Hunt­ing a cure, Ex-No­var­tis ex­ec Bas­tiano San­na takes the reins at Cam­bridge di­a­betes start­up Sem­ma

A start­up try­ing to de­vel­op a stem cell cure for type 1 di­a­betes has re­cruit­ed for­mer Ma­gen­ta ex­ec­u­tive Bas­tiano San­na — a guy best known for lead­ing the de­vel­op­ment of No­var­tis’ cell-based med­i­cines — to serve as the com­pa­ny’s new CEO.

Bas­tiano San­na

Cam­bridge-based Sem­ma Ther­a­peu­tics is bring­ing San­na in to re­place its in­ter­im CEO Eliz­a­beth Ston­er. San­na comes di­rect­ly from Ma­gen­ta (an­oth­er start­up de­vel­op­ing stem cell tech), where he was chief op­er­at­ing of­fi­cer. Be­fore that, San­na was an ex­ec­u­tive at No­var­tis’ cell and gene ther­a­py di­vi­sion, over­see­ing the de­vel­op­ment of CAR-T drugs.

“Bas­tiano has the per­fect set of skills and ex­pe­ri­ences to lead Sem­ma through our next phase of growth as a com­pa­ny af­ter a very suc­cess­ful Se­ries B fi­nanc­ing,” said Sem­ma’s board chair­man Mark Fish­man in a state­ment. “Few lead­ers have such a strong cell ther­a­py back­ground com­bined with his lev­el of strate­gic and busi­ness ex­pe­ri­ence.”

Doug Melton

Sem­ma’s tech is based on re­search by Har­vard’s Doug Melton, whose lab de­vel­oped a way to turn em­bry­on­ic stem cells in­to in­sulin-pro­duc­ing be­ta cells in a dish. Sem­ma is now de­vel­op­ing an im­plantable, cred­it card-sized de­vice con­tain­ing these be­ta cells that would do the work of a healthy pan­creas. The de­vice, made to pro­tect the cells from be­ing at­tacked by the body’s im­mune sys­tem, would func­tion as an al­ter­na­tive to in­sulin pumps and in­jec­tions.

Sem­ma isn’t the on­ly com­pa­ny de­vel­op­ing an ap­proach like this to di­a­betes. There’s a com­pa­ny in San Diego called Vi­a­Cyte with a sim­i­lar cred­it card-sized de­vice be­ing test­ed in pa­tients with type 1 di­a­betes (Phase I/II tri­als).

Still, Sem­ma has at­tract­ed con­sid­er­able fi­nan­cial back­ing for its ap­proach. Since be­ing found­ed in 2014, the com­pa­ny has raised a to­tal of $163 mil­lion, in­clud­ing a whop­ping $114 mil­lion Se­ries B round last year. Its in­vestors in­clude MPM Cap­i­tal, F-Prime Cap­i­tal Part­ners, ARCH Ven­ture Part­ners, and No­var­tis.

“Sem­ma is a leader in re­gen­er­a­tive med­i­cine, and I couldn’t be more ex­cit­ed to lead this in­cred­i­ble team,” San­na said. “By com­bin­ing our deep un­der­stand­ing of stem cell bi­ol­o­gy with our cut­ting-edge de­vice tech­nol­o­gy, we have the op­por­tu­ni­ty to ex­pand the cu­ra­tive pow­er of cell ther­a­py to a range of clin­i­cal in­di­ca­tions where cell re­place­ment is nec­es­sary, and to im­prove the lives of mil­lions of pa­tients.”

Up­dat­ed: FDA re­mains silent on or­phan drug ex­clu­siv­i­ty af­ter last year's court loss

Since losing a controversial court case over orphan drug exclusivity last year, the FDA’s Office of Orphan Products Development has remained entirely silent on orphan exclusivity for any product approved since last November, leaving many sponsors in limbo on what to expect.

That silence means that for more than 70 orphan-designated indications for more than 60 products, OOPD has issued no public determination on the seven-year orphan exclusivity in the Orange Book, and no new listings of orphan exclusivity appear in OOPD’s searchable database, as highlighted recently by George O’Brien, a partner in Mayer Brown’s Washington, DC office.

Big week for Alzheimer’s da­ta; As­traZeneca buys cell ther­a­py start­up; Dig­i­tal ther­a­peu­tics hits a pay­er wall; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

You may start to notice more stories exclusively available to Premium subscribers. This week alone, paid subscribers can read our in-depth reporting on Alzheimer’s data, digital therapeutics and Allogene’s cell therapy for solid tumors, as well as scoops on Twitter ads and Catalent. With your support, we can keep growing our team and spend more time on quality work. We have both individual and company plans available — check them out to unlock the full Endpoints experience.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Am­gen, years be­hind ri­vals, says PhI obe­si­ty drug shows dura­bil­i­ty signs

While NBC ran “The Biggest Loser” for 17 seasons, deemed toxic by critics for the reality show’s punishing exercise and diet upheavals, researchers in pharmaceutical labs have been attempting to create prescription drugs that induce weight loss — and one pharma betting it can require less frequent dosing is out with a new crop of data.

