Grist for the MIL: CDMO Cognate making cell therapies for WindMIL

WindMIL Therapeutics has upped a contract with Cognate BioServices to make its marrow-infiltrating lymphocyte (MIL) cell therapies but says it is developing plans to eventually build in-house manufacturing capabilities.

WindMIL, a cancer immunotherapy firm developing autologous cell therapies based on its marrow-infiltrating lymphocytes (MILs), initially began working with contract development and manufacturing organization (CDMO) Cognate last year. Now the firm has expanded the contract to add extra clinical manufacturing capacity.

“We are securing one additional manufacturing suite at Cognate’s Memphis, Tennessee facility,” Patrick Dougherty, SVP of Strategy, Planning & Operations for WindMIL Therapeutics, told Bioprocess Insider.

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“Our existing relationship with Cognate was the driver. WindMIL doesn’t have its own manufacturing currently and expansion of our relationship with Cognate was the most expeditious way to secure additional capacity to support the demand for our ongoing Phase IIa study in non-small-cell lung cancer (NSCLC).”

Marrow-infiltrating lymphocytes (MILs) are made using WindMIL’s proprietary manufacturing process that activates and expands bone marrow-derived T cells.

“The bone marrow is a natural reservoir for memory T cells, which are naturally poly-antigen specific, highly cytotoxic and highly persistent – all highly desirable qualities for T cells used in adoptive T cell therapy,” Dougherty explained. “WindMIL is exploring use of both ‘unmodified’ MILs and ‘gene-modified’ MILs (CAR-MILs) to treat hematologic and solid tumor cancers.”

The MILs are made through an activation and expansion process that takes approximately 10 days. “The process is unique to each tumor type. The starting material for each is ~200mL of bone marrow aspirate from the patient.”

As well as the NSCLC program, WindMIL has an ongoing Phase II study sponsored by John Hopkins targeting multiple myeloma and a Phase I trial with unmodified MILs for patients who relapse after allogeneic transplant.

Cognate has an 80,000 square-foot site in Memphis, originally built in 2017 for autologous cell therapy manufacturing. The CDMO acquired Swedish plasmid DNA and viral vector manufacturer Cobra Biologics last November for an undisclosed fee.

“We are extremely happy to be able to provide expanded manufacturing capacity to WindMIL,” J. Kelly Ganjei, Cognate BioServices’ CEO said in a statement. “WindMIL and Cognate share the same patient-focused mindset and dedication to producing products of the highest quality for patients with currently unmet medical needs. We look forward to expanding the partnership between our two organizations.”