ACRV

The registrational intent ACR-368 Phase 2b study is advancing with a prespecified simultaneous interim analysis and data update for both all-comer (biopsy-independent) serous endometrial cancer arms in second half 2026 The ACR-2316 Phase 1/2 study is advancing towards expansion phase demonstrating favorable tolerability, primarily transient neutropenia, with durable clinical activity at weekly dosing regimens in subjects with AP3-prioritized tumors, including heavily pretreated lung cancers Cash, cash equivalents, and marketable securities of $97.7 million as of March 31, 2026, plus proceeds of $7.3 million from subsequent equity financing, expected to fund operations into third quarter of 2027 and through multiple anticipated clinical milestones WATERTOWN, Mass., May 13, 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 reported financial results for the first quarter ended March 31, 2026 and reviewed recent business highlights. “2026 is an important catalyst year for Acrivon as we advance our two differentiated, AP3-guided clinical oncology programs towards key data read-outs,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president and co-founder of Acrivon. “For ACR-368, we are increasingly focused on serous endometrial cancer, a disease with high unmet need contributing upwards of 50% of all endometrial cancer deaths every year. This focus is supported by the compelling clinical activity observed thus far and the enthusiastic endorsement by external KOLs. We are particularly excited by the prospect of rapid enrollment of the serous population in our Phase 2b study in the U.S. and EU given that there is no requirement for a biopsy. Given the accelerated enrollment, we are now planning to conduct a pre-specified simultaneous interim analysis of both Arms 3 and 4 in second half of 2026. In parallel, we continue advancing ACR-2316 which has shown exciting initial clinical activity in AP3-prioritized tumor types, including lung cancers which are traditionally not sensitive to WEE1 inhibitors. With cash runway expected...

Maturing data from the ongoing registrational intent Phase 2b ACR-368 study showed a confirmed overall response rate (cORR) of 52% in serous endometrial cancer (EC) Late-breaking oral presentation and corporate KOL panel at ESGO 2026 highlighted strong ACR-368 data in serous EC, a high unmet need subtype responsible for ~50% of EC mortality Initiated Arm 3 (ACR-368 + ultra low-dose gemcitabine) and adding Arm 4 (ACR-368) Phase 2b cohorts in all-comer (biopsy-independent) serous EC subjects Initial Phase 1 ACR-2316 data in AP3-prioritized solid tumor types showed favorable tolerability and promising clinical activity, notably in heavily pre-treated lung cancer subjects Cash, cash equivalents and marketable securities of $118.6 million as of December 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., March 19, 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 reported financial results for the fourth quarter and full year ended December 31, 2025 and reviewed recent business highlights. “It’s an exciting time for the company as we build on strong maturing data and clinical momentum,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “Our compelling data from ACR-368 in EC was well received at the ESGO Congress, reinforced by powerful commentary from world-renowned key opinion leaders at our live webcast, after the late-breaking oral presentation by Dr. Konstantinopoulos from the Dana- Farber Cancer Institute. Serous EC represents a particularly significant unmet need with a mortality rate resulting in 40-50% of all EC deaths. Through our rapidly maturing data, we are strategically generating multiple opportunities towards potential registration for ACR-368, including our announcement today of a fourth arm to our study to investigate ACR-368 monotherapy in biomarker-unselected serous EC subjects. Elsewhere in our pipeline, ACR-2316 has already shown promising clinical activity in lung cancer, underscoring the potential of its differentiated mechanism of ac...

Advancement of ACR-368 in registrational-intent Phase 2b trial for the treatment of patients with endometrial cancer Preparing for initial clinical data disclosure for ACR-2316 from the Phase 1 trial in AP3-prioritized solid tumor types Expanding power of Generative Phosphoproteomics AP3 supersedes conventional target-centric drug discovery, yielding differentiated compounds with desired pathway effects Cash, cash equivalents and marketable securities of $134.4 million as of September 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Nov. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the third quarter ended September 30, 2025 and reviewed recent business highlights. “Our team continues to efficiently advance our AP3-enabled pipeline of targeted agents, maintaining strong momentum over the past quarter,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and co-founder of Acrivon. “With our prospective biomarker-driven registrational intent Phase 2b trial of ACR-368 in endometrial cancer we aim to address a high unmet need in relapsed patients. Additionally, we are pursuing another opportunity in endometrial cancer with a biomarker-unselected Phase 2b arm in patients with limited prior lines of therapy using low dose gemcitabine as a sensitizer to ACR-368 based on insights by the AP3 platform. We also recently showcased three presentations at the AACR-NCI-EORTC International Conference highlighting the ability of our innovative AP3 generative ensemble model (KaiSR) to accurately assess compound-induced pathway effects, thereby enabling rational drug design aimed at superior activity, as demonstrated by robust preclinical data for ACR-2316. We look forward to sharing initial Phase 1 data for ACR-2316 later this year, expanding upon the early safety and initial clinical activity observed during dose escalation, with tumor shrinkage and a confirmed partial res...

