FDA approves IND application for peanut allergy drug candidate

By Jenni Spinner contact

- Last updated on GMT

(dturphoto/iStock via Getty Images Plus)
(dturphoto/iStock via Getty Images Plus)

Related tags: allergy, Immune response, Fda, IND applications, Injectables

The US agency has given the go-ahead to Cour Pharmaceuticals to evaluate the safety and efficacy of CNP-201, a drug intended to treat peanut allergies.

Cour Pharmaceuticals, a biotechnology firm working on novel nanoparticles to treat immune disorders, has announced the US Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application for its CNP-201. The proof-of-concept study will test the safety and efficacy of the drug in a proof-of-concept (Phase I/II) study in patients suffering from an allergy to peanuts.

Jon Puisis (president, CEO, and co-founder of Cour) said, "This will be the first clinical trial with a first-in-class therapy to reprogram the immune system to stop the allergic response to peanuts. Our hope is the clinical trials will confirm that CNP-201 can help eliminate the potentially fatal health risks associated with patients who have a peanut allergy​."

CNP-201 is a biodegradable nanoparticle that encapsulates purified peanut protein extract and is administered via intravenous infusion. The nanoparticles containing peanut allergens are consumed by immune-presenting cells; when the particles and allergens are presented by the immune-presenting cell, they trigger reprogramming of the cellular functions of the immune system, reducing and possibly eliminating the potential risk of severe allergic reactions.

According to Food Allergy Research and Education​, peanuts are the third-most common food allergen among US residents (behind shellfish and milk), with approximately 6.1m people in the country dealing with the allergy. The organization estimates that about 32m people total suffer one or more food allergies.

However, peanut allergies are among the most severe, and potentially deadly, food allergies. Their immune systems can respond dramatically to even miniscule amounts of peanuts consumed, possibly triggering life-threatening anaphylaxis.

"The nanoparticles reprogram upstream T cells to shut down B cell's responsible for the production of allergic Immunoglobulin E (IgE) antibodies, which result in significant and deadly allergic responses​," Puisis related. "This is a revolutionary endeavor because today the only therapy is de-sensitization, that softens the blow of allergic IgE, but can never shut it down.​"

Researchers from Stanford University’s Sean N. Parker Center for Allergy and Asthma Research Kari Nadeau (director) and Sharon Chinthrajah (clinical research director) said they have followed the Cour work on peanut allergy treatment with interest.

Our team were early supporters of the potential of COUR's immune reprogramming platform, so we're eager to see data showing CNP-201 can reprogram T cells, shut down B cells, and protect the allergy patient from continual B cell production of IgE and associated allergic cytokines, which are so deleterious to patients' quality-of-life​," they commented.

CNP-201 reportedly is the company’s second nanoparticle immune-modifying drug to enter clinical trials; the first—CNP-101 for celiac disease—is partnered with Takeda Pharmaceuticals. According to Cour, its nanoparticle immune-modifying platform could potentially be applicable in treating any autoimmune or allergic condition. 

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