John Oyler at the US-China Biopharma Innovation and Investment Summit in Shanghai on October 23, 2018. (Credit: Endpoints News, PharmCube)

Plough­ing through a crowd­ed PD-(L)1 mar­ket, BeiGene loads up on promis­ing lung can­cer da­ta

BeiGene’s en­try to the PD-1 mar­ket — as the fourth do­mes­tic drug­mak­er to score ap­proval in Chi­na, lag­ging months be­hind multi­na­tion­al play­ers — might have been un­re­mark­able. But the fol­low-up act is where it plans to shine.

Three months af­ter post­ing pos­i­tive top-line pro­gres­sion-free sur­vival re­sults for their piv­otal Chi­nese study with tislelizum­ab and chemo for front­line squa­mous non-small cell lung can­cer, BeiGene said the PD-1 an­ti­body hit the same mark for non-squa­mous cas­es of NSCLC. In both tri­als, the drug was paired with chemother­a­py and the reg­i­men was com­pared to chemo alone.

Why does it mat­ter? SVB Leerink an­a­lyst An­drew Berens summed it up this way:

This pos­i­tive out­come in non-squa­mous NSCLC, and pri­or suc­cess in squa­mous NSCLC, along with ap­proved in­di­ca­tions in blad­der can­cer and clas­sic Hodgkin’s lym­phoma, could po­ten­tial­ly en­able Tisle to have the broad­est la­bel among all Chi­na do­mes­tic PD-1/L1 agents, which could give the com­pa­ny a com­pet­i­tive ad­van­tage and broad na­tion­al re­im­burse­ment, which could ul­ti­mate­ly chal­lenge the multi­na­tion­al agents.

The com­pa­ny has in­di­cat­ed that it plans to sub­mit an sN­DA for first-line squa­mous NSCLC in Chi­na in 2020. Once the over­all sur­vival re­sults, which con­sti­tute one of the sec­ondary end­points in these tri­als, are in, Berens ex­pects BeiGene to lever­age the datasets to sup­port po­ten­tial fil­ing in the US.

Yong Ben

Tislelizum­ab is be­ing stud­ied in more than 25 tri­als world­wide, added Yong Ben, CMO of im­muno-on­col­o­gy. They in­clude a Phase III pit­ting the drug against do­c­etax­el in sec­ond-line or third-line NSCLC, ex­pect­ed by ear­ly 2021, in ad­di­tion to tri­als in he­pa­to­cel­lu­lar car­ci­no­ma and esophageal can­cer.

Berens es­ti­mates peak rev­enues at $460 mil­lion in Chi­na, with $28 mil­lion in 2020 — which he said “could prove to be very con­ser­v­a­tive if the com­pa­ny is able to cap­ture a sig­nif­i­cant por­tion of the rapid­ly grow­ing PD-1 mar­ket.”

CEO John Oyler is go­ing all out. Just days ago BeiGene nabbed its first sol­id tu­mor OK in lo­cal­ly ad­vanced or metasta­t­ic urothe­lial car­ci­no­ma. Chi­na’s Na­tion­al Med­ical Prod­uct Ad­min­is­tra­tion, which grant­ed the sN­DA pri­or­i­ty re­view pre-pan­dem­ic, based its de­ci­sion on a sin­gle-arm piv­otal Phase II.

It marked tislelizum­ab’s sec­ond in­di­ca­tion af­ter the ini­tial ap­proval for clas­si­cal Hodgkin’s lym­phoma in De­cem­ber 2019.

Like urothe­lial can­cer, pa­tients with Stage II­IB or Stage IV non-squa­mous NSCLC are al­so in need of more treat­ment op­tions, BeiGene said. Its ri­vals at In­novent and Hen­grui ev­i­dent­ly agree, lin­ing up their own pro­grams to tack­le the mar­ket.

UP­DAT­ED: In a fresh dis­ap­point­ment, Am­gen spot­lights a ma­jor safe­ty is­sue with KRAS com­bo

Amgen had hoped that its latest study matching its landmark KRAS G12C drug Lumakras with checkpoint inhibitors would open up its treatment horizons and expand its commercial potential. Instead, the combo spurred safety issues that blunted efficacy and forced the pharma giant to alter course on its treatment strategy, once again disappointing analysts who have been tracking the drug’s faltering sales and limited therapeutic reach.

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Ad­dress­ing the ‘Ca­pac­i­ty Crunch’ with a Scal­able Plat­form Process Ap­proach

The field of gene therapy has been diligently moving forward over the past several decades to bring potentially life-saving treatments to patients with genetic diseases. In addition to two approved adeno-associated viral (AAV) gene therapies, there are more than 250 AAV gene therapies in various clinical trial stages.1 AAV vectors remain the most frequently used vector for delivering therapeutic transgenes to target tissues due to their demonstrated and lasting clinical efficacy and extensive safety track record. As AAV therapies advance through clinical trials and into commercialization, many biotech companies are turning to contract development and manufacturing organizations (CDMOs) to prepare their programs for late-stage clinical and commercial scale manufacturing. Given the scope and scale of the manufacturing needs that will accompany regulatory approvals for these assets, CDMOs continue to expand their capacity to meet the needs of increasing prevalent patient populations. However, despite rapid growth, projected gene therapy manufacturing demands still outpace the collective capacity of the CDMO industry.

