Rahul Singhvi, Resilience CEO

A Bob Nelsen start­up turns to Har­vard to help sharp­en its tech, in­spir­ing first spin­out

One of Bob Nelsen’s lat­est projects is head­ed to Har­vard.

Re­silience, a com­pa­ny start­ed with the goal of es­tab­lish­ing it­self as a “one-stop-shop” for com­pa­nies look­ing to scale man­u­fac­tur­ing, in­clud­ing for hard-to-de­vel­op cell and gene ther­a­pies, is less than a year old. Fri­day, it an­nounced a five-year R&D deal with Har­vard Uni­ver­si­ty that in­cludes $30 mil­lion to de­vel­op bi­o­log­ics, in­clud­ing vac­cines, nu­cle­ic acids and cell and gene ther­a­pies.

Lee Ru­bin

Re­silience will fund re­search fo­cused on cer­tain ther­a­peu­tics and bio­man­u­fac­tur­ing tech­nolo­gies in the uni­ver­si­ty’s labs. New com­pa­nies are ex­pect­ed to arise out of this re­search as well, the com­pa­ny said. One spin­out, dubbed Cir­cle Ther­a­peu­tics, has al­ready been cre­at­ed, and will car­ry for­ward Har­vard bi­ol­o­gist Lee Ru­bin’s work on skele­tal mus­cle stem cells for use in in vit­ro cell ther­a­pies. That aca­d­e­m­ic project is led by staff sci­en­tist Feodor Price.

“For six decades since the dis­cov­ery of the satel­lite cell, it has not been pos­si­ble to ex­pand ther­a­peu­tic num­bers of satel­lite cells in vit­ro, un­til we made re­al head­way on it at Har­vard,” Ru­bin, a pro­fes­sor of stem cell and re­gen­er­a­tive bi­ol­o­gy, said in the press re­lease. “We’re tru­ly ex­cit­ed for the pos­si­ble ther­a­peu­tic im­pact of our in­no­va­tions.”

Ru­bin’s lab has pre­vi­ous­ly re­ceived sup­port from the Blavat­nik Bio­med­ical Ac­cel­er­a­tor. The hope is that with ad­di­tion­al fund­ing, the team will be able to fast-track the tech­nol­o­gy to treat pa­tients. Re­silience and Har­vard have asked for calls for pro­pos­als to iden­ti­fy oth­er projects to be fund­ed at Har­vard, and Re­silience will get op­tions to li­cense the tech­nol­o­gy com­ing from the projects.

Isaac Kohlberg

“This re­search al­liance with Re­silience will help sup­port bio­med­ical in­no­va­tion at Har­vard,” Isaac Kohlberg, Har­vard’s chief tech­nol­o­gy de­vel­op­ment of­fi­cer, said. “Col­lab­o­rat­ing to both ad­vance Har­vard sci­ence and place aris­ing tech­nolo­gies with ded­i­cat­ed new ven­tures, we can pro­vide yet an­oth­er valu­able source of sup­port and in­dus­try ex­per­tise to trans­la­tion­al bio­med­ical re­searchers across Har­vard’s schools as they seek to im­pact hu­man health for the bet­ter.”

In Ju­ly, Re­silience shelled out $110 mil­lion to buy a lentivi­ral vec­tor man­u­fac­tur­ing site in Durham, NC. As a part of the deal, blue­bird and spin­off 2sev­en­ty will still have ac­cess to the LVV man­u­fac­tur­ing for the pipeline pro­grams. Re­silience and 2sev­en­ty are col­lab­o­rat­ing on its emerg­ing pipeline.

Be­fore that, Re­silience picked up CD­MO Ol­o­gy Bioser­vices, a Flori­da CD­MO that has part­nered with the De­part­ment of De­fense on a Covid-19 an­ti­body. It’s al­so es­tab­lished it­self in Cana­da, af­ter a pair of deals. One gave it $163 mil­lion in spend­ing from Prime Min­is­ter Justin Trudeau’s ad­min­is­tra­tion, and the sec­ond was an agree­ment with Mod­er­na to make mR­NA for the drug­mak­er’s Covid-19 vac­cine.

Biotech in­vestors and CEOs see two paths to growth, but are they equal­ly vi­able?

The dynamic in the biotech market has been highly volatile in the last few years, from the high peaks immediately after the COVID vaccine in 2021, to the lowest downturns of the last 20 years in 2022. This uncertainty makes calling the exact timing of the market’s turn something of a fool’s errand, according to Dr. Chen Yu, Founder and Managing Partner of TCG Crossover (TCG X). He speaks with RBC’s Noël Brown, Head of US Biotechnology Investment Banking, about the market’s road ahead and two possible paths for growth.

Dave Marek, Myovant CEO

My­ovant board balks as ma­jor­i­ty own­er Sum­it­o­mo swoops in with a $2.5B deal to buy them out

Three years after Sumitomo scooped up Roivant’s 46% stake in the publicly traded Myovant $MYOV as part of a 5-company, $3 billion deal, they’re coming back for the whole thing.

But these other investors at Myovant want more than what the Japanese pharma company is currently offering to pay at this stage.

Sumitomo is bidding $22.75 a share for the outstanding stock, which now represents 48% of the company after Sumitomo bumped its ownership since the original deal with Roivant. Myovant, however, created a special committee on the board, and they’re shaking their heads over the offer.

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Vlad Coric, Biohaven CEO

Vlad Coric charts course for 'New Bio­haven' with neu­ro­science push and Big Phar­ma vets on board

What’s Biohaven without its CGRP portfolio? That’s what CEO Vlad Coric is tasked with deciding as he maps out the “New Biohaven” post-Pfizer takeover.

Pfizer officially scooped up Biohaven’s CGRP assets on Monday, including blockbuster migraine drug Nurtec and the investigational zavegepant, for $11.6 billion. As a result, Coric spun the broader pipeline into an independent company on Tuesday — with the same R&D team behind Nurtec but about 1,000 fewer staffers and a renewed focus on neuroscience and rare disease.

In AstraZeneca's latest campaign, wild eosinophils called Phils personify the acting up often seen in uncontrolled asthma

As­traZeneca de­buts an­noy­ing pur­ple ‘Phil’ crea­tures, per­son­i­fied asth­ma eosinophils ‘be­hav­ing bad­ly’

There are some odd-looking purple creatures lurking around the halls of AstraZenca lately. The “Phil” character cutouts are purple, personified eosinophils with big buggy eyes and wide mouths, and they’re a part of AZ’s newest awareness effort to help people understand eosinophilic asthma.

The “Asthma Behaving Badly” characters aren’t only on the walls at AZ to show the new campaign to employees, however. The “Phils” are also showing up online on the campaign website, and in digital and social ads and posts on Facebook and Instagram.

Ying Huang, Legend CEO

Lentivi­ral vec­tor ramp-up: J&J and Leg­end to in­vest $500M in New Jer­sey man­u­fac­tur­ing to sup­port Carvyk­ti

In response to a question on manufacturing scale at Legend Biotech’s R&D day yesterday, the company’s top exec said its partnership with Johnson & Johnson will be doubling its investment in its New Jersey manufacturing center and will be investing a total of $500 million.

With an eye on their BCMA-directed CAR-T therapy Carvykti (cilta-cel), approved in February as a fifth-line treatment for multiple myeloma, Legend CEO Ying Huang said that the ramp-up in production and the decision to manufacture its own lentiviral vectors — currently in shortage worldwide — means they won’t have to deal with that shortage.

Kite Phar­ma gets FDA to sign off on new Cal­i­for­nia-based vec­tor man­u­fac­tur­ing fa­cil­i­ty

Kite Pharma just got FDA approval to kick off operations at a new manufacturing campus.

The cancer-focused, CAR-T cell therapy player made the announcement Monday, saying that the federal regulatory agency gave the green light to Kite’s 100,000 square-foot, retroviral vector manufacturing facility in Oceanside, CA.

Kite’s global head of technical operations Chris McDonald tells Endpoints News that the facility has been in the works for about four years, after Kite teamed up with its parent company Gilead. Gilead acquired Kite Pharma for just shy of $12 billion in 2017.

Casey McPherson shows his daughters Rose (left) and Weston around Everlum Bio, a lab that he co-founded to spark a treatment for Rose and others with ultra-rare conditions. (Ilana Panich-Linsman)

Fa­ther starts lab af­ter in­tel­lec­tu­al prop­er­ty is­sues stymie rare dis­ease drug de­vel­op­ment

Under bright lab lights, Casey McPherson holds his 6-year-old daughter, Rose. His free hand directs Rose’s gaze toward a computer screen with potential clues in treating her one-of-a kind genetic condition.

Gray specks on the screen show her cells that scientists reprogrammed with the goal of zeroing in on a custom medicine. McPherson co-founded the lab, Everlum Bio, to spark a treatment for Rose — and others like her. A regarded singer-songwriter, McPherson never imagined going into drug development.

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Marc Dunoyer, Alexion CEO (AstraZeneca via YouTube)

Up­dat­ed: As­traZeneca nabs a small rare dis­ease gene ther­a­py play­er for 667% pre­mi­um

AstraZeneca is kicking off the fourth quarter with a little M&A Monday for a gene editing player recently overcoming a second clinical hold to its only program in human studies.

The Big Pharma and its subsidiary Alexion are buying out little LogicBio for $2.07 per share. That’s good for a massive 667% premium over its Friday closing price, when it headed into the weekend at 27 cents and just weeks after Nasdaq said LogicBio would have to delist, which has been put on hold as the biotech requests a hearing. It’s one of two biotech deals to commence October, alongside the news of Incyte buying a vitiligo-focused biotech.

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Bob Duggan (Duggan Investments)

Biotech bil­lion­aire Bob Dug­gan flies the white flag as Sum­mit hunts a new own­er, or part­ner, for sole clin­i­cal-stage ef­fort

Bob Duggan’s Summit Therapeutics $SMMT is running out of moves for its sole clinical-stage candidate.

The biotech issued a terse statement in an SEC filing that it’s pulling the plug on the only active clinical trial for ridinilazole, which has been through a failed late-stage trial for C. difficile. A pediatric study is being curtailed as Summit says it decided a few days ago to either partner out the therapy or get a buyer — if they can find one.

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