27 September 2022 - - Enrollment for the Phase I clinical study of BAT2022 has been completed, showing that BAT2022 is well-tolerated and there were no DLT observed up to the dose of 1500mg, the highest dose tested, China-based biopharmaceutical company Bio-Thera Solutions, Ltd. (SH: 688177) said.

BAT2022 is a broadly potent neutralizing bi-specific antibody against SARS-CoV-2. Plasma concentrations of BAT2022 were analyzed and determined, showing very favorable PK parameters, and more importantly, the plasma levels of BAT2022 in the clinical study have shown a very high neutralizing titer in a pseudotyped ex vivo assay of pharmacodynamics.

This data suggests that BAT2022 can be developed not only as a therapeutic for COVID-19 patients, but also as a potential prophylactic to healthy people at higher risk of infection, such as healthcare workers, and immunocompromised individuals, such as seniors.

As the SARS-CoV-2 virus continues to evolve throughout the pandemic and variants continue to emerge, some have become more contagious, virulent, or more resistant to the current vaccines and neutralizing antibodies, such as omicron, which is highly transmissible and resistant to most of our current countermeasures.

Therefore, novel antibodies that maintain their neutralization strength and breadth against the abovementioned resistant variants and possibly future emerging variants are urgently needed.

By utilizing its proprietary IDEAL (Intelligent Design and Engineered Antibody Libraries) platform, the Bio-Thera team has discovered and developed BAT2022, a broadly potent neutralizing bi-specific antibody against SARS-CoV-2.

BAT2022 binds simultaneously with high affinity to two non-overlapping epitopes on the Receptor-Binding Domain of SARS-CoV-2 virus and competitively blocks the binding of RBD to human Angiotensin-Converting Enzyme 2.

Preclinical study results were recently published in Virology: Current Research (Zhang, H., et al. "Broadly Potent Neutralizing Bispecific Antibody against SARS-CoV-2." Virology: Current Research 6: S1,2022).

Data from the article showed that BAT2022 potently neutralizes all of the SARS-CoV-2 mutants (Alpha, Beta, Gamma, Delta, and Omicron) tested, with IC50 values ranging from 20-160 pM, and specifically, a IC50 value of 30 pM was obtained for Omicron BA.2.76, which is currently circulating in many parts of China.

In a mouse model of SARS-CoV-2, BAT2022 shows strong prophylactic and therapeutic effects. Prophylactically, a single dose of BAT2022 completely protected mice from body weight loss, as compared to up to 20% loss of body weight in placebo-treated mice; in all mice treated with BAT2022 either prophylactically or therapeutically, the lung viral titers were reduced to undetectable levels, as compared to around 1 × 105 PFU/g lung tissue in placebo-treated mice.

These preclinical data, together with the phase 1 clinical data, strongly suggest that BAT2022 is a potential candidate for prophylactic and therapeutic use against SARS-CoV-2.

Bio-Thera Solutions, Ltd., a global biotechnology company in Guangzhou, China.