Alexandre Reeber, Core Biogenesis CEO

French biotech armed with Se­ries A looks to build out man­u­fac­tur­ing fa­cil­i­ty for plant-based pro­tein tech

Us­ing plant-based sup­ply to man­u­fac­ture vac­cines and oth­er phar­ma­ceu­ti­cal ma­te­ri­als has be­come more preva­lent in the biotech space, but one French biotech is look­ing to ap­ply it to the cell ther­a­py mar­ket.

Core Bio­gen­e­sis, based in Stras­bourg, France, us­es a plant-based bio­pro­duc­tion plat­form to pro­duce pro­teins. Ac­cord­ing to CEO Alexan­dre Reeber, the com­pa­ny us­es cameli­na, oth­er­wise known as wild flax tra­di­tion­al­ly used in gas­tron­o­my, to man­u­fac­ture pro­teins from the seeds of the plant. Core has se­cured $10.5 mil­lion in a Se­ries A to push its tech for­ward.

The com­pa­ny pro­duces its pro­teins in the seeds of the plants and har­vests them us­ing ba­sic agri­cul­tur­al meth­ods. Once in­side the seeds, re­searchers ex­tract the mol­e­cules and then pu­ri­fy them with their tech­nol­o­gy, leav­ing them with raw ma­te­ri­als that can then be ap­plied to phar­ma­ceu­ti­cal prod­ucts. The com­pa­ny has set its sights on pro­vid­ing pa­tients with cell ther­a­py.

Chouaib Mezia­di

Ac­cord­ing to Reeber, the idea for the com­pa­ny came dur­ing an in­tern­ship at a Stras­bourg hos­pi­tal’s on­col­o­gy unit. He first en­coun­tered cell ther­a­py at the unit but found it very ex­pen­sive to man­u­fac­ture. Two years lat­er in 2020, the oth­er co-founder, Chouaib Mezia­di, was do­ing a post-doc on plant epi­ge­net­ics where he iden­ti­fied the com­bi­na­tion of three key genes in­volved in the de­fense mech­a­nisms of the plant. The two even­tu­al­ly formed the com­pa­ny lat­er that year.

“This key in­no­va­tion will al­low us to mass pro­duce re­com­bi­nant pro­teins, and with mass pro­duc­tion al­so comes a dras­tic re­duc­tion in the price of the process,” Reeber said in an in­ter­view with End­points News.

Reeber said while the com­pa­ny pre­vi­ous­ly has net­ted some seed in­vest­ment of around $3 mil­lion, their Se­ries A now will go to­wards scal­ing up their man­u­fac­tur­ing ca­pa­bil­i­ties and open­ing a new fa­cil­i­ty. The round al­so gives the com­pa­ny a run­way of two years, but Reeber said the com­pa­ny will be look­ing at an­oth­er round of fi­nanc­ing to ac­cel­er­ate com­mer­cial­iza­tion.

For their new man­u­fac­tur­ing fa­cil­i­ty, which is still un­der con­struc­tion, Reeber said it is plan­ning to come on­line some­time in Q1 or Q2 next year. Around 600 square me­ters of the fa­cil­i­ty are ded­i­cat­ed to grow­ing the plants in growth cham­bers with an­oth­er 100 square me­ters ded­i­cat­ed to ex­trac­tion in pu­rifi­ca­tion. The lo­ca­tion of the fa­cil­i­ty will be in the city cen­ter of Stras­bourg.

Reeber al­so has a team of 30 peo­ple work­ing at the fa­cil­i­ty and will look to hire a di­rec­tor of man­u­fac­tur­ing.

While Reeber and Core Bio­gen­e­sis are fo­cused on cell ther­a­py, he is join­ing oth­er man­u­fac­tur­ing star­tups that are us­ing nov­el tech­niques in the in­dus­try.

Ac­cord­ing to Reeber, sev­er­al fac­tors set the com­pa­ny from the rest of the pack. Core promis­es to of­fer a more cost-ef­fi­cient prod­uct by us­ing cameli­na, which he said can guar­an­tee a bioac­tive and sta­ble sup­ply chain, but it al­so cuts down on us­ing an­i­mal-de­rived prod­ucts.

