The U.S. Food and Drug Administration has green-lighted a Phase 2 clinical trial that will assess the safety and effectiveness of the small molecule 2X-121 in advanced ovarian cancer patients, Oncology Venture has announced.
The trial will also use the 2x-121 Drug Response Predictor biomarker to identify patients likely to respond to and benefit from treatment with 2X-121.
The 2x-121 Drug Response Predictor is a screening platform that uses gene expression (protein production) signatures from patient biopsies to identify their likelihood of responding to or resisting specific cancer-fighting therapies. The platform is able to screen over 400 genes.
2X-121 inhibits several members of the Poly(ADP-Ribose) Polymerase (PARP) enzymes, key factors involved in DNA damage repair in cancer cells. PARPs act as DNA damage sensors, binding to the sites of DNA damage and leading to its repair.
Cancer cells rely on PARPs to survive and proliferate. 2x-121 targets the PARP-1 and PARP-2 members, as well as the tankyrases (TNKS1 and TNKS2), also members of the PARP family.
The Phase 2 trial will take place in the U.S. and Germany and expects to recruit up to 30 advanced ovarian cancer patients. The participants will receive 2X-121, administered orally as a daily 600 mg dose. Treatment will continue until signs of disease progression.
The study’s primary objective (its endpoint) is to assess patients’ response to the therapy, both complete remission or partial responses. Other measures of the therapy’s effectiveness and safety parameters will also be evaluated.
In a previous Phase 1 trial (NCT01618136) evaluating the safety and efficacy of 2X-121 in patients with different types of solid tumors, including those with ovarian tumors, the results showed that 2X-121 was generally well-tolerated at the 600 mg daily dose, and with evidence of antitumor activity.
The 2X-121 Drug Response Predictor was applied in the trial where it was able to distinguish patients who were sensitive to the treatment from those who were treatment-resistant.
The results were presented at the 2018 ASCO Annual Meeting in a presentation titled, “First-in-human phase 1 study of the PARP/tankyrase inhibitor 2X-121 (E7449) as monotherapy in patients with advanced solid tumors and validation of a novel drug response predictor (DRP) mRNA biomarker.”
The FDA investigational new drug (IND) and investigational device exemption (IDE) applications, both needed to begin the Phase 2 trial, were submitted by the Medical Prognosis Institute, a Denmark-based biotech company that was recently acquired by Oncology Venture.
“I’m proud to obtain this first Oncology Venture prepared FDA IND and IDE approval to run trials with our PARP inhibitor in the U.S. and look forward to initialize study in ovarian cancer to prove the patient benefit of our PARP inhibitor and it’s DRP for precision treatment”, Marie Foegh, MD, the chief medical officer of Oncology Venture, said in a press release.
“Our Drug Response Prediction – DRP technology to track, match and treat patients with our PARP inhibitor enables us to be precise in selecting patients who will benefit from PARP inhibitor treatment,”
Peter Buhl Jensen, MD, the CEO of Oncology Venture, said the company expects the clinical trials “will confirm the DRP technology advantage and will position us very favorably in the market.”
A Phase 2 trial (NCT03562832) evaluating 2X-121 in patients with metastatic breast cancer is currently recruiting participants.
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