Clarus spear­heads a big, $150M raise so Galera can flip the PhI­II card on its new drug to treat ra­di­a­tion ef­fects

Any­one look­ing for sol­id ev­i­dence of the kind of im­pact the new, flush fund­ing en­vi­ron­ment — along with a more ac­com­mo­dat­ing FDA — is hav­ing on biotech need look no fur­ther than Galera Ther­a­peu­tics this morn­ing.

Mel Sorensen

Armed with pos­i­tive Phase IIb da­ta for a new can­cer-re­lat­ed ther­a­py, the small, 18-per­son crew at Galera has pieced to­geth­er a whop­ping $150 mil­lion raise; $70 mil­lion in an am­bi­tious Se­ries C with an $80 mil­lion roy­al­ty deal com­ing from one of its biggest back­ers. And CEO Mel Sorensen says that com­bo gives the com­pa­ny all the mon­ey it needs to get through a piv­otal study in the next cou­ple of years that could put them on the thresh­old of a mar­ket­ing de­ci­sion from the FDA.

“This fund­ing al­lows us to get all the way through the process,” Sorensen tells me, “to turn over the Phase III card.”

The “beach­head” in­di­ca­tion for Malvern, PA-based Galera is se­vere oral mu­cosi­tis, a com­mon side ef­fect in pa­tients with head and neck can­cer. Their drug, GC4419, tar­gets the tox­ic ef­fect of ra­di­a­tion ther­a­py as su­per­ox­ide swift­ly builds up in pa­tients, af­flict­ing the sen­si­tive tis­sue in their mouths.

The FDA has helped con­sid­er­ably, giv­ing Galera a break­through drug des­ig­na­tion and get­ting the CEO’s thumbs up for help­ing with the tri­al de­sign and keep­ing things on a rel­a­tive­ly tight sched­ule. Sorensen ex­pects to get the piv­otal Phase III un­der­way in the up­com­ing quar­ter, and he adds that it will like­ly take ap­prox­i­mate­ly 18 to 24 months to com­plete once they are un­der­way.

Em­mett Cun­ning­ham

At one point not long ago, the idea of a small biotech com­pa­ny tack­ling Phase III with­out at least a ma­jor part­ner would have ter­ri­fied most in­vestors. But times have changed, and the lev­el of cash flow­ing through the in­dus­try in the last 2 years has reached an un­prece­dent­ed depth. In Galera’s case, that means push­ing through Phase III while al­so lay­ing the foun­da­tion for a com­mer­cial­iza­tion ef­fort that could re­quire 50 peo­ple. Along the way, Galera will al­so study new in­di­ca­tions for their drug to see how they can build the fran­chise. 

Pre­sum­ably, an IPO has been on the ta­ble, es­pe­cial­ly as the cur­rent wave of biotechs go­ing pub­lic is dom­i­nat­ed by pre­clin­i­cal com­pa­nies with­out any­thing like a Phase IIb da­ta set. Sorensen, though, sim­ply says the com­pa­ny is keep­ing all op­tions on the ta­ble, pre­fer­ring to fo­cus now on the big step ahead.

In this case, Clarus not on­ly led the round, the firm al­so sup­plied the roy­al­ty cash through an­oth­er spe­cial­ized fund it runs. 

Clarus is jump­ing in along­side oth­er new in­vestors: Adage Cap­i­tal Man­age­ment, HBM Health­care In­vest­ments, Nan Fung Life Sci­ences, RA Cap­i­tal, Rock Springs Cap­i­tal and Tekla Cap­i­tal Man­age­ment LLC. Ex­ist­ing in­vestors Cor­re­la­tion Ven­tures, Galera An­gels, New En­ter­prise As­so­ci­ates, No­var­tis Ven­ture Fund, No­vo Ven­tures and Sofinno­va Ven­tures al­so par­tic­i­pat­ed. And Clarus’ man­ag­ing di­rec­tor Em­mett Cun­ning­ham is jump­ing on the board.

Jim Mellon [via YouTube]

Health­i­er, longer lifes­pans will be a re­al­i­ty soon­er than you think, Ju­ve­nes­cence promis­es as it clos­es $100M round

Earlier this year, an executive from Juvenescence-backed AgeX predicted the field of longevity will eventually “dwarf the dotcom boom.” Greg Bailey, the UK-based anti-aging biotech’s CEO, certainly hopes so.

On Monday, Juvenescence completed its $100 million series B round of financing. The company is backed by British billionaire Jim Mellon — who wrote his 400-page guide to investing in the field of longevity shortly after launching the company in 2017.  Bailey, who served as a board director for seven years at Medivation before Pfizer swallowed the biotech for $14 billion, is joined by Declan Doogan, an industry veteran with stints at Pfizer and Amarin.

John Hood [file photo]

UP­DATE: Cel­gene and the sci­en­tist who cham­pi­oned fe­dra­tinib's rise from Sanofi's R&D grave­yard win FDA OK

Six years after Sanofi gave it up for dead, the FDA has approved the myelofibrosis drug fedratinib, now owned by Celgene.

