Acrivon Therapeutics Announces FDA has Granted Breakthrough Device Designation for ACR-368 OncoSignature Assay for Ovarian Cancer
November 28 2023 - 7:00AM
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, Acrivon Predictive Precision
Proteomics or AP3, announced the U.S. Food and Drug Administration
(FDA) has granted Breakthrough Device designation for the ACR-368
OncoSignature assay, a multiplex immunofluorescence assay for the
identification of ovarian cancer patients who may benefit from
ACR-368 treatment. The designation reflects FDA’s determination
that the device is reasonably expected to provide for more
effective treatment or diagnosis of life-threatening or
irreversibly debilitating human disease or conditions.
“We are pleased that our ACR-368 OncoSignature
assay, developed specifically to predict tumor sensitivity to
ACR-368 and used in our ongoing registrational-intent clinical
study to treat patients based on OncoSignature-predicted
sensitivity, has been designated by the FDA as a Breakthrough
Device,” said Peter Blume-Jensen, M.D., Ph.D., chief executive
officer, president, and founder of Acrivon Therapeutics. “It is
exclusively through our proprietary AP3 platform that we are able
to develop these proteomic-based assays that are designed to
predict the patients most likely to benefit from treatment with our
drug candidates. We believe this designation is the first of its
kind for such an assay, and represents yet another powerful
validation of our AP3 platform. The designation importantly also
highlights meaningful potential value to patients as we continue to
progress ACR-368 in the clinic.”
The Breakthrough Devices Program is intended to
provide patients and health care providers with timely access to
medical devices by speeding up development, assessment, and review
for premarket approval, 510(k) clearance, and marketing
authorization.
Acrivon has partnered with Akoya Biosciences to
co-develop, validate, and commercialize Acrivon’s ACR-368
OncoSignature assay.
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 statements because they contain words such as
“anticipate,” “believe,” “contemplate,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “plan,” “potential,”
“predict,” “project,” “should,” “target,” “will,” or “would” or the
negative 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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