In light of In­cyte's epaca­do­stat de­ba­cle, NewLink scraps PhI­II plans for its own IDO drug

Af­ter see­ing its shares get dragged down by In­cyte’s late-stage de­ba­cle, NewLink Ge­net­ics is scrap­ping a PhI­II tri­al for its own IDO drug, rais­ing fur­ther ques­tions about the path­way.

It will not ini­ti­ate the ran­dom­iza­tion por­tion of In­di­go301, the Ames, IA-based com­pa­ny $NLNK said, a melanoma study that would have eval­u­at­ed in­dox­i­mod in com­bi­na­tion with check­point in­hibitors Keytru­da or Op­di­vo in 600 pa­tients. In a press re­lease, NewLink ex­plained the de­ci­sion was made “in the con­text of the fail­ure of a com­peti­tor’s tri­al of its en­zy­mat­ic IDO in­hibitor in a sim­i­lar clin­i­cal set­ting.”

In­cyte suf­fered a bit­ter set­back for its IDO1 drug epaca­do­stat al­most two weeks ago, as in­ves­ti­ga­tors halt­ed a Phase III study in metasta­t­ic melanoma af­ter find­ing the com­bo of epaca­do­stat and Mer­ck’s PD-1 star Keytru­da in­ef­fec­tive in pro­gres­sion-free sur­vival and un­like­ly to ex­tend over­all sur­vival. A leader in the IDO field, the com­pa­ny told an­a­lysts that the ECHO-301 study fail­ure “has a neg­a­tive im­pact on the prob­a­bil­i­ty of suc­cess of the oth­er (com­bi­na­tion) stud­ies.”

Charles Link, NewLink

NewLink has ap­par­ent­ly heed­ed its ri­val’s warn­ing. The plan now is for the clin­i­cal team to look in­to an al­ter­na­tive way to test in­dox­i­mod in melanoma — the de­sign, tri­al size and fea­si­bil­i­ty. They will take in­to ac­count the full da­ta set from the com­pa­ny’s sin­gle-arm PhII melanoma tri­al, with fi­nal re­sults sched­uled to come out lat­er this year.

Last year, re­searchers rolled out a set of da­ta from the PhII study with in­dox­i­mod and Keytru­da, tout­ing a me­di­an pro­gres­sion-free sur­vival rate at 12.9 months. They al­so re­port­ed an in­crease in the com­plete re­sponse rate from 12% to 20%n an over­all re­sponse rate of 61% and a dis­ease con­trol rate of 80%.

De­spite the switch-up, the com­pa­ny wants peo­ple to re­mem­ber that in­dox­i­mod has a dif­fer­ent mech­a­nism of ac­tion from di­rect en­zy­mat­ic in­hibitors like epaca­do­stat.

NewLink’s shares took an­oth­er dip at the news, falling as much as 15% (though noth­ing se­ri­ous com­pared to the 44% hit it took af­ter the In­cyte fail­ure broke) be­fore climb­ing back up.

Mi­no­ryx and Sper­o­genix ink an ex­clu­sive li­cense agree­ment to de­vel­op and com­mer­cial­ize lerigli­ta­zone in Chi­na

September 23, 2020 – Hong Kong, Beijing, Shanghai (China) and Mataró, Barcelona (Spain)  

Minoryx will receive an upfront and milestone payments of up to $78 million, as well as double digit royalties on annual net sales 

Sperogenix will receive exclusive rights to develop and commercialize leriglitazone for the treatment of X-linked adrenoleukodystrophy (X-ALD), a rare life-threatening neurological condition

FDA chief Stephen Hahn on Capitol Hill earlier this week (Getty Images)

As FDA buck­les un­der the strain of a pan­dem­ic work­load, Trump again ac­cus­es the agency of a po­lit­i­cal hit job

Peter Marks appeared before a virtual SVB Leerink audience yesterday and said that his staff at FDA’s CBER is on the verge of working around the clock. Manufacturing inspections, policy work and sponsor communications have all been pushed down the to-do list so that they can be responsive to Covid-related interactions. And the agency’s objective right now? “To save as many lives as we can,” Marks said, likening the mortality on the current outbreak as equivalent to “a nuclear bomb on a small city.”

