[Translation] Phase IIa clinical study of a single-dose per cycle recombinant human IL-21 oncolytic poxvirus injection (hV01) in the treatment of patients with advanced sarcoma and cervical cancer

主要目的：评价hV01每周期单次瘤内注射治疗晚期肉瘤、宫颈癌的初步有效性。次要目的：进一步评价hV01每周期单次瘤内注射给药的安全性。探索性目的：探索外周血免疫相关指标的改变与疗效的相关性。

[Translation]

Primary purpose: To evaluate the preliminary effectiveness of hV01 single intratumoral injection per cycle in the treatment of advanced sarcoma and cervical cancer. Secondary purpose: To further evaluate the safety of hV01 single intratumoral injection per cycle. Exploratory purpose: To explore the correlation between changes in peripheral blood immune-related indicators and efficacy.

Start Date09 Apr 2025

Sponsor / Collaborator

Hangzhou Converd Co., Ltd.

NCT05914376

/ RecruitingPhase 1

A Phase I Dose Escalation Study to Evaluate the Safety, Tolerance, Pharmacokinetics, and Biological Properties of Recombinant Human IL-21-expressing Oncolytic Vaccinia Virus Injection (hV01) in Patients With Advanced Malignant Solid Tumors

The goal of this clinical trial is to evaluate the safety, tolerance, pharmacokinetics, and biological properties of recombinant human IL-21-expressing oncolytic vaccinia virus injection (hV01) in patients with advanced solid tumors.

Start Date05 Jul 2023

Sponsor / Collaborator

Hangzhou Converd Co., Ltd.

CTR20231668

/ RecruitingPhase 1

评价重组人IL-21溶瘤痘病毒注射液（hV01）治疗对标准治疗无效或失败的晚期恶性实体瘤的安全性、耐受性、药代动力学特征和生物学作用的剂量递增I期临床研究。

[Translation] A dose-escalation Phase I clinical study to evaluate the safety, tolerability, pharmacokinetic characteristics and biological effects of recombinant human IL-21 oncolytic poxvirus injection (hV01) in the treatment of advanced malignant solid tumors that are ineffective or have failed standard treatment.

主要目的： 1. 评价hV01治疗末线晚期恶性实体瘤的安全性和耐受性； 2. 探索hV01的最大耐受剂量（MTD），确定Ⅱ期临床试验的推荐剂量（RP2D）。次要目的： 1. 初步评价hV01瘤内注射给药的药代动力学（PK）特征及病毒排出情况； 2. 初步评价hV01瘤内注射给药治疗末线晚期恶性实体瘤的有效性（根据RECIST v1.1和iRECIST标准）。

[Translation]

Primary objectives: 1. To evaluate the safety and tolerability of hV01 in the treatment of terminal advanced malignant solid tumors; 2. To explore the maximum tolerated dose (MTD) of hV01 and determine the recommended dose (RP2D) for Phase II clinical trials. Secondary objectives: 1. To preliminarily evaluate the pharmacokinetic (PK) characteristics and viral excretion of hV01 after intratumoral injection; 2. To preliminarily evaluate the effectiveness of hV01 intratumoral injection in the treatment of terminal advanced malignant solid tumors (according to RECIST v1.1 and iRECIST standards).

Start Date05 Jul 2023

Sponsor / Collaborator

Hangzhou Converd Co., Ltd.

100 Clinical Results associated with Hangzhou Converd Co., Ltd.

0 Patents (Medical) associated with Hangzhou Converd Co., Ltd.

Literatures (Medical) associated with Hangzhou Converd Co., Ltd.

