Based in The Woodlands, Texas, Opexa’s cGMP cell therapy manufacturing facility was acquired for a lump sum by the contract development and manufacturing organisation (CDMO) KBI.
KBI will assume Opexa’s lease for the site, which has four of the remaining five years left on facility lease, and two years remaining on equipment.
The facility was originally the key manufacturing site for Opexa’s autologous cell therapy, Tcelna, based on the firm’s proprietary immunotherapy platform, ImmPath.
However, in October Opexa released results for a Phase IIb trial for Tcelna saying it had failed both primary and secondary endpoints for secondary progressive multiple sclerosis (SPMS), which led the firm to reduce its workforce by 40%.
KBI will now use Opexa’s facility to offer manufacturing services, including use of ImmPath, to other biotech and pharma companies developing cell therapies.
“Being able to exit from those two leases and the related future obligations was a priority for us,” said Neil Warma, President and CEO of Opexa Therapeutics, Inc.
Warma added “[The lease] enabled us to eliminate our two major liabilities for Opexa shareholders, as we continue to assess strategic opportunities.”
Opexa’s Chief scientific officer, Donald Healey, has also transitioned to KBI to servce as Senior VP of Operations and Site Head, relinquishing his position with Opexa.
Primary Endpoint
Opexa’s Abili-T study was a 183 patient Phase IIb trial of the efficacy of Tcelna (imilecleucel-T) in treating SPMS.
On October 28, Opexa announced Tcelna had failed both primary and secondary endpoints: reduction in brain volume change (atrophy) and reduction of the rate of sustained disease progression in SPMS patients, respectively.
In response to the results, in November the firm cut 40% of its workforce and accepted the resignation of its chief development officer, Donna Rill.
At the time, Warma said “This reduction in force is a difficult but necessary step as a result of the disappointing results of our lead product candidate, Tcelna.”
He added Opexa “would review cash preservation options while [it] considers the best path forward for the company.”
Manufacturing services
The facility in The Woodlands is a 10,200 sq ft site with three ISO7 cGMP manufacturing suites and a specialized Flow Cytometry laboratory.
The build also has QA QC, R&D and microscopy labs, and a warehouse for materials management.
Warma commented “[Opexa’s former CSO] Healey [will provide] expertise in managing the operations of the local facility should result in a smooth transition and provide a solid foundation from which KBI can build and offer services to cell therapy companies across the country.”
The annual lease value including tax and insurance is $1 million, and KBI’s ownership came into effect February 1.