15 Apr 2021

Lonza and Immunitas Therapeutics Announce Manufacturing Agreement to Rapidly Advance Lead Program to the Clinic

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  • Lonza will provide a customized version of the Ibex® Design program to rapidly advance Immunitas' lead program, IMT-009, from Development Candidate to IND

Quote from Henit Lapid, Head Mammalian Commercial Development and Marketing, Lonza:

"Immunitas' extensive knowledge in human immunology is a great match for the unique speed and flexibility of our Ibex® Design, which supports our customer's needs for manufacturing agility. Lonza's advanced gene to IND platform achieves speed without compromising quality and offers an optimal program profile for a seamless transition from gene to IND and beyond."

Quote from Amanda Wagner, Vice President of Strategy, Immunitas Therapeutics:

"We are diligently progressing IMT-009, our first-in-class lead program targeting CD161, into the clinic, and this innovative collaboration with Lonza allows us to utilize the validated components of the Ibex® Design program to accelerate our IND. We believe Lonza will be a great collaborator as we work to rapidly advance our pipeline."

Basel, Switzerland, 15 April 2021 – Lonza and Immunitas Therapeutics today announced an agreement to advance the manufacturing process for the company's lead drug candidate, IMT-009, using a customized, accelerated version of Lonza's Ibex® Design program. Under the terms of the agreement, Lonza's Ibex® Design end-to-end offering will cover the development stages of IMT-009 from Development Candidate through early clinical studies.

Immunitas uses a single cell sequencing platform to identify novel oncology targets. The company is currently advancing a number of programs toward early human studies, including IMT-009, which targets CD161, a therapeutic T and NK cell target recently highlighted in the journal Cell. IMT-009 is a monoclonal antibody that disinhibits T cells and NK cells in the tumor microenvironment and is being advanced for use in both solid tumors and hematological malignancies.

As part of the customized agreement with Immunitas, Lonza has tailored The Ibex® Design Program to provide rapid access to material for GLP toxicology and cGMP manufacturing for Phase 1 clinical study start. Lonza will carry out complete CMC development, drug substance and drug product manufacturing, enabling a rapid timeline from candidate selection to phase 1 study start. The expression of IMT-009 will be performed using a robust cell line constructed with the GS Xceed® Expression System and will utilize well-optimized process development and logistics workflows. Lonza's Applied Protein Services platform will support the manufacturing.