21 Apr 2025·Cancer Research

Abstract 957: A novel therapeutic modality integrating antibody therapy and oncolytic virotherapy for enhanced tumor targeting and treatment

Author: Cheng, Hongjie ; Cai, Jinlu ; Jiang, Mengshi ; Zhang, Yang ; Chen, Can ; Liu, Mengmeng ; Ding, Lieming ; Hu, Fang ; Xu, Wenxin ; Xu, Deyu ; Zheng, Huan ; Xu, Jieying ; Zhang, Li

AbstractBackground:In contemporary oncopharmacology, antigenic targets remain a pivotal focus, especially within the realm of immunotherapy, where tumor-specific antigens are of critical importance. Extensive research on these antigens has spurred the development of innovative therapeutic modalities, such as antibody therapies, CAR-T/NK cell therapies, XDC conjugate drug therapies, tumor neoantigen therapies, and gene therapies. However, these therapeutic strategies encounter significant challenges related to antigen target specificity. Although engineered antigen-targeting drugs typically provide high specificity and low toxicity, they can still disrupt normal signaling pathways and produce off-target effects, leading to adverse reactions that may compromise treatment duration and patient outcomes.To mitigate these challenges, we have devised a novel oncological strategy that synergizes antibody therapy with oncolytic virotherapy. This approach uses a genetically modified oncolytic virus to present a human-absent antigen on the surface of tumor cells, which is then targeted by a CD3 bispecific antibody to achieve the desired therapeutic effect. This combinatorial approach could expand treatment options for cancer patients, especially those with resistant tumors. It may also alter the tumor microenvironment, creating a bystander effect that boosts treatment effectiveness.Methods:Through comprehensive mega data analytics, non-primate endogenous antigenic proteins were identified. Advanced genetic engineering techniques were employed to integrate the antigenic complex TT3 into the genome of a genetically modified oncolytic vaccinia virus, ensuring stable expression on the surface of virus-infected tumor cells. Then a TT3/CD3 bispecific antibody, designated BK-001, was developed. The binding affinity of BK-001 was rigorously evaluated using ELISA, FACS, and BLI methodologies. The functional potency was determined using RGA, and in vitro cytotoxicity assessed via RTCA. Anti-tumor efficacy of BK-001 was validated using preclinical models, and a comprehensive non-clinical safety assessment was conducted on cynomolgus monkeys.Results and Conclusion:BK-001 is a bispecific T-cell engager antibody designed to boost the immune response against tumors infected by oncolytic viruses, promoting the destruction of cancer cells and improving the tumor microenvironment. The activation of BK-001 relies on the presence of TT3 antigen, which guarantees targeted immune response against tumors. In efficacy studies, BK-001 demonstrated robust tumor growth inhibition at minimal doses, with statistically significant differences compared to control groups. Furthermore, BK-001 exhibited prolonged activity and a favorable safety profile, underpinning its clinical development potential when used in conjunction with oncolytic virus therapy.Citation Format:Wenxin Xu, Can Chen, Huan Zheng, Jieying Xu, Mengshi Jiang, Li Zhang, 1 Deyu Xu, Hongjie Cheng, Yang Zhang, Mengmeng Liu, Jinlu Cai, Fang Hu, Lieming Ding. A novel therapeutic modality integrating antibody therapy and oncolytic virotherapy for enhanced tumor targeting and treatment [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 957.

01 Jul 2019·Cancer Research

Abstract 1471: Short hairpin RNA-expressing oncolytic adenovirus-mediated inhibition of PDL1 significantly suppresses human cancer cell growth

Author: Kang, Sanmao ; Sheng, Jipo ; Wang, Xue ; Hu, Fang ; Fu, Jin ; Dong, Xiaoming

