhD, Chair of Compass’ Board.
Development Pipeline Updates:
CTX-009 (DLL4 and VEGF-A bispecific
antibody)
- We continue to enroll patients in COMPANION-002, a U.S. Phase
2/3 study of CTX-009 in combination with Paclitaxel in BTC.
- This randomized Phase 2/3 study is designed to enroll 150
patients with BTC who have received one prior systemic
therapy.
- The primary endpoint of the study is overall response rate
(ORR), and secondary endpoints include progression free survival
(PFS), overall survival (OS), clinical benefit rate (CBR) and
duration of response (DOR).
- Enrollment is expected to be completed by mid-year 2024; top
line data are expected from this study in the second half of
2024.
- Enrollment of patients in COMPANION-003, a U.S. Phase 2 study
of CTX-009 as a monotherapy in patients with advanced, metastatic
CRC, has been extended to first quarter 2024.
- The study design is an Adaptive Simon Two-Stage, with Stage 1
of the study enrolling 37 patients; if 3 or more responses are
confirmed in Stage 1, the study will advance to Stage 2, and an
additional 47 patients will be enrolled.
- The study is enrolling patients with CRC who have received two
or three prior systemic therapies irrespective of their KRAS
mutation status.
- Patients are being evaluated for safety and tolerability, as
well as clinical response.
- We expect to report top-line data from this study by mid-year
2024.
CTX-471 (CD137 agonist)
- CTX-471 is a CD137 agonistic antibody, which binds to a unique
epitope of the co-stimulatory molecule 4-1BB with an optimized
affinity.
- We continue to dose and follow patients in the Phase 1b
monotherapy study of CTX-471 where five responses have been
observed, all in patients who previously received checkpoint
blocker(s). A durable PR in a patient with SCLC has converted to a
CR, as confirmed by a PET scan. Additionally, a new PR in a patient
with advanced melanoma, was observed, leading to an ORR in the
subset of patients with advanced melanoma of 27% (3 of 11). The
fifth response occurred in a patient with mesothelioma.
- Phase 1b combination arm of CTX-471 and Merck’s anti-PD-1
therapy KEYTRUDA® (pembrolizumab) in patients with select solid
tumors is ongoing. The dose-escalation portion of the study has
been fully enrolled and enrollment in the dose expansion cohorts
has begun. In the expansion cohort, we plan on enrolling 60
patients with melanoma, NSCLC and SCLC, who will be randomized into
two doses.
CTX-8371 (PD-1 x PD-L1 bispecific antibody)
- CTX-8371 is a next generation bispecific checkpoint inhibitor
that simultaneously targets PD-1 and PD-L1 and exhibits a unique
mechanism-of-action that involves cleavage of cell surface
PD-1.
- Following the FDA acceptance of the IND for CTX-8371, the first
patient is expected to be dosed in the Phase 1 clinical trial in
the first quarter of 2024.
Corporate Highlights:
- The Company’s CEO succession plan is effective as of January 9,
2024, with the elevation of Vered Bisker-Leib, PhD, to Chief
Executive Officer and her addition to the Compass board of
directors.
- Thomas Schuetz, MD, PhD, Compass’ Scientific Founder and
current Chief Executive Officer will transition to President of
Research and Development and assume the role of Vice Chair of the
Compass board of directors.
About Compass TherapeuticsCompass Therapeutics,
Inc. is a clinical-stage oncology-focused biopharmaceutical company
developing proprietary antibody-based therapeutics to treat
multiple human diseases. Compass’s scientific focus is on the
relationship between angiogenesis, the immune system, and tumor
growth. The company pipeline of novel product candidates is
designed to target multiple critical biological pathways required
for an effective anti-tumor response. These include modulation of
the microvasculature via angiogenesis-targeted agents, induction of
a potent immune response via activators on effector cells in the
tumor microenvironment, and alleviation of immunosuppressive
mechanisms used by tumors to evade immune surveillance. Compass
plans to advance its product candidates through clinical
development as both standalone therapies and in combination with
proprietary pipeline antibodies based on supportive clinical and
nonclinical data. The company was founded in 2014 and is
headquartered in Boston, Massachusetts. For more information, visit
the Compass Therapeutics website
at https://www.compasstherapeutics.com.
Forward-Looking StatementsThis press release
contains forward-looking statements. Statements in this press
release that are not purely historical are forward-looking
statements. Such forward-looking statements include, among other
things, references to Compass’s financial position to continue
advancing its product candidates, expectations about cash runway,
business and development plans, and statements regarding Compass’s
product candidates, including their development and clinical trial
milestones such as the expected trial design, timing of enrollment,
patient dosing and data readouts, regulatory plans with respect to
Compass’s product candidates and the therapeutic potential thereof.
Actual results could differ from those projected in any
forward-looking statements due to numerous factors. Such factors
include, among others, Compass’s ability to raise the additional
funding it will need to continue to pursue its business and product
development plans, the inherent uncertainties associated with
developing product candidates and operating as a development stage
company, Compass’s ability to identify additional product
candidates for development, Compass’s ability to develop, complete
clinical trials for, obtain approvals for and commercialize any of
its product candidates, competition in the industry in which
Compass operates and market conditions. These forward-looking
statements are made as of the date of this press release, and
Compass assumes no obligation to update the forward-looking
statements, or to update the reasons why actual results could
differ from those projected in the forward-looking statements,
except as required by law. Investors should consult all of the
information set forth herein and should also refer to the risk
factor disclosure set forth in the reports and other documents
Compass files with the U.S. Securities and Exchange Commission
(SEC) available at www.sec.gov, including without limitation
Compass’s latest Annual Report on Form 10-K, Quarterly Report on
Form 10-Q and subsequent filings with the SEC.
Investor Contactir@compasstherapeutics.com
Media Contact Anna Gifford, Communications
Manager media@compasstherapeutics.com617-500-8099
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