Man­u­fac­tur­ing roundup: Avid Bioser­vices ex­pands in Cal­i­for­nia; Charles Riv­er nets cell ther­a­py pro­duc­tion deal

A Cal­i­for­nia-based CD­MO will be look­ing to ex­pand its ca­pa­bil­i­ties in its home state to keep up with mar­ket de­mand.

Avid Bioser­vices is ex­pand­ing its lab­o­ra­to­ries in Tustin, Cal­i­for­nia around its ca­pac­i­ty for its mam­malian cell busi­ness.

The in­vest­ment is priced at $6 mil­lion, and the 4,500-square-foot ex­pan­sion is ex­pect­ed to be com­plet­ed by the end of the year. No out­side funds were nec­es­sary and the com­pa­ny used cash on hand to fund the project. This ex­pan­sion tails oth­er in­vest­ments the com­pa­ny has made to in­crease process de­vel­op­ment ca­pac­i­ty in 2019 and 2022.

Ex­pand­ing its lab­o­ra­to­ries could sup­port an ad­di­tion­al $20 mil­lion in an­nu­al process de­vel­op­ment rev­enue, dou­bling the com­pa­ny’s cur­rent process de­vel­op­ment ca­pac­i­ty, ac­cord­ing to a state­ment.

“Avid is fo­cused on en­sur­ing that it al­ways has avail­able ca­pac­i­ty to meet the needs of its cus­tomers (cur­rent and fu­ture),” said Nick Green, CEO of Avid, in an email to End­points News. “This lat­est project will gen­er­ate ad­di­tion­al up­stream and down­stream process de­vel­op­ment ca­pac­i­ty at the front-end of the mam­malian cell busi­ness, which is crit­i­cal for the ef­fi­cient on-board­ing of new cus­tomer projects.”

This comes on the heels of Avid open­ing an an­a­lyt­i­cal and process de­vel­op­ment suite with­in the com­pa­ny’s cGMP man­u­fac­tur­ing fa­cil­i­ty. The launch of these is to ex­pand its CD­MO ser­vice of­fer­ing in­to the rapid­ly grow­ing cell and gene ther­a­py mar­ket, with the com­pa­ny look­ing to ful­fill those ca­pa­bil­i­ties in 2023.

Charles Riv­er inks deal to man­u­fac­ture gene ther­a­py with ASC Ther­a­peu­tics

Mass­a­chu­setts-based Charles Riv­er Lab­o­ra­to­ries and ASC Ther­a­peu­tics, a pri­vate­ly held bio­phar­ma that spe­cial­izes in gene ther­a­pies, have agreed to man­u­fac­ture ASC618, a gene ther­a­py for he­mo­phil­ia A.

Fi­nan­cial de­tails and a time­line of the arrange­ment were not dis­closed.

Ker­stin Dolph, SVP for bi­o­log­ics so­lu­tions man­age­ment at Charles Riv­er, said that the com­pa­ny has been work­ing with ASC since 2019, to help es­tab­lish a man­u­fac­tur­ing process for their pre­clin­i­cal re­search. To­geth­er both com­pa­nies have es­tab­lished a process for AAV8 pro­duc­tion.

Dolph al­so said that the plas­mid man­u­fac­tur­ing and test­ing, GMP-up­stream and -down­stream process­es, and the fill/fin­ish for ASC are hap­pen­ing at their fa­cil­i­ty in Rockville, MD.

BioCi­na opens new DNA man­u­fac­tur­ing site

Af­ter ac­quir­ing Pfiz­er-owned Hos­pi­ra Ade­laide, the San Diego CD­MO BioCi­na has ex­pand­ed its ser­vice of­fer­ings to in­clude the man­u­fac­ture of plas­mid DNA (pDNA) in a new GMP suite.

While no fi­nan­cial or size de­tails were pre­sent­ed, the suite is now open and has up to 300 L sin­gle-use fer­men­ta­tion ca­pac­i­ty and scaled down­stream pro­cess­ing equip­ment to com­ple­ment their man­u­fac­tur­ing ca­pa­bil­i­ties.

“With our ex­treme­ly strong his­to­ry of qual­i­ty in man­u­fac­tur­ing, an ex­em­plary reg­u­la­to­ry in­spec­tion his­to­ry, and our cus­tomer-cen­tric busi­ness ap­proach, BioCi­na is in a strong po­si­tion to add sig­nif­i­cant val­ue to com­pa­nies work­ing in the RNA and gene and cell ther­a­py space that are strug­gling to find re­li­able and col­lab­o­ra­tive out­sourc­ing part­ners,” said BioCi­na CEO Ian Wisen­berg.

Ac­cord­ing to the com­pa­ny, its de­ci­sion to ex­pand its ser­vice of­fer­ing in­to pDNA de­vel­op­ment and man­u­fac­tur­ing was dri­ven by the de­mand for GMP-grade pDNA.

Eu­ro­pean-based man­u­fac­tur­ers come to­geth­er for an­ti­body drug pro­duc­tion

Swiss drug man­u­fac­tur­er Lon­za and French phar­ma­ceu­ti­cal group Pierre Fab­re an­nounced on Wednes­day that the com­pa­nies have en­tered in­to a man­u­fac­tur­ing agree­ment.

While no fi­nan­cial de­tails were re­vealed, the col­lab­o­ra­tion will be cen­tered around man­u­fac­tur­ing W0180, a mon­o­clon­al an­ti­body dis­cov­ered by Pierre Fab­re tar­get­ing the VISTA check­point. The as­set is be­ing in­ves­ti­gat­ed as a sin­gle agent and in com­bi­na­tion with pem­brolizum­ab in Phase I clin­i­cal tri­al in var­i­ous sol­id can­cer tu­mors.

The deal will have Lon­za pro­vide cGMP drug prod­uct man­u­fac­tur­ing ser­vices for clin­i­cal sup­ply from its fill and fin­ish fa­cil­i­ty in Stein, Switzer­land.

Lon­za has been on the move across the globe re­cent­ly, as it has not on­ly re­cent­ly col­lab­o­rat­ed with a VC in Is­rael, but has al­so com­plet­ed a man­u­fac­tur­ing fa­cil­i­ty in Bend, Ore­gon.

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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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