AbstractIn cancer immunotherapy, it is known that aberrant expression of immune checkpoint proteins in tumor cells and their resulting immunosuppression in surrounding tumor microenviroment and even in whole immune system represent the crucial limiting factors toward successful cancer treatment. Multiple studies evidenced that oncolytic viruses carrying biological molecule including cytokines, shRNAs and miRNAs relieve or attenuate immunosuppression, and may be a promising way toward curing tumor. In this study we generated an oncolytic adenovirus with expression of shRNA targeting human PDL1. The adenovirus exhibited proliferation activity more than two orders of magnitude higher in human cancer cells than in human normal primary cells. Western blot showed significantly decreased expressing levels of PDL1 protein in human cancer cells upon infection of the PDL1 shRNA expressing-oncolytic virus. FACS assay also showed decreased expression levels of PDL1 on the cell membrane after the infection of same viruses. In vivo experiments in two different genetic backgrounds mouse model <NOD-SCID mice and BALBC nude mice> demonstrated that the PDL1 shRNA expressing adenoviruses lysed the majority of the tumor cells derived from HCT116 colorectal cancer cells that were subcutaneously inoculated. Moreover, the adenoviruses downregulated PDL1 expression levels within the HCT116 colon cell-derived tumor cells, remarkably attenuated immunosuppression surrounding the HCT116 tumor. Consisted with these observations, TIL cell counts in the tumors derived from mice with shRNA expressing oncolytic adenovirus treatment were significantly higher than that from mice in other control groups. The growth of HCT116 colon cell-derived tumor in mice with oncolytic adenovirus treatment was greatly inhibited for a longer period compared with that in mice in other control groups. The oncolytic adenovirus described in this study features highly selective amplification in human tumor cells versus normal cells and inhibition of PDL1 expression in tumor cells, therefore it may be important toward developing novel method for cancer therapy.Citation Format: Jipo Sheng, Xue Wang, Xiaoming Dong, Jin Fu, Sanmao Kang, Fang Hu. Short hairpin RNA-expressing oncolytic adenovirus-mediated inhibition of PDL1 significantly suppresses human cancer cell growth [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 1471.

01 Jul 2019·Cancer Research

Abstract 4072: A combinational therapy of oncolytic virus and nature killer cells for melanoma treatment

Author: Zhang, Haiyan ; Chen, Xianju ; Hu, Fang ; Chen, Lin ; Li, Meng ; Tan, Xiankui ; Wang, Xiaoyuan

AbstractImmunotherapy has obtained substantial impact on the clinical treatment of melanoma which is largely resistant to current therapies as chemotherapy and radiotherapy. Oncolytic virotherapy of melanoma is an appealing approach for inducing not only tumor cell death but also antitumor immunity. Furthermore, NK cells, a lineage of innate lymphocytes, not relying on peptides presented in an HLA class I context, have gained more and more attention as anti-melanoma effector cells. However, the combination of oncolytic adenovirus and NK cells has not yet been explored in melanoma. In this study, the combinational efficacies of oncolytic virus H101 and NK cells was tested in vitro. The combination of H101 and NK cells resulted more efficient killing of tumor cells (HT29, A549 and HepG2) compared to the monotherapies, and displayed no significant cytolytic effect of normal cells (HUVEC and MRC-5). In addition, we present a patient with right maxillary sinus malignant melanoma who was treated with the combination of H101 and adoptive NK cells. We observed intratumoral injections of H101 without dose-limiting toxicity. H101 injections stimulated self-immunity response with transient whole body fever. Furthermore, NK injections caused tumor temperature rise although contralateral cheek temperature was normal and body temperature was normal. Data are consistent with the hypothesis that virus-infected cancer cells attracted NK accumulation within tumor. The homing NK cells attacked targeted cancer cells, causing local temperature rise. Two courses of combination therapy in conjunction mediated the significant durable regression of melanoma, which had been ongoing for >22 months, and it represents a new immunotherapy approach for the treatment of these patients.Citation Format: Lin Chen, Xianju Chen, Xiankui Tan, Meng Li, Fang Hu, Haiyan Zhang, Xiaoyuan Wang. A combinational therapy of oncolytic virus and nature killer cells for melanoma treatment [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2019; 2019 Mar 29-Apr 3; Atlanta, GA. Philadelphia (PA): AACR; Cancer Res 2019;79(13 Suppl):Abstract nr 4072.

100 Deals associated with Hangzhou Converd Co., Ltd.

100 Translational Medicine associated with Hangzhou Converd Co., Ltd.

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Pipeline

Pipeline Snapshot as of 09 May 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

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

Recombinant human IL-21-expressing Oncolytic Vaccinia Virus (Hangzhou Converd)	Advanced Sarcoma More	Phase 2
KX2-361 ( SRC )	Malignant glioma of brain More	Phase 1
CVD-1301.H03	Herpes Simplex More	Clinical
CVD-1301.V01 ( IL-21R )	Poxviridae Infections More	IND Application
CVD-2102	Respiratory Tract Infections More	Preclinical

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