G1 Ther­a­peu­tics joins a grow­ing biotech win­ners cir­cle with $105M IPO

Mark Vel­le­ca

G1 Ther­a­peu­tics is now the lat­est in a string of biotech IPOs to start out with a hit on its price range. The Re­search Tri­an­gle Park, NC-based out­fit raised $105 mil­lion by sell­ing 7 mil­lion shares at $15 each. That’s the bot­tom of the range, but that qual­i­fies as an­oth­er suc­cess­ful out­ing for the lat­est in a slate of biotechs find­ing a rel­a­tive­ly warm re­cep­tion on Wall Street af­ter a fair­ly chilly Q1.

The com­pa­ny will now start trad­ing as $GTHX.

The spate of IPOs in­cludes a big $168 mil­lion wind­fall for Bio­Haven Phar­ma $BHVN, which went over its range with an up­sized of­fer­ing and an­oth­er suc­cess for Uro­Gen $URGN. Ovid $OVID stuck to the low end of its range, but is now trad­ing be­low its ini­tial price.

Next up: Ar­genx $ARGX, a Dutch an­ti­body biotech which just up­sized its of­fer­ing to 5 mil­lion shares.

G1 like­ly gained a sig­nif­i­cant amount of in­sid­er sup­port for its IPO, a com­mon fea­ture since the biotech IPO boom be­gan to fade in 2015.

The biotech has been close­ly fo­cused on CDK 4/6. CEO Mark Vel­le­ca and the crew at G1 feel they have start­ed down the path to de­vel­op­ing CDK 4/6 drugs that they be­lieve can do much bet­ter in tack­ling can­cer than the first wave. Ibrance is close­ly linked with neu­trope­nia, forc­ing physi­cians to give the drug on an in­ter­mit­tent sched­ule with time off to help pa­tients han­dle the side ef­fects. G1 be­lieves its IV CDK 4/6 is a first-in-class con­tender that can su­per­sede the fron­trun­ners on the mar­ket. And it has an­oth­er ther­a­py in the clin­ic that’s aimed at pro­tect­ing the im­mune sys­tem from the rav­ages of chemother­a­py, help­ing am­pli­fy chemo’s pos­i­tive ef­fects while blunt­ing the side ef­fects.

Hat­teras Ven­ture Part­ners owns the biggest chunk of eq­ui­ty, at 19.8%. They are fol­lowed by Med­Im­mune Ven­tures (16%), Es­hel­man (15%) and RA Cap­i­tal — al­so be­hind Bio­Haven — (10%). Vel­le­ca owns a lit­tle less than 3% of the com­pa­ny.

(John Car­roll con­tributed to this sto­ry.)

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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Joseph Kim, Inovio CEO (Andrew Harnik, AP Images)

Caught in a stand­off with its con­tract man­u­fac­tur­er over Covid-19 vac­cine, In­ovio files suit in an at­tempt to break free while ri­vals race ahead

Inovio was one of the first vaccine developers to snag attention for a jab that their execs said promised to end the Covid-19 pandemic. Using their own unique DNA tech, CEO Joseph Kim said it took just 3 hours to work it out.

But while rivals are racing to the finish line with ambitious plans to make vast quantities of their vaccines with billions of dollars of deals, Inovio is still stuck at the starting line on manufacturing.

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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