On March 13, 2014 Takara Bio reported that its application to conduct clinical research in Japan using CD19 antigen specific CAR (Chimeric Antigen Recepter) gene therapy to target B cell non-Hodgkin Lymphoma, which Takara Bio has been preparing in collaboration with Jichi Medical University, Utsunomiya/Tochigi, Japan, was approved as of March 4th, 2014, by Health Science Council of Japanese Ministry of Health, Labour and Welfare (MHLW).

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CAR gene therapy is one method for ex-vivo gene therapy. In the United States and Europe, many CAR clinical trials targeting Malignant Lymphoma (ML), Acute Lymphocytic Leukemia (ALL), and Chronic Lymphocytic Leukemia (CLL) have been conducted. Since a research team at Memorial Sloan-Kettering Cancer Center (MSKCC; New York, US) reported remarkable efficacies of CD19-CAR gene therapy, it has been actively developed as a promising new cancer therapy. In 2011 Takara Bio and MSKCC executed an agreement, whereby MSKCC would provide its clinical data and materials relevant to the clinical trials of the CD19-CAR gene therapy that MSKCC has been conducting in the United States since 2007, so that Takara Bio and Jichi Medical University could start their planned clinical research in Japan. In this clinical research, Takara Bio will manufacture a GMP-grade CD19-CAR retrovirus vector itself utilizing virus producer cells provided by MSKCC, which will be used for the gene transduction in combination with the RetroNectin reagent, Takara Bio’s efficient gene transduction reagent.

Takara Bio positions the CD19-CAR gene therapy as one of the most important pipelines in its gene therapy portfolio and will accelerate clinical development for it, evaluating its safety and efficacy in this clinical research.

[ Outline of planned clinical research ]
Title Clinical Research of gene therapy for refractory B-cell non-Hodgkin Lymphoma using autologous T cells expressing a chimeric antigen receptor specific to the CD19 antigen
Subjects CD19 antigen positive patients with refractory B cell non-Hodgkin Lymphoma
Location of clinical research Jichi Medical University, Utsunomiya/Tochigi, Japan
Method CAR genes that are capable of specifically recognizing CD19 antigens of cancer cells are transduced into the patient’s own lymphocytes obtained from peripheral blood, which are expanded and then re-infused into the patient.
Primary outcomes To evaluate the safety of the CD19-CAR gene therapy
Secondary outcomes To evaluate clinical effect (Anti-tumor effect)
Number of subjects 6 subjects (max. 18)
Trial period To evaluate clinical effect (Anti-tumor effect)

On March 12, 2014 TNI BioTech reported the U.S. Patent and Trademark Office (USPTO) has granted a key patent for IRT-101 (MENK) for inducing sustained immune response of T-Cells (Press release, TNI BioTech, MAR 12, 2014, View Source [SID:1234501364]).

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The present invention relates to methods of stimulating and promoting a sustained natural immune system response, resulting in increased resistance and inhibition of infectious agents, including viruses, bacteria, fungi and parasites, and other immunodeficiency-related ailments. More specifically, the invention relates to an intermittent dose schedule for promoting a sustained increased level of T-cell production (cytotoxic T-cells) including CD3, CD4, CD8, natural killer (NK) cells, CD38 cells, and interleukin II receptor. Pursuant to the patent, these therapies can be used on immunocompromised individuals including patients with cancer, or undergoing x-ray, surgery, or chemotherapy treatments.

The patent assigned to TNI BioTech from Nicholas Plotnikoff, which is already the subject of a previously granted U.S. patent, protects the activated NK cells. Similar patent protection has been obtained in India, Russia and the United Kingdom.

IRT-101 (MENK) is an active immunotherapy with MENK for patients with deficient functioning of the immune system. It works by restoring the patient’s immune functions and by activating the lymphocytes to attack cancer cells and infectious diseases, such as HIV/AIDS. This is accomplished because MENK binds to opioid receptors on both immune cells and on cancer cells, which directly inhibits the growth of cancer cells and increases the number and functions of T-cells, NK cells, NK-T cells, and gamma/delta T-cells. These cells then destroy infective organisms and tumor cells while simultaneously inhibiting the ability of T regulatory (Treg) cells to block the functions of anti-cancer or anti-infectious disease lymphocytes.

Noreen Griffin, CEO of TNI BioTech said, "We are pleased to be able to expand our patent portfolio and believe this patent plus the many other patents surrounding MENK provide us with broad composition-of-matter protection for our suite of immunotherapy treatments."

On March 12, 2014 Geron reported that the company has received verbal notice from the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) application for imetelstat has been placed on full clinical hold, affecting all ongoing company-sponsored clinical trials (Press release Geron, MAR 12, 2014, View Source;p=RssLanding&cat=news&id=1908172 [SID:1234500269]). A full clinical hold is an order that the FDA issues to a trial sponsor to suspend an ongoing clinical trial or delay a proposed trial.
The clinical hold affects the remaining eight patients in the company’s Phase 2 study (NCT01731951) in essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two patients in the company’s Phase 2 study (NCT01242930) in multiple myeloma. In addition, the company’s planned Phase 2 clinical trial in myelofibrosis will likely be delayed due to the clinical hold. It is possible that other studies using imetelstat, such as ongoing investigator-sponsored trials, may also be placed on clinical hold by the FDA.
Geron has not yet received written notice of its clinical hold from the FDA, but based on the verbal communication yesterday afternoon, the FDA indicated that the clinical hold is due to the occurrence of persistent low-grade liver function test (LFT) abnormalities observed in the Phase 2 study of imetelstat in ET/PV patients and the potential risk of chronic liver injury following long-term exposure to imetelstat. The FDA expressed concern about whether these LFT abnormalities are reversible. Geron plans to work diligently with the FDA to seek the release of the clinical hold.

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The anti-AMHR2 product (3C23K) which is under development by GamaMabs is an Emabling engineered humanized mAb directed against the receptor of the anti-Müllerian hormone (AMHR2), alternatively known as Müllerian Inhibiting Substance Receptor II (MISRII) (Company Pipeline GamaMabs Pharma, MAR 12, 2014, View Source [SID:1234500268]).

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(Press release, Selvita, MAR 11, 2014, View Source [SID:1234504706])

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