Timothy A. Yap, MBBS, Ph.D., FRCP, of The University of Texas MD Anderson Cancer Center to present results from the dose escalation phase of the ACR-2316 Phase 1/2 trial on November 20, 2026
Durable clinical activity, including confirmed complete and partial responses (RECIST 1.1) with ACR-2316 monotherapy in heavily pretreated, AP3-predicted tumor types, including endometrial and lung cancers
Activity in K-Ras pathway mutated cancers and reported synthetic lethality for WEE1 inhibition in K-Ras gain-of-function and TP53 loss-of-function tumors support expansion of study to include pancreatic ductal adenocarcinoma (PDAC)
Favorable, differentiated safety profile to date, primarily limited to transient, asymptomatic neutropenia
Strong synergistic activity observed with immune checkpoint inhibitors (ICI) and topoisomerase 1 (TOPO1) inhibitors support potential for broader frontline combination strategies across solid tumors
WATERTOWN, Mass., Oct. 29, 2026 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical-stage biotechnology company discovering and developing precision medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform deployed for rational drug design and predictive clinical development, today announced that dose escalation data from the ongoing Phase 1/2 study of ACR-2316, the company’s first-in-class, oral WEE1/PKMYT1 inhibitor, will be presented in a late-breaking oral plenary session at the 38th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, taking place November 18–20, 2026, in Barcelona, Spain. The company also reported continued progress in the study, with durable clinical activity in subjects with endometrial and lung cancers, including a confirmed complete response (CR) in a heavily pretreated subject with squamous non-small cell lung cancer (NSCLC). Additionally, the company announced inclusion of subjects with PDAC for further investigation.
"I’m looking forward to presenting these data at the EORTC-NCI-AACR Symposium,” said Timothy A. Yap, MBBS, Ph.D., FRCP, professor of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center. “The activity of ACR-2316 in endometrial and lung cancers, including a confirmed complete response in a heavily pretreated patient with squamous NSCLC, stands out, as lung cancers have not been previously shown to be sensitive to existing WEE1 or PKMYT1 inhibitors. The durability we’ve seen is also impressive, with several patients remaining on treatment for more than one year, along with a favorable safety profile.”
“Our data speak to the differentiation of ACR-2316 and the power of AP3-based drug design and indication finding,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “The long-lasting clinical benefit observed already during dose escalation in subjects with AP3-predicted tumor types, including heavily pretreated lung cancers, is notable. Together with a safety profile primarily limited to asymptomatic neutropenia, this underscores the potential of ACR-2316 to address difficult-to-treat cancers. Given the strong synergy we have observed with PD-(L)1 and TOPO1 inhibitors, together with its oral dosing route and favorable safety profile, we see great potential for combination development across solid tumor types where ICI and ADCs are beneficial. Furthermore, reported synthetic lethality of WEE1 inhibition in K-Ras-driven, TP53-deficient tumors warrants further investigation of ACR-2316 in PDAC, both as monotherapy and combined with K-Ras inhibitors.”
In the dose escalation phase, long-lasting clinical benefit was observed across multiple subjects with lung cancer and a median of three prior lines of systemic therapy, including chemotherapy and immune modulators. A subject with squamous NSCLC and four prior lines of therapy achieved a confirmed CR per RECIST 1.1, which included a complete metabolic response by FDG-PET, after a long-lasting confirmed PR. In addition, several patients with lung adenocarcinoma remained on treatment for more than one year, and a PR was observed in a small cell lung cancer patient. ACR-2316 has shown a favorable, differentiated safety profile to date, with adverse events primarily limited to transient, asymptomatic, mechanism-based neutropenia.
The study is now in dose expansion, with the study continuing to evaluate subjects with AP3-predicted, molecularly-defined lung, endometrial, ovarian, cervical, esophago-gastric junction, and pancreatic cancers.
Late-Breaking Oral Presentation Details
Title: Safety, dose optimization, and preliminary antitumor activity from a Phase 1 dose escalation study of ACR-2316, a novel WEE1/PKMYT1 inhibitor
Presenter: Timothy A. Yap, MBBS, Ph.D., FRCP, The University of Texas MD Anderson Cancer Center
Abstract number: 11LBA
Session: Plenary Session 7 Proffered Papers: Novel Agents and Targets
Date and time: November 20, 2026, 16:12 CET
A copy of the presentation will be available on the Acrivon website following the session.
About Acrivon Therapeutics
Acrivon is a clinical-stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative AI-driven, Phosphoproteomics AP3 platform. The platform allows the company to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased manner, yielding terabytes of proprietary data and delivering rapid, actionable insights. The AP3 platform is comprised of a growing suite of powerful, internally-developed tools, including the AP3 Data Portal, converting multimodal data into structured data for generative AI analyses, including the AP3 Kinase Substrate Relationship Predictor and the AP3 Interactome. These distinctive capabilities enable the company to go beyond the limitations of traditional drug discovery, as well as current AI-based target-centric drug discovery and rapidly design highly differentiated compounds with desirable pathway effects through intracellular protein network analyses and advance these agents into the clinic for streamlined development.
Acrivon is currently advancing its lead program, ACR-368 (also known as prexasertib), a selective small molecule inhibitor targeting CHK1 and CHK2 in a potentially registrational Phase 2 trial for endometrial cancer (EC). The company has received Fast Track designation from the Food and Drug Administration, or FDA, for the investigation of ACR-368 as a monotherapy based on OncoSignature-predicted sensitivity in patients with EC. The FDA has granted a Breakthrough Device designation for the ACR-368 OncoSignature assay for the identification of patients with endometrial cancer who may benefit from ACR-368 treatment.
In addition, Acrivon is leveraging its proprietary Generative AI-driven Phosphoproteomics AP3 platform for developing wholly-owned, internally discovered, co-crystallography-driven pipeline programs. These include ACR-2316, a first-in-class, potent, selective WEE1/PKMYT1 inhibitor preclinically designed for superior single-agent activity. The Phase 1/2 study of ACR-2316 is advancing in a randomized dose expansion phase in AP3-predicted tumor types. Initial data has shown a highly differentiated, favorable safety profile primarily limited to only transient neutropenia. Clinical activity has been observed across multiple heavily pretreated, AP3-predicted tumor types, including a subject with a confirmed CR in squamous non-small cell lung cancer (NSCLC), a PR in small cell lung cancer (SCLC), as well long-lasting clinical benefit (over one year) observed in subjects with lung adenocarcinoma, tumor types not shown sensitive to current single-agent WEE1 or PKMYT1 inhibitors.
In addition, the company is advancing ACR-7280, its next AP3-enabled innovation program, a first-in-class, oral, highly selective CDK11 inhibitor development candidate, in IND-enabling studies. AP3 indication finding identified AML as a predicted sensitive tumor type, and in preclinical studies, ACR-7280 demonstrated potent anti-tumor activity and complete tumor regression in aggressive AML models.
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.
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Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com
Alexandra Santos
asantos@wheelhouselsa.com
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