Seer en­tices ex FDA com­mis­sion­er Mc­Clel­lan to its board; Van­da tests tradip­i­tant in mo­tion sick­ness study

→ The re­volv­ing door be­tween gov­ern­ment and the bio­phar­ma­ceu­ti­cal in­dus­try is spin­ning. On Wednes­day, life sci­ences and health da­ta com­pa­ny Seer un­veiled that it had lured for­mer FDA com­mis­sion­er and ex-CMS ad­min­is­tra­tor Mark Mc­Clel­lan on to its board. “Mark’s deep un­der­stand­ing of the health care ecosys­tem and vi­sion­ary in­sights on pol­i­cy re­form will be cru­cial in in­form­ing our think­ing as we work to bring our liq­uid biop­sy and life sci­ences prod­ucts to mar­ket,” said Seer chief and founder Omid Farokhzad in a state­ment.

In ad­di­tion to adding Mc­Clel­lan, the found­ing di­rec­tor of the Duke-Mar­go­lis Cen­ter for Health Pol­i­cy at Duke Uni­ver­si­ty, to its board, Seer has se­cured $17.5 mil­lion in a Se­ries C round of fi­nanc­ing. New in­vestors Wing VC and Aju IB par­tic­i­pat­ed in the round, along with ex­ist­ing in­vestors Mav­er­ick Ven­tures and In­vus, and oth­er in­sti­tu­tion­al and pri­vate in­vestors.

→ Mo­tion sick­ness? Van­da Phar­ma­ceu­ti­cals $VN­DA is on the case. The com­pa­ny’s tradip­i­tant — a neu­rokinin-1 re­cep­tor an­tag­o­nist it in-li­censed from Eli Lil­ly $LLY in 2012 — is be­ing test­ed for use in atopic der­mati­tis, gas­tro­pare­sis and mo­tion sick­ness. The proof-of-con­cept Phase II study in­clud­ed 126 peo­ple with a pri­or his­to­ry of mo­tion sick­ness who were sub­ject­ed to sea trav­el in the Pa­cif­ic Ocean in over sev­en boat trips that took place be­tween Jan­u­ary and May of 2019 off the coast of Los An­ge­les. The main goals of the study were: per­cent­age of par­tic­i­pants vom­it­ing, and Mo­tion Sick­ness Sever­i­ty Scale (MSSS) Worst score. Da­ta showed a sig­nif­i­cant­ly high­er per­cent­age of par­tic­i­pants ex­pe­ri­enced vom­it­ing in the place­bo arm as com­pared to the tradip­i­tant arm, 39.7% ver­sus 17.5% re­spec­tive­ly. The MSSS Worst score end­point al­so fa­vored tradip­i­tant, but the dif­fer­ence did not reach sta­tis­ti­cal sig­nif­i­cance, the com­pa­ny said.

→ Lon­don-list­ed PureTech Health — which is de­vel­op­ing ther­a­peu­tics to tack­le dys­func­tions in the brain-im­mune-gut ax­is — on Wednes­day said it has ac­quired an ear­ly-stage drug de­signed to treat lym­phat­ic and im­munofi­brot­ic dis­eases, in­clud­ing a chron­ic con­di­tion char­ac­ter­ized by se­vere swelling of the limbs or oth­er tis­sues, called lym­phede­ma. The drug, LYT-100, was pur­chased for an undis­closed amount from an un­named large phar­ma­ceu­ti­cal com­pa­ny where it was orig­i­nal­ly be­ing de­vel­oped in an­oth­er in­di­ca­tion, PureTech said, adding that it ex­pects to be­gin a proof-of-con­cept study next year.

→ Cell ther­a­py com­pa­ny Im­mu­soft has man­aged to snag Am­gen‘s $AMGN for­mer head of bi­o­log­ics Robert Hayes as its chief sci­en­tif­ic of­fi­cer. The Seat­tle-based firm has de­vel­oped a tech­nol­o­gy en­gi­neered to in­sert func­tion­al genes in­to im­mune cells us­ing a non-vi­ral vec­tor. Its lead ther­a­py is de­signed to help pa­tients with a rare, lethal child­hood ge­net­ic dis­ease that af­fects the body’s abil­i­ty to pro­duce an es­sen­tial en­zyme that helps to break down long-chain sug­ars in­side cells.

Con­quer­ing a silent killer: HDV and Eiger Bio­Phar­ma­ceu­ti­cals

Hepatitis delta, also known as hepatitis D, is a liver infection caused by the hepatitis delta virus (HDV) that results in the most severe form of human viral hepatitis for which there is no approved therapy.

HDV is a single-stranded, circular RNA virus that requires the envelope protein (HBsAg) of the hepatitis B virus (HBV) for its own assembly. As a result, hepatitis delta virus (HDV) infection occurs only as a co-infection in individuals infected with HBV. However, HDV/HBV co-infections lead to more serious liver disease than HBV infection alone. HDV is associated with faster progression to liver fibrosis (progressing to cirrhosis in about 80% of individuals in 5-10 years), increased risk of liver cancer, and early decompensated cirrhosis and liver failure.
HDV is the most severe form of viral hepatitis with no approved treatment.
Approved nucleos(t)ide treatments for HBV only suppress HBV DNA, do not appreciably impact HBsAg and have no impact on HDV. Investigational agents in development for HBV target multiple new mechanisms. Aspirations are high, but a functional cure for HBV has not been achieved nor is one anticipated in the forseeable future. Without clearance of HBsAg, anti-HBV investigational treatments are not expected to impact the deadly course of HDV infection anytime soon.

