CDMO KBI Biopharma has entered into a development and manufacturing contract with Alanis Therapeutics for its pre-clinical lead therapeutic antibody.
The monoclonal antibody (mAb) has been specifically designed to treat myelodysplastic syndromes (MDS) and acute myeloid leukaemia (AML) — two types of blood cancers with poor long-term prognosis.
Under the terms of this agreement, KBI will be responsible for overseeing cell line development, analysis, formulation development and the process optimisation of the pre-clinical mAb.
Following steps to successfully develop Alanis' lead therapeutic, KBI will also oversee the mAb's manufacture using its platform SUREmAb.
By accelerating and optimising the antibody production process, KBI hopes to prepare Alanis' candidate for imminent clinical testing.
CEO of Alanis Therapeutics, Dr Robert Goodenow, commented: “We are pleased to select KBI as our trusted CDMO to advance our lead antibody to the Notch pathway,”
“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.”