Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing

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Viaskin Peanut would clear the agency. “It’s a very long reach to believe it is going to be approved,” he said. “None of their data is statistically significant.”

Even if Viaskin Peanut does get approved, Dallas predicted that the patch won’t work in eight of 10 kids who use it. He said the patch includes a miniscule dose and requires proteins to be dissolved in sweat and absorbed. “So the concept of that getting into the body and generating immunity is tricky,” he said. “It’s a problem for all patches.”

CHANGING MEDICAL PRACTICE

Dallas has been involved in many high-profile launches over the past 25 years. Prior to joining Aimmune in June 2018, he served as chief commercial officer at Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), overseeing the launches of its first two products, Mepsevii (vestronidase alfa-vjbk) and Crysvita (burosumab).

He also served as general manager of Roche in the UK and head of global commercial strategy groups focused on oncology, immunology, and ophthalmology at Genentech Inc., and headed the specialty medicines operating unit for Novartis (NYSE: NVS) in the US.

The launch of Palforzia differs from his previous work as it breaks totally new ground. “To actually get something approved that is going to rewrite medical textbooks and change medical practice all over the world is just phenomenal,” he said.

Aimmune, previously called Allergen Research Corporation, was established in 2011 with seed funding from the nonprofit group Food Allergy Research & Education. The group held a research retreat earlier that year with members of the food allergy community to reach a consensus on the future of food allergy research. Aimmune said the participants, which included members of the pharmaceutical industry and representatives of the FDA and the National Institutes of Health, decided to focus on oral immunotherapy, the practice of giving a small amount of the allergen protein with a gradual increase in dose to desensitize a patient.

On 16 March, Aimmune announced its analysis of ARC004, the open-label follow-on trial to the 52-week pivotal PALISADE trial. The data had been scheduled to be presented at the American Academy of Allergy, Asthma & Immunology’s annual meeting in Dallas, which was cancelled due to the COVID-19 pandemic. The company said the analysis showed that patients tolerated more peanut protein, experienced fewer adverse events and continued immunomodulation as evidenced by reductions in peanut-specific immunoglobuin (IgE) blood levels after an additional 56 weeks of daily treatment with Palforzia.

Aimmune has a Phase 3 study underway to expand the indication for use in children aged 1 to less than four years. Last month it licensed AIMab7195, an investigational anti-IgE monoclonal antibody with three mechanisms of action, from Xencor (NASDAQ: XNCR). The company’s goal is to see if a larger proportion of patients can achieve remission from their food allergy more quickly with concomitant therapy with AIMaB7195 than on immunotherapy alone.

GAINING REGULATORY CONFIDENCE

Dallas said getting the first food-derived medicine through the FDA’s robust review process “gives us a lot of comfort that our concept and the platform of characterized oral immunotherapy actually works and we can show it works and we can persuade regulators that it is a valuable therapeutic option for people with food allergies.”

The company has two additional products in the pipeline, AR201 in Phase 2 for treatment of egg allergy, and a single therapy for treatment of allergies to five tree nuts (walnuts, hazelnuts, cashews, pistachios and pecans) in pre-IND development. Dallas said this is a new challenge in terms of how you make a multitherapeutic in a single product and deal with regulators. But he said doing a development program for five nuts would take too long and be too complicated and be clinically quite challenging for individuals to desensitize five different times to five different things.

“We think it’s much more elegant to do it in one,” he said.

The experience gained in getting Palforzia through regulatory authorities, past payers and convincing physicians to give it to patients will provide the company important lessons that will help it with the additional programs.

Next up, though, is the expected approval of Palforzia in Europe at the end of the first quarter. Dallas said the company will launch in Germany first, as other countries require a product to obtain reimbursement prior to marketing.

This article was first published on 26 February 2020 in The Pink Sheet.

Image: iStock/Professor25

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Brenda Sandburg is a senior writer who covers legal issues and FDA regulatory policy, with a particular focus on patents, biosimilars, and government investigations. She can be reached at Brenda.Sandburg@informa.com Follow @brendasandburg

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