Daniel O'Day, Gilead CEO (Kevin Dietsch/UPI/Bloomberg via Getty Images)

Play-by-play of Gilead­'s $21B Im­munomedics buy­out de­tails a fren­zied push — and mints a new biotech bil­lion­aire

Immunomedics had not really been looking for a buyout when the year began. Excited by its BLA for Trodelvy, submitted to the FDA in late 2019, executive chairman Behzad Aghazadeh started off looking for potential licensing deals and zeroed in on four potential partners, including Gilead, following January’s JP Morgan Healthcare Conference in San Francisco. Such talks advanced throughout the year, with discussions advancing to the second round in mid-August.

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The win­dow is wide open as four more biotechs join the go-go IPO class of 2020

It’s another day of hauling cash in the biopharma world as four more IPOs priced Friday and a fifth filed its initial paperwork.

The biggest offering comes from PMV Pharma, an oncology biotech focusing on p53 mutations, which raised $211.8 million after pricing shares at $18 apiece. Prelude Therapeutics, developing PRMT5 inhibitors for rare cancers, was next with a $158 million raise, pricing shares at $19 each. Graybug Vision raised $90 million after pricing at $16 per share for its wet AMD candidates, and breast cancer biotech Greenwich Lifesciences brought up the rear with a small, $7 million raise after pricing shares at $5.75.

J&J of­fers PhI/IIa da­ta show­ing its sin­gle-dose vac­cine can stir up suf­fi­cient im­mune re­sponse

Days after J&J dosed the first participants of its Phase III ENSEMBLE trial, the pharma giant has detailed the early-stage data that gave them confidence in a single-dose regimen.

Testing two dose levels either as a single dose or in a two-dose schedule spaced by 56 days in, the scientists from Janssen, the J&J subsidiary developing its vaccine, reported that the low dose induced a similar immune response as the high dose. The interim Phase I/IIa results were posted in a preprint on medRxiv.

President Donald Trump reacts after signing an executive order following his remarks on his healthcare policies yesterday in Charlotte, North Carolina (Getty Images)

Op-ed: Will phar­ma re­al­ly pay for Trump’s lat­est law­less promise to 33 mil­lion Medicare ben­e­fi­cia­ries? Not like­ly

Sitting atop the executive branch, President Donald Trump is the ultimate authority at the FDA. He can fast track any vaccine to approval himself. If it came to that, of course.

What he can’t do is unilaterally order the legislative branch to loosen the Treasury’s coffers for $6.6 billion. Nor can he command pharmaceutical companies to pay for $200 vouchers sent to 33 million Medicare beneficiaries for prescription drugs before the election.

Pal­la­dio bags $20 mil­lion Se­ries B to top­ple a prob­lem­at­ic kid­ney dis­ease drug

Palladio Biosciences just took one step further in its quest to topple Otsuka’s Samsca with its own — it hopes safer — autosomal dominant polycystic kidney disease (ADPKD) drug.

The Pennsylvania-based biotech announced a $20 million Series B on Friday, which will fund a 10-person Phase III trial of its vasopressin V2 receptor agonist, lixivaptan. CEO Alex Martin expects to read out data in the first half of next year, then launch straight into a larger pivotal Phase III study with about 1,200 participants.

New York governor Andrew Cuomo (AP Images)

An­drew Cuo­mo says New York will un­der­take its own vac­cine re­view process, and wouldn’t rec­om­mend trust­ing the fed­er­al gov­ern­ment

The concerns keep mounting over President Donald Trump’s politicization of the FDA and other federal agencies guiding the development of a safe and effective vaccine. And today, the telegenic New York governor Andrew Cuomo appeared to introduce even more politics into the matter — latest in an ongoing series of incidents that have cast the proudly independent FDA in starkly political terms.

During his daily press conference Cuomo said that the state will review any coronavirus vaccines approved by the federal government, citing a lack of trust in the Trump administration. The announcement comes one day after Trump accused the FDA of making an “extremely political” move in proposing stricter vaccine guidance.

Laura Shawver (Silverback Therapeutics)

Fol­low­ing a hefty Se­ries B, Sil­ver­back Ther­a­peu­tics quick­ly pulls in $85M for 'an im­por­tant growth phase'

Months after reeling in a $78 million Series B round, Silverback Therapeutics has hooked an even larger Series C.

The Seattle-based company announced Wednesday that it netted $85 million from a slate of new and previous investors. The quick boost could be a sign that an IPO is on the way.

In an email, Silverback CEO Laura Shawver told me she was “not able to provide any additional comments about Silverback” beyond what was shared in the company’s news release. In the prepared statement, she said the company is at “an important growth phase.”