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)

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Tom Barnes (Orna)

The mR­NA era is here. MPM be­lieves the fu­ture be­longs to oR­NA — and Big Phar­ma wants a seat at the ta­ble

If the ultra-fast clinical development of Covid-19 vaccines opened the world’s eyes to the promises of messenger RNA, the subsequent delays in supply offered a crash course on the ultra-complex process of producing them. Even before the formulation and fill-finish steps, mRNA is the precious end product from an arduous journey involving enzyme-aided transcription, modification and purification.

For Bristol Myers Squibb, Novartis Institutes for Biomedical Research, Gilead’s Kite and Astellas, it’s time to rethink the way therapeutic RNA is engineered.

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FDA re­view­ers en­dorse J&J sin­gle-dose shot, lay­ing path for 3rd US vac­cine

J&J’s single-dose vaccine may not have produced quite the stellar numbers of the mRNA shots, but it still won a ringing endorsement from FDA reviewers, who argued in briefing documents that it could provide robust protection against the still-raging virus.

The FDA confirmed that across just under 40,000 volunteers, the vaccine proved 66% effective at preventing symptomatic Covid-19, including 72% effective in the United States. Although that’s short of the 95% figures put up by Moderna and Pfizer-BioNTech, the shot was still 85% effective at stopping severe disease 28 days after administration. There were seven deaths in the placebo group — zero in the vaccine group.

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S&P ex­pects steady ero­sion in Big Phar­ma's cred­it pro­file in 2021 as new M&A deals roll in — but don't un­der­es­ti­mate their un­der­ly­ing strength

S&P Global has taken a look at the dominant forces shaping the pharma market and come to the conclusion that there will be more downgrades than upgrades in 2021 — the 8th straight year of steady decline.

But it’s not all bad news. Some things are looking up, and there’s still plenty of money to be made in an industry that enjoys a 30% to 40% profit margin, once you factor in steep R&D expenses.

Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Ken Frazier, Merck CEO (Bess Adler/Bloomberg via Getty Images)

UP­DAT­ED: Mer­ck takes a swing at the IL-2 puz­zle­box with a $1.85B play for buzzy Pan­dion and its au­toim­mune hope­fuls

When Roger Perlmutter bid farewell to Merck late last year, the drugmaker perhaps best known now for sales giant Keytruda signaled its intent to take a swing at early-stage novelty with the appointment of discovery head Dean Li. Now, Merck is signing a decent-sized check to bring an IL-2 moonshot into the fold.

Merck will shell out roughly $1.85 billion for Pandion Pharmaceuticals, a biotech hoping to gin up regulatory T cells (Tregs) to treat a range of autoimmune disorders, the drugmaker said Thursday.

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Biden is look­ing be­yond Wood­cock or Sharf­stein for FDA com­mis­sion­er — re­port

Neither Janet Woodcock nor Joshua Sharfstein is likely to be nominated as the permanent FDA commissioner, Steve Usdin at BioCentury reports.

The White House is looking for alternatives to Woodcock, the acting chief and longtime CDER director, after opposition from several Democratic senators who are calling on others to block her nomination if her name is put forth, according to Usdin. Sharfstein, the former principal deputy FDA commissioner and current Johns Hopkins professor, is out of the running altogether.