This is a phase 1, open-label, multicenter dose-escalation study to determine the RP2D of CI 8993 for administration to patients with relapsed/refractory solid tumors by evaluating the safety and tolerability and characterizing the PK, PD, and anti cancer activity of CI-8993 in this population.

Start Date22 Sep 2020

Sponsor / Collaborator

Curis, Inc.

NCT02671955

/ TerminatedPhase 1

An Open-label, First-in-Human, Phase 1 Study of the Safety, Pharmacokinetics, and Pharmacodynamics of JNJ-61610588, a Fully Human IgG1 Kappa Anti-VISTA (V-domain Ig Suppressor of T-cell Activation) Monoclonal Antibody, in Subjects With Advanced Cancer

The purpose of this study is to evaluate the safety and tolerability of JNJ-61610588 in participants with advanced cancer in order to determine a recommended Phase 2 dose (RP2D) for further evaluation in specific tumor types.

Start Date01 Jan 2016

Sponsor / Collaborator

Janssen Research & Development LLC

100 Clinical Results associated with Onvatilimab

100 Translational Medicine associated with Onvatilimab

100 Patents (Medical) associated with Onvatilimab

Literatures (Medical) associated with Onvatilimab

01 Jan 2026·BMJ oncology

First-in-human phase 1 dose-escalation study of W0180, an anti-VISTA monoclonal antibody, with and without pembrolizumab in patients with locally advanced or metastatic solid tumours

Article

Author: Jegou, David ; Gueguen-Dorbes, Geneviève ; Primard, Marie ; Marabelle, Aurélien ; Cassier, Philippe Alexandre ; Pétain, Aurélie ; Dupuy, Elena ; Gomez-Roca, Carlos ; Saccareau, Mathilde ; Danlos, Francois-Xavier ; Fabre, Claire ; Castañón Álvarez, Eduardo ; Champiat, Stéphane ; Melero, Ignacio

Objective:

W0180 is a humanised IgG1κ antagonistic monoclonal antibody against the V domain-containing immunoglobulin suppressor of T-cell activation (VISTA) designed to enhance antitumour activities by inhibiting the immunosuppressive role of VISTA in myeloid cells and T cells in solid tumours.

Methods and analysis:

Preclinical experiments evaluated the pharmacodynamics and antitumour activity of W0180. A first-in-human phase 1 dose-escalation study investigated the maximum tolerated dose (MTD), safety/tolerability, preliminary efficacy, pharmacokinetics and pharmacodynamics of W0180, both as monotherapy and in combination with pembrolizumab (an anti-programmed cell death protein-1 (PD-1) therapy), with the aim of establishing a recommended dose for expansion (RDE). In the monotherapy arm, cohorts of patients with locally advanced/metastatic solid tumours received once-weekly W0180 at increasing doses (from 3.5 to 600 mg). In the combination therapy arm, patients with relapsed/refractory, advanced/metastatic solid tumours and ≥1 prior anti-PD (ligand)-1 therapy line received W0180 (60 or 300 mg)+pembrolizumab.

Results:

W0180 exhibited pH-independent blockade of the VISTA-ligand interaction in vitro and showed antitumour activity in a syngeneic preclinical murine model expressing human VISTA. In the phase 1 study, of the 33 patients in the monotherapy (n=24) or combination therapy (n=9) arms, 28 contributed to dose determination. Dose-limiting toxicities were Grade 2 cerebral infarction and Grade 3 infusion-related reaction (IRR; n=1 each). The study was terminated prematurely in the dose-escalation phase (due to a business decision by the sponsor) before the MTD/RDE was reached. Common related treatment-emergent adverse events were IRR and fatigue; most were of mild severity. No patients achieved Response Evaluation Criteria in Solid Tumours objective response; two had prolonged stable disease (SD; one from each arm). Biomarker analysis suggested a dose-dependent pharmacodynamic effect of W0180.

Conclusion:

W0180 demonstrated manageable safety, preliminary signs of clinical activity with prolonged SD and dose-dependent pharmacodynamics consistent with preclinical data (even though MTD was not reached) in patients with locally advanced/metastatic tumours, both as monotherapy and in combination with anti-programmed cell death protein-1 therapy.

Trial registration number:

NCT04564417 .

