Acrivon Announces Late-Breaking Oral Plenary Presentation of Early Phase 1/2 Clinical Results in AP3-Predicted Tumors for its First-in-Class WEE1/PKMYT1 Inhibitor ACR-2316 at the 38th EORTC-NCI-AACR Symposium

Several lung adenocarcinoma patients remained on treatment for more than one year during the ongoing early-stage study.

Rhea-AI Summary

Acrivon Therapeutics (ACRV) reported early ACR-2316 cancer trial responses and will present dose-escalation results at a plenary session on November 20, 2026.

The ongoing Phase 1/2 trial evaluates an oral WEE1/PKMYT1 inhibitor in tumor types predicted by the company's AP3 platform. A heavily pretreated patient with squamous non-small cell lung cancer achieved a confirmed complete response after a sustained confirmed partial response. Several lung adenocarcinoma patients remained on treatment for more than one year; a partial response also occurred in small cell lung cancer. Confirmed responses were reported across predicted tumor types, including endometrial and lung cancers.

Adverse events were primarily transient, asymptomatic neutropenia, or low neutrophil counts. The trial is now in dose expansion and includes pancreatic ductal adenocarcinoma. Acrivon sees potential for combination development based on observed drug synergy.

Positive

• Minor pointA confirmed complete response occurred in squamous non-small cell lung cancer after four prior therapy lines.
• Minor pointConfirmed complete and partial responses occurred with monotherapy in heavily pretreated, AP3-predicted tumors, including endometrial and lung cancers.
• Minor pointSeveral lung adenocarcinoma patients remained on treatment for more than one year.
• Minor pointA partial response was observed in a small cell lung cancer patient.
• Minor pointDose expansion is underway, with pancreatic ductal adenocarcinoma included for further investigation.
• Minor point. Forward-looking: it has not happened yet and may not happen.Acrivon sees combination-development potential from observed synergy with immune checkpoint inhibitors and topoisomerase 1 inhibitors.

Negative

• Minor pointAdverse events were primarily transient, asymptomatic neutropenia, a reduction in neutrophil counts.

Key Figures

Confirmed complete response: 1 confirmed complete response Treatment duration: More than one year Prior systemic therapy: Median of three prior lines

Confirmed complete response

1 confirmed complete response

Heavily pretreated subject with squamous NSCLC and four prior lines of therapy

Treatment duration

More than one year

Several patients with lung adenocarcinoma remained on treatment

Prior systemic therapy

Median of three prior lines

Subjects with lung cancer in the dose-escalation phase

Previous Clinical trial Reports

2 past events · Latest: Aug 05

Same Type 2 events

1. Aug 05

   Clinical trial update

   24h Move

   +5.1%

   ACR-2316 advanced into randomized dose expansion after dose-escalation activity and favorable safety findings.

2. Jan 08

   Clinical trial update

   24h Move

   -34.6%

   Initial ACR-2316 Phase 1 data reported tumor shrinkage in 9/20 evaluable patients and a confirmed endometrial response.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

recist 1.1, fdg-pet, synthetic lethality, neutropenia, +1 more

5 terms

recist 1.1 medical

"confirmed CR per RECIST 1.1"

RECIST 1.1 is a standardized set of rules used in cancer clinical trials to measure how solid tumors respond to treatment by tracking changes in size on medical scans. Think of it as a consistent ruler and scorecard that tells doctors and regulators whether a drug is shrinking tumors, keeping them stable, or allowing them to grow. Investors care because RECIST-based results are common primary endpoints that influence regulatory decisions, trial success, and a therapy’s commercial prospects.

fdg-pet medical

"complete metabolic response by FDG-PET"

FDG-PET is a medical imaging scan that uses a radioactive glucose tracer (fluorodeoxyglucose labeled with fluorine-18) and a positron emission tomography (PET) camera to map tissues' metabolic activity. Areas that take up more FDG appear as higher signal on the scan, which helps detect and monitor conditions—commonly cancers, some brain disorders, and inflammatory processes—but it shows metabolic activity rather than fine anatomical detail, so it is often interpreted alongside CT or MRI images.

synthetic lethality medical

"reported synthetic lethality of WEE1 inhibition"

Synthetic lethality occurs when two separate weaknesses in a cell—each harmless alone—combine to cause the cell to die; targeting the partner weakness lets a drug kill diseased cells while sparing healthy ones. Think of it like removing the second support of a wobbly chair: a targeted nudge collapses only the defective ones. For investors, therapies based on this idea can offer more precise drugs, clearer patient selection tests, and potentially faster, less risky development paths.

neutropenia medical

"transient, asymptomatic, mechanism-based neutropenia"

Neutropenia is a medical condition where the blood has an unusually low number of neutrophils, the white blood cells that act like the body’s front-line security guards against bacterial and fungal infections. For investors, it matters because neutropenia can signal safety or tolerability problems for drugs or treatments, driving clinical trial setbacks, regulatory scrutiny, additional monitoring costs, or label warnings that can influence a company’s commercial outlook and stock value. Monitoring for neutropenia is a common part of assessing medical risk and long-term financial impact.

immune checkpoint inhibitors medical

"synergistic activity observed with immune checkpoint inhibitors"

Drugs that release the immune system’s natural “brakes,” allowing immune cells to recognize and attack cancer cells; imagine taking the safety off a guard dog so it can chase intruders. They matter to investors because they can become high-value treatments with large sales potential, but their commercial success depends on clinical trial results, regulatory approval, competition and side-effect management, which all affect a company’s valuation.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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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.

Acrivon intends to use its website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD. For more information, please visit www.acrivon.com.

Investor and Media Contacts:
Adam D. Levy, Ph.D., M.B.A.
alevy@acrivon.com

Alexandra Santos
asantos@wheelhouselsa.com

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Acrivon's early ACR-2316 trial show in lung cancer?

A patient with squamous non-small cell lung cancer achieved a confirmed complete response after four prior lines of therapy. Several lung adenocarcinoma patients remained on treatment for more than one year, and a partial response was observed in a small cell lung cancer patient.

When will Acrivon present the ACR-2316 dose-escalation results?

Timothy A. Yap will present the results on November 20, 2026, at 16:12 CET during a late-breaking oral plenary session at the EORTC-NCI-AACR Symposium in Barcelona.

Which cancers are being evaluated in Acrivon's ACR-2316 dose-expansion study?

The study continues to evaluate AP3-predicted, molecularly defined lung, endometrial, ovarian, cervical, esophago-gastric junction and pancreatic cancers. AP3 is Acrivon's predictive platform used to guide clinical development.

Why is Acrivon investigating ACR-2316 in pancreatic ductal adenocarcinoma?

Acrivon cites activity in K-Ras pathway-mutated cancers and reported synthetic lethality of WEE1 inhibition in tumors with K-Ras gain-of-function and TP53 loss-of-function changes as reasons for further investigation. The company sees grounds to investigate monotherapy and combinations with K-Ras inhibitors.