Takara Bio has completed Enrollment of a Phase I Clinical Trial in the US for HF10 Anti-Cancer Therapy

On April 7th, 2014, Takara Bio Inc. announced that as of April 4 Takara Bio had completed enrollment of a Phase I clinical trial of HF10 in patients with solid tumors in the US; 28 patients enrolled and 22 patients evaluable. A phase II clinical trial in the US is now under preparation so that it will start soon.

This trial is an open label, non-randomized, multicenter, two-stage, dose escalation Phase I study evaluating single and repeated intratumoral injections of the oncolytic virus, HF10, in patients with refractory head and neck cancer, or solid tumors with cutaneous and/or superficial lesions (e.g., squamous cell carcinoma of the skin, carcinoma of the breast, and malignant melanoma). It is observed that treatment with intratumorally-injected HF10 has been well tolerated in multiple types of solid tumor malignancies. Takara Bio aims to commercialize the HF10 anti-cancer therapy by the fiscal year ending in March 2019.

Dosing of the First Patient in Phase I Clinical Trial using endoribonuclease MazF for HIV infections in the U.S.

On August 13, 2013, endoribonuclease MazF transduced CD4+ T cells were dosed to the first patient in Phase I clinical trial for the treatment of HIV-1 infections in the U.S. which have been conducted by Takara Bio in collaboration with University of Pennsylvania and Drexel University College of Medicine.

Takara Bio has developed an investigational retroviral technology for HIV gene therapy, in which MazF, an endoribonuclease from Escherichia coli, confers resistance to a broad-spectrum of HIV on CD4+ T cells. This Phase 1 clinical trial is open labeled study and the patients will be monitored for safety, tolerability and immunogenicity of the autologous CD4+ T cells modified with the MazF endoribonuclease for six months. The estimated total enrollment is twelve subjects, six in each of the Cohorts 1 and 2.

Takara Bio disclosed the results of pre-clinical study using endoribonuclease MazF for HIV-1 gene therapy at the 19th Annual Meeting of Japan Society of Gene Therapy (JSGT) 2013

On July 4, 2013, Takara Bio and its collaborator disclosed the experimental data of nonhuman primate model for HIV-1 gene therapy using endoribonuclease MazF transduced CD4+ T cells as an oral presentation at the 19th Annual Meeting of JSGT 2013 held in Okayama, Japan.

In this study, rhesus macaques were infected with pathogenic simian/human immunodeficiency virus (SHIV) and then autologous MazF-transduced CD4+ T (MazF-T) cells were infused, followed by the examination of the CD4 counts and the plasma viral loads.

We showed that MazF-T cells persisted in vivo after infusion even in the presence of SHIV having an increase of CD4 count and reduction of viral load, suggesting that MazF-T cells are protected from SHIV infection with little or no immunogenicity in rhesus macaques.

Takara Bio is conducting a Phase I clinical trial in the U.S. in its program for HIV-1 infections using endoribonuclease MazF.

Click here for the summary of the presentation

Takara Bio Disclosed Preliminary Results of Phase I Clinical Trial for HF10 Oncolytic Virus at ASCO Annual Meeting 2013

On June 3, 2013, Takara Bio Inc. and its collaborators disclosed preliminary data of phase I clinical trial in its program for HF10 Oncolytic Virus, in its poster presentation at ASCO (the American Society of Clinical Oncology) Annual Meeting 2013 held in Chicago, Illinois. Nine patients out of 16 achieved stable disease during the study period. The phase I clinical trial is to be completed in this fiscal year ending March 31, 2014.

Click here for the poster

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