01 Jul 2025·Cell Reports

VISTA immune checkpoint blunts radiotherapy-induced antitumor immune response

Article

Author: Boyd-Kirkup, Jerome D ; Frank, Jessica ; Cochran, Jennifer R ; Laseinde, Eyiwunmi Eghonghon ; Dharmadhikari, Bhushan ; Islam, Md Tauhidul ; Nambiar, Dhanya K ; Wang, Xiao-Jing ; Kong, Christina ; Mehta, Nishant ; Divi, Vasu ; Cheunkarndee, Tia ; Aleman, John ; Real, Alexander ; Thakkar, Dipti ; Sunwoo, John B ; Finegersh, Andrey ; Liu, Junyan ; Cao, Hongbin ; Xing, Lei ; Langthasa, Jimpi ; Maddineni, Sainiteesh ; Viswanathan, Vignesh ; Le, Quynh-Thu

Radiotherapy (RT) is a key treatment for solid neoplasms like head and neck cancer (HNC), but it can also activate and recruit immunosuppressive myeloid cells, causing treatment failure. In this study, we examine the role of V-domain immunoglobulin suppressor of T cell activation (VISTA) on myeloid cells during RT. We discovered high VISTA expression on myeloid cells in the tumor microenvironment (TME) of both murine and human HNC, with RT increasing VISTA⁺ myeloid cells in the TME and circulation. Compared to VISTA^+/+ mice, VISTA^-/- mice showed improved tumor control with RT, with their macrophages and neutrophils exhibiting antitumorigenic properties on sc-RNA-seq analysis, especially with RT. Combining anti-VISTA antibodies (active or silent Fc) with RT (fractionated or ablative) significantly decreased tumor volume compared to either treatment alone in multiple preclinical models (HNC, breast cancer, and colorectal cancer), enhancing systemic antitumor immune response with augmented intra-tumoral T cell function through myeloid repolarization. Targeting VISTA could improve the efficacy of RT.

01 Dec 2023·International immunopharmacology

VISTA blockade alleviates immunosuppression of MDSCs in oral squamous cell carcinoma

Article

Author: Yu, Hai-Jun ; Liu, Jie ; Xiao, Yao ; Sun, Zhi-Jun ; Yang, Qi-Chao ; Lin, Wen-Ping ; Bushabu Fidele, Nyimi

V-domain Ig suppressor of T-cell activation (VISTA) is a novel immune checkpoint regulator that can inhibit T cell-mediated antitumor immunity. Although the use of anti-VISTA monoclonal antibody has demonstrated encouraging outcomes in the therapy of various malignancies, its specific impact and underlying mechanisms in oral squamous cell carcinoma (OSCC) remain to be explored. In this work, we analyzed human OSCC tissue microarrays, human peripheral blood mononuclear cells, and immunocompetent transgenic mouse models to investigate the relationship between high VISTA expression and markers of myeloid-derived immunosuppressive cells (MDSCs; CD11b, CD33, Arginase-1), tumor-associated macrophages (CD68, CD163, CD206), and T cell function (CD8, PD-L1, Granzyme B). In OSCC, we discovered that VISTA was highly expressed and stably expressed in MDSCs. Furthermore, we established a mouse OSCC orthotopic xenograft tumor model to investigate the impact of VISTA blockade on the tumor microenvironment. We found that VISTA blockade reduces the immunosuppressive microenvironment and delays tumor growth. This is achieved by suppressing the quantity and function of MDSCs while boosting the function of tumor-infiltrating T cells. Our research indicated that VISTA expressed by MDSCs has a crucial function in the progression of OSCC and that VISTA blockade therapy is a promising immune checkpoint blockade therapy.

