DBV lays off em­ploy­ees, scales down pro­grams af­ter re­ceiv­ing no word from FDA

For years, it was a two-com­pa­ny race to de­vel­op the first treat­ment for peanut al­ler­gy. Then in Jan­u­ary, Aim­mune won ap­proval for its peanut pow­der pill and now it looks like their com­peti­tor and the erst­while fron­trun­ner is strug­gling to stay alive.

DBV Tech­nolo­gies said to­day that it has not heard from the FDA since the agency said they were con­cerned about how ef­fec­tive DBV’s ex­per­i­men­tal peanut patch would be and, as a re­sult, plan to lay off a “sig­nif­i­cant” num­ber of em­ploy­ees. These cuts will be part of a “glob­al and com­pre­hen­sive re­struc­tur­ing plan” that will be­gin im­me­di­ate­ly and at­tempt to keep the com­pa­ny sol­vent past Q1 2021.

A spokesper­son for DBV de­clined to com­ment on how many em­ploy­ees would be laid off and in what de­part­ments, but the com­pa­ny’s re­lease in­di­cates they will si­lo them­selves tight­ly around their lead drug, scal­ing down both their oth­er clin­i­cal pro­grams and their pre­clin­i­cal re­search. Those pro­grams in­cludes a cow’s milk al­ler­gy patch, a hen’s egg patch, a di­ag­nos­tics pro­gram with Nestlé and five oth­er non-dis­closed projects.

Daniel Tassé

“We have care­ful­ly re­viewed the sit­u­a­tion and giv­en the pre­vail­ing un­cer­tain­ties, the goal of the plan that we are launch­ing aims to pre­serve our core func­tions, ex­tend our cash run­way and main­tain op­er­at­ing lat­i­tude to bring the first and on­ly epi­cu­ta­neous im­munother­a­py for the treat­ment of peanut al­ler­gy to pa­tients in need, if ap­proved,” CEO Daniel Tassé said in a state­ment.

The trou­bles for DBV be­gan near­ly a year and a half ago, when the French com­pa­ny pulled their first FDA sub­mis­sion, cit­ing con­cerns that the BLA lacked “suf­fi­cient de­tail re­gard­ing da­ta on man­u­fac­tur­ing pro­ce­dures and qual­i­ty con­trols.” Known as Vi­askin, the com­pa­ny’s patch is de­signed to build tol­er­ance in kids with se­vere peanut al­ler­gy. Aim­mune was try­ing to do the same with a pill, but DBV had got­ten to reg­u­la­tors first, and were in a po­si­tion to be­come the first ap­proved ther­a­py be­fore they with­drew the ap­pli­ca­tion.

DBV re­filed last Au­gust and the FDA ac­cept­ed their re­view in Oc­to­ber, set­ting up an ad­vi­so­ry com­mit­tee hear­ing in May and a de­ci­sion by Au­gust 2020.  Then in March, two months af­ter Aim­mune won ap­proval, DBV dis­closed that the FDA had ques­tions about their sec­ond patch too, this time about ef­fi­ca­cy.

The com­pa­ny had just missed the pri­ma­ry end­point on their Phase III tri­al, falling short of a 15% con­fi­dence in­ter­val they had set for im­proved peanut tol­er­ance af­ter one year. Tassé said, though, that the is­sue had to do with re­ports that kids could scratch the patch off.

“This has noth­ing to do with the 15% con­fi­dence in­ter­val,” he told in­vestors on a con­fer­ence call. “The ques­tion for the agency has to do with the po­ten­tial im­pact on ef­fi­ca­cy of path ad­he­sion and patch at­tach­ments.”

DBV sub­mit­ted da­ta it said showed the stick­i­ness of the patch didn’t in­ter­fere with ef­fi­ca­cy. Nev­er­the­less, the FDA can­celed the ad­vi­so­ry com­mit­tee hear­ing, rais­ing con­cern among some an­a­lysts that a de­ci­sion on the drug would like­ly be de­layed and it could be re­ject­ed.

“At this point, we view DB­VT as ef­fec­tive­ly dead in the wa­ter,” Baird an­a­lyst Bri­an Sko­r­ney, who has been con­sis­tent­ly bull­ish on Aim­mune’s prospects, said in a note.

Joseph Schwartz of SVB Leerink, though far less bear­ish, still called it “a sticky sit­u­a­tion.”

“With many cur­rent un­knowns,” he wrote, “we look for­ward to up­dates on DB­VT’s dis­cus­sions with the FDA and the next steps for Vi­askin Peanut’s BLA re­view.”

Now DBV said that al­though it asked for guid­ance, dis­cus­sions nev­er ma­te­ri­al­ized, aside from a mes­sage that the da­ta were be­ing re­viewed and the tar­get date for a de­ci­sion was still Au­gust 5. The com­pa­ny’s cash bal­ance now stands at €262.4 mil­lion. With the cuts, that will be enough to go “be­yond” first quar­ter of 2021, they said.

So­cial: Daniel Tassé (DBV Tech­nolo­gies)

Vi­a­tris with­draws ac­cel­er­at­ed ap­proval for top­i­cal an­timi­cro­bial 24 years lat­er

After 24 years without confirming clinical benefit, the FDA announced Tuesday morning that Viatris (formed via Mylan and Pfizer’s Upjohn) has decided to withdraw a topical antimicrobial agent, Sulfamylon (mafenide acetate), after the company said conducting a confirmatory study was not feasible.

Sulfamylon first won FDA’s accelerated nod in 1998 as a topical burn treatment, with the FDA noting that last December, Mylan told the agency that it wasn’t running the trial.

