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.”

Tar­get­ing a Po­ten­tial Vul­ner­a­bil­i­ty of Cer­tain Can­cers with DNA Dam­age Re­sponse

Every individual’s DNA is unique, and because of this, every patient responds differently to disease and treatment. It is astonishing how four tiny building blocks of our DNA – A, T, C, G – dictate our health, disease, and how we age.

The tricky thing about DNA is that it is constantly exposed to damage by sources such as ultraviolet light, certain chemicals, toxins, and even natural biochemical processes inside our cells.¹ If ignored, DNA damage will accumulate in replicating cells, giving rise to mutations that can lead to premature aging, cancer, and other diseases.

Roivant par­lays a $450M chunk of eq­ui­ty in biotech buy­out, grab­bing a com­pu­ta­tion­al group to dri­ve dis­cov­ery work

New Roivant CEO Matt Gline has crafted an all-equity upfront deal to buy out a Boston-based biotech that has been toiling for several years now at building a supercomputing-based computational platform to design new drugs. And he’s adding it to the Erector set of science operations that are being built up to support their network of biotech subsidiaries with an eye to growing the pipeline in a play to create a new kind of pharma company.

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The fu­ture of mR­NA, J&J's vac­cine ad­comm, Mer­ck­'s $1.85B au­toim­mune bet and more

Welcome to the third installment of 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.

If this report was helpful in recapping it all for you, please do share it with your colleagues.

Get ready for FDA’s third Covid-19 vaccine

On the heels of a ringing endorsement from FDA reviewers earlier in the week, J&J‘s single-dose vaccine — which proved 66% effective at preventing symptomatic Covid-19, and 85% effective at stopping severe disease 28 days after administration — the advisory committee convened by the agency voted unanimously to recommend its emergency use authorization. It was “a relatively easy call,” according to one of the committee members — although that doesn’t mean they didn’t have questions. Jason Mast has the highlights from the discussion, including new information from the company, on this live blog.

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With dust set­tled on ac­tivist at­tack, Lau­rence Coop­er leaves Zio­pharm to a new board

Laurence Cooper has done his part.

In the five years since he left a tenured position at Houston’s MD Anderson Cancer Center to become CEO of Boston-based Ziopharm, he’s steered the small-cap immunotherapy player through patient deaths in trials, clinical holds, short attacks and, most recently, an activist attack on the board.

So when the company has “fantastic news” like an IND clearance for a TCR T cell therapy program, he’s ready to pass on the baton.

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Fol­low biotechs go­ing pub­lic with the End­points News IPO Track­er

The Endpoints News team is continuing to track IPO filings for 2021, and we’ve designed a new tracker page for the effort.

Check it out here: Biopharma IPOs 2021 from Endpoints News

You’ll be able to find all the biotechs that have filed and priced so far this year, sortable by quarter and listed by newest first. As of the time of publishing on Feb. 25, there have already been 16 biotechs debuting on Nasdaq so far this year, with an additional four having filed their S-1 paperwork.

Steve Cutler, Icon CEO (Icon)

In the biggest CRO takeover in years, Icon doles out $12B for PRA Health Sci­ences to fo­cus on de­cen­tral­ized clin­i­cal work

Contract research M&A had a healthy run in recent years before recently petering out. But with the market ripe for a big buyout and the Covid-19 pandemic emphasizing the importance of decentralized trials, Wednesday saw a tectonic shift in the CRO world.

Icon, the Dublin-based CRO, will acquire PRA Health Sciences for $12 billion in a move that will shake up the highest rungs of a fragmented market. The merger would combine the 5th- and 6th-largest CROs by 2020 revenue, according to Icon, and the merger will set the newco up to be the second-largest global CRO behind only IQVIA.

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Doug Ingram (file photo)

Why not? Sarep­ta’s third Duchenne MD drug sails to ac­cel­er­at­ed ap­proval

Sarepta may be running into some trouble with its next-gen gene therapy approach to Duchenne muscular dystrophy. But when it comes to antisense oligonucleotides, the well-trodden regulatory path is still leading straight to an accelerated approval for casimersen, now christened Amondys 45.

We just have to wait until 2024 to find out if it works.

Amondys 45’s approval was unceremonious, compared to its two older siblings. There was no controversy within the FDA over approving a drug based on a biomarker rather than clinical benefit, setting up a powerful precedent that still haunts acting FDA commissioner Janet Woodcock as biotech insiders weighed her potential permanent appointment; no drama like the FDA issuing a stunning rejection only to reverse its decision and hand out an OK four months later, which got more complicated after the scathing complete response letter was published; no anxious tea leaf reading or heated arguments from drug developers and patient advocates who were tired of having corticosteroids as their loved ones’ only (sometimes expensive) option.

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Tal Zaks, Moderna CMO (AP Photo/Rodrique Ngowi, via still image from video)

CMO Tal Zaks bids Mod­er­na a sur­prise adieu as biotech projects $18.4B in rev­enue, plots post-Covid ex­pan­sion

How do you exit a company after six years in style? Developing one of the most lucrative and life-saving products in pharma history is probably not the worst way to go.

Tal Zaks, Moderna’s CMO since 2015, will leave the mRNA biotech in September, the biotech disclosed in their annual report this morning. The company has already retained the recruitment firm Russell Reynolds to find a replacement.

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Masayoshi Son, SoftBank CEO (glen photo/Shutterstock)

Japan's Soft­Bank plots bil­lions in biotech in­vest­ments in move that could keep the val­u­a­tion flood ris­ing — re­port

The valuation crazy train in biotech continues to roll into the new year with more than a dozen companies taking a chance on Nasdaq and money flowing in from all sides. Now, a Japanese institutional investor is reportedly weighing an entry into the market in a big way — will it keep the bitcoin-esque flood rising?

Already a part-time investor in biotech, SoftBank could drop billions of dollars into the industry as part of helmsman Masayoshi Son’s plan to spend around $80 billion of the firm’s own assets, according to a report from Bloomberg citing people familiar with the plan.

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