[Translation] A single-arm, multicenter phase I clinical study to evaluate the safety and tolerability of intratumoral administration of a recombinant oncolytic adenovirus injection (KD01) in patients with advanced solid tumors

评估KD01瘤内给药在晚期实体瘤患者人群中的安全性和耐受性，并探索其在人体中的最大耐受剂量（MTD）或II期临床推荐剂量（RP2D）。

[Translation]

To evaluate the safety and tolerability of intratumoral administration of KD01 in patients with advanced solid tumors and explore its maximum tolerated dose (MTD) or recommended dose for Phase II clinical trials (RP2D) in humans.

Start Date16 Apr 2024

Sponsor / Collaborator

Wuhan Kaidejinuo Biotechnology Co., Ltd.

NCT06552598

/ RecruitingPhase 1IIT

The Safety, Tolerability, and Efficacy of Intratumoral Administration of the Recombinant Oncolytic Adenovirus Injection (KD01) in Patients With Cervical Malignancies

The recombinant oncolytic adenovirus injection (KD01) primarily consists of a recombinant human type 5 adenovirus with a deletion in the E3 region, where the ADP gene is replaced by the tBID apoptosis protein gene. This virus exhibits a conditional replication capability, with a 27 base pair deletion in the E1A region corresponding to nucleotides 920-946 of Ad5. This trial is a researcher-initiated clinical study aimed at concurrently evaluating the safety, tolerability, and preliminary efficacy of intratumoral administration of KD01 in patients with cervical malignancies.

Start Date01 Apr 2024

Sponsor / Collaborator

Tongji Hospital Tongji Medical College of HUST

ChiCTR2200066168

/ SuspendedNot ApplicableIIT

A randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of KD-1 capsules in the treatment of mild and normal COVID-19

Start Date21 Nov 2022

Sponsor / Collaborator

The First Affiliated Hospital of Guangzhou Medical University

100 Clinical Results associated with KD01

100 Translational Medicine associated with KD01

100 Patents (Medical) associated with KD01

Literatures (Medical) associated with KD01

01 Apr 2025·Cancer Gene Therapy

Ferroptosis enhances the therapeutic potential of oncolytic adenoviruses KD01 against cancer

Article

Author: Dai, Zhoutong ; Xiong, Shengfeng ; Ye, Jiaqi ; Si, Yao ; Li, Wenhuan ; Ji, Teng ; Sun, Xiaohui ; Li, Fei

Oncolytic virotherapy has emerged as a promising strategy for cancer treatment by selectively targeting and lysing tumor cells. However, its efficacy is often limited in certain tumor types due to multiple factors. This study explores the combination of oncolytic adenoviruses with Erastin, a potent ferroptosis inducer, to enhance antitumor efficacy in oncolytic virus-insensitive cancer cell lines. In vitro experiments demonstrated that Erastin significantly increased the cytotoxicity of oncolytic virotherapy, leading to greater inhibition of cell proliferation and elevated rates of cell death compared to monotherapies. The combination treatment further promoted ferroptosis, as evidenced by increased reactive oxygen species (ROS) levels, enhanced lipid peroxidation, and disrupted redox homeostasis. RNA sequencing identified the downregulation of Dickkopf-1 (DKK1) as a key mediator of the enhanced ferroptotic effect. Restoring the expression of DKK1 partially mitigated the cytotoxic effects of the combination therapy, highlighting its crucial role in mediating the enhanced ferroptosis-induced oncolytic virotherapy efficacy. In vivo studies further validated these findings, demonstrating that the combined treatment significantly reduced tumor growth without inducing notable toxicity. This novel therapeutic approach has great potential to enhance the efficacy of oncolytic virotherapy in cancers resistant to oncolytic viruses by inducing ferroptosis. Further investigation in clinically relevant models is warranted to fully elucidate the underlying mechanisms and to optimize this combination strategy for potential clinical applications.

