Good Manufacturing Practice (GMP) – manufactured Monoclonal Antibody

Procurement Summary

UB-421 is a monoclonal antibody which is being used to treat individuals living with HIV (PLWH) carrying multidrug resistant virus (MDR). NIH, NIAID, LIR is currently treating two patients harboring MDR HIV at the NIH Clinical Center(Institutional Review Board #IRB001672 and IRB001927) under an expanded access program approved by the Food and Drug Administration (Investigational New Drug #169181 and 166203). United Biopharma, located in Taiwan, is the patent holder for UB-421,the only company that possesses the cell line that needs to be used to produce UB-421 and as a result the only known source to produce this drug. These Study participants have no viable HIV treatment options because they developed resistant virus to many, if not all, the FDA-approved drugs. The LIR initiated the treatment program in March 2023 to prolong the lives of these two patients using an optimized drug regimen that included UB-421. To continue the lifesaving treatment for these two patients, the LIR must request United Biopharma, a foreign corporation, to manufacture a lot of UB-421 (100 liters) and perform the FDA-mandated stability tests of the new lot. If the drug UB-421 is not acquired and the use is discontinued, the HIV viral load will rebound on these two patients and their life expectancy will dramatically be shortened. Additionally, the LIR has an ongoing clinical trial entitled “A trial of anti-CD4 antibody UB-421 in combination with optimized background antiretroviral therapy in patients with multidrug-resistant HIV-1infection”. This study was approved by the NIH Institutional Review Board and the FDA (Clinicaltrials.gov ID NCT05582694, https://clinicaltrials.gov /study/NCT05582694?term=UB-421&rank=5). The purpose of this clinical trial is to evaluate the efficacy of UB-421 and to seek FDA approval to treat PLWH harboring MDR HIV who do not have any viable treatment option with UB-421. To continue this ongoing clinical trial, it is necessary to obtain clinical grade per the FDA’s mandate. As explained above, only United Biopharma can manufacture UB-421 because United Biopharma holds the patent on this antibody and United Biopharma is the only company that possesses the cell line that needs to be used to produce UB-421.

Yes

Yes