The drug will be sold as Inrebic, and will soon land in the portfolio at Bristol-Myers Squibb, which is finalizing a deal to acquire Celgene.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: AveX­is sci­en­tif­ic founder was axed — and No­var­tis names a new CSO in wake of an ethics scan­dal

Now at the center of a storm of controversy over its decision to keep its knowledge of manipulated data hidden from regulators during an FDA review, Novartis CEO Vas Narasimhan has found a longtime veteran in the ranks to head the scientific work underway at AveXis, where the incident occurred. And the scientific founder has hit the exit.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Ab­b­Vie gets its FDA OK for JAK in­hibitor upadac­i­tinib, but don’t look for this one to hit ex­ecs’ lofty ex­pec­ta­tions

Another big drug approval came through on Friday afternoon as the FDA OK’d AbbVie’s upadacitinib — an oral JAK1 inhibitor that is hitting the rheumatoid arthritis market with a black box warning of serious malignancies, infections and thrombosis reflecting fears associated with the class.

It will be sold as Rinvoq — at a wholesale price of $59,000 a year — and will likely soon face competition from a drug that AbbVie once controlled, and spurned. Reuters reports that a 4-week supply of Humira, by comparison, is $5,174, adding up to about $67,000 a year.

The top 10 fran­chise drugs in bio­phar­ma his­to­ry will earn a to­tal of $1.4T (tril­lion) by 2024 — what does that tell us?

Just in case you were looking for more evidence of just how important Amgen’s patent win on Enbrel is for the company and its investors, EvaluatePharma has come up with a forward-looking consensus estimate on what the list of top 10 drugs will look like in 2024.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

UP­DAT­ED: Sci­en­tist-CEO ac­cused of im­prop­er­ly us­ing con­fi­den­tial in­fo from uni­corn Alec­tor

The executive team at Alector $ALEC has a bone to pick with scientific co-founder Asa Abeliovich. Their latest quarterly rundown has this brief note buried inside:

On June 18, 2019, we initiated a confidential arbitration proceeding against Dr. Asa Abeliovich, our former consulting co-founder, related to alleged breaches of his consulting agreement and the improper use of our confidential information that he learned during the course of rendering services to us as our consulting Chief Scientific Officer/Chief Innovation Officer. We are in the early stage of this arbitration proceeding and are unable to assess or provide any assurances regarding its possible outcome.

There’s no explicit word in the filing on what kind of confidential info was involved, but the proceeding got started 2 days ahead of Abeliovich’s IPO.

Abeliovich, formerly a tenured associate professor at Columbia, is a top scientist in the field of neurodegeneration, which is where Alector is targeted. More recently, he’s also helped start up Prevail Therapeutics as the CEO, which raised $125 million in an IPO. And there he’s planning on working on new gene therapies that target genetically defined subpopulations of Parkinson’s disease. Followup programs target Gaucher disease, frontotemporal dementia and synucleinopathies.

But this time Abeliovich is the CEO rather than a founding scientist. And some of their pipeline overlaps with Alector’s.

Abeliovich and Prevail, though, aren’t taking this one lying down.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

Chi­na has be­come a CEO-lev­el pri­or­i­ty for multi­na­tion­al phar­ma­ceu­ti­cal com­pa­nies: the trend and the im­pli­ca­tions

After a “hot” period of rapid growth between 2009 and 2012, and a relatively “cooler” period of slower growth from 2013 to 2015, China has once again become a top-of-mind priority for the CEOs of most large, multinational pharmaceutical companies.

At the International Pharma Forum, hosted in March in Beijing by the R&D Based Pharmaceutical Association Committee (RDPAC) and the Pharmaceutical Research and Manufacturers of America (PhRMA), no fewer than seven CEOs of major multinational pharmaceutical firms participated, including GSK, Eli Lilly, LEO Pharma, Merck KGaA, Pfizer, Sanofi and UCB. A few days earlier, the CEOs of several other large multinationals attended the China Development Forum, an annual business forum hosted by the research arm of China’s State Council. It’s hard to imagine any other country, except the US, having such drawing power at CEO level.

As dis­as­ter struck, Ab­b­Vie’s Rick Gon­za­lez swooped in on Al­ler­gan with an of­fer Brent Saun­ders couldn’t say no to

Early March was a no good, awful, terrible time for Allergan CEO Brent Saunders. His big lead drug had imploded in a Phase III disaster and activists were after his hide — or at least his chairman’s title — as the stock price continued a steady droop that had eviscerated share value for investors.

But it was a perfect time for AbbVie CEO Rick Gonzalez to pick up the phone and ask Saunders if he’d like to consider a “strategic” deal.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.

CEO Pascal Soriot via Getty Images

As­traZeneca's jug­ger­naut PARP play­er Lyn­parza scoops up an­oth­er dom­i­nant win in PhI­II as the FDA adds a 'break­through' for Calquence

AstraZeneca’s oncology R&D group under José Baselga keeps churning out hits.

Wednesday morning the pharma giant and their partners at Merck parted the curtains on a successful readout for their Phase III PAOLA-1 study, demonstrating statistically significant improvement in progression-free survival for women with ovarian cancer in a first-line maintenance setting who added their PARP Lynparza to Avastin. This is their second late-stage success in ovarian cancer, which will help stave off rivals like GSK.

Endpoints News

Basic subscription required

Unlock this story instantly and join 57,400+ biopharma pros reading Endpoints daily — and it's free.