SelectImmune Pharma, a company developing immunotherapeutics and alternatives to antibiotics, and Lonza, a CDMO, agreed to develop processes for NlpD, a novel immunotherapy protein.

Antibiotic resistance represents a major threat to public health. The existing pool of antibiotics and our ability to protect patients from bacterial infections is threatened by the rise of antibiotic resistance.

Instead of targeting the pathogenic bacteria, the patient’s immune system can be boosted to balance the immune response and enhance the beneficial gene expression. This new concept shifts the balance in favor of beneficial symbiotic bacteria and away from pathogenic infections.

NlpD is a protein originating in beneficial bacteria present in the human microbiome and has been found to inhibit infection and inflammation in animal models. This  RNA polymerase II (Pol II) inhibitor can be purified in large quantities.

Advancing a drug candidate from late-stage discovery into the clinic represents one of the most critical development steps. Process de-risking and assessing developability and manufacturability early on helps maximize the chances of success further down the development and manufacturing pathway.

Under the terms of the agreement, SelectImmune will leverage Lonza’s early development services, which include non-GMP expression and lab-scale process development, to lay the groundwork for future pre-clinical studies of NlpD. The early development activities will be carried out at Lonza’s Cambridge (UK) site.

By supporting the early selection, engineering, and optimization of NlpD, this collaboration will bring value to SelectImmune’s therapeutic protein candidate while establishing the potential for future clinical manufacturing, according to Ann Gidner, CEO, SelectImmune Pharma.

“The discovery of NlpD is important and provides new possible strategies to treat infections with immunotherapy. Lonza is a well-known international player, and we look forward to developing the best possible process to have a robust drug candidate in our pipeline,” she said.

“De-risking early on can maximize chances of success further down the development and manufacturing pathway. We offer flexible support based on our customers’ unique therapeutic goals and timelines while improving the safety and manufacturability of therapeutics,” added Yvette Stallwood, head of applied protein sciences, Lonza. “Our early development services have been supporting companies of various sizes in advancing their drug candidates from late-stage discovery into the clinic for over 10 years. The collaboration with SelectImmune illustrates the value in establishing the foundation on which to build an optimized clinical development program.”