LLS backs 5 new can­cer drug projects with up to $50M; Trodelvy con­tin­ues to im­press with more TNBC da­ta

The Leukemia and Lym­phoma So­ci­ety has tapped 5 new ear­ly-stage projects to back with up to $10 mil­lion each in fresh in­vest­ments. The 5 biotechs are:

Rachel Hau­r­witz

— Cari­bou, head­ed by Rachel Hau­r­witz and co-found­ed by Jen­nifer Doud­na, is work­ing on next-gen, off-the-shelf CAR-Ts to re­place the pa­tient-de­rived cells now in use.

— The LLS sup­port­ed Nex­Im­mune’s IPO, help­ing fund its work on nanopar­ti­cles that can gin up an im­mune re­sponse di­rect­ed at can­cer cells. The biotech has 2 projects now in Phase I tri­als.

— Im­mune-Onc Ther­a­peu­tics is get­ting help with their ear­ly work on IO-202, “a first-in-class an­ti­body tar­get­ing the im­mune in­hibito­ry re­cep­tor Leuko­cyte Im­munoglob­u­lin-Like Re­cep­tor sub­fam­i­ly B (LIL­RB) mem­ber 4 (LIL­RB4, al­so knowns ILT3).”

— Saar Gill’s Caris­ma, spun out of Penn, is get­ting help with its CAR-en­gi­neered macrophages.

— Abin­tus Bio is get­ting fi­nan­cial sup­port for its in vi­vo-gen­er­at­ed CARs that avoid ex­tract­ing cells, en­gi­neer­ing them and then trans­fus­ing them, back in­to pa­tients.

Hau­r­witz had this to say:

“We’re par­tic­u­lar­ly ex­cit­ed to be work­ing with LLS TAP be­cause it gives us ac­cess to their deep knowl­edge of blood can­cer and their net­work of pa­tients and drug de­vel­op­ment ex­perts.” — John Car­roll

Trodelvy con­tin­ues to im­press with more TNBC da­ta

The drug be­hind Gilead’s $21 bil­lion ac­qui­si­tion of Im­munomedics last Sep­tem­ber con­tin­ues to post good da­ta re­sults from its con­fir­ma­to­ry Phase III study.

In a pa­per pub­lished in the New Eng­land Jour­nal of Med­i­cine on Thurs­day, the drug Trodelvy se­cured a sta­tis­ti­cal­ly sig­nif­i­cant pro­gres­sion-free sur­vival and over­all sur­vival in pa­tients with re­lapsed or re­frac­to­ry metasta­t­ic triple-neg­a­tive breast can­cer. Me­di­an PFS was 5.6 months com­pared to 1.7 months on chemo, and me­di­an OS was 12.1 months ver­sus chemo’s 6.7 months.

Mer­dad Parsey

Trodelvy al­so record­ed an ob­jec­tive re­sponse rate of 35%, com­pared to just 5% on chemother­a­py.

“For a pa­tient pop­u­la­tion whose can­cer is par­tic­u­lar­ly dif­fi­cult to treat, these re­sults are ex­treme­ly en­cour­ag­ing and re­in­force the sig­nif­i­cant treat­ment ad­vance that Trodelvy rep­re­sents for pa­tients with pre­vi­ous­ly treat­ed un­re­sectable lo­cal­ly ad­vanced or metasta­t­ic TNBC,” Gilead CMO Mer­dad Parsey said in a state­ment.

Just a few weeks ago, Trodelvy se­cured a full FDA ap­proval with a broad­er la­bel than its ac­cel­er­at­ed OK in­di­ca­tion, ex­pand­ing the pa­tient pop­u­la­tion to in­clude those with un­re­sectable lo­cal­ly ad­vanced TNBC rather than just metasta­t­ic cas­es. Pa­tients must have re­ceived two or more pri­or sys­temic ther­a­pies, at least one of them for metasta­t­ic dis­ease.

The heart of Gilead’s Im­munomedics buy­out, Trodelvy came to fruition af­ter Im­munomedics worked on de­vel­op­ing the drug for about 37 years. The drug’s da­ta were so im­pres­sive at last sum­mer’s ES­MO that Gilead CEO Dan O’Day an­gled to get a deal done be­fore the con­fer­ence. — Max Gel­man

Chi­na-based mR­NA spin­off rais­es $10M as Covid-19 vac­cine IND looms

Sir­naomics’ mR­NA spin­off RNAim­mune has gath­ered a $10 mil­lion seed round to con­tin­ue build­ing out its plat­form, with a fo­cus on in­fec­tious dis­eases, can­cer and rare dis­eases.

