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.

The DCT-OS: A Tech­nol­o­gy-first Op­er­at­ing Sys­tem - En­abling Clin­i­cal Tri­als

As technology-enabled clinical research becomes the new normal, an integrated decentralized clinical trial operating system can ensure quality, deliver consistency and improve the patient experience.

The increasing availability of COVID-19 vaccines has many of us looking forward to a time when everyday things return to a state of normal. Schools and teachers are returning to classrooms, offices and small businesses are reopening, and there’s a palpable sense of optimism that the often-awkward adjustments we’ve all made personally and professionally in the last year are behind us, never to return. In the world of clinical research, however, some pandemic-necessitated adjustments are proving to be more than emergency stopgap measures to ensure trial continuity — and numerous decentralized clinical trial (DCT) tools and methodologies employed within the last year are likely here to stay as part of biopharma’s new normal.

Onno van de Stolpe, Galapagos CEO (Thierry Roge/Belga Mag/AFP via Getty Images)

Gala­pa­gos chops in­to their pipeline, drop­ping core fields and re­or­ga­niz­ing R&D as the BD team hunts for some­thing 'trans­for­ma­tive'

Just 5 months after Gilead gutted its rich partnership with Galapagos following a bitter setback at the FDA, the Belgian biotech is hunkering down and chopping the pipeline in an effort to conserve cash while their BD team pursues a mission to find a “transformative” deal for the company.

The filgotinib disaster didn’t warrant a mention as Galapagos laid out its Darwinian restructuring plans. Forced to make choices, the company is ditching its IPF molecule ’1205, while moving ahead with a Phase II IPF study for its chitinase inhibitor ’4617.

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Stéphane Bancel, Getty

Mod­er­na CEO brush­es off US sup­port for IP waiv­er, eyes more than $19B in Covid-19 vac­cine sales in 2021

Moderna is definitively more concerned with keeping pace with Pfizer in the race to vaccinate the world against Covid-19 than it is with Wednesday’s decision from the Biden administration to back an intellectual property waiver that aims to increase vaccine supplies worldwide.

In its first quarter earnings call on Thursday, Moderna CEO Stéphane Bancel shrugged off any suggestion that the newly US-backed intellectual property waiver would impact his company’s vaccine or bottom line. Still, the company’s stock price fell by about 9% in early morning trading.

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'Chang­ing the whole game of drug dis­cov­ery': Leg­endary R&D vet Roger Perl­mut­ter leaps back in­to work as a biotech CEO

Roger Perlmutter needs no introduction to anyone remotely involved in biopharma. As the R&D chief first at Amgen and then Merck, he’s built a stellar reputation and a prolific career steering new drugs toward the market for everything from cancer to infectious diseases.

But for years, he’s also held a less known title: science partner at The Column Group, where he’s regularly consulted about the various ideas the VCs had for new startups.

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Ad­comm splits slight­ly in fa­vor of FDA ap­prov­ing Chemo­Cen­tryx’s rare dis­ease drug

The FDA’s Arthritis Advisory Committee on Thursday voted 10 for and 8 against the approval of ChemoCentryx’s $CCXI investigational drug avacopan as a treatment for adults with a rare and serious disease known as anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis.

The vote on whether the FDA should approve the drug was preceded by a split vote of 9 to 9 on whether the efficacy data support approval, and 10 to 8 that the safety profile of avacopan is adequate enough to support approval.

Gold­man Sachs jumps aboard Bain-backed 503(b) com­pound­ing phar­ma­cy with a $275M debt loan to sup­ply hos­pi­tals

Long the bane of the FDA’s existence, compounding pharmacies have seen a minor resurgence in the past year as short-term saviors for hospital drug shortages. Now, a 503(b) company specializing in hospital meds has earned a big backer to keep expanding its 200-drug strong portfolio.

Goldman Sachs and Owl Rock Capital Partners have doled out a $275 million debt loan to QuVa Pharma, a 503(b)-certified outsourcing facility providing compounded drugs to hospitals, the company said Thursday.

Bill Lis, Jasper Therapeutics

Jasper and its stem cell con­di­tion­ing an­ti­body earn a tick­et to Nas­daq in lat­est SPAC re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

Another biotech SPAC deal has landed as the glut of blank-check companies continues to make waves in the industry.

Thursday’s winner is Jasper Therapeutics, joining forces with Amplitude Healthcare Acquisition Corp. in a $100 million reverse-merger, Jasper announced. The deal also comes with a PIPE financing of an additional $100 million, setting Jasper up with a $490 million market cap once the merger closes in the third quarter.

Brent Saunders (Richard Drew, AP Images)

OcuWho? Star deal­mak­er turned aes­thet­ics czar Brent Saun­ders flips back in­to biotech. But who’s he team­ing up with now?

Brent Saunders went on a tear of headline-blazing deals building Allergan, merging and rearranging a variety of big companies into one before an M&A pact with Pfizer blew up and sent him on a bout of biotech drug deals. That didn’t work so well, so under pressure, he got his buyout at AbbVie — which needed a big franchise like Botox. And it was no big surprise to see him riding the SPAC wave into a recent $1 billion-plus deal that left him in the executive chairman’s seat at an aesthetics outfit — now redubbed The Beauty Health Company — holding a big chunk of the equity.

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Drug pric­ing watch­dog joins the cho­rus of crit­ics on Bio­gen's ad­u­canum­ab: What about charg­ing $2,560 per year?

As if Biogen’s aducanumab isn’t controversial enough, the researchers at drug pricing watchdog ICER have drawn up the contours of a new debate: If the therapy does get approved for Alzheimer’s by June, what price should it command?

Their answer: At most $8,290 per year — and perhaps as little as $2,560.

Even at the top of the range, the proposed price is a fraction of the $50,000 that Wall Street has reportedly come to expect (although RBC analyst Brian Abrahams puts the consensus figure at $11.5K). With critics, including experts on the FDA’s advisory committee, making their fierce opposition to aducanumab’s approval loud and clear, the pricing pressure adds one extra wrinkle Biogen CEO Michel Vounatsos doesn’t need as he orders full-steam preparation for a launch.