From mega-round to $172M IPO in weeks, Or­chard is bundling cash to back its play on GSK's gene ther­a­py cast-offs

A few weeks ago, when Or­chard Ther­a­peu­tics fol­lowed its much buzzed about ne­go­ti­a­tions to carve out Glax­o­SmithK­line’s gene ther­a­py op­er­a­tions with a $150 mil­lion mega-round, I asked if an IPO would be next.

It turns out, the F-1 must have been in the fi­nal edit­ing process.

The Lon­don-based group has de­liv­ered their IPO pack­age now, pen­cil­ing in $172.5 mil­lion for the raise and mak­ing the case that there’s a vi­able busi­ness to be had in a field that a strug­gling GSK sim­ply want­ed out of. The F-1 re­veals that Or­chard’s team hand­ed over a £10 mil­lion up­front — not much in the way of a re­turn for GSK’s in­vest­ment — along with 15 mil­lion shares and promis­es of roy­al­ty streams to come.

In re­turn, Or­chard land­ed a pi­o­neer­ing gene ther­a­py — Strimvelis — that is even more rarely seen than the dis­ease it is in­tend­ed to treat. But there’s al­so a slate of fol­low-up pro­grams which the biotech says can ad­dress $2 bil­lion in mar­ket op­por­tu­ni­ty. And with a faster, more fo­cused team con­nect­ed to some of the ex­perts in the gene ther­a­py field, they be­lieve that they can be­come one of the biotech lead­ers to lead the way in this field, with its hot­ly an­tic­i­pat­ed ap­proach to once-and-done treat­ments.

Their time­line in­cludes a 2020 FDA ap­pli­ca­tion for their ADA-SCID ther­a­py fol­lowed a year lat­er with their first pitch for Wiskott-Aldrich syn­drome.

That won’t be cheap.

Or­chard rolled up $260 mil­lion in ven­ture dol­lars to get to this point, and now needs more cash to see its way through the short-term tran­si­tion it’s mapped out for it­self.

Along the way, they helped demon­strate that the Lon­don Stock Ex­change is all but dead as far as new biotech list­ings are con­cerned. Nas­daq has be­come the place to go in search of pub­lic suc­cess, and this year we’ve seen in­vestors ea­ger­ly em­brace a whole slate of new play­ers look­ing to make some his­to­ry — and mon­ey.

F-Prime is the big gam­bler here, with about 30% of the stock. The ven­ture group is fol­lowed by GSK with 18%, with Deer­field in com­mand of a 6.7% chunk. The Scot­tish Mort­gage In­vest­ment Trust is in at 5.6%.

If they are suc­cess­ful, Or­chard will have one of the most suc­cess­ful biotech IPOs of the year. The com­pa­ny plans to list as $OR­TX.

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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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

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.

David Meline, incoming Moderna CFO

Am­gen vet David Meline finds a new CFO roost at Mod­er­na, tak­ing a ride on the Covid-19 tiger as de­part­ing ex­ec cash­es out with $12M

We found out a few weeks ago that Moderna CFO Lorence Kim isn’t waiting around to see how the biotech wunderkind makes out in its frantic race to field a messenger RNA vaccine that can quell Covid-19. And now we know who’s stepping on board to take his place in the latest move in the executive suite.

David Meline, who forged his rep during a 6-year run at Amgen, slipped out the exit right after his Q2 “retirement” party in California — presumably virtual — and started the next chapter of his career at a biotech company betting big on revolutionizing the vaccine R&D space.

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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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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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