United BioPharma Signs clinical trial agreement with NIH/NIAID for sponsorship of a multi-drug resistant HIV trial with UB-421

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Taipei, Taiwan –November 25 2019 –United BioPharma (UBP) announced today the  signing of a clinical trial agreement with NIH/NIAID (National Institute of Allergy and Infectious Diseases) for their sponsorship of a  clinical trial with UB-421 for  treatment of multi-drug resistant (MDR) HIV infection.  NIAID will be responsible for the submission of an IND and execution of the trial entitled “A Single arm Open Label Phase 2 trial of anti-CD4 Antibody UB-421 in Combination with Optimized Background Antiretroviral Therapy in Patients with Multi-Drug Resistant HIV-1 Infection”.  Under the agreement, UBP will provide the study drug, UB-421, and perform pharmacokinetic and immunogenicity assays.

UBP has been in collaboration with NIAID since 2015, in particular, with HIV Immunovirology Unit Chief, Dr. Tae-Wook Chun under the direction of the NIAID Director, Dr. Anthony Fauci.  Through this collaboration, Nnmerous studies were conducted demonstrating the unique and superior properties of UB-421 as compared to broadly neutralizing antibodies and as a potential for functional cure.

In view of recent publication of UB-421 monotherapy clinical trial results at New England Journal of Medicine (NEJM) and the approval of UBP’s own IND for treatment of HIV MDR in April this year, the Principal Investigator, Dr. Michael C. Sneller and Dr. Tae-Wook Chun at NIAID are enthusiastic to evaluate UB-421 in a trial for MDR patients who have very few treatment options available.

As published  in the NEJM article, UB-421 monotherapy is effective in suppressing  HIV  levels to  undetectable for at least 4 months, and without occurrence of on-treatment resistant viral rebound in all ART-stabilized participants. The intrinsic antiretroviral potency of UB-421 as a single agent was also tested and defined in two clinical trials with treatment-naïve HIV-infected individuals.  “The durable maintenance of virologic control by a single agent such as UB-421 is unprecedented. This opens up the potential of new treatment option against resistance-prone HIV infection.” said Chang Yi Wang, Ph.D., Chief Scientific Officer and Chairperson of UBP.   Phase II/III development plans, including long term ART-substitution, multi drug resistant infection, and functional cure are currently in progress for UB-421.

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 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 research, development and manufacturing of novel monoclonal antibodies (mAbs) 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.

For more detailed information, please visit the website at: http://www.unitedbiopharma.com

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.

Company contact:

Dr. Mei June Liao, Executive Vice President, Product Development

+886-3-5979288 # 6700



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