Two Genen­tech vets re­unite at Im­mune-Onc to help steer its $33M dri­ve to the clin­ic

Adri­an Jubb

Look for yet an­oth­er play­er work­ing in the im­muno-on­col­o­gy space to en­ter the clin­ic with a nim­ble team of ex­pe­ri­enced ex­ecs fo­cused on dis­man­tling im­muno­sup­pres­sion.

Pa­lo Al­to-based Im­mune-Onc an­nounced to­day that co-founder Char­lene Liao has wooed fel­low Genen­tech vets Adri­an Jubb and An Song to join her in prep­ping the start­up for first-in-hu­man stud­ies, fu­eled by $33 mil­lion in Se­ries B fund­ing. North­ern Light Ven­ture Cap­i­tal, Vi­vo Cap­i­tal and the Stan­ford-StartX Fund are tout­ed as the star in­vestors in the round.

An Song

For Jubb, the chief med­ical of­fi­cer, this marks a re­turn to on­col­o­gy af­ter a four-year stint at an­tibi­otics com­pa­ny Achao­gen. There, as head of ear­ly de­vel­op­ment, he had a di­rect hand in build­ing the case for the ex­per­i­men­tal pla­zomicin, which even­tu­al­ly gained ap­proval for one (but not the oth­er) in­di­ca­tion it filed for.

Song jumps di­rect­ly from Genen­tech, leav­ing be­hind a 16-year tenure and a se­nior di­rec­tor po­si­tion su­per­vis­ing the as­say de­vel­op­ment and tech­nol­o­gy group. She will now have broad au­thor­i­ty over the start­up’s trans­la­tion­al de­vel­op­ment, in­clud­ing “pre­clin­i­cal PKPD and tox­i­col­o­gy eval­u­a­tion, clin­i­cal phar­ma­col­o­gy, bio­an­a­lyt­i­cal and bio­mark­er/di­ag­nos­tic de­vel­op­ment and cer­tain an­a­lyt­i­cal as­pects of tech­ni­cal de­vel­op­ment.”

Char­lene Liao

“As we pre­pare to move from trans­la­tion­al re­search in­to the clin­ic, Adri­an and An’s decades of in­dus­try ex­per­tise in drug de­vel­op­ment will be crit­i­cal in ad­vanc­ing our mis­sion to de­vel­op nov­el bio­ther­a­peu­tics for hard-to-treat can­cers,” said Liao, who’s al­so pres­i­dent and CEO of Im­mune-Onc.

With 14 years of drug de­vel­op­ment ex­pe­ri­ence at Genen­tech un­der her belt, Liao struck out on her own in 2016 to start Im­mune-Onc with Guo-Liang Yu, who pre­vi­ous­ly found­ed and sold the an­ti­body com­pa­ny Epit­o­mics to Ab­cam. They got start­ed with a $7 mil­lion Se­ries A and are now pur­su­ing IND-en­abling stud­ies for the lead pro­gram, which might have ap­pli­ca­tions in acute myeloid leukemia as well as oth­er hema­to­log­ic and sol­id tu­mors.

Guo-Liang Yu

The com­pa­ny isn’t di­vulging much about the pro­gram, ex­cept that it tar­gets “an im­mune in­hibito­ry re­cep­tor.” That fits in­to Im­mune-Onc’s over­all strat­e­gy to dis­arm im­mune sup­pres­sion and tu­mor in­fil­tra­tion — a strat­e­gy ce­ment­ed on li­cens­ing and col­lab­o­ra­tion deals with lead­ing re­search in­sti­tu­tions like Al­bert Ein­stein Col­lege of Med­i­cine, Memo­r­i­al Sloan Ket­ter­ing Can­cer Cen­ter and The Uni­ver­si­ty of Texas South­west­ern Med­ical Cen­ter.

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.

Stéphane Bancel, Moderna CEO

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Even as public health officials remain guarded about their comments on the likelihood Omicron will escape the reach of the currently approved Covid-19 vaccines, there’s growing scientific consensus that we’re facing a variant that threatens to overwhelm the vaccine barricades that have been erected.

Stéphane Bancel, the CEO of Moderna, one of the leading mRNA players whose quick vault into the markets with a highly effective vaccine created an instant multibillion-dollar market, added his voice to the rising chorus early Tuesday. According to Bancel, there will be a significant drop in efficacy when the average immune system is confronted by Omicron. The only question now is: How much?