“And so in­her­ent to the use of plants we are com­plete­ly an­i­mal-ori­gin free and bio-risk free with ze­ro risk of con­t­a­m­i­na­tion of the most an­noy­ing con­t­a­m­i­nants that are usu­al­ly seen in­side of gene ther­a­py,” he said.

Reeber al­so states that his prod­uct is heav­i­ly sus­tain­able. With most com­pa­nies us­ing biore­ac­tor-based fer­men­ta­tion, the com­pa­ny’s method is car­bon neg­a­tive and pro­duces far few­er pol­lu­tants than what can be found by their com­peti­tors in the space.

As far as cus­tomers and part­ners are con­cerned, Reeber said that they have start­ed with a few se­lect part­ners and ear­ly adopters of their tech­nol­o­gy but now are open for more as they head to­ward full com­mer­cial­iza­tion.

The fund­ing round was led by XAnge, with oth­er in­vestors in­clud­ing Blue Hori­zon Ven­tures and Thia Ven­tures.

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In­no­v­a­tive MedTech De­mands Spe­cial­ist Clin­i­cal Tri­al Reg­u­la­to­ry Af­fairs and De­sign

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Ted Love, Global Blood Therapeutics CEO

Up­dat­ed: Pfiz­er scoops up Glob­al Blood Ther­a­peu­tics and its sick­le cell ther­a­pies for $5.4B

Pfizer is dropping $5.4 billion to acquire Global Blood Therapeutics.

Just ahead of the weekend, word got out that Pfizer was close to clinching a $5 billion buyout — albeit with other potential buyers still at the table. The pharma giant, flush with cash from Covid-19 vaccine sales, apparently got out on top.

The deal immediately swells Pfizer’s previously tiny sickle cell disease portfolio from just a Phase I program to one with an approved drug, Oxbryta, plus a whole pipeline that, if all approved, the company believes could make for a $3 billion franchise at peak.

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BREAK­ING: Math­ai Mam­men makes an abrupt ex­it as head of the big R&D group at J&J

In an after-the-bell shocker, J&J announced Monday evening that Mathai Mammen has abruptly exited J&J as head of its top-10 R&D group.

Recruited from Merck 5 years ago, where the soft spoken Mammen was being groomed as the successor to Roger Perlmutter, he had been one of the top-paid R&D chiefs in biopharma. His group spent $12 billion last year on drug development, putting it in the top 5 in the industry.

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No­vavax shares shred­ded as Covid vac­cine sales fall more than 90% in Q2

Months after Novavax celebrated its first profitable quarter as a commercial company, the Gaithersburg, MD-based company is back in the red.

Sales for Novavax’s Covid-19 vaccine slipped to $55 million last quarter, down from $586 million in Q1, CEO Stanley Erck revealed on Monday after market close. The company’s stock $NVAX plummeted more than 32% in after-hours trading.

Upon kicking off the call with analysts and investors, Erck addressed the elephant in the room:

Uğur Şahin, BioNTech CEO (Kay Nietfeld/picture-alliance/dpa/AP Images)

De­spite falling Covid-19 sales, BioN­Tech main­tains '22 sales guid­ance

While Pfizer raked in almost $28 billion last quarter, its Covid-19 vaccine partner BioNTech reported a rise in total dose orders but a drop in sales.

The German biotech reported over $3.2 billion in revenue in Q2 on Monday, down from more than $6.7 billion in Q1, in part due to falling Covid sales. While management said last quarter that they anticipated a Covid sales drop — CEO Uğur Şahin said at the time that “the pandemic situation is still very much uncertain” — Q2 sales still missed consensus by 14%.

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FDA commissioner Rob Califf (Tom Williams/CQ Roll Call via AP Images)

With drug pric­ing al­most done, Con­gress looks to wrap up FDA user fee leg­is­la­tion

The Senate won’t return from its summer recess until Sept. 6, but when it does, it officially has 18 business days to finalize the reauthorization of the FDA user fee programs for the next 5 years, or else thousands of drug and biologics reviewers will be laid off and PDUFA dates will vanish in the interim.

FDA commissioner Rob Califf recently sent agency staff a memo explaining how, “Our latest estimates are that we have carryover for PDUFA [Prescription Drug User Fee Act], the user fee funding program that will run out of funding first, to cover only about 5 weeks into the next fiscal year.”

