$105M raised to support clinical trial of CNP-106 in gMG patients

Proof-of-concept study into therapy aiming to 'reprogram the immune system'

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by Andrea Lobo |

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Cour Pharmaceuticals announced that it has raised $105 million in Series A financing to advance its investigational therapy, CNP-106, into a Phase 1b/2a clinical trial as a possible treatment of myasthenia gravis (MG).

A company request for clinical testing of CNP-106 was cleared by the U.S. Food and Drug Administration in 2022, and the proof-of-concept study is due to open in April.

“We are excited to have this support as we advance our pipeline and revolutionize antigen-specific immune tolerance while avoiding immune system suppression in our mission to potentially bring to market life changing therapies for patients,” John J. Puisis, Cour’s founder and CEO, said in a company press release.

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A Phase 1b/2a clinical trial is set to enroll adults with generalized MG

MG is caused by self-reactive antibodies that target and attack proteins in the neuromuscular junction — the site where nerve and muscle cells communicate to coordinate voluntary movements. Current MG treatments help to suppress the immune system to keep disease symptoms under control, but they do not address its underlying cause.

CNP-106 is designed to prevent self-reactive antibodies from attacking proteins at the neuromuscular junction. According to Cour, the goal is to reprogram the immune system to achieve immune tolerance — the absence of immune responses against the body’s own proteins.

This is achieved by loading MG antigens — parts of proteins that can trigger an immune response — into tiny particles (nanoparticles) that, together with negative co-stimulating factors, instruct the immune system to recognize them as “self-proteins,” preventing an immune response.

“By harnessing the immune system’s built-in learning and regulatory pathways, COUR nanoparticle technology can reprogram the immune system — providing clinicians with a breakthrough approach to treating autoimmune disease,” the company reports on a webpage.

The upcoming Phase 1b/2a trial (NCT06106672) is expected to enroll up to 54 adults, ages 18 to 75, with generalized MG and antibodies against acetylcholine receptors, the disease’s most common cause.

Participants will be randomly assigned to CNP-106 or a placebo, delivered by intravenous infusion. The study, due to finish in early 2027, will assess the treatment’s safety, tolerability, pharmacological properties, and preliminary efficacy.

Series A financing refers to a first round of venture capital investment money given a start-up company. Cour’s round was co-led by Lumira Ventures and Alpha Wave Ventures, with the participation of other investors, including Roche Venture Fund, Pfizer, and Bristol Myers Squibb.

Proceeds also are intended to move a potential type 1 diabetes treatment, called CNP-103, into a clinical trial and help to advance other therapy candidates, the company reported.

“There is an urgent need for innovative strategies aimed at restoring self-tolerance safely and more effectively in autoimmune disorders. We believe COUR’s proprietary and strongly differentiated platform is a versatile and first-in-class approach to meet this critical medical need,” said Benjamin Rovinski, PhD, Lumira Ventures’ managing director.