Spero strikes $125M roy­al­ty deal for cU­TI drug; French firm launch­es $100M ear­ly biotech fund

French in­vest­ment firm Ad­vent France Biotech­nol­o­gy (AFB) an­nounced to­day the first clos­ing of its sec­ond fund for a to­tal of $102 mil­lion.

In­vestors and par­tic­i­pants in AFB’s fund in­clud­ed the Eu­ro­pean In­vest­ment Fund (EIF) and the Fonds na­tion­al d’amorçage 2 (the French Seed Fund 2), which is man­aged on be­half of the French State by Bpifrance. Oth­er par­tic­i­pants in­clud­ed cor­po­rate ven­ture funds such as Boehringer In­gel­heim’s ven­ture fund.

This new fund will be ded­i­cat­ed to ear­ly-stage in­vest­ments in Eu­ro­pean life sci­ences com­pa­nies with a fo­cus on France.

AFB will con­tin­ue to work close­ly with Eu­ro­pean re­search in­sti­tu­tions and with Eu­ro­pean ven­ture cap­i­tal part­ners to se­lect and back en­tre­pre­neurs and ear­ly-stage com­pa­nies with the po­ten­tial to de­liv­er first- or best-in-class ther­a­peu­tics, the com­pa­ny said in a pre­pared state­ment.

The fund plans to se­lect and fi­nance two star­tups be­fore the end of this year.

“We firm­ly be­lieve that ear­ly-stage fi­nanc­ing is crit­i­cal for the life sci­ences in­dus­try, where the needs are huge and still not met, es­pe­cial­ly in France,” said AFB man­ag­ing part­ner and chair­man Alain Huriez in a state­ment. “This sec­ond fund shows the rel­e­vance of our po­si­tion­ing as en­tre­pre­neur-in­vestors in life sci­ences, con­firmed by the re­newed sup­port of our lim­it­ed part­ners.”

Mass­a­chu­setts biotech en­ters deal with in­vest­ment firm for up to $125 mil­lion on cU­TI drug

Spero Ther­a­peu­tics is en­ter­ing a rev­enue in­ter­est fi­nanc­ing agree­ment with in­vest­ment firm Health­Care Roy­al­ty Part­ners for up to $125 mil­lion for its com­pli­cat­ed Uri­nary Tract In­fec­tion, or cU­TI oral can­di­date.

Spero in­tends to use the pro­ceeds from the agree­ment and ex­ist­ing cash on hand to pre­pare for the an­tic­i­pat­ed launch of oral cU­TI can­di­date tebipen­em HBr, al­so known as Tebi, ac­cord­ing to a pre­pared state­ment.

As part of the agree­ment, Spero will re­ceive $50 mil­lion from Health­Care Roy­al­ty Part­ners by Oct. 21. If the FDA ap­proves Tebi for a cU­TI in­di­ca­tion, Spero will re­ceive an ad­di­tion­al $50 mil­lion, plus an ad­di­tion­al $25 mil­lion up­on an undis­closed com­mer­cial mile­stone.

In ex­change for the po­ten­tial $125 mil­lion, the in­vest­ment firm will re­ceive tiered roy­al­ty on ap­plic­a­ble rev­enue gen­er­at­ed by Tebi and oth­er prod­ucts mar­ket­ed by Spero un­til the amount paid back to Health­Care Roy­al­ty Part­ners® is 2.5 times the to­tal in­vest­ment amount fund­ed.

“We look for­ward to tebipen­em HBr’s an­tic­i­pat­ed NDA fil­ing and reg­u­la­to­ry re­view, along with the ad­vance­ment of Spero’s broad­er clin­i­cal-stage pipeline,” said Health­Care Roy­al­ty Part­ners chair­man and CEO Clarke Futch in a state­ment.

Is­rael’s Geneti­ka+ fin­ished $10 mil­lion Se­ries A for com­pa­ny ex­pan­sion

Is­raeli biotech Geneti­ka+ an­nounced this morn­ing that they closed a $10 mil­lion Se­ries A VC round led by Boston-based Grey­Bird Ven­tures.

Oth­er com­pa­nies such as Meron Cap­i­tal, Jump­speed Ven­tures, and B Cap­i­tal Group joined in on the round.

