Vivek Ra­maswamy launch­es yet an­oth­er Vant, this time in Asia with a TCR-fo­cused Medi­gene part­ner­ship

Vivek Ra­maswamy’s com­pa­ny-churn­ing shop Roivant is op­er­at­ing at full steam. Af­ter un­veil­ing Chi­nese bio­phar­ma up­start Sino­vant last year, the two en­ti­ties on Thurs­day de­buted a fresh cell ther­a­py com­pa­ny — Cy­to­vant Sci­ences — ded­i­cat­ed to the Asian mar­ket, armed with a part­ner­ship with Ger­many’s im­munother­a­py-fo­cused Medi­gene.

John Xu

Un­der the deal, Medi­gene has grant­ed Cy­to­vant ex­clu­sive li­cens­es to de­vel­op, man­u­fac­ture, and com­mer­cial­ize Medi­gene’s re­search-stage T cell im­munother­a­py tar­get­ing New York esophageal squa­mous cell car­ci­no­ma (NY-ESO-1 ) — a well-known can­cer-testis anti­gen ex­pressed by var­i­ous can­cers — as well as a den­drit­ic cell vac­cine tar­get­ing leukemia-as­so­ci­at­ed anti­gens — WT-1 and PRAME —in Greater Chi­na, South Ko­rea, and Japan. Cy­to­vant and Medi­gene will al­so dis­cov­er and col­lab­o­rate on T-cell re­cep­tor (TCR) im­munother­a­pies for two ad­di­tion­al tar­gets, tai­lored specif­i­cal­ly to Asian pa­tients.

One of the key com­po­nents of the im­mune sys­tem are T cells, which oblit­er­ate can­cer cells by us­ing T cell re­cep­tor (TCR) recog­ni­tion of cell sur­face mark­ers known as anti­gens. When a T cell rec­og­nizes a tu­mor anti­gen via the TCR, it snuffs the ma­lig­nant cell on which it re­sides. TCR tech typ­i­cal­ly in­volves reengi­neer­ing T-cell re­cep­tors so that they can bet­ter rec­og­nize can­cer pro­teins, spark­ing an as­sault on tu­mors. Un­like CAR-T cells that can rec­og­nize ab­nor­mal pro­teins ex­pressed on the sur­face, TCRs can rec­og­nize tu­mor-spe­cif­ic pro­teins on the in­side of cells. The ap­petite for TCR ther­a­pies and their po­ten­tial to tar­get sol­id tu­mors — a lim­i­ta­tion of ex­ist­ing cel­lu­lar ther­a­pies — has bur­geoned, fu­el­ing a string of deals. Ear­li­er this year, Roche’s Genen­tech agreed to fork out a meaty $300 mil­lion up­front for ac­cess to Adap­tive Biotech­nolo­gies’ tech plat­form, which is de­signed to iden­ti­fy T-cell re­cep­tors (TCRs) for ther­a­peu­tic use.

Medi­gene is get­ting $10 mil­lion up­front for the deal, and is el­i­gi­ble to re­ceive up to $1 bil­lion in mile­stone pay­ments for the four prod­ucts across mul­ti­ple in­di­ca­tions, in ad­di­tion to roy­al­ty pay­ments on net sales. Cy­to­vant will al­so re­im­burse all R&D costs in­curred by Medi­gene with­in the col­lab­o­ra­tion.

John Xu, a mol­e­c­u­lar im­mu­nol­o­gist and trans­la­tion­al sci­en­tist, has joined Cy­to­vant as its pres­i­dent. Pri­or to join­ing Cy­to­vant, Xu served as CSO of Mab-Leg­end Biotech, a Shang­hai-based an­ti­body dis­cov­ery com­pa­ny.


Im­age: Shut­ter­stock

In starved an­tibi­ot­ic field, Melin­ta soars as FDA grants speedy drug re­view

Such is the state of af­fairs in an­tibi­ot­ic land that the FDA agree­ing to pri­or­i­ty re­view an ap­pli­ca­tion to ex­pand the use of an an­tibi­ot­ic can rock­et up a stock more than two-fold.

On Wednes­day, Melin­ta Ther­a­peu­tics said its ap­proved an­tibi­ot­ic Baxdela had been grant­ed pri­or­i­ty re­view for use in com­mu­ni­ty-ac­quired bac­te­r­i­al pneu­mo­nia (CAPB). The FDA is ex­pect­ed to make its de­ci­sion by Oc­to­ber 24. Shares of the Con­necti­cut drug­mak­er $ML­NT cat­a­pult­ed, clos­ing up near­ly 224% at $6.41.

Brent Saunders at an Endpoints News event in 2017 — File photo

An­a­lyst call with Al­ler­gan ex­ecs stokes an­tic­i­pa­tion of a plan to split the com­pa­ny in ‘a month or two’

So what’s up at Al­ler­gan?

Ear­li­er this week the ubiq­ui­tous Ever­core ISI an­a­lyst Umer Raf­fat was on the line with com­pa­ny ex­ec­u­tives to probe in­to the lat­est on the num­bers as well as CEO Brent Saun­ders’ re­cent de­c­la­ra­tion that he’d be do­ing some­thing de­fin­i­tive to help long-suf­fer­ing in­vestors who have watched their shares dwin­dle in val­ue.

He came away with the im­pres­sion that a sig­nif­i­cant com­pa­ny split is on the way. And not on some dis­tant time hori­zon.

Ken Frazier appears before the Senate Committee on Finance for a hearing on prescription drug pricing on Capitol Hill in Washington, DC, February 26, 2019. Chris Kleponis for CNP via AP Images

Who’s next in line to suc­ceed Ken Fra­zier as CEO of the Keytru­da-blessed Mer­ck?

