PhI­II deal­mak­ing fren­zy in i/o con­tin­ues as As­traZeneca fol­lows PA­CIF­IC with a new In­cyte IDO1 com­bo

In­cyte CEO Hervé Hop­penot made it clear a long time ago that he was hap­pi­ly fast and loose about which ap­proved PD-(L)1 drug he part­nered with on his IDO1 drug epaca­do­stat. He launched piv­otal com­bo stud­ies with Mer­ck and Bris­tol-My­ers Squibb, and now he’s kick­ing off a new Phase III tie-up with As­traZeneca’s Imfinzi (dur­val­um­ab) in stage III non-small cell lung can­cer, con­tin­u­ing a re­la­tion­ship that dates back three years.

Hervé Hop­penot

For As­traZeneca, this is a chance to fol­low up on its PA­CIF­IC study af­ter un­veil­ing some (very bad­ly need­ed) pos­i­tive da­ta in Sep­tem­ber for in­op­er­a­ble, lo­cal­ly ad­vanced stage 3 lung can­cer where the can­cer had not ad­vanced af­ter chemo.

Stage 3 it­self rep­re­sents a third of NSCLC in­ci­dence, and As­traZeneca CEO Pas­cal So­ri­ot with chief med­ical of­fi­cer Sean Bo­hen ex­plained at ES­MO that it po­si­tioned Imfinzi as the lead check­point in the front half of the crit­i­cal lung can­cer mar­ket for stages 1 through 3, with a strate­gic ad­van­tage for mov­ing in­to stage 4 cas­es.

That suc­cess was re­port­ed just two months af­ter a ma­jor set­back on their late-stage com­bo study us­ing dur­val­um­ab with the CT­LA-4 drug treme­li­mum­ab, which failed the first leg of a two-part piv­otal tri­al. That helped raise new doubts about the fu­ture of CT­LA-4 drug com­bi­na­tions, though As­traZeneca has con­sid­er­able hope that the over­all sur­vival stats in the study will be pos­i­tive.

Sean Bo­hen

The new com­bo study al­so high­lights the fren­zy of part­ner­ing that’s been go­ing on in the check­point field. PD-(L)1 drugs can be used sys­tem­i­cal­ly against a wide range of on­col­o­gy tar­gets and have a lot of po­ten­tial in terms of com­bi­na­tions with more tar­get­ed agents. It al­so fol­lows close­ly on the heels of a new deal that In­cyte struck with Macro­Gen­ics to in-li­cense an ex­per­i­men­tal PD-1 drug af­ter their own in-house pro­gram ran smack in­to some safe­ty is­sues, es­sen­tial­ly ru­in­ing its com­mer­cial po­ten­tial.

“Imfinzi has shown ex­cit­ing clin­i­cal po­ten­tial in treat­ing pa­tients with lo­cal­ly-ad­vanced lung can­cer. We are pleased to build on re­cent da­ta from the PA­CIF­IC tri­al to fur­ther ex­plore how Imfinzi, in com­bi­na­tion with an IDO1 en­zyme in­hibitor, could pro­vide ad­di­tion­al ben­e­fit to pa­tients with lo­cal­ly-ad­vanced lung can­cer,” said Sean Bo­hen, As­traZeneca’s chief med­ical of­fi­cer.

Novotech CRO Ex­pands Chi­na Team as Biotech De­mand for Clin­i­cal Tri­als In­creas­es up to 79%

An increase in demand of up to 79% for clinical trials in China has prompted Novotech the Asia-Pacific CRO to rapidly expand the China team, appointing expert local clinical executives to their Shanghai and Hong Kong offices. The company is planning to expand their team by 30% over the next quarter.

Novotech China has seen considerable demand recently which is borne out by research from GlobalData:
A global migration of clinical research is occurring from high-income countries to low and middle-income countries with emerging economies. Over the period 2017 to 2018, for example, the number of clinical trial sites opened by biotech companies in Asia-Pacific increased by 35% compared to 8% in the rest of the world, with growth as high as 79% in China.
Novotech CEO Dr John Moller said China offers the largest population in the world, rapid economic growth, and an increasing willingness by government to invest in research and development.
Novotech’s 23 years of experience working in the region means we are the ideal CRO partner for USA biotechs wanting to tap the research expertise and opportunities that China offers.
There are over 22,000 active investigators in Greater China, with about 5,000 investigators with experience on at least 3 studies (source GlobalData).

Daniel O'Day [via AP Images]

UP­DAT­ED: Gilead un­leash­es a $5B late-stage cash al­liance with Gala­pa­gos — lay­ing out O'­Day's R&D strat­e­gy

Daniel O’Day is executing his first major development deal since taking over as CEO of Gilead $GILD. And he’s going in deep to ally himself with a longstanding partner.

