ATI and KBI team up to manufacture antagonistic antibody candidateATI and KBI team up to manufacture antagonistic antibody candidate

Alanis Therapeutics (ATI) signed a manufacturing agreement with contract development and manufacturing organization (CDMO) KBI Biopharma, to develop and manufacture its lead candidate preclinical antibody. The antibody is designed to treat blood cancers such as myelodysplastic syndromes (MDS) and acute myeloid leukemia (AML).

MDS describes a series of cancers that occur when the blood marrow produces immature blood cells that do not develop into healthy cells. AML is also a cancer that starts in the bone marrow and can spread throughout the blood and organs.

According to ATI’s website, its candidate has shown promise in preclinical studies done in collaboration with Columbia University in New York. “In preclinical studies, Alanis’s anti-JAG1 antibody (ATI-D1), capable of inhibiting notch signaling, rescued anemia, thrombocytopenia, neutrophilia and lymphocytopenia, restored LT-HSCs (the leukemia initiating population), relieved myeloid differentiation block and eliminated blasts.”

Under terms of the agreement, KBI will also oversee cell-line development, process optimization, and analytical and formulation development for ATI’s mAb candidate. KBI said that it will focus on streamlining, accelerating, and optimizing the mAb production process for clinical testing.

“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,” said Robert Goodenow, CEO of ATI. “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, KBI’s parent company. Lowery explained that KBI’s SUREmAb platform enables the company to streamline manufacturing processes and achieve high productivity levels. “This enables Alanis to expedite their mAb toward investigational new drug (IND) submission and bring it one step closer to patients, underscoring KBI’s commitment to advancing innovative therapies.”