In a stun­ner, FDA im­me­di­ate­ly drops its hold on Juno’s lead CAR-T

So much for bu­reau­cra­cy. In what may well be the short­est high-pro­file FDA clin­i­cal hold in the agency’s his­to­ry, Juno re­port­ed to­day that the FDA has lift­ed the halt on its lead CAR-T pro­gram, sat­is­fied that it found the cause for three pa­tient deaths.

Juno’s bat­tered shares $JUNO im­me­di­ate­ly rock­et­ed back up 28%.

Juno con­found­ed in­vestors last week when it re­port­ed the deaths and the sur­pris­ing hold, cit­ing the re­cent ad­di­tion of the chemother­a­py agent flu­dara­bine to its pre­con­di­tion­ing of pa­tients as a like­ly cul­prit. Some ex­perts, who had used the drug in oth­er stud­ies to help clear the path for a fol­lowup ther­a­py, pub­licly ques­tioned the ra­tio­nale. But the agency had no prob­lem pro­vid­ing a quick green light to re­sume the piv­otal study.

The Phase II ROCK­ET study will now con­tin­ue in adult pa­tients with re­lapsed or re­frac­to­ry B-cell acute lym­phoblas­tic leukemia (r/r ALL), us­ing on­ly cy­clophos­phamide in pre-con­di­tion­ing pa­tients for JCAR015.

Not im­me­di­ate­ly clear is whether Juno will be able to gain an ap­proval in 2017, as it had hoped be­fore the hold, putting it back in a race with ri­val Kite.

CAR-T ther­a­pies like this take cells from pa­tients and reengi­neer them with chimeric anti­gen re­cep­tors so they can be rein­ject­ed in­to pa­tients, mul­ti­ply and swarm can­cer cells. Ear­ly stud­ies have im­pressed in­ves­ti­ga­tors with their po­ten­tial for blood can­cers. But Juno roiled the field just days ago with news that a new kind of neu­ro­tox­i­c­i­ty had killed sev­er­al can­cer pa­tients in a study.

Some in­ves­ti­ga­tors, though, note that flu­darib­ine has been used in many oth­er stud­ies, with­out the kind of tox­i­c­i­ty Juno’s ther­a­py trig­gered. And be­cause it was used to help amp up the ef­fect of the drug, some won­der if Juno’s lead ther­a­py may not mea­sure up to Kite’s, which now ap­pears to be in the lead for the first, pi­o­neer­ing ap­proval.

Brad Lon­car, who man­ages an in­dex of the top 30 im­munother­a­py com­pa­nies on the mar­ket, not­ed that Juno CEO Hans Bish­op in­di­cat­ed that he would up­date in­vestors on the time­line for JCAR015 in Au­gust. Kite, mean­while, is push­ing full steam ahead on their piv­otal study. And No­var­tis in­di­cat­ed back in late May that it is on track to file an ap­proval for CTL019 in ear­ly 2017.


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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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.

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.

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.