Genmab Announces Phase III Study of Daratumumab in Relapsed or Refractory Multiple Myeloma

On March 5, 2014 Genmab reported that its partner, Janssen Biotech will start a Phase III study of daratumumab in relapsed or refractory multiple myeloma (Press release Genmab, MAR 5, 2014, View Source [SID:1234500247]). The study will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
This Phase III study will include approximately 500 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).

(Filing, 10-Q, Merrimack, MAR 4, 2014, View Source [SID:1234505642])

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20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

Qiagen has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release QIAGEN, MAR 3, 2014, View Source [SID1234500243]).

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Takara Bio obtains a governmental grant for commercialization of
its TCR gene therapy projects

On March 3, 2014 Takara Bio reported that it has obtained a project grant from the Japan Science and Technology Agency (JST) (Press release Takara Bio, MAR 3, 2014, View Source [SID:1234501505]). On the same day, JST publicly disclosed on its website that Takara Bio’s TCR gene therapy projects would receive funding through JST’s A-STEP program (Adaptable & Seamless Technology Transfer Program through Target-driven R&D) for FY 2014.

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The JST has acknowledged the vast potential of Takara Bio’s TCR gene therapy program because of our ground breaking technological innovations in the field. The main mechanism of action for TCR gene therapy is via gene-transduced lymphocytes, which acquire the capability to specifically recognize and attack cancer cells and eliminate them. TCR genes that are capable of recognizing cancer antigens are transduced into the patient’s own lymphocytes, which are then re-infused into the patient. Our MAGE-A4 antigen-specific TCR gene therapy and NY-ESO-1 antigen-specific TCR gene therapy have both been selected for the A-STEP program. These therapies have been developed in collaboration with Mie University.

The outline of the selected project is as follows;
Funding agency Japan Science and Technology Agency (JST)
Project Purpose HLA-A*24:02 positive patients with solid tumors which are
1) To prepare and conduct phase I and II clinical trials of MAGE-A4
antigen-specific TCR gene therapy in Japan
2) To prepare and conduct phase I and II clinical trials of NY-ESO-1
antigen-specific TCR gene therapy in Japan
3) To establish a medical care system for the new gene medicine in order
to acquire an approval for manufacturing and distribution
Contract Period Up to five years
Total amount Up to ¥1,000 million

The Japanese government is instituting a wide range of measures as an important governmental policy to accelerate the commercialization of the regenerative medicine, where the Ministry of Education, Culture, Sports, Science and Technology (MEXT), the Ministry of Economy, Trade and Industry (METI) and the Ministry of Health, Labour and Welfare (MHLW) collaborate tightly to seamlessly advance the practical application and commercialization of regenerative medicine from basic research through clinical trials. JST, one of the core institutions responsible for the implementation of science and technology policy in Japan under the umbrella of MEXT, designs several types of the competitive funding programs called A-STEP, where the optimal R&D funding and R&D period will be offered depending on the R&D phase and objectives of each particular project. Takara Bio’s TCR gene therapy projects were chosen as the final R&D phase for practical application of drug development. With this governmental support, Takara Bio aims to advance its TCR gene therapy projects with further effectiveness and efficiency.

Genocea Biosciences Announces Collaboration to Characterize T Cell Responses to Cancer Antigens

On March 3, 2014 Genocea Biosciences reported a joint research collaboration with Dana-Farber Cancer Institute and Harvard Medical School to characterize anti-tumor T cell responses in melanoma patients (Press release Genocea Biosciences, MAR 3, 2014, View Source [SID:1234500896]). This collaboration extends the use of the company’s proprietary ATLAS platform for the rapid discovery of T cell antigens to cancer immunotherapy approaches.

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"ATLAS has proven its value for the rapid discovery of promising vaccine antigens in the field of infectious diseases, enabling Genocea to take four programs in three infectious diseases from start to animal proof-of-concept in less than three years," said Chip Clark, president and chief executive officer of Genocea. "We believe this collaboration speaks to the promise of our ATLAS technology to discover a subset of antigens relevant to positive anti-tumor T cell responses in melanoma patients, which might form the basis for an effective immunotherapeutic. In addition, the information gained through this effort should provide useful data for patient-stratification in clinical trials, as well as potential applications for monitoring patients post-treatment."

The collaboration, sponsored by Ludwig Trust, includes Darren Higgins, Ph.D., in the Department of Microbiology and Immunobiology at Harvard Medical School, who originally devised the ATLAS technology, and the team of Stephen Hodi, MD and Glenn Dranoff, MD at the Dana-Farber Cancer Institute. Drs. Hodi and Dranoff have investigated the biologic and anti-tumor activities of anti-CTLA-4 (anti- cytotoxic T lymphocyte-associated antigen-4) antibody therapy, which has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of advanced melanoma. This collaboration with Genocea is aimed at learning more about the immune responses stimulated with this treatment. In a Phase 1 study of this antibody therapy, certain subjects responded very favorably, while investigators did not see a clinically meaningful response with other subjects.

Dr. Higgins’ team will create a cancer antigen protein library for screening in ATLAS. The Dana-Farber team will obtain peripheral blood mononuclear cells (PBMC) from a subset of positive responders from the Phase 1 trial participants treated with the anti-CTLA-4 antibody. Genocea will then use the ATLAS platform to screen the protein library against the patient-derived immune cells to identify a small number of highly relevant T-cell antigens for further testing.

About the ATLAS (AnTigen Lead Acquisition System)

Genocea’s vaccine programs are built around the ATLAS platform for the rapid discovery of T cell antigens. T cell antigens, specifically antigens that stimulate CD4+ and CD8+ T cells, are critical to generating disease-specific cellular immune response and long-term T cell memory. At the core of ATLAS is a high throughput screening process that mimics the natural mammalian immune response to protein antigens. Critically, Genocea screens all of a pathogen or cancer-type’s proteins against T cells from human donors with diverse HLA types who have generated a potentially protective or ineffective immune response after exposure to a target pathogen or cancer antigen. As a result, ATLAS winnows what can be as many as several thousand protein antigens to a small number that correlate with immunity.