Continued advancement of two clinical-stage assets, both with clinically demonstrated single-agent anti-tumor activity -- ACR-368 in a registrational-intent Phase 2 study in endometrial cancer and ACR-2316 in a Phase 1 study in AP3-predicted tumor types New paradigm for accelerated design and development of novel compounds, like ACR-2316, based on optimal intracellular pathway selectivity, uniquely enabled by AI-driven AP3 Generative Phosphoproteomics platform Cash, cash equivalents and marketable securities of $147.6 million as of June 30, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., Aug. 13, 2025 (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 designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the second quarter ended June 30, 2025 and reviewed recent business highlights. “The strength of the clinical data across our two clinical assets speaks to the expanding capabilities of our AP3 platform to enable pathway-based drug design and optimized drug development by delivering actionable insights,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “With ACR-368, we have seen deep and durable responses in patients with various types of aggressive endometrial cancer who had all progressed on prior chemotherapy and anti-PD1 therapy – a high unmet need population. Based on our clinical data, and the AP3-discovered insight that ultra low-dose gemcitabine sensitizes tumors to ACR-368 treatment, we believe there is an opportunity to further expand the patient population benefiting from ACR-368 by treating all-comer, biomarker-unselected 2nd line patients, who have all received prior chemotherapy and anti-PD-1, with ACR-368 and ultra low-dose gemcitabine. Our fully internally developed second clinical-stage asset, ACR-2316, which is being advanced in a Phase 1 trial, has demonstrated initial clinical activity during dose escalation in several solid tumor types, including an ongoing confirmed partial re...

Corporate R&D event highlighted positive ACR-368 data in endometrial cancer patients who had all received prior anti-PD-1 and platinum-based chemotherapy Confirmed overall response rate (cORR) of 35% and median duration of response (mDOR) >5.6 months (not yet reached) observed in OncoSignature-positive (BM+) patients, a majority of whom were refractory to last prior therapy, and cORR of 50% and mDOR >10 months (not yet reached) for BM+ patients who had relapsed on last prior therapy Three dose escalation cohorts completed in ACR-2316 Phase 1 trial with tumor shrinkage observed already at dose level (DL)3, below projected recommended Phase 2 dose AACR presentation of ACR-2316 revealing mechanisms underlying its superior preclinical activity with potent mitotic tumor cell death using AP3 Generative Phosphoproteomics Mansoor Raza Mirza, M.D. appointed chief medical officer; accomplished clinician with stellar track record of successfully leading registrational trials through regulatory approvals, and establishing new standards of care in gynecological oncology Cash, cash equivalents and marketable securities of $164.8 million as of March 31, 2025, expected to fund operations into the second quarter of 2027 WATERTOWN, Mass., May 14, 2025 (GLOBE NEWSWIRE) -- Acrivon Therapeutics, Inc. (“Acrivon” or “Acrivon Therapeutics”) (Nasdaq: ACRV), a clinical stage biotechnology company discovering and developing precision oncology medicines utilizing its proprietary Generative Phosphoproteomics AP3 (Acrivon Predictive Precision Proteomics) platform designed to interpret and quantify compound specific, drug-regulated pathway activity levels inside the intact cell in an unbiased and actionable manner, today reported financial results for the first quarter ended March 31, 2025 and reviewed recent business highlights. “We made substantial progress in the first quarter in the advancement of our clinical pipeline and the expansion of our Generative Phosphoproteomics AP3 capabilities, as well as strengthening the executive team,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “At our corporate R&D event, we reported positive updated interim data from our ongoing ACR-368 Phase 2b study in endometrial cancer patients with large tumors and aggressive histopathologies – all of whom had progressed after prior platinum-based chemothera...

Generative Phosphoproteomics AP3 platform designed to enable streamlined, rational drug discovery, with proprietary, proteome-wide SAR delivering desirable pathway effects R&D event highlighted positive ACR-368 endometrial cancer data in OncoSignature-positive (BM+) patients with heavily pretreated aggressive tumors, and who had all progressed on prior anti-PD-1 and chemotherapy, with 35% confirmed overall response rate (cORR), which is >2-fold higher than last prior line of therapy (15%) In the BM+ patients who had relapsed after prior anti-PD-1 and chemotherapy, the cORR was 50% with the median duration of response (mDOR) not yet reached (>10 months), while in BM+ patients who were refractory to their last prior line of therapy, the cORR was 33% and mDOR was ~3.4 months Endometrial cancer prioritized given limited treatment options and compelling commercial opportunity; represents first potential regulatory approval opportunity for ACR-368 Phase 1 trial of ACR-2316 ahead of schedule with enrollment in first three dose-escalation cohorts completed; initial clinical activity with tumor shrinkage already observed at dose level three Cash runway extended into 2027 WATERTOWN, Mass., March 27, 2025 (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 reported financial results for the fourth quarter and full year ended December 31, 2024 and reviewed recent business highlights. “We continue executing our highly differentiated Generative Phosphoproteomics AP3-enabled strategy, delivering rapid progress towards key milestones across all programs, including our clinical assets, ACR-368 and ACR-2316,” said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. “We previously identified endometrial cancer as a sensitive tumor type with our AP3 platform prior to clinical entry. At our recent R&D event, we shared positive data for ACR-368 in patients with stage III/IV endometrial cancer who had all progressed after prior anti-PD-1 and chemotherapy. Despite patients presenting with large, heavily pretreated...