In­novent and Lil­ly win sec­ond Chi­na OK for Tyvyt in front­line NSCLC, ramp­ing up pres­sure on king Keytru­da

In­novent Bi­o­log­ics and its part­ners at Eli Lil­ly have notched an­oth­er ar­row in their quiver in their bid to take down Mer­ck’s Keytru­da.

Chi­nese reg­u­la­tors grant­ed a promi­nent new ap­proval for the pair’s Tyvyt on Wednes­day, in­di­cat­ing the drug for first-line treat­ment of non­squa­mous non-small cell lung can­cer in com­bi­na­tion with peme­trexed and plat­inum chemo. It’s the sec­ond ap­proval in the coun­try for the Chi­nese pow­er­house and Amer­i­can Big Phar­ma, af­ter Tyvyt was OK’ed in 2018 for re­lapsed or re­frac­to­ry clas­si­cal Hodgkin’s lym­phoma af­ter two lines of chemother­a­py.

Tyvyt is look­ing to break in­to a space where Keytru­da has long dom­i­nat­ed, hav­ing been al­ready ap­proved in both spaces. In the third quar­ter of 2020 alone, Keytru­da tal­lied $3.7 bil­lion in glob­al sales.

In­novent’s green light comes on the ba­sis of a ran­dom­ized, dou­ble-blind, Phase III tri­al with 397 NSCLC pa­tients. In­di­vid­u­als re­ceived ei­ther Tyvyt or a place­bo, plus Al­im­ta and plat­inum chemother­a­py as a first-line treat­ment. Those on Tyvyt saw a me­di­an pro­gres­sion-free sur­vival of 8.9 months, as op­posed to just five months on the place­bo.

The da­ta pack­age al­so in­clud­ed over­all sur­vival fig­ures, which had not been ready as of the in­ter­im analy­sis re­port­ed back in Au­gust. Af­ter an ex­tend­ed fol­low-up, the me­di­an OS of the drug arm was still not reached, while the place­bo group saw a me­di­an OS of 16 months. That notched a p-val­ue of p=0.0025.

Lung can­cer has the high­est in­ci­dence and mor­tal­i­ty rates among all tu­mor types, In­novent VP of med­ical sci­ence Hui Zhou said in a state­ment.

In­novent has had high ex­pec­ta­tions ever since its found­ing back in 2011, with the goal to lead the first biosim­i­lar wave in Chi­na. The com­pa­ny part­nered with Lil­ly in 2015 to de­vel­op and com­mer­cial­ize Tyvyt, and raised a then-record $260 mil­lion Se­ries D round in 2016.

It reached uni­corn sta­tus dur­ing its 2018 IPO that reaped it an­oth­er $421 mil­lion in fundrais­ing. And a few months af­ter its de­but, In­novent be­came the first drug­mak­er to get a home­grown Chi­nese check­point in­hibitor across the fin­ish line in the coun­try when Tyvyt gained ap­proval in Hodgkin’s lym­phoma.

Then, this past June, In­novent picked up an­oth­er part­ner­ship with a big-time phar­ma play­er — Roche. In­novent is re­search­ing bis­pe­cif­ic an­ti­bod­ies and cell ther­a­pies for use in hema­to­log­i­cal and sol­id can­cers, with Roche on the hook for near­ly $2 bil­lion in mile­stones if it ex­er­cis­es all its op­tions.

In­novent is fac­ing stiff com­pe­ti­tion from oth­er Chi­nese com­pa­nies, how­ev­er. Last Sep­tem­ber, Jun­shi de­clared a Phase III suc­cess for its lead drug tori­pal­imab in re­cur­rent or metasta­t­ic forms of na­sopha­ryn­geal car­ci­no­ma, da­ta that earned the pro­gram break­through sta­tus. And just this past Mon­day, Co­herus Bio­Sciences dropped $150 mil­lion up­front for the rights to the drug, with Jun­shi hand­ing back $50 mil­lion to in­vest in the com­pa­ny the next day.

In­novent CEO Michael Yu (Pho­tog­ra­ph­er: An­tho­ny Kwan/Bloomberg via Get­ty Im­ages)

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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EMA safe­ty com­mit­tee seeks more in­fo on heart in­flam­ma­tion fol­low­ing Pfiz­er Covid-19 vac­cine

The European Medicines Agency’s safety committee said Friday that it’s aware of cases of inflammation of the heart muscle and inflammation of the membrane around the heart, mainly reported following vaccination with Pfizer’s Covid-19 vaccine, known in Europe as Comirnaty.

“There is no indication that these cases are due to the vaccine,” the EMA’s Pharmacovigilance Risk Assessment Committee said.

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Angela Merkel (AP Photo/Michael Sohn)

Covid-19 roundup: Pfiz­er sub­mits vac­cine for full ap­proval; Merkel op­pos­es Biden pro­pos­al to sus­pend IP for vac­cines

Pfizer and BioNTech said Friday that they’ve submitted a biologics license application to the FDA for full approval of their mRNA vaccine for those over the age of 16.

How long it will take the FDA to decide on the BLA will be set once it’s been formally accepted by the agency.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, previously told Endpoints News that the review of the BLA should take between three and four months, but it may be even faster than that.

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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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.

An­oth­er failed tri­al for Or­p­hazyme's 'pipeline-in-a-pro­duc­t' leaves shad­ow on drug's fu­ture

The tumultuous ride for Orphazyme continued on Friday as the company announced that a pivotal trial for its lead drug arimoclomol failed yet again, this time in the treatment of ALS, seeding doubt in a drug that had recently been cleared by the FDA for priority review. The latest failure casts a darker shadow on the upcoming decision despite Orphazyme’s upbeat outlook.

In a statement, the Danish biotech announced that the drug did not meet its primary or secondary endpoints evaluating function and survival. But the company has not announced any data surrounding the failure, instead saying that it will publish the complete results later this year.

In­cyte ponies up $12M to set­tle char­i­ty foun­da­tion kick­back claims; US ex­er­cis­es op­tion for more dos­es of mon­key­pox vac­cine

One in a string of lawsuits targeting copay charity foundations, the DOJ has been hunting drugmaker Incyte for what prosecutors alleged was a kickback scheme to court patients. Now, Incyte is clearing its name.

Incyte will shell out $12.6 million to settle claims it funneled funds through a charity foundation to cover federal copays for patients taking its JAK inhibitor Jakafi, the DOJ said this week.

CEO Khurem Farooq (Gyroscope)

Hours be­fore ex­pect­ed de­but, Gy­ro­scope post­pones its IPO as 2 oth­er biotechs hold the line on their march to Nas­daq

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In a surprising turn of events, UK-based Gyroscope Therapeutics has postponed its IPO mere hours before it was set to debut on Nasdaq.

Working on a gene therapy for wet AMD, Gyroscope was all set and ready to go public earlier this week, setting terms for a $142 million raise with a price range of $20 to $22. But in the wee hours of Friday morning, the company put out a press release saying they would delay their debut “in light of market conditions,” CEO Khurem Farooq said in a statement.

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