Smooth Riv­er and Hong Kong Hon­grun led the in­vest­ment, with par­tic­i­pa­tion from Shang­hai Wal­ga Biotech­nol­o­gy, High For­est In­vest­ment and Ter­ra Mag­num Sig­ma.

Found­ed in ear­ly 2020, the lead pro­gram is for an­oth­er mR­NA vac­cine point­ed against Covid-19. As J&J and As­traZeneca run in­to in­creased flak over safe­ty fears for their vac­cines, an­a­lysts have be­gun won­der­ing how the rest of the mar­ket will play out as Pfiz­er/BioN­Tech and Mod­er­na dom­i­nate the field. That still may leave op­por­tu­ni­ties ahead, and the fledg­ling start­up sees a shot at get­ting in­to the sec­ond wave.

Patrick Lu

The biotech has an R&D cen­ter in Chi­na and raised $2.35 mil­lion in its orig­i­nal fund­ing round. An IND for Covid is planned lat­er in the year with an­oth­er pro­gram in the works for a RAS tu­mor vac­cine.

Patrick Lu, chair­man of the board of RNAim­mune, said:

“The re­cent suc­cess of Mod­er­na’s and BioN­Tech’s mR­NA vac­cines has demon­strat­ed that mR­NA tech­nolo­gies for de­vel­op­ment of nov­el ther­a­peu­tics and vac­cines are dra­mat­i­cal­ly chang­ing the land­scape of the glob­al phar­ma­ceu­ti­cal in­dus­try. RNAim­mune has tremen­dous op­por­tu­ni­ties as a glob­al mR­NA in­no­vat­ing com­pa­ny.” — John Car­roll

Ac­ne treat­ment from Bausch’s spin­out Or­tho hits all 3 end­points

In a sec­ond Phase III tri­al, Or­tho Der­ma­to­log­ics’ lat­est ac­ne treat­ment showed a ben­e­fit of pa­tients as ear­ly as 2 weeks in­to us­age, the Bausch Health spin­out an­nounced Thurs­day.

The tri­al test­ed IDP-126, a com­bi­na­tion retinoid, an­ti-bac­te­r­i­al and an­tibi­ot­ic top­i­cal to treat ac­ne vul­garis in pa­tients. If the treat­ment is ap­proved, it would be the first to use this triple com­bi­na­tion, the re­lease said.

The study achieved all 3 of its end­points at week 12, in­clud­ing a change in in­flam­ma­to­ry and non­in­flam­ma­to­ry le­sion counts with a p-val­ue of less than 0.001. Treat­ment suc­cess was 50.5% and 20.5% for IDP-126 and its place­bo, re­spec­tive­ly.

For 12 weeks, the 193 pa­tients ages 9 and up ap­plied ei­ther IDP-126 or a place­bo to their face once a day in 13 lo­ca­tions in the US.

Or­tho hopes to sub­mit a new drug ap­pli­ca­tion with the FDA in the lat­ter half of 2022, pres­i­dent Scott Hirsch said in the state­ment. — Josh Sul­li­van

Mov­ing Out of the Clin­ic with Dig­i­tal Tools: Mo­bile Spirom­e­try Dur­ing COVID-19 & Be­yond

An important technology in assessing lung function, spirometry offers crucial data for the diagnosis and monitoring of pulmonary system diseases, as well as the ongoing measurement of treatment efficacy. But trends in the healthcare industry and new challenges introduced by the COVID-19 pandemic are causing professionals in clinical practice and research to reevaluate spirometry’s deployment methods and best practices.

Paul Hudson (Getty Images)

Sanofi, Glax­o­SmithK­line jump back in­to the PhI­II race for a Covid vac­cine — as the win­ners con­gre­gate be­hind the fin­ish line

Sanofi got out early in the race to develop a vaccine using more of a traditional approach, then derailed late last year as their candidate failed to work in older people. Now, after likely missing the bus for the bulk of the world’s affluent nations, they’re back from that embarrassing collapse with a second attempt using GSK’s adjuvant that may get them back on track — with a potential Q4 launch that the rest of the world will be paying close attention to.

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SCO­TUS de­clines to re­view En­brel biosim­i­lar case, tee­ing up 30+ years of ex­clu­siv­i­ty and $20B more for Am­gen’s block­buster

As the House Oversight Committee is set to grill AbbVie CEO Richard Gonzalez on Tuesday over tactics to block competition for its best-selling drug of all time, another decision on Capitol Hill on Monday opened the door for billions more in Amgen profits over the next eight years.