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Susan Galbraith, AstraZeneca EVP, oncology R&D, at EUBIO22 (Rachel Kiki for Endpoints News)

Up­dat­ed: As­traZeneca jumps deep­er in­to cell ther­a­py 2.0 space with $320M biotech M&A

Right from the start, the execs at Neogene had some lofty goals in mind when they decided to try their hand at a cell therapy that could tackle solid tumors.

Its founders have helped hone a new approach that would pack in multiple neoantigen targets to create a personalized TCR treatment that would not just make the leap from blood to solid tumors, but do it with durability. And they managed to make their way rapidly to the clinic, unveiling their first Phase I program for advanced tumors just last May.

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Ei­sai’s ex­pand­ed Alzheimer’s da­ta leave open ques­tions about safe­ty and clin­i­cal ben­e­fit

Researchers still have key questions about Eisai’s investigational Alzheimer’s drug lecanemab following the publication of more Phase III data in the New England Journal of Medicine Tuesday night.

In the paper, which was released in conjunction with presentations at an Alzheimer’s conference, trial investigators write that a definition of clinical meaningfulness “has not been established.” And the relative lack of new information, following topline data unveiled in September, left experts asking for more — setting up a potential showdown to precisely define how big a difference the drug makes in patients’ lives.

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Illustration: Assistant Editor Kathy Wong for Endpoints News

Twit­ter dis­ar­ray con­tin­ues as phar­ma ad­ver­tis­ers ex­tend paus­es and look around for op­tions, but keep tweet­ing

Pharma advertisers on Twitter are done — at least for now. Ad spending among the previous top spenders flattened even further last week, according to the latest data from ad tracker Pathmatics, amid ongoing turmoil after billionaire boss Elon Musk’s takeover now one month ago.

Among 18 top advertisers tracked for Endpoints News, only two are spending: GSK and Bayer. GSK spending for the full week through Sunday was minimal at just under $1,900. Meanwhile, German drugmaker Bayer remains the industry outlier upping its spending to $499,000 last week from $480,000 the previous week. Bayer’s spending also marks a big increase from a month ago and before the Musk takeover, when it spent $16,000 per week.

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Catal­ent to cut about 200 jobs in Mary­land and Texas

Contract manufacturing company Catalent is cutting about 200 jobs in Maryland and Texas, according to WARN notices, trimming back some of its pandemic-era expansion.

The company will cut 77 jobs by Jan. 15 of next year at a cell therapy facility in Webster, TX, just outside of Houston. In Maryland, the company is reducing staff at two locations, with 82 jobs being eliminated at Catalent’s facility in Gaithersburg, and 53 in Rockville. The layoffs go into effect at those locations on Jan. 14.

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Mar­ket­ingRx roundup: Pfiz­er, BioN­Tech re-up iHeartRa­dio hol­i­day spon­sor­ship; WHO re­names mon­key­pox to 'm­pox'

It’s that time of year again for pop music fans with the return of the iHeartRadio Jingle Ball tour — and Pfizer and BioNTech’s sponsorship. For the second year, the Covid-19 vaccine collaborators are the pharma national sponsors among consumer brand partners, including ESPN, Dunkin, M&Ms, Mercedes and Pepsi.

Pfizer and BioNTech are also sponsoring the official Jingle Ball Radio streaming station on iHeart’s network, programmed with music from past and present concert performers. This year they include Lizzo, Dua Lipa, Dove Cameron and Charlie Puth. Pfizer-sponsored radio ads and online video and digital banner ads encourage listeners to get updated Covid-19 booster shots.

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Mark Schneider, Nestlé CEO (AP Images)

Nestlé re­con­sid­ers peanut al­ler­gy pro­gram two years af­ter $2.6B buy­out

It seems Nestlé is experiencing some buyer’s remorse two years after throwing down $2.6 billion for Aimmune Therapeutics and its peanut allergy pill Palforzia.

CEO Mark Schneider announced on Tuesday that Nestlé is “exploring strategic options” for Palforzia following lower-than-expected demand. A company spokesperson declined to confirm whether a potential sale is in consideration.

“The review is expected to be completed in the first half of 2023. Going forward, Nestlé Health Science will sharpen its focus on Consumer Care and Medical Nutrition,” the company said in a news release.

Tom Riga, Spectrum Pharmaceuticals CEO

Spec­trum im­plodes af­ter a harsh pub­lic slap­down and now a CRL from Richard Paz­dur

The FDA has gone out of its way several times to flatten any expectations for Spectrum’s lung cancer drug poziotinib, including slamming the regulatory door in the biotech’s face four years ago when the their executive crew came calling for a breakthrough drug designation and encouragement from the oncology wing of the FDA.

That stinging early rebuke pointed straight down the path to a corrosive in-house agency review of Spectrum’s attempt to land an accelerated approval for the oral EGFR TKI and a public whipping that included a classic takedown by none other than Richard Pazdur, who slammed the company for “poor drug development” that led to confusion over the dose needed for a slice of NSCLC patients harboring HER2 exon 20 insertion mutations.

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iECURE CEO Joe Truitt and founder Jim Wilson

Jim Wil­son biotech iECURE gets fresh $65M to push pe­di­atric liv­er dis­ease gene ther­a­py in­to the clin­ic

Jim Wilson-founded biotech iECURE has wrapped a $65M Series A extension round to get its lead candidate — a gene replacement therapy for a rare inherited liver disease known as ornithine transcarbamylase deficiency, or OTC — into the clinic.

This round was co-led by Novo Holdings and LYFE Capital, followed by initial investors Versant and OrbiMed as well. In September 2021, iECURE raised a $50 million Series A led by the latter two. The new cash infusion will get iECURE through an initial in-human trial, which CEO Joe Truitt told Endpoints News iECURE hopes to read out in 2024.

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