Sriram Subramaniam, Gandeeva Therapeutics founder and CEO

Cryo-EM fo­cused biotech from long­time NIH vet­er­an se­cures $40M back­ing from Bay­er in Se­ries A

“It’s al­ways nice to get mon­ey in the bank.”

That’s what Gan­dee­va Ther­a­peu­tics’ founder and CEO Sri­ram Sub­ra­ma­ni­am said af­ter re­veal­ing that his com­pa­ny land­ed $40 mil­lion in Se­ries A fund­ing. Gan­dee­va will use the mon­ey for its ar­ti­fi­cial in­tel­li­gence-en­abled plat­form to iden­ti­fy small mol­e­cules and bi­o­log­ics at a faster pace.

The com­pa­ny is on a mis­sion to show that it can lever­age cryo-EM and AI to make a mean­ing­ful im­pact on drug dis­cov­ery, and it plans to do so with speed, us­ing AI for ex­per­i­ment pre­dic­tion.

Lux Cap­i­tal and Leaps by Bay­er led the round, with Ob­vi­ous Ven­tures, Am­gen Ven­tures, Am­pli­tude Ven­tures and Air Street Cap­i­tal al­so par­tic­i­pat­ing.

It’s a jour­ney that start­ed more than 20 years ago for Sub­ra­ma­ni­am, who spent 15 years as an in­ves­ti­ga­tor for the Na­tion­al In­sti­tute of Health’s in­tra­mur­al re­search pro­gram be­fore branch­ing out on his own.

“Walk­ing in­to cells and tis­sues was sci­ence fic­tion at that time,” he said in a call with End­points News Fri­day,

Over time, though, new tools emerged, most no­tably cryo-EM, a method by which sci­en­tists can im­age pro­teins and oth­er bi­o­log­i­cal en­ti­ties by freez­ing them and as­sault­ing them with elec­trons.

“It was clear to me that this ap­proach would be a turn­ing point for struc­tur­al bi­ol­o­gy, and it has been,” he said. “There’s no doubt that it’s been rev­o­lu­tion­ary. “

Jür­gen Eck­hardt

Speed is the foun­da­tion up­on which the plat­form is built, and for­tu­nate tim­ing is what has shaped the com­pa­ny’s work so far. Sub­ra­ma­ni­am said that his aca­d­e­m­ic lab was on­ly per­mit­ted to con­tin­ue its worth through the start of the Covid-19 pan­dem­ic if they of­fered to work on so­lu­tions for the virus. Most re­cent­ly, the com­pa­ny pub­lished a pa­per about the struc­tur­al analy­sis of the Omi­cron vari­ant in Sci­ence.

“I had nev­er worked on coro­n­avirus­es be­fore, but overnight, we switched to work­ing on coro­n­avirus­es and pret­ty much have looked at the struc­tures of every vari­ant, and pret­ty much every mu­tant,” he said. “From the be­gin­ning, I knew that’s where it would be head­ed, that there would be mu­ta­tions.”

In a state­ment, Jür­gen Eck­hardt, head of Leaps by Bay­er, said:

We be­lieve Gan­dee­va’s plat­form will al­low us to com­bine pre­dic­tion and ex­per­i­men­ta­tion to vi­su­al­ize and op­ti­mize drug de­sign at atom­ic scale and with un­prece­dent­ed speed. Gan­dee­va’s re­lent­less fo­cus on us­ing their pow­er­ful imag­ing tech­nolo­gies to cast a spot­light on the im­por­tance of pro­tein con­for­ma­tion in drug de­sign is aligned with our am­bi­tion to use nov­el da­ta-dri­ven meth­ods to bring pre­ci­sion med­i­cines and break­through cures to pa­tients.

This is the sec­ond time Leaps has led a fi­nanc­ing round for a start­up in just three weeks, as it led the $80 mil­lion Se­ries A for Celli­no, a Boston-based biotech fo­cused on cell ther­a­py man­u­fac­tur­ing. Sub­ra­ma­ni­am said that hav­ing the bal­ance of in­vestors, from the tech-fo­cused minds of Lux Cap­i­tal to the in­no­va­tion-mind­ed Leaps is a “dream come true.”

“We sit at this re­al­ly in­ter­est­ing in­ter­face, so to have an in­vest­ment syn­di­cate that re­flects the vi­sion and mis­sion of the com­pa­ny, that’s very spe­cial to me,” he 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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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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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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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.

No­var­tis' ap­proved sick­le cell dis­ease drug fails to beat place­bo in PhI­II

Novartis’ sickle cell drug, approved in 2019 and branded as Adakveo, has failed an ongoing Phase III, according to preliminary results.

The Swiss pharma giant unveiled early data from the ongoing STAND Phase III study on Friday, saying that crizanlizumab showed no statistically significant difference between the drug at two different dose levels compared to placebo in annualized rates of vaso-occlusive crises that lead to a healthcare visit over the first year since being randomized into the trial.