MedPath

Acrivon Therapeutics' ACR-368 Shows Promise in Endometrial Cancer; ACR-2316 Cleared for Phase 1 Trials

• Acrivon Therapeutics reported a 62.5% response rate in endometrial cancer patients treated with ACR-368, selected using the OncoSignature assay, with ongoing treatment and no median duration of response reached. • The FDA has cleared Acrivon's ACR-2316 for Phase 1 trials, with dosing scheduled to commence in Q4 2024, marking a significant milestone in the drug's development. • Acrivon Therapeutics maintains a strong financial position, with sufficient funding to sustain operations until the second half of 2026, supporting ongoing research and development efforts.

Acrivon Therapeutics, Inc. has announced promising Phase 2 clinical trial data for ACR-368 in endometrial cancer patients and FDA clearance for ACR-2316 to enter Phase 1 trials. The Phase 2 data revealed a 62.5% response rate among endometrial cancer patients selected using Acrivon's OncoSignature assay. These patients remain in treatment, and the median duration of response has not yet been reached at approximately 6 months. Dosing for ACR-2316 is expected to begin in Q4 2024.

ACR-368 Efficacy in Endometrial Cancer

The Phase 2 trial results highlight the potential of ACR-368 as a targeted therapy for endometrial cancer. The OncoSignature assay is used to identify patients most likely to respond to ACR-368, demonstrating a precision medicine approach. The 62.5% response rate is clinically significant, especially considering the challenges in treating advanced endometrial cancer. The fact that responders are still in treatment and the median duration of response has not been reached suggests a durable benefit.

ACR-2316 Advancement to Phase 1

The FDA clearance of ACR-2316 for Phase 1 trials marks a crucial step in its development. This allows Acrivon to begin evaluating the safety, tolerability, and pharmacokinetics of ACR-2316 in humans. The initiation of dosing in Q4 2024 will provide initial data on the drug's potential and inform further development strategies.

Financial Stability

Acrivon Therapeutics reports a solid financial foundation, with sufficient funds to operate until the second half of 2026. This financial stability allows the company to continue its research and development programs, including the advancement of ACR-368 and ACR-2316, as well as leverage its AP3 Interactome platform for precision medicine.

AP3 Interactome Platform

Acrivon's proprietary AP3 Interactome platform continues to be a key driver of its precision medicine approach. This platform enables the identification of drug targets and the development of therapies tailored to specific patient populations, as demonstrated by the OncoSignature assay used in the ACR-368 trial.
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Axcynsis Therapeutics' AT03-65, a CLDN6-Targeting ADC, Receives FDA IND Clearance

Axcynsis Therapeutics received FDA clearance for its IND application for AT03-65, an ADC targeting CLDN6-positive solid tumors, marking a key regulatory milestone.
AT03-65 utilizes AxcynDOT™, Axcynsis' proprietary payload with a novel mechanism, representing the first program using this technology to enter clinical trials.

Arvinas and Pfizer's Vepdegestrant Plus Abemaciclib Shows Promise in Breast Cancer Trial

Preliminary Phase 1b data of vepdegestrant with abemaciclib shows a 62.5% clinical benefit rate in advanced breast cancer patients previously treated with CDK4/6 inhibitors.
The combination therapy demonstrated a tolerable safety profile, with no significant drug-drug interaction observed between vepdegestrant and abemaciclib.

Atacicept Shows Sustained eGFR Stabilization in IgAN Patients Over 96 Weeks

Vera Therapeutics' atacicept demonstrated stabilization of kidney function in IgAN patients over 96 weeks in the ORIGIN Phase 2b trial.
The study showed significant reductions in Gd-IgA1, hematuria, and proteinuria, suggesting disease modification.

Vera Therapeutics' Atacicept Shows Sustained Kidney Function Stabilization in IgAN Patients

Vera Therapeutics announced 96-week data from its ORIGIN Phase 2b trial of atacicept, demonstrating stabilized kidney function in IgA nephropathy (IgAN) patients.
The study showed a 66% reduction in Gd-IgA1, 75% resolution of hematuria, and a 52% reduction in proteinuria, indicating significant disease modification.

Livionex's C-KAD Eye Drop Receives Positive FDA Feedback for Cataract Treatment

Livionex reports successful end-of-Phase 2 meeting with the FDA for C-KAD, a 2.6% EDTA ophthalmic solution, aimed at treating early-to-moderate cataracts.
The FDA has aligned with Livionex on key elements of the Phase 3 program, supporting a New Drug Application (NDA) filing for C-KAD.

Acrivon Therapeutics Grants Equity Awards to Employees Under Nasdaq Rule 5635(c)(4)

Acrivon Therapeutics has granted equity awards to employees under its 2023 Inducement Plan, consisting of options to purchase 61,950 shares of common stock.
The stock options vest over time, contingent upon continued employment, with 25% vesting after one year and the remainder in monthly installments.

Acrivon Therapeutics Initiates Phase 1 Trial of WEE1/PKMYT1 Inhibitor ACR-2316 for Solid Tumors

Acrivon Therapeutics has dosed the first patient in a Phase 1 clinical trial of ACR-2316, a novel WEE1/PKMYT1 inhibitor, for treating selected solid tumors.
ACR-2316 was developed using Acrivon's AP3 platform and is designed to induce complete tumor regression through potent activation of CDK1, CDK2, and PLK1.

Recursion's REC-1245 Receives FDA Clearance for Phase 1/2 Cancer Trial

Recursion's REC-1245, a novel chemical entity, has been cleared by the FDA for a Phase 1/2 clinical trial targeting solid tumors and lymphoma.
The trial, set to begin in Q4 2024, will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and potential efficacy of REC-1245 as a monotherapy.

Acrivon's ACR-368 Shows Promise in Endometrial Cancer, ACR-2316 Advances to Clinic

Acrivon Therapeutics reported a 62.5% confirmed overall response rate in OncoSignature-positive endometrial cancer patients treated with ACR-368 in a Phase 2 trial.
The study demonstrated statistically significant segregation of responders based on the OncoSignature biomarker (p = 0.009), with a median duration of response not yet reached.

Reference News

[1]
Acrivon Therapeutics: Promising Trial Results and FDA Clearance - TipRanks.com
tipranks.com · Sep 16, 2024

Acrivon Therapeutics reports 62.5% response rate for ACR-368 in endometrial cancer patients, with no median duration rea...

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy