Delving into the Latest Updates on ImmVirX Pty Ltd. with Synapse

Overview

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ImmVirX Pty Ltd. is an Australian company located in New Lambton Heights. The firm develops oncotic viral immunotherapy. It was founded in 2019 by Darren Shafren and Malcolm L. McColl.

Tags

Endocrinology and Metabolic Disease

Digestive System Disorders

Neoplasms

Oncolytic virus

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Disease Domain	Count

Endocrinology and Metabolic Disease	1
Neoplasms	1

Top 5 Drug Type	Count

Oncolytic virus	1

This is a Phase 1 open-label, non-randomized, multi-center clinical trial of intratumoral IVX037 as monotherapy and in combination with an immune checkpoint inhibitor in patients with advanced micro satellite-stable (MSS) colorectal cancer, or gastric or ovarian cancer.
The study is run in 2 parts. Phase 1a is dose escalation IVX037 monotherapy and Phase 1b is IVX037 with checkpoint inhibitor, sintilimab.

Start Date17 Feb 2023

Sponsor / Collaborator

ImmVirX Pty Ltd.

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100 Clinical Results associated with ImmVirX Pty Ltd.

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0 Patents (Medical) associated with ImmVirX Pty Ltd.

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1

Literatures (Medical) associated with ImmVirX Pty Ltd.

01 Jul 2021·Cancer Research

Abstract CT139: Intratumoral oncolytic virus V937 in combination with pembrolizumab (pembro) in patients (pts) with advanced melanoma: Updated results from the phase 1b CAPRA study

Author: Zambrano-Acosta, Edwin ; Shafren, Darren ; Wu, Cai ; Guerreiro, Leslie ; Palmeri, Marisa ; Kaufman, Howard L. ; Bryan, Jennifer ; Grose, Mark ; Zloza, Andrew ; Bommareddy, Praveen K. ; Vieth, Joshua A. ; Medina, Daniel ; Fein, Seymour ; Norrell, Jacqueline T. ; Silk, Ann W. ; O'Day, Steven J. ; Imbergamo, Casey ; Fox, Bernard A. ; Ballesteros-Merino, Carmen ; Mehnert, Janice M. ; Portal, Daniella

AbstractBackground: Coxsackievirus A21 (V937) is an RNA oncolytic virus targeting ICAM-1 receptors. Pharmacodynamic effects of oncolytic viruses in the tumor microenvironment (TME), including increased CD8+ T cells and PD-L1 expression, support their use in combination with checkpoint inhibitors. We present updated clinical and correlative data from the multicenter phase 1b CAPRA study (NCT02565992) of V937 + pembro in pts with advanced melanoma. Methods: Eligible pts had metastatic/unresectable stage IIIB-IV melanoma and ≥1 cutaneous/subcutaneous tumor or lymph node amenable to V937 intratumoral injection. Pts received V937 on days 1, 3, 5, and 8; then Q3W for up to 19 injections (maximum dose, 3 × 108 50% TCID50). Pts received IV pembro 2 mg/kg Q3W on day 8, continuing for up to 2 y. Primary endpoints were incidence of AEs, serious AEs (SAEs), and dose-limiting toxicities (DLTs). Secondary endpoints were ORR, duration of response (DOR), PFS, and OS. Biomarkers were an exploratory endpoint. Results: 36 pts were enrolled (mean age, 68.5 y; 75% male; 22% had prior immunotherapy). As of 4 Nov 2019, median (range) time from first dose to data cutoff was 32.0 (10.7−45.3) mo. No DLTs occurred. Grade 3-5 treatment-related AEs occurred in 5 (14%) pts. 3 (8%) pts had treatment-related SAEs (autoimmune encephalitis and septic shock in 1 pt, keratoacanthoma, autoimmune hepatitis); 1 died from septic shock. Efficacy results included ORR of 47% (CR, 22%; PR, 25%; Table 1). In comparing responders vs nonresponders, baseline tumor samples showed no difference in PD-L1 expression and lower CD3+CD8- infiltrate in responders. Conclusions: V937 + pembro had manageable safety and promising efficacy in pts with advanced melanoma. Response was not associated with an inflamed TME at baseline, indicating that V937 may induce an immune responsive TME. The combination is being studied in the neoadjuvant setting in pts with stage III melanoma (KEYMAKER-U02).Table 1.Efficacy OutcomesV937 + Pembro (N = 36)ORR,a % (95% CI)b47 (30-65)- CR22 (10-39)- PR25 (12-42)DOR,c median (range), moNR (1.4+ to 22.0+)PFS,c,d median (95% CI), mo11.9 (3.4-NR)12-mo PFS,c % (95% CI)45 (28-60)OS,c median (95% CI), mo30.9 (20.3-40.5)12-mo OS,c % (95% CI)85 (68-94)+ indicates no PD by the time of last disease assessment. NR, not reached.aBest overall response with confirmation based on investigator assessment per immune-related response criteria; imaging was performed Q6W.bBased on the exact method for binomial data.cKaplan-Meier estimate.dBased on investigator assessment per immune-related response criteria.Citation Format: Ann W. Silk, Steven J. O'Day, Howard L. Kaufman, Jennifer Bryan, Jacqueline T. Norrell, Casey Imbergamo, Daniella Portal, Edwin Zambrano-Acosta, Marisa Palmeri, Seymour Fein, Cai Wu, Leslie Guerreiro, Daniel Medina, Praveen K. Bommareddy, Andrew Zloza, Bernard A. Fox, Carmen Ballesteros-Merino, Darren Shafren, Mark Grose, Joshua A. Vieth, Janice M. Mehnert. Intratumoral oncolytic virus V937 in combination with pembrolizumab (pembro) in patients (pts) with advanced melanoma: Updated results from the phase 1b CAPRA study [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2021; 2021 Apr 10-15 and May 17-21. Philadelphia (PA): AACR; Cancer Res 2021;81(13_Suppl):Abstract nr CT139.

100 Deals associated with ImmVirX Pty Ltd.

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100 Translational Medicine associated with ImmVirX Pty Ltd.

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

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

Phase 1 Clinical

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