Af­ter win­ning an ear­ly deal on XO1, the vir­tu­al biotech gang gets back to­geth­er for Su­perX

A lit­tle less than two years af­ter J&J swooped in to snag the pre­clin­i­cal an­tithrom­bin drug at XO1 in the UK, the vir­tu­al team of en­tre­pre­neurs who cre­at­ed that as­set-cen­tered ven­ture is back to­geth­er again. This time they’re op­er­at­ing as Su­perX, and they’re work­ing in a very fa­mil­iar re­search space.

With a very fa­mil­iar bud­get.

Like XO1, Su­perX is get­ting a liftoff with an $11 mil­lion round — this time drawn from Medicxi and part­ners at John­son & John­son In­no­va­tion. Uni­ver­si­ty of Cam­bridge Pro­fes­sor Jim Hunt­ing­ton is the CSO. Trevor Baglin is the CMO. X01 co-founder and Medicxi part­ner David Grainger is on the team, along with Kevin John­son, al­so at Medicxi, tak­ing the chair­man’s role. XO1 vets Bob Schroff will be op­er­a­tions chief with Jo Davies once again han­dling the in­tel­lec­tu­al prop­er­ty.

The busi­ness mod­el here is some­thing that Medicxi is quite com­fort­able with. It’s a tight bud­get with no room for a ded­i­cat­ed staff. You can ex­pect a CRO to do much of the heavy pre­clin­i­cal lift­ing as they get the man­u­fac­tur­ing squared away.

Medicxi isn’t known for splash­ing large sums on ear­ly-stage drugs. But they have a suc­cess­ful track record in set­ting up ear­ly deals af­ter demon­strat­ing some val­ue ahead of the clin­ic, stay­ing “laser fo­cused,” in Grainger’s words, on a sin­gle project. And while there are no op­tions or strings at­tached on J&J’s in­volve­ment, the same phar­ma gi­ant that is tak­ing XO1’s drug ahead will have a front row seat to see how this new fol­low-up ther­a­py per­forms.

“The whole an­ti­co­ag­u­lant space is sim­ply enor­mous,” Grainger tells me, “with so many dif­fer­ent trig­gers for throm­bo­sis. We still be­lieve the XO1 drug is a mag­nif­i­cent drug,” but there’s still plen­ty of types of throm­bo­sis to tack­le.

Be­sides, he added, the team all agreed that “wouldn’t it be great to do it again?”

Like X01, says Baglin, the com­pa­ny’s sole pro­gram emerged out of ob­ser­va­tions around the case stud­ies of pa­tients that should bleed, but didn’t, build­ing on the same ex­pe­ri­ence that in­spired the pre­de­ces­sor pro­gram but com­ing at it from a dif­fer­ent an­gle. In the XO1 case, a pa­tient that should have been suf­fer­ing from he­mo­phil­ia was able to stop bleed­ing nat­u­ral­ly, and they took the an­ti­body that did that and syn­the­sized it.

The part­ners are en­thu­si­as­tic about this new ven­ture, but they’re al­so play­ing their cards close to the vest. The an­ti­bod­ies they’re work­ing with have prop­er­ties for an­ti­co­ag­u­la­tion, look­ing to block throm­bo­sis that caus­es heart at­tacks and strokes. The goal is to de­vel­op an ide­al an­ti­co­ag­u­lant for chron­ic use, with­out the threat of bleed­ing posed by the cur­rent gen­er­a­tion of ther­a­pies.

But don’t ask about the tar­get yet.

Jim Hunt­ing­ton

“The (new) tar­get we haven’t dis­closed yet,” says Hunt­ing­ton, “so it’s im­pos­si­ble to say why we’ve de­cid­ed on this tar­get. But it’s an in­cred­i­bly cool sto­ry.”

The team is look­ing at a cou­ple of years work be­fore this next drug will be ready for the clin­ic. And then they can see whether they mount the first hu­man study them­selves, or a part­ner comes along to snag it for them­selves.

