Delving into the Latest Updates on OVV-01 with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine, Oncolytic virus

Synonyms

C045, OVV 01, OVV-1

Target

NY-ESO-1

Action

inhibitors

Mechanism

NY-ESO-1 inhibitors(Cancer/testis antigen 1 inhibitors)

Therapeutic Areas

NeoplasmsOther Diseases

Active Indication

Soft Tissue Sarcoma

Inactive Indication-

Originator Organization

Shanghai Joint Biosciences Ltd.

Active Organization

Shanghai Joint Biosciences Ltd.

Inactive Organization-

License Organization-

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

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Phase Ia: To investigate the safety, tolerability and efficacy of OVV-01 injection in the treatment of patients with advanced solid tumors (OVV-01 single dose gradient exploration).
Phase Ib: To evaluate the safety, tolerability and efficacy of OVV-01 injection combined with immune checkpoint inhibitors pembrolizumab (anti-PD-1 monoclonal antibody) or atezolizumab (anti-PD-L1 monoclonal antibody) in the treatment of patients with advanced solid tumors (OVV-01 combined with PD-1/PD-L1 monoclonal antibody dose gradient exploration);
Phase Ic: A cohort expansion of Phase Ib to further analyze the efficacy and safety of OVV-01 injection combined with immune checkpoint inhibitor injection in the treatment of advanced solid tumors.

Start Date16 Feb 2021

Sponsor / Collaborator

Joint Biosciences （HK） Limited

100 Clinical Results associated with OVV-01

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100 Translational Medicine associated with OVV-01

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100 Patents (Medical) associated with OVV-01

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1

Literatures (Medical) associated with OVV-01

01 Jun 2025·Journal for ImmunoTherapy of Cancer

Phase 1, open-label, multicenter, dose escalation safety and tolerability study of oncolytic virus OVV-01 in advanced solid tumors

Article

Author: Ma, Liang ; Wang, Shuhang ; Li, Ning ; Yuan, Ruirong ; Hua, Yingqi ; Wang, Chongren ; Wu, Hui ; Yuan, Peng ; Zhou, Guoqing ; Han, Yanjie ; Lu, Yinying ; Lv, Yu ; Zuo, Dongqing ; Li, Fan ; Lin, Qiang ; Zhang, Fan ; Sun, Mengxiong ; Wang, Yan

Background:

OVV-01 is a genetically engineered vesicular stomatitis virus oncolytic virus designed to selectively amplify in tumor cells and express tumor-associated antigen NY-ESO-1. This study was designed to evaluate the safety, tolerability, and efficacy of OVV-01 in patients with advanced solid tumors.

Methods:

This is a phase 1, first-in-human, open-label, multicenter study of OVV-01 in patients with advanced solid tumors. OVV-01 was intratumorally injected biweekly (every two weeks, Q2W), 3 weeks after the first dose for a total of six doses. Dose escalation follows a 3+3 design at four doses of 6×107Plaue-Forming Unit (PFU), 6×108PFU, 6×109PFU, and 1.2×1011PFU. The primary endpoints were safety and tolerability. The second endpoints included overall response rate (ORR) and disease control rate (DCR) of OVV-01, by investigators per Response Evaluation Criteria in Solid Tumors V.1.1.

Results:

18 patients were enrolled into four dose groups, among whom 6 were soft tissue sarcoma (STS). No dose-limiting toxicities and treatment-related severe adverse events were observed. 11 patients were evaluated for efficacy, and the ORR was 27.3%, and the DCR was 63.6%. Among the four evaluable patients with advanced STS, the ORR was 75%. Two patients with STS achieved CR at doses above 6.0×109 PFU.

Conclusions:

The intratumor injection of OVV-01 was safe and well-tolerated in patients with advanced solid tumors. A significant response was observed in patients with STS.

Trial registration number:

NCT04787003.

100 Deals associated with OVV-01

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Soft Tissue Sarcoma	Phase 2	China	Shanghai Joint Biosciences Ltd.	-

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04787003 (Phase 1, Pubmed \| J Immunother Cancer)	Phase 1	Advanced Malignant Solid Neoplasm NY-ESO-1	18	OVV-01 6×10^7 PFU	yhqkzkpokl(jewkntxvot) = ystioafort tlzmgayidu (jvddxmmpss ) View more	Positive	01 Jun 2025
				OVV-01 1.2×10^11 PFU	oaxltvlbmp(avnepwbafu) = dgarwafnbj rnqgcmento (ydwcbtispr )
NCT04787003 (ESMO2024) Manual	Phase 1	Advanced Malignant Solid Neoplasm \| Soft Tissue Sarcoma	18	OVV-01 3×10^7 PFU	bnrkisdlpn(hnpgtxfpdi) = not observed xggiyrspzl (bmxodayjwt ) View more	Positive	16 Sep 2024
				OVV-01 3×108 PFU