Thomas Lingelbach, Valneva CEO

Pfiz­er nabs $95M stake in Val­ne­va as Ly­me dis­ease vac­cine ap­proach­es piv­otal study

Pfiz­er is in­vest­ing some mon­ey in its Ly­me dis­ease part­ner biotech as the pair gears up for a Phase III study.

The Big Phar­ma chipped in $95 mil­lion in eq­ui­ty for Val­ne­va, good enough for an 8.1% stake in the French vac­cine mak­er. Mon­day’s deal comes af­ter the two com­pa­nies ini­tial­ly agreed to de­vel­op the can­di­date in April 2020 and a few months af­ter the pro­gram read out Phase II pe­di­atric re­sults.

Kathrin Jansen

“As the ge­o­graph­ic foot­print of Ly­me dis­ease widens, the med­ical need for vac­ci­na­tion be­comes even more im­per­a­tive,” Pfiz­er’s head of vac­cines R&D Kathrin Jansen said in a state­ment. “We are ex­cit­ed to con­tin­ue part­ner­ing with Val­ne­va on the de­vel­op­ment of VLA15 and look for­ward to work­ing to­geth­er to progress the pro­gram.”

The eq­ui­ty deal val­ued Val­ne­va’s stock price at $10.02 per share. In­vestors re­act­ed warm­ly to the news, with Val­ne­va shares $VALN jump­ing 83% while the mar­ket was closed for the June­teenth hol­i­day, af­ter drop­ping 13% in the fi­nal min­utes of last Fri­day’s trad­ing ses­sion.

On top of the eq­ui­ty fi­nanc­ing, Pfiz­er and Val­ne­va are al­so slight­ly amend­ing their orig­i­nal Ly­me dis­ease vac­cine deal. Val­ne­va will now take on 40% of the re­main­ing shared de­vel­op­ment costs in­stead of 30%, and Pfiz­er will pay roy­al­ties rang­ing from 14% to 22% in­stead of start­ing at 19%. Pfiz­er will add an­oth­er $100 mil­lion in po­ten­tial sales mile­stones as well.

Val­ne­va had made most of its head­lines in the last cou­ple years for its work in Covid-19 vac­cines, promis­ing to de­vel­op an al­ter­na­tive shot to the wide­ly used Pfiz­er, Mod­er­na and As­traZeneca jabs. Though Val­ne­va’s shot even­tu­al­ly got across the fin­ish line in the UK, the vac­cine like­ly will not be avail­able in Eu­rope much longer af­ter the EU de­cid­ed to ter­mi­nate its pur­chase agree­ment last month.

And last week, the com­pa­ny said chances of re­viv­ing the con­tract are slim, send­ing its shares plung­ing.

But the Ly­me dis­ease pro­gram has rolled right along, pass­ing a Phase II test for adults last Sep­tem­ber and achiev­ing its goals in an­oth­er Phase II study in April. Funds from Mon­day’s eq­ui­ty fi­nanc­ing are ex­pect­ed to go to­ward the piv­otal Phase III tri­al, which will like­ly launch in the third quar­ter, the com­pa­nies said.

Late Fri­day ap­proval; Trio of biotechs wind down; Stem cell pi­o­neer finds new fron­tier; Biotech icon to re­tire; 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.

I hope your weekend is off to a nice start, wherever you are reading this email. As for me, I’m trying to catch the tail of the Lunar New Year festivities.

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Pfiz­er lays off em­ploy­ees at Cal­i­for­nia and Con­necti­cut sites

Pfizer has laid off employees at its La Jolla, CA, and Groton, CT sites, according to multiple LinkedIn posts from former employees.

The Big Pharma confirmed to Endpoints News it has let go of some employees, but a spokesperson declined to specify how many workers were impacted and the exact locations affected. Earlier this month, the drug developer had confirmed to Endpoints it was sharpening its focus and doing away with some early research on areas such as rare disease, oncology and gene therapies.

