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Digestive System Disorders

Neoplasms

Oncolytic virus

Disease domain score

A glimpse into the focused therapeutic areas

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Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Neoplasms	3

Top 5 Drug Type	Count

Oncolytic virus	3

Top 5 Target	Count

GPC3(Glypican-3)	2
CTNNB1 x GPC3	1

AbstractIntroduction:Oncolytic viral therapies (OVTs) have shown promise in cancer treatment, though efficacy and selectivity challenges remain. HGI627 is an engineered vesicular stomatitis virus (VSV) featuring a synthetic glycoprotein retargeted to glypican-3 (GPC3) and a beta-catenin (CTNNB1)-dependent aptazyme as a genetic ON switch. This dual targeting strategy enhances specificity to liver cancer cells.Methods:HGI627 was constructed and rescued using a synthetic virology platform [Moles et al., Viruses 2024], and viral titers were measured by TCID50 assay on Hep3B cells. Cytotoxicity and selectivity were evaluated using real-time imaging (IncuCyte system) on liver cancer (e.g. Hep3B), off-target (e.g. SW-480), and normal (e.g. THLE-2) cells. To further evaluate this virus in vivo, an efficacy study performed in Hep3B xenograft-bearing NSG mice. To evaluate potential acute toxicity and maximum tolerated dose (MTD), a study in NSG mice (n=5/group) was then conducted using single and multiple 1x109 TCID50 doses.Results:HGI627 demonstrated robust lytic activity in vitro at low MOIs (0.01) in GPC3+/CTNNB1+ cells with minimal to no cytotoxicity in off-target and normal cells at MOI=10. In vivo, a single intraperitoneal (i.p.) injection of 1×10 TCID50 HGI627 (n=9) achieved a 100% complete response and significantly extended survival to day 49 (end of study) compared to median survival of 15 days in vehicle group (p<0.005). In the safety study, even multiple (n=3) high-dose (1×10 TCID50) administrations of HGI627 were well tolerated, and no signs of clinical toxicity were observed up to 14 days; Importantly, this highest dosing group received an equivalent of >100× the proposed first-in-human starting dose without adverse effects.Conclusion:These results highlight HGI627's potency, selectivity, and safety, overcoming previous OVT challenges. HGI627 exemplifies a promising approach for liver cancer treatment using a dual-targeting mechanism for enhanced precision. Current studies include an orthotopic HepG2-luciferase model to further validate efficacy.Citation Format:Chad M. Moles, Rupsa Basu, Brenda Ho, Manal Farhat, Jason Kent, Peter Weijmarshausen, Bruce F. Smith, Michael A. Whitt. Novel oncolytic virus targeting GPC3 and CTNNB1 demonstrates complete response in hepatocellular carcinoma (HCC) xenograft with a single, systemic administration [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 946.

International Review of Cell and Molecular Biology

Rational selection of an ideal oncolytic virus to address current limitations in clinical translation

Author: Moles, Chad M. ; Basu, Rupsa

Oncolytic virus therapy (OVT) is a promising modality that leverages the propensity of natural or engineered viruses to selectively replicate in and kill cancer cells.Over the past decade, (pre)clin. studies have focused on the development and testing of adenovirus, herpes simplex virus, and vaccinia virus-based vectors.These studies have identified barriers to success confronting the field.Here, we propose a set of selection criteria or ideal properties of a successful oncolytic virus, which include lack of pathogenicity, low seroprevalence, selectivity (infection and replication), transgene carrying capacity, and genome stability.We use these requirements to analyze the oncolytic virus landscape, and then identify a potentially optimal species for platform development - vesicular stomatitis virus.

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Pipeline

Pipeline Snapshot as of 20 Dec 2025

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

HG001(Humane Genomics ) ( GPC3 )	Liver Cancer More	Preclinical
HGI-498 ( GPC3 )	Liver Cancer More	Preclinical
HGI627 ( CTNNB1 x GPC3 )	Hepatocellular Carcinoma More	Preclinical