O’Day announced today that he is spending $5 billion in cash to add new late-stage drugs to Gilead’s pipeline, picking up rights to Galapagos’ $GLPG Phase III IPF drug GLPG1690 alongside adoption of the biotech’s Phase IIb drug GLPG1972 for osteoarthritis. And Gilead is also putting billions more on the table for milestones, gaining options for everything else in Galapagos’ pipeline, with a shot at all rights outside of Europe.

Altogether, Gilead is gaining rights to 6 clinical-stage assets, 20 preclinical programs and everything else being hatched in translation.

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Hal Barron [File photo]

Hal Bar­ron's team at GSK scores a win with pos­i­tive Ze­ju­la PhI­II front­line study — now comes the hard part

Score one for Hal Barron and the new R&D team steering GlaxoSmithKline’s pipeline.

The pharma giant reported this morning that its recently acquired PARP, Zejula (niraparib), hit the primary endpoint on progression-free survival in a frontline maintenance setting for women suffering ovarian cancer — following chemo and regardless of their BRCA status.

GSK bet $5 billion on the Tesaro buyout primarily to get this drug, drawing the shaking heads of biopharma. Why pay a big premium for a drug like this when AstraZeneca was going from strength to strength with Lynparza, ran the argument, having won a hugely important accelerated approval to jump out ahead — way ahead — of the rest of the PARP players? Lynparza — now co-owned by a powerhouse cancer team at Merck — won the first approval in frontline maintenance in ovarian cancer.

Alk­er­mes adds bipo­lar I dis­or­der to its FDA wish­list; Con­go con­firms first Ebo­la case in large city

→ An ever-ambitious Alkermes $ALKS team plans to add bipolar I disorder to its list of conditions for ALKS-3831, which it plans to pitch to the FDA in Q4. Alkermes says they were persuaded to add bipolar I disorder after a pre-NDA meeting with the agency, which came about 7 months after the biotech reported positive data for schizophrenia. The drug is a combo using olanzapine/samidorphan, which they hope will be shown to be as effective as olanzapine without the substantial increase in the risk of weight gain.

Pe­ter Kolchin­sky and Raj Shah raise a $300M fund de­vot­ed to biotech star­tups

Peter Kolchinsky and Raj Shah have another $300 million-plus to play with on the biotech venture side of their investment business. 

The two announced Monday morning that they’ve put together their first pure-play venture fund at RA Capital Management, which has been known to bet on just about every angle in healthcare investing — from rounds to follow-on investments at public companies. This new fund of theirs arrives well into a go-go era of new startup financing, with a particular focus on building new biotechs.

Boehringer buys Swiss biotech in its lat­est M&A deal, go­ing the next-gen can­cer vac­cine route

Boehringer Ingelheim has snapped up a Swiss biotech startup and added their group as a new platform for the oncology pipeline. 

The German biopharma company has bagged Geneva-based AMAL Therapeutics, paying out an unspecified upfront in a $358 million deal — cash, milestones and everything else, all in. Plus there’s 100 million euros on the line for commercial milestones.

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Ab­b­Vie beefs up the on­col­o­gy pipeline, bag­ging an up­start STING play­er with its own unique ap­proach

AbbVie isn’t letting its $63 billion buyout of Allergan stop its M&A/deals team from continuing their work.

Monday morning we learned that the pharma giant is snapping up tiny Mavupharma out of Seattle, a Frazier-backed startup that has its own unique take on STING — which is on the threshold of their first clinical trial.

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Billing it­self as the first AI biotech to launch hu­man tri­als, Re­cur­sion adds $121M C round

Billing itself as the first AI biotech with programs in the clinic, Salt Lake City-based Recursion now has a $121 million bankroll to start gathering human data to see if it’s on the right track. 

“We’re trying to build this discovery engine,” Recursion CEO Chris Gibson tells me ahead of the C round news. “We now have the first two programs in the clinic.” And that, he adds, qualifies as a first for any AI establishment “that actually have something in the clinic.”

FDA bats back As­traZeneca's SGLT di­a­betes drug for Type 1 di­a­betes — block­ing a class on safe­ty fears

The FDA has just fired its latest salvo at the SGLT class of diabetes drugs, blowing up some commercial opportunity at AstraZeneca as part of the collateral damage.

The pharma giant reported early Monday that the FDA has rejected its blockbuster drug Farxiga for Type 1 diabetes that can’t be controlled by insulin. And while the pharma giant maintained its usual grim silence in the face of a setback, this one should be easy to interpret.