10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Heat Biologics has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Heat Biologics, MAR 27, 2015, View Source [SID1234502578]).

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10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

EntreMed has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, EntreMed, MAR 27, 2015, View Source [SID1234502575]).

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Advirna

Advirna is a biotechnology company developing innovative solutions for efficient delivery of oligonucleotides (Company Web Page, MirImmune, MAR 27, 2015, View Source [SID:1234502854]). Through a research and development agreement with Advirna, MirImmune gains access to sdRNA lead compounds for new checkpoint targets and novel types of sdRNA.

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RXi Pharmaceuticals and MirImmune LLC Enter into an Exclusive Licensing Agreement for RXi’s Self-Delivering RNAi (sd-rxRNA) Technology to Develop Cell-based Immunotherapies to Treat Cancer

On March 27, 2015 RXi Pharmaceuticals Corporation reported that they have entered into an exclusive license agreement to RXi’s novel and proprietary sd-rxRNA technology for use in developing innovative cell-based cancer immunotherapies (Press release, RXi Pharmaceuticals, MAR 27, 2015, View Source [SID:1234502580]). The collaboration has the potential to result in novel, more effective and patient friendly cancer treatments that could be a significant step toward personalized medicine.

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Under the terms of the agreement, MirImmune will be responsible for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. It will develop cell-based therapeutics utilizing RXi’s sd-rxRNA technology to target immune inhibitory pathways (checkpoints) which are responsible for limiting the efficacy of cancer immunotherapies. According to the terms, MirImmune will gain access to RXi’s sd-rxRNA and rxRNAori patent families for ex vivo modification of cells for the treatment of cancer. These patents include the composition of the sd-rxRNA and rxRNAori RNAi structures, as well as potential targets for cell-based therapeutics.

As consideration for this license, RXi will receive an annual licensing fee, clinical milestone payments, sublicensing income and single digit royalties. Pending MirImmune’s achievement of a few gating milestones, RXi will have the right to acquire a double-digit equity stake in MirImmune.

"We are pleased to provide MirImmune access to our novel self-delivering RNAi compounds for ex vivo cell therapy for the treatment of cancer," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added, "This license agreement marks the latest milestone for the Company to partner and collaborate with industry to provide new and innovative therapeutics, while also providing the potential for a long-term financial return for our shareholders."

Dr. Craig Mello, Chairman of RXi Pharmaceuticals Scientific Advisory Board, said that, "Not only is this collaboration a visionary step forward by RXi because it has the potential to develop cutting edge cell-based therapeutics for cancer immunotherapy and possibly other unmet medical needs, it also further validates the Company’s proprietary self-delivering RNAi technology platform."

"We are delighted to work with RXi Pharmaceuticals and their cutting-edge, self-delivering RNAi compounds as we progress research and development efforts with our cell-based therapy approach," said Alexey Eliseev, CEO of MirImmune LLC. "Following careful evaluation of the various siRNA delivery platforms, we believe RXi’s self-delivering technology is best suited for cell-based therapeutics for the following reasons:

sd-rxRNAs easily transfect any cell type;
sd-rxRNAs do not require formulation in a complex delivery system for efficient cellular uptake. This allows for a streamlined manufacturing process;
The sd-rxRNA platform was demonstrated to be safe and well-tolerated in GLP toxicology studies (dermal and systemic) and in dermal clinical trials; and
sd-rxRNA allows for the ability to target multiple genes of interest simultaneously.

Access to RXi’s technology transforms our ability to move forward with our efforts to develop targeted cancer cell therapeutics."

About Cancer Immunotherapies

Cancer cells are formed in the body almost every day but we are normally not affected by them as they are destroyed by the body’s immune system. The immune system is a complex network of various cells and organs that work together to attack foreign and non-self invaders. When the immune system is weaker, cancer cells can evolve as a disease and begin to grow.

Cancer immunotherapy attempts to treat the disease by stimulating the immune system to reject and destroy tumors. There are three main classes of this type of immunotherapy: cell-based therapies, antibody therapies and cytokine therapies.

Cell-based cancer immunotherapy, also known as Autologous Immune Enhancement Therapy (AIET), is a treatment that uses a patient’s own cells. Immune cells (peripheral blood-derived NK cells, Cytotoxic T Lymphocytes and others) are taken out of the body, cultured and processed to become activated (in this case with sd-rxRNA compounds) and are then reinfused to attack cancer cells. Researchers have found that this type of cell therapy primarily targets cancer cells and not healthy cells. This approach differs from chemotherapy and radiotherapy where healthy cells are also destroyed.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

Tokai Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Tokai Pharmaceuticals, MAR 26, 2015, View Source [SID1234502573]).

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