Year: 2017

RXI PHARMACEUTICALS COMPLETES ACQUISITION OF MIRIMMUNE INC. AND APPOINTS NEW CHIEF BUSINESS OFFICER

On January 9, 2017 RXi Pharmaceuticals Corporation (NASDAQ: RXII), a clinical-stage RNAi company developing innovative therapeutics that address significant unmet medical needs, reported the closing of its acquisition of all of the outstanding capital stock of MirImmune Inc., a privately-held company focused on the development of next generation immunotherapies for the treatment of cancer, pursuant to that previously disclosed exclusive option agreement (Press release, RXi Pharmaceuticals, JAN 9, 2017, View Source [SID1234517343]).

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Under the terms of the stock purchase agreement, MirImmune shareholders will initially receive a total of approximately 2.75 million shares of the Company’s common stock and an additional 1.1 million shares of Series C Preferred Stock, which is convertible 1:1 into common stock, subject to receipt of stockholder approval. MirImmune’s shareholders will also be entitled to potential additional consideration contingent upon the achievement of certain milestones set forth in the stock purchase agreement.

To date, MirImmune’s data using RXi’s propriety self-delivering RNAi (sd-rxRNA) platform have demonstrated the unique applicability of sd-rxRNA for immune checkpoint modulation in cellular immuno-oncology therapies. The advantages of the sd-rxRNA technology include excellent transfection efficiency with little to no loss in cell viability and allows for the potential to silence multiple check points at once including both extracellular and intracellular targets.

"This is an exciting and promising start of 2017 for RXi Pharmaceuticals," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He further added that, "The outstanding work done by MirImmune using RXi’s proprietary self-delivering RNAi technology has clearly established the unique competitive advantages of the sd-rxRNA platform for cell therapy and immuno-oncology. We anticipate that evaluating our RNAi platform in the immuno-oncology space will open up novel and better therapeutic approaches for treatment of some of the more difficult to treat cancers, including hematological malignancies as well as solid tumors. Finally, the addition of this immuno-oncology program strengthens and diversifies RXi’s existing clinical pipeline providing significant value to our shareholders."

To lead the Company in this effort, Alexey Eliseev, PhD has been appointed as RXi’s Chief Business Officer. In this new role, Dr. Eliseev will spearhead the business development initiatives for the Company’s immunotherapy program. Dr. Eliseev is a highly accomplished leader with over 20 years of experience in academia, biotechnology industry and venture capital and most recently was the founder and CEO of MirImmune Inc. He also co-founded Therascope, later Alantos Pharmaceuticals, with a number of prominent founders including French Nobel Laureate Jean-Marie Lehn, where he later became CTO of the company and President of its US division. Alantos was acquired by Amgen in 2007. Dr. Eliseev was also among the founders of AC Immune (Switzerland) and Boston BioCom LLC. Over recent years, he has worked with Maxwell Biotech Venture Fund as its Managing Director and ran the investment activity of the fund in the United States. Dr. Eliseev earned his PhD in Bioorganic Chemistry from Moscow State University and MBA from the MIT Sloan School of Management. Following postdoctoral research in Germany and in the US, he joined the faculty at SUNY Buffalo in 1995 where he was awarded tenure in 2000.

Dr. Eliseev said, "I look forward to joining the team at RXi and applying its unique self-delivering RNAi platform to the development of cell-based cancer immunotherapies." James D. Griffin, MD, Chairman, Department of Medical Oncology, Dana-Farber Cancer Institute further added that, "The formation of one entity through the merger of RXi Pharmaceuticals and MirImmune Inc. is exciting news for the immuno-oncology and cell therapy space."

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

RXi’s proprietary sd-rxRNA technology has many advantages over its competitors in the RNAi space. Scientists at RXi have designed chemically-modified RNAi compounds with improved drug-like properties that are potent, stable and specific. These proprietary compounds have built-in delivery properties and therefore do not require a delivery vehicle for local therapeutic applications. The enhanced properties of sd-rxRNA include: 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.

DelMar Pharmaceuticals Receives Additional Non-Dilutive Funding from the Government of Canada to Support Expanded Research with Lead Product Candidate VAL-083

On January 9, 2017 DelMar Pharmaceuticals, Inc. (NASDAQ: DMPI) ("DelMar" and the "Company"), a biopharmaceutical company focused on the development and commercialization of new cancer therapies, reported an increase in funding of up to CDN$413,000 from the National Research Council of Canada Industrial Research Assistance Program (NRC-IRAP) to support ongoing research with VAL-083 (Press release, DelMar Pharmaceuticals, JAN 9, 2017, View Source [SID1234517323]).

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DelMar Pharmaceuticals Logo
This increased funding will support additional research into VAL-083’s mechanism of action including validation of molecular targets responsible for the drug’s activity against cancer, investigation of combination therapies and pivotal in vivo models in new indications.

Research will be conducted in collaboration with the University of British Columbia, the Vancouver Prostate Centre and the B.C. Cancer Agency.

"We are very pleased with NRC-IRAP’s continued support of our non-clinical research of our lead product candidate VAL-083," said Jeffrey Bacha, chairman & CEO of DelMar Pharmaceuticals. "NRC-IRAP’s support to date has been instrumental in the progress our team has made in understanding VAL-083’s unique mechanism of action and to broadening the focus of our research into new indications."

