Promis­ing to match more NSCLC pa­tient with tar­get­ed drugs, Cam­bridge spin­out Ini­va­ta read­ies US launch of liq­uid biop­sy

This has been a big month for Ini­va­ta, the liq­uid biop­sy com­pa­ny spun out from Can­cer Re­search UK and Cam­bridge Uni­ver­si­ty. Af­ter se­cur­ing Medicare cov­er­age for its first blood test — used to pro­file ad­vanced non-small cell lung can­cer pa­tients — it has of­fi­cial­ly closed a $52.6 mil­lion (£39.8 mil­lion) Se­ries B to fund a com­mer­cial roll­out.

Clive Mor­ris

While ad­vances in tar­get­ed ther­a­py have dra­mat­i­cal­ly ex­pand­ed treat­ment op­tions for NSCLC pa­tients — from check­points to ty­ro­sine ki­nase in­hibitors to nov­el RET in­hibitors — it is of­ten dif­fi­cult to test pa­tients for all FDA-ap­proved drugs us­ing the tra­di­tion­al tis­sue biop­sy, Ini­va­ta CEO Clive Mor­ris tells me. Some­times the pa­tients sim­ply don’t have enough tis­sue to draw from; oth­er times there are med­ical rea­sons stand­ing in the way.

“So when you think about that, with bil­lions in R&D dol­lars spent, the time spent to get those things all the way through FDA, and ac­tu­al­ly what they are say­ing is more than 90% of pa­tients are not pro­filed for all of the drugs that are avail­able,” the As­traZeneca vet said, re­fer­ring to a 2017 pa­per study­ing ge­nom­ic pro­fil­ing of the dis­ease in com­mu­ni­ty set­tings.

Ini­va­ta’s In­Vi­sion­First test, in con­trast, is de­signed to hunt down “tiny, tiny lit­tle pieces of” cir­cu­lat­ing tu­mor DNA in blood and look for all types of ge­net­ic al­ter­ations, from in­ser­tions, dele­tions and sin­gle nu­cleotide vari­a­tions to gene fu­sions and translo­ca­tions.

That’s the pitch it will be tak­ing to on­col­o­gists across the US with a grow­ing team of sales, mar­ket­ing, med­ical ed­u­ca­tion and pay­er li­ai­son per­son­nel — in a mar­ket that al­ready has some en­trenched tis­sue testers, in­clud­ing Roche’s Foun­da­tion Med­i­cine.

Mean­while, some of the funds will go to­ward R&D in Cam­bridge, UK, where it’s delv­ing in­to new as­says and cook­ing up clin­i­cal pro­grams for dif­fer­ent tu­mor types in ear­li­er stages. Mor­ris sees a wide range of po­ten­tial ap­pli­ca­tions for Ini­va­ta next-gen­er­a­tion se­quenc­ing tech out­side of the ini­tial pro­fil­ing, in­clud­ing mon­i­tor­ing of pa­tients and de­tec­tion of re­spons­es/re­sis­tance to drugs.

Com­ing from new in­vestor RT Ven­tures and old sup­port­ers Wood­ford Pa­tient Cap­i­tal Trust, IP Group, Cam­bridge In­no­va­tion Cap­i­tal and John­son & John­son In­no­va­tion – JJDC, the Se­ries B more than dou­bled Ini­va­ta’s ear­li­er haul from a “small-ish seed round” and a Se­ries A on which the com­pa­ny was set up. That in­clud­ed labs in both North Car­oli­na and Cam­bridge. This fi­nal close fol­lowed an ini­tial tranche of cash hand­ed over last Au­gust.

So what will be next for the In­Vi­sion plat­form? Mor­ris prefers to stay silent on that score, but vol­un­teered that as a small com­pa­ny of few­er than 80, they will be look­ing for part­ners to pur­sue the whole port­fo­lio of in­di­ca­tions.

Hal Barron and Rick Klausner (GSK, Lyell)

Ex­clu­sive: GSK’s Hal Bar­ron al­lies with Rick Klaus­ner’s $600M cell ther­a­py start­up, look­ing to break new ground blitz­ing sol­id tu­mors

LONDON — Chances are, you’ve heard little or nothing about Rick Klausner’s startup Lyell. But that ends now.

Klausner, the former head of the National Cancer Institute, former executive director for global health at the Gates Foundation, co-founder at Juno and one of the leaders in the booming cell therapy field, has brought together one of the most prominent teams of scientists tackling cell therapy 2.0 — highlighted by a quest to bridge a daunting tech gap that separates some profound advances in blood cancers with solid tumors. And today he’s officially adding Hal Barron and GlaxoSmithKline as a major league collaborator which is pitching in a large portion of the $600 million he’s raised in the past year to make that vision a reality.

“We’ve being staying stealth,” Klausner tells me, then adding with a chuckle: “and going back to stealth after this.”

“Cell therapy has a lot of challenges,” notes Barron, the R&D chief at GSK, ticking off the resistance put up by solid tumors to cell therapies, the vein-to-vein time involved in taking immune cells out of patients, engineering them to attack cancer cells, and getting them back in, and more. “Over the years Rick and I talked about how it would be wonderful to take that on as a mission.”

