Acrivon Advances ACR-7280, an Optimized, AP3-Enabled, Potential First-in-Class, Oral CDK11 Inhibitor Toward IND Filing in First Half of 2027

Complete tumor regression in AML mouse models supports planned development of ACR-7280 alone and in combinations.

Rhea-AI Summary

Acrivon Therapeutics (ACRV) advanced oral CDK11 inhibitor ACR-7280 as its next development candidate, with initial development focused on acute myeloid leukemia (AML). Studies supporting an Investigational New Drug (IND) application are underway; the company expects submission to the FDA in the first half of 2027.

ACR-7280 produced complete tumor regression in AML mouse xenograft models and showed preclinical activity in NPM1-mutated and KMT2A-rearranged tumors. It also demonstrated combination synergy with venetoclax and menin inhibitors across several AML models. Development will pursue both single-agent and combination approaches. These findings are preclinical, not human trial results.

6 points · 0 major

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0 major · 0 points

Hollow bars mark forward-looking points. How the balance works

Positive

• Moderate point. Forward-looking: it has not happened yet and may not happen.IND-enabling studies are underway; Acrivon targets FDA submission in the first half of 2027.
• Moderate pointACR-2316 advanced to randomized dose expansion in its Phase 1/2 study.
• Minor pointACR-7280 achieved complete tumor regression in AML mouse xenograft models.
• Minor pointACR-7280 showed preclinical anti-tumor activity in NPM1-mutated and KMT2A-rearranged AML tumors.
• Minor pointACR-7280 demonstrated preclinical combination synergy with venetoclax and menin inhibitors across several AML models.
• Minor point. Forward-looking: it has not happened yet and may not happen.Initial AML development will pursue single-agent and combination approaches.

Negative

• None.

Key Figures

IND submission timing: First half of 2027

IND submission timing

First half of 2027

Submission remains on track

Historical Context

1 past event · Latest: Aug 12

1 event

1. Aug 12

   Pipeline update

   24h Move

   +7.6%

   Earlier update placed the CDK11 inhibitor program in IND-enabling studies, with first-half 2027 filing planned.

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

Key Terms

xenograft, pre-mrna splicing, co-crystallography, acute myeloid leukemia

4 terms

xenograft medical

"in vivo AML xenograft models"

A xenograft is biological tissue or cells taken from one species and placed into another, most commonly human tumor cells implanted into laboratory animals to study disease or test drugs. Investors watch xenograft results because they serve like a controlled dress rehearsal for a therapy: positive responses in these models can de‑risk programs, attract funding or partnerships, and influence the likelihood and timing of clinical trials and regulatory milestones.

pre-mrna splicing technical

"transcription, pre-mRNA splicing and mitosis"

Pre-mRNA splicing is the cellular process that edits a newly copied RNA message by cutting out non-coding bits and joining the remaining pieces so a correct blueprint for a protein is produced; think of it like film editing, where raw footage is cut and stitched into the final scene. For investors, splicing matters because errors or deliberate changes in this editing can cause disease or be targeted by drugs and diagnostics, influencing the commercial value and risk of biotech and pharmaceutical programs.

co-crystallography technical

"identified through its co-crystallography and AP3-driven discovery platform"

The process of determining the three-dimensional arrangement of atoms in a molecular complex by forming crystals that contain both a target (often a protein) and a bound small molecule or ligand, then using X‑ray diffraction or similar techniques to solve the structure. It reveals how the ligand sits in the target’s binding site and the atomic contacts involved; producing such a co‑crystal requires that the complex can be crystallized, and the resulting structure is a static snapshot that may not capture all motions or solution behaviors of the molecules.

acute myeloid leukemia medical

"identified acute myeloid leukemia (AML) as a predicted sensitive tumor type"

A fast‑moving blood cancer that starts in the bone marrow and crowd out healthy blood cell production, leaving the body short of normal red cells, white cells and platelets. It matters to investors because the disease creates urgent medical need, drives demand for new diagnostics and treatments, and so clinical trial results, regulatory decisions and drug pricing can rapidly change the commercial prospects and valuation of companies working on therapies.

