Bris­tol-My­ers’ check­point star Op­di­vo fails a PhI­II study for glioblas­toma

Bris­tol-My­ers Squibb $BMY has had an­oth­er set­back on the check­point in­hi­bi­tion front, though this one they can take in stride.

Fouad Namouni, Bris­tol-My­ers Squibb

Their big drug Op­di­vo failed to beat out Avastin in treat­ing re­cur­rent glioblas­toma, or brain can­cer, in im­prov­ing over­all sur­vival rates. In­ves­ti­ga­tors are hold­ing back the ac­tu­al da­ta for a pre­sen­ta­tion at an up­com­ing con­fer­ence in Zurich.

Check­mate-143 was the first ran­dom­ized study of a PD-1 check­point for glioblas­toma, says Bris­tol-My­ers, which is still pur­su­ing two first-line GBM clin­i­cal tri­als, Check­Mate -498 and Check­Mate -548, eval­u­at­ing the com­bi­na­tion of Op­di­vo with ra­di­a­tion ther­a­py with or with­out temo­zolo­mide in O6-methyl­gua­nine-DNA methyl­trans­ferase (MGMT)-un­methy­lat­ed and methy­lat­ed pa­tients.

Once the lead­ing play­er in PD-1, Bris­tol-My­ers has had to deal with bit­ter set­backs on the non-small cell lung can­cer front, as Mer­ck has surged past with Keytru­da. But with four play­ers now in the mar­ket, with the ar­rival of avelum­ab, all the ma­jor league de­vel­op­ers here are scram­bling for­ward in hun­dreds of stud­ies try­ing com­bos or monother­a­py for a wide range of can­cers.

All of that ac­tiv­i­ty seems to be ramp­ing up with new stud­ies every day as these com­pa­nies hus­tle to claim their share of a multi­bil­lion-dol­lar mar­ket.

While Bris­tol-My­ers ac­knowl­edged this fail­ure, the com­pa­ny was al­so post­ing more pos­i­tive da­ta on Op­di­vo, in­clud­ing its 2-year over­all sur­vival da­ta for its Yer­voy com­bo on first-line melanoma.

“GBM is a his­tor­i­cal­ly dif­fi­cult dis­ease to treat and con­ven­tion­al treat­ment op­tions have demon­strat­ed lim­it­ed re­spons­es,” said Fouad Namouni, the head of On­col­o­gy De­vel­op­ment and head of Med­ical for Bris­tol-My­ers Squibb. “We re­main stead­fast in our pur­suit of treat­ments for dis­eases with the high­est un­met need and con­tin­ue our work to de­ter­mine how our Im­muno-On­col­o­gy agents can po­ten­tial­ly im­prove out­comes for these pa­tients.”

Paul Hudson, Sanofi CEO (Getty Images)

Sanofi CEO Paul Hud­son has $23B burn­ing a hole in his pock­et. And here are some hints on how he plans to spend that

Sanofi has reaped $11.1 billion after selling off a big chunk of its Regeneron stock at $515 a share. And now everyone on the M&A side of the business is focused on how CEO Paul Hudson plans to spend it.

After getting stung in France for some awkward politicking — suggesting the US was in the front of the line for Sanofi’s vaccines given American financial support for their work, versus little help from European powers — Hudson now has the much more popular task of managing a major cash cache to pull off something in the order of a big bolt-on. Or two.

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The Advance Clinical leadership team: CEO Yvonne Lungershausen, Sandrien Louwaars - Director Business Development Operations, Gabriel Kremmidiotis - Chief Scientific Officer, Ben Edwards - Chief Strategy Officer

How Aus­tralia De­liv­ers Rapid Start-up and 43.5% Re­bate for Ear­ly Phase On­col­o­gy Tri­als

About Avance Clinical

Avance Clinical is an Australian owned Contract Research Organisation that has been providing high-quality clinical research services to the local and international drug development industry for 20 years. They specialise in working with biotech companies to execute Phase 1 and Phase 2 clinical trials to deliver high-quality outcomes fit for global regulatory standards.

As oncology sponsors look internationally to speed-up trials after unprecedented COVID-19 suspensions and delays, Australia, which has led the world in minimizing the pandemic’s impact, stands out as an attractive destination for early phase trials. This in combination with the streamlined regulatory system and the financial benefits including a very favourable exchange rate and the R & D cash rebate makes Australia the perfect location for accelerating biotech clinical programs.

Roger Perlmutter, Merck R&D chief (YouTube)

UP­DAT­ED: Backed by BAR­DA, Mer­ck jumps in­to Covid-19: buy­ing out a vac­cine, part­ner­ing on an­oth­er and adding an­tivi­ral to the mix

Merck execs are making a triple play in a sudden leap into the R&D campaign against Covid-19. And they have more BARDA cash backing them up on the move.

Tuesday morning the pharma giant simultaneously announced plans to buy an Austrian biotech that has been working on a preclinical vaccine candidate, added a collaboration on another vaccine with the nonprofit IAVI and inked a deal with Ridgeback Biotherapeutics on an early-stage antiviral.

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Dan O'Day, Gilead CEO (Andrew Harnik, AP Images)

UP­DAT­ED: Gilead leas­es part­ner rights to TIG­IT, PD-1 in a $2B deal with Ar­cus. Now comes the hard part

Gilead CEO Dan O’Day has brokered his way to a PD-1 and lined up a front row seat in the TIGIT arena, inking a deal worth close to $2 billion to align the big biotech closely with Terry Rosen’s Arcus. And $375 million of that comes upfront, with cash for the buy-in plus equity, along with $400 million for R&D and $1.22 billion in reserve to cover opt-in payments and milestones..

Hotly rumored for weeks, the 2 players have formalized a 10-year alliance that starts with rights to the PD-1, zimberelimab. O’Day also has first dibs on TIGIT and 2 other leading programs, agreeing to an opt-in fee ranging from $200 million to $275 million on each. There’s $500 million in potential TIGIT milestones on US regulatory events — likely capped by an approval — if Gilead partners on it and the stars align on the data. And there’s another $150 million opt-in payments for the rest of the Arcus pipeline.

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Bryan Roberts, Venrock

Ven­rock sur­vey shows grow­ing recog­ni­tion of coro­n­avirus toll, wan­ing con­fi­dence in ar­rival of vac­cines and treat­ments

When Venrock partner Bryan Roberts went to check the results from their annual survey of healthcare leaders, what he found was an imprint of the pandemic’s slow arrival in America.

The venture firm had sent their form out to hundreds of insurance and health tech executives, investors, officials and academics on February 24 and gave them two weeks to fill it out. No Americans had died at that point but the coronavirus had become enough of a global crisis that they included two questions about the virus, including “Total U.S. deaths in 2020 from the novel coronavirus will be:”.

Fabrice Chouraqui, Cellarity CEO-partner (LinkedIn)

Drug de­vel­op­er, Big Phar­ma com­mer­cial ex­ec, now an up­start biotech chief — Fab­rice Chouraqui is ready to try some­thing new as a ‘CEO-part­ner’ at Flag­ship

Fabrice Chouraqui’s career has taken some big twists along his life journey. He got his PharmD at Université Paris Descartes and jumped into the drug development game for a bit. Then he took a sharp turn and went back to school to get his MBA at Insead before returning to pharma on the commercial side.

Twenty years later, after steadily rising through the ranks and journeying the globe to nab a top job as president of US pharma for the Basel-based Novartis, Chouraqui exited in another career switch. And now he’s headed into a hybrid position as a CEO-partner at Flagship, where he’ll take a shot at leading Cellarity — one of the VC’s latest paradigm-changing companies of the groundbreaking model that aspires to deliver a new platform to the world of drug R&D.

Al­ny­lam nabs speedy re­view, set­ting up 3rd pos­si­ble ap­proval in 3 years

After nearly two decades in the haze of preclinical and clinical development, things seem to be coming into focus for Alnylam Pharmaceuticals.

Two years ago the company landed the first approved drug for RNA interference (RNAi), a Nobel Prize-winning technique discovered in plants and pioneered around the turn of the century. Then last year, they landed another approval. Now, fresh off a massive investment from Blackstone, they’ve received an FDA priority review designation for a third therapy, setting them up to potentially nab three different approvals in three consecutive years.

UP­DAT­ED: GSK adds to its trove of pos­i­tive da­ta for mul­ti­ple myelo­ma con­tender as ri­vals con­tin­ue to com­mand the spot­light

GlaxoSmithKline’s cancer R&D team put up more positive numbers for its ADC belantamab mafodotin, one of its top pipeline prospects.

Flashing the results just ahead of a busy ASCO weekend, Axel Hoos and the team noted new multiple myeloma data highlighting promising responses from their open-label DREAMM-6 study — after confirming the overall response rate of 32% among heavily pre-treated patients reviewed in DREAMM-2.

UP­DAT­ED: Dupix­ent clears PhI­II tri­al in new dis­ease as block­buster looks to ex­pand past Re­gen­eron-Sanofi split

Sanofi and Regeneron may be splitting up, but their billion-dollar baby, Dupixent, keeps on growing.

Already grossing over $2 billion last year based on FDA approvals for asthma and atopic dermatitis and a form of rhinosinusitis, Dupixent may be nearing a fourth indication: Eosinophilic esophagitis (EoE), an inflammatory disease marked by the buildup of white blood cells in the esophagus and which affects around 160,000 US patients annually.