Patrick Soon-Shiong, Chairman of Chan Soon-Shiong Family Foundation, Executive Chairman at ImmunityBio, and Executive Chairman of the Los Angeles Times, shared a post on X:
“So here is the logic. Anktiva (IL-15) was ranked number One to cure cancer. Keytruda was ranked number Two by NCI in 2007. Anktiva Grows T Cells. Keytruda takes the Brakes Off The T Cells.
Eventually Keytruda fails since there are no T cells to take the brakes off. So if T cells could be replenished by Growing T Cells Within Your Body As The Factory and Stimulated With IL-15 by growing T crlls together with NK cells, Keytruda can be rescued and allow T cells to work again and prolong life.
Well that is Exactly what we showed in our lung cancer trials and our trial with over 10 different tumor types and presented this data to Saudi FDA… resulting in approval of Anktiva in combination with Keytruda to prolong lives of patients with lung cancer who had failed all standards of care and whose tumors were spreading and growing while on Keytruda!
So in short the combination of number 1 with number 2 ranked molecules of the immune system is both biologically rational and logical based on their Mechanism of Action. And last night Jay Bhattacharya mentioned loudly that FDA wants to accelerate approvals based on their doctrine of ‘plausible mechanism of action’. Anktiva’s mechanism has been validated by FDA themselves within the approved package insert!
With regard to single arm trials: Number two ranked drug developed over last decade (with 40 FDA approvals and approved for multiple tumor types with Single Arm Trials for MSI high for Merck). So when combined with the Number One ranked drug to rescue the number two, then magic happens. But it’s not magic… it’s the biology of your immune system… NK cells rescue T cells. The single arm trial with very mature data was accepted by Saudi FDA to enable their population to have access to this combination. This is the enlightenment that is needed!”
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