The Supreme Court on Monday denied Novartis subsidiary Sandoz’s petition to review a Federal Circuit’s July 2020 decision concerning its biosimilar Erelzi (etanercept-szzs), which FDA approved in 2016 as a biosimilar to Amgen’s Enbrel (etanercept). Samsung’s Enbrel biosimilar Eticovo also won approval in 2019 and remains sidelined.

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John­son & John­son do­nates Ebo­la vac­cine amid new out­break; Ji Xing promis­es more than $127M for Mile­stone's nasal spray for rapid heart rate

As Johnson & Johnson continues to roll out its Covid-19 shot, the company is also focused on another vaccine.

J&J is donating up to 200,000 doses of its Ebola vaccine regimen developed with Bavarian Nordic to help health authorities deal with a new outbreak in Sierra Leone. The regimen, Zabdeno and Mvabea, was granted prequalification by the WHO in April, which will help accelerate its registration in countries where Ebola is a threat.

How to man­u­fac­ture Covid-19 vac­cines with­out the help of J&J, Pfiz­er or Mod­er­na? Bi­ol­yse sees the dif­fi­cul­ties up close

When Biolyse, an Ontario-based manufacturer of sterile injectables, forged a deal with Bolivia last week to manufacture up to 50 million J&J Covid-19 vaccine doses, the agreement kicked off what will prove to be a test case for how difficult the system of compulsory licenses is to navigate.

The first problem: When Biolyse asked J&J, via a March letter, to license its Covid-19 vaccine, manufacture it in Canada and pay 5% royalties on shipments to needy, low-income countries, J&J rejected the offer, refusing to negotiate. J&J also did not respond to a request for comment.

Tim Mayleben (L) and Sheldon Koenig (Esperion)

On the heels of a sting­ing Q1 set­back, Es­pe­ri­on's long­time cham­pi­on is ex­it­ing the helm and turn­ing the wheel over to a mar­ket­ing pro

Just days after getting stung by criticism from a badly disappointed group of analysts, there’s a big change happening today at the helm of Esperion $ESPR.

Longtime CEO Tim Mayleben, who championed the company for 9 years from early clinical through a lengthy late-stage drive to successfully get their cholesterol drug approved for a significant niche of patients in the US, is out of the C suite, effective immediately. Sheldon Koenig — hired at the end of 2020 with a resume replete with Big Pharma CV sales experience —  is stepping into his place, promising to right a badly listing commercial ship that’s been battered by market forces.

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No­var­tis' En­tresto takes its 2nd fail­ure of the week­end at ACC, show­ing no ben­e­fit in most dire heart fail­ure pa­tients

Novartis’ Entresto started the ACC weekend off rough with a trial flop in heart attack patients, slowing the drug’s push into earlier patients. Now, an NIH-sponsored study is casting doubt on Entresto’s use in the most severe heart failure patients, another black mark on the increasingly controversial drug’s record.

Entresto, a combination of sacubitril and valsartan, could not beat out valsartan alone in an outcomes head-to-head for severe heart failure patients with a reduced ejection fraction (HFrEF), according to data presented Monday at the virtual American College of Cardiology meeting.

Matt Gline (L) and Vivek Ramaswamy

In­sid­er ac­count of Roivan­t's SPAC deal — and that $7.3B val­u­a­tion — re­veals a few se­crets as Matt Gline po­si­tions the com­pa­ny as the new ‘Big Phar­ma’

It was Oct. 7, 2020, and Matt Gline wasn’t wasting any time.

The CEO of Roivant had word that KKR vet Jim Momtazee’s SPAC had priced late the night before, triggering a green light for anyone interested in pursuing a big check for future operations and riding the financial instrument to Nasdaq. So he wrote a quick email congratulating Momtazee, whom he knew, for the launch.

Oh, and maybe Momtazee would like to schedule something with Gline and his executive chairman, Roivant founder Vivek Ramaswamy, to chat about Roivant and its business?

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$DNA is once again on NYSE; FDA clears Soliris chal­lenger for the mar­ket; Flag­ship’s think­ing big again with eR­NA; and more

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I still remember the uncertainty in the air last year when nobody was sure whether ASCO would cancel their in-person meeting. But it’s now back again for the second virtual conference, and Endpoints News is here for it. Check out our 2-day event reviewing the landscape of cancer R&D and send news our way.

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