Lonza will develop an immunotherapeutic drug candidate for SelectImmune, an antibody for ValenzaBio and extends its collaboration with Pinteon. All in a week’s work for the Swiss CDMO.

SelectImmune Pharma has collaborated with Swiss contract development manufacturing organization (CDMO) Lonza to develop processes for a novel immunotherapy protein drug (NIpD).

“SelectImmune is developing NlpD, an anti-infectious and anti-inflammatory protein that is released by beneficial bacteria in our gut,” Yvette Stallwood, head of Applied Protein Services at Lonza told us. “This protein can boost human immune response and enhance beneficial gene expression, which can, in turn, help to combat harmful bacterial infections.”

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Under the terms of the agreement, Lonza will provide SelectImmune with access to vector construction, early material needed for pre-clinical testing, and non-GMP expression of a nIpD candidate.

The activities will be performed at Lonza’s facility located in Cambridge, United Kingdom.

According to Stallwood, there is no need to scale-up equipment to service this deal as “the present collaboration represents the very first step towards assessing the manufacturability of the API (active pharmaceutical ingredient).”

“Our team will provide laboratory-scale process development and related protein production.”

With antibiotic resistance increasing and threatening the current pool of antibiotics, alternative approaches like immunotherapy drugs are seen as a possible solution.

“Relying on identifying new antibiotics might not be feasible in the long run,” said Stallwood.

Together, the firms work on a concept that shifts the balance in favor of beneficial symbiotic bacteria instead of targeting pathogenic bacteria.

No financial details have been disclosed.

ValenzaBio

The manufacturing agreement will see Lonza deliver ValenzaBio a tailored program to advance VB421, an anti-insulin-like growth factor 1 receptor (anti-IGF-1R) antibody for autoimmune diseases such as thyroid eye disease (TED).

TED is an autoimmune disease that causes eye bulging, vision change, and potentially blindness.

Lonza will provide ValenzaBio with clinical materials, drug substance manufacturing, and management of drug product production at its 17,000 m² mammalian facility in Guagnzhou, China.

“The drug substance (consisting of the active pharmaceutical ingredient – not a final formulation) will be produced at the Guangzhou site and shipped to Switzerland for the drug product fill and finish,” Jeetendra Vaghjiani, senior director of Clinical Development and Strategic Marketing at Lonza told us.

He added: “At the moment, the process does not require any scale-up activities. However, ValenzaBio chose to collaborate with Lonza due to our well-performing GS expression system, experience with therapy commercialization, and scale-up opportunities.”

A spokeswoman for Lonza told this publication in April that the GS Xceed Gene Expression System is “a robust, fully integrated, scalable platform with a proven track record of successfully taking programs from gene through development to commercial production.”

She continued: “With the ability to rapidly and reliably generate high-producing cell lines, the system can support the optimal expression of monoclonal antibodies and next-generation biologics, helping reduce the time to market.”

Vaghjiani could not disclose information concerning the duration of the deal.

Pinteon

In 2018, Lonza provided drug substance manufacturing for PNT001’s Phase I clinical supply from its plant in Slough, UK.

PNT001 is a mAb that targets an epitope on a neurotoxic conformation of the tau protein entitled cis-pT231 tau. It is a potential treatment for patients with Alzheimer’s disease and traumatic brain injury.

The extended manufacturing agreement enables future clinical production and studies of Pineton’s candidate, PNT001.

Lonza will carry out drug substance manufacturing at its Guagzhou facility with the aim of aiding Pinteon to conduct additional clinical studies in the US in Q4 2021 and the potential to expand into Europe.