NLG802 / Lumos Pharma - LARVOL DELTA

Safety of Navoximod and NLG802 With Stereotactic Body Radiotherapy (SBRT) Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=0 | Withdrawn | Sponsor: Luke, Jason, MD | N=30 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Oncology • Solid Tumor

Safety of Navoximod and NLG802 With Stereotactic Body Radiotherapy (SBRT) Treatment of Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Luke, Jason, MD

Combination therapy • New P1 trial • Oncology • Solid Tumor

NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=26; Completed; Sponsor: NewLink Genetics Corporation; Active, not recruiting ➔ Completed

Clinical • Trial completion • Glioblastoma • Oncology • Solid Tumor

NewLink Genetics presents phase 1 data supporting significantly higher exposure with indoximod prodrug, NLG802, and biomarker data from two phase 2 trials illustrating indoximod’s impact on the tumor microenvironment at SITC 2018 (GlobeNewswire) - "NewLink Genetics Corporation...announced that data from three separate trials are being presented at the Society for Immunotherapy of Cancer (SITC) Annual Meeting in Washington D.C. Data from a Phase 1a clinical trial of NLG802, a prodrug of indoximod, as well as biomarker data from two Phase 2 studies of indoximod in combination therapy...'We are delighted to be able to present these data supporting both activity of indoximod within the tumor microenvironment and the higher exposure levels obtained by indoximod prodrug, NLG802, supporting the potential for these drugs to elicit therapeutic responses and improve the lives of patients with cancer'..."

P1 data • P2 data • Gastrointestinal Cancer • Melanoma • Oncology • Pancreatic Cancer • Solid Tumor

NewLink Genetics announces indoximod biomarker data and prodrug NLG802 pharmacokinetic data to be presented at SITC 2018 (GlobeNewswire) - "NewLink Genetics Corporation...announced today that two abstracts were accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 33rd Annual Meeting being held November 7-11, 2018 in Washington, D.C.  These poster presentations will feature pharmacokinetic (PK) data from the Company’s Phase 1a study [N=36, NCT03164603] of NLG802, a prodrug of indoximod, in patients with advanced solid tumors and biomarker data from its Phase 2 study [N=132, NCT02073123] of indoximod in combination with checkpoint inhibition for patients with advanced melanoma."

Biomarker • P1 data • P2 data • Melanoma • Oncology

Discovery of indoximod prodrugs and characterization of clinical candidate NLG802. (PubMed, Eur J Med Chem) - "NLG802 markedly enhanced the anti-tumor responses of tumor-specific pmel-1 T cells in a melanoma tumor model. In conclusion, NLG802 is a prodrug of indoximod expected to increase clinical drug exposure to indoximod above the current achievable levels, thus increasing the possibility of therapeutic effects in a larger fraction of the target patient population."

Clinical • Journal • Melanoma • Oncology • Solid Tumor

NLG802: “NLG802 produced 4-fold increases in Cmax and AUC after a single dose, and 4–5.5 fold increases in Cmax and AUC after continuous BID dosing compared with the molar equivalent of indoximod dosing” (NewLink Genetics) - SITC 2018

P1 data • Oncology • Solid Tumor

NewLink Genetics provides corporate update and reports second quarter 2019 financial results (GlobeNewswire) - "The Company presented updated data from a Phase 1 dose-escalation study of NLG802, a prodrug of indoximod, at the Immuno-Oncology 2019 2^nd World Congress in Barcelona, Spain, May 23-24, 2019....Updated results from the cohort of patients with DIPG in the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors are anticipated later in 2019."

P1 data

NLG802: “MTD/MBAD has not been reached, RP2D established at 1452 mg BID based on achieving exposure levels required for PD effects of indoximod”; Solid tumor (NewLink Genetics) - Immuno-Oncology 2019 World Congress: “Daily exposure at steady state after NLG802 1452 mg Q12h dosing was ~726 μM·h, which compared favorably to 240 μM·h obtained with indoximod 1200 mg BID”

P1 data

"#NewLinkGenetics Presents Updated #NLG802 Results at the #ImmunoOncology 2019 World Congress $NLNK https://t.co/AkVix9cW5U" (@1stOncology)

NewLink Genetics Presents Updated NLG802 Results at the Immuno-Oncology 2019 World Congress (GlobeNewswire, NewLink Genetics Corporation) - NLG802, a prodrug of indoximod, produced significantly higher pharmacokinetic (PK) exposure in patients compared to molar equivalent of indoximod while maintaining encouraging safety profile. Notable response in 5th line pancreatic cancer patient re-challenged with chemotherapy after NLG802 treatment ended .

Clinical data

NewLink Genetics Reports First Quarter 2019 Financial Results and Provides Clinical Activities Update (GlobeNewswire, NewLink Genetics Corporation) - The Company has had an abstract accepted, and plans to present updated data from a Phase 1 dose-escalation study of NLG802, a prodrug of indoximod, at the Immuno-Oncology 2019 2nd World Congress in Barcelona, Spain, May 23-24, 2019...Updated results from the cohort of patients with DIPG in the efficacy portion of a Phase 1b study of indoximod for the treatment of pediatric patients with recurrent malignant brain tumors are anticipated later in 2019.

Clinical data

NLG802 Indoleamine 2,3-Dioxygenase (IDO) Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - P1; N=36; Active, not recruiting; Sponsor: NewLink Genetics Corporation; Recruiting ➔ Active, not recruiting; Trial completion date: Oct 2018 ➔ Oct 2019; Trial primary completion date: May 2018 ➔ Apr 2019

Clinical • Enrollment closed • Trial completion date • Trial primary completion date

NLG802: Patent expiry in 2036 (NewLink Genetics) - Annual Report 2018

Patent

NewLink Genetics reports fourth quarter, year-end 2018 financial results and provides update for clinical programs (GlobeNewswire) - "Results from a Phase 2 study of NLG207 (formerly CRLX101)...for patients with recurrent ovarian cancer, has been accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2019, at the Georgia World Conference Center, in Atlanta, March 29 - April 3, 2019; Updated results from a Phase 1 study of NLG802, a prodrug of indoximod with enhanced pharmacokinetic properties, are anticipated in 2019."

P1 data • P2 data