News (Medical) associated with Onvatilimab

26 Jun 2025

·www.fiercebiotech.com

Hummingbird uses VISTA buzz to secure $290M pact for phase 2-ready tumor drug

Hummingbird Bioscience has taken its monoclonal antibody HMBD-002 through a phase 1 study in the U.S.\n Hummingbird Bioscience could one day feather its nest with up to $290 million if its decision to license a phase 2-ready cancer drug to Percheron Therapeutics pays off.In return for up to $290 million in upfront and potential milestone payments—Hummingbird didn’t offer a breakdown of the financial details—Percheron has received the license to HMBD-002, an anti-VISTA monoclonal antibody designed to inhibit tumor growth.Hummingbird has already taken the monoclonal antibody through a phase 1 study in the U.S., which “showed the drug to be pharmacologically active and generally safe and well-tolerated,” according to the June 25 post-market release.Percheron’s CEO James Garner said the Australian biotech selected HMBD-002 “out of more than a hundred individual drug candidates from more than 70 companies.”“We very much hope that this exciting program can bring meaningful benefit to patients confronting the enormous challenge of a cancer diagnosis,” said Garner, who is looking to launch a phase 2 study next year.Researchers have previously shown that VISTA, which stands for V-type immunoglobulin domain-containing suppressor of T-cell activation, is a checkpoint inhibitor present on naïve T cells, maintaining their dormancy and tolerance of self-antigens. HMBD-002 has been engineered to inhibit VISTA and neutralize its immunosuppressive activity while allowing VISTA-expressing cells to continue to function effectively in the immune system. “Given the potential benefits of VISTA blockade in multiple cancers that have strong evidence of VISTA-mediated immune suppression, HMBD-002 is a scientifically compelling asset for both monotherapy and combination approaches,” Hummingbird CEO Piers Ingram, Ph.D., said in the release.“We have confidence in the potential clinical benefit of HMBD-002 and in Percheron’s ability to successfully progress HMBD-002 through the clinic,” Ingram added.Johnson & Johnson had been interested in VISTA at one point, teaming up with ImmuNext on an anti-VISTA antibody called JNJ-61610588 before returning the rights to the biotech for what it called “business reasons\" after a phase 1 study saw one patient experience side effects related to cytokine release syndrome.ImmuNext has since found a new partner in Curis, which took the drug into the clinic for solid tumor patients. Meanwhile, Sensei Biotherapeutics said a phase 1/2 readout of its own anti-VISTA antibody in 2023 showed the candidate had “potentially best-in-class pharmacokinetics and encouraging cytokine release profile across multiple dose cohorts.”

Phase 1License out/inImmunotherapyADC

26 Jun 2025

·pipelinereview.com

Hummingbird Bioscience Licenses HMBD-002, Phase II-Ready Anti-VISTA Monoclonal Antibody to Percheron Therapeutics

SINGAPORE I June 26, 2025 I Hummingbird Bioscience, a biotherapeutics company discovering and developing transformative medicines for hard-to-treat diseases, today announced that it has granted Percheron Therapeutics Limited (ASX: PER) an exclusive worldwide license to develop, manufacture, and commercialize HMBD-002 in all territories and indications. Under the terms of the agreement, Hummingbird Bioscience will be eligible to receive up to USD 290 million in upfront and milestone payments, plus royalties on net sales. HMBD-002 is a monoclonal antibody therapy targeting VISTA, a novel checkpoint involved in the body’s immune response to cancer. HMBD-002 has successfully completed a phase I clinical trial in the United States, under an Investigational New Drug application with the US Food and Drug Administration, which showed the drug to be pharmacologically active and generally safe and well-tolerated. Percheron Therapeutics aims to continue clinical development of HMBD-002 in CY2026. “Given the potential benefits of VISTA blockade in multiple cancers that have strong evidence of VISTA-mediated immune suppression, HMBD-002 is a scientifically compelling asset for both monotherapy and combination approaches. We are pleased to have Percheron Therapeutics continue the clinical development of HMBD-002,” said Piers Ingram, PhD, co-founder and Chief Executive Officer of Hummingbird Bioscience. “We have confidence in the potential clinical benefit of HMBD-002 and in Percheron’s ability to successfully progress HMBD-002 through the clinic.” “Hummingbird Bioscience lies at the cutting edge of novel drug design, and we are delighted to partner with them to take forward this very promising drug candidate,” said Dr. James Garner, Chief Executive Officer of Percheron Therapeutics. “We selected HMBD-002 out of more than a hundred individual drug candidates from more than seventy companies, and we very much hope that this exciting program can bring meaningful benefit to patients confronting the enormous challenge of a cancer diagnosis.” About HMBD-002 HMBD-002 is a novel anti-VISTA neutralizing antibody, and the only IgG4 isotype anti-VISTA antibody currently in development. HMBD-002 was engineered to bind to VISTA at a specific site that is predicted to be essential for ligand binding and function, thus inhibiting VISTA and neutralizing its immunosuppressive activity without depleting VISTA-expressing cells that play many important roles in the immune system. About Hummingbird Bioscience Hummingbird Bioscience is a biotherapeutics company working at the interface of artificial intelligence and human innovation to discover and develop transformative medicines for hard-to-treat diseases. Hummingbird Bioscience’s computational and systems biology technologies have generated a pipeline of innovative clinical-stage monoclonal antibodies and antibody-drug conjugates in oncology and autoimmunity. At Hummingbird Bioscience, the commitment to rigorous science, teamwork, and intellectual integrity underpins our passion to accelerate the journey of new drugs from concept to clinic. For more information, please visit www.hummingbirdbioscience.com , and follow Hummingbird Bioscience on LinkedIn , X (formerly Twitter) , and YouTube . About Percheron Therapeutics Limited Percheron Therapeutics Limited [ASX: PER | US OTC: PERCF] is a publicly listed biotechnology company focused on the development and commercialization of novel therapies for oncology and rare diseases. The company’s lead program is HMBD-002, a monoclonal antibody targeting the immune checkpoint regulator, VISTA. HMBD-002 has completed a phase I clinical trial in patients with advanced cancer, which has shown the drug to be generally safe and well-tolerated. For more information, please contact info@PercheronTx.com . SOURCE: Hummingbird Bioscience

