Recipharm, Ahead team up to develop new treatment for MG
Reestablishing immune tolerance key to new therapy
“Together with our partner, we are determined to help them turn hope into reality for people living with myasthenia gravis,” Ulrike Lemke, PhD, president of Recipharm’s Sterile Fill & Finish business unit, said in a company press release. “We have the expertise to help Ahead Therapeutics bring drugs to market faster, so they can continue to deliver on their promise to change patients’ lives.”
MG is marked by an abnormal immune response targeting proteins involved in nerve-muscle communication. The autoimmune disease can lead to weakness in the muscles of the eye and eyelids, but it can also cause widespread muscle weakness throughout the body.
“Autoimmune diseases affect approximately one in ten individuals, meaning 0.8 billion patients globally will be able to benefit from the drugs derived from our platform,” said Martí Dalmases Arnella, MD, PhD, Ahead’s CEO. “Recipharm is dedicated to helping organisations like ours that work to develop treatments for rare diseases. This agreement represents a key milestone and the beginning of an exciting journey.”
Ahead’s approach to treating autoimmune diseases like MG is based on nano-technologies designed to reestablish immune tolerance — the process that prevents the immune system from seeing healthy tissues as a threat and launching a misdirected attack against them.
A fragment of the self-protein wrongly targeted by the immune system, called an autoantigen, is encapsulated in a liposome — a small, artificial vesicle made up of fatty molecules. These liposomes are made such that they are engulfed by immune dendritic cells via a well-known biological process known as efferocytosis, whereby dead or dying cells are removed from the body.
Treatment creates tolerogenic dendritic cells, which actively suppress the self-reactive immune response and stimulate the expansion of anti-inflammatory T-regulatory cells and the activation of immune signaling cascades to achieve immune tolerance in MG patients.
By changing the liposome-encapsulated autoantigen, the therapy can potentially be adapted to be used to treat several autoimmune diseases, including multiple sclerosis.
Analytics, process development assistance to aid Ahead
Under the agreement, Recipharm will help Ahead, a Spanish start-up biotech company, with analytics and process development to support toxicology studies. Recipharm also will manufacture the liposome that encapsulates the autoantigens and scale up manufacturing to be ready for commercialization under Good Laboratory Practice, regulatory-guided lab methods to ensure the generation of high-quality and reliable data.
“Recipharm is the pharmaceutical industry’s best-in-class provider of contract development and manufacturing solutions, and we are looking forward to working closely with the team on this project,” Arnella said.
“We are proud to be partnering with Ahead Therapeutics and look forward to providing a GLP environment to scale up production for a vital treatment to tackle what is currently an unmet patient need,” Lemke said.