Ham­mered by a se­ries of set­backs, NewLink ax­es staff (again) and cir­cles its wag­ons around trou­bled IDO pro­gram

Three months af­ter NewLink Ge­net­ics scrapped a com­bi­na­tion pro­gram for its IDO path­way drug in­dox­i­mod in the gen­er­al rout that fol­lowed the fail­ure of In­cyte’s big IDO project for epaca­do­stat, the biotech is nev­er­the­less cir­cling its wag­ons around a last stand ef­fort to prove their ther­a­py can work and make it to the mar­ket. In the process, the Iowa-based com­pa­ny has slashed close to a third of its staff and re­or­ga­nized the C suite in the process.

Jack Hen­ne­man

Re­duc­ing the cash burn, NewLink — helmed by Chuck Link — says it ex­pects to spend about $40 mil­lion a year, with enough cash to get in­to the sec­ond half of 2021.

Three years ago the stock $NLNK trad­ed at around $55. To­day it closed at $3.78, with a mar­ket cap of $140 mil­lion.

All the mon­ey is rid­ing on a drug that has come un­der a very dark cloud in­deed, since In­cyte’s IDO drug im­plod­ed in a piv­otal com­bi­na­tion study with Keytru­da. Once a dar­ling of the I/O crowd as a like­ly win­ner in the race to de­vel­op next-gen drugs, In­cyte’s suc­cess had in­spired oth­ers to fol­low.

In­cyte’s ug­ly fail­ure had the re­verse ef­fect, forc­ing NewLink to scrap a Phase III while Mer­ck and Bris­tol-My­ers and As­traZeneca all re­viewed their plans and re­treat­ed from am­bi­tious de­vel­op­ment sched­ules. Now the com­pa­ny is ax­ing 25 staffers in the re­struc­tur­ing while al­so turn­ing to a re­lat­ed pro­gram for NLG802.

Bri­an Wi­ley

That’s about all NewLink has left. The biotech has been hit by a se­ries of shud­der­ing blows. A year ago Roche wrote off a col­lab­o­ra­tion on an IDO dubbed navox­i­mod af­ter that drug foundered in the clin­ic. And a year be­fore that NewLink was forced to re­struc­ture af­ter the fail­ure of a pan­cre­at­ic can­cer vac­cine.

The SEC fil­ing by NewLink to­day al­so re­vealed that CFO Jack Hen­ne­man re­signed his po­si­tion to be­come chief ad­min­is­tra­tive of­fi­cer as he plans his de­par­ture for lat­er in the year. He’ll get $42,360 plus a bonus and 12 months salary for sev­er­ance. Chief com­mer­cial of­fi­cer Bri­an Wi­ley left a few days ago.

Elias Zerhouni (Photo by Vincent Isore/IP3/Getty Images)

Elias Zer­houni dis­cuss­es ‘am­a­teur hour’ in DC, the de­struc­tion of in­fec­tious dis­ease R&D and how we need to prep for the next time

Elias Zerhouni favors blunt talk, and in a recent discussion with NPR, the ex-Sanofi R&D and ex-NIH chief had some tough points to make regarding the pandemic response.

Rather than interpret them, I thought it would be best to provide snippets straight from the interview.

On the Trump administration response:

It was basically amateur hour. There is no central concept of operations for preparedness, for pandemics, period. This administration doesn’t want to or has no concept of what it takes to protect the American people and the world because it is codependent. You can’t close your borders and say, “OK, we’re going to be safe.” You’re not going to be able to do that in this world. So it’s a lack of vision, basically just a lack of understanding, of what it takes to protect the American people.

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George Yancopoulos (Regeneron)

Re­gen­eron co-founder George Yan­copou­los of­fers a com­bat­ive de­fense of the po­lice at a high school com­mence­ment. It didn’t go well

Typically, the commencement speech at Yorktown Central School District in Westchester — like most high schools — is an opportunity to encourage students to face the future with confidence and hope. Regeneron president and co-founder George Yancopoulos, though, went a different route.

In a fiery speech, the outspoken billionaire defended the police against the “prejudice and bias against law enforcement” that has erupted around the country in street protests from coast to coast. And for many who attended the commencement, Yancopoulos struck the wrong note at the wrong time, especially when he combatively challenged someone for interrupting his speech with a honk for “another act of cowardness.”

