Treadwell Therapeutics, a clinical stage, multi-modality biotechnology company developing novel therapeutics for highly aggressive cancers, and Genezen, a cell and gene therapy Contract Development and Manufacturing Organization (CDMO) have confirmed a partnership agreement to accelerate the production of T cell receptor (TCR)-based candidates to address unmet needs in cancer patients.
The agreement will see Genezen, which focuses on early-phase process development, vector production and analytical testing services, take two Treadwell TCRypt platform assets from early-phase development through scale up, past first clinical stages to GMP readiness and manufacturing.
Treadwell’s Head of Cell Therapy, Dr. Shawn Kubli said: “We are very confident that Genezen’s extensive viral vector experience and industry-leading manufacturing expertise will bring great benefits for this partnership and further our success in the timely advancement of our cell therapy clinical program, with expected initiation of clinical studies in 2023.”
The Treadwell projects will be initiated in Genezen’s new process development and analytical lab, which offers a full suite of process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research grade and preclinical vector production, and analytical assay development and validation.
“Genezen’s new state-of-the-art facility, a dedicated viral vector process and analytical development lab, was a major factor in our decision alongside great customer service and support. The team’s flexibility and responsiveness are vital for our early-stage projects and key to delivering potentially life-saving therapies for patients” added Ryan Dietz, VP Corporate Development at Treadwell.
Raymond Kaczmarek, Chief Executive Officer at Genezen said: “Our partnership provides Treadwell with a range of services for its pre-clinical and clinical pipeline of next generation TCR cell therapy programs.
“As a client, Treadwell can leverage our team’s expertise and proven track record to successfully accelerate its development programs. We are fully committed to supporting Treadwell in its drive to take drug products to market and patients faster.”
Genezen’s new lab is the first phase of a multiphase master plan for a 75,000+ square foot cGMP-compliant lentiviral and retroviral vector production facility. The next phase, with cGMP production suites, is currently underway and due to complete in early 2022.
The end-to-end capabilities will facilitate Genezen’s delivery of optimized closed and semi-automated processes for viral vector production.