KBI Biopharma Inc., a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), has entered a manufacturing contract with Alanis Therapeutics, Inc. (ATI) for the development of an innovative pre-clinical therapeutic antibody to treat myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML) blood cancers.
 
Under this collaborative agreement, KBI will leverage its advanced monoclonal antibody development and manufacturing platform, SUREmAb, to oversee critical development stages for ATI’s lead antagonistic antibody (mAb). These stages include cell line development, process optimization, analytical and formulation development, and the production of clinical-grade material. By streamlining and accelerating the mAb production process, KBI aims to expedite ATI’s clinical testing timeline.
 
“We are pleased to select KBI as our trusted CDMO to advance our lead antibody to the Notch pathway,” said Dr. Robert Goodenow, CEO of Alanis Therapeutics. “By collaborating with KBI, we aim to accelerate the development process and move closer to evaluating the full therapeutic potential of our antibody in clinical trials. This is a step forward in our mission to improve outcomes for patients affected by these challenging diseases.”
 
“We are proud to support Alanis and spearhead the development of its lead target,” said Tim Lowery, CEO of KBI Biopharma and President of JSR Life Sciences. “Our advanced platforms are optimized to streamline manufacturing, and with our SUREmAb technology at the forefront, our integrated workflow, high productivity levels, and streamlined process provide a fast path from cell line transfection to the final stages of cGMP drug substance manufacturing. This enables Alanis to expedite their mAb toward investigational new drug submission (IND) and bring it one step closer to patients, underscoring KBI’s commitment to advancing innovative therapies.”