So­lid­i­fy­ing a new cor­po­rate struc­ture, IFM launch­es sec­ond unit fo­cused on cGAS-STING

For Gary Glick and his crew at IFM, life af­ter spin­ning out their on­col­o­gy as­sets to Bris­tol-My­ers Squibb has in­volved con­stant dis­cus­sions about which tar­gets — out of all the ideas on their draw­ing board — to go af­ter in the adap­tive im­mune sys­tem. Their next big ques­tion? When they should launch a new sub­sidiary to pur­sue the drugs, or how many of these units to form.

Gary Glick

Those dis­cus­sions led to IFM Tre, which got start­ed last Ju­ly with $31 mil­lion to tack­le a troi­ka of NL­RP3 tar­gets. With one of those pro­grams on the cusp of en­ter­ing the clin­ic, Glick is now ready an­nounce their next ven­ture: IFM Due (pro­nounced “du-way,” Ital­ian for “two”), com­mit­ted to the cGAS-STING path­way.

Com­pris­ing cyclic GMP-AMP syn­thase and the more well-known stim­u­la­tor of in­ter­fer­on genes, the cGAS-STING path­way, when aber­rant­ly ac­ti­vat­ed, is tied to ex­cess pro­duc­tion of in­flam­ma­to­ry cy­tokines that un­der­lies both rare, ge­net­ic dis­eases like Aicar­di-Goutières syn­drome (AGS), STING-as­so­ci­at­ed vas­cu­lopa­thy with on­set in in­fan­cy (SAVI) and com­mon dis­eases like NASH, Parkin­son’s and even senes­cence, the com­pa­ny said.

De­tails are scant on the two pre­clin­i­cal as­set cur­rent­ly in the pipeline, which Glick di­vulged are cur­rent­ly in the lead op­ti­miza­tion stage.

While ac­knowl­edg­ing that large bio­phar­ma com­pa­nies have been in­ter­est­ed in the path­way (Eli Lil­ly $LLY and Aduro $ADRO, for in­stance, have a re­search col­lab­o­ra­tion in place, al­though Aduro ran in­to re­peat­ed set­backs in can­cer), he held back on the specifics of their tech­nol­o­gy, choos­ing in­stead to high­light the un­der­stand­ing, reagents and an­i­mal mod­els brought to the ta­ble by found­ing sci­en­tist An­drea Ablass­er of the École Poly­tech­nique Fédérale de Lau­sanne in Switzer­land.

An­drea Ablass­er

The ap­point­ment of Ablass­er, who was in­tro­duced to the team by IFM co-founder Eicke Latz, re­flects the com­pa­ny’s ap­proach of mar­ry­ing aca­d­e­m­ic sci­en­tists’ in­sights with their drug dis­cov­ery ca­pa­bil­i­ties, Glick said. At its core, IFM’s 35-mem­ber team hasn’t grown since the last sub­sidiary was cre­at­ed; sci­en­tists are sim­ply mov­ing around new projects as their skills as need­ed.

“The on­ly thing that sits in IFM Due is the IP re­lat­ed to the projects,” he told me, with “half a dozen” R&D staffers cur­rent­ly work­ing on cGAS-STING to­geth­er with ex­ter­nal help.

The flex­i­bil­i­ty al­lows IFM to do right by each set of as­sets — six oth­er in­flam­ma­somes are be­ing con­sid­ered as new tar­gets. But don’t ex­pect a Roivant-style mush­room­ing of new com­pa­nies.

“My sense is it’s not gonna look too dif­fer­ent than hav­ing two, maybe three sub­sidiaries run­ning at a time,” Glick says. “I’m more of (the opin­ion) few­er and high­er qual­i­ty is bet­ter than larg­er and more dif­fused and (…) lit­tle bit less con­trol.”

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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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.

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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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.