Paul Sekhri, eGenesis CEO

George Church spin­off swal­lows a key man­u­fac­tur­ing part­ner as it preps CRISPR-edit­ed pig or­gans for an­i­mal test­ing

Re­search­ing, cloning and breed­ing gene-edit­ed pigs are core to eGe­n­e­sis’ au­da­cious mis­sion to grow or­gans that can be xeno­trans­plant­ed in­to hu­mans. But per­haps un­sur­pris­ing­ly, lit­tle of that ac­tu­al­ly hap­pens at its Cam­bridge, MA labs.

Rather, the biotech works with ex­ter­nal par­ties for that part of the R&D and man­u­fac­tur­ing work. As eGe­n­e­sis ap­proach­es a fi­nal ver­sion of the gene-edit­ed or­gans that it will test in an­i­mals, it’s ac­quir­ing one of those part­ners and in­te­grat­ing it as a sub­sidiary.

ICBiotec’s 15-per­son team will stay in the Mid­west. In ad­di­tion to the ex­ist­ing fa­cil­i­ties and equip­ment, eGe­n­e­sis al­so gains ac­cess to un­de­vel­oped land they can build on.

The way they work to­geth­er — with eGe­n­e­sis study­ing fi­brob­last cells in dish­es and turn­ing over gene-edit­ing pay­loads they de­vel­op in the lab to ICB for fur­ther test­ing — won’t change, said CEO Paul Sekhri; eGe­n­e­sis is mere­ly tran­si­tion­ing from the largest client of ICB to its own­er.

“They have a few oth­er cus­tomers that we’ll prob­a­bly en­sure that there’s a prop­er tran­si­tion, but to be hon­est with you I think we will need all of their ca­pa­bil­i­ties, which is one of the rea­sons why we did the trans­ac­tion in the first place,” he said.

De­spite pan­dem­ic-re­lat­ed re­stric­tions, eGe­n­e­sis is still on track to fi­nal­ize the recipe for ge­net­i­cal­ly en­gi­neer­ing the pigs from which they will har­vest or­gans to test in an­i­mal mod­els for safe­ty and ef­fi­ca­cy — be­gin­ning with the kid­ney. In the US alone, there are al­most 100,000 peo­ple on the kid­ney wait­ing list but on­ly around 14,000 trans­plants per­formed each year.

“The re­search nev­er stopped, it just was slowed down a bit be­cause you just lit­er­al­ly couldn’t have the same con­cen­tra­tion of peo­ple in the lab as we had in the past,” Sekhri said.

The slog to­ward the clin­ic will in­volve many more reg­u­la­tor hur­dles, some of which would be un­fa­mil­iar even to the FDA as it deals with the eth­i­cal and tech­ni­cal im­pli­ca­tions of this sci-fi wor­thy un­der­tak­ing. The chief re­quire­ment for a green light to the clin­ic, Sekhri has pre­vi­ous­ly not­ed, is con­sis­tent pre­clin­i­cal re­sults among non-hu­man pri­mates.

Mov­ing ICB ca­pa­bil­i­ties in-house adds band­width for this cru­cial ex­er­cise, he added. Hav­ing bagged $100 mil­lion last No­vem­ber, the deal “doesn’t sig­nif­i­cant­ly im­pact our cash run­way.”

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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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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Mar­ket­ingRx Matchup: How Ab­b­Vie and Bio­haven ads rank in head-to-head mi­graine chal­lenge

Are you ready to rumble? DTC brands that is. MarketingRx is launching a new monthly feature today called MarketingRx Matchup. We’re pitting two pharma brands’ DTC advertising in the same therapeutic category against each other to find out what consumers and patients really think.

Market research company Leger is handling the polling and analysis each month, and I’ll be writing up the results — along with my own take — inside MRx on the first Tuesday of the month.

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Wendy Lund, Organon chief communications officer

Q&A: Organon chief com­mu­ni­ca­tions of­fi­cer Wendy Lund talks about the Mer­ck spin­off, women’s health and why it mat­ters

One of Wendy Lund’s earliest jobs was head of marketing at Planned Parenthood. As the youngest person on its management team, she introduced them to emerging new technologies, and in return, she learned the importance of fighting for what you believe in.

Now as chief communications officer at Organon, the women’s health company recently spun off by Merck, Lund is keeping that point top of mind. That’s in part because women’s health hasn’t been a spotlight therapy area for Big Pharma in years. Several companies have spun off, sold or at least considered selling women’s health assets to focus on “core” products.

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Mar­ket­ingRx roundup: Pfiz­er re-ups pneu­mo­nia ads as Mer­ck threat looms; Re­al Chem­istry founder CEO Jim Weiss steps back

Every autumn, leaves fall from the trees and people start holiday shopping – and for the last few years Pfizer debuts a new “Know Pneumonia” awareness TV ad. This year the commercial, launched a week ago, features different people who talk about why they got vaccinated against pneumococcal pneumonia. Actors portray a young female firefighter with asthma, a mechanic with heart disease and an older woman with her grandchild. A Pfizer spokesperson declined comment on the latest iteration of the long-running campaign.

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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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