Long jour­ney for DBV peanut patch ends in re­jec­tion by FDA

DBV Tech­nolo­gies’ long and wind­ing saga with the FDA has end­ed — for now, at least — with a CRL for their peanut al­ler­gy skin patch.

The re­jec­tion comes 21 months af­ter the com­pa­ny first filed for ap­proval. At the time, the French biotech was in a two-way race with Cal­i­for­nia’s Aim­mune to pro­duce the first FDA-ap­proved treat­ment for peanut al­ler­gy. But since then Aim­mune cleared that hur­dle, while DBV, af­ter a with­draw­al and re­sub­mis­sion, in­di­cat­ed that com­mu­ni­ca­tion be­tween them and reg­u­la­tors had bro­ken down.  In June, the com­pa­ny be­gan cut­ting pro­grams and em­ploy­ees.

As de­tailed in DBV’s press re­lease, the con­cerns raised in the CRL may take more than a few months to rem­e­dy. On top of CMC is­sues, DBV said that the agency al­so had ques­tions about how the ad­he­sive­ness, or lack there­of, of their skin patch could af­fect ef­fi­ca­cy.  They want­ed DBV to mod­i­fy the patch and then con­duct a new hu­man fac­tor study and pro­vide new clin­i­cal da­ta.

Daniel Tassé

CEO Daniel Tassé struck a con­cil­ia­to­ry tone, adding they plan to meet with the FDA to dis­cuss re­sub­mis­sion be­fore up­dat­ing in­vestors. The com­pa­ny had €225.9 mil­lion – $266.4 mil­lion – in cash as of June 30. They did not in­di­cate how much run­way that gave them, but the re­struc­tur­ing plan ini­ti­at­ed in June was in­tend­ed to keep them sol­vent through the first quar­ter of 2021.

“We plan to ful­ly col­lab­o­rate with the FDA with re­gards to the out­stand­ing is­sues and be­lieve that the EPIT patch tech­nol­o­gy plat­form lends it­self well to po­ten­tial mod­i­fi­ca­tions to en­hance patch func­tion­al­i­ty,” he said in a state­ment, us­ing the brand­ed name for their patch tech­nol­o­gy.

The com­pa­ny’s stock {DB­VT}, hav­ing al­ready tum­bled from $19.83 to $6.70 this year, fell to $4.74 on the news.

Trou­ble for DBV be­gan in De­cem­ber of 2018, when the com­pa­ny with­drew their first BLA, say­ing reg­u­la­tors in­di­cat­ed their ini­tial ap­pli­ca­tion lacked “suf­fi­cient de­tail re­gard­ing da­ta on man­u­fac­tur­ing pro­ce­dures and qual­i­ty con­trols.” That set­back gave Aim­mune a win­dow to file for their peanut pow­der cap­sule, lat­er known as Pal­forzia, al­low­ing it to be­come the first FDA-ap­proved peanut al­ler­gy ther­a­py in Jan­u­ary.

Nei­ther ther­a­pies are cures. Rather, they try to get kids to build tol­er­ance to peanuts by re­peat­ed ex­po­sure — through es­ca­lat­ing dos­es of pow­der in Aim­mune’s case and through es­ca­lat­ing dos­es of their “Vi­askin” patch in DBV’s case. Ear­ly da­ta point­ed to Aim­mune hav­ing the more ef­fec­tive but per­haps less tol­er­a­ble ther­a­py, as DBV failed to reach sta­tis­ti­cal sig­nif­i­cance in late-stage tri­als be­fore head­ing to the FDA.

DBV re-filed last Au­gust and the FDA ac­cept­ed the sub­mis­sion in Oc­to­ber, set­ting up an ad­vi­so­ry com­mit­tee hear­ing in May and a PDU­FA date in Au­gust. In March, though, DBV dis­closed the FDA had con­cerns that kids could eas­i­ly scratch off their patch, in­ter­fer­ing with its over­all ef­fi­ca­cy, and that the agency had can­celed their ad­vi­so­ry com­mit­tee hear­ing.

The com­pa­ny sub­mit­ted new da­ta to as­suage those con­cerns. In June, though, they an­nounced that they had yet to hear back from the FDA and, fac­ing the pos­si­bil­i­ty of re­jec­tion in Au­gust, were lay­ing off staff and cut­ting pro­grams to stay above wa­ter long-term.

That an­nounce­ment di­vid­ed an­a­lysts. SVB Leerink’s Joseph Schwartz called it “a sticky sit­u­a­tion.” Baird’s Bri­an Sko­r­ney, who had been bull­ish on Aim­mune, pre­pared fu­ner­al rites. “At this point, we view DBV as ef­fec­tive­ly dead in the wa­ter,” he wrote in a note fol­low­ing the an­nounce­ment.

The re­jec­tion means Aim­mune will have a clear path to take the peanut al­ler­gy mar­ket, but the com­pa­ny is fac­ing its own is­sues. They had planned ex­ten­sive train­ing ses­sions with al­ler­gists to help launch Pal­forzia, but Covid-19 stunt­ed those ef­forts. The com­pa­ny said last week they re­port­ed ze­ro Pal­forzia sales in Q2. Their stock is down to $13.60 from a post-ap­proval high of over $36 in Jan­u­ary, al­though Sko­r­ney is still con­fi­dent they’re worth far more.

“We be­lieve in­ter­est in the prod­uct re­mains high, were en­cour­aged to hear man­age­ment’s com­ments sur­round­ing an uptick in new starts in Ju­ly,” he said in a note last week. “That be­ing said, we are re­duc­ing our price tar­get to $47 as we be­lieve near-term COVID head­winds could con­tin­ue to ham­per the launch, in­creas­ing the po­ten­tial for a di­lu­tive cap­i­tal raise.”

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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J&J ad­comm live blog: Com­mit­tee votes 22-0 to rec­om­mend an FDA OK for the J&J vac­cine, set­ting up 3rd US Covid-19 jab

The US could have a third authorized Covid-19 vaccine within hours.

The FDA’s advisory committee voted unanimously — 22-0 — to recommend the agency issue an emergency use authorization for J&J’s vaccine. If they follow the precedent of the Pfizer and Moderna vaccine,  the FDA will likely authorize the vaccine by Saturday, immediately adding a few million doses to the US supply and adding a 100 million by June. An authorization would give the world its first single-dose vaccine, a major weapon in the effort to vaccinate the world and bring the virus to heel, particularly in rural and developing areas.

Gos­samer push­es ahead with failed asth­ma drug; Cull­gen gets $50M Se­ries B for pro­tein de­graders

After getting beaten up by investors over the key failure of its lead drug GB001, Gossamer had already indicated that they thought they could move ahead in asthma, though likely through a partnership. And the biotech is pushing forward on that front, according to a Q4 statement today, following talks with regulators.

The company reported:

Gossamer engaged with the FDA and the EMA about the clinical development path in asthma, and based off those interactions, Gossamer believes that there is a viable clinical development path for GB001, or its backup molecule, in asthma. Gossamer does not currently plan to move forward with GB001, or its backup molecule, in further clinical trials without a partner.