NewLink grabs the AACR spot­light with IDO path­way, Keytru­da com­bo -- shares blitzed

At­ten­dees, speak­ers and awardees dur­ing AACR’s 2017 Open­ing Cer­e­mo­ny © AACR/Todd Buchanan 2017

WASH­ING­TON, DC — Re­searchers at NewLink Ge­net­ics are in the spot­light at AACR this morn­ing with da­ta show­ing that their pair-up of the biotech’s IDO path­way in­hibitor in­dox­i­mod with Mer­ck’s Keytru­da sig­nif­i­cant­ly pushed up re­sponse rates over what the PD-1 check­point alone nor­mal­ly pro­duces for ad­vanced melanoma.

The his­tor­i­cal per­cent­age re­sponse rate for Keytru­da alone in this field is in the low 30s, but for all the 60 evalu­able pa­tients in the study the ORR was 52% — in­clud­ing hard-to-tread oc­u­lar melanoma cas­es. If you leave out the oc­u­lar (eye) pa­tients, the suc­cess ra­tio ris­es to 59%, with a dis­ease con­trol rate of 80%. And the re­searchers say the safe­ty pro­file for the com­bo looked sim­i­lar to Keytru­da alone, which will help the biotech start mak­ing the case that it can add a ther­a­py to a check­point with­out push­ing tox­i­c­i­ty, the way a CT­LA-4 drug like Yer­voy would.

A group of crit­ics on Twit­ter hit the da­ta quick­ly Tues­day morn­ing, though, ques­tion­ing the re­sults and dri­ving the stock down 22% in ear­ly trad­ing.

NewLink $NLNK is un­usu­al in this field. The biotech — which was ham­mered in 2016 with the fail­ure of its pan­cre­at­ic can­cer vac­cine — part­nered with Genen­tech in 2014 on GDC-0919, a spe­cif­ic IDO en­zy­mat­ic in­hibitor. Genen­tech has that pro­gram un­der its wing af­ter pay­ing $150 mil­lion up­front with more than a bil­lion dol­lars promised in mile­stones.

Charles Link

NewLink CEO Chuck Link de­scribes in­dox­i­mod as its whol­ly-owned IDO path­way in­hibitor, sep­a­rate from the en­zy­mat­ic spe­cif­ic group, which in­cludes In­cyte’s lead­ing epaca­do­stat, now head­ed in­to a full slate of late-stage com­bi­na­tions with Keytru­da (Mer­ck) and Op­di­vo (Bris­tol-My­ers).

“In­dox­i­mod is a drug we’re try­ing to ful­ly un­der­stand,” Link tells me. The drug acts on both den­drit­ic cells and T cells, he says, al­low­ing the T cells to repli­cate in fight­ing can­cer. It does not bind with the kind of speci­fici­ty that char­ac­ter­izes the en­zy­mat­ic class.

The next step is to push ahead in­to a reg­is­tra­tion study. The lat­est da­ta comes from a Phase II that does not have a con­trol arm, which will be reme­died in the late-stage tri­al. And Link says he ex­pects the study to get un­der­way lat­er this year.

Link wasn’t ready to pro­vide an es­ti­mate of when the da­ta will read out. That might de­pend on a va­ri­ety of things, he says, in­clud­ing some de­sign el­e­ments that might al­low for an ear­ly cut of the re­sults that could be tak­en to the FDA in search of an ac­cel­er­at­ed ap­proval.

Time will tell.

IDO in­hi­bi­tion came in­to full fo­cus dur­ing the last few days as In­cyte surged on its late-stage de­vel­op­ment plans. Be­hind the lead­ers you’ll find a host of ear­ly-stage ef­forts un­der­way, and Link be­lieves that there may be a fu­ture for com­bin­ing IDO path­way and IDO en­zyme in­hibitors.

What In­cyte, NewLink and all the oth­er play­ers are won­der­ing is if an IDO/PD-1 or IDO/PD-L1 check­point can do as well as a check­point match-up us­ing a CT­LA-4. Those CT­LA-4s are ef­fec­tive, but well known for a harsh tox­i­c­i­ty that makes them hard to tol­er­ate. And that would have ma­jor im­pli­ca­tions not on­ly for Yer­voy’s fu­ture, but al­so com­bos like As­traZeneca’s dur­val­um­ab and treme­li­mum­ab, a CT­LA-4 that oc­cu­pies a cen­tral role in the phar­ma gi­ant’s plans to leap from last place in­to the fore­front, pre­sum­ing they can get a rel­a­tive­ly quick OK as the fifth in a se­ries.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

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.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

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.

In­cyte keeps rolling on top­i­cal cream for JAK in­hibitor, pass­ing two PhI­II tests in vi­tili­go

As Incyte prepares to potentially hit the market with a topical formulation of its cash cow ruxolitinib in atopic dermatitis, the Wilmington, DE-based company is beefing up its data package for another indication: vitiligo.

Incyte released Phase III results from two of its clinical vitiligo programs Monday morning, saying both studies met their primary endpoints of patients achieving at least 75% improvement from baseline in repigmentation of the face. The data will likely lead Incyte to ask for approval in both the US and Europe for those older than 12 before the end of the year.

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.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.

Days ahead of Am­gen split, Cy­to­ki­net­ics reads out post-hoc da­ta sug­gest­ing heart drug works bet­ter in sick­er pa­tients — but can the CEO win over skep­tics?

While Cytokinetics’ heart drug technically met its primary endpoint back in November, it missed a key secondary endpoint — reduction in cardiovascular death — which eventually cost the company two partnerships. Now the team is back with data suggesting the drug works better in sicker patients, and it’s planning a trip to the FDA.

In a post-hoc analysis, which can be a very difficult sale at the FDA, Cytokinetics separated patients from the Phase III GALACTIC-HF study into four quartiles based on ejection fraction, a measurement of how well the left ventricle pumps blood with each heartbeat. Patients in the lower two quartiles — those with an EF of 22% or lower, and between 29% to 32% — saw a 15% and 17% relative risk reduction of heart failure events and cardiovascular death combined, Cytokinetics reported at ACC. No difference was seen in the upper two quartiles.

Neil Desai, Aadi Bioscience CEO (Specialised Therapeutics via YouTube)

Patrick Soon-Sh­iong's for­mer chief sci­en­tist takes can­cer com­pa­ny pub­lic in $155M re­verse merg­er

Editor’s note: Interested in following biopharma’s fast-paced IPO market? You can bookmark our IPO Tracker here.

SPACs have become the preferred fast track for public markets over the past year, but apparently there’s still room for a good, old-fashioned reverse merger.

Cancer-focused Aadi Bioscience announced Monday that they would merge with the struggling public biotech Aerpio Pharmaceuticals. To go along with the merger, Aadi raised $155 million from private investors to commercialize their lead drug, Fyarro, which is now sitting before the FDA. Acuta Capital Partners and KVP Capital led the round.

Endpoints News

Keep reading Endpoints with a free subscription

Unlock this story instantly and join 105,400+ biopharma pros reading Endpoints daily — and it's free.