This new com­pa­ny comes just days af­ter Medicxi joined a syn­di­cate in­volv­ing Touch­stone and Cam­bridge En­ter­prise to back an­oth­er spin­out from the labs of Hunt­ing­ton and Baglin. Apcin­teX Lim­it­ed picked up a £14 mil­lion Se­ries A fund­ing round to back a new he­mo­phil­ia drug.

Brent Saunders [Getty Photos]

UP­DAT­ED: Ab­b­Vie seals $63B deal to buy a trou­bled Al­ler­gan — spelling out $1B in R&D cuts

Brent Saunders has found his way out of the current fix he’s in at Allergan $AGN. He’s selling the company to AbbVie for $63 billion in the latest example of the hot M&A market in biopharma.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Zo­genix plans quick re­turn to the FDA with their spurned ap­pli­ca­tion on Dravet syn­drome drug — shares spike

Zo­genix shares are claw­ing back some of the val­ue they lost 2 months ago af­ter the FDA hit the biotech with a refuse-to-file no­tice on their ex­per­i­men­tal ther­a­py for Dravet syn­drome. 

Com­pa­ny ex­ecs said this morn­ing that they worked out reg­u­la­tors’  is­sues with the ap­pli­ca­tion for Fin­tepla, which cen­tered on a pair of big prob­lems: the ab­sence of non-clin­i­cal stud­ies need­ed to al­low as­sess­ment of the chron­ic ad­min­is­tra­tion of fen­flu­ramine and the in­clu­sion of an in­cor­rect ver­sion of a clin­i­cal dataset. Now they plan to re­sub­mit in Q3 af­ter get­ting off the hook on both scores — which trig­gered a sigh of re­lief among in­vestors.

Turned back at the FDA, Im­muno­Gen is ax­ing 220 staffers, sell­ing pro­grams and hun­ker­ing down for a new PhI­II gam­ble

After being stymied by FDA regulators who were unconvinced by ImmunoGen’s $IMGN desperation shot at an accelerated OK based on a secondary endpoint, the struggling biotech is slashing its workforce, shuttering R&D projects and looking for buyers to pick up some of its experimental cancer assets as it goes back into a new Phase III with the lead drug.

We found out last month that the FDA had batted back their case for an accelerated approval of their antibody-drug conjugate mirvetuximab soravtansine, which had earlier failed a Phase III study for ovarian cancer. Now the other shoe is dropping.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Bridge­Bio takes crown for biggest biotech IPO of 2019, as fel­low uni­corn Adap­tive rais­es of­fer­ing size and price

Bridge­Bio Phar­ma and Adap­tive Biotech­nolo­gies have not just up­sized IPO of­fer­ings — the pair of uni­corns have al­so raised their of­fer­ing prices above the range, haul­ing in a com­bined $648.5 mil­lion.

Neil Ku­mar’s Bridge­Bio Phar­ma, found­ed in 2015, has a sta­ble of com­pa­nies fo­cused on dis­eases that are dri­ven by de­fects in a sin­gle gene — en­com­pass­ing der­ma­tol­ogy, car­di­ol­o­gy, neu­rol­o­gy, en­docrinol­o­gy, re­nal dis­ease, and oph­thal­mol­o­gy — and can­cers with clear ge­net­ic dri­vers. The start­up mill birthed a pletho­ra of firms such as Ei­dos, Navire, QED Ther­a­peu­tics and Pelle­Pharm, which func­tion as its sub­sidiaries.

As­traZeneca chal­lenges Roche on front­line SCLC af­ter seiz­ing an in­ter­im win — and Mer­ck may not be far be­hind

The crowded playing field in the PD-1/L1 marketing game is about to get a little more complex.

This morning AstraZeneca reported that its CASPIAN study delivered a hit in an interim readout for their PD-L1 Imfinzi combined with etoposide and platinum-based chemotherapy options for frontline cases of small cell lung cancer, a tough target which has already knocked back Bristol-Myers’ shot in second-line cases. The positive data  — which we won’t see before they roll it out at an upcoming scientific conference — give AstraZeneca excellent odds of a quick vault to challenging Roche’s Tecentriq-chemo combo, approved 3 months ago for frontline SCLC in a landmark advance.