01 Apr 2025·Cancer Gene Therapy

Chimeric Ad5/35 oncolytic adenovirus overcome preexisting neutralizing antibodies and enhance tumor targeting efficiency

Article

Author: Ye, Jiaqi ; Si, Yao ; Li, Ying ; Gao, Qinglei ; Dai, Zhoutong ; Jin, Xin ; Li, Fei ; Xiong, Shengfeng ; Ma, Ding

KD01, a third-generation conditionally replicating adenovirus serotype 5 developed by our team, has approved by the China Center for Drug Evaluation (CDE) for Phase I clinical trials (NCT06552598). However, 60% seroprevalence of anti-Ad5 neutralizing antibodies is a major hurdle for Ad5-based oncolytic viruses. To address this issue, we developed oAd5/35-HF, a fourth-generation oncolytic adenovirus vector designed to enhance infection efficiency and evade pre-existing neutralizing antibodies (NABs). To achieve this, we introduced targeted capsid modifications, replacing hexon hypervariable regions (HVRs) 1 and 5 with those from adenovirus serotype 35 (Ad35), along with alterations to the fiber region. These combined modifications significantly improved infection efficiency, maintained high viral titers, and enabled the virus to resist NABs. This is the first report of replacing both the Ad5 hexon HVRs and fiber regions with those from Ad35 in an oncolytic adenovirus, resulting in potent antitumor activity across multiple cancer types, even in the presence of high NAB levels. The oAd5/35-HF backbone provides a versatile platform for developing new chimera oncolytic adenovirus and adenovirus vector-based vaccine.

12 Dec 2023·Environmental Science & Technology

Superoxide-Mediated Extracellular Mercury Reduction by Aerobic Marine Bacterium Alteromonas sp. KD01

Article

Author: Hu, Ligang ; Zhang, Xiaoyan ; Zhao, Lixia ; Liu, Yanwei ; Guo, Yingying ; Li, Yanbin ; Shi, Jianbo ; Yin, Yongguang ; Jiang, Guibin ; Cai, Yong ; Liu, Guangliang

Microbial reduction plays a crucial role in Hg redox and the global cycle. Although intracellular Hg(II) reduction mediated by MerA protein is well documented, it is still unclear whether or how bacteria reduce Hg(II) extracellularly without its internalization. Herein, for the first time, we discovered the extracellular reduction of Hg(II) by a widely distributed aerobic marine bacterium Alteromonas sp. KD01 through a superoxide-dependent mechanism. The generation of superoxide by Alteromonas sp. KD01 was determined using 3-bis(2-methoxy-4-nitro-5-sulfophenyl)-2H-tetrazolium-5-carboxanilide and methyl cypridina luciferin analogue as probes via UV-vis and chemiluminescence detection, respectively. The results demonstrated that Hg(II) reduction was inhibited by superoxide scavengers (superoxide dismutase (SOD) and Cu(NO₃)₂) or inhibitors of reduced nicotinamide adenine dinucleotide (NADH) oxidoreductases. In contrast, the addition of NADH significantly improved superoxide generation and, in turn, Hg(II) reduction. Direct evidence of superoxide-mediated Hg(II) reduction was provided by the addition of superoxide using KO₂ in deionized water and seawater. Moreover, we observed that even superoxide at an environmental concentration of 9.6 ± 0.5 nM from Alteromonas sp. KD01 (5.4 × 10⁶ cells mL^-1) was capable of significantly reducing Hg(II). Our findings provide a greater understanding of Hg(II) reduction by superoxide from heterotrophic bacteria and eukaryotic phytoplankton in diverse aerobic environments, including surface water, sediment, and soil.

100 Deals associated with KD01

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Indication	Highest Phase	Country/Location	Organization	Date
Advanced Malignant Solid Neoplasm	Phase 1	China	Wuhan Kaidejinuo Biotechnology Co., Ltd.	16 Apr 2024

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