Data from Clinical Studies of NewLink Genetics' Two Distinct IDO Pathway Inhibitors to Be Presented at ASCO 2017
An infographic accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/b945495b-6286-4184-881f-b4ea49aa46b4
"The IDO pathway is a key immuno-oncology target and
Indoximod in combination with the therapeutic cancer vaccine, PROVENGE®
Results from a randomized, double-blind, placebo-controlled, multi-institutional Phase 2 investigator initiated study with indoximod in combination with the therapeutic cancer vaccine,
PROVENGE® (sipuleucel-T), for patients with metastatic castration resistant prostate cancer will be presented as a poster (Abstract number 3066) by
In the study, forty-six patients were randomized into two arms to receive either twice daily oral indoximod (n=22) or placebo (n=24) for 6 months beginning the day after the third and final PROVENGE infusion. Conclusions indicate that treatment with the IDO pathway inhibitor, indoximod, post PROVENGE therapy, leads to significant improvement in radiographic progression free survival (rPFS) when compared to placebo and is well-tolerated.
Key findings presented from the study include:
- Statistically significant improvement in median rPFS was 10.3 months in the treatment arm compared to 4.1 months in the placebo arm (p = 0.011)
- Median Overall Survival (OS) has not yet been reached
- Patients tolerated therapy with indoximod with no significant differences in adverse events between the two arms
- There was no statistical difference in the primary endpoint of ELISPOT assay immune response to PA2024, the PROVENGE-related fusion protein, in the 35 of 46 patients who had clinical samples available for testing
"These data further support the hypothesis that targeting the IDO Pathway in combination with a broad backbone of treatment regimens including chemotherapy, anti-PD-1 antibodies and therapeutic vaccines across multiple indications has the potential to provide meaningful clinical benefit without compromising tolerability," commented
Navoximod in combination with TECENTRIQ® (atezolizumab) in multiple solid tumors
Initial data from a Phase 1b dose-escalation study of navoximod in combination with TECENTRIQ® for patients with locally advanced or metastatic solid tumors conducted by our partner,
This Phase 1b, open-label, dose-escalation study is designed to characterize safety and tolerability. Secondary objectives include identifying a maximum tolerated dose (MTD) and recommended Phase 2 dose, and evaluating pharmacokinetics, pharmacodynamics, and anti-tumor activity. Patients were given TECENTRIQ (1200 mg IV every 3 weeks) and escalating doses of navoximod (orally twice daily, for 21 days) using a standard 3+3 design. Initial results from this study (n=52, non-selected heterogeneous population during the dose escalation) found the combination was generally well-tolerated, with peripheral IDO1 modulation, and some early activity signals. Patients were previously treated with prior systemic therapies with a median number of 3 and a range of 1-9. Two patients also received prior immunotherapy.
The design of the trial includes the initial dose-escalation phase reported in this abstract, followed by disease-specific expansion cohorts (enrollment target is 305 patients) for patients with select tumor types including non-small-cell lung cancer (NSCLC), renal cell cancer (RCC), urothelial bladder cancer (UBC), triple negative breast cancer (TNBC), to further
evaluate safety, response, and peripheral and tumor pharmacodynamics. Updates for this study will continue to be reported by
About
NewLink Genetics is a biopharmaceutical company at the forefront of discovering, developing and commercializing novel immuno-oncology product candidates to improve the lives of patients with cancer. NewLink Genetics' product candidates are designed to harness multiple components of the immune system to combat cancer. For more information, please visit http://www.newlinkgenetics.com.
PROVENGE® is a registered trademark of
TECENTRIQ® is a registered trademark of
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements of
Investor Contact:Source:Lisa Miller Director of Investor Relations,NewLink Genetics 515-598-2555 lmiller@linkp.com Media:Andrew Mastrangelo AVP, Public & Media Relations LaVoieHealthScience 617-374-8800, ext. 108 amastrangelo@lavoiehealthscience.com
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