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AMORFIX AND TRELLIS BIOSCIENCE TO COLLABORATE ON ANTI-CD38 ANTIBODY TREATMENT FOR CANCER

On March 17, 2014 Amorfix Life Sciences reported that it has entered into a collaboration with Trellis Bioscience to develop antibodies against misfolded CD38 protein as a treatment for hematological malignancies including leukemia and lymphoma (Press release Amorfix Life Sciences, MAR 17, 2014, View Source [SID:1234500301]).
Trellis is a private, South San Francisco-based therapeutic antibody company formed around a breakthrough discovery platform capable of isolating therapeutic grade antibodies directly from the blood cells of humans. The Company’s discovery platform, called CellSpotTM, uses computerized microscopy to drastically miniaturize a multiplexed antigen binding assay capable of characterizing millions of individual antibody producing B cells. Hence, CellSpot enables discovery of very rare high quality human antibodies usually not detectable with standard techniques.
Amorfix’s ProMIS Discovery technology identifies disease specific epitopes (DSE’s) that are present only on diseased cells. Together, the complementary technologies will enable the companies to isolate and develop fully human therapeutic antibodies that will target only cancer cells and not healthy ones. Under the terms of the collaboration, Amorfix will have an exclusive option to develop any resulting antibodies.

Five Prime Therapeutics and Bristol-Myers Squibb Sign Collaboration Agreement to Discover Novel Immuno-Oncology Therapies for Two Immune Checkpoint Pathways

On March 17, 2014 Five Prime Therapeutics and Bristol-Myers Squibb Company reported that they have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime’s proprietary target discovery platform (Press release Bristol-Myers Squibb, MAR 17, 2014, View Source [SID:1234500292]).
Bristol-Myers Squibb will leverage Five Prime’s platform to advance its existing immuno-oncology programs by identifying the most viable drug targets for continued research and development. Drug candidates developed against these new and existing targets may be studied either as single agents or in combination with existing or potential Bristol-Myers Squibb immuno-oncology therapies.
Under the terms of the agreement, Bristol-Myers Squibb will obtain exclusive, worldwide rights to develop and commercialize products directed toward certain protein targets identified by Five Prime prior to and during the collaboration. Bristol-Myers Squibb will make an upfront payment of $20 million to Five Prime and provide up to $9.5 million in research funding over the course of the research term. Additionally, Bristol-Myers Squibb will make a payment of approximately $21 million to acquire 4.9% of Five Prime’s outstanding common stock purchased at approximately a 30% premium. Five Prime will be eligible to receive up to $300 million in future development, regulatory and sales based milestone payments per collaboration target and tiered mid-single-digit rising to low-double-digit royalty payments on net sales of each product commercialized by Bristol-Myers Squibb.

Approval for Additional Indication for PTCL and CTCL of Mogamulizumab

On March 17, 2014 Kyowa Hakko Kirin reported that it has received approval for additional indication for relapsed or refractory CCR4-positive peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL) of Mogamulizumab (brand name: POTELIGEO Injection) from Japan’s Ministry of Health, Labour and Welfare (MHLW) (Press release Kyowa Hakko Kirin, MAR 17, 2014, View Source [SID:1234500287]).

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Mogamulizumab is a novel, humanized monoclonal antibody directed against CC chemokine receptor 4 (CCR4), which is over-expressed on various malignant T cells, including PTCL and CTCL cells. Engineered by Kyowa Hakko Kirin’s unique POTELLIGENT Technology, the antibody is designed to kill its target cells through potent antibody-dependent cellular cytotoxicity (ADCC). Mogamulizumab was also granted orphan drug designations for the treatment of PTCL and CTCL in March 2013 by the MHLW.
Mogamulizumab was launched in Japan with the brand name POTELIGIO Injection 20 mg on May 29, 2012 for the treatment of patients with relapsed or refractory CCR4-positive ATL and is being investigated world-wide in a number of clinical studies for other potential indications.

Clinical research protocol of gene therapy targeting B cell non-Hodgkin Lymphoma was approved by Japanese Ministry

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).

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)

Progenics Pharmaceuticals Announces Fourth Quarter and Year-End 2013 Financial Results and Initiates Clinical Development of Small Molecule Targeted Therapeutic

MIP-1095 is a PSMA-targeted small molecule radiopharmaceutical which is under development by Progenics for the treatment of prostate cancer (Press release Progenics Pharmaceuticals, MAR 13, 2014, View Source [SID:1234500273]).