NewLink wields ax, clearing the way for leaner IDO program | Tech Science

has cut its headcount by a third to buy the time it needs to prove that—despite setbacks—its inhibitor indoximod is still worth pursuing.

The biotech has also decided that its best chances of success with indoximod are in front-line acute myeloid leukemia, recurrent pediatric brain , and front-line treatment of diffuse intrinsic pontine glioma (DIPG). It will also continue to develop a prodrug of indoximod in that delivers higher levels of the active drug to the body and should have initial clinical data later this year.

NewLink says the staffing cutbacks will reduce its outgoings by around $10 million per quarter and allow it to eke out its cash until the second half of 2021. It was sitting on reserves of around $137 million at the end of June.

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It’s worth pointing out that the selected indications don’t include advanced melanoma, which was the target of a phase 2 trial NewLink highlighted at this year’s ASCO meeting as evidence that it was too soon to give up on IDO as an immuno- target.

NewLink has been among the pioneers of IDO inhibitor development, but has been affected by waning confidence in the class after the high-profile failure of rival Incyte’s epacadostat paired with Merck & Co’s Keytruda (pembrolizumab) in a phase 3 trial left the candidate all but shelved, and was followed by the shuttering of IDO programs at Merck and Bristol-Myers Squibb.  

NewLink has had its own problems with IDO as well, including a failed breast cancer trial and the loss of a $1 billion partnership with Genentech on follow-up IDO candidate navoximod.

Analysts at Jefferies said that the changes make sense, but caution that AML in particular is “a challenging indication” to go after. They’ll be looking for proof-of-concept data to justify management’s plan in this setting.

They are more upbeat on DIPG, saying that an update of phase 1 trial of indoximod in combination with chemotherapy and radiation—presented at the AACR meeting in April—seem to be “incrementally positive.”

Data on six patients were reported at AACR and a few weeks ago NewLink reported updated results in 10 out of a target population of 30 patients, showing improvement in symptoms across the board. With an average time on drug of just over eight months though, Jefferies notes it is “too early for meaningful survival data.”

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The benefit of DIPG is that it could provide a rapid route through regulatory review and onto the market. NewLink has said that as DIPG is a rare diseases with an incidence of around 300 patients a year in the U.S., it may be able to go for accelerated approval based on data due in the first half of 2019.

The restructuring will also see Chief Financial Officer Jack Henneman move to the role of chief administrative officer ahead of his retirement from the company in November. He’ll be replaced as CFO by Carl Langren.

“We are grateful for the service and contributions made by Jack and all of those who have been a part of the NewLink team,” said the firm’s President Nicholas Vahanian, M.D.  “This necessary transition is difficult for our company and our people, and we don’t take these changes lightly.” 

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