As gener­ic com­pe­ti­tion stut­ter sales of top on­col­o­gy drugs, Roche se­cures speedy re­view for pair of ex­per­i­men­tal can­cer of­fer­ings

As drug de­vel­op­ers seek ways to ex­pand ther­a­peu­tic ap­pli­ca­tions and over­come the hur­dles seen with the first gen­er­a­tion of an­ti­body drug con­ju­gates (AD­Cs), Roche is cap­i­tal­iz­ing on its tro­jan horse ADC — pow­ered by Seat­tle Ge­net­ics’ tech­nol­o­gy — as gener­ics eat in­to the sales of its tri­fec­ta of top can­cer drugs. On Tues­day, the Swiss drug­mak­er said its an­ti-CD79b ADC — po­latuzum­ab ve­dotin — had won the FDA’s pri­or­i­ty re­view for use in pa­tients with re­lapsed or re­frac­to­ry dif­fuse large B-cell lym­phoma (DL­B­CL), a field that is with­in the clutch of CAR-T ther­a­pies.

The FDA is ex­pect­ed to make its de­ci­sion by Au­gust 19, Roche said on Tues­day.

Po­latuzum­ab ve­dotin is be­ing re­viewed by the reg­u­la­tor when added to ben­damus­tine and Rit­ux­an (BR). The triplet had pre­vi­ous­ly se­cured break­through ther­a­py sta­tus. The pri­or­i­ty re­view was grant­ed on the ba­sis of an 80-pa­tient study in heav­i­ly pre-treat­ed sub­jects that showed the com­bo eclipsed me­di­an over­all sur­vival (an ex­plorato­ry end­point) com­pared to BR alone, help­ing pa­tients live longer by 12.4 months ver­sus 4.7 months. Da­ta al­so showed 40% of peo­ple treat­ed with po­latuzum­ab ve­dotin plus BR achieved a com­plete re­sponse (CR), while on­ly 18% of peo­ple treat­ed with BR alone achieved a CR.

The CD79b pro­tein is ex­pressed in the ma­jor­i­ty of types of B-cell non-Hodgkin lym­phomas, the most com­mon sub­type of NHL. Al­though pa­tients are gen­er­al­ly re­spon­sive to first­line treat­ment, as many as 40% of pa­tients re­lapse, af­ter which op­tions are lim­it­ed and sur­vival is short. Po­latuzum­ab ve­dotin, which is be­ing test­ed for use in sev­er­al types of NHL, binds to CD79b and dec­i­mates B-cells via a tar­get­ed ap­proach: min­i­miz­ing the ef­fects on healthy cells while max­i­miz­ing tu­mour cell death, us­ing ADC tech that is some­times likened to a tro­jan horse as it is en­gi­neered to go un­no­ticed, de­liv­er­ing chemother­a­pies to cells ex­press­ing the anti­gen tar­get.

Sep­a­rate­ly, Roche has al­so won a pri­or­i­ty re­view for en­trec­tinib, a drug for use in neu­rotroph­ic tropomyosin re­cep­tor ki­nase (NTRK) fu­sion-pos­i­tive, lo­cal­ly ad­vanced or metasta­t­ic sol­id tu­mors in pa­tients whose can­cer has pro­gressed de­spite ther­a­py as well as pa­tients with metasta­t­ic ROS-1 pos­i­tive non-small cell lung can­cer (NSCLC).

The FDA is ex­pect­ed to make its de­ci­sion on the drug, which has pre­vi­ous­ly se­cured break­through ther­a­py sta­tus, by Au­gust 18, Roche said.

Roche, which bagged en­trec­tinib late in 2017 with its $1.7 bil­lion Igny­ta buy­out, hopes the drug will fare well ver­sus Bay­er’s Vi­t­rakvi — the first drug ap­proved by the FDA for NTRK fu­sion can­cers and the run­ner up ’tis­sue ag­nos­tic’ can­cer treat­ment that won the US reg­u­la­to­ry nod. With­in NSCLC, en­trec­tinib will be up against Pfiz­er’s Xalko­ri, which is the stan­dard treat­ment in ROS-1 pos­i­tive 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.

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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Covid-19 roundup: Roche pairs Actem­ra with remde­sivir in new PhI­II; GSK makes its own 1B vac­cine man­u­fac­tur­ing plan

A month after a small study in France suggested that Roche’s IL-6 inhibitor Actemra helped Covid-19 patients do better — even as Sanofi and Regeneron found somewhat disappointing results with their rival drug — Roche is doubling down on the strategy.

The Swiss pharma giant is kicking off a second Phase III global placebo-controlled study involving Actemra. But rather than testing it as a monotherapy, they will add Gilead’s remdesivir to the regimen.

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Bris­tol My­ers Squibb fi­nal­ly gets in the front­line NSCLC game dom­i­nat­ed by Mer­ck, adding a sec­ond Op­di­vo/Yer­voy-based op­tion

Bristol Myers Squibb may be trailing Merck and Roche in the checkpoint race to treat frontline cases of non-small cell lung cancer, but as it does, it makes sure to bring its best feet forward.

Just days after scoring a landmark NSCLC approval for Opdivo and Yervoy alone for PD-L1 positive patients, the company said the FDA has also OK’d using the two agents with a limited course of chemo regardless of the biomarker status.

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FDA ex­plains im­pact of Covid-19 on ap­pli­ca­tions, for­mal meet­ings

The FDA on Tuesday issued immediately effective guidance explaining how the coronavirus disease public health emergency is impacting the conduct of formal meetings and its review of certain user fee-funded applications.

The guidance features 11 questions and answers on how the agency intends to handle disruptions affecting meetings and goals under its user fee programs established by the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BSUFA) and the Generic Drug User Fee Amendments (GDUFA).

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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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.