When Mer­ck waved off a loom­ing forced re­tire­ment for Ken Fra­zier last Sep­tem­ber, the board cit­ed flex­i­bil­i­ty in CEO tran­si­tion as a key fac­tor in the de­ci­sion. Hav­ing Fra­zier — who’s al­so chair­man of the com­pa­ny — around be­yond his 65th birth­day in 2019 would en­sure they in­stall the best per­son at the best time, they said.

The board has ev­i­dent­ly be­gun that process with a clear pref­er­ence for in­ter­nal can­di­dates, sources told Bloomberg. CFO Robert Davis, chief mar­ket­ing of­fi­cer Michael Nal­ly, and chief com­mer­cial of­fi­cer Frank Clyburn are all in the run­ning, ac­cord­ing to an in­sid­er.

John Reed at JPM 2019. Jeff Rumans for Endpoints News

Sanofi's John Reed con­tin­ues to re­or­ga­nize R&D, cut­ting 466 jobs while boost­ing can­cer, gene ther­a­py re­search

The R&D reorganization inside Sanofi is continuing, more than a year after the pharma giant brought in John Reed to head the research arm of the Paris-based company.
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How small- to mid-sized biotechs can adopt pa­tient cen­tric­i­ty in their on­col­o­gy tri­als

By Lucy Clos­sick Thom­son, Se­nior Di­rec­tor of On­col­o­gy Pro­ject Man­age­ment, Icon

Clin­i­cal tri­als in on­col­o­gy can be cost­ly and chal­leng­ing to man­age. One fac­tor that could re­duce costs and re­duce bar­ri­ers is har­ness­ing the pa­tient voice in tri­al de­sign to help ac­cel­er­ate pa­tient en­roll­ment. Now is the time to adopt pa­tient-cen­tric strate­gies that not on­ly fo­cus on pa­tient needs, but al­so can main­tain cost ef­fi­cien­cy.

UP­DAT­ED: Chica­go biotech ar­gues blue­bird, Third Rock 'killed' its ri­val, pi­o­neer­ing tha­lassemia gene ther­a­py in law­suit

Blue­bird bio $BLUE chief Nick Leschly court­ed con­tro­ver­sy last week when he re­vealed the com­pa­ny’s be­ta tha­lassemia treat­ment will car­ry a jaw-drop­ping $1.8 mil­lion price tag over a 5-year pe­ri­od in Eu­rope — mak­ing it the plan­et’s sec­ond most ex­pen­sive ther­a­py be­hind No­var­tis’ $NVS fresh­ly ap­proved spinal mus­cu­lar at­ro­phy ther­a­py, Zol­gens­ma, at $2.1 mil­lion. A Chica­go biotech, mean­while, has been fum­ing at the side­lines. In a law­suit filed ear­li­er this month, Er­rant Gene Ther­a­peu­tics al­leged that blue­bird and ven­ture cap­i­tal group Third Rock un­law­ful­ly prised a vi­ral vec­tor, de­vel­oped in part­ner­ship with the Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter (MSK), from its grasp, and thwart­ed the de­vel­op­ment of its sem­i­nal gene ther­a­py.

A new num­ber 1 drug? Keytru­da tapped to top the 10 biggest block­busters on the world stage by 2024

Analysts may be fretting about Keytruda’s longterm prospects as a host of rival therapies elbow their way to the market. But the folks at Evaluate Pharma are confident that last year’s $7 billion earner is headed for glory, tapping it to beat out the current #1 therapy Humira as AbbVie watches that franchise swoon over the next 5 years.

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The top 10 block­buster drugs in the late-stage pipeline — Eval­u­ate adds 6 new ther­a­pies to heavy-hit­ter list

Vertex comes in for a substantial amount of criticism for its no-holds-barred tactical approach toward wresting the price it wants for its commercial drugs in Europe. But the flip side of that coin is a highly admired R&D and commercial operation that regularly wins kudos from analysts for their ability to engineer greater cash flow from the breakthrough drugs they create.

Both aspects needed for success in this business are on display in the program backing Vertex’s triple for cystic fibrosis. VX-659/VX-445 + Tezacaftor + Ivacaftor — it’s been whittled down to 445 now — was singled out by Evaluate Pharma as the late-stage therapy most likely to win the crown for drug sales in 5 years, with a projected peak revenue forecast of $4.3 billion.

The latest annual list, which you can see here in their latest world preview, includes a roster of some of the most closely watched development programs in biopharma. And Evaluate has added 6 must-watch experimental drugs to the top 10 as drugs fail or go on to a first approval. With apologies to the list maker, I revamped this to rank the top 10 by projected 2024 sales, instead of Evaluate's net present value rankings.

It's how we roll at Endpoints News.

Here is a quick summary of the rest of the top 10:

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Step­ping on Roche's toes, Mer­ck cuts in­to SCLC niche with third-line Keytru­da OK

In the in­creas­ing­ly crowd­ed check­point race, small cell lung can­cer has been a rare area where Roche, a sec­ond run­ner-up, has a lead over the en­trenched lead­ers Mer­ck and Bris­tol-My­ers Squibb. But Mer­ck is fi­nal­ly mak­ing some head­way in that di­rec­tion with the lat­est ap­proval for its PD-1 star.

The lat­est green light en­dors­es Keytru­da in the third-line treat­ment of metasta­t­ic SCLC, where it would be giv­en to pa­tients whose dis­ease ei­ther don’t re­spond to or re­lapse af­ter chemother­a­py, which would have fol­lowed at least one pri­or line of ther­a­py.