Neon Ther­a­peu­tics bags a $70M round for ear­ly-stage neoanti­gen re­search

Hugh O’Dowd

Neoanti­gens emerged as one of the hot new trends in biotech R&D a lit­tle more than a year ago. Af­ter a slate of can­cer vac­cines had strug­gled and failed in the clin­ic, the idea that you could fash­ion a vac­cine di­rect­ly tar­get­ing an in­di­vid­ual pa­tient’s tu­mors be­came fash­ion­able in cer­tain seg­ments of the ven­ture com­mu­ni­ty. And a group of in­vestors has joined hands to fund the next stage of clin­i­cal de­vel­op­ment at Neon Ther­a­peu­tics with a hefty $70 mil­lion B round.

The Cam­bridge, MA-based Neon was launched by Third Rock back in late 2015. And it’s al­ready in a Phase Ib study with its lead pro­gram NEO-PV-01. That study launched in No­vem­ber, look­ing to re­cruit 90 pa­tients in 3 co­horts cov­er­ing melanoma, blad­der can­cer and non-small cell lung can­cer. Pa­tients are get­ting a cus­tom-built vac­cine along with Op­di­vo, one of the top check­point in­hibitors.

“This is first be­spoke (made to suit) vac­cine,” says CEO Hugh O’Dowd, a No­var­tis vet who made the jump to biotech. “When I was look­ing at a va­ri­ety of op­por­tu­ni­ties ear­li­er, I frankly looked down on the vac­cine op­por­tu­ni­ties of the past.” Tu­mor-as­so­ci­at­ed anti­gens were the fo­cus, but it took tu­mor spe­cif­ic anti­gens, these neoanti­gens, to get his at­ten­tion.

“I don’t think any­one could spell neoanti­gens 5 years ago,” he adds. “And we’re learn­ing every day. One of the most re­cent pa­tients with non-small cell lung can­cer, had 2,400 unique mu­ta­tions in their tu­mor. If you take a num­ber of lung can­cer pa­tients, there’s no sim­i­lar­i­ty in mu­ta­tions from pa­tient to pa­tient. We call them non-small cell lung can­cer, but mu­ta­tions are dri­ving their dis­ease.”

And you’re go­ing to need a be­spoke, per­son­al­ized, on time can­cer vac­cine to stop it. That means work­ing on a pro­duc­tion and de­liv­ery mod­el that can tai­lor each pa­tient’s vac­cine in a time­ly and ef­fi­cient man­ner.

Says O’Dowd: “We are think­ing cost of goods and one that is scal­able for a mod­el that can work around the world.”

Neon is al­so build­ing out its pipeline. Build­ing on a foun­da­tion of re­search from the Broad In­sti­tute and Dana-Far­ber Can­cer In­sti­tute, the biotech is work­ing on NEO-PTC-01, a pre­clin­i­cal per­son­al­ized adop­tive T cell pro­gram, as well as a “Shared Neoanti­gen Pro­gram.”

The first round of da­ta from their work should be avail­able lat­er in the year.

Neon is ob­vi­ous­ly not alone. UK in­vestors launched Achilles Ther­a­peu­tics last fall, a year af­ter Grit­stone land­ed $102 mil­lion for its work. Mod­er­na and Mer­ck — keen­ly fo­cused on ex­pand­ing its Keytru­da fran­chise — are part­nered on a per­son­al­ized can­cer vac­cine. Sean Park­er’s new in­sti­tute has been cre­at­ing a neoanti­gen col­lab­o­ra­tive. And biotech bil­lion­aire Patrick Soon-Sh­iong has shown in­ter­est as well.

Part­ner Fund Man­age­ment stepped in to lead the lat­est round. They were joined by Third Rock Ven­tures and Ac­cess In­dus­tries, with ad­di­tion­al new in­vestors that in­clud­ed Fi­deli­ty Man­age­ment & Re­search Com­pa­ny, Welling­ton Man­age­ment Com­pa­ny, In­bio Ven­tures and Nex­tech In­vest.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Merck waved off a looming forced retirement for Ken Frazier last September, the board cited flexibility in CEO transition as a key factor in the decision. Having Frazier — who’s also chairman of the company — around beyond his 65th birthday in 2019 would ensure they install the best person at the best time, they said.

The board has evidently begun that process with a clear preference for internal candidates, sources told Bloomberg. CFO Robert Davis, chief marketing officer Michael Nally, and chief commercial officer Frank Clyburn are all in the running, according to an insider.

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In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Dave Barrett, Brian Chee, Amir Nashat, Amy Schulman. Polaris

Bob Langer's first port of call — Po­laris Part­ners — maps $400M for ninth fund

Health and tech ven­ture group Po­laris Part­ners, which counts Alec­tor, Al­ny­lam and Ed­i­tas Med­i­cine as part of its port­fo­lio, is set­ting up its ninth fund, rough­ly two years af­ter it closed Po­laris VI­II with $435 mil­lion in the bank, sur­pass­ing its tar­get by $35 mil­lion.

The Boston-based firm, in an SEC fil­ing, said it in­tends to raise $400 mil­lion for the fund. Po­laris — which rou­tine­ly backs com­pa­nies mold­ed out of the work done in the lab of pro­lif­ic sci­en­tist Bob Langer of MIT  — typ­i­cal­ly in­vests ear­ly, and sticks around till com­pa­nies are in the green. Like its peers at Flag­ship and Third Rock, Po­laris is all about cham­pi­oning the lo­cal biotech scene with a steady flow of start­up cash.