Google backs a $60M tran­si­tion round for FLX’s switch to a CCR4 strat­e­gy

FLX Bio isn’t the biotech it start­ed out to be.

Formed as a spin­out of Flexus af­ter Bris­tol-My­ers Squibb stepped in to buy the fledg­ling and an ear­ly-stage IDO1 ther­a­py for the jaw-drop­ping sum of $1.25 bil­lion, the biotech went on to pur­sue a FLT3/CDK4/6 drug for can­cer. Then the founders — Ter­ry Rosen and Juan Jaen — left to start their own com­pa­nies and the new crew at FLX wound up ter­mi­nat­ing their orig­i­nal lead drug ear­li­er this year and switch­ing fo­cus to an­oth­er tar­get in on­col­o­gy: CCR4, fo­cused on reg­u­la­to­ry T cells.

Rekha Hem­ra­jani

To­day, the South San Fran­cis­co-based biotech is tak­ing the wraps off a $60 mil­lion round to com­plete the makeover, bring­ing its to­tal raise in just two years to a hefty $139 mil­lion with the help of GV (read Google) along with The Col­umn Group, Klein­er Perkins, Top­spin Part­ners and Cel­gene Cor­po­ra­tion.

Their old lead “just didn’t get there” on safe­ty and ef­fi­ca­cy, says chief med­ical of­fi­cer William Ho, which didn’t cut it in a com­pet­i­tive field. But Ho and his col­leagues now be­lieve that the biotech’s oral CCR4 an­tag­o­nist has a much bet­ter shot at suc­cess.

“Our pro­gram we be­lieve is def­i­nite­ly best in class and quite dif­fer­ent from the oth­er pro­grams,” as­serts COO Rekha Hem­ra­jani.

On­col­o­gy spe­cial­ists will re­call that Ky­owa Hakko re­cent­ly un­veiled pos­i­tive Phase III da­ta for their an­ti-CCR4 ther­a­py moga­mulizum­ab, which has been dis­patched for re­view at the FDA with pos­i­tive pro­gres­sion-free sur­vival. But FLX is in the busi­ness of mak­ing what it be­lieves is a bet­ter small mol­e­cule drug that can have a much more tar­get­ed ef­fect.

William Ho

Any an­ti­body tar­get­ing CCR4 will like­ly have se­ri­ous safe­ty is­sues, they say, tak­ing a sledge­ham­mer ap­proach to T cells to their scalpel.

The strat­e­gy here is that a small mol­e­cule drug can pre­vent reg­u­la­to­ry T cells from en­ter­ing a tu­mor iden­ti­fied by the ex­pres­sion of lig­ands, po­ten­tial­ly amp­ing up im­munother­a­pies like PD-1/L1 and CT­LA4 check­points. And like a lot of play­ers in this field, FLX is lin­ing up a check­point ther­a­py for a com­bo ap­proach.

FLX is hop­ing to have some clear da­ta high­light­ing their drug’s an­ti-tu­mor po­ten­tial in 2019.

Ho says it can be a chal­lenge mount­ing can­cer stud­ies these days, with hun­dreds of drugs and com­bi­na­tions com­pet­ing for pa­tients. That will re­quire FLX to do every­thing it can to stand out from the crowd to win over the in­ves­ti­ga­tors and sites con­sid­er­ing which ther­a­pies to test first.

The chal­lenge al­so makes it more im­por­tant for them to come up with a seam­less de­vel­op­ment strat­e­gy, mov­ing from healthy vol­un­teers in­to pa­tients to dose es­ca­la­tion and ex­pan­sion co­horts with a com­bi­na­tion. And the biotech al­so be­lieves it may be able to pur­sue a bas­ket ap­proach, tak­ing a tu­mor ag­nos­tic strat­e­gy that would al­low them to test the drug in any pa­tient that met the right lig­and pro­file.

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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John Chiminski, Catalent CEO - File Photo

'It's a growth play': Catal­ent ac­quires Bris­tol-My­er­s' Eu­ro­pean launch pad, ex­pand­ing glob­al CD­MO ops

Catalent is staying on the growth track.

Just two months after committing $1.2 billion to pick up Paragon and take a deep dive into the sizzling hot gene therapy manufacturing sector, the CDMO is bouncing right back with a deal to buy out Bristol-Myers’ central launchpad for new therapies in Europe, acquiring a complex in Anagni, Italy, southwest of Rome, that will significantly expand its capacity on the continent.

There are no terms being offered, but this is no small deal. The Anagni campus employs some 700 staffers, and Catalent is planning to go right in — once the deal closes late this year — with a blueprint to build up the operations further as they expand on oral solid, biologics, and sterile product manufacturing and packaging.

