FDA Permits the Study of a Novel Cancer Drug for Multiple Solid Tumors to Continue


The study the FDA allowed to continue is investigating the safety and efficacy of the novel cancer drug ACR-368 in patients with endometrial, urothelial and ovarian cancer.

The Food and Drug Administration (FDA) OK’d the continued study of the novel drug ACR-368 to treat patients with endometrial, urothelial and ovarian cancer, according to Acrivon Therapeutics, the manufacturer of the checkpoint inhibitor

Trial participants will be broken up into two groups, guided by the OncoSignature proteomic companion diagnostic, which determines if a patient’s disease has certain biomarkers that can be attacked by the drug. OncoSignature-positive patients will receive ACR-368 in a phase 2 study, while OncoSignature-negative patients will receive ACR-368 plus a low-dose of the chemotherapy gemcitabine in a phase 1b/2 study.

“Acrivon’s next generation proteomics-based precision medicine platform is engineered to uncover the disease-driving mechanisms that are uniquely sensitive to our drugs or rational drug combinations in individual patient tumors, independent of genetic alterations,” said Dr. Peter Blume-Jensen, president and CEO of Acrivon, in a press release. “Our strategy is to apply the ACR-368-tailored OncoSignature test to a tumor biopsy from the patient before the start of treatment and use that result to direct ACR-368 to only those patients predicted to be most likely to benefit from either monotherapy treatment or the combination therapy.”

For patients who are OncoSignature-negative, the phase 1b of the study will determine if ACR-368 is safe and efficacious in treating their cancer alongside increasing doses of low-dose gemcitabine. Then, the phase 2 of the study will use the recommended dose of gemcitabine found in phase 1b and analyze the anti-tumor activity of the ACR-368, measured by the percentage of patients whose disease shrinks (known as overall response rate).

ACR-368 inhibits CHK1 and CHK2, two proteins that could be involved in the growth and proliferation of cancer cells. Previous small studies have found that the cancer drug has anti-tumor activity in patients with certain solid tumor types. Researchers hope that the utilization of OncoSignature will help determine which patients are more likely to benefit from the drug, offering patients with cancer more individualized care.

“By using OncoSignature to screen across human cancer tissue samples, we found that a proportion of endometrial and urothelial cancers is also sensitive to the drug and following further confirmation in preclinical patient-derived xenograft models, we have included these together with platinum-resistant ovarian cancer in our upcoming trial. With Acrivon’s rigorous science-based and selective methodologies, we aim to forge a paradigm change in personalized medicine for optimal patient care,” said Acrivon’s chief medical officer, Dr. Erick Gamelin, in the release.

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