Plant-derived biotherapeutic specialist Phylloceuticals has successfully produced the first batch of a PD-1 inhibitor monoclonal antibody (mAb) biosimilar.
This achievement comes 12 weeks after the company initiated operations at its new laboratory space in Rapid City, SD.
According to the company, this achievement marks a major technical and organisational milestone for the company, acting as a potential paradigm shift in how complex biologics are developed and manufactured.
Phylloceuticals produced microgram quantities of the plant-based PD-1 inhibitor mAb in April, which was achieved through the use of a proprietary rapid expression technology and green biomanufacturing process.
“Going from zero infrastructure to active biologics production in under three months is not just uncommon—it’s nearly unheard of in this industry,” said Susan Stipa, CEO of Phylloceuticals.
“This validates both the strength of our platform and the depth of experience across our scientific and engineering teams. It also signals what’s possible when plant-based systems are designed with speed, efficiency and therapeutic relevance at the core.”
PD-1 inhibitors, which block the interaction between the PD-1 receptor and its ligand, are among the most effective immuno-oncology agents used to treat a wide range of cancers.
Although these show great promise in the oncological field, current production methods are costly, resource-intensive and inaccessible to many regions of the world.
By offering a biosimilar that is sustainable, cost-effective and rapid to produce, Phylloceuticals hopes to offer more patients treatment opportunities globally.
“Our goal isn’t just to replicate what others have done—we aim to transform access to advanced biologics through a platform that’s fast, flexible, and environmentally sound,” said Phylloceuticals' Chief Technical Officer, Dr Lynn Dickey.
“This first PD-1 biologic for Phylloceuticals is only the beginning.”