Phase 1License out/inADC

06 Oct 2023

·www.biospace.com

Curis Reports Inducement Grants Under NASDAQ Listing Rule 5635(c)(4) - October 06, 2023

LEXINGTON, Mass., Oct. 6, 2023 /PRNewswire/ -- Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, today announced that on October 2, 2023, the independent Compensation Committee of the Board of Directors of Curis approved the grant of inducement stock options to purchase a total of 11,340 shares of Curis common stock to two new employees, with a grant date of October 2, 2023 (the "Q4 2023 Inducement Grants"). Each of the Q4 2023 Inducement Grants has an exercise price per share equal to the closing price of the Company's common stock on October 2, 2023. Each stock option has a 10 year term and vests over four years, with 25% of the original number of shares underlying the award vesting on the first anniversary of the employee's date of hire and an additional 6.25% of the original number of shares underlying the award vesting on each successive three-month period thereafter, subject to the employee's continued service with the Company through the respective vesting dates. Each stock option was granted as an inducement equity award outside of the Company's Fourth Amended and Restated 2010 Stock Incentive Plan and was made as an inducement material to the employee's acceptance of employment with the Company. About Curis, Inc. Curis is a biotechnology company focused on the development of emavusertib, an orally available, small molecule IRAK4 inhibitor for the treatment of hematologic malignancies. In 2015, Curis entered into a collaboration with Aurigene in the areas of immuno-oncology and precision oncology. As part of this collaboration, Curis has exclusive licenses to oral small molecule antagonists of immune checkpoints including the VISTA/PDL1 antagonist CA-170, and the TIM3/PDL1 antagonist CA-327, as well as the IRAK4 kinase inhibitor, emavusertib (CA-4948). Emavusertib is currently undergoing testing in the Phase 1/2 TakeAim Lymphoma trial in patients with hematologic malignancies, such as non-Hodgkin's lymphoma and other B cell malignancies, both as a monotherapy and in combination with BTK inhibitor ibrutinib, and the Phase 1/2 TakeAim Leukemia trial in patients with acute myeloid leukemia and myelodysplastic syndrome, for which it has received Orphan Drug Designation from the U.S. Food and Drug Administration. In addition, Curis is engaged in a collaboration with ImmuNext for development of CI-8993, a monoclonal anti-VISTA antibody. Curis is also party to a collaboration with Genentech, a member of the Roche Group, under which Genentech and Roche are commercializing Erivedge® for the treatment of advanced basal cell carcinoma. For more information, visit Curis's website at . View original content to download multimedia: SOURCE Curis, Inc. Company Codes: NASDAQ-NMS:CRIS

ImmunotherapyOrphan DrugLicense out/in

100 Deals associated with Onvatilimab

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	United States	Curis, Inc.	22 Sep 2020
Advanced Malignant Solid Neoplasm	Phase 1	Australia	Curis, Inc.	22 Sep 2020
Solid tumor	Phase 1	United States	ImmuNext, Inc.	27 Aug 2020
Advanced cancer	Phase 1	United States	Janssen Research & Development LLC	01 Jan 2016

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