About VAL-083
VAL-083 is a "first-in-class," small-molecule chemotherapeutic. In more than 40 Phase I and II clinical studies sponsored by the U.S. National Cancer Institute, VAL-083 demonstrated clinical activity against a range of cancers including lung, brain, cervical, ovarian tumors and leukemia both as a single-agent and in combination with other treatments.

DelMar’s research has demonstrated that VAL-083 is active against GBM cell lines that are resistant to standard-of-care chemotherapy due to features such as high expression of MGMT, in vitro.

DelMar presented data from its Phase I/II clinical trial in refractory GBM at the 2016 American Association of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual meeting demonstrating that the median survival of 22 patients receiving an assumed therapeutic dose of VAL-083 (≥20mg/m2) was 8.35 months following Avastin (bevacizumab) failure compared to published literature where survival of approximately two to five months has been reported.

VAL-083 has received an orphan drug designation in Europe for the treatment of malignant gliomas and the U.S. FDA Office of Orphan Products has granted an orphan designation to VAL-083 for the treatment of glioma, medulloblastoma and ovarian cancer.

Further details can be found at View Source

Atreca, Inc. to Present Cancer Immunotherapy Platform and Data at the PepTalk 2017 Conference

On January 9, 2017 Atreca, Inc., a biotechnology company focused on developing novel therapeutics based on a deep understanding of the human immune response, reported the scheduled presentation of positive preclinical findings generated via the Company’s Immune Repertoire Capture (IRC) technology (Press release, Atreca, JAN 9, 2017, View Source [SID1234522957]). The findings will be presented at the 16th Annual PepTalk: The Protein Science Week Conference, taking place at the Hilton San Diego Bayfront, January 9-13, 2017. The presentation, entitled "Natively Paired B- and T-Cell Immune Repertoires and the Discovery of Potent Antibody Therapeutics," will be delivered by Atreca research scientist Sean Carroll, Ph.D., on Thursday, January 12, at 2:35 p.m. Pacific Time.

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N. Michael Greenberg, Ph.D., Atreca’s Chief Scientific Officer and Senior Vice President, stated, "We are proud of the high quality and productivity of our proprietary platform that profiles active anti-tumor immune responses driving positive outcomes in cancer patients undergoing treatment. It is because of the unique features and capabilities of our platform that we are discovering and developing these nextgeneration antibody-based immunotherapies to deliver differentiated combination treatments across a potentially wide range of indications. We look forward to bringing our programs to IND-enabling studies and clinical testing."

Atreca’s IRC technology reveals natively paired and complete variable regions of immunoglobulins expressed by specifically selected B- and T-cells. Using IRC, Atreca has generated repertoires from active immune responses of many patients across multiple indications as well as from target-immunized mice. Analyses of these essentially unbiased and error-free repertoires have yielded immunologic insights as well as potent antibodies targeting tumors, infectious disease antigens, and autoimmune epitopes.

Virtici Announces a New Spin-Out, Rise Therapeutics, Focused on Microbiome Platform Technologies for the Development of Immunological-Based Therapies

On January 9, 2017 Virtici, LLC reported the spin-out of a new drug development company, Rise Therapeutics, which is focused on developing microbiome-based, immunological therapies (Press release, Rise Therapeutics, JAN 9, 2017, View Source [SID1234519822]). To form the spin-out, Rise obtained key microbiome-related intellectual property and technologies incubated at Virtici to support the development of first-in-class, orally-delivered, biological medicines.

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With the growing understanding of the microbiome and the processes by which the microbiome modulates the human immune system, Rise Therapeutics is developing the next generation of first-in-class immune-modulating therapies based upon a vast new array of targets. Rise Therapeutics leverages its unique and proprietary TriPartite X (TPX) platform to deliver targeted biologics orally, a novel step forward in the context of protein-based medicines. As a delivery vehicle, TPX is ideally suited to deliver any biological therapy orally and, in the context of Rise’s therapeutics product development interests, targeting immunology of the gut is a key breakthrough that gives Rise a competitive drug development advantage. At present, two product candidates have been selected for clinical testing with the identification and characterization of other possible novel targets underway.

"The microbiome of the gut is a critical immunological ecosystem" says Gary Fanger, President and CEO of Rise Therapeutics. "By understanding how the microbiome influences our immune system via the intestinal tract, we can design appropriate immunological medicines that can treat a variety of diseases including inflammation, autoimmunity and cancer. With our proprietary TPX delivery platform, we can exploit these microbiome discoveries to deliver biological-based medicines orally that target key pathways in the intestinal tract."

Rise’s proprietary TPX technology is based upon work from the laboratory of Dr. David Pascual, Professor at the University of Florida. The Intellectual property to support the platform and initial therapeutic programs were licensed from the University of Florida and Montana State University. With these novel scientific discoveries, Rise is rapidly moving its first program into clinic development. In addition, Rise is expanding the core foundation technologies and working with its partners in the context of more broadly exploiting TPX to deliver oral biological therapies.

Rise Therapeutics represents another spin-out from the three affiliate companies, Virtici, Celdara Medical, and MBV. With a goal of enhancing industry innovation, Virtici, Celdara Medical, and MBV specialize in identifying and developing novel early-stage innovations from research institutions from across North America and increasingly, beyond. Partnerships and new spin-outs are core to accelerating the value base of the model from these three affiliated companies.

ABOUT RISE THERAPEUTICS, LLC

At the crossroads of the microbiome and immunology, Rise Therapeutics is developing immunologically-directed biological therapies using a unique and proprietary oral delivery platform. Based in Rockville, Maryland, Rise leverages its target discovery expertise to understand microbiota gut biology as it relates