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Acrivon Acquires ACR-525 to Expand I&I Portfolio
Acrivon Therapeutics announced that it has acquired ACR-525, a Phase 2-ready, oral, highly selective Janus kinase 1, or JAK1, inhibitor, and a protein kinase C theta, or PKC, inhibitor preclinical program, from Aqilion. The acquisition establishes I&I as a strategic pillar for Acrivon alongside its oncology programs. The transaction delivers on Acrivon's previously communicated commitment to I&I as an expanded therapeutic area well-suited for its AP3 platform. The complex dysregulated, disease-driving signaling networks that underpin autoimmune and inflammatory disease lend themselves to AP3's unbiased, pathway-level interrogation of drug activity inside the intact cell without relying on genetic alterations. Acrivon intends to use AP3 for identification of ACR-525-sensitive I&I disorders, optimal patient selection, PD biomarker-guided dose optimization, and clinical biomarker-based early endpoints. The PKC inhibitor preclinical program, which targets a kinase central to T-cell activation, adds depth to the I&I pipeline. As part of its due diligence, Acrivon applied global AP3 phosphoproteomic profiling to quantify ACR-525's drug-regulated cellular pathway effects against six approved JAK inhibitors and dupilumab. These analyses characterized ACR-525 as a highly selective, JAK1 inhibitor with minimal off-target effects compared to approved JAK inhibitors and broader cellular effects than dupilumab. This supports Acrivon's view that ACR-525 has the potential to be a best-in-class JAK1 inhibitor. Given its high selectivity and oral availability, ACR-525 has potential in IBD and other immune disorders, both as a single agent and in combination with approved I&I therapies. Based on two completed Phase 1 studies, and a formulation designed for patients with difficulty swallowing, EoE is targeted as first potential indication. Under the terms of the asset purchase agreement, Acrivon acquired Aqilion's rights to AQ280 and the PKC inhibitor preclinical programs, including the associated intellectual property rights, data, regulatory filings and drug supply, for an undisclosed cash consideration without future royalties or milestone obligations. Concurrently, Acrivon, Aqilion and LEO Pharma entered into an agreement terminating all future royalty and milestone obligations on ACR-525 previously agreed to between Aqilion and LEO Pharma. The transaction was approved by the boards of directors of Acrivon and Aqilion and closed concurrently with the signing of the definitive agreement.
Acrivon CEO Looks Forward to Rapid Clinical Advancements in Precision Medicine in H2 2026
"As we look ahead to the second half of 2026, we remain excited about the continued rapid clinical advancement of our precision medicine pipeline," said Peter Blume-Jensen, chief executive officer, president and co-founder of Acrivon. "For ACR-368, this includes the prespecified interim analysis of the registrational-intent, all-comer, serous endometrial cancer arms of the Phase 2b study. For ACR-2316, we have recently entered the randomized dose expansion stage in our Phase 1/2 study, supported by a favorable, differentiated safety profile and durable single-agent activity, including in heavily pretreated lung cancer subjects. Several subjects from the dose escalation phase now remain on treatment for more than one year."
Acrivon to Advance Two Clinical Programs in 2026
"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, 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 into the third quarter of 2027, we believe we are well positioned to execute through multiple potential value-inflection milestones."
Acrivon CEO Highlights ACR-368's Potential in Endometrial Cancer
"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 action. Finally, we continue to build our pipeline with our next development candidate, ACR-6840, and new programs, reflecting our sustained AP3-driven innovation and commitment to long-term value creation."
Company Plans to Initiate Fourth Cohort of ACR-368 Study in H1 2026
Building on clinical data and observed biomarker upregulation in serous EC, the company announced today that it plans to initiate a fourth cohort in the ongoing ACR-368 Phase 2b study in the first half of 2026. This arm will enroll all-comer serous EC subjects, similar to Arm 3, but subjects will be treated with ACR-368 monotherapy and otherwise identical inclusion criteria to Arm 3. Company also announced today that it has completed the exploratory Arm 2 of the study which treated BM- EC subjects with less than or equal to3 prior LoT using ACR-368 with ULDG sensitization. Objectives of this arm were achieved, supporting that ULDG may contribute to ACR-368 efficacy in BM- subjects with a favorable tolerability profile.
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