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FDA ad­comm nar­row­ly votes in fa­vor of Mer­ck­'s an­tivi­ral for out­pa­tient Covid-19

With little explanation for why Merck’s potential Covid-19 antiviral was less effective in reducing Covid hospitalizations and deaths in a full analysis of a Phase III trial versus an interim look, the FDA’s antimicrobial drugs advisory committee on Tuesday voted 13-10 in favor of the pill’s benefits outweighing the risks for adults within 5 days of developing Covid symptoms.

Molnupiravir will likely be authorized by FDA in the coming days for adults with mild or moderate Covid-19. While Pfizer’s antiviral may prove to be more effective, Merck’s pill will be another weapon in the armamentarium of Covid-19 treatments for countries around the world, adding to the mAb treatments already in use in the outpatient space from Regeneron, Eli Lilly and Vir/GlaxoSmithKline.

Philip Dormitzer, new GSK global head of vaccines R&D

Glax­o­SmithK­line poach­es Pfiz­er's vi­ral vac­cines lead in rush to cap­i­tal­ize on fu­ture of mR­NA

GlaxoSmithKline has appointed Philip Dormitzer, formerly chief scientific officer of Pfizer’s viral vaccines unit, as its newest global head of vaccines R&D, looking to leverage one of the leading minds behind Pfizer and BioNTech’s RNA collaboration that led to Covid-19 jab Comirnaty, the British drug giant said Tuesday.

Dormitzer had been with Pfizer for a little more than six years, joining up after a seven-year stint with Novartis, where he reached the role of US head of research and head of global virology for the company’s vaccines and diagnostics unit.

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In­tro­duc­ing End­points Stu­dio, a new way to ad­ver­tise with End­points-craft­ed brand­ing cam­paigns

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Ap­peals court puts the fi­nal nail in the cof­fin for Tec­fidera patent, adding to Bio­gen's bur­geon­ing set­backs

In another setback for Biogen, the big biotech lost its appeal to revive a patent for the once-blockbuster drug Tecfidera, marking a likely conclusion to the case.

The US Court of Appeals for the Federal Circuit issued the ruling Tuesday morning, saying Biogen failed to satisfy the “written description” requirement for patent law. As a result, Mylan-turned-Viatris will be able to sell its multiple sclerosis generic without fear of infringement and Biogen will have to find a new revenue driver elsewhere.

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Tillman Gerngross (Adagio)

Till­man Gern­gross on Omi­cron: 'It is a grim sit­u­a­tion...we’re go­ing to see a sig­nif­i­cant drop in vac­cine ef­fi­ca­cy'

Tillman Gerngross, the rarely shy Dartmouth professor, biotech entrepreneur and antibody expert, has been warning for over a year that the virus behind Covid-19 would likely continue to mutate, potentially in ways that avoid immunity from infection and the best defenses scientists developed. He spun out a company, Adagio, to build a universal antibody, one that could snuff out any potential mutation.

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In­cor­po­rat­ing Ex­ter­nal Da­ta in­to Clin­i­cal Tri­als: Com­par­ing Dig­i­tal Twins to Ex­ter­nal Con­trol Arms

Most drug development professionals are familiar with the nerve-racking wait for the read-out of a large trial. If it’s negative, is the investigational therapy ineffective? Or could the failure result from an unforeseen flaw in the design or execution of the protocol, rather than a lack of efficacy? The team could spend weeks analyzing data, but a definitive answer may be elusive due to insufficient power for such analyses in the already completed trial. These problems are only made worse if the trial had lower enrollment, or higher dropout than expected due to an unanticipated event like COVID-19. And if a trial is negative, the next one is likely to be larger and more costly — if it happens at all.

Mar­ket­ingRx roundup: Ab­b­Vie’s Hu­mi­ra TV turns fo­cus to HS skin con­di­tion; Sanofi amps par­ent­ing pol­i­cy

After years as the top spending pharma TV advertiser, AbbVie’s Humira brand finally downshifted earlier this year, ceding much of its marketing budget to up-and-coming sibling meds Skyrizi and Rinvoq. However, now Humira is back on TV with ads for another condition — Hidradenitis suppurativa (HS).

The chronic and painful skin condition results in lumps and abscesses caused by inflammation or infection of sweat glands, most often in the armpits or groin. Humira was first approved to treat HS in 2015 and remains the only FDA-approved drug for the condition. Two TV ads both note more than 30,000 people with HS have been prescribed Humira.