Acrivon Therapeutics, Inc. Stock Price, News & Analysis

Acrivon Therapeutics (NASDAQ: ACRV) announced upcoming data presentation at AACR Annual Meeting 2025 regarding their clinical-stage drug candidate ACR-2316, a selective WEE1/PKMYT1 inhibitor. The Phase 1 trial is progressing ahead of schedule, with three dose-escalation cohorts completed without safety concerns.

Key highlights include:

• ~25% RECIST tumor shrinkage observed at dose level 3
• Drug target engagement confirmed at dose levels 1 and 2
• No dose-limiting toxicities reported
• Currently enrolling dose level 4

The presentation will reveal how ACR-2316, developed using their AP3 Generative Phosphoproteomic platform, induces mitotic and replicative tumor cell death. The drug has shown superior anti-cancer activity in preclinical studies compared to benchmark inhibitors.

Acrivon Therapeutics (Nasdaq: ACRV) has appointed Dr. Mansoor Raza Mirza as Chief Medical Officer, effective April 9, 2025, replacing Jean-Marie Cuillerot. Dr. Mirza, a world-renowned oncology expert specializing in gynecologic malignancies, will lead clinical development including the ongoing ACR-368 Phase 2b registrational-intent trial in endometrial cancer and the ACR-2316 Phase 1 study in solid tumors.

Dr. Mirza joins from Copenhagen University National Medical Center, where he served as chief oncologist. He has authored seven articles in the New England Journal of Medicine and led numerous successful trials, including those leading to approvals of Zejula for ovarian cancer and a new frontline therapy for endometrial cancer combining platinum-based chemotherapy with anti-PD-1 checkpoint inhibitor.

Acrivon Therapeutics (NASDAQ: ACRV) reported its Q4 and full year 2024 financial results, highlighting significant progress in its clinical programs. The company's ACR-368 showed promising results in endometrial cancer patients, achieving a 35% confirmed overall response rate in OncoSignature-positive patients who had previously progressed on anti-PD-1 and chemotherapy.

Key clinical highlights include a 50% response rate in relapsed patients with duration of response exceeding 10 months, and 33% response rate in refractory patients. The Phase 1 trial of ACR-2316 is ahead of schedule, with initial clinical activity observed. The company has prioritized endometrial cancer development while deprioritizing ovarian and bladder cancer programs.

Financial results show a net loss of $22.8 million for Q4 2024 and $80.6 million for the full year. With $184.6 million in cash and investments as of December 31, 2024, Acrivon expects to fund operations into 2027.

Acrivon Therapeutics (Nasdaq: ACRV) has announced a virtual R&D event scheduled for March 25, 2025, from 4:00 p.m. to 5:15 p.m. ET. The event will showcase the company's Generative Phosphoproteomics AP3 platform capabilities and provide updates on two key clinical programs:

• Phase 2b study of ACR-368
• Phase 1 study of ACR-2316

The event will feature presentations from Acrivon's leadership team and distinguished key opinion leaders in endometrial cancer, including:

• Dr. Mansoor Raza Mirza, chief oncologist at Copenhagen University Hospital
• Dr. Robert L. Coleman, co-director of the Gynecologic Oncology Group Partners Foundation
• Dr. Jesper Olsen, professor at the University of Copenhagen

A live webcast will be accessible through the company's investor relations website and will remain available for at least 30 days after the event.

Acrivon Therapeutics (ACRV) announces FDA Breakthrough Device designation for its ACR-368 OncoSignature assay in endometrial cancer. This multiplex immunofluorescence assay is designed to identify patients likely to respond to ACR-368 treatment, currently in a registrational-intent Phase 2b trial.

The company's clinical data at ESMO 2024 showed a confirmed overall response rate of 62.5% and demonstrated significant segregation between biomarker-positive and negative patient groups (p=0.009). The assay was developed using their AP3 (Acrivon Predictive Precision Proteomics) platform, which combines generative AI for drug design and indication finding.

Market research indicates strong interest in ACR-368's clinical profile, with an estimated 30,000 annual cases of high-grade, locally advanced or metastatic, recurrent endometrial cancer in the U.S.

Acrivon Therapeutics reported Q3 2024 financial results and business highlights. The company achieved a 62.5% confirmed overall response rate in their Phase 2b endometrial cancer study for ACR-368. The trial demonstrated statistical significance (p=0.009) in patient selection using their OncoSignature technology. The company completed enrollment for their first dose-escalation cohort in the Phase 1 study of ACR-2316. Financial position remains strong with $202.8 million in cash and equivalents, expected to fund operations into H2 2026. Q3 2024 net loss was $22.4 million, with R&D expenses of $18.9 million and G&A expenses of $6.3 million.

Acrivon Therapeutics (Nasdaq: ACRV) will present data on its AP3 platform at two scientific conferences: HUPO World Congress and EORTC-NCI-AACR Symposium. The presentations will showcase AP3's capabilities in drug discovery and clinical development.

Key highlights include:

• AP3-identified clinical biomarkers for ACR-368 led to a response-predictive OncoSignature assay, showing statistically significant prospective validation in an ongoing Phase 2b study.
• ACR-2316, a novel WEE1/PKMYT1 inhibitor, was optimized using AP3 to deliver superior single agent activity and complete tumor regression.
• AP3 enables overcoming challenges in biopharma, including biomarker discovery, resistance mechanism identification, and patient responder prediction.

The company will present posters on ACR-368 and ACR-2316 at both conferences, demonstrating AP3's impact on streamlined clinical development and drug design.

Acrivon Therapeutics (Nasdaq: ACRV), a clinical stage precision medicine company, announced the approval of equity awards under its 2023 Inducement Plan for certain employees. The awards, granted on October 15, 2024, consist of stock options to purchase a total of 61,950 shares of Acrivon common stock.

The stock options will vest according to the following schedule:

• 25% on the first anniversary of the first day of the month following each employee's effective employment date
• Additional 2.083% installments monthly thereafter

Vesting is subject to continued employment. The inducement grants were approved by Acrivon's Board of Directors in compliance with Nasdaq Rule 5635(c)(4) and serve as a material inducement to employment.

Acrivon Therapeutics (NASDAQ: ACRV) reported positive data from its ongoing Phase 2 trial of ACR-368 in endometrial cancer at ESMO. Key highlights include:

- 62.5% confirmed overall response rate in OncoSignature-positive patients

- Statistically significant segregation of responders (p-value = 0.009)

- Median duration of response not yet reached (~6 months at data cut-off)

- Endometrial cancer anticipated as first potential accelerated approval indication

Additionally, Acrivon announced FDA clearance of the IND for ACR-2316, with first-in-human dosing expected in Q4 2024. The company's AP3 Interactome platform is generating proprietary insights for drug development and patient selection.