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.

Spe­cial re­port: Meet 20 ex­tra­or­di­nary women who are su­per­charg­ing bio­phar­ma R&D

Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go.

Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment.

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Op­ti­miz­ing Oral Drug De­liv­ery us­ing Zy­dis® Oral­ly Dis­in­te­grat­ing Tablet Tech­nol­o­gy to Ad­dress Pa­tient Chal­lenges

KEY POINTS

Patients prefer oral dosing, but swallowing tablets can be a challenge for many patients.
The Zydis® orally disintegrating tablet (ODT) platform addresses challenges associated with oral dosing, expanding benefits for patients and options for healthcare providers.
A strong growth trajectory is expected for ODTs given therapeutic innovation and continued technology development.

Many patients prefer conventional tablets for the administration of medications, but some geriatric and pediatric patients and those with altered mental status and physical impairments find swallowing tablets to be difficult. Orally disintegrating tablets (ODTs), which dissolve completely without chewing or sucking, offer a patient-friendly dosage form for the administration of small-molecule drugs, peptides and proteins. With the potential for multiple sites of drug absorption, often faster onset action for the active pharmaceutical ingredient (API), and potentially greater bioavailability, ODTs are an attractive option for drug developers considering first-to-market formulations or product line extensions of existing drugs with compatible API. In this report, we look at how innovation in the industry-leading Zydis ODT platform is expanding oral formulation options and bringing benefits to patients.

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Geoffrey Porges (SVB Leerink)

The 2022 wave com­ing? Top an­a­lyst says Big Phar­ma will have more than $1T avail­able to sat­is­fy its grow­ing ap­petite for biotech M&A

All through this year you could practically feel the frustration of the biotech investor class as M&A activity continued to drag behind expectations — or desires. Buyouts of public companies provide the essential juice for keeping stocks lively, and there’s been a notable lack of juice in 2021.

So is all that about to change, big time?

SVB Leerink’s Geoffrey Porges, a longtime student of biotech M&A, thinks so. In a lengthy analysis he put out last week, Porges totted up the cash flow of the major pharmas and determined that there was a good long list of industry buyers who would have around a half trillion dollars of cash to play with in 2022. Leverage that up with added debt and you could get that deal cache to $1.6 trillion.

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Mer­ck pumps the brakes on two more PhI­II tri­als for its lead an­ti-HIV drug

After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since.

On Monday, the biopharma company announced it’s pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir.

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James Sabry

'We're in': Roche and Genen­tech join forces on a multi­bil­lion-dol­lar dis­cov­ery pact with a brash AI up­start

Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level.

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Brett Monia, Ionis CEO

As­traZeneca grabs PhI­II AT­TR drug from Io­n­is — in­fus­ing $200M cash in­to strug­gling part­ner

AstraZeneca is plucking another antisense drug out of Ionis’ prolific pipeline.

Paying $200 million in cash, AstraZeneca has inked a development and commercialization deal around eplontersen — the Phase III TTR amyloidosis drug formerly known as IONIS-TTR-LRX. On top of the upfront and $485 million worth of conditional payments to follow regulatory approvals, the pharma giant is promising $2.9 billion in sales-related milestones should the drug reach megablockbuster status, plus royalties.

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Bolt Bio CEO Randy Schatzman

Bolt Bio goes bust as in­vestors boo sin­gle re­sponse in ear­ly test against HER2-ex­press­ing tu­mors

Bolt Bio’s BDC-1001, an antibody conjugate drug designed to amp up the body’s innate immune system response to tumors, posted a single partial response in a Phase I/II study in patients with HER2-expressing solid tumors after a year of dosing. Just 13 of 40 evaluable patients showed any signs of “clinical activity,” the biotech said Monday.

BDC-1001 links a HER2-targeting biosimilar of Herceptin with a TLR7/8 agonist, which is designed to activate myeloid cells in the innate immune system and drive tumor cytotoxicity, Bolt said. But the early results paint the picture of a drug with little effect on HER2 tumors, one of the most highly validated tumor targets in drug development.

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Biohaven CEO Vlad Coric (Photo Credit_ Andrew Venditti)

Bio­haven shakes up lead­er­ship team as it feels the heat from mi­graine com­peti­tors

As Biohaven Pharma comes off a rollercoaster pipeline year, its CEO will take on more responsibility in a full C-suite makeover.

Vlad Coric was unanimously elected to the role of chairman of the board of directors, after Declan Doogan’s retirement. Matthew Buten will take over the role of CFO after James Engelhart’s retirement, and director Michael Heffernan has been appointed lead independent director. All of the appointments are effective immediately, a company press release said.

Chen Schor, Adicet CEO

Adicet un­veils ear­ly re­spons­es for off-the-shelf drug lever­ag­ing rare T cells. Will dura­bil­i­ty hold up?

On the hunt for the next generation of “off-the-shelf” cell therapies, biotech players like Adicet Bio have looked to leverage some of the less-obvious members of the immune system as potent cancer fighters. In Adicet’s case, scarce gamma delta T cells are on the menu, and an early cut of data is showing some promise.

Adicet’s AD-001, an off-the-shelf cell therapy developed by engineering a CD20-targeting chimeric antigen receptor (CAR) onto a donor’s gamma delta T cells, posted two complete responses across four patients in an early Phase I study testing the drug in patients with heavily pretreated B cell non-Hodgkin’s lymphoma, the biotech said Monday.

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