On October 12 of 2016, ImmuneOnco Biopharma Co., Ltd., an emerging biotech company fully focusing on discovery and development of tumor immunotherapy, reported that, its first patent titled with "Recombinant Bi-functional Fusion Proteins, Preparations and Methods for Treating Disease" (U.S. Patent No. 14/666328) has been granted in the United States (Press release, ImmuneOnco Biopharma, OCT 12, 2016, View Source [SID1234519829]). This patent was originally invented by Macroimmune Inc which was acquired recently by ImmuneOnco. The new patent covers both composition-of-matter and method of treatment claims for the bi-functional protein. Related patent applications are pending in Europe, Japan, China and a number of other countries worldwide.

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"The Bi-functional protein simultaneously targeting CD47/VEGF is one of many exciting programs in our preclinical development portfolio," said Dr. Wenzhi Tian, Chairman and Chief Executive Officer of ImmuneOnco. "The anti-angiogenesis activity of the protein will help shrink the tumor volume, making it more accessable to and easier for immune attack activated by the same protein blocking the SIRPa signals. We plan to file the IND of our novel bi-functional protein as early as late 2017 or early 2018." In preclinical studies, the combined inhibition of VEGF and SIRPa has resulted in significant anti-tumor activity in a variety of xenograft models.

On October 12, 2016 Aeterna Zentaris Inc. (NASDAQ: AEZS, TSX: AEZ) (the "Company") and Specialised Therapeutics Asia ("STA") reported the signing of an exclusive license agreement for the Company’s lead investigational anti-cancer compound, Zoptrex (zoptarelin doxorubicin), for the territories of Australia and New Zealand (the "Territory") (Press release, AEterna Zentaris, OCT 12, 2016, View Source [SID:SID1234515780]). Zoptrex, a novel synthetic peptide carrier linked to doxorubicin, is currently undergoing a fully-enrolled Phase 3 clinical trial to evaluate the compound in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in 2016 and, if the results of the trial warrant doing so, to submit a new drug application for Zoptrex to the United States Food and Drug Administration (FDA) in the first half of 2017. Zoptrex is the Company’s proposed tradename for zoptarelin doxorubicin. The proposed tradename is subject to approval by the FDA.

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Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to STA of the Company’s intellectual property related to Zoptrex and the grant to STA of the right to commercialize Zoptrex in the Territory. STA has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones, as well as double-digit royalties on future net sales of Zoptrex in the Territory. STA will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory. The Company and STA have also entered into a supply agreement, pursuant to which the Company will supply Zoptrex to STA for the duration of the license agreement.

David Dodd, President and CEO of the Company, stated, "I am very pleased that we have now concluded four agreements for the commercial rights to Zoptrex, if approved, outside the United States. We believe that the interest in Zoptrex expressed by our licensees supports our view that Zoptrex, if it is approved by the FDA for its initial indication, could be an important treatment option for women with the most severe form of endometrial cancer. We are particularly pleased to have a company of the caliber of STA as a licensee. STA enjoys the highest reputation in its markets and, with its existing portfolio of oncology products, it has the capability to position Zoptrex very well in the market."

STA Chief Executive Officer Mr. Carlo Montagner said Zoptrex had demonstrated great potential and was poised to add further value to the company’s expanding oncology portfolio. "All results to date suggest Zoptrex is a potent new compound and we look forward to collaborating closely with Aeterna Zentaris to maximise its full potential in our key markets," he said.

About Zoptrex

Zoptrex (zoptarelin doxorubicin) is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is (D)-Lys6-LHRH, a modified natural hormone believed to have a strong affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors. Potential benefits of this targeted approach include enhanced efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin.

On October 12, 2016 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, reported that it has entered into an exclusive option agreement to acquire all outstanding capital stock of MirImmune Inc., a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, in consideration for a number of shares equal to 19.99% of the then outstanding shares of common stock of RXi, plus additional potential consideration contingent on MirImmune reaching certain milestones (Press release, RXi Pharmaceuticals, OCT 12, 2016, View Source [SID:SID1234515779]). RXi Pharmaceuticals can exercise the option to acquire MirImmune on the terms set forth in the option agreement at any time prior to April 5, 2017 but has no obligation to do so.

