NewLink Genetics (NASDAQ:NLNK) Phase I/II combination trial of indoximod with Bristol-Myers Squibb’s (NYSE:BMY) Yervoy (ipilumumab) in metastatic melanoma is expected to present a better safety profile than BMS’s Yervoy/Opdivo (nivolumab) and at least match efficacy, experts said.
Preclinical data indicates immune modulatory IDO inhibitors are poised to be a significant synergistic addition to immune-oncology therapies like checkpoint inhibitors, experts said. Though standard caveats on the unpredictable shift from preclinical to human trials persist when trying to forecast trial success, experts noted.
Phase I results of the novel combination of IDO inhibitor indoximod and checkpoint inhibitor Yervoy (ipilimumab) echo preclinical and animal data, said experts [Gangadhar et al, J ImmunoTherapy of Cancer 2015 3(Suppl 2):O7]. Preclinical models suggest that blocking the IDO pathway looks to enhance the antigen-presenting process that educates T cells that are subsequently activated by checkpoint inhibition, said study investigator and IDO pioneer Dr David Munn, associate professor of medicine, Georgia Cancer Center, Augusta University, Augusta, Georgia.
Incyte’s (NASDAQ:INCY) promising Phase I/II efficacy signals of epacodostat -- presented at this month’s ESMO 2016 conference (abstract 1110PD) -- have bolstered expectations for NewLink’s indoximod, though different molecules. If indoximod retains its stable safety profile and its Phase II response rates echo epacodostat’s Phase II results, indoximod is expected to fare well in a historical comparison against Opdivo/Yervoy and continue to a Phase III like epacodostat’s.