Acrivon Therapeutics Announces ACR-2316, a Novel Dual WEE1 and PKMYT1 Inhibitor Development Candidate, Designed Using Acrivon’s AP3 Platform to Achieve Potent Single Agent Activity, as Demonstrated in Preclinical Studies
September 05 2023 - 4:05PM
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, today announced a novel,
internally developed clinical candidate, ACR-2316, a dual WEE1 and
PKMYT1 inhibitor. The company plans to prioritize Investigational
New Drug (IND) enabling studies for ACR-2316 to be ready for IND
submission by the fourth quarter of 2024.
“The rapid generation and optimized design of ACR-2316 further
demonstrates the broad utility of the AP3 platform in drug
discovery, in addition to its applications in clinical
development,” said Kristina Masson, Ph.D., M.B.A., co-founder,
executive vice president, and site head of Acrivon AB, Acrivon
Therapeutics’ wholly-owned drug discovery and phosphoproteomics
subsidiary in Medicon Village, Lund, Sweden. “This dual inhibitor
development candidate is yet another powerful validation of our
AI-enabled AP3 platform, which has been instrumental for the
identification of this compound, optimized for superior strong
single agent activity compared to existing WEE1 and PKMYT1
inhibitors.”
“Previously, we have shown how AP3 can be used to develop
drug-tailored predictive OncoSignature tests for effective
identification of patients likely to respond to a given therapy, as
we have done for our clinical stage CHK1/2 inhibitor, ACR-368,”
said Peter Blume-Jensen, M.D., Ph.D., chief executive officer,
president, and founder of Acrivon Therapeutics. “We now believe
that we have shown how AP3 can be used to go beyond the limitations
of traditional drug discovery methods by enabling biological
pathway-based rational design of development candidates with
optimal target selectivity profile and potency, with ACR-2316 being
the first example. This novel dual WEE1/PKMYT1 inhibitor has the
potential to address significant unmet needs across many solid
tumor types based on its compelling preclinical profile, with the
potential for monotherapy development in tumors predicted to be
sensitive to ACR-2316 using our OncoSignature patient selection
approach.”
Based on the emerging favorable preclinical profile of ACR-2316,
the company has entered into IND-enabling studies. The compound is
designed for high selectivity towards WEE1 and PKMYT1, exhibiting
single-digit nM IC50 potency in a carefully predetermined ratio to
ensure strong single agent anti-tumor activity, as demonstrated in
tumor-bearing rodent models and other preclinical analyses. Using
AP3 for unbiased quantitative high-resolution measurement of the
effects of ACR-2316 on the human tumor cell phosphoproteome, this
compound has been further optimized for potent induction of mitotic
catastrophe, which is key to its strong single agent activity in
preclinical models and potentially favorable clinical profile for
monotherapy development.
“The preclinical data we have generated thus far is consistent
with potential clinical advantages and possible differentiation
compared to current single inhibitors of WEE1 and PKMYT1, both
critically important cell cycle regulators with demonstrated
clinical activity,” said Erick Gamelin, M.D., Ph.D., chief medical
officer of Acrivon. “We are particularly encouraged by its
compelling target selectivity and preclinical potency profile. With
ACR-2316, we have demonstrated that the company’s data-driven,
streamlined AP3 approach can generate molecules with desirable
preclinical properties tailored for clinical monotherapy
development.”
Additional information regarding ACR-2316 can be found in the
company’s updated corporate presentation, which can be found on the
company’s website 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 enables 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,” “possible,” “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.Aalevy@acrivon.com
Alexandra Santos asantos@wheelhouselsa.com
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