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MirImmune was co-founded by Tim Barberich, founder and former Chairman and CEO of Sepracor, Inc. In early 2015, RXi and MirImmune entered into an exclusive license agreement to RXi’s novel and proprietary sd-rxRNA technology for use in developing innovative cell-based cancer immunotherapies. MirImmune’s progress in cell therapy using RXi’s RNAi technology during the past 18 months forms a strong foundation for therapeutic development in the immuno-oncology space. If RXi exercises its option to acquire MirImmune, the acquisition would enable RXi to expand its pipeline and enter into the rapidly expanding field of immuno-oncology using the unique competitive advantages of sd-rxRNA technology.

The advantages of RXi’s RNAi technology, listed below, have been verified in in vitro testing by MirImmune and their partners, and offer support that sd-rxRNA technology is uniquely suited for immune checkpoint modulation in cellular immuno-oncology therapies, such as CAR T-cells.

Multiple immune checkpoints can be targeted at the same time using a combination of sd-rxRNA compounds;
sd-rxRNA have been able to block both extracellular immune check points as well as intracellular targets that are not accessible to antibody therapies; and
Rapid and efficient transfection of T-cells with sd-rxRNA compounds in cell culture (>98%) is obtained while maintaining close to 100% cell viability.
In addition to demonstrating the effectiveness of our sd-rxRNA platform for cell therapy, MirImmune’s progress to date also includes:

Selection of six lead sd-rxRNA compounds against six different extracellular and intracellular immune check points;
Preclinical data that demonstrate silencing of all six targets in vitro, singly and in combinations;
Efficient and long-lasting knockdown of immune checkpoints in vivo;
Demonstrating the applicability of sd-rxRNA transfection in cell therapy to solid tumors in addition to blood cancers by:
Providing preclinical data demonstrating that mesothelin-targeted CAR T-cells modified with the anti-PD1 targeted sd-rxRNA significantly slow in vivo tumor growth in a human ovarian cancer model in mice compared to vehicle control
Generating promising results in ex vivo testing on melanoma cells obtained from a patient-donor, using sd-rxRNA reduction of PD1 in tumor infiltrating lymphocytes (TILs) resulting in destruction of those melanoma cells; and
Filing of intellectual property that covers the use of RNAi compounds for use in cell therapy.
"We are very pleased to have the opportunity to welcome MirImmune into our Company," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, "This acquisition would not only allow us to create value for our shareholders; it more importantly sets the stage for what could potentially be a transformational change in the way we treat patients with various malignancies, including solid tumors. Our ultimate goal, through our own efforts as well as through partnerships, is the development of more tolerable treatments resulting in better quality of life and extended survival of family members we would otherwise lose prematurely. This approach is a key first step into the field of cell-based therapies, where sd-rxRNA has numerous advantages over other gene-modulating technologies."

"We are very excited to join our efforts with RXi in the development of RNAi for immunotherapy of cancer," said Dr. Alexey Eliseev, CEO of MirImmune, Inc. He added that, "We at MirImmune have taken first steps in improving the properties of cell-based immunotherapies, such as CAR T‑cells, by RNAi and enabling them to work in the immunosuppressive environment of solid tumors. CAR T‑cell treatments have shown an enormous promise in the treatment of hematological malignancies, but they have been only marginally effective with solid tumors. We treat therapeutic immune cells with RNAi compounds ex-vivo to knock down immune checkpoints, such as PD-1, LAG-3 and others. This treatment boosts the anti-tumor activity of the cells when they are subsequently administered to the patients. RXi’s sd-rxRNA is arguably the best RNAi technology for such ex vivo treatment of cells. Our plan is to develop sd-rxRNA as a more safe and effective alternative to gene editing of the immune cells or checkpoint blockade with monoclonal antibodies."

About RXi’s Proprietary Self-delivering RNAi (sd-rxRNA) Technology Platform

RNAi is a powerful molecular tool that has the ability to "silence" or down-regulate the expression of a specific gene that may be overexpressed in a disease condition. Scientists at RXi developed a robust RNAi therapeutic platform that includes self-delivering RNA (sd-rxRNA) compounds where drug-like properties are built into the RNAi compound itself. These proprietary compounds are novel RNAi compounds with enhanced properties for therapeutic use including: efficient spontaneous cellular uptake, stability, reduced potential for immune stimulation, and potent, long-lasting intracellular activity. All cell types tested (primary, neuronal and non-adherent) internalize sd-rxRNA compounds uniformly and efficiently, resulting in potent and long lasting silencing. sd‑rxRNA compounds have the ability to selectively block the expression of any target in the genome providing applicability to a broad spectrum of therapeutic areas.