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.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

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UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

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Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

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UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

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Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

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CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

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ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.