Acrivon Therapeutics Presents Data Demonstrating Capabilities of its AP3 Platform and ACR-368 OncoSignature Assay for Patient Responder Identification at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
16 Ottobre 2023 - 2:00PM
Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon
Therapeutics”) (Nasdaq: ACRV), a clinical stage biopharmaceutical
company developing precision oncology medicines that it matches to
patients whose tumors are predicted to be sensitive to each
specific medicine by utilizing its proprietary proteomics-based
patient responder identification platform, announced data
highlighting its AP3 approach to identify and evaluate biomarkers
for its OncoSignature assay designed specifically to predict
sensitivity to ACR-368, the company’s selective small molecule
inhibitor targeting CHK1 and CHK2, currently in
registrational-intent Phase 2 clinical trials. The data were
presented in two posters at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics in Boston
this past week.
“Our AP3 platform is designed to directly measure the activity
state of the drug-regulated, disease-driving proteins and
drug-induced compensatory resistance mechanisms to enable an exact
match with drug mechanism-of-action, independent of genetic
alterations,” said Peter Blume-Jensen, M.D., Ph.D., chief executive
officer, president, and founder of Acrivon Therapeutics. “We
leverage this distinctive capability to create drug-tailored
OncoSignature assays as a companion diagnostic aiming to identify
and treat patients most likely to benefit from treatment. We are
excited to have presented some key data supporting these pioneering
technologies and their application in the clinical development of
ACR-368 at this year’s AACR-NCI-EORTC conference.”
Acrivon Posters Presented at This Year’s
AACR-NCI-EORTC Conference
The poster (#C002) titled “Identification of
Biomarkers Predictive of Sensitivity to the CHK1/2 Inhibitor
ACR-368 Using High-Resolution Phosphoproteomics and Development of
an ACR-368-Tailored Patient Responder Identification 3-Marker Test,
ACR-368 OncoSignature” showed data leveraging the company’s AP3
approach, including ultra-high resolution, quantitative mass
spectrometry-based phosphoproteomics profiling combined with
proprietary approaches to identify three classes of functionally
orthogonal candidate biomarkers specifically predictive of
sensitivity to ACR-368. Biomarker candidates were initially
evaluated through pathway reconstitution and in cellular functional
assays, after which they were assembled into the ACR-368
OncoSignature assay for further functional validation. The
quantitative multiplex in situ ACR-368 OncoSignature assay was used
to provide a direct readout of the activity state of the drug
target signaling axis regulated by ACR-368 and that the tumor
depends on for dysregulated CHK1/2-driven DNA repair and
replication stress. The company’s ACR-368-specific OncoSignature
assay accurately predicted sensitivity to ACR-368 in genetically
non-modified ovarian cancer patient-derived xenograft (PDX) models
with an area under the curve (AUC) of 0.9 (95% confidence interval:
0.71 to 1; p-value = 0.025). These data support the use of the
company’s ACR-368 OncoSignature assay in its ongoing
registrational-intent Phase 2 clinical trials, and demonstrate the
distinctive, practical application of the company’s AP3
platform.
The poster (#B012) titled “Validation of the
OncoSignature Assay, an ACR-368-Tailored Response-Predictive
Quantitative Multiplexed Immunofluorescent Assay for Prediction of
Sensitivity to the CHK1/2 Inhibitor ACR-368 in Individual Patients
with Cancer” provided data validating the ability of the
AP3-derived ACR-368-specific OncoSignature assay to predict tumor
response to ACR-368 in multiple blinded, prospectively-designed
preclinical studies, including two separate studies on pretreatment
tumor biopsies from past Phase 2 clinical trials in patients with
ovarian cancer and in tumor types predicted sensitive to ACR-368,
including endometrial cancer. In the two pretreatment tumor biopsy
studies, the ACR-368 OncoSignature test was overall able to
segregate responders from non-responders with high accuracy and
enrich for responders, achieving an overall response rate of 47%
and 58% with strong statistical significance. Endometrial and
bladder cancers were identified as new tumor types predicted
sensitive to ACR-368 in 30-40% of cases. Data in the poster
confirmed the predicted efficacy in genetically non-modified, PDX
models of endometrial cancer, and further demonstrated that the
ACR-368 OncoSignature assay could predict sensitive from
insensitive models with an AUC of 0.88 in blinded studies. The data
presented in this poster, along with other confidential data not
disclosed in the poster, were previously submitted to and reviewed
by the FDA to support the Investigational New Drug Application
clearance of the registrational-intent design of the ongoing
monotherapy ACR-368 Phase 2 trials.
The posters can be viewed at www.acrivon.com in
the publications section using this link.
About Acrivon Therapeutics
Acrivon is a clinical stage biopharmaceutical
company developing precision oncology medicines that it matches to
patients whose tumors are predicted to be sensitive to each
specific medicine by utilizing Acrivon’s proprietary
proteomics-based patient responder identification platform, Acrivon
Predictive Precision Proteomics, or AP3. The AP3 platform is
engineered to measure compound-specific effects on the entire tumor
cell protein signaling network and drug-induced resistance
mechanisms in an unbiased manner. These distinctive capabilities
enable AP3’s direct application for drug design optimization for
monotherapy activity, the identification of rational drug
combinations, and the creation of drug-specific proprietary
OncoSignature companion diagnostics that are used to identify the
patients most likely to benefit from Acrivon’s drug candidates.
Acrivon is currently advancing its lead candidate, ACR-368, a
selective small molecule inhibitor targeting CHK1 and CHK2 in a
potentially registrational Phase 2 trial across multiple tumor
types. The company has received Fast Track designation from the
Food and Drug Administration, or FDA, for the investigation of
ACR-368 as monotherapy based on OncoSignature-predicted sensitivity
in patients with platinum-resistant ovarian or endometrial cancer.
Acrivon’s ACR-368 OncoSignature test, which has not yet obtained
regulatory approval, has been extensively evaluated in preclinical
studies, including in two separate, blinded, prospectively-designed
studies on pretreatment tumor biopsies collected from past
third-party Phase 2 trials in patients with ovarian cancer treated
with ACR-368. In addition to ACR-368, Acrivon is also leveraging
its proprietary AP3 precision medicine platform for developing its
internally-discovered preclinical stage pipeline programs,
consisting of its development candidate, ACR-2316, a selective,
dual WEE1/PKMYT1 inhibitor, and additional programs targeting these
two critical nodes in the DNA Damage Response, or DDR,
pathways.
Forward-Looking Statements
This press release includes certain disclosures that contain
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995 about us and our industry
that involve substantial risks and uncertainties. All statements
other than statements of historical facts contained in this press
release, including statements regarding our future results of
operations or financial condition, business strategy and plans and
objectives of management for future operations, are forward-looking
statements. In some cases, you can identify forward-looking
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of these words or other similar terms or expressions.
Forward-looking statements are based on Acrivon’s current
expectations and are subject to inherent uncertainties, risks and
assumptions that are difficult to predict. Factors that could cause
actual results to differ include, but are not limited to, risks and
uncertainties that are described more fully in the section titled
“Risk Factors” in our reports filed with the Securities and
Exchange Commission. Forward-looking statements contained in this
press release are made as of this date, and Acrivon undertakes no
duty to update such information except as required under applicable
law.
Investor and Media Contacts: Adam D. Levy,
Ph.D., M.B.A.alevy@acrivon.com
Alexandra Santos asantos@wheelhouselsa.com
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