Aim­mune's peanut al­ler­gy im­munother­a­py clears Eu­ro­pean PhI­II with fly­ing col­ors, paving way for first US, EU ther­a­peu­tic ap­proval

Days af­ter the FDA fi­nal­ly ac­cept­ed the ap­pli­ca­tion to re­view its peanut al­ler­gy im­munother­a­py, Aim­mune laid out pos­i­tive piv­otal study da­ta from its Eu­ro­pean Phase III study on Mon­day, paving the way for an EMA mar­ket­ing ap­pli­ca­tion by mid-2019.

The drug de­vel­op­er, which has es­sen­tial­ly leapfrogged its arch ri­val DBV Tech­nolo­gies $DB­VT in the Unit­ed States, said its drug — AR101 — helped shore up tol­er­ance in peanut-al­ler­gic sub­jects in a 175-pa­tient tri­al called ARTEMIS. Pa­tients un­der­went ap­prox­i­mate­ly six months of dose es­ca­la­tion and then three months at a dai­ly ther­a­peu­tic dose of AR101 at 300 mg or place­bo, fol­lowed by a place­bo-con­trolled food chal­lenge.

AR101 met the main goal of sig­nif­i­cant­ly im­prov­ing pa­tients’ abil­i­ty to tol­er­ate a 1,000-mg sin­gle dose of peanut pro­tein (p<0.00001) — which cor­re­lates to at least three or four peanuts — ver­sus those who got the place­bo. Over­all, the me­di­an tol­er­at­ed dose of peanut pro­tein for AR101-treat­ed pa­tients im­proved 100-fold, from 10 mg at base­line to 1,000 mg at ex­it, the com­pa­ny said.

Jayson Dal­las

“This lev­el of pro­tec­tion pro­vides am­ple buffer be­yond a typ­i­cal bite of a peanut-con­tain­ing food in the re­al world,” said Aim­mune chief Jayson Dal­las in a state­ment. “AR101 has the po­ten­tial to be­come the first ap­proved ther­a­py for peanut al­ler­gy in both the Unit­ed States and Eu­rope, where up to two per­cent of chil­dren in many coun­tries are af­fect­ed.”

The ARTEMIS find­ings echo the re­sults from the high­est lev­el test­ed in Aim­mune’s land­mark Phase III PAL­ISADE tri­al, which formed an in­te­gral por­tion of Aim­mune’s US ap­pli­ca­tion. PAL­ISADE da­ta showed 50.3% of AR101-treat­ed pa­tients tol­er­at­ed a sin­gle high­est dose of 1,000 mg of peanut pro­tein af­ter ap­prox­i­mate­ly six months of dose es­ca­la­tion fol­lowed by six months at a dai­ly ther­a­peu­tic dose of 300 mg, com­pared to 2.4% of place­bo pa­tients (p<0.00001).

Daniel Adel­man

“The ARTEMIS da­ta demon­strate that most pa­tients ex­ceed­ed what we con­sid­er to be pro­tec­tive lev­els well be­fore a full year of treat­ment…these da­ta build up­on the in­sights gained through­out the en­tire AR101 pro­gram re­gard­ing the de­sen­si­ti­za­tion process and the abil­i­ty of our pa­tients to tol­er­ate rel­a­tive­ly large chal­lenge-dos­es of peanut pro­tein,” Aim­mune’s CMO Daniel Adel­man said.

The FDA is ex­pect­ed to make a de­ci­sion on AR101 by Jan­u­ary 2020, Cal­i­for­nia-based Aim­mune said last week.

DBV $DB­VT re­scind­ed an ap­pli­ca­tion to mar­ket its peanut al­ler­gy patch on De­cem­ber 20 in re­sponse to FDA con­cerns about the state of man­u­fac­tur­ing and qual­i­ty con­trol da­ta sub­mit­ted, and the fol­low­ing day, Aim­mune $AIMT sub­mit­ted its ap­pli­ca­tion for AR101, in ef­fect leapfrog­ging its com­pe­ti­tion for a first-mover shot at cap­tur­ing the so far un­tapped mar­ket, which is ex­pect­ed to grow to $4.5 bil­lion in 2027 glob­al­ly, ac­cord­ing to Glob­al­Da­ta. The US shut­down be­gan on De­cem­ber 22. By mid-Jan­u­ary, Aim­mune said the health reg­u­la­tor had no­ti­fied them that it would not be able to re­view the ap­pli­ca­tion un­til the lapse in ap­pro­pri­a­tions end­ed. Ten days lat­er, on Jan­u­ary 25th, the gov­ern­ment re­opened, and the AR101 ap­pli­ca­tion was back in con­tention.

Aim­mune’s in­ves­ti­ga­tion­al egg al­ler­gy prod­uct — AR201 — is ex­pect­ed to be eval­u­at­ed in a Phase II study mid-2019. The con­di­tion af­fects an es­ti­mat­ed 6 mil­lion peo­ple in the US, Eu­rope, Japan and Chi­na.

Fangliang Zhang, AP Images

UP­DAT­ED: Leg­end fetch­es $424 mil­lion, emerges as biggest win­ner yet in pan­dem­ic IPO boom as shares soar

Amid a flurry of splashy pandemic IPOs, a J&J-partnered Chinese biotech has emerged with one of the largest public raises in biotech history.

Legend Biotech, the Nanjing-based CAR-T developer, has raised $424 million on NASDAQ. The biotech had originally filed for a still-hefty $350 million, based on a range of $18-$20, but managed to fetch $23 per share, allowing them to well-eclipse the massive raises from companies like Allogene, Juno, Galapagos, though they’ll still fall a few dollars short of Moderna’s record-setting $600 million raise from 2018.

