Eye­ing a trio of tri­al ini­ti­a­tions, Jim Wilson's gene ther­a­py start­up woos Bruce Gold­smith from Deer­field as CEO

Pas­sage Bio — Jim Wil­son’s self-de­scribed “lega­cy com­pa­ny” — has wooed a sea­soned biotech ex­ec­u­tive to steer the clin­i­cal en­try of its first three gene ther­a­py pro­grams.

Bruce Gold­smith

Bruce Gold­smith jumps to the helm of Pas­sage af­ter a brief CEO stint at Civet­ta, a can­cer-fo­cused start­up he helped launch while a ven­ture part­ner at Deer­field. He takes over from Or­biMed part­ner and in­ter­im chief Stephen Squin­to, who will now lead the R&D team.

He joins as the biotech preps IND fil­ings for three lead pro­grams in rare, mono­genic dis­eases of the cen­tral ner­vous sys­tem in 2020 — the lyso­so­mal stor­age dis­or­ders GM1 gan­gliasi­do­sis and Krabbe dis­ease, as well as fron­totem­po­ral de­men­tia.

“Bruce is ide­al­ly suit­ed to lead Pas­sage Bio as chief ex­ec­u­tive of­fi­cer giv­en his strong neu­ro­science back­ground cou­pled with his ro­bust health­care and biotech­nol­o­gy in­dus­try ex­pe­ri­ence,” board chair­man Tachi Ya­ma­da said in a state­ment.

Pas­sage launched last Feb­ru­ary with $115 mil­lion from a mar­quee group of Se­ries A in­vestors in­clud­ing Fra­zier (where Ya­ma­da is a part­ner), Or­biMed, Ver­sant Ven­tures, New Leaf Ven­ture Part­ners, Vi­vo Cap­i­tal and Lil­ly Asia Ven­tures. With an of­fice just a 10-minute walk away from Wil­son’s lab at the Uni­ver­si­ty of Penn­syl­va­nia, the com­pa­ny was de­signed to ap­ply the gene ther­a­py pi­o­neer’s 35-year ex­pe­ri­ence in­to “cross-cor­rec­tion­al ther­a­pies” for CNS.

Stephen Squin­to

Ac­cord­ing to what he calls the Jim Wil­son 90/10 rule, Squin­to pre­vi­ous­ly told End­points News, AAV vec­tors can cov­er and trans­duce 90% of mo­tor neu­ron cells but on­ly 10% to 15% of oth­er brain cells — mak­ing it dif­fi­cult to go af­ter in­di­ca­tions where broad trans­duc­tion is need­ed. But it can still prove use­ful in dis­or­ders that re­sult from mu­ta­tions in en­zymes that can be tak­en up by neigh­bor­ing cells once se­cret­ed nor­mal­ly.

A close pact with Penn’s Gene Ther­a­py Pro­gram and Or­phan Dis­ease Cen­ter gave Pas­sage rights to five pro­grams right out of the gate, with op­tions to li­cense sev­en more.

“It’s a very ag­gres­sive clin­i­cal de­vel­op­ment strat­e­gy across a mul­ti­tude of pro­grams,” Squin­to said as he closed a $110 mil­lion Se­ries B in Sep­tem­ber. “We’re not gonna re­ly on any one pro­gram to dri­ve the val­ue of Pas­sage, we’re gonna re­ly on what is a very very full pipeline of op­por­tu­ni­ties.”

Gold­smith will now lead a team of about 25 to build on pre­clin­i­cal and IND-en­abling da­ta from Wil­son’s lab — a com­pa­ny grow­ing ex­er­cise he honed as COO of Lyc­era. There, he was al­so cred­it­ed for a num­ber of busi­ness de­vel­op­ment ini­tia­tives.

The tran­si­tion in­to the clin­ic would al­so mean mov­ing pro­duc­tion from ear­ly fa­cil­i­ties at Penn to Paragon’s GMP sites, and even­tu­al­ly to a cus­tomized suite slat­ed for com­ple­tion in the third quar­ter of this year.

Squin­to, a rare dis­ease ex­pert who de­vot­ed much of his ca­reer to Alex­ion, will con­tin­ue to help over­see all of that as a board di­rec­tor.

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

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Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; 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.

I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.