• AP3-identified clinical biomarkers for ACR-368 led to the development of a response-predictive OncoSignature assay which has shown statistically significant prospective validation and responder enrichment in the ongoing registrational-intent Phase 2b study
• ACR-2316, a novel WEE1/PKMYT1 inhibitor, was uniquely enabled and optimized by AP3 to deliver superior single agent activity, complete tumor regression and pro-apoptotic tumor cell death through potent activation of CDK1, CDK2, and PLK1
• Acrivon scientists to present data at two key scientific conferences demonstrating AP3’s proprietary and actionable machine learning-driven capabilities for drug discovery and clinical development

WATERTOWN, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage precision medicine company utilizing its Acrivon Predictive Precision Proteomics (AP3) platform for the discovery, design, and development of drug candidates through a mechanistic match to patients whose disease is predicted sensitive to the specific treatment, today announced the company will be presenting data on the ability of its AP3 platform to uniquely enable the clinical development of ACR-368 and the discovery and design of ACR-2316 at two upcoming scientific congresses: Human Proteome Organization (HUPO) World Congress taking place from October 20-24, 2024 in Dresden, Germany and EORTC-NCI-AACR (ENA) Symposium taking place from October 23-25, 2024 in Barcelona, Spain.

“We are excited to have these three presentations highlighting the unique and actionable capabilities of AP3 featured at two premier scientific conferences in Europe this month,” said Kristina Masson, Ph.D., M.B.A., co-founder and executive vice president of business operations at Acrivon and president and CEO of the company's research subsidiary Acrivon AB in Lund, Sweden. “The presentations are the product of the efficient integration of our two teams of research scientists. In Lund, we utilize and leverage a world-class mass spectrometry and precision phosphoproteomics infrastructure. In Boston, we generate data and actionable insights through AP3 using state-of-the-art, fully scripted, algorithm-based, machine learning-enabled pathway and biomarker analyses. Our AP3 platform thus enables us to overcome many of the challenges facing the biopharma industry, including the discovery of clinical biomarkers, the identification of resistance mechanisms, indication finding, and prediction of patient responders. We have applied actionable insights from AP3 to the streamlined clinical development of ACR-368, and to rapidly design, discover and advance ACR-2316 into monotherapy clinical development in selected tumor types predicted sensitive with our AP3 platform. We firmly remain a science- and data-driven company, and it is always gratifying to be able to share our work at prestigious scientific conferences.”

HUPO 2024 World Congress Posters Details:

ENA 2024 Symposium Poster Details:

The above poster presentations will be available on Acrivon’s website in the “Science and Publications” section shortly after they are presented at the respective conferences.

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 (also known as prexasertib), 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. The FDA has granted Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of ovarian cancer patients who may benefit from ACR-368 treatment. The company reported positive clinical data for ovarian and endometrial cancers in April 2024, and in September 2024 it reported additional positive clinical data for endometrial cancer, including a confirmed overall response rate of 62.5% (95% C.I. 30.4% - 86.5%) and further validation of its prospective OncoSignature selection of patients predicted sensitive to ACR-368 by showing segregation of responders in OncoSignature-positive versus OncoSignature-negative patients (p = 0.009). The median duration of treatment was not yet reached, but the duration on study was 6 months at the time of the data cut.

In addition to ACR-368, Acrivon is also leveraging its proprietary AP3 precision medicine platform for developing its co-crystallography-driven, internally-discovered pipeline programs. These include ACR-2316, the company’s second clinical stage asset, a potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity as demonstrated in preclinical studies against benchmark inhibitors. The company is also progressing internally- developed preclinical programs, including a cell cycle program with an undisclosed target.

Acrivon has developed AP3 Interactome, a proprietary, computational analytics platform driven by machine learning for integrated comprehensive analyses across all large, in-house AP3 phosphoproteomic drug profiling data sets to advance its in-house research programs.

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, preclinical and clinical results, 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