Alligator Bioscience, announced today a temporary halt in the recruitment of new patients to the company's ongoing Phase I clinical trials with the drug candidates ATOR-1015 and ATOR-1017. Patients currently enrolled in clinical studies are expected to continue with their scheduled visits as planned. The company intends to, in consultation with clinical sites and authorities, resume the recruitment of patients as soon as possible.
"Our first priority now is the health of our employees, our patients, the employees of our clinical sites and our collaboration partners. The Covid-19 pandemic has a major impact on society and, not least, on the health care system which is heavily burdened and faces many difficult priorities. We are thoroughly monitoring the development and how it affects our ongoing clinical studies and have a close dialogue with all concerned parties to ensure that cancer patients will be able to participate in our studies again as soon as possible", said Per Norlén, CEO of Alligator Bioscience.
Alligator has moved quickly to more extensive virtual operations, except for essential laboratory work which continues with additional covid-19-related safety measures.
The company complies with the authorities' guidelines and is evaluating appropriate measures to minimize any delay that may be caused by the temporary pause in patient recruitment. For the time being it is too early to estimate if the halt of recruitment affects the study completion timelines.
ATOR-1015 is a bispecific antibody in clinical Phase I targeting the CTLA-4and OX40 molecules, developed as targeted therapy for metastatic cancer. ATOR-1015 is since March 2019 being evaluated in an ongoing dose escalation study planned to comprise up to 53 patients. The principal investigator is Dr Jeffrey Yachnin from the Department of Oncology at Karolinska University Hospital in Stockholm. The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1015 and to determine the recommended dose for subsequent Phase II studies.
ATOR-1017 is a monoclonal antibody in clinical Phase I activating the 4-1BB receptor on T and NK cells in the tumor region and has been developed for the treatment of metastatic cancer. ATOR-1017 is since December 2019 being evaluated in an ongoing dose-ranging study comprising up to 50 patients. The study is conducted at three different clinics in Sweden. The primary endpoint of the study is to investigate the safety and tolerability of ATOR-1017, and to determine the recommended dose for subsequent Phase II studies.
The clinical project AC101 (HLX22) is run and funded by the Chinese company Shanghai Henlius. AC101 is in clinical phase I and is developed primarily for the treatment of disseminated breast cancer. Information about the ongoing study can be found at
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