Lon­za en­ters the ex­o­some ther­a­py space with ac­qui­si­tion of still-new Co­di­ak site

In an­tic­i­pa­tion of tack­ling the man­u­fac­tur­ing prob­lems that come with ex­o­some ther­a­peu­tics head on, Co­di­ak Bio­Sciences built a 12,000-square-foot man­u­fac­tur­ing site in Lex­ing­ton, MA. Tues­day, it an­nounced that it will hand over the reins to a pow­er­house CD­MO.

Swiss man­u­fac­tur­er Lon­za will ac­quire IP rights and the fa­cil­i­ty from Co­di­ak in ex­change for $65 mil­lion worth of man­u­fac­tur­ing ser­vices, the com­pa­nies said.

Doug Williams

“I think we both see this as a modal­i­ty that’s re­al­ly com­ing in­to its own,” CEO Doug Williams said in a call with End­points News. “One of the things we’ve been vey proac­tive about as a com­pa­ny, re­al­ly from the very found­ing of Co­di­ak, is the im­por­tance of man­u­fac­tur­ing … not just at the ear­ly stages but think­ing about it as a long-term com­mit­ment. We’ve in­vest­ed a lot at Co­di­ak, and I think this deal is a recog­ni­tion of the long-term in­vest­ment we’ve made.”

“And we’ve now part­nered with one of the best CD­MOs on the plan­et to re­al­ly ful­fill the promise … and re­al­ly so­lid­i­fy­ing a path to com­mer­cial­iza­tion.”

Ex­o­somes are nano-sized mem­brane vesi­cles that are se­cret­ed by many cell types, play­ing a role in cell-to-cell com­mu­ni­ca­tion. Fur­ther de­vel­op­ment of the ex­o­some plat­form has the po­ten­tial to make cell and gene ther­a­pies avail­able for a large pa­tient pop­u­la­tion, Co­di­ak said. Williams says that he thinks his com­pa­ny is out ahead of the pack in this field, but the Lon­za deal en­sures that they aren’t rest­ing on their lau­rels.

Co­di­ak will re­tain all IP core to its ex­o­some en­gi­neer­ing plat­form, the com­pa­ny said, but the two com­pa­nies will cre­ate a Cen­ter of Ex­cel­lence to ad­vance ex­o­some man­u­fac­tur­ing tech­nolo­gies and Lon­za will be­come the ex­clu­sive man­u­fac­tur­ing part­ner for Co­di­ak. That Cen­ter of Ex­cel­lence — in Lex­ing­ton — will use both com­pa­nies’ strengths to ad­vance ex­o­some pro­duc­tion, pu­rifi­ca­tion and an­a­lyt­ics.

A lit­tle more than a year ago, Co­di­ak hit Wall Street in its sec­ond at­tempt to go pub­lic, rais­ing $83 mil­lion by pric­ing 5.5 mil­lion shares at $15. It backed out of its first IPO in Ju­ly 2019 due to un­fa­vor­able mar­ket con­di­tions but found more suc­cess dur­ing biotech’s red-hot 2020.

Co­di­ak en­gi­neers ex­o­somes to de­liv­er a range of ther­a­peu­tic pay­loads. Its fo­cus at the time it went pub­lic was a pro­gram that us­es a STING path­way ag­o­nist that was li­censed from French biotech Kay­la Ther­a­peu­tics. About half of its IPO went to­ward that Phase I/II tri­al, while $34.3 mil­lion went to the en­gEx Plat­form. A third can­di­date, ex­oIL-12, is ex­pect­ed to be sub­mit­ted for an in­ves­ti­ga­tion­al new drug ap­pli­ca­tion with the FDA by the end of this year.

Al­ber­to San­tagosti­no

“Ob­vi­ous­ly it’s a set of pro­grams that are on the move for us right now,” Williams said.

Lon­za’s SVP of cell and gene tech­nolo­gies, Al­ber­to San­tagosti­no, will take over the op­er­a­tions of the Lex­ing­ton site, which Williams said will al­most cer­tain­ly see the ad­di­tion of new em­ploy­ees in the com­ing years.

“We be­lieve it’s go­ing to co-ex­ist and have a very im­por­tant role on the over­all en­vi­ron­ment,” San­tagosti­no said in an in­ter­view. “Lon­za in gen­er­al terms through­out his­to­ry has been ex­treme­ly com­mit­ted, and we found our­self to en­abling those new­er tech­nolo­gies that come to mar­ket, hav­ing a pres­ence in ex­o­somes to­day, it feels like as im­por­tant as it was set­ting the foun­da­tion of cell and gene ther­a­pies back in the day.”

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His­toric drug pric­ing re­forms pass; Pfiz­er ac­quires GBT; The long search for non-opi­oid pain drugs; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

The Endpoints Weekly has officially crossed the 60,000 mark on subscribers — thanks to all of your support. As the editorial team grows, we’ve been able to do a lot more, with many of those on display this week. Be sure to check out Lei Lei Wu’s deep dive on pain R&D. If you missed it, you may also rewatch her companion panel here.

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Gold for adults, sil­ver for in­fants: Pfiz­er's Pre­vnar 2.0 head­ed to FDA months af­ter Mer­ck­'s green light

Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.

Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.

Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.

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No­var­tis re­ports two pa­tient deaths af­ter treat­ment with Zol­gens­ma

Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.

The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.

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House pass­es his­toric drug pric­ing re­forms, lin­ing up decades-in-the-mak­ing win for Biden and De­moc­rats

The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.

Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.

Senate Finance Committee Chair Ron Wyden (D-OR) (Francis Chung/E&E News/POLITICO via AP Images)

Sen­ate Fi­nance chair con­tin­ues his in­ves­ti­ga­tion in­to phar­ma tax­es with re­quests for Am­gen

Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.

Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.

Ab­bott pumps $450M+ in­to new Ire­land-based man­u­fac­tur­ing site project and hir­ing spree

As Ireland continues to see more investments and building projects from pharma companies, another contender is looking to place more investment in the Emerald Isle.

According to a report from The Irish Times on Friday, Abbott Laboratories is investing €440 million, or about $451 million, to build a new manufacturing plant in Kilkenny, located in the country’s southeast, to make more of its glucose monitors.

FDA ap­proves sec­ond in­di­ca­tion for As­traZeneca and Dai­ichi's En­her­tu in less than a week

AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.

Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.

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J&J to re­move talc prod­ucts from shelves world­wide, re­plac­ing with corn­starch-based port­fo­lio

After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.

J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.