United Biomedical-Asia (UBI-Asia) Announces Phase 1/2 and Phase 1 Extension Trial Results of Multitope SARS-CoV-2 Vaccine Published in the Journal of Clinical Investigation

UBI-Asia's Multitope SARS-CoV-2 Vaccine Candidate Provides Long-Lasting B- and T-cell Immunity against Delta and Omicron Variants

TAIPEI, Taiwan, April 6, 2022 /PRNewswire/ -- United Biomedical, Inc.-Asia (UBI-Asia), a Taiwan-based biologics company innovating antibody and long-acting protein biopharmaceutical technologies to promote human and animal health globally, today announced the publication of a study in the Journal of Clinical Investigation that demonstrates that UBI-Asia's Multitope SARS-CoV-2 Subunit Vaccine, UB-612, elicited long-lasting B- and T-cell immunity against the Omicron and Delta variants in Phase 1/2 and Phase 1 extension clinical trials.

The paper, entitled "A Multitope SARS-COV-2 Vaccine Provides Long-Lasting B- and T-cell Immunity against Delta and Omicron Variants," concluded that UB-612 elicited long-lasting viral-neutralizing antibodies and broad T-cell immunity against SARS-CoV2 Variants of Concern (VoCs), including the Omicron and Delta variants. UB-612 was found to generate strong booster-recalled memory immunity with high cross-reactive neutralizing titers against the Omicron and Delta variants.

In a Phase 1 clinical trial of primary and booster third-dose series, participants (n = 60, aged 20-55 years) received two initial doses of 10-, 30-, or 100-μg UB-612 28 days apart followed by a third booster (100-ug) dose for fifty of the study participants 7-9 months post-second dose. A separate placebo-controlled and randomized Phase 2 study was conducted with two doses of 100-μg UB-612 (n = 3,875, aged 18-85 years). No vaccine-related serious adverse events (SAE) were recorded.

The studies concluded that while inducing a modest level of neutralizing titer after 2 doses, a single booster dose of UB-612 prompted striking neutralizing antibodies against the original Wuhan strain (VNT50 of 3,992) associated with an unusually high cross-neutralization effect against Delta variant (VNT50 of 2,358, with GeoMean Fold Reductions (GMFRs) of 1.7 vs the original) and Omicron (pVNT50 2,325 with GMFRs of 5.2 vs the original) strains which rivalled titers observed in the most effective vaccines until now.

"We are pleased that our COVID-19 vaccine candidate, UB-612, provided long lasting B- and T-cell immunity in recent clinical trials. UB-612 may serve as a timely solution in response to the recent call by global health organizations for a new generation of vaccines that incorporate T-cell immunity components beyond the Spike protein," said UBI-Asia Founder, Chairperson, and CEO Dr. Chang Yi Wang. "T-cell immunity is critical for the development of long-term immune responses and strong immunological memory. We believe our COVID-19 vaccine candidate UB-612 will serve as a turning point in the fight against the pandemic."

With a cross-reactive booster effect on B- and T-cell immunity, UB-612 may function as a  homologous, universal vaccine or a heterologous booster to elicit comprehensive immunity enhancement against emerging VoCs.

The data from the Phase 1/2 and Phase 1 extension clinical trials evaluating the safety, tolerability, and efficacy of UB-612 are published in the Journal of Clinical Investigation (JCI), a premier publication by the American Society of Clinical Investigation, and are accessible at https://www.jci.org/articles/view/157707.  

UB-612 is a novel multitope peptide vaccine anticipated to effectively combat the current globally dominant Omicron and Delta variants of the SARS-CoV-2 virus. Designed to activate both B- and T-cell immunities, UB-612 is safe and well tolerated in three Phase 1/2 and Phase 1 extension clinical trials, the results of which are published in the Journal of Clinical Investigation. The data suggest that UB-612 induces immunological memory for B- and T-cell immunity when recalled by a vaccine booster or natural infection. Studies further demonstrate that UB-612 produces long-lasting neutralizing antibodies, antigen-specific Th1-oriented and CD8 cytotoxic T-cell responses, and a strong memory response to a third (booster) immunization with high neutralizing antibody titers against the original (VNT50 3992 or IU/mL 2614) and Delta (VNT₅₀ 2358) strains which rivalled titers observed in the most effective vaccines until now.

UBI-Asia is a Taiwan-based biologics company innovating antibody and long-acting protein biopharmaceutical technologies to promote human and animal health globally. UBI-Asia is a joint venture between United Biomedical Inc (UBI U.S.) and the Taiwan National Development Fund and Ministry of Economic Affairs. In 1998, UBI's founder, Chairperson, and CEO, Dr. Chang Yi Wang, responded to the Taiwan government's promotion of the biotechnology industry by establishing UBI-Asia as UBI's Asia-Pacific operations center. With the acquisition of Roche and GSK's pharmaceutical operations and manufacturing facilities in Taiwan, UBI-Asia has expanded under Dr. Wang's leadership in CMC manufacturing, clinical development, and commercialization. UBI-Asia's proprietary technology platform for R&D has led to numerous clinical trials evaluating its protein and antibody products, along with the successful commercialization of its products with high barriers to entry. UBI-Asia has commercialized over 5 billion doses of its foot-and-mouth disease vaccine for swine in China, through its UBI affiliate UBI Shanghai (Shen Lian Bio, 688098). Through its collaboration with its French partner Ceva, UBI-Asia has commercialized its LHRH vaccine for immunological castration in swine with tens of millions of doses sold. UBI-Asia executed successful spinoffs of United BioPharma and UBI Pharma and maintains its close R&D collaboration with UBI U.S. in vaccine development.

The information in this press release should be considered accurate only as of the date of the release. UBI-Asia 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 UBI-Asia's actual results may differ materially from those in the forward-looking statements.

David Schull
Russo Partners
(858) 717-2310
[email protected]

Maddie Stabinski
Russo Partners
(484) 868-5822
[email protected]

SOURCE United Biomedical, Inc.-Asia