Acrivon Therapeutics announced that the FDA has granted a Fast Track designation for ACR-368 in the platinum-resistant endometrial and ovarian cancer biospace.
In previous Phase 2 clinical trials involving more than 400 patients, ACR-368 produced profound and long-lasting responses, including complete responses, to monotherapy in a group of patients. patients with solid tumors, including platinum-resistant ovarian cancer.
A blinded prospective study found that ACR-368 OncoSignature detected two independent pre-treatment tumors in ovarian cancer patients previously treated with ACR-368 and in a model Foreign transplantation of endometrial cancer patients.
WATERTOWN, May 9, 2023 (GLOBAL NEWS WIRE) — Acrivon Therapeutics, Inc. using a protein-based patient response recognition platform to determine individual drug sensitivities, today announced that the company has been granted two Fast Track status for the development of ACR-368 in platinum-resistant ovarian cancer and endometrial cancer. The Fast Track status is intended to facilitate and accelerate the development and testing of promising research drugs for the treatment of serious diseases with unmet medical needs.
Accelerated development program awarded to study ACR-368 as monotherapy in OncoSignature® patients
ACR-368, also known as prexasertib, is a targeted DNA damage response inhibitory therapy. ACR-368 was evaluated in a multicenter, open-label, phase 2 clinical trial based on the OncoSignature assay for ACR-368. The OncoSignature trial is the first drug-specific companion diagnostic test to use proteomic biomarkers. Identify patients who may have a drug candidate. The OncoSignature test was developed using Acrivon’s Accurate Predictive Proteomics (AP3) platform,
“We are pleased that the FDA has granted Fast Track certification to the ACR-368 development program in recognition of its potential in improving outcomes for patients with ovarian cancer,” said Peter Blum-Jensen, MD. and OncoSignature-positive platinum-resistant endometrium”. PhD, CEO, President, and Founder of Acrivon. “We received the Fast Track designation in the Phase 2 study ACR-368, a tumor type for which we are assessing the need for new therapies that are not viable. Five-year survival for patients with metastatic ovarian cancer is about 30%., the 5-year survival rate for patients with metastatic endometrial cancer is at least 20%.we can increase the chances of stopping it one way. effect, or reverse it. Based on this goal, we demonstrated that the ACR-368 OncoSignature assay can be used to predict drug response in patients and a xenograft study designed with preprocessed tumor biopsies collected from clinical studies before. We look forward to continuing this important work and working with the FDA to advance ACR-368. A prospective, prospective, blind-sided study of tumor biopsies and patient xenograft studies of pre-treatment drug response. We look forward to continuing this important work and working with the FDA to advance ACR-368. “Our drug development approach is based on these goals, and we have demonstrated that the ACR-368 OncoSignature assay can be used in blind studies using tumor biopsies collected from clinical trials. previous clinical studies. and predict drug response. continue this important work and work with the FDA to move ACR-368 forward.”
Introduction to ACR-368 and ACR-368 Phase 2 Studies
ACR-368, a potent and selective CHK1 and CHK2 inhibitor, has been granted orphan drug status in several phase 2 studies, including platinum-resistant squamous cell and ovarian carcinoma, as well. such as head, neck and rectal cancer. In monotherapy studies, ACR-368 demonstrated an excellent pharmacokinetic and pharmacokinetic profile and a favorable safety profile at the phase 2 recommended dose. 2 clinical trials in patients patients with platinum-resistant ovarian cancer, endometrial adenocarcinoma, and urothelial carcinoma based on predictive sensitivity to ACR-368. Using the company’s own OncoSignature® _
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Introduction to Acrivon Therapy
Acrivon, a clinical-stage biopharmaceutical company, is developing cancer drugs precisely tailored to patients with predictable drug responses using a disease response detection platform. kernel-based proteomics, Acrivon Predictive Precision Proteomics, or AP3. AP3 platform enables drug-specific OncoSignature® creation
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a forward-looking statement
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