Fu­eled by ear­ly suc­cess, Enan­ta paves way for mid-stage RSV study in adult pa­tients lat­er this year

RSV, a field lit­tered with fail­ure, has an­oth­er hope­ful.

On Fri­day, Enan­ta Phar­ma­ceu­ti­cals showed that its ex­per­i­men­tal treat­ment, EDP-938, con­ferred a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion in the res­pi­ra­to­ry syn­cy­tial virus (RSV) vi­ral load in healthy adults in­oc­u­lat­ed with the virus. Now comes the hard part.

Jay Lu­ly Enan­ta

“While we view to­day’s pos­i­tive re­sults from the Phase 2a hu­man chal­lenge study as en­cour­ag­ing, we an­tic­i­pate that re­sults from the Phase 2b will go a much longer way as to de­ter­min­ing whether EDP-938 is a vi­able treat­ment for RSV…We think the path to com­mer­cial­iza­tion here is par­tic­u­lar­ly dif­fi­cult to nav­i­gate, giv­en that RSV in­fec­tion re­solves fair­ly quick­ly with­out in­ter­ven­tion and the key will be show­ing a dif­fer­ence in terms of time to res­o­lu­tion,” Baird’s Bri­an Sko­r­ney wrote in a note.

Once 115 healthy adults were in­oc­u­lat­ed with the virus, pa­tients were ran­dom­ized to ei­ther get place­bo or ad­min­is­tered two dif­fer­ent EDP-938 reg­i­mens. The Enan­ta drug is an N-pro­tein in­hibitor, which the com­pa­ny be­lieves has an edge over fu­sion in­hibitors cur­rent­ly in de­vel­op­ment, as it tar­gets the virus’ repli­ca­tion ma­chin­ery. Com­pared to the place­bo, pa­tients giv­en ei­ther reg­i­men achieved a sta­tis­ti­cal­ly sig­nif­i­cant re­duc­tion (p<0.001) in RSV vi­ral load and was well tol­er­at­ed, Enan­ta said.

“We think this study large­ly con­firms the an­ti-vi­ral ac­tiv­i­ty of this drug, but was wide­ly ex­pect­ed and the pro­gram is now mov­ing in­to the more cost­ly and dif­fi­cult pe­ri­od of clin­i­cal de­vel­op­ment…Re­call, RSV has been a tough space, with John­son and John­son dis­con­tin­u­ing de­vel­op­ment of lu­mic­itabine, even af­ter the med­ica­tion had pro­duced promis­ing Phase 2a re­sults from a sim­i­lar hu­man chal­lenge mod­el,” Sko­r­ney not­ed.

The com­plex mol­e­c­u­lar struc­ture of RSV has large­ly thwart­ed drug­mak­ers from de­vel­op­ing a vac­cine or a treat­ment for an in­fec­tion that af­flicts most Amer­i­can in­fants be­fore their sec­ond birth­day. For most old­er healthy chil­dren and adults, RSV caus­es lit­tle dis­com­fort be­yond a com­mon cold, but in high-risk groups with com­pro­mised im­mune sys­tems such as in­fants and the el­der­ly, it can lead to more se­ri­ous lung and air­way in­fec­tions.

But ef­forts to sti­fle the in­fec­tion have cul­mi­nat­ed in a litany of fail­ures. Most re­cent­ly, J&J $JNJ ter­mi­nat­ed Phase IIb tri­als of its RSV drug lu­mic­itabine, Re­gen­eron $REGN aban­doned its RSV drug af­ter a late-stage fail­ure and No­vavax’s $NVAX RSV vac­cine has failed a pair of Phase III tri­als (al­though it in­sists there’s a way for­ward). The on­ly sil­ver lin­ing is from As­traZeneca $AZN, the orig­i­nal mak­er of the on­ly pre­ven­ta­tive treat­ment, Synagis, for se­ri­ous low­er res­pi­ra­to­ry tract in­fec­tions (LR­TI) caused by RSV in in­fants and young chil­dren. In Feb­ru­ary, the British drug­mak­er was grant­ed ex­pe­dit­ed re­view from US and EU reg­u­la­tors for its long-act­ing RSV drug, ME­DI8897.

Buoyed by its ear­ly suc­cess, Enan­ta is plan­ning its Phase IIb study by the end of 2019 in adult out­pa­tients with con­firmed RSV in­fec­tions, com­pa­ny chief Jay Lu­ly said.

The com­pa­ny’s shares $EN­TA ini­tial­ly rose, but closed down about 12% at $85.81 on Fri­day. “I just don’t think RSV treat­ment is an in­di­ca­tion that in­vestors are ready to give cred­it to at this stage so it be­came a sell the news event,” Sko­r­ney told End­points News.

So­cial im­age: Shut­ter­stock

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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Bris­tol My­ers is clean­ing up the post-Cel­gene merg­er pipeline, and they’re sweep­ing out an ex­per­i­men­tal check­point in the process

Back during the lead up to the $74 billion buyout of Celgene, the big biotech’s leadership did a little housecleaning with a major pact it had forged with Jounce. Out went the $2.6 billion deal and a collaboration on ICOS and PD-1.

Celgene, though, also added a $530 million deal — $50 million up front — to get the worldwide rights to JTX-8064, a drug that targets the LILRB2 receptor on macrophages.

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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.

Gilead bol­sters its case for block­buster hope­ful fil­go­tinib as FDA pon­ders its de­ci­sion

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Pfiz­er’s Doug Gior­dano has $500M — and some ad­vice — to of­fer a cer­tain breed of 'break­through' biotech

So let’s say you’re running a cutting-edge, clinical-stage biotech, probably public, but not necessarily so, which could see some big advantages teaming up with some marquee researchers, picking up say $50 million to $75 million dollars in a non-threatening minority equity investment that could take you to the next level.

Doug Giordano might have some thoughts on how that could work out.

The SVP of business development at the pharma giant has helped forge a new fund called the Pfizer Breakthrough Growth Initiative. And he has $500 million of Pfizer’s money to put behind 7 to 10 — or so — biotech stocks that fit that general description.

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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.