KBI Biopharma to Lead Development and Manufacturing of Alanis Therapeutics’ Antagonistic Antibody Candidate

KBI Biopharma Selected as CDMO of Choice to Fast-Track Development of Pre-Clinical Antibody for Blood Cancers Using SUREmAb^TM Technology

Durham, North Carolina (December 3, 2024) — KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and global cGMP contract development and manufacturing organization (CDMO), announces 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.

As part of this collaborative agreement, KBI will oversee cell line development, process optimization, analytical and formulation development, and the manufacturing of Alanis’ pre-clinical jagged-1 antagonistic antibody (mAb). Utilizing KBI’s advanced monoclonal antibody development and manufacturing platform, SUREmAb™, KBI will begin the production of ATI’s lead antibody, focusing on streamlining, accelerating, and optimizing the mAb production process for clinical testing.

“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.”

About KBI Biopharma, Inc.

KBI Biopharma, Inc., a JSR Life Sciences company, together with its affiliates, is a global contract development and manufacturing organization (CDMO) providing fully integrated, accelerated drug development and biologics manufacturing services and expertise to life science companies. As a global leader in mammalian cell line development, with best-in-class modular technology and highly specialized solutions, KBI enables the life sciences industry to rapidly discover, develop, and commercialize innovative medicines and vaccines. With each of its 500+ customer partners, KBI works closely to personalize and rapidly accelerate drug development programs.

Global partners are utilizing KBI’s technologies to advance more than 170 drug candidates in preclinical and clinical development and the manufacture of ten commercial products. Built upon a foundation of world-class analytics capabilities and extensive scientific and technical expertise, KBI delivers robust process development and clinical and commercial cGMP manufacturing services for mammalian and microbial programs. Recognized for quality manufacturing, KBI helps partners advance drug candidates to the market. KBI serves its global customers with six locations in Europe and the USA. More information is available at www.kbibiopharma.com.

About SUREmAb™

Built on the SUREtechnology Platform, SUREmAb optimizes monoclonal antibody (mAb) development and manufacturing processes, fast-tracking the path to clinic and market. SUREmAb offers a simplified process for mAb development and manufacturing that increases efficiencies and speed while continuing to deliver the exceptional quality our SUREtechnology Platform is known for. Specifically designed for robust, secure monoclonal antibody development and manufacturing under accelerated timelines, SUREmAb delivers high titers of up to 18 g/L with a streamlined, lower-cost workflow for maximum return on investment (ROI). Our SUREmAb offering leverages our proprietary SURE CHO-M Cell Line™ to generate high-performing, mammalian-based cell lines that move seamlessly into manufacturing and commercialization. Our world-class expertise and depth of proprietary technology and processes allow us to significantly reduce the time, effort, and cost associated with the development of high-performance mAb-producing cell lines for therapeutic protein production.

About Alanis Therapeutics Inc.

Alanis Therapeutics Inc. (ATI) is a San Diego-based startup developing innovative antibody therapeutics to address unmet needs in cancer and autoimmune diseases. ATI's lead program is rooted in a groundbreaking discovery from collaboration with investigators at Columbia University. The antibody, ATI-D1, inhibits Notch 1 signaling in the bone marrow of Myelodysplastic Syndromes/Acute Myeloid Leukemia (MDS/AML) patients, a key oncogenic driver of leukemogenesis and tumor progression. Unlike competing approaches that target mutant clones emerging from the marrow, ATI’s antibody targets the underlying pathway driving leukemic stem cells, aiming to eradicate the source of the disease. This preclinical stage program has been recognized with awards from the prestigious V Foundation and a NIH Phase II SBIR grant. More information is available at www.alanistx.com.

KBI Biopharma, Inc. Company Inquiries
Sarah Wakefield
KBI Biopharma, Inc.

swakefield@kbibiopharma.com

KBI Biopharma, Inc. Media Inquiries
Kelly Biele
CG Life

kbiele@cglife.com

Alanis Therapeutics, Inc. Inquires

Robert Goodenow, CEO

Alanis Therapeutics Inc.

Robert.goodenow@alanistx.com