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United BioPharma Received Approval from China NMPA for a Phase 2 Trial to Evaluate the Reduction Effect of UB-421 mAb on Latent HIV Reservoirs in ART-stabilized HIV Patients

Taipei, Taiwan – March 17, 2020 – United BioPharma (UBP) announced today that they have received Investigational New Drug (IND) approval from China National Medical Products Administration (NMPA) to conduct a Phase 2 clinical trial to evaluate UB-421’s efficacy on reduction of latent HIV reservoirs in Antiretroviral Therapy (ART)-stabilized HIV patients.
This is a proof-of-concept (POC) study for functional cure of HIV infection. A similar study protocol has been approved by the Taiwan FDA, with  a  clinical trial  in progress since September 2019.

The trial in China will enroll 40 ART-stabilized patients whose plasma HIV viral load is maintained at a level below 50 copies/mL. During the 48-week treatment period, study participants will receive 25 mg/kg  of UB-421 either bi-weekly or monthly in addition to ART. At the end of the study, several key parameters, including the level of total HIV DNA, will be analyzed. 
ART alone cannot cure HIV infection due to permanent persistence of latent HIV reservoirs.  Patients must adhere to ART for lifebecause plasma HIV viral load will rebound shortly upon ART interruption.  The latently infected cells can reactivate and  begin to produce HIV when the suppressive effect of ART is removed. 

Researchers around the world have been diligently seeking therapy for cure of HIV infection. A “functional cure of HIV infection” represents that an HIV infected individual has healthy immune function and the ability to maintain the viral load at an undetectable level in the absence of ART, so as to prevent disease progression and transmission.

One of the hypothesized strategies to reach HIV functional cure is “Shock, Kill and Block”. “Shock” means to reactivate the latently infected cells, leading to virus transcription, protein expression and virion production. “Kill” means to potentially trigger immune-mediated clearance following the HIV antigen presentation on the infected cell surface. “Block” means to prevent re-infection and new formation of latent viral reservoirs.

UB-421 monotherapy in ART-stabilized HIV patients (phase 2 study) has been shown to maintain a durable viral remission for at least up to 16 weeks, in which UB-421 treatment reduced the quantity of  HIV proviral DNA (a surrogate marker of latent reservoirs) by approximately 50%. Furthermore, UB-421 exhibits immunomodulatory effects, including the reduction of CD4 regulatory T cells that harbor the bulk of HIV latent reservoirs, and increase the HIV-specific CD8+ T cells that help the clearance of HIV.
 “We believe UB-421 is an unusual antibody for activating/modulating T cells to do many things, including clearance of latent HIV from the body,” says Dr. Chang-Yi Wang, Chief Scientific Officer and Chairperson of the company. “If the immune system can be retrained by UB-421 to fight against HIV more effectively, that could lead to a longer pill-free period and eventually, perhaps, to a functional cure of HIV, meaning that patients after UB-421 treatment may not need to following a stringent ART therapy model  for years and still keep the HIV viral load undetectable.”

About UB-421
UB-421 is an Fc-aglycosylated, non-T cell depleting and CD4-specific humanized IgG1 derived from the parent murine B4, which binds to discontinuous, conformational epitopes on the HIV-receptor complex, including CD4 (domain 1), and competitively blocks HIV entry. Both the murine and humanized mAbs bind to CD4+ T cells with approximately 50-100-fold higher affinity than HIV-gp120. UB-421 has been shown to inhibit viral entry with remarkable viral load reduction potency in Phase 1 and Phase 2a clinical studies involving treatment-naïve HIV-infected patients. In the Phase 2 study with ART-stabilized HIV-infected patients, UB-421 monotherapy maintains viral suppression for up to 16 weeks without viral rebound in the absence of ART. UB-421 is currently in the stage of a multi-nation and multi-center clinical trial for ART substitution, as well as other trials for multi-drug resistance and proof-of-concept study of HIV functional cure.

About latent HIV reservoir
A latent HIV reservoir is a group of immune cells in the body that are infected with HIV but are not actively producing new HIV.
HIV attacks immune system cells in the body and uses the cells’ machinery to make copies of itself. However, some HIV-infected immune cells go into a resting (or latent) state. While in this resting state, the infected cells don’t produce new HIV. HIV can hide out inside these cells for years, forming a latent HIV reservoir. At any time, cells in the latent reservoir can become active again and start making more HIV. Latent HIV reservoirs are established during the earliest stage of HIV infection.

About United BioPharma
United BioPharma (UBP) is a clinical stage biopharmaceutical company, founded in 2013 as a spin-off from UBIAsia, its parent company. UBP is dedicated to the research, development and manufacture of novel monoclonal antibodies (mAbs best crossbow) for infectious diseases, cancer and immune disorders. UBP’s Headquarter is located in Taiwan, with subsidiary companies in Shanghai and Yangzhou China, and liaison offices in the U.S. The company has a global team, highly passionate about developing first-in-class, best-in-class therapeutic mAbs and delivering high-quality, affordable medicines to bring better life to the patients.
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United BioPharma Forward-Looking Statements
The information in this press release should be considered accurate only as of the date of the release. UBP has no intention of updating and specifically disclaims any duty to update the information in this press release. The press release may contain forward-looking statements involving risks and uncertainties and UBP’s actual results may differ materially from those in the forward-looking statements.

News contact:
Dr. Mei June Liao, Executive Vice President, Product Development
+886-3-5979288 # 6700