Monkeys The Bioasis study with non-human primates back in 2018 DID NOT show that xB3-001 works in monkeys. It was a silly study because the monkeys had no health issues, such as brain tumours. It was otherwise not news that xB3 can transport drugs across the BBB, something it should be able to with most mammals.
It was serendipitous that it was discovered that in addition to crossing the BBB, an xB3 construct could also enter the lymph system.
Because there were no tumour HER2+ targets in the monkeys’ brains because they could not be harmed in any way, xB3-001 disappeared from the CNS very quickly, providing no information on actual or potential efficacy.
It was my opinion at the time that the study shouldn't have been done because it could not provide any valuable information. However, the lymph system discovery did provide a valuable but unexpected result. I got an excited call from MD in early July about the discovery but I couldn't say anything about it until the news was released later in the year.
For a number of reasons, including the decades of experience with Herceptin, monkey studies should not be required for advancement of xB3-001 to IND approval and clinical trials. The ethics of killing non-human primates enter the discussion as well.
jd