Catalent and Humanigen Expand Cooperation
US biotechs Catalent and Humanigen are extending their standing collaboration on lenzilumab, Humanigen’s proprietary anti-human granulocyte macrophage-colony stimulating factor (GCM-CSF) monoclonal antibody, with a new supply agreement covering Phase 3 clinical studies.
Lenzilumab is the California-based clinical stage biopharma company’s lead therapeutic candidate focusing on preventing and treating the cytokine storm seen in Covid-19 patients. In US diagnostics center Mayo Clinic’s first clinical use of lenzilumab in 12 patients with severe and critical Covid-19 pneumonia, the majority reportedly showed rapid recovery and hospital discharge.
As part of the companies’ ongoing collaboration, New Jersey-based Catalent Biologics has already provided early-stage development and clinical cGMP drug substance manufacturing for lenzilumab at its Madison, Wisconsin, facility, using its proprietary GPEx cell line development technology. With the expansion, it will support its partner’s Phase 3 potential registration study in Covid-19 from its Philadelphia facility.
Separately, Humanigen and Kite, a Gilead subsidiary, are evaluating lenzilumab in combination with Yescarta (axicabtagene ciloleucel) in patients with relapsed or refractory large B-cell lymphoma in a clinical collaboration.
Humanigen is additionally exploring the effectiveness of its GM-CSF neutralization technologies either through the use of lenzilumab as a neutralizing antibody or through GM-CSF gene knockout in combination with other CAR-T, bispecific or natural killer (NK) T cell engaging immunotherapy treatments.
After completing all studies, the next step is to secure approval or, alternatively, Emergency Use Authorization, for lenzuilumab from the US Food and Drug Administration (FDA). Here, Humanigen CEO Cameron Durrant said Catalent’s deep expertise and its integrated OneBio solution will accelerate the company’s ability to get this therapy to patients.
Karen Flynn, president and chief commercial officer of Catalent Biologics, added that the New Jersey biotech’s prior work with Humanigen renders it well suited to help make the promising therapy available to COVID-19 patients as soon as possible.
Catalent to create center of excellence in France
In other news, Catalent Biologics is investing $30 million to create a European center of excellence for clinical biologics formulation development and drug product fill-finish services in Limoges, France. The project is being supported with a French grant worth €1.3 million.
The Limoges site will be fully modernized to handle large molecule programs, with additional capacity for small molecule dosage form development. The facility will also work closely with Catalent’s European biologics sites in Anagni, Italy and Brussels, Belgium as well as its Bloomington, Indiana and Madison, Wisconsin, sites in the US to provide integrated clinical development and commercial manufacturing solutions.
The work will commence in September 2020, with completion anticipated for 2022. Catalent said it also plans to “gradually hire” around 80 additional employees to support the new center’s updated capabilities.
