Alladapt Immunotherapeutics, a well-financed biotech working in the food allergy field, shut down following talks with the FDA, according to a source familiar with the company.
After
claiming success
in a
Phase 1/2 trial
in June 2023, Alladapt prepared for a Phase 3 of its experimental food allergy drug. Codenamed ADP101, the oral candidate had received the FDA
fast track
tag for mono- and multi-food allergies.
But a late-stage trial proved too financially daunting.
The “FDA guidance for the Phase 3 trial made it economically unviable,” according to the source, who confirmed the company closure to
Endpoints News
on the condition of anonymity. Investors got a “partial recovery on their investment,” the source added.
The Menlo Park, CA-based startup was co-founded in 2018 by CEO Ashley Dombkowski and Kari Nadeau, a former Stanford allergist and now chair of the Department of Environmental Health at Harvard School of Public Health.
Dombkowski didn’t respond to an Endpoints inquiry.
Alladapt disclosed a
$119 million funding round
in June 2022 and a
$50 million loan
with Hercules Capital two months later. The biotech disclosed
construction
of a manufacturing facility on the outskirts of Philadelphia the year prior. The facility was expected to be completed in “late 2024,”
according to
architecture and engineering firm Genesis.
The company’s investors included Patient Square Capital’s Enavate Sciences, Gurnet Point Capital, AllerFund, Red Tree Venture Capital, Novartis and others.
Its equipment was listed for
auction
in July. Rock Creek Advisors, a firm that works on liquidations and restructurings, lists Alladapt as a client on its website. Some of its top executives left this year for posts at
Eccogene
and
Navigator Medicines
.
The food allergy space has been through a series of ups and downs in recent years.
Nestlé’s attempt to market a peanut allergy drug — known as Palforzia, from its $2.6 billion Aimmune acquisition —
had failed commercially.
There was a major win in February with the
FDA approval
of Novartis and Genentech’s Xolair for children and adults with one or more food allergies. Novartis had also
axed
a peanut allergy Phase 3 trial earlier this year, but said it expected to start a new study of the anti-inflammatory, dubbed ligelizumab, later in 2024.
With its ADP101 candidate, Alladapt aimed to deliver small bits of protein from the “big nine” food allergies — milk, eggs, wheat, fish, shellfish, peanuts, tree nuts, soy and sesame — so that patients wouldn’t be as sensitized to the allergens. The startup also
terminated
an open-label extension study this year.
Also in the food allergy space are Leaps by Bayer-backed
Ukko
and Regeneron, which is testing Dupixent combined with its hematology drug linvoseltamab in
Phase 1
.