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Eliot Forster, F-star CEO (Rachel Kiki for Endpoints News)

F-star gets down to the wire with $161M sale to Chi­nese buy­er as na­tion­al se­cu­ri­ty con­cerns linger

With the clock ticking on F-star Therapeutics’ takeover by a Chinese buyer, the companies are still scrambling to remove a hold on the deal from the US government’s Committee on Foreign Investment in the United States.

F-star and invoX Pharma said they are “actively negotiating” with CFIUS “about the terms of a mitigation agreement to address CFIUS’s concerns regarding potential national security risks posed by the transaction.”

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Rodney Rietze, iVexSol CEO

Bris­tol My­ers, Charles Riv­er join Se­ries A fund­ing for iVex­Sol

Massachusetts-based iVexSol has secured funding to the tune of $23.8 million in its latest Series A round. The new investors include Bristol Myers Squibb, manufacturer Charles River Laboratories and Asahi Kasei Medical.

iVexSol is a manufacturer of lentiviral vectors (LVV), used in making gene therapies, and this latest round of fundraising brings its total Series A total over $39 million, which will be used to recruit more employees and bolster its technology.

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Jake Van Naarden, Loxo@Lilly CEO

Lil­ly en­ters ripe BTK field with quick FDA nod in man­tle cell lym­phoma

Eli Lilly has succeeded in its attempt to get the first non-covalent version of Bruton’s tyrosine kinase, or BTK, inhibitors to market, pushing it past rival Merck.

The FDA gave an accelerated nod to Lilly’s daily oral med, to be sold as Jaypirca, for patients with relapsed or refractory mantle cell lymphoma.

The agency’s green light, disclosed by the Indianapolis Big Pharma on Friday afternoon, catapults Lilly into a field dominated by covalent BTK inhibitors, which includes AbbVie and Johnson & Johnson’s Imbruvica, AstraZeneca’s Calquence and BeiGene’s Brukinsa.

Filip Dubovsky, Novavax CMO

No­vavax gets ready to take an­oth­er shot at Covid vac­cine mar­ket with next sea­son plans

While mRNA took center stage at yesterday’s FDA vaccine advisory committee meeting, Novavax announced its plans to deliver an updated protein-based vaccine based on new guidance.

Vaccines and Related Biological Products Advisory Committee (VRBPAC) members voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all future vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

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Alon Seri-Levy, Sol-Gel Technologies CEO

Bridge­Bio com­pa­ny sells off rare dis­ease can­di­date to Gal­der­ma part­ner

Israeli biotech Sol-Gel Technologies announced Friday that it got its hands on a rare disease drug candidate from PellePharm for almost $75 million, amid claims that the drug has the potential to reach a $300 million market.

Execs said on a conference call Friday morning that patidegib, a hedgehog signaling pathway blocker, is being investigated to treat Gorlin syndrome, a rare genetic disorder that increases the risk of developing certain kinds of cancer such as basal cell skin cancer and medulloblastoma, a type of brain cancer. The disease affects around one in every 31,000 people, and an estimated 70,000 people worldwide.

CBER Director Peter Marks (Susan Walsh/AP Images)

FDA ad­vi­so­ry com­mit­tee votes unan­i­mous­ly in fa­vor of bi­va­lent Covid shots re­plac­ing pri­ma­ry se­ries

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously in favor of “harmonizing” Covid vaccine compositions, meaning all current vaccine recipients would receive a bivalent vaccine, regardless of whether they’ve gotten their primary series.

The vote marks an effort to clear up confusion around varying formulations and dosing schedules for current primary series and booster vaccines, as well as “get closer to the strains that are circulating,” according to committee member Paul Offit, professor of pediatrics at the Children’s Hospital of Philadelphia.

John Rim, Samsung Biologics CEO (Samsung/PR Newswire)

Sam­sung Bi­o­log­ics spells out ex­pan­sion plans in South Ko­rea and US

The CDMO arm of one of South Korea’s largest conglomerates has posted its year-end results and plans for 2023, which include new construction.

Samsung Biologics netted north of KRW 3 trillion ($2.4 billion) in 2022 revenue and an operating profit of KRW 983.6 billion ($799 million), which the company touted on Friday as “record-high earnings.” The revenue boost was 55% compared to 2021.