“This is the first trial offering the flexibility of combining immunotherapy with different platinum-based regimens in small cell lung cancer, expanding treatment options,” noted AstraZeneca cancer R&D chief José Baselga in a statement.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Af­ter rais­ing $158M, this up­start's founders have star back­ers and plans to break new ground in gene ther­a­py

Back in 2014, Stephanie Tagliatela opted to take an early exit out of her PhD program after working in Mark Bear’s lab at MIT, where she specialized in the synaptic connections between neuronal cells in the brain. She never finished that PhD, but she and fellow MIT student Kartik Ramamoorthi — who was on the founding team at Voyager — came away with some ideas for a gene therapy startup.

Today, fully 5 years later, she and Ramamoorthi are taking the wraps off of a $104 million mega-round designed to take the cumulative work of their preclinical formative stage for Encoded Therapeutics into human studies. They’ve now raised $158 million since starting out in Illumina’s incubator in the Bay Area, and they believe they are firmly on track to do something unique in gene therapy.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.

Novotech CEO Dr. John Moller

Novotech CRO Award­ed Frost & Sul­li­van Best Biotech CRO Asia-Pa­cif­ic 2019

Known in the in­dus­try as the Asia-Pa­cif­ic CRO, Novotech is now lead CRO ser­vices provider for the grow­ing num­ber of in­ter­na­tion­al biotechs se­lect­ing the re­gion for their stud­ies.

Re­flect­ing this Asia-Pa­cif­ic growth, Novotech staff num­bers are up 20% since De­cem­ber 2018 to 600 in-house clin­i­cal re­search peo­ple across a full range of ser­vices, across the re­gion.

Novotech’s ca­pa­bil­i­ties have been rec­og­nized by an­a­lysts like Frost & Sul­li­van, most re­cent­ly with the pres­ti­gious Asia-Pa­cif­ic CRO Biotech of the year award for best prac­tices in clin­i­cal re­search for biotechs for the fifth year. See oth­er awards here.

Image: Chris Varma. Frontier

UP­DAT­ED: Chris Var­ma un­veils MP­M's lat­est start­up — eye­ing 'un­drug­gable' can­cer tar­gets and pow­ered by ma­chine learn­ing, $67M

Two years af­ter MPM Cap­i­tal en­list­ed Chris Var­ma on its busy on­col­o­gy team, the for­mer en­tre­pre­neur-in-res­i­dence is un­veil­ing his first ven­ture project out of his new stomp­ing grounds in the Bay Area: Fron­tier Med­i­cines.

For Var­ma, who’s al­so co-found­ed Blue­print Med­i­cines and built com­pa­nies at Third Rock and Flag­ship, this marks an­oth­er op­por­tu­ni­ty to ap­ply some cut­ting-edge sci­ence to “sev­er­al of the most im­por­tant and dif­fi­cult tar­gets in can­cer” — tar­gets that oth­ers have tried to tack­le with more clas­si­cal meth­ods and failed. The launch round comes in at $67 mil­lion, which should go some way in scaf­fold­ing a pre­clin­i­cal pipeline and push one or more as­sets in­to the clin­ic three years from now, he tells me.

Richard Gonzalez testifying in front of Senate Finance Committee, February 2019 [AP Images]

Ab­b­Vie's $63B buy­out spot­lights the re­turn of ma­jor M&A deals — de­spite the back­lash

Big time M&A is back. But for how long?

Over the past 18 months we’ve now seen three major buyouts announced: Takeda/Shire; Bristol-Myers/Celgene and now AbbVie/Allergan. And with this latest deal it’s increasingly clear that the sharp fall from grace suffered by high-profile players which have seen their share prices blasted has created an opening for the growth players in big pharma to up their game — in sharp contrast to the popular bolt-on deals that have been driving the growth strategy at Novartis, Merck, Roche and others.

Endpoints News

Basic subscription required

Unlock this story instantly and join 53,600+ biopharma pros reading Endpoints daily — and it's free.