This is an uncommon deal, Catalent CEO John Chiminski tells me. But it offers a shortcut for rapid growth that cuts years out of developing a green fields project. That’s time Catalent doesn’t have as the industry undergoes unprecedented expansion around the world.

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Partners Innovation Fund

David de Graaf now has his $28.5M launch round in place, build­ing a coen­zyme A plat­form in his lat­est start­up

Long­time biotech ex­ec David de Graaf has the cash he needs to set up the pre­clin­i­cal foun­da­tion for his coen­zyme A me­tab­o­lism com­pa­ny Comet. A few high-pro­file in­vestors joined the ven­ture syn­di­cate to sup­ply Comet with $28.5 mil­lion in launch mon­ey — enough to get it two years in­to the plat­form-build­ing game, with­in knock­ing dis­tance of the clin­ic.

Canaan jumped in along­side ex­ist­ing in­vestor Sofinno­va Part­ners to co-lead the round, with par­tic­i­pa­tion by ex­ist­ing in­vestor INKEF Cap­i­tal and new in­vestor BioIn­no­va­tion Cap­i­tal.

Arc­turus ex­pands col­lab­o­ra­tion, adding $30M cash; Ku­ra shoots for $100M raise

→  Rare dis­ease play­er Ul­tragenyx $RARE is ex­pand­ing its al­liance with Arc­turus $ARCT, pay­ing $24 mil­lion for eq­ui­ty and an­oth­er $6 mil­lion in an up­front as the two part­ners ex­pand their col­lab­o­ra­tion to in­clude up to 12 tar­gets. “This ex­pand­ed col­lab­o­ra­tion fur­ther so­lid­i­fies our mR­NA plat­form by adding ad­di­tion­al tar­gets and ex­pand­ing our abil­i­ty to po­ten­tial­ly treat more dis­eases,” said Emil Kakkis, the CEO at Ul­tragenyx. “We are pleased with the progress of our on­go­ing col­lab­o­ra­tion. Our most ad­vanced mR­NA pro­gram, UX053 for the treat­ment of Glyco­gen Stor­age Dis­ease Type III, is ex­pect­ed to move in­to the clin­ic next year, and we look for­ward to fur­ther build­ing up­on the ini­tial suc­cess of this part­ner­ship.”

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.

Neil Woodford. Woodford Investment Management via YouTube

Wood­ford braces po­lit­i­cal storm as UK fi­nan­cial reg­u­la­tors scru­ti­nize fund sus­pen­sion

The shock of Neil Wood­ford’s de­ci­sion to block with­drawals for his flag­ship fund is still rip­pling through the rest of his port­fo­lio — and be­yond. Un­der po­lit­i­cal pres­sure, UK fi­nan­cial reg­u­la­tors are now tak­ing a hard look while in­vestors con­tin­ue to flee.

In a re­sponse let­ter to an MP, the Fi­nan­cial Con­duct Au­thor­i­ty re­vealed that it’s opened an in­ves­ti­ga­tion in­to the sus­pen­sion fol­low­ing months of en­gage­ment with Link Fund So­lu­tions, which tech­ni­cal­ly del­e­gat­ed Wood­ford’s firm to man­age its funds.

Gilead baits new al­liance with $45M up­front, div­ing in­to the busy pro­tein degra­da­tion field

Gilead is jump­ing on board the pro­tein degra­da­tion band­wag­on. And they’re turn­ing to a low-pro­file Third Rock start­up for the ex­per­tise. But if you were look­ing for a trans­for­ma­tion­al deal to kick up fresh en­thu­si­asm for Gilead, you’ll have to re­main pa­tient.

This one will have a long way to go be­fore they get in­to the clin­ic.

The big biotech said Wednes­day morn­ing that it is pay­ing $45 mil­lion up­front and re­serv­ing a whop­ping $2.3 bil­lion in biotech bucks if San Fran­cis­co-based Nurix can point the way to new can­cer ther­a­pies, as well as drugs for oth­er, un­spec­i­fied dis­eases.

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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In­vestor day prep at Mer­ck in­cludes a new strat­e­gy to pick up the pace on M&A — re­port

Mer­ck’s re­cent deals to buy up two bolt-on biotechs — Ti­los and Pelo­ton — weren’t an aber­ra­tion. In­stead, both ac­qui­si­tions mark a new strat­e­gy to beef up its dom­i­nant can­cer drug op­er­a­tions cen­tered on Keytru­da while look­ing to ad­dress grow­ing con­cerns that too many of its eggs are in the one I/O bas­ket for their PD-1 pro­gram. And Mer­ck is go­ing af­ter more small- and mid-sized buy­outs to calm those fears.