Pascal Soriot, AstraZeneca CEO (David Zorrakino/Europa Press via AP Images)

As­traZeneca and Dai­ichi Sankyo sprint to mar­ket af­ter FDA clears En­her­tu in just two weeks

Regulators didn’t keep AstraZeneca and Daiichi Sankyo waiting long at all for their latest Enhertu approval.

The partners pulled a win on Friday in HER2-low breast cancer patients who’ve already failed on chemotherapy, less than two weeks after its supplemental BLA was accepted. While this isn’t the FDA’s fastest approval — Bristol Myers Squibb won an OK for its blockbuster checkpoint inhibitor Opdivo in just five days back in March — it comes well ahead of Enhertu’s original Q4 PDUFA date.

Bernhardt Zeiher, outgoing Astellas CMO (Astellas)

Q&A: Astel­las' re­tir­ing head of de­vel­op­ment re­flects on gene ther­a­py deaths

For anyone who’s been following discussions about the safety alarms surrounding the adeno-associated viruses (AAV) commonly used to deliver gene therapy, Astellas should be a familiar name.

The Japanese pharma — which bought out Audentes Therapeutics near the end of 2019 and later built a gene therapy unit around the acquisition — rocked the field when it reported three patient deaths in a trial testing AT132, the lead program from Audentes designed to treat a rare muscle disease called X-linked myotubular myopathy (XLMTM).

When the company restarted the trial, it adjusted the dose and instituted a battery of other measures to try to prevent the same thing from happening again. But tragically, the first patient to receive the new regimen died just weeks after administration. The therapy remains under clinical hold, and just weeks ago, Astellas flagged another safety-related hold for a separate gene therapy candidate. In the process of investigating the deaths, the company has also taken flak about the way it disclosed information.

Big questions remain — questions that can have big implications about the future of AAV gene therapies.

Bernhardt Zeiher did not imagine any of it when he first joined Astellas as the therapeutic area leader in inflammation, immunology and infectious diseases. But his ascent to chief medical officer and head of development coincided almost exactly with Astellas’ big move into gene therapy, putting him often in the driver’s seat to grapple with the setbacks.

As Zeiher prepares to retire next month after a 12-year tenure — leaving the unfinished tasks to his successor, a seasoned cancer drug developer — he chatted with Endpoints News, in part, to discuss the effort to understand what happened, lessons learned and the criticism along the way.

The transcript has been lightly edited for length and clarity.

Endpoints: I want to also ask you a bit about the gene therapy efforts you’ve been working on. Astellas has really been at the forefront of discovering the safety concerns associated with AAV gene therapy. What’s that been like for you?

Zeiher: Well, I have to admit, it’s been a bit of a roller coaster. We acquired Audentes. Huge amount of enthusiasm. What we saw with AT132 — that was the lead program in XLMTM — was just remarkable efficacy. I mean, kids who went from being on ventilators, not able to eat for themselves, sit up, do things like that, to off ventilators, walking, you know, really — one investigator called it this Lazarus-like effect. It was just really dramatic efficacy. And then to have the safety events that occurred. So they actually occurred within that first year of the acquisition. So we had the three patient deaths. Me and my organization became very, very much involved. In fact, Ed Conner, who had been the chief medical officer, he left after some of the deaths, but I stepped in as the kind of acting chief medical officer, we had another chief medical officer who was involved, and then we had a fourth death, and I became acting again for a period of time.

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Steve Paul, Karuna Therapeutics CEO (Third Rock)

Karuna's schiz­o­phre­nia drug pass­es a close­ly-watched PhI­II test, will head to FDA in mid-2023

An investigational pill that combines a former Eli Lilly CNS compound with an overactive bladder drug was better than placebo at reducing a scale of symptoms experienced by patients with schizophrenia in a Phase III trial.

Karuna Therapeutics’ drug passed the primary goal in EMERGENT-2, the Boston biotech said early Monday morning, alongside quarterly earnings. The study is the first of Karuna’s four Phase III clinical trials to read out in schizophrenia and will provide the backbone to the biotech’s first drug approval application, slated for mid-2023.

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