Zephyrm Bioscience is gusting toward the Hong Kong stock exchange, filing (PDF) for an IPO to bankroll phase 3 trials of its cell therapy in a lung condition and graft-versus-host disease (GvHD).
Working in collaboration with the Chinese Academy of Sciences and the Beijing Institute for Stem Cell and Regeneration, Zephyrm has rounded up technologies to support the development of a pipeline derived from pluripotent stem cells. The biotech raised 258 million Chinese yuan ($37 million) across a three-part series B round from 2022 to 2024, funding the progression of its lead asset to the cusp of phase 3.
The lead candidate, ZH901, is a cell therapy that Zephyrm sees as a treatment for a range of conditions defined by injury, inflammation and degeneration. The cells secrete cytokines to suppress inflammation and growth factors to promote the healing of injured cells.
In an ongoing phase 2 trial, Zephyrm saw a 77.8% response rate in acute GvHD patients who received the cell therapy. Zephyrm plans to take ZH901 into phase 3 in the indication in 2025. Incyte’s Jakafi is already approved in the setting, as are allogeneic mesenchymal stromal cells, but Zephyrm sees an opportunity for an asset without the hematological toxicity associated with the JAK inhibitor.
Other companies are pursuing the same opportunity. Zephyrm counted five stem-cell-derived therapies in clinical development in the setting in China. The biotech has a clearer run in its other lead indication, acute exacerbation of interstitial lung disease (AE-ILD), where it believes it has the only stem-cell-derived therapy in the clinic. A phase 3 trial of ZH901 in AE-ILD is scheduled to start in 2025.
Zephyrm’s belief ZH901 can move the needle in AE-ILD is built on studies it ran in people with pulmonary fibrosis caused by COVID-19. In that setting, the biotech saw improvements in lung function, aerobic capacity, exercise endurance and shortness of breath. The evidence also informed Zephyrm’s targeting of acute respiratory distress syndrome, a setting in which it aims to complete a phase 2 trial in 2026.
The biotech has other irons in the fire, with a phase 2/3 trial of ZH901 in people with meniscus injuries set to start in 2025 and filings to study other candidates in humans slated for 2026. Zephyrm’s early-stage pipeline features potential treatments for Parkinson’s disease, age-related macular degeneration (AMD) and corneal endothelium decompensation, all of which are scheduled to reach the IND stage in 2026.
The Parkinson’s prospect, ZH903, and AMD candidate, ZH902, are already in investigator-initiated trials. Zephyrm said most recipients of ZH903 have experienced improvements in motor function, alleviation of non-motor symptoms, extension of on-time duration and enhancements in sleep.