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As it hap­pened: A bid­ding war for an an­tibi­ot­ic mak­er in a mar­ket that has rav­aged its peers

In a bewildering twist to the long-suffering market for antibiotics — there has actually been a bidding war for an antibiotic company: Tetraphase.

It all started back in March, when the maker of Xerava (an FDA approved therapy for complicated intra-abdominal infections) said it had received an offer from AcelRx for an all-stock deal valued at $14.4 million.

The offer was well-timed. Xerava was approved in 2018, four years after Tetraphase posted its first batch of pivotal trial data, and sales were nowhere near where they needed to be in order for the company to keep its head above water.

Is a pow­er­house Mer­ck team prepar­ing to leap past Roche — and leave Gilead and Bris­tol My­ers be­hind — in the race to TIG­IT dom­i­na­tion?

Roche caused quite a stir at ASCO with its first look at some positive — but not so impressive — data for their combination of Tecentriq with their anti-TIGIT drug tiragolumab. But some analysts believe that Merck is positioned to make a bid — soon — for the lead in the race to a second-wave combo immuno-oncology approach with its own ambitious early-stage program tied to a dominant Keytruda.

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GSK presents case to ex­pand use of its lu­pus drug in pa­tients with kid­ney dis­ease, but the field is evolv­ing. How long will the mo­nop­oly last?

In 2011, GlaxoSmithKline’s Benlysta became the first biologic to win approval for lupus patients. Nine years on, the British drugmaker has unveiled detailed positive results from a study testing the drug in lupus patients with associated kidney disease — a post-marketing requirement from the initial FDA approval.

Lupus is a drug developer’s nightmare. In the last six decades, there has been just one FDA approval (Benlysta), with the field resembling a graveyard in recent years with a string of failures including UCB and Biogen’s late-stage flop, as well as defeats in Xencor and Sanofi’s programs. One of the main reasons the success has eluded researchers is because lupus, akin to cancer, is not just one disease — it really is a disease of many diseases, noted Al Roy, executive director of Lupus Clinical Investigators Network, an initiative of New York-based Lupus Research Alliance that claims it is the world’s leading private funder of lupus research, in an interview.

Drug man­u­fac­tur­ing gi­ant Lon­za taps Roche/phar­ma ‘rein­ven­tion’ vet as its new CEO

Lonza chairman Albert Baehny took his time headhunting a new CEO for the company, making it absolutely clear he wanted a Big Pharma or biotech CEO with a good long track record in the business for the top spot. In the end, he went with the gold standard, turning to Roche’s ranks to recruit Pierre-Alain Ruffieux for the job.

Ruffieux, a member of the pharma leadership team at Roche, spent close to 5 years at the company. But like a small army of manufacturing execs, he gained much of his experience at the other Big Pharma in Basel, remaining at Novartis for 12 years before expanding his horizons.

Covid-19 roundup: Ab­b­Vie jumps in­to Covid-19 an­ti­body hunt; As­traZeneca shoots for 2B dos­es of Ox­ford vac­cine — with $750M from CEPI, Gavi

Another Big Pharma is entering the Covid-19 antibody hunt.

AbbVie has announced a collaboration with the Netherlands’ Utrecht University and Erasmus Medical Center and the Chinese-Dutch biotech Harbour Biomed to develop a neutralizing antibody that can treat Covid-19. The antibody, called 47D11, was discovered by AbbVie’s three partners, and AbbVie will support early preclinical work, while preparing for later preclinical and clinical development. Researchers described the antibody in Nature Communications last month.

Leen Kawas, Athira CEO (Athira)

Can a small biotech suc­cess­ful­ly tack­le an Ever­est climb like Alzheimer’s? Athi­ra has $85M and some in­flu­en­tial back­ers ready to give it a shot

There haven’t been a lot of big venture rounds for biotech companies looking to run a Phase II study in Alzheimer’s.

The field has been a disaster over the past decade. Amyloid didn’t pan out as a target — going down in a litany of Phase III failures — and is now making its last stand at Biogen. Tau is a comer, but when you look around and all you see is destruction, the idea of backing a startup trying to find complex cocktails to swing the course of this devilishly complicated memory-wasting disease would daunt the pluckiest investors.

President Donald Trump (left) and Moncef Slaoui, head of Operation Warp Speed (Alex Brandon, AP Images)

UP­DAT­ED: White House names fi­nal­ists for Op­er­a­tion Warp Speed — with 5 ex­pect­ed names and one no­table omis­sion

A month after word first broke of the Trump Administration’s plan to rapidly accelerate the development and production of a Covid-19 vaccine, the White House has selected the five vaccine candidates they consider most likely to succeed, The New York Times reported.

Most of the names in the plan, known as Operation Warp Speed, will come as little surprise to those who have watched the last four months of vaccine developments: Moderna, which was the first vaccine to reach humans and is now the furthest along of any US effort; J&J, which has not gone into trials but received around $500 million in funding from BARDA earlier this year; the joint AstraZeneca-Oxford venture which was granted $1.2 billion from BARDA two weeks ago; Pfizer, which has been working with the mRNA biotech BioNTech; and Merck, which just entered the race and expects to put their two vaccine candidates into humans later this year.

Mer­ck wins a third FDA nod for an­tibi­ot­ic; Mereo tack­les TIG­IT with $70M raise in hand

Merck — one of the last big pharma bastions in the beleaguered field of antibiotic drug development — on Friday said the FDA had signed off on using its combination drug, Recarbrio, with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The drug could come handy for use in hospitalized patients who are afflicted with Covid-19, who carry a higher risk of contracting secondary bacterial infections. Once SARS-CoV-2, the virus behind Covid-19, infects the airways, it engages the immune system, giving other pathogens free rein to pillage and plunder as they please — the issue is particularly pertinent in patients on ventilators, which in any case are breeding grounds for infectious bacteria.