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.

Paul Hudson, Sanofi CEO (Cyril Marcilhacy/Bloomberg via Getty Images)

FDA side­lines Paul Hud­son's $3.7B MS drug af­ter es­tab­lish­ing link to liv­er dam­age

One of Sanofi CEO Paul Hudson’s top picks in the pipeline — picked up in a $3.7 billion buyout 2 years ago — has just been sidelined in the US by a safety issue.

The pharma giant put out word early Thursday that the FDA has put their Phase III studies of tolebrutinib in multiple sclerosis and myasthenia gravis on partial clinical hold, halting enrollment and suspending dosing for patients who have been on the drug for less than 60 days. Patients who have completed at least 60 days of treatment can continue therapy as researchers explore a “limited” — but unspecified in Sanofi’s statement — number of cases of liver injury.

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Phar­ma re­acts to post-Roe; Drug­mak­ers beef up cy­ber de­fense; Boehringer, Roche qui­et­ly axe drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

As a reminder, we are off on Monday for the Fourth of July. I hope this recap will kick off your (long) weekend well and that the rest of it will be just what you need. See you next week for a shortened edition!

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Eric Hughes, incoming Teva EVP of global R&D and CMO

Te­va chief raids Ver­tex for his new glob­al head of re­search and de­vel­op­ment

Teva CEO Kåre Schultz has found his new R&D chief and CMO in Vertex’s ranks.

The global generics giant, which has some 3,500 staffers in the R&D group, has named Eric Hughes to the top research spot in the company. He’ll be replacing Hafrun Fridriksdottir, who held the role for close to five years, on Aug. 1.

Hughes hasn’t been at Vertex for long, though. He jumped from Novartis less than a year ago, after heading the immunology, hepatology & dermatology global development unit. Before that, he completed a five-year stint as head of early clinical research for the specialty discovery medicine department in the exploratory clinical & translational research group at Bristol Myers Squibb, according to his LinkedIn profile.

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#BIO22: Man­ag­ing a biotech in tur­bu­lent times. 'There's a per­fect shit­show out there'

On Tuesday, June 14, Endpoints News EIC John Carroll sat down with a group of biotech execs to discuss the bear market for industry stocks and how they were dealing with it. Here’s the conversation, which has been lightly edited for brevity.

Martin Meeson, sponsor opening:

Thank you, John. Hello everyone. My name’s Martin Meeson, I’m the CEO of Fujifilm Diosynth. For those of you who don’t know Fujifilm Diosynth, we operate in the development of clinical and commercial product scale up, we have facilities in Europe and the US, and around about 4,000 employees. We run on average about 150 programs, so when it comes to managing in turbulent times over the last two years, we’ve had quite a lot of experience of that. Not just keeping the clinical pipelines and the commercial pipelines open, but also our response to the pandemic and the molecules that we’ve had within there. One of the phrases that I coined probably about a year ago when we were talking at JP Morgan, was I talked about managing through turbulent times. Well, it’s become the fact that we are not managing and leading through these times, we are managing in them, which is why that’s really the purpose of and the topic that we’ve got today.

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On Friday, Lonza announced plans to construct a large-scale commercial drug product fill and finish facility in the town of Stein, Switzerland.

Lon­za to in­vest $500M+ on fill-fin­ish fa­cil­i­ty on its home turf

Lonza has been expanding its reach across the globe, bringing sites in China and the US online this year, but now they are looking closer to home for their next major investment.

The Swiss manufacturer on Friday announced plans to construct a large-scale commercial drug fill and finish facility in the town of Stein, Switzerland. The new facility will be delivered through an investment of approximately CHF 500 million, or $519 million, and is expected to be completed in 2026. The facility will also be constructed on the same campus as Lonza’s current clinical drug product facility.

Kate Haviland, Blueprint Medicines CEO

What bear mar­ket? Blue­print lines up $1.25B to ex­pand la­bels, maybe tack on more drugs

As it works to pad the case for expanding its Ayvakit and Gavreto labels, Blueprint Medicines has lined up $1.25 billion in funding, with some of that money seemingly earmarked for acquisitions or pipeline expansion projects.

Following the likes of BioCryst, Cytokinetics and MorphoSys, Blueprint is aiming to monetize the royalties of its RET+ non-small cell lung cancer and thyroid cancer drug Gavreto with Royalty Pharma. The investment group will dole out $175 million upfront and might tack on another $165 million in biobucks as part of Blueprint’s royalties receivable from net sales of the drug by Roche outside the US, sans China.

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Fu­ji­film in­vests an­oth­er $1.6B in­to its CD­MO arm to up­grade facil­lites in the US and Eu­rope

Fujifilm’s spending spree into its CDMO arm is not slowing down.

The multinational announced on Wednesday that it will invest $1.6 billion to enhance and expand the cell culture manufacturing services of the CDMO arm of the Japanese conglomerate Fujifilm Diosynth.

The investment will enhance Fujifilm Diosynth Biotechnologies’ sites in Hillerød, Denmark, and College Station, TX. The investment is expected to create approximately 450 jobs across both facilities.

Anand Parikh, Faeth Therapeutics CEO

Sid Mukher­jee, Lew Cant­ley be­hind new can­cer biotech with food+drug com­bo treat­ment am­bi­tions 

Famed oncologist Sid Mukherjee and repeat biotech co-founder Lew Cantley have teamed up to form Faeth Therapeutics, a startup aiming to treat cancer the way other conditions are addressed: pairing nutrition with therapeutics.

The goal is to transform cancer treatment with nutrition and make it the fourth “pillar” in the oncology regimen, which to date has centered on radiotherapy, surgery and drugs, Faeth CEO Anand Parikh told Endpoints News. Other conditions have already been addressed with a side of nutrients or diet, he said, pointing to diabetes, irritable bowel syndrome and other diseases.

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Amgen's taking social media followers around the globe as it introduces the many different

From Tam­pa to Mu­nich, Am­gen’s ‘Places’ cam­paign in­tro­duces its lo­ca­tions around the world

Amgen is taking social media followers around the world with its latest corporate campaign. Called “Places of Amgen,” the twice monthly posts highlight the biopharma’s different offices and sites – and the people who work there.

Each post runs on LinkedIn, Facebook and Instagram with details about the work Amgen does in that location, when it was established, comments from people who work there and other interesting facts. The most recent one about Paris, France, for example, notes that Amgen France last year signed a French association charter committed to the inclusion of LBGT+ people in the workplace.

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