Can a 're­dis­cov­ered' drug from In­dia make it big in US im­munol­o­gy space? Dan Brad­bury and his team at Equi­l­li­um want to prove yes

Biotech com­pa­nies typ­i­cal­ly knock on Nas­daq’s doors with sev­er­al rounds of fi­nanc­ing un­der their belt. Equi­l­li­um, how­ev­er, went straight for it.

Hav­ing reaped a $65.4 mil­lion IPO last month, the San Diego-based biotech is emerg­ing from stealth mode to dis­cuss for the first time that atyp­i­cal route — a some­what un­ex­pect­ed one, CEO Dan Brad­bury would add — and the atyp­i­cal arrange­ment that made it pos­si­ble for an op­er­a­tion that on­ly launched 18 months ago.

Equi­l­li­um li­censed North Amer­i­can rights to its one and on­ly drug, itolizum­ab, from In­di­an biosim­i­lar gi­ant Bio­con. Sold in In­dia as a pso­ri­a­sis treat­ment, the same drug has been rechris­tened EQ001 and is be­ing de­vel­oped for a num­ber of oth­er im­muno-in­flam­ma­to­ry dis­eases.

Brad­bury — who has known Bio­con founder Ki­ran Mazum­dar-Shaw since his days as CEO of di­a­betes drug­mak­er Amylin and cur­rent­ly sits on the Bio­con board — says Equi­l­li­um’s ap­proach is nov­el in the sense that re­cent ad­vances in im­munol­o­gy has al­lowed his team to “re­dis­cov­er” a prod­uct that was de­vel­oped in the 2000s to hit a tar­get, CD6, first dis­cov­ered in the 1980s.

In­hibit­ing CD6, new re­search has found, blocks ef­fec­tor T cell ac­tiv­i­ty with­out tam­per­ing with reg­u­la­to­ry T cells, a se­lec­tive ap­proach com­pared to some “brute force” bi­o­log­ics cur­rent­ly on the mar­ket, he says.

Bruce Steel

At the same time, he adds, since itolizum­ab is al­ready clin­i­cal­ly val­i­dat­ed and man­u­fac­tured at com­mer­cial scale, “it’s ac­tu­al­ly a fair­ly late-stage pro­gram rel­a­tive to many pro­grams that have gone pub­lic in the biotech­nol­o­gy space.”

Soon af­ter Equi­l­li­um li­censed the drug, Bio­con com­plet­ed “a large amount of work” need­ed to demon­strate that the prod­uct it was man­u­fac­tur­ing for Equi­l­li­um was bio­com­pa­ra­ble to what it was sell­ing on the mar­ket, as they are man­u­fac­tured on dif­fer­ent cell lines. It al­so wrapped a Phase I study for both sub­cu­ta­neous and IV forms of EQ001 in Aus­tralia (though part of the tri­al was ter­mi­nat­ed ear­ly, ac­cord­ing to the S-1) and got a thumbs up from the FDA re­gard­ing the man­u­fac­tur­ing fa­cil­i­ty it’s us­ing to make biosim­i­lars to be sold in the US — all good news for Equi­l­li­um.

That’s prob­a­bly part of what at­tract­ed the en­cour­age­ment from pub­lic in­vestors, many of whom had al­so worked with Brad­bury be­fore Amylin was sold to Bris­tol-My­ers Squibb for $5.3 bil­lion. The oth­er part? All the clin­i­cal plans lined up for 2019: Phase Ib/II aGVHD tri­al ear­ly on; Phase II cGVHD tri­al in H1; and proof-of-con­cept in se­vere asth­ma, with a goal to choose an ad­di­tion­al in­di­ca­tion be­fore wrap­ping up the year.

All told, the cash run­way should ex­tend to the next 24 months af­ter go­ing pub­lic at $14, the low end of the range. The stock has edged up, though, and is now rid­ing above $15 per share. The mar­ket cap is a mod­est $277 mil­lion.

Stephen Con­nel­ly

And Equi­l­li­um can do all this with­out wor­ry­ing about man­u­fac­tur­ing: Aside from a 13.9% stake in the com­pa­ny, Bio­con isn’t charg­ing any­thing for sup­ply­ing itolizum­ab for test­ing in up to three or­phan in­di­ca­tions. Pro­duc­tion cost of ad­di­tion­al prod­ucts, the $30 mil­lion promised in reg­u­la­to­ry mile­stones and $565 mil­lion sales pay­ments won’t be due un­til — or if — Equi­l­li­um nabs its first ap­proval in the US.

Mean­while, Brad­bury adds, Equi­l­li­um’s “small but mighty” team of 11 is still on the hunt for ad­di­tion­al as­sets to beef up its im­munol­o­gy pipeline.

Brad­bury and Bruce Steel, a co-founder of the com­pa­ny now serv­ing as pres­i­dent and CBO, own the largest chunks of stocks at 22.1% each. Stephen Con­nel­ly — co-founder, CSO and Steel’s for­mer col­league at Bio­Med Ven­tures — is in for 7.7%.

Im­age: Dan Brad­bury. EQUI­L­LI­UM

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.

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.

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.

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.

ICER blasts FDA, PTC and Sarep­ta for high prices on DMD drugs Em­flaza, Ex­ondys 51

ICER has some strong words for PTC, Sarepta and the FDA as the US drug price watchdog concludes that as currently priced, their respective new treatments for Duchenne muscular dystrophy are decidedly not cost-effective.

The final report — which cements the conclusions of a draft issued in May — incorporates the opinion of a panel of 17 experts ICER convened in a public meeting last month. It also based its analysis of Emflaza (deflazacort) and Exondys 51 (eteplirsen) on updated annual costs of $81,400 and over $1 million, respectively, after citing “incorrect” lower numbers in the initial calculations.