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.”

It’s time for a new FDA commissioner to come on board, a rite of passage for Joe Biden’s administration that should help seal the new president’s rep on seeking out the experts to lead the government over the next 4 years.

As of now, the competition for the top job appears to have narrowed down to 2 people: The longtime CDER chief Janet Woodcock and Joshua Sharfstein, the former principal deputy at the FDA under Peggy Hamburg. Both were appointed by Barack Obama.

With the contract manufacturing market on a hot streak with the Covid-19 vaccine rollout, Lonza has opened its war chest in recent months for a suite of expansions. But now, with its focus elsewhere, the company is looking to contract its capsule offerings for pharma.

The CDMO giant will offload its lipid capsule production sites in Ploërmel, France, and Edinburgh, UK, as part of a plan to exit the pharmaceutical capsules space while maintaining its market foothold in consumer health and nutrition, the company said Tuesday.

Agios vet John Evans has demonstrated how to raise big money for a little biotech.

The Beam Therapeutics CEO — and ARCH partner — has pieced together a $260 million private placement from a group of backers that includes Perceptive Advisors, Farallon Capital, Casdin Capital, Redmile Group and Cormorant Asset Management. And there are 3 main goals they’ll pursue with it: clinical development, strategic partnerships and general corporate purposes.

AstraZeneca’s big gamble on Daiichi Sankyo’s antibody-drug conjugate Enhertu has already paid off with a big approval in breast cancer more than a year ago. But the partners have big plans for their blockbuster in the making, and a new nod in gastric cancer will raise their spirits even higher.

The FDA on Friday approved Enhertu to treat locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma in patients who have previously undergone at least one round of treatment with a Herceptin-based regimen, AstraZeneca said in a release.