Shanghai, China – July 22, 2025 — Biomissile Pharmaceuticals and Fudan University today announced the publication of Phase 2 clinical trial results for BM219, a novel inhaled bispecific single-domain antibody for mild-to-moderate COVID-19. The double-blind, placebo-controlled trial demonstrated that BM219 is safe, well tolerated, and effective in reducing symptom duration and viral load.
The findings were published in the peer-reviewed article titled “Inhaled bispecific single-domain antibody BM219 for mild-to-moderate COVID-19: a double-blind, randomized, placebo-controlled phase 2 trial” in Cell Discovery, a journal under the Nature Publishing Group.
Compared to traditional intravenous antibody administration, inhalation delivers the drug directly to the site of infection in the lungs, not only significantly enhancing efficacy but also avoiding the systemic side effects commonly associated with conventional antibody therapies. This innovative approach simultaneously addresses two major challenges: immune evasion by viral variants and drug delivery efficiency.
BM219 is a novel bispecific nanobody derived from Biomissile’s proprietary fully-human domain antibody (UDAB)-based multi-specific antibodies (UDAB-MTM) platform technology. It targets two conserved, non-overlapping epitopes on the SARS-CoV-2 spike protein, enabling broad neutralization across variants. Nebulized delivery ensures high lung concentrations (200–300× serum levels) with minimal systemic exposure. In the epidemic strain JN.1 subgroup, the 60 mg BID regimen showed the fastest clinical recovery—over five days faster than placebo, while the 120 mg BID regimen achieved the largest viral load reduction (−1.18 log₁₀ copies/ml).
“The success of this trial highlights Biomissile’s strength in our translating cutting-edge academic discoveries into clinical-stage therapeutics and validates our platform technologies,” said Dr. Chao Tu, CEO of Biomissile. “We’re proud to have advanced BM219 from concept to a successful Phase 2 asset, enabling a practical, scalable solution to address immune-evasive COVID-19 variants.”
“BM219 was engineered to achieve synergistic binding through bispecific targeting of structurally distinct RBD epitopes, including a deeply buried conserved site,” said Dr. Tianlei Ying, professor at Fudan University. “This rational design underpins its broad neutralization profile and resilience against viral escape mutations.”
About Biomissile Pharmaceuticals
Biomissile Pharmaceuticals is a clinical-stage biotech company developing fully human domain antibody (UDABTM)-based multi-specific antibodies (UDAB-MTM) for solid tumors, autoimmune diseases, and infectious diseases. Leveraging these proprietary platforms, we have developed a highly differentiated pipeline that selectively activates NK/T cells and IL-15, effectively targeting cold tumors, including TAA-low and ADC-resistant solid tumors. In addition to oncology, UDAB-M molecules have been successfully expanded into autoimmune diseases, demonstrating superior B cell depletion compared to other therapies, including T cell engagers.
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