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Pfiz­er shares surge on pos­i­tive im­pact of their mR­NA Covid-19 vac­cine — part­nered with BioN­Tech — in an ear­ly-stage study

Pfizer and their partners at the mRNA specialist BioNTech have published the first glimpse of biomarker data from an early-stage study spotlighting the “robust immunogenicity” triggered by their Covid-19 vaccine, which is one of the leaders in the race to vanquish the global pandemic.

Researchers selected 45 healthy volunteers 18-55 years of age for the study. They were randomized to receive 2 doses, separated by 21 days, of 10 µg, 30 µg, or 100 µg of BNT162b1, “a lipid nanoparticle-formulated, nucleoside-modified, mRNA vaccine that encodes trimerized SARS-CoV-2 spike glycoprotein RBD.” Their responses were compared against the effect of a natural, presumably protective defense offered by a regular infection.

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An ex­pe­ri­enced biotech is stitched to­geth­er from transpa­cif­ic parts, with 265 staffers and a fo­cus on ‘new bi­ol­o­gy’

Over the past few years, different teams at a pair of US-based biotechs and in labs in Japan have labored to piece together a group of cancer drug programs, sharing a single corporate umbrella with research colleagues in Japan. But now their far-flung operations have been knit together into a single unit, creating a pipeline with 10 cancer drug development programs — going from early-stage right into Phase III — and a host of discovery projects managed by a collective staff of some 265 people.

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Sec­ond death trig­gers hold on Astel­las' $3B gene ther­a­py biotech's lead pro­gram, rais­ing fresh con­cerns about AAV

Seven months after Astellas shelled out $3 billion to acquire the gene therapy player Audentes, the biotech company’s lead program has been put on hold following the death of 2 patients taking a high dose of their treatment. And there was another serious adverse event recorded in the study as well, with a total of 3 “older” patients in the study affected.

The incidents are derailing plans to file for a near-term approval, which had been expected right about now.

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Randy Schatzman, Bolt CEO (Bolt Biotherapeutics)

Bolt Bio­ther­a­peu­tics nabs $93.5M to push Provenge in­ven­tor's new idea deep­er in the clin­ic

A cancer-fighting concept from the inventor of the first cancer vaccine is nearing prime time, and its biotech developer has received a significant new infusion of cash to get it there.

Bolt Biotherapeutics announced a $93.5 million Series C round led by Sofinnova Investments and joined by more than 9 others, including Pfizer Ventures and RA Capital Management. That money will go toward pushing the San Francisco biotech’s platform of innate immune-boosting warheads through its first trial on metastatic solid tumors and into several more.

Days af­ter In­ter­cept re­jec­tion, Akero surges on ‘un­prece­dent­ed‘ NASH da­ta

A year and a half after scoring a $70 million Series B and a top Gilead executive as CEO, Akero Therapeutics has announced new data on their NASH drug. And with the field still reeling from a surprise FDA rejection this week, the news was enough to send their stock surging.

Akero had already said in March that its lead drug had beaten placebo in its Phase II trial, reducing liver fat by 14% in the highest dose group compared to 0.3% in placebo, according to MRI scans. But although NASH is an obesity-related condition and results from fatty buildup in the liver, the real immediate question for any therapy is whether it can resolve the fibrosis and inflammation that results from that buildup. Those data require biopsying the patients, a longer and more invasive process that was further complicated by a pandemic.

Covid-19 has roiled clin­i­cal tri­al plans around the world, rais­ing con­cerns over the in­dus­try’s fu­ture on new drug ap­provals

Over the past 4 months, a group of analysts at GlobalData tracked 322 biopharma companies — biotechs, pharmas, CROs and such — reporting on the trouble Covid-19 has caused for their clinical development plans.

Slightly more than half — 179 — are US operations, with about 1 in 4 scattered throughout Europe and in Canada. And the disruptions are clustered around mid-stage development, though a hefty number of late-stage derailments may well blunt the stream of approvals down the road.

New stan­dard of care? FDA hands Pfiz­er, Mer­ck KGaA an OK for Baven­cio in blad­der can­cer

The breakthrough therapy designation Pfizer and Merck KGaA notched for Bavencio in bladder cancer has quickly paved way for a full approval.

The PD-L1 drug is now sanctioned as a first-line maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma, applicable in cases where cancer hasn’t progressed after platinum-containing chemotherapy.

Petros Grivas, the principal investigator of the supporting Phase III JAVELIN Bladder 100, called the approval “one of the most significant advances in the treatment paradigm in this setting in 30 years.”