Nisha sells NLNK 38.12: GDC-0919 also is being evaluated in a Phase 1b study in combination with atezolizumab (PD-L1 inhibitor) in patients with recurrent or advanced solid tumors.

Thirty seven percent of patients available for tumor assessments (7/17) achieved stable disease. GDC-0919 was well tolerated up to 800 mg BID (twice daily) on a 21/28 day cycle. The data showed an acceptable safety profile, disease stabilization and preliminary evidence of peripheral pharmacodynamic modulation. GDC-0919, a small molecule investigational immunotherapy designed to inhibit IDO1 for the treatment of immune tolerance associated with cancer, is intended as a combination therapy with other immunotherapies and oncology therapeutics. The primary objectives of this study are to evaluate the safety and tolerability of GDC-0919 in patients with advanced solid tumors as well as to define the maximum tolerated dose (MTD) or maximum biologically effective dose and recommended Phase 2 dose.


Hope:
The Phase 2 dose for indoximod has been established at 1,200 mg BID (twice daily), and the primary endpoint will be preliminary efficacy as measured by median progression-free survival.

Nana:
Five patients in the study had progressive disease, and two patients are still awaiting follow up.

Loraine:
Of the seven patients evaluable for a response, one patient had a complete response and one patient had a partial response by RECIST criteria.

Odilia:
Combination therapy with indoximod and ipilimumab showed encouraging clinical activity in some patients.

Susana:
IDO pathway inhibitors, such as indoximod, are designed to be used in combination with other therapeutic agents to maximize the body's immune response against tumors.

Charleen:
Indoximod is an orally available, small molecule, broad IDO pathway inhibitor that has shown the potential to interfere with multiple targets within the IDO pathway.

Trang:
The data reported today are from a Phase 1b safety study of nine patients to determine the safety of indoximod and to establish the dose for a Phase 2 study of indoximod in combination with ipilimumab, which is currently enrolling patients.

Leana:
NewLink Genetics anticipates that subsequent events and developments will cause its views to change.

Candance:
The rVSV-ZEBOV (Ebola) vaccine candidate was originally developed by the Public Health Agency of Canada (PHAC) and was subsequently licensed to a subsidiary of NewLink Genetics.

Lavonna:
NewLink has exclusively licensed research, development and manufacturing of the rVSV-ZEBOV vaccine to Merck.

Newlink Genetics Corporation (NASDAQ:NLNK)
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