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.

At the In­flec­tion Point for the Next Gen­er­a­tion of Can­cer Im­munother­a­py

While oncology researchers have long pursued the potential of cellular immunotherapies for the treatment of cancer, it was unclear whether these therapies would ever reach patients due to the complexity of manufacturing and costs of development. Fortunately, the recent successful development and regulatory approval of chimeric antigen receptor-engineered T (CAR-T) cells have demonstrated the significant benefit of these therapies to patients.

All about Omi­cron; We need more Covid an­tivi­rals; GSK snags Pfiz­er’s vac­cine ex­ec; Janet Wood­cock’s fu­ture at FDA; and more

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Biospec­i­men M&A: Dis­cov­ery ac­quires Al­bert Li's he­pa­to­cyte project; PhI­II tri­al on Bay­er's Nube­qa reached pri­ma­ry end­point

Discovery Life Sciences has acquired what claims to be the Maryland-based host of the world’s largest hepatocyte inventory, known as IVAL, to help researchers select more effective and safer drug candidates in the future.

The combined companies will now serve a wider range of drug research and development scientists, according to Albert Li, who founded IVAL in 2004 and is set to join the Discovery leadership team as the CSO of pharmacology and toxicology.

Usama Malik

Ex-Im­munomedics CFO charged with in­sid­er trad­ing, faces up to 20 years in prison af­ter al­leged­ly tip­ping off girl­friend and rel­a­tives of a PhI­II suc­cess

The former CFO of Immunomedics, who helped steer the company to its $21 billion buyout by Gilead last year, has been charged with insider trading, the Department of Justice announced Thursday.

Usama Malik tipped off his then-girlfriend and four others that a Phase III study for Trodelvy would be stopped early four days before Immunomedics publicly announced the result in April 2020, DoJ alleged in its complaint. The individuals then purchased Immunomedics shares, selling them after the news broke and Immunomedics’ stock price doubled.

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Merck's new antiviral molnupiravir (Quality Stock Arts / Shutterstock)

As Omi­cron spread looms, oral an­tivi­rals ap­pear to be one of the best de­fens­es — now we just need more

After South African scientists reported a new Covid-19 variant — dubbed Omicron by the WHO — scientists became concerned about how effective vaccines and monoclonal antibodies might be against it, which has more than 30 mutations in the spike protein.

“I think it is super worrisome,” Dartmouth professor and Adagio co-founder and CEO Tillman Gerngross told Endpoints News this weekend. Moderna CEO Stéphane Bancel echoed similar concerns, telling the Financial Times that experts warned him, “This is not going to be good.”

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Ab­b­Vie tacks on a new warn­ing to Rin­voq la­bel as safe­ty frets crimp JAK class

The safety problems that continue to plague the JAK class as new data highlight some severe side effects are casting a large shadow over AbbVie’s Rinvoq.

As a result of a recent readout highlighting major adverse cardiac events (MACE), malignancy, mortality and thrombosis with Xeljanz a couple of months ago, AbbVie put out a notice late Friday afternoon that it is adding the new class risks to its label for their rival drug.

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Pfiz­er, Am­gen and Janssen seek fur­ther clar­i­ty on FDA's new ben­e­fit-risk guid­ance

Three top biopharma companies are seeking more details from the FDA on how the agency conducts its benefit-risk assessments for new drugs and biologics.

While Pfizer, Amgen and Janssen praised the agency for further spelling out its thinking on the subject in a new draft guidance, including a discussion of patient experience data as part of the assessment, the companies said the FDA could’ve included more specifics in the 20-page draft document.

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Re­searchers move clos­er to de­ci­pher­ing blood clots from As­traZeneca, J&J's Covid-19 vac­cines

Researchers may be nearing an answer for the mysterious and life-threatening blood clots that appeared on very rare occasions in people who received the J&J or AstraZeneca Covid-19 vaccine.

The new work builds on an early hypothesis researchers in Norway put forward last spring, when the cases first cropped up. They proposed the events were similar to blood clots that can occur in a small subset of patients who receive heparin, one of the most commonly used blood thinners.

Janet Woodcock (AP Images)

Janet Wood­cock plots her fu­ture at FDA, with se­nior ad­vi­sor role to fall back on if Califf wins con­fir­ma­tion

Acting FDA commissioner Janet Woodcock has been the face of just about every drug approval decision at the agency since the turn of the century. Since the pandemic began, she’s moved between the top of the drugs center to the head of therapeutics at Operation Warp Speed, leading the drive for work on Covid-targeted mAbs and antivirals.

Looking forward — and pending a quick Senate confirmation to cement Rob Califf’s return to the top of FDA early next year — Woodcock’s role at the agency will again be in flux.

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