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First place fin­ish: Eli Lil­ly just moved to fran­chise leader with their sec­ond mi­graine drug OK in 1 year

In a rare twist for Eli Lilly’s historically slow-moving R&D group, the pharma giant has seized bragging rights to a first-in-class new drug approval. And all signs point to an aggressive marketing followup as they look to outclass some major franchise rivals hobbled by internal dissension.

The FDA came through with an OK for lasmiditan on Friday evening, branding it as Reyvow and lining it up — once a substance classification comes through from the DEA — for a major market release. The oral drug binds to 5-HT1F receptors and is designed to stop an acute migraine after it starts. That makes it a complementary therapy to their CGRP drug Emgality, which has a statistically significant impact on preventing attacks.

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Allogene HQ Open House on September 17, 2019 in South San Francisco. (Jeff Rumans, Endpoints News)

The next 10 years: Where is biotech head­ed?

The last 10 years have seen a revolution in drug development. Timelines have shortened, particularly in oncology. Regulators have opened up. Investment has skyrocketed. China became a player. Biotechs have multiplied as gene and cell therapy has exploded — offering major new advances in the way diseases are treated, and sometimes cured.

So where are we headed from here? I journeyed out to San Francisco in September to discuss the answer to that question at Allogene’s open house. If the last 10 years have been an eye-opener, what does the next decade hold in store?

Patrick Mahaffy, Getty Images

Court green-lights Clo­vis case af­ter de­tail­ing ev­i­dence the board ‘ig­nored red flags’ on false safe­ty and ef­fi­ca­cy da­ta

Clovis investors have cleared a major hurdle in their long-running case against the board of directors, with a Delaware court making a rare finding that they had a strong enough case against the board to proceed with the action.

In a detailed ruling at the beginning of the month that’s been getting careful scrutiny at firms specializing in biotech and corporate governance, the Delaware Court of Chancery found that the attorneys for the investors had made a careful case that the board — a collection of experts that includes high-profile biotech entrepreneurs, a Harvard professor and well-known investigator as well as Clovis CEO Patrick Mahaffy — repeatedly ignored obvious warnings that Mahaffy’s executive crew was touting inflated, unconfirmed data for their big drug Roci. Serious safety issues were also reportedly overlooked while the company continued a fundraising campaign that brought in more than a half-billion dollars. And that leaves the board open to claims related to their role in the fiasco.

The bottom line:

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Bill Gates backs Gink­go Biowork­s' $350M raise to fu­el the buzzy syn­thet­ic bi­ol­o­gy 'rev­o­lu­tion'

If you want to understand Ginkgo Bioworks, the name should suffice: Bioworks, a spin off “ironworks,” that old industrial linchpin devoted to leveraging scale as a wellspring for vast new industries capable of remaking society. Ginkgo wants to be the ironworks for the revolution it’s heralded with as much fanfare as they can, playing off of one of the buzziest technologies in biotech.

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UCB bags a ri­val to Soliris in $2.1B buy­out deal — but will an in­creas­ing­ly vig­i­lant FTC sign off?

UCB is buying out Ra Pharma $RARX, announcing an acquisition deal that rings up at $48 a share, or $2.1 billion net of cash, and puts them toe-to-toe with Alexion on a clinical showdown.

Ra shares closed at $22.70 on Wednesday.

There’s a small pipeline in play at Ra, but UCB is going for the lead drug — a C5 inhibitor called zilucoplan in Phase III for myasthenia gravis (MG) looking to play rival to Alexion’s Soliris. Soliris has the market advantage, though, with a much earlier approval in MG in late 2017 that UCB feels confident in challenging.

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A new play­er is tak­ing the field in a push for a he­mo­phil­ia A gene ther­a­py, and it’s a big one

BioMarin, the execs at Spark (and buyer-to-be Roche) as well as the Sangamo/Pfizer team have a new rival striding onto the hemophilia block. And it’s a big one.

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Stuck with a PhI­II gene ther­a­py fail­ure at 96 weeks, Gen­Sight prefers the up­beat as­sess­ment

Two years after treatment, the best thing that GenSight Biologics $SIGHT can say about their gene therapy for vision-destroying cases of Leber Hereditary Optic Neuropathy is that it’s just a bit better than a placebo — just maybe because one treatment can cover both eyes.

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George Scangos / Credit: Cornell University

ARCH, Soft­Bank-backed Vir Biotech­nol­o­gy un­der­whelms with $143 mil­lion IPO

George Scangos went back to Wall Street, and came back 700 million pennies short.

Scangos’ vaunted startup Vir Biotechnology raised $143 million in an IPO they hoped would earn $150 million. Shares were priced at $20, the low-end of the $20-$22 target.

Launched with backing from ARCH Venture’s Robert Nelsen, Masayoshi Son’s SoftBank Vision Fund, and the Bill & Melinda Gates Foundation, the infectious disease startup was one of a new wave of well-resourced biotechs that emerged with deep enough coffers to pursue a full R&D line rather than slowly build their case by picking off a single lead program.