Phase I Study Investigating the Safety of Navoximod and NLG802 in Combination With Stereotactic Body Radiotherapy (SBRT) in Subjects With Advanced Solid Tumors

This early phase trial proposes to study of stereotactic body radiation therapy (SBRT) with navoximod and NLG802, a prodrug of indoximod. Combinations of immune-oncology (IO) agents with complementary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy. Radiation therapy induces immunogenic cell death, increases production of tumor specific antigens, enhances TH cell functioning, and modulates immunosuppressive cell populations such as T regulatory cells and myeloid derived suppressor cells.

Start Date01 Oct 2022

Sponsor / Collaborator

Lumos Pharma, Inc.

NCT03164603

/ CompletedPhase 1

A Phase 1 Study of NLG802 for Adult Patients With Recurrent Advanced Solid Tumors

This is an open-label Phase I study to evaluate the safety, tolerability, and pharmacokinetics of escalating oral doses of NLG802, an investigational agent intended to inhibit the indoleamine 2,3-dioxygenase 1 (IDO1) enzyme and help the human immune system attack solid tumor cells more effectively.

Start Date29 Jun 2017

Sponsor / Collaborator

NewLink Genetics Corp.

100 Clinical Results associated with NLG-802

100 Translational Medicine associated with NLG-802

100 Patents (Medical) associated with NLG-802

Literatures (Medical) associated with NLG-802

01 Jul 2020·European Journal of Medicinal ChemistryQ1 · MEDICINE

Discovery of indoximod prodrugs and characterization of clinical candidate NLG802

Q1 · MEDICINE

Article

Author: Zhuang, Hong ; Kumar, Sanjeev ; Brincks, Erik L ; Adams, James ; Link, Charles ; Vahanian, Nicholas ; Van Allen, Clarissa ; Marcinowicz, Agnieszka ; Mautino, Mario R ; Jaipuri, Firoz A ; Waldo, Jesse P ; Potturi, Hima

A series of different prodrugs of indoximod, including estesrs and peptide amides were synthesized with the aim of improving its oral bioavailability in humans. The pharmacokinetics of prodrugs that were stable in buffers, plasma and simulated gastric and intestinal fluids was first assessed in rats after oral dosing in solution or in capsule formulation. Two prodrugs that produced the highest exposure to indoximod in rats were further tested in Cynomolgus monkeys, a species in which indoximod has oral bioavailability of 6-10% and an equivalent dose-dependent exposure profile as humans. NLG802 was selected as the clinical development candidate after increasing oral bioavailability (>5-fold), C_max (6.1-3.6 fold) and AUC (2.9-5.2 fold) in monkeys, compared to equivalent molar oral doses of indoximod. NLG802 is extensively absorbed and rapidly metabolized to indoximod in all species tested and shows a safe toxicological profile at the anticipated therapeutic doses. 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.

100 Deals associated with NLG-802

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	US	NewLink Genetics Corp.	29 Jun 2017
Advanced Malignant Solid Neoplasm	Phase 1	US	NewLink Genetics Corp.	29 Jun 2017
Relapsed Solid Neoplasm	Phase 1	US	NewLink Genetics Corp.	29 Jun 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


SITC2018	Phase 1	-	-	NLG802 180 mg	nabnyhfxmy(kdipjfjdbb) = jklteegmhm lnbffbqfoi (erxngfzwpv ) View more	-	06 Nov 2018
				NLG802 360 mg	nabnyhfxmy(kdipjfjdbb) = bgxeofidhf lnbffbqfoi (erxngfzwpv ) View more

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