The biotech, which fo­cus­es on per­son­al­ized treat­ments for neu­ro­log­i­cal and psy­chi­atric dis­eases, will fo­cus its fund­ing on ex­pand­ing clin­i­cal tri­als, in­creas­ing man­u­fac­tur­ing ca­pa­bil­i­ties, and es­tab­lish­ing a clin­i­cal lab in Boston, MA.

No­var­tis an­nounces progress to­ward cli­mate goals

No­var­tis shared progress against its En­vi­ron­men­tal, So­cial and Gov­er­nance (ESG) tar­gets at its eighth an­nu­al ESG in­vestor event host­ed to­day. More specif­i­cal­ly, No­var­tis dis­cussed the com­pa­ny’s more ma­te­r­i­al ESG top­ics, in­clud­ing ac­cess to med­i­cines, pa­tient health and safe­ty, in­no­va­tion and eth­i­cal stan­dards.

Some of the spe­cif­ic goals No­var­tis said the com­pa­ny tar­get­ed in­clud­ed re­duc­ing their car­bon emis­sions by more than 28% since 2016, and pledg­ing $20 mil­lion in col­lab­o­ra­tion with HB­CUs to ad­dress health dis­par­i­ties in the US.

Vas Narasimhan

“ESG is cen­tral to the No­var­tis strat­e­gy and is crit­i­cal to de­liv­er­ing on our pur­pose to reimag­ine med­i­cine to im­prove and ex­tend peo­ple’s lives. Cou­pled with our in­spired, cu­ri­ous and un­bossed cul­ture, we be­lieve ESG ef­forts on our most ma­te­r­i­al top­ics will help dri­ve our over­all per­for­mance as a com­pa­ny and de­liv­er long-term val­ue for our stake­hold­ers,” said No­var­tis CEO Vas Narasimhan.

Ire­land’s Iterum meets with FDA on re­sub­mit­ting NDA for in­ves­ti­ga­tion­al uU­TI can­di­date

Irish biotech Iterum Ther­a­peu­tics said to­day in a state­ment that they held a Type A meet­ing with the FDA in Q3 2021 to dis­cuss the steps re­quired for po­ten­tial re­sub­mis­sion of the New Drug Ap­pli­ca­tion (NDA) for their drug su­lopen­em et­zadrox­il/probenecid (oral su­lopen­em) for the treat­ment of un­com­pli­cat­ed Uri­nary Tract In­fec­tions, or uU­TI.

Back in Ju­ly, Iterum re­ceived a Com­plete Re­sponse Let­ter from the FDA want­i­ng more da­ta to sup­port the ap­proval of oral su­lopen­em for the treat­ment of adult women with a uU­TI.

“We had a suc­cess­ful meet­ing with the FDA and have es­tab­lished var­i­ous po­ten­tial paths for­ward to ad­dress the re­quest in the CRL for ad­di­tion­al da­ta in sup­port of our NDA,” said Iterum CEO Corey Fish­man. “We are cur­rent­ly eval­u­at­ing the op­ti­mal de­sign for an ad­di­tion­al Phase III uU­TI study to be con­duct­ed pri­or to the po­ten­tial re­sub­mis­sion of the NDA. We con­tin­ue to be­lieve in the abil­i­ty of su­lopen­em to treat the grow­ing prob­lem of mul­ti-drug re­sis­tant UTIs in the com­mu­ni­ty.

Adap­tive Phage Ther­a­peu­tics re­ceives $8 mil­lion more in bac­te­rio­phage de­vel­op­ment from DoD

Mary­land biotech Adap­tive Phage Ther­a­peu­tics was award­ed an ad­di­tion­al $8 mil­lion from the US De­part­ment of De­fense for con­tin­ued de­vel­op­ment of their bac­te­rio­phage ther­a­py Phage­Bank for the treat­ment of in­fec­tious dis­eases. The new fund­ing brings the to­tal con­tract award­ed to APT to more than $31 mil­lion.

“We are thank­ful for the op­por­tu­ni­ty to col­lab­o­rate with the U.S. mil­i­tary to cre­ate po­ten­tial­ly life­sav­ing ther­a­pies for our na­tion’s ser­vice mem­bers,” said APT CEO and co-founder Greg Mer­ril in a pre­pared state­ment.

The biotech had closed a $40+ mil­lion Se­ries B back in May for their work on bac­te­rio­phages against drug-re­sis­tant bac­te­r­i­al in­fec­tions.

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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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.

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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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.