CytoDyn has contracted Samsung BioLogics to produce the drug substance for its candidate leronlimab and says it will need at least two CMOs once the HIV inhibitor is approved.
CytoDyn’s lead candidate leronlimab (PRO 140) has demonstrated antiviral activity and shown to significantly reduce viral burden in people infected with HIV in Phase II clinical trials. The fully humanized IgG4 monoclonal antibody blocks the predominant HIV (R5) subtype entry into T-cells by masking the required co-receptor, CCR5.
The firm has filed with the US Food and Drug Administration (FDA) the non-clinical portion of its Biologics License Application (BLA) using the FDA’s Rolling Review process and has begun ramping up production of the monoclonal antibody through a contract with Samsung BioLogics.
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Under the terms of the agreement, the Korean contract manufacturing organization (CMO) will produce approximately $1 billion (€900 million) worth of leronlimab drug substance, based upon projected revenues of $120,000 per patient per year, from its facilities in Songdo, Incheon.
“We are going to need a very large amount of leronlimab if our monotherapy is approved,” CytoDyn’s CEO Nader Pourhassan told Bioprocess Insider. Pourhassan added this is projected to be about $5-7 billion worth of leronlimab per year, “and Samsung [BioLogics] is on the top of the list of top manufacturing in the world.
“They also realized that we need to work financials in a way that CytoDyn can handle the payments around post approval.”
According to an SEC filing, CytoDyn “is obligated to make specified minimum purchases of Product from Samsung [BioLogics] pursuant to the Company’s forecasted requirements.”
This will initially represent approximately $60 million, “with approximately $30 million payable over the course of calendar 2020 and approximately $30 million more payable in the first quarter of 2021,” the filing states. “Thereafter, the Company will pay Samsung per 15,000L batch according to the pricing terms specified in the Agreement.”
Second CMO
The contract could last until 2027, but if leronimab is approved Samsung BioLogics will not be the sole manufacturer of the drug substance. According to Pourhassan, approval could come by the end of the year or Q1 2020.
“We are going to need at least two CMO and we hope to meet with our current CMO next week to have them produce the same amount also and hopefully with the same terms.”
Pourhassan did not divulge who its other CMO is, but in the firm’s FY2018 annual report it stated its own liquidity issues at the time had led to its CMO suspending “certain preparations for future commercialization activities which are integral for the timely completion of a BLA filing.”
As of May 31, 2018, CytoDyn had negative working capital of approximately $13.4 million.
However, the firm said at the time “relations with the CMO remain accommodative and resumption of certain CMC activities will be contingent on a material improvement in our liquidity. Certain other CMO activities related to BLA preparations remain on schedule at present, and provided liquidity improves, we are confident that existing BLA schedules will be maintained.”