Am­gen chops 172 more staffers in R&D, op­er­a­tions and sales amid neu­ro­science ex­it, rev­enue down­turn

Neuroscience wasn’t the only unit that’s being hit by a reorganization underway at Amgen. As well as axing 149 employees in its Cambridge office, the company has disclosed that 172 others nationwide, including some from its Thousand Oaks, CA headquarters, are being let go.

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Ahead of strate­gic up­date, new Sanofi CEO mulls op­tions for con­sumer health­care arm — re­ports

Big pharma has made moves to sharpen its focus on developing new medicines, while slow-growing consumer health divisions fall by the wayside. Looks like another large drugmaker is considering a similar move. On Thursday, reports citing sources indicated that Sanofi is reportedly mulling a joint venture, sale, or a public listing of its consumer health arm.

The French group is in discussions for options that could value the division at $30 billion, Bloomberg and Reuters reported, citing sources familiar with the matter.

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The triple crown in biotech: An all-or-noth­ing bet on an FDA ap­proval of 3 drugs over 16 months starts to­day

Bristol-Myers Squibb’s $74 billion Celgene deal closed as expected Wednesday evening. And now a new clock has begun to tick down for Celgene shareholders who came away from the deal with CVRs — contingent value rights — worth $9 or nothing. Those CVRs start trading today as $BMYRT.

The new deadline they have is the end of March 2021, a little more than 16 months from now, when Bristol-Myers will need to gain approvals on 3 late-stage drugs it’s picking up in the buyout: Ozanimod and liso-cel (JCAR017) are due up at the end of 2020, with bb2121 deadlined at the end of Q1 in 2021.

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Genap­sys fi­nal­ly un­veils vaunt­ed se­quencer, but can it dent Il­lu­mi­na?

Hesaam Esfandyarpour holds what looks like a mini-cooler up to the computer screen in his California office.

Esfandyarpour is in his late-30s, with crows feet creeping up against a youthful face. He wears a gray polo and the device in his hand — with its hard plastic-looking shell, blue-and-white pattern, and a white plastic paddle resembling a handle jutting out the front — might contain diced strawberries and peanut-butter sandwiches to meet mom and the kids at a SoCal park. Instead, Esfandyarpour tells me it’s going to change medicine and biopharma research.

Brii Bio backs in­fec­tious dis­ease start­up while ink­ing deal for its lead TB drug, dou­bling down on an­tibi­otics

Almost two years after leaving GSK to launch Brii Bio with a whopping $260 million in funding, Zhi Hong is seeing the trans-Pacific infectious disease specialist he set out to build take shape.

“Our pipeline is coming together,” he told Endpoints News, with 12 partnered assets plus some internal programs.

As its latest partner, AN2 Therapeutics, comes into the limelight for the first time with a $12 million seed round, so is Brii’s plans in the antibiotics space. Brii has obtained China rights to AN2’s antibacterial targeting mycobacterium tuberculosis for multi-drug resistant TB, which it says is in the clinical stage.

UP­DAT­ED: Make that 2 ap­proved RNAi drugs at Al­ny­lam af­ter the FDA of­fers a speedy OK on ul­tra-rare dis­ease drug

Seventeen years into the game, Alnylam’s pivot into commercial operations is picking up speed.
The bellwether biotech $ALNY has nabbed their second FDA OK for an RNAi drug, this time for givosiran, the only therapy now approved for acute hepatic porphyria. This second approval came months ahead of the February deadline — even after winning priority review following their ‘breakthrough’ title earlier.
AHP is an extremely rare disease, with some 3,000 patients in Europe and the US, not all diagnosed, and analysts have projected peak revenue of $600 million to $700 million a year. The drug will be sold as Givlaari.

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David Ricks. Eli Lilly

Eli Lil­ly touts $400M man­u­fac­tur­ing ex­pan­sion, 100 new jobs to much fan­fare in In­di­anapo­lis — even though it's been chop­ping staff

Eli Lilly is pouring in $400 million to beef up manufacturing facilities at its home base of Indianapolis. The investment, which was lauded by the city’s mayor, is expected to create 100 new jobs.

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No­var­tis, Bay­er, Long­wood back ge­nomics start­up to speed search for im­munother­a­py tar­gets

Nearly a century passed between the first proto-immunotherapy attempts in cancer — crude and obscure but nonetheless with some scientific basis — and Jim Allison’s first T cell paper. Thirty-plus years flipped between the discovery of CTLA-4 as an off-switch and the approval of Yervoy. Twenty-two rolled between PD-1’s isolation and Opdiva and Keytruda. 

Longwood co-founder Lea Hachigian is betting she can hasten that. It’s a bet on newly established single-cell genomic analysis tech and the ability to crunch endless troves of data at a rate few others can, and investors including Leaps by Bayer and Novartis Venture Fund just put $39 million behind it. They call it Immunitas.