Mar­i­jn Dekkers

There’s a gi­ant need for cell and gene ther­a­py man­u­fac­tur­ing op­tions go­ing for­ward, as com­pa­nies move to in­vest mas­sive­ly in­to that space. Ori Biotech is the lat­est, as the UK-based biotech an­nounced it has se­cured more than $100 mil­lion in its over­sub­scribed Se­ries B fund­ing round Tues­day.

No­valis Life­Sciences led the round. The Boston-based com­pa­ny is led by chair­man Mar­i­jn Dekkers and part­ner Paul Meis­ter, who built Ther­mo Fish­er Sci­en­tif­ic. Dekkers went on to be­come the CEO of Bay­er, and is cur­rent­ly al­so the chair­man at Gink­go Bioworks.

In a state­ment, Meis­ter said:

We view Ori Biotech as the best-in-class so­lu­tion to solve many of the sig­nif­i­cant chal­lenges now fac­ing CGT re­searchers and de­vel­op­ers. We think Ori is well po­si­tioned, and are pleased to part­ner with their in­dus­try lead­ing man­age­ment team.

Puhua Cap­i­tal and Chimera Abu Dhabi came in as new in­vestors, with ex­ist­ing in­vestors Amadeus Cap­i­tal, Delin Ven­tures, North­pond Ven­tures and Oc­to­pus Ven­tures con­tribut­ing $30 mil­lion.

Paul Meis­ter

One re­sult of the in­vest­ment is a hir­ing spree. The com­pa­ny is look­ing 12 to 18 months out at its first com­mer­cial launch in 2023, Ori CEO Ja­son Fos­ter said, and the ma­jor­i­ty of the funds will go to­ward build­ing out its qual­i­ty sys­tem, sup­ply chain and man­u­fac­tur­ing. It’s al­so launch­ing its Light­speed Ear­ly Ac­cess Pro­gram, which al­lows part­ners to gain pre-launch ac­cess to the plat­form this year.

“The man­u­fac­tur­ing bot­tle­neck has been how do we trans­late these al­most aca­d­e­m­ic process­es on steroids to a com­mer­cial scale man­u­fac­tur­ing process so we can treat thou­sands or 10s of thou­sands of pa­tients. Thus far, we’re strug­gling to treat even 10s or hun­dreds of pa­tients,” Fos­ter said in an in­ter­view with End­points News. “Those process­es haven’t been able to scale. What we’re try­ing to do is au­to­mate when we can. Our process is to shrink the foot­print.”

Ori is try­ing to au­to­mate, dig­i­tize and stan­dard­ize the man­u­fac­tur­ing of cell and gene ther­a­pies. By fo­cus­ing on the man­u­fac­tur­ing process ear­ly on in pre­clin­i­cal tri­als, the team hopes to elim­i­nate the is­sues that come along with try­ing to scale.

“It takes a dif­fer­ent set of skills to de­vel­op a prod­uct and make it com­mer­cial­ly suc­cess­ful,” Fos­ter said. “We’re re­al­ly look­ing for­ward to the first clin­i­cal ap­pli­ca­tion of the tech­nol­o­gy. Ob­vi­ous­ly, we’re all here to help pa­tients, and so the soon­er we can get it in­to the clin­i­cal tri­als and demon­strate that we can im­prove qual­i­ty, hope­ful­ly, de­crease cost of goods sub­stan­tial­ly and in­crease through­put, that’ll bring us much clos­er to bring­ing these prod­ucts wide­ly avail­able for pa­tients.”

Ori has land­ed an­oth­er three biotech and CD­MO part­ners. UK-based Achilles Ther­a­peu­tics and Mi­naris Re­gen­er­a­tive Med­i­cine in New Jer­sey have al­ready signed on to work with them, and Fos­ter said that some oth­er ear­ly-ac­cess part­ner­ships will be an­nounced in the be­gin­ning of this year as well, though he stayed mum on just who those part­ners might be.

Across the world, there are con­cerns about a com­mer­cial-scale man­u­fac­tur­ing short­age for cell and gene ther­a­py. While a ton of mon­ey has been pumped in­to ex­pan­sion projects in the last two years, it takes about a year, some­times two, for those projects to be­come op­er­a­tional.

Ed­i­tor’s Note: For more news and ex­clu­sive cov­er­age from the man­u­fac­tur­ing beat, sub­scribe to the End­points Man­u­fac­tur­ing week­ly re­port in your read­er pro­file.

As concerns related to uptake and distribution continue to linger, Switzerland is among the first countries that plans to destroy hundreds of thousands of expired and unused Covid-19 vaccine doses.

The European country said it plans to destroy more than 600,000 doses of Moderna’s Spikevax Covid-19 vaccine as the doses have reached their expiration date.

However, Moderna CEO Stéphane Bancel told the World Economic Forum in Davos, Switzerland that he’s in the process of throwing 30 million doses in the garbage, exclaiming, “We have a big demand problem.”

At the end of January, the European Medicines Agency officially launched its new clinical trials info system (CTIS), although the migration to the new platform has only really just begun, and sponsors have until the end of January 2023 before all initial trial applications must be submitted through CTIS.

Overall, 56 clinical trial applications have been submitted in CTIS during the first 3 months since the launch of the system on Jan. 31, according to new data posted by the EMA. By comparison, about 4,000 new trials are authorized each year across Europe.

More than 500 stakeholders sent comments to the FTC on whether the commission should look further into pharma middlemen, known as PBMs, with many of the commenters calling for more federal oversight.

Similar to the critical open comment period in a deadlocked FTC session last February, pharmacies and pharmacy groups are continuing to call out the lack of transparency among the top 3 PBMs, which control about 80% of the market.

HHS on Thursday finalized its decision to withdraw a rule, proposed just before former President Donald Trump left office, that would’ve caused thousands of HHS and FDA regulations to automatically expire if they weren’t reviewed within two years, and every 10 years thereafter.

The decision follows the filing of a lawsuit last March, in which several nonprofits alleged that the outgoing administration planted “a ticking timebomb” for HHS, essentially forcing it to devote an enormous amount of resources to the unprecedented and infeasible task of reviewing thousands of regulations regularly.