Adastra Pharmaceuticals welcomes CRO pitches for a Phase II trial of zotiraciclib in adults with recurrent high-grade gliomas and an isocitrate dehydrogenase (IDH) mutation, CEO Scott Megaffin said. In addition, the company has initiated a $45m Series B round to finance the study and other clinical trial development.
The Princeton, New Jersey-based company aims to start the trial by 2Q21 with trial sites in both the US and Europe, Megaffin said. Adastra eyes a CRO with previous experience working with small molecules and conducting high-grade glioma trials, he added. The company would prefer a full-service CRO, with no specific preferences for CRO size or geographic location, he explained.
Though the trial details will be based on upcoming regulatory conversations, the trial could enrol approximately 200–300 patients, Megaffin said. Adastra is considering overall survival and median progression-free survival (PFS) after 6 and 12 months as possible trial endpoints, as are consistent with industry standards, he noted.
Previously, a Phase Ib trial measuring safety and efficacy of zotiraciclib with temozolomide in patients with recurrent high-grade gliomas found a stronger efficacy signal in the subset of patients with IDH-mutated tumours, Megaffin said. Currently, there are no trials focusing on this specific subpopulation, indicating a significant unmet need in the field, he added.
The Phase Ib, which was conducted by the National Cancer Institute, met its PFS endpoint, according to topline results published in a 13 January company press release. Adastra plans to publish the full study results during ASCO in June, Megaffin said.
To finance the upcoming Phase II trial, and to bring zotiraciclib to clinic in several other oncology indications with metastasis-initiating cells, Adastra is now initiating a Series B fundraising round, Megaffin said. The company hopes to close the round in 2Q21, shortly before it begins the Phase II, he explained.
Currently, there is significant internal interest among a number of blue-chip venture capital firms and partners in China and Russia that have already invested in the company, Megaffin said. Adastra’s current investors include Domain Associates, Lee’s Pharma, Morgenthaler Private Equity, ProQuest, RusnanoMedInvest and Mitsubishi, according to the company website. Adastra will also open the round to outside private investors, though the company has not yet determined what specific types of investors it seeks, he added. An unspecified amount of current company funding will last up to the start of the Phase II trial, he explained.
Zotiraciclib is a potent oral cyclin-dependent kinase 9 inhibitor that can cross the blood-brain barrier and deplete antiapoptotic oncogenes, according to the company website.
William Newton is a Reporter for Clinical Trials Arena parent company GlobalData’s investigative journalism team. A version of this article originally appeared on the Insights module of GlobalData’s Pharmaceutical Intelligence Center. To access more articles like this, visit GlobalData.