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

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ACR-7280 demonstrated complete tumor regression in aggressive AML xenograft models

Prioritized among multiple AP3-discovered, highly selective CDK11 inhibitor candidates based on potent single agent activity and strong synergy with BCL-2 and menin inhibitors

IND-enabling studies ongoing with IND submission on track for first half of 2027

WATERTOWN, Mass., Oct. 20, 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 the advancement of ACR-7280, a potential first-in-class, oral CDK11 inhibitor, as its next development candidate generated from its AI-enabled AP3 innovation platform. Investigational New Drug (IND)-enabling studies are underway, and the company remains on track to submit an IND to the U.S. Food and Drug Administration (FDA) in the first half of 2027.

ACR-7280 was prioritized from multiple series of CDK11 inhibitor compounds the company identified through its co-crystallography and AP3-driven discovery platform. AP3-based indication finding identified acute myeloid leukemia (AML) as a predicted sensitive tumor type, and ACR-7280 has shown complete tumor regression in in vivo AML xenograft models. Moreover, it has demonstrated potent preclinical anti-tumor activity across AML models, including NPM1-mutated and KMT2A-rearranged tumors, as well as strong synergy in combination with both venetoclax and menin inhibitors across several AML models. Based on this, initial development will focus on AML, both as single agent and in combination.

“ACR-7280 provides another powerful validation of our AP3 innovation engine,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “AP3 profiling and analyses enabled us to identify ACR-7280 as a highly selective CDK11 inhibitor with optimized, desirable cellular pathway effects, which has translated to complete tumor regression in aggressive AML mouse models. While CDK11 has historically been a difficult target to drug, we believe ACR-7280 provides a first-in-class opportunity with broad potential in refractory/relapsed AML. The oral administration route may also provide flexibility for combining with standard-of-care agents, like venetoclax and menin inhibitors, potentially in earlier line settings. We look forward to advancing ACR-7280 swiftly towards the clinic, with IND submission on track for the first half of 2027.”

CDK11 is a challenging but compelling target with multiple isoforms and broad roles in cell cycle control, spanning transcription, pre-mRNA splicing and mitosis. ACR-7280 was rationally designed using the AP3 platform to achieve optimal on-target pathway effects, the same approach that was used to design ACR-2316, the company’s potential first-in-class, oral WEE1/PKMYT1 inhibitor which was rapidly advanced to the randomized dose expansion phase of its Phase 1/2 study.

About Acrivon Therapeutics
Acrivon is a clinical-stage biopharmaceutical company discovering and developing precision medicines utilizing its proprietary Generative 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, 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.

Acrivon is also leveraging its proprietary Generative AI-driven Phosphoproteomics AP3 platform for developing its co-crystallography-driven, internally discovered pipeline programs. These include ACR-2316, a novel, potent, selective WEE1/PKMYT1 inhibitor designed for superior single-agent activity. The Phase 1/2 study of ACR-2316 is advancing in a randomized dose expansion phase. Initial data has shown a highly differentiated, favorable safety profile primarily limited to only transient, mechanism-based hematological adverse events, predominantly only neutropenia. Clinical activity has been observed across multiple tumor types, including small cell lung cancer (SCLC), squamous non-small cell lung cancer (NSCLC) and lung adenocarcinoma, tumor types not shown sensitive to current single-agent WEE1 or PKMYT1 inhibitors. Durable clinical activity has been observed, with certain lung cancer subjects remaining on treatment for more than one year.

In addition, the company is advancing ACR-7280, its next AP3-enabled, potential first-in-class program, an oral CDK11 inhibitor which is currently being advanced 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.

When does Acrivon expect to submit the ACR-7280 IND application?

Acrivon expects to submit the ACR-7280 Investigational New Drug application to the FDA in the first half of 2027. Supporting studies are underway.

What did Acrivon's ACR-7280 show in preclinical AML studies?

ACR-7280 demonstrated complete tumor regression in AML mouse xenograft models. It also showed preclinical anti-tumor activity in NPM1-mutated and KMT2A-rearranged tumors and combination synergy with venetoclax and menin inhibitors across several AML models.