Ashley Dombkowski, Alladapt CEO

Al­ladapt gets $100M+ to see its all-in-one oral im­munother­a­py al­ler­gy drug through clin­i­cal tri­als

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.

Has the mo­ment fi­nal­ly ar­rived for val­ue-based health­care?

RBC Capital Markets’ Healthcare Technology Analyst, Sean Dodge, spotlights a new breed of tech-enabled providers who are rapidly transforming the way clinicians deliver healthcare, and explores the key question: can this accelerating revolution overturn the US healthcare system?

Key points

Tech-enabled healthcare providers are poised to help the US transition to value, not volume, as the basis for reward.
The move to value-based care has policy momentum, but is risky and complex for clinicians.
Outsourced tech specialists are emerging to provide the required expertise, while healthcare and tech are also converging through M&A.
Value-based care remains in its early stages, but the transition is accelerating and represents a huge addressable market.

No­vo Nordisk re­mains un­der UK scruti­ny as MHRA con­ducts its own re­view in 'in­cred­i­bly rare' case

The UK’s Medicines and Healthcare products Regulatory Agency is now reviewing Novo Nordisk’s marketing violation that resulted in its loss of UK trade group membership last week. Novo Nordisk was suspended on Thursday from the Association of the British Pharmaceutical Industry (ABPI) for two years after an investigation by its regulatory arm found the pharma broke its conduct rules.

MHRA said on Tuesday that its review of the Prescription Medicines Code of Practice Authority (PMCPA) investigation is standard practice. An MHRA spokesperson emphasized in an email to Endpoints News that the situation with Novo Nordisk is “incredibly rare” while also noting ABPI took “swift and proportionate action.”

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Andy Plump, Takeda R&D chief (Jeff Rumans for Endpoints News)

What kind of PhI­Ib da­ta is worth $4B cash? Take­da’s Andy Plump has some thoughts on that

A few months back, when Takeda caused jaws to drop with its eye-watering $4 billion cash upfront for a mid-stage TYK2 drug from Nimbus, it had already taken a deep dive on the solid Phase IIb data Nimbus had assembled from its dose-ranging study in psoriasis.

Now, it’s rolling that data out, eager to demonstrate what inspired the global biopharma to go long in a neighboring, but new, disease arena for the pipeline. And the most avid students of the numbers will likely be at Bristol Myers Squibb, who will have a multi-year head start on pioneering the TYK2 space with Sotyktu (deucravacitinib) as Takeda makes its lunge for best-in-class status.

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FDA warns Proc­ter & Gam­ble over NyQuil la­bel's in­gre­di­ent list­ings

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.

FTC says patent bat­tle over Parkin­son's drug could have 'sig­nif­i­cant im­pli­ca­tion­s' for pa­tients

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.

FDA in­di­cates will­ing­ness to ap­prove Bio­gen ALS drug de­spite failed PhI­II study

Ahead of Wednesday’s advisory committee hearing to discuss Biogen’s ALS drug tofersen, the FDA appeared open to approving the drug, newly released briefing documents show.

Citing the need for flexibility in a devastating disease like ALS, regulators signaled a willingness to consider greenlighting tofersen based on its effect on a certain protein associated with ALS despite a failed pivotal trial. The documents come after regulatory flexibility was part of the same rationale the agency expressed when approving an ALS drug last September from Amylyx Pharmaceuticals, indicating the FDA’s openness to approving new treatments for the disease.

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Growth hor­mone from No­vo Nordisk is in short­age over man­u­fac­tur­ing de­lays

Novo Nordisk’s growth hormone Norditropin is in shortage because of manufacturing delays, according to an FDA site that tracks drug shortages as well as the American Society of Health-System Pharmacists’ shortages list.

The FDA has shortages of the drug listed for its 5, 10, 15 and 30 mg doses, while the pharmacists’ group, also known as ASHP, reported shortages of the same doses, except for the 15 mg version.

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PhRMA calls for more di­verse in­fra­struc­ture up­grades to US emer­gency tri­als frame­work

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.

Mar­ket­ingRx roundup: What could a US Tik­Tok ban mean for phar­ma? Pfiz­er, Lil­ly lead phar­ma March Mad­ness ad­ver­tis­ers

Just as pharma marketers finally make moves into TikTok, the threat of a US ban on the social media channel is now looming. Already banned on federal employee phones by an initial Congressional act, more bills and maybe bans are on the way. With rare bipartisan agreement, lawmakers have introduced legislation that would give the US president the power to ban TikTok (although not mentioned by name) and other foreign-owned technology platforms that represent a security threat to the US.

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