Hous­ing As­traZeneca's old R&D ef­forts in an­tibi­otics, En­ta­sis files for $86M IPO

When As­traZeneca spun out its strug­gling an­tibi­otics unit a few years back, the tech — and a much small­er team — was de­posit­ed in­to a com­pa­ny called En­ta­sis. Now, that up­start has filed for an $86 mil­lion IPO to push a few of its prod­uct can­di­dates through hu­man tri­als.

The tiny Waltham com­pa­ny is on­ly a frac­tion of what the phar­ma gi­ant’s an­tibi­otics ef­fort used to be. At one point, the unit had 175 staffers. But it was pared down over the years un­til En­ta­sis launched in 2015 with on­ly 21 em­ploy­ees. To­day, ac­cord­ing to its prospec­tus, it em­ploys 34.

En­ta­sis has a pipeline of clin­i­cal-stage prod­uct can­di­dates meant to treat in­fec­tions caused by mul­ti-drug re­sis­tant Gram-neg­a­tive bac­te­ria. Its lead prod­uct, ETX2514, in­hibits one of the most com­mon forms of bac­te­r­i­al re­sis­tance: b-lac­ta­mase en­zymes, so named be­cause of their abil­i­ty to in­ac­ti­vate b-lac­tam an­tibi­otics, one of the most com­mon­ly used class­es of an­tibi­otics. En­ta­sis has an­oth­er pipeline ther­a­py, ETX0282, that in­hibits the same en­zymes.

“By block­ing this re­sis­tance mech­a­nism, these prod­uct can­di­dates, when ad­min­is­tered in com­bi­na­tion with b-lac­tam an­tibi­otics, are de­signed to re­store the ef­fi­ca­cy of those an­tibi­otics,” the com­pa­ny said in its prospec­tus.

En­ta­sis plans to use its IPO funds to ad­vance ETX2514 through a Phase III tri­al, and to move 0282 through a mul­ti-part Phase I. The rest of the cash will go to­ward oth­er R&D and gen­er­al cor­po­rate pur­pos­es.

The com­pa­ny will list on the Nas­daq un­der the tick­er sym­bol $ET­TX.

The an­tibi­otics R&D field has been rife with hur­dles, and new­com­ers like Za­vante and Cidara have failed to make big waves like once hoped. In fact, Za­vante fiz­zled in­to an ac­qui­si­tion less than three years af­ter its launch. And Cidara suf­fered a Phase II tri­al flop last year that dropped its stock price about 50%. And al­though fed­er­al in­cen­tives have spurred new ac­tiv­i­ty in the field, the small mar­gins that dis­cour­aged de­vel­op­ment ef­forts a decade ago — lead­ing to our cur­rent crit­i­cal short­age — still ham­per the niche.

BiTE® Plat­form and the Evo­lu­tion To­ward Off-The-Shelf Im­muno-On­col­o­gy Ap­proach­es

Despite rapid advances in the field of immuno-oncology that have transformed the cancer treatment landscape, many cancer patients are still left behind.1,2 Not every person has access to innovative therapies designed specifically to treat his or her disease. Many currently available immuno-oncology-based approaches and chemotherapies have brought long-term benefits to some patients — but many patients still need other therapeutic options.3

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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FDA de­lays de­ci­sion on No­var­tis’ po­ten­tial block­buster MS drug, wip­ing away pri­or­i­ty re­view

So much for a speedy review.

In February, Novartis announced that an application for their much-touted multiple sclerosis drug ofatumumab had been accepted and, with the drug company cashing in on one of their priority review vouchers, the agency was due for a decision by June.

But with June less than 48 hours old, Novartis announced the agency has extended their review, pushing back the timeline for approval or rejection to September. The Swiss pharma filed the application in December, meaning their new schedule will be nearly in line with the standard 10-month window period had they not used the priority voucher.

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Fangliang Zhang (Imaginechina via AP Images)

The big mon­ey: Poised to make drug R&D his­to­ry, a Chi­na biotech un­veils uni­corn rac­ing am­bi­tions in a bid to raise $350M-plus on Nas­daq

Almost exactly three years after Shanghai-based Legend came out of nowhere to steal the show at ASCO with jaw-dropping data on their BCMA-targeted CAR-T for multiple myeloma, the little player with Big Pharma connections is taking a giant step toward making it big on Wall Street. And this time they want to seal the deal on a global rep after staking out a unicorn valuation in what’s turned out to be a bull market for biotech IPOs — in the middle of a pandemic.

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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.

Covid-19 roundup: Mod­er­na read­ies to en­ter PhI­II in Ju­ly, As­traZeneca not far be­hind; EU ready to ne­go­ti­ate vac­cine ac­cess with $2.7B fund

Moderna may soon add another first to the Covid-19 vaccine race.

In March, the mRNA biotech was the first company to put a Covid-19 vaccine into humans. Next month, they may become the first company to put their vaccine into the large, late-stage trials that are needed to prove whether the vaccine is effective.

In an interview with JAMA editor Howard Bauchner, NIAID chief Anthony Fauci said that a 30,000-person, Phase III trial for Moderna’s vaccine could start in July. The news comes a week after Moderna began a Phase II study that will enroll several hundred people.

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José Basel­ga finds promise in new class of RNA-mod­i­fy­ing can­cer tar­gets, lock­ing in 3 pre­clin­i­cal pro­grams with $55M

Having dived early into some of the RNA breakthroughs of the last decades — betting on Moderna’s mRNA tech and teaming up with Silence on the siRNA front — AstraZeneca is jumping into a new arena: going after proteins that modify RNA.

Their partner of choice is Accent Therapeutics, which is receiving $55 million in upfront payment to steer a selected preclinical program through to the end of Phase I. After AstraZeneca takes over, the Lexington, MA-based startup has the option to co-develop and co-commercialize in the US — and collect up to $1.1 billion in milestones in the long run. The deal also covers two other potential drug candidates.

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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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