Delving into the Latest Updates on Burfiralimab with Synapse

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

hzVSF

+ [1]

Target

vimentin

Mechanism

vimentin inhibitors(Vimentin inhibitors), Virus replication inhibitors

Therapeutic Areas

Infectious DiseasesDigestive System DisordersImmune System Diseases+ [1]

Active Indication

Rheumatoid ArthritisHepatitis B, Chronic

Inactive Indication

COVID-19

Originator Organization

ImmuneMed, Inc.

Active Organization

ImmuneMed, Inc.

Inactive Organization-

Drug Highest PhasePhase 2

First Approval Date-

Regulation-

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Gene Sequence

Sequence Code 12977731L

Source: *****

Sequence Code 12977888H

Source: *****

This is a multicenter, randomized, double-blind, parallel group, 48-week follow-up, Phase IIa clinical study. This study has been designed to evaluate the change in HBsAg (log10 IU/mL) after administration of hzVSF-v13 50 mg/dose and hzVSF-v13 200 mg/dose in combination with an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) compared to an oral antiviral agent in combination with a placebo (normal saline) in patients with chronic hepatitis B who are stably receiving an oral antiviral agent (Tenofovir or entecavir, including salt-free or salt-modifying drugs) for at least 24 weeks.

Start Date11 Jan 2022

Sponsor / Collaborator

ImmuneMed, Inc.

NCT04679350 / TerminatedPhase 2

A Multi Center, Randomized, Double-blind, Parallel Design, Phase 2 Study to Evaluate the Efficacy and Safety of hzVSFv13 Compared to Standard of Care After Intravenous(IV) Administration With Add-on Standard of Care in COVID-19 Moderate to Severe Patients

To explore the efficacy and confirm the safety of the concomitant administration of the standard of care and hzVSF-v13 in patients with COVID-19 infection

Start Date18 Mar 2021

Sponsor / Collaborator

ImmuneMed, Inc.

100 Clinical Results associated with Burfiralimab

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100 Translational Medicine associated with Burfiralimab

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100 Patents (Medical) associated with Burfiralimab

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14

Literatures (Medical) associated with Burfiralimab

19 Oct 2022·Precision Clinical Medicine

Patient-derived organoids potentiate precision medicine in advanced clear cell renal cell carcinoma

Article

Author: Zheng, Junhua ; Tao, Yiying ; Xue, Yizheng ; Xue, Wei ; Zhai, Wei ; Xia, Jun ; Yuan, Kedi ; Wang, Bingran

AbstractTo investigate the role of patient-derived organoid (PDO) model in the precision medicine of advanced clear cell renal cell carcinoma (ccRCC), we retrospectively analyzed the clinical data of seven cases of ccRCC diagnosed by operation and pathology in Renji Hospital from September 2021 to September 2022. The seven patients were diagnosed with advanced ccRCC with or without remote metastasis. Cytoreductive and radical nephrectomy was performed respectively. To predict the response to immunotherapy and provide personalized medicine recommendation, a PDO model based on air-liquid interface system was established from the surgical resected tumor and subsequent drug screening was performed. Hematoxylin and eosin (H&E) staining and immunohistochemistry revealed that the PDO recapitulated the histological feature of parent tumor. Immunofluorescence staining identified that CD3+ T cells, SMA+ cancer associated fibroblasts, and CD31+ endothelial cells were preserved in PDO models. Fluorescence activated cell sorter (FACS) revealed an evidently increased ratio of CD8+/CD4+ T cells and apoptotic tumor cells in PDO treated with toripalimab than those treated with IgG4. The results showed that toripalimab is able to rescue the excessive death of CD8+ T cells by critically reversing the immune exhaustion state of ccRCC in PDO model. This research validated that PDO is a promising and faithful preclinical model for prediction of immunotherapy response in patients with ccRCC.

01 Jul 2021·Heliyon

Humanized virus-suppressing factor inhibits hepatitis B virus infection by targeting viral cell entry

Article

Author: Koike, Kazuhiko ; Otsuka, Motoyuki ; Sekiba, Kazuma ; Funato, Kazuyoshi ; Miyakawa, Yu

Although nucleos(t)ide analogs and interferons suppress hepatitis B virus (HBV) replication, they must be taken continuously and have a low response rate. Therefore, therapeutics for HBV with novel modes of action are needed. Humanized virus-suppressing factor (hzVSF) is a monoclonal antibody against vimentin that exhibits broad-spectrum antiviral activity. Here, hzVSF significantly inhibited HBV infection. Although hzVSF inhibited HBV RNA production, it did not affect viral transcription from minicircle DNA mimicking covalently closed circular DNA. Additionally, hzVSF did not inhibit viral protein or DNA release from infected cells. Rather, hzVSF inhibited the cell entry of viral preS1 peptides, possibly by altering intracellular vimentin localization, which is important for HBV cell entry. These results suggest that hzVSF has therapeutic potential for HBV infection with a novel mode of action.

01 Nov 2020·Journal of Medical Virology

Compassionate use of hzVSF‐v13 in two patients with severe COVID‐19

Letter

Author: Kim, Nam‐Joong ; Kang, Chang Kyung ; Park, Sungman ; Choe, Pyoeng Gyun ; Kim, Yoon‐Won ; Kim, Taek Soo ; Oh, Myoung‐don ; Seong, Moon‐Woo ; Park, Wan Beom

We report 2 patients with COVID-19 pneumonia who recovered after the compassionate use of hzVSF-v13.hzVSF-v13 treatment not only reduced the viral load but also decreased the proinflammatory cytokine levels.therefore, hzVSF-v13 may be a promising drug for treating COVID-19.

100 Deals associated with Burfiralimab

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 2	NL	ImmuneMed, Inc.	01 Mar 2024
Hepatitis B, Chronic	Phase 2	KR	ImmuneMed, Inc.	11 Jan 2022
COVID-19	Phase 2	RU	ImmuneMed, Inc.	11 Dec 2020
COVID-19	Phase 2	IT	ImmuneMed, Inc.	11 Dec 2020
COVID-19	IND Application	RU	ImmuneMed, Inc.	11 Dec 2020
COVID-19	IND Application	IT	ImmuneMed, Inc.	11 Dec 2020

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03653208 (CTgov)	Phase 1	-	56	hzVSF-v13 (Group 1 (hzVSF-v13 10mg))	hpbauclqfh(vpnggxqazg) = togigwpasg uormrkvtio (lxpdxzbbfw, ddvakhvhkh - agdpostanj) View more	-	02 Apr 2021
				hzVSF-v13 (Group 2 (hzVSF-v13 20mg))	hpbauclqfh(vpnggxqazg) = tfeynvvtgz uormrkvtio (lxpdxzbbfw, jwczzvsawx - dqowdqdhvw) View more