UB-421 IV / United BioPharma - LARVOL DELTA

Sustained virologic suppression of multidrug-resistant HIV in an individual treated with anti-CD4 domain 1 antibody and lenacapavir. (PubMed, Nat Med) - "The clinical management of people with multidrug-resistant (MDR) human immunodeficiency virus (HIV) remains challenging despite continued development of antiretroviral agents. The individual received three cycles of liposomal doxorubicin and five doses of anti-programmed cell death protein 1 (PD-1) monoclonal antibody pembrolizumab that resulted in improvement in KS with flattening of lesions. Our data demonstrate that combination therapy with UB-421 could provide sustained virologic suppression in people harboring MDR HIV with limited therapeutic alternatives."

Journal • Human Immunodeficiency Virus • Infectious Disease • Kaposi Sarcoma • Oncology • Sarcoma • Solid Tumor

Ex vivo sensitivity to broadly neutralizing antibodies and anti-CD4 antibody UB-421 of infectious viral isolates from people living with multidrug-resistant HIV. (PubMed, EBioMedicine) - "Our data suggest that combination therapy with HIV-specific bNAbs and/or UB-421 in the presence of optimized background therapy could potentially provide sustained virologic suppression in PLWH with MDR HIV. However, this therapeutic strategy needs to be evaluated in human clinical trials."

IO biomarker • Journal • Preclinical • Allergy • Human Immunodeficiency Virus • Immunology • Infectious Disease • CD8 • PD-1 • TIGIT

Development of Individualized Antibody Treatment Regimens for Patients With Multidrug-Resistant HIV (CROI 2024) - "We determined the sensitivity of infectious viral isolates obtained from the participants against 8 bNAbs (3BNC117, 10-1074, VRC01, VRC07, N6, 10E8, PGDM1400, and PGT121) and 2 anti-CD4 antibodies (ibalizumab and anti-domain 1 CD4 antibody UB-421) using a TZM-bl-based neutralization/suppression assay.There was no significant difference in plasma viremia between the study participants with MDR HIV and the control group (P=0.2929). The data from our study has direct clinical implications. Our data suggest that the therapeutic options for heavily treatment-experienced PLWH with MDR viruses could be potentially expanded to include HIV-specific bNAbs and UB-421, an avenue that has not been explored until now."

Clinical • IO biomarker • Human Immunodeficiency Virus • Infectious Disease • CD8 • PD-1 • TIGIT

A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection (clinicaltrials.gov) - P2 | N=25 | Recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Human Immunodeficiency Virus • Infectious Disease • CD4

A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: UBP Greater China (Shanghai) Co., Ltd | Trial completion date: Dec 2026 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - P3 | N=0 | Withdrawn | Sponsor: United BioPharma | N=520 ➔ 0 | Recruiting ➔ Withdrawn

Enrollment change • Monotherapy • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: United BioPharma | Trial completion date: May 2023 ➔ May 2024 | Trial primary completion date: Mar 2023 ➔ Mar 2024

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - P3 | N=50 | Not yet recruiting | Sponsor: United BioPharma | Trial completion date: Jun 2025 ➔ Jun 2026 | Trial primary completion date: Jun 2025 ➔ Jun 2026

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - P2 | N=11 | Completed | Sponsor: United BioPharma | Recruiting ➔ Completed | Trial completion date: Dec 2023 ➔ Feb 2023 | Trial primary completion date: Jun 2023 ➔ Feb 2023

Trial completion • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Trial of Anti-CD4 Antibody UB-421 in Combination With Optimized Background Antiretroviral Therapy in Patients With Multi-Drug Resistant HIV-1 Infection (clinicaltrials.gov) - P2 | N=25 | Not yet recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Combination therapy • New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - P2 | N=20 | Not yet recruiting | Sponsor: UBP Greater China (Shanghai) Co., Ltd | Trial completion date: Dec 2025 ➔ Dec 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - P2 | N=39 | Not yet recruiting | Sponsor: UBP Greater China (Shanghai) Co., Ltd | Trial completion date: Jun 2024 ➔ Jun 2025 | Trial primary completion date: Jun 2022 ➔ Jun 2024

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - P3 | N=520 | Recruiting | Sponsor: United BioPharma | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Dec 2025

Monotherapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - P2 | N=10 | Not yet recruiting | Sponsor: United BioPharma | Trial completion date: May 2022 ➔ May 2023 | Trial primary completion date: Mar 2022 ➔ Mar 2023

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - P2 | N=31 | Completed | Sponsor: United BioPharma | Active, not recruiting ➔ Completed

Combination therapy • Trial completion • Human Immunodeficiency Virus • Infectious Disease

UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - P3 | N=50 | Not yet recruiting | Sponsor: United BioPharma | Trial completion date: Jun 2022 ➔ Jun 2025 | Trial primary completion date: Jun 2022 ➔ Jun 2025

Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

To Investigate the Efficacy and Safety of UB-421 Monotherapy in HIV-1 Infected Adults (clinicaltrials.gov) - P3 | N=520 | Recruiting | Sponsor: United BioPharma | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2022 ➔ Dec 2023 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Enrollment open • Monotherapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - P2; N=10; Recruiting; Sponsor: United BioPharma; Not yet recruiting ➔ Recruiting; Trial primary completion date: Jun 2022 ➔ Jun 2023

Clinical • Enrollment open • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

A Proof-of-concept Trial to Evaluate the Safety and Efficacy of UB-421 Plus Chidamide in Changing HIV Reservoirs (clinicaltrials.gov) - P2; N=10; Not yet recruiting; Sponsor: United BioPharma

Clinical • New P2 trial • Human Immunodeficiency Virus • Infectious Disease

A Proof of Concept Study to Evaluate the Effect of UB-421 in Combination With Chidamide on HIV Viral Reservoir (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: UBP Greater China (Shanghai) Co., Ltd

New P2 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Emerging drugs for the treatment of HIV/AIDS: A Review of 2019/2020 phase II and III trials. (PubMed, Expert Opin Emerg Drugs) - "The majority of the trials focus on long acting drugs, but also new orally-administered compounds are in study.Expert opinion The biggest news in antiretroviral therapy (ART) is the approval of cabotegravir/rilpivirine as a complete long-acting (LA) therapeutic regimen...Results of phase 3 Islatravir trials are awaited. Lenacapavir may soon reach phase 3...Fostemsavir has been recently approved. Albuvirtide, a fusion inhibitor approved in China, presents several limitations as its intravenous use only. UB-421 and VRC01 are monoclonal antibodies against HIV. This emerging technology has shown interesting results, but needs further studies."

Journal • P2 data • P3 data • Review • Human Immunodeficiency Virus • Infectious Disease

UB-421 Combine With Optimized Background Therapy Regimen in Multi-Drug Resistant HIV-1 Infection Patients (clinicaltrials.gov) - P2; N=10; Not yet recruiting; Sponsor: United BioPharma; Trial completion date: Nov 2020 ➔ May 2022; Trial primary completion date: Sep 2020 ➔ Mar 2022

Clinical • Combination therapy • Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease

UB-421 in Combination With Optimized Background Regimen in Patients With Multi-drug Resistant HIV-1 Infection (clinicaltrials.gov) - P3; N=50; Not yet recruiting; Sponsor: United BioPharma; Initiation date: Jun 2020 ➔ Dec 2021

Clinical • Combination therapy • Trial initiation date • Human Immunodeficiency Virus • Infectious Disease

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - P2; N=39; Not yet recruiting; Sponsor: UBP Greater China (Shanghai) Co., Ltd; Initiation date: Jun 2020 ➔ Dec 2021

Clinical • Combination therapy • Trial initiation date • Human Immunodeficiency Virus • Infectious Disease

The HIV Functional Cure Potential of UB-421 in ART Stabilized HIV-1 Patients (clinicaltrials.gov) - P2; N=31; Active, not recruiting; Sponsor: United BioPharma; Recruiting ➔ Active, not recruiting; Trial completion date: Dec 2020 ➔ Dec 2021

Clinical • Combination therapy • Enrollment closed • Trial completion date • Human Immunodeficiency Virus • Infectious Disease