Most food al­ler­gy care in­volves avoid­ance — check­ing in­gre­di­ent la­bels, no peanut ta­bles in schools, and so on. How­ev­er, that par­a­digm has been shift­ing with oral im­munother­a­pies, or OITs for short, in which pa­tients pur­pose­ly eat a bit of their al­ler­gen in the form of a mod­i­fied pro­tein in hopes of train­ing their im­mune sys­tem to tol­er­ate it.

Al­ladapt Im­munother­a­peu­tics is cre­at­ing a sin­gle OIT for all ma­jor IgE-me­di­at­ed food al­ler­gies — “what we call the big nine,” as Al­ladapt CEO Ash­ley Dom­bkows­ki said — for milk, eggs, wheat, fish, shell­fish, peanuts, tree nuts, soy and sesame. Now, the biotech has $119 mil­lion to push that drug through clin­i­cal tri­als.

Aim­mune got the first peanut OIT for chil­dren ap­proved back in Jan­u­ary of 2020, though it faced con­tro­ver­sy for the cost of its drug, more or less a ver­sion of peanut pro­tein, that came with an an­nu­al price tag of over $10,000. And soon af­ter get­ting that ap­proval, Aim­mune was bought by Nestlé.

Kari Nadeau

Al­ladapt’s drug works sim­i­lar­ly to Aim­mune’s, but in­stead of just peanuts, it con­tains bits from nine al­ler­gen groups. The drug was de­vel­oped based on the work of its co-founder, Stan­ford al­ler­gist Kari Nadeau.

Dom­bkows­ki said the ba­sis of that all-in-one drug de­sign is that pa­tients who have one al­ler­gy are more like­ly to have oth­ers, and those mul­ti-al­ler­gic pa­tients are more like­ly to have se­vere re­ac­tions. And if a pa­tient were mul­ti-al­ler­gic, get­ting an in­di­vid­ual im­munother­a­py for each of their al­ler­gies would be com­pli­cat­ed, but ac­cord­ing to Nadeau’s re­search, pa­tients can be si­mul­ta­ne­ous­ly de­sen­si­tized to mul­ti­ple al­ler­gens, Dom­bkows­ki not­ed.

“The ap­proach where we have all of these anti­gens to­geth­er is kind of like a mul­ti­va­lent vac­cine — you’d love to get a shot that cov­ers all the vari­ants of a po­ten­tial re­ac­tion or in­fec­tion,” she said.

Al­ladapt’s can­di­date OIT, dubbed ​​ADP101, is cur­rent­ly in Phase I/II clin­i­cal tri­als, and the Men­lo Park, CA-based biotech an­nounced that it fin­ished en­rolling the tri­al at the start of this year. Al­ladapt al­so be­gan an open-la­bel ex­ten­sion tri­al in March.

No­tably, most OIT work, es­pe­cial­ly with peanuts, has been done with chil­dren, but Al­ladapt is run­ning tri­als for both chil­dren and adults. When asked about po­ten­tial low­er re­sponse rates in adults, Dom­bkows­ki said that from what she has seen from Nadeau’s re­search, adults tend to strug­gle more with ad­her­ing to the OIT, but there are adults who do re­spond to the treat­ment.

Al­ladapt’s lat­est fi­nanc­ing round was led by Ena­vate Sci­ences, and al­so in­clud­ed its found­ing in­vestor Gur­net Point Cap­i­tal, along­side Aller­Fund, Red Tree Ven­ture Cap­i­tal, WestRiv­er Group and, in­ter­est­ing­ly, No­var­tis.

Al­ladapt plans to read out its Phase I/II tri­al ear­ly next year and hopes to start a Phase III tri­al in 2024, Dom­bkows­ki said.

The FDA on Tuesday released a warning letter sent earlier this month to the Mason, OH-based site of Procter & Gamble Manufactura, raising questions about the list of ingredients on the label and in the electronic filing.

The warning says that for P&G’s over-the-counter Vicks Nyquil Severe Hot Remedy Cold and Flu Plus Congestion, there’s a “mismatched” list of active ingredients between the labeling and the electronic listing file. The listing file for the active ingredients did not match the active ingredients in the electronic file.

The Federal Trade Commission has gotten involved in a patent feud over Supernus’ Parkinson’s drug Apokyn, a case the agency said may have ‘‘significant implications” for patients who rely on the drug.

Sage Chemical won the first generic approval for its Apokyn formulation (also known as apomorphine hydrochloride injection) back in 2022. The non-ergoline dopamine agonist is approved to treat Parkinson’s symptoms during “off episodes,” such as difficulty moving, tremors and intense cramping. However, regulators specified that the approval pertained to the generic drug cartridges only, not the injector pen required for administration.

The White House’s Office of Science and Technology Policy (OSTP) last year sought to find ways to better coordinate large-scale clinical trials in the US — as the UK lead by example during the pandemic — especially for these emergency clinical trials.

The lobbying group PhRMA Tuesday called for more clinical trial diversity in underserved areas, including by making participation less of a burden, and expanding eligibility criteria when appropriate.