Amgen was relatively late to the game compared to its approved competitor Novo Nordisk and green light-approaching rival Eli Lilly. But early data suggested Amgen’s AMG 133 led to a 14.5% weight reduction in the first few months of dosing, buoying shares earlier this fall, and now the California pharma is out with its first batch of durability data showing that figure fell slightly to 11.2% about 150 days after the last dose. Amgen presented at the 20th World Congress on Insulin Resistance, Diabetes & Cardiovascular Disease on Saturday afternoon.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

Illustration: Assistant Editor Kathy Wong for Endpoints News

As mon­ey pours in­to dig­i­tal ther­a­peu­tics, in­sur­ance cov­er­age crawls



Talk therapy didn’t help Lily with attention deficit hyperactivity disorder, or ADHD. But a video game did.

As the 10-year-old zooms through icy waters and targets flying creatures on the snow-capped planet Frigidus, she builds attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She’s now less anxious and scattered, allowing her to stay on a low dose of ADHD medication, according to her mom Violet Vu.

Endpoints Premium

Premium subscription required

Unlock this article along with other benefits by subscribing to one of our paid plans.

Eli Lil­ly’s Alzheimer’s drug clears more amy­loid ear­ly than Aduhelm in first-ever head-to-head. Will it mat­ter?

Ahead of the FDA’s decision on Eli Lilly’s Alzheimer’s drug donanemab in February, the Big Pharma is dropping a first cut of data from one of the more interesting trials — but less important in a regulatory sense — at an Alzheimer’s conference in San Francisco.

In the unblinded 148-person study, Eli Lilly pitted its drug against Aduhelm, Biogen’s drug that won FDA approval but lost Medicare coverage outside of clinical trials. Notably, the study didn’t look at clinical outcomes, but rather the clearance of amyloid, a protein whose buildup is associated with Alzheimer’s disease, in the brain.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

US month­ly costs for biosim­i­lars 'sub­stan­tial­ly high­er' than Ger­many or Switzer­land, JA­MA re­search finds

As the global biologics market is expected to hit nearly the half-trillion-dollar mark this year, new JAMA research points to the importance of timely biosimilar entry, particularly as fewer biosimilars are entering the US than in Europe, and as monthly treatment costs for biosimilars were “substantially higher” in the US compared with Germany and Switzerland.

Among the three countries, biosimilar market share at launch was highest in Germany, but increased at the fastest rate in the US, the authors from the University of Zurich’s Institute of Law wrote in JAMA Network Open today.

Kirk Myers is shown in a still image from a new film series showcasing the efforts of HIV advocates funded by Gilead.

Gilead spot­lights HIV projects and the com­mu­ni­ty lead­ers dri­ving them in new mi­ni-doc­u­men­tary films

Gilead is going behind the scenes of some of the HIV initiatives it funds through grants in a new film series narrated by the people helming the projects.

The first four films and leaders come from across the US — Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Their HIV-focused efforts range from addressing unmet needs of the transgender community to delivering social services and high-quality health care in underserved communities.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.

EMA pulls an opi­oid from the 1950s used to treat dry cough

The European Medicines Agency said Friday that it’s pulling from all European markets pholcodine-containing medicines, which are an opioid used in adults and children for the treatment of dry cough and in combo with other drugs as a treatment for cold and flu.

The decision to pull the medicines comes as the EMA points to the results from the recent ALPHO study, which show that use of pholcodine during the 12 months preceding anesthesia is linked to a risk of an anaphylactic reaction related to the neuromuscular blocking agents (NMBAs) used (with an adjusted OR of 4.2, and a 95% confidence interval of 2.5 to 6.9).

SQZ Biotech slash­es head­count by 60% as founder/CEO hits ex­it — while Syn­log­ic lays off 25%

It’s a tough time for early-stage companies developing highly promising, but largely unproven, new technologies.

Just ask SQZ Biotechnologies and Synlogic. The former is bidding farewell to its founder and CEO and slashing the headcount by 60% as it pivots from its original cell therapy platform to a next-gen approach; the latter — a synthetic biology play founded by MIT’s Jim Collins and Tim Lu — is similarly “optimizing” the company to focus on lead programs. The resulting realignment means 25% of the staffers will be laid off.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 154,000+ biopharma pros reading Endpoints daily — and it's free.