A $5B Pfiz­er buy­out? Am­gen, Gilead head­line M&A Thurs­day; Al­ny­lam's AT­TR sweep; An­drew Lo's rare dis­ease quest; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

One of the cool things about adding EndpointsPharma to the daily roster is that my colleagues can now dedicate time to tracking quarterly updates and tuning into calls with Big Pharma companies. Check out their dispatch from the Q2 earnings below.

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Bob Bradway, Amgen CEO (Justin Kase Conder/AP Images for Amgen)

UP­DAT­ED: Am­gen chief Brad­way nabs a rare dis­ease play­er in $4B buy­out as the M&A tem­po ac­cel­er­ates

Amgen CEO Bob Bradway is bellying up to the M&A table today, scooping up the newly anointed commercial biotech ChemoCentryx $CCXI and its recently approved rare disease drug for $3.7 billion out of the cash stockpile. The deal comes in at $52 a share — a hefty increase over the $24.11 close yesterday.

Bradway and the Amgen team get a drug called Tavneos (avacopan) in the deal, a complement factor C5a inhibitor OK’d to treat anti-neutrophil cytoplasmic autoantibody (ANCA)-vasculitis, an autoimmune disease which can be lethal.

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George Yancopoulos, Regeneron president and CSO (Brendan McDermid/Reuters/Alamy)

George Yan­copou­los says he's on the trail of the holy grail: ‘This could rep­re­sent the next break­through for im­munother­a­py’

Two of the most outspoken — and successful — drug developers in biotech say they’ve collected early-stage clinical data that are pointing them down the trail to the holy grail in cancer immunotherapy R&D.

While analysts largely busied themselves today with chronicling the ongoing success of Regeneron’s two big cash cows — Dupixent and Eylea — chief scientist George Yancopoulos and CEO Len Schleifer used the Q2 call to spotlight their early success with a combination of the “homegrown” PSMAxCD28 costimulatory bispecific antibody REGN5678 in combination with their PD-1 checkpoint Libtayo. The presentation comes just weeks after Regeneron completed a deal to gather all rights to the PD-1 that had been in Sanofi’s hands. And the two top execs are unstinting in their praise of the potential of a whole set of costimulatory pipeline projects which they say may finally deliver the long-awaited next-level approach to broadening the immunotherapy field of drugs.

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Albert Bourla, Pfizer CEO (Laurent Gillieron/Keystone via AP)

Break­ing: Pfiz­er in hot pur­suit of a $5B buy­out of Glob­al Blood Ther­a­peu­tics — re­port

Pfizer CEO Albert Bourla has vowed to leave no stone unturned in the search for new biotech deals, and the BD team is not letting him down.

The Wall Street Journal reported today that Pfizer is in the final stages of acquiring Global Blood Therapeutics for $5 billion. According to the Journal report, though, Pfizer is not the only buyer at the deal table and while the pharma giant may be close to clinching it, there are no guarantees it will continue.

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(AP Photo/Richard Vogel, File)

US de­clares mon­key­pox a na­tion­al health emer­gency, as new drug­mak­ers con­sid­er en­ter­ing vac­cine race

Rising monkeypox cases have put the US on high alert as it announces a national health emergency, which grants the government more power in its response.

The news comes as Bavarian Nordic continues to fill orders for its Jynneos vaccine and other companies – including Moderna – consider jumping into the vaccine race. Meanwhile, the New York Times reports that the US has allowed around 20 million doses of smallpox vaccine in its stockpile to expire.

Pfiz­er ter­mi­nates PhI­II study of rare car­dio­vas­cu­lar drug picked up in $11.4B Ar­ray ac­qui­si­tion

While Pfizer’s $11.4 billion acquisition of Array BioPharma in the summer of 2019 was mainly focused on oncology, namely Braftovi and Mektovi, there were a few non-cancer assets, including a Phase III drug being tested in a rare cardiovascular disease.

The late-stage trial is now being axed, alongside any further development of the oral small molecule, the pharma giant disclosed after the closing bell on Wednesday. Based on an interim futility analysis of the global Phase III REALM-DCM trial, Pfizer determined a path forward was not in its best interest. Pfizer no longer expected the study would meet its primary goal.

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Vlad Coric, Biohaven CEO

Bio­haven touts surge in Nurtec sales ahead of Pfiz­er takeover

Forget buyer’s remorse, Pfizer is likely feeling pretty good about its $11.6 billion Biohaven takeover deal following reports of a 57% sales boost for migraine med Nurtec.

Biohaven reported in Q2 results on Friday that it’s cleared the necessary antitrust hurdles to move forward with the sale of its calcitonin gene-related peptide (CGRP) assets to Pfizer. However, because the company is “focused on workstreams related to the closing” of the deal, it did not host a call with analysts and investors.