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.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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 hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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FDA ap­proves an­oth­er in­di­ca­tion for Keytru­da, this time in the ad­ju­vant NSCLC set­ting

Merck’s blockbuster cancer treatment Keytruda has been handed another indication by the FDA.

The US regulator announced on Thursday that it has approved Keytruda to serve as an adjuvant treatment for non-small cell lung cancer (NSCLC), which is its fifth indication in NSCLC and 34th indication overall.

According to a Merck release, the approval is based on data from a Phase III trial, dubbed Keynote-091, which measured disease-free survival in patients who received chemotherapy following surgery. The data from Merck displayed that Keytruda cut down on the risk of disease recurrence or death by 27% versus placebo.