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.

JPRN-JapicCTI-163330

/ Unknown statusPhase 1

PHASE I STUDY OF GDC-0919 AS A SINGLE AGENT AND IN COMBINATION WITH OTHER ANTICANCER DRUGS IN PATIENTS WITH ADVANCED SOLID TUMORS

Start Date01 Jun 2016

Sponsor / Collaborator

Chugai Pharmaceutical Co., Ltd.

NCT02471846

/ CompletedPhase 1

A Phase Ib, Open-Label, Dose-Escalation Study of the Safety and Pharmacology of GDC-0919 Administered With Atezolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, tolerability, and pharmacokinetics of the combination of GDC-0919 and atezolizumab in participants with locally advanced, recurrent, or metastatic incurable solid malignancy that has progressed after available standard therapy or for which standard therapy is ineffective, intolerable, or inappropriate. Participants will be enrolled in two stages, including a dose-escalation stage and an expansion stage.

Start Date28 Jul 2015

Sponsor / Collaborator

Genentech, Inc.

100 Clinical Results associated with Navoximod

100 Translational Medicine associated with Navoximod

100 Patents (Medical) associated with Navoximod

169

Literatures (Medical) associated with Navoximod

31 Dec 2025·Journal of Maternal-Fetal & Neonatal Medicine

Novel therapeutic targets uncovered by genome-wide integrative analysis in bronchopulmonary dysplasia

Article

Author: Xiong, Zhenyu ; Zhu, Qingxiong ; Hang, Lei

BACKGROUND:

Bronchopulmonary dysplasia (BPD) is the most common chronic respiratory disease in extremely premature infants. This study aims to identify gene expression dysregulation and explore various molecular pathways implicated in BPD.

METHODS:

This study integrated BPD genome-wide association study (GWAS), single-cell transcriptomics (scRNA-seq), and Mendelian randomization (MR) analysis to investigate the causal relationship between gene expression and BPD.

RESULTS:

Cell annotation and ligand-receptor analysis highlighted myofibroblasts as the most interactive cell type. Key genes, including CDH4, ENC1, and PAM, were identified as protective factors against BPD, while GRB10 was associated with increased disease risk. Immune metabolism-related pathways showed elevated activity of PAM, GRB10, and ENC1 in epithelial-mesenchymal transition. The Drug-Gene Interaction Database (DGIdb) predicted three drugs-LM10, navoximod, and ziprasidone-that potentially interact with these key genes.

CONCLUSION:

This integrative genome-wide analysis provides valuable insights into the genetic mechanisms underlying BPD. The findings facilitate the identification of novel therapeutic targets and pave the way for personalized treatment strategies for affected neonates.

01 Jul 2025·COLLOIDS AND SURFACES B-BIOINTERFACES

A novel NIR-dependent IDO-inhibiting ethosomes treatment melanoma through PTT/PDT/immunotherapy synergy

Article

Author: Shen, Hongping ; Yang, Xun ; Liu, Li ; Wang, Jianv ; He, Qingqing ; Xia, Dengmei ; Liao, Hongye ; He, Yuanmin ; Sun, Changzhen ; Yuan, Yuan ; Sun, Qin ; Liao, Yongmei ; Xia, Tong ; Xiong, Xia

Phototherapy is a treatment method that uses the characteristics of different bands of light to treat diseases. Tumor immunotherapy, on the other hand, treats tumors by regulating the body's immune system. The combination of phototherapy and immunotherapy can significantly enhance the treatment of melanoma. In this study, we prepared and characterized INEs, a novel ethosome composed of the photosensitizer IR251 and the Indoleamine-2, 3-dioxygenase (IDO) inhibitor NLG919. INEs demonstrated excellent phototherapeutic properties, strong phototoxicity, and a notable ability to inhibit IDO. Under 808 nm laser irradiation, INEs effectively induced immunogenic cell death (ICD) in melanoma cells. In vivo experiments demonstrated that INEs injection into primary tumors triggered ICD, promoted maturation of DC cells, and activated naive T cells, leading to the production of effector T cells (specifically CD4⁺ and CD8⁺ T cells) that targeted and killed tumor cells. Both primary and distant tumors were treated simultaneously with favorable biosafety. In conclusion, INEs represent a promising strategy for melanoma treatment by a combination of phototherapy and immunotherapy with high safety. This study provides new insights and a theoretical basis for the clinical treatment of melanoma.

01 May 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

An albumin-prodrug injectable formulation for synergistic cancer immunotherapy

Article

Author: Ma, Zhangqiang ; Tuo, Zhan ; Bi, Qiuchen ; Tang, Longguang ; Wang, Hanxi ; Zhu, Xiaoling ; Lu, Yuting ; Li, Yang ; Wang, Jianwei ; Ali, Kamran ; Zhang, Huamiao ; Wu, Tao ; Zhu, Heping ; Liu, Huiping

The emergence of immunotherapy has significantly transformed cancer therapy, and achieved promising outcomes. However, low patient response rates and the potential immune-related adverse events remain critical challenges, warranting extensive research. In this study, we developed an albumin-prodrug injection formulation (PIF) to enhance cancer immunotherapy. The stimulator of interferon genes (STING) agonist MSA-2 was esterified with the Indoleamine 2,3-dioxygenase (IDO) inhibitor NLG919 to synthesize the prodrug MSA-NLG. Subsequently, bovine serum albumin (BSA) was employed to prepare the anti-tumor injection formulation MSA-NLG@BSA, which effectively prolonged the circulation time of the prodrug, improved pharmacokinetic properties, and promoted tumor aggregation and penetration. This strategy ensures that the drug remains inactive in normal tissues, thereby reducing immune activation-induced damage. The prodrug was dissociated into MSA-2 and NLG919 within tumor cells overexpressing esterase. The MSA-2 molecule stimulates immune cells to secrete cytotoxic cytokines, triggering an anti-tumor immune response and reshaping immune cell population. Meanwhile, NLG919 regulates the recognition and killing of tumor cells by immune cells, effectively blocking the immunosuppression caused by IDO overexpression. This study highlights the potential of a tumor environment-responsive prodrug strategy to enhance the efficacy of immunotherapy, demonstrating the promising clinical translation of the novel MSA-NLG@BSA (PIF) formulation.

News (Medical) associated with Navoximod

07 Nov 2017

·www.biospace.com

Confident Bristol-Myers to Launch 700-Patient Phase III IDO Trial for Melanoma

Bristol-Myers is initiating a Phase III clinical trial of BMS-986205 with nivolumab in patients with advanced melanoma. Bristol-Myers Squibb Company is initiating a Phase III clinical trial of BMS-986205 with nivolumab in patients with advanced melanoma. Although the trial is not yet open, it has been announced on the ClinicalTrials.gov website. The compound, BMS-986205, is a IDO1 inhibitor. Nivolumab is the company’s powerful cancer drug, Opdivo. IDO inhibitors are a new class of cancer drugs, although the research on them is fairly new, so not much is known about them, including if they work. And there appears to be some concern that they don’t, although Bristol-Myers’ launch of a trial in this case suggests they, at least, think they do. Stat writes , “The next incremental answer to that question is coming this week, when Bristol-Myers Squibb will present early-stage data on a combination of its IDO drug and the multibillion-dollar cancer-killer called Opdivo. The results, known only to Bristol and its collaborators right now, were apparently positive enough to convince the company to launch a 700-patient Phase III trial, testing the combination against advanced melanoma.” Stat argues that the data must be significant, given that Phase III clinical trials are expensive and high-risk. Both Merck and Incyte are running similar trials with Keytruda and a different IDO inhibitor, with a data readout expected in the first half of 2018. “And thus if Bristol had concerns about the overarching idea, it could simply wait to see its competitors’ results. The fact that the company is wasting literally no time suggests Bristol is convinced IDO is for real.” The trial, according to the ClinicalTrials.gove website, “is to see if BMS-096205 combined with nivolumab, compared to nivolumab by itself, is more effective in treating melanoma that has spread or is unable to be removed by surgery, and has not previously been treated.” Back in April, Bristol-Myers’ oncology development head, Faoud Namouni, told Endpoints News ’ John Carroll, “It seems our IDO has the potential to be one of the most potent in the class.” Perhaps clouding the issue is a failed IDO inhibitor trial with Genentech ’ s Tecentriq and NewLink Genetics ’ IDO inhibitor indoximod , which resulted in Genentech turning the rights to the drug back. Derek Lowe, writing for Science Translational Medicine, said, “Something’s wrong, but what? Incyte is developing an IDO inhibitor of their own (epacadostat) and combining it with Merck’s Keytruda is providing the results that one would hope for. So the mechanism is likely to be sound. Complicating the picture, though, is that the Roche/Genentech PD-L1 antibody used in this study (Tecentriq, atezolizumab) had a recent unexpected failure in bladder cancer. It will be tempting for NewLink (and their investors) to think that the antibody was the problem, but there’s just not enough evidence to make that case one way or another. NewLink itself is under a lot of pressure after they’ve had disappointing results with their other IDO inhibitor, indiximod, in breast cancer, and it might be tough to round up another partner at this point. There’s a fair chance that we may never find out why GDC-0919 did what it did, but I hope that we eventually get some idea.”

Phase 3

08 Jun 2017

·www.biospace.com

NewLink Genetics Stock Plunges After Genentech Bails on $1 Billion+ IDO Deal

June 8, 2017 By Mark Terry , BioSpace.com Breaking News Staff Ames, Iowa – NewLink Genetics announced that Genentech was returning the rights to its IDO inhibitor GDC-0919 (navoximod). However, the overall research collaboration the two companies have to identify the next generation IDO/TDO (tryptophan 2,3-dioxygenase) inhibitors will continue. The original deal had an upfront payment of $150 million and with milestones, could have hit over $1 billion. The deal was inked in October 2014. NewLink licensed GDC-0919, which was then called NLG919, to Roche/Genentech . Genetic Engineering & Biotechnology News writes , “The companies reasoned that targeting the IDO and TDO pathways represented a breakthrough approach to fighting cancer, citing earlier studies showing that the IDO pathway was active both within tumor cells as a direct defense against T-cell attack, and within antigen presenting cells in tumor-draining lymph nodes.” John Carroll, writing for Endpoints News , says, “This is the latest in a series of gut punches to NewLink, which was sent reeling last year and was forced to restructure in the wake of the failure of its pancreatic cancer vaccine. IDO, a hot ticket in biotech now with Incyte evidently well in the lead, was supposed to be its path back.” It was only a week ago that NewLink announced that its Phase II trial of indoximod plus taxane chemotherapy, either docetaxel or paclitaxel, did not meet its primary endpoints. The endpoints were a statistically significant difference in progression-free survival versus placebo plus taxane chemotherapy in metastatic breast cancer. “We are obviously disappointed in this decision,” said Charles Link , NewLink Genetics’ chief executive officer, in a statement. “We remain committed to advancing our IDO pathway inhibitor indoximod, which continues to generate exciting data in combination with anti-PD-1 agents, cancer vaccines, and chemotherapy in multiple cancer types including melanoma, prostate cancer, acute myeloid leukemia, and pancreatic cancer.” NewLink Genetics , which had been trending downward since March, took a hard hit and is currently trading for $10.62. Shares traded on March 31 for $24.10, dropped to $15.50 on April 13, climbed back to $19.05 on April 26 before beginning a strong drop. This drop follows only a few days after Michael Uln , an analyst with Baird, gave the stock an “Outperform” rating and a price target of $25 after hosting an investor lunch at ASCO in Chicago. At that time, Baird suggested that the IDO pipeline was underappreciated. Carroll writes, “The writing, though, was on the wall when investigators reported that GDC-0919 delivered only a 10 percent overall response rate in all tumor types in a combination study with Tecentriq—a PD-L1 checkpoint that is also under a cloud since the big Phase III failure in bladder cancer. Genentech is not known for pursuing futile work in cancer.” At one point in April, the idea of Gilead Sciences acquiring NewLink Genetics was floated. Generally, the top suggestion has been Incyte Corporation , at least until its baricitinib for rheumatoid arthritis was rejected by the U.S. Food and Drug Administration (FDA) . The rationale for NewLink was promising interim results from a Phase II trial of indoximod in combination with checkpoint inhibitors to treat advanced melanoma. Incyte’s epacadostat is an IDO inhibitor, and so is NewLink’s indoximod and GDC-0919. But NewLink is a lot less expensive than Incyte—even more so now. Todd Campbell, writing for The Motley Fool in April, said, “Despite the solid showing (of indoximod), many industry watchers believe that apacadostat delivers a better blend of efficacy and safety because it targets IDO directly. Unlike apacadostat, indoximod disables IDO via cell signaling.” But, depending on what NewLink plans to do with their newly reacquired IDO inhibitor, it may be a moot point.

VaccinePhase 2License out/inPhase 3

22 May 2017

·www.biospace.com

6 (Plus 2!) Most Notable ASCO Abstracts So Far

May 22, 2017 By Mark Terry , BioSpace.com Breaking News Staff The American Society of Clinical Oncology (ASCO) meeting is being held in Chicago from June 2 through 6. In preparation, most companies and researchers have already submitted abstracts of presentations and posters, giving everyone interested, including investors, an advanced look at the data. Shanthi Rexaline , writing for Benzinga , takes a look at six notable abstracts—so far. 1. NewLink Genetics Based in Ames, Iowa, NewLink Genetics is presenting data from two clinical trials of its IDO pathway inhibitors, indoximod and navoximod, that are being evaluated in combination therapeutics in multiple solid tumors. GDC-0919 is being tested in a Phase Ib trial with Genentech ’s Tecentriq. Indoximod is being evaluated with Dendreon ’s Provenge in a Phase II trial in patients with metastatic castration resistant prostate cancer. NewLink Genetics is currently trading for $14.78. 2. Incyte Corporation Headquartered in Wilmington, Del., Incyte Corporation is presenting data from its Phase I/II ECHO-204 clinical trial of epacadostat in combination with Bristol-Myers Squibb ’s Opdivo in patients with squamous cell carcinoma of the head and neck (SCCHN), melanoma (MEL), ovarian cancer (OVC), and colorectal cancer (CRC). Rexaline notes that, “New data to be presented by Incyte showed that Epacadostat in combination with Merck & Co ’s PD-1 therapy Keytruda was well tolerated and demonstrated durable clinical responses across multiple solid tumor.” Incyte is currently trading for $131.43. 3. Merus NV Based in Utrecht, the Netherlands, Merus NV will present the results of its first-in-human Phase I/II trial of MCLA-128 in solid tumors, as well as final Phase I data in HER2-positive metastatic breast cancer (MBC) from the Phase II part of the trial. MCLA-127 is designed to block HER3-heregulin-dependent tumor growth and survival in addition to enhancing immune-mediated cytotoxicity in tumors.” Merus is currently trading for $19.78. 4. Syndax Pharmaceuticals Headquartered in Waltham, Mass., Syndax Pharmaceuticals is presenting data fron the ongoing Phase II ENCORE 601 trial of entinostat in combination with Merck’s Keytruda in multiple cancer indications. The poster is titled, “ENCORE 601: A Phase II study of entinostat (ENT) in combination with pembrolizumab (PEMBRO) in patients with melanoma.” Syndax is currently trading for $14.34. 5. CytRx Corporation Based in Los Angeles, Calif., CytRx Corporation is presenting two abstracts, one in an oral presesntation. The first is an update from its Phase III trial of aldoxorubicin versus the investigator’s choice in patients with relapsed and refractory soft tissue sarcomas (STS). The second presentation, a poster, is an update of an ongoing Phase I/II clinical trial combining aldoxorubicin with ifosfamide/mesna (I-M) in first- and second-line soft tissue sarcomas. “In addition to the significantly prolonged progression-free survival achieved by both North American and L-sarcoma patients, the data presented at ASCO this year demonstrate that, unlike any other drugs in this class, aldoxorubicin can be dosed continuously with minimal to no cardiotoxicity,” said Sant Chawla , director of the Sarcoma Oncology Center in Santa Monica, Calif., and principal investigator for the Phase III trial, in a statement. “Another distinct advantage is its ability to be administered to patients who have already been treated with doxorubicin. Taken together, these findings support aldoxorubicin’s potential as a superior anthracycline treatment for patients suffering with these highly complex and difficult to treat types of cancer.” CytRX is currently trading for $0.52. 6. ESSA Pharma Headquartered in Vancouver, Canada, ESSA Pharma is presenting data from the Phase I part of its ongoing Phase I/II clinical trial of EPI-506 in prostate cancer. Abstract 5032 is titled, “Efficacy, safety, tolerability and pharmacokinetics of EPI-506 (ralaniten acetate), a novel androgen receptor (AR) N-terminal domain (NTD) inhibitor, in men with metastatic castration resistant prostate cancer (ImCRPC) progressing after enzalutamide and/or abiraterone.” ESSA is currently trading for $2.29. Rexaline also offers up to other companies, Leap Therapeutics , which is releasing positive interim data from a Phase I trial of DKN-01 in combination with chemotherapy for advanced biliary tract cancers, and ImmunoGen , which is presenting top-line data from a Phase I trial of mirvetuximab soravtansine in ovarian cancer.

Phase 1ASCOPhase 2Phase 3Clinical Result

100 Deals associated with Navoximod

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KEGG	Wiki	ATC	Drug Bank
D11255	-	-	DB15439

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Melanoma	Phase 1	United States	Genentech, Inc.	28 Jul 2015
Melanoma	Phase 1	France	Genentech, Inc.	28 Jul 2015
Melanoma	Phase 1	South Korea	Genentech, Inc.	28 Jul 2015
Melanoma	Phase 1	Spain	Genentech, Inc.	28 Jul 2015
Non-Small Cell Lung Cancer	Phase 1	United States	Genentech, Inc.	28 Jul 2015
Non-Small Cell Lung Cancer	Phase 1	France	Genentech, Inc.	28 Jul 2015
Non-Small Cell Lung Cancer	Phase 1	South Korea	Genentech, Inc.	28 Jul 2015
Non-Small Cell Lung Cancer	Phase 1	Spain	Genentech, Inc.	28 Jul 2015
Renal Cell Carcinoma	Phase 1	United States	Genentech, Inc.	28 Jul 2015
Renal Cell Carcinoma	Phase 1	France	Genentech, Inc.	28 Jul 2015

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02471846 (Pubmed \| Clin Cancer Res) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	157	Navoximod +Atezolizumab	csngrpzbxh(ervtijrdvn) = fatigue 22%, rash 22%, and chromaturia 20% clwmgqlnjt (tdbdusmmfz )	Positive	01 Jun 2019
NCT02048709 (Pubmed \| J Immunother Cancer) Manual	Phase 1	HR-positive/HER2-low Solid Tumors	22	GDC-0919	ccmihnhulc(wrvmpulxqy) = ylrjbfpqwa zndzbvmflm (zyovtfdbhm ) View more	Positive	20 Jun 2018
NCT02471846 (ASCO 12017 \| ASCO 22017) Manual	Phase 1	Solid tumor	52	GDC-0919+Atezolizumab	fnecwdagdc(sbuwmxwytd) = dykgbnkydp zdtjxcvzkp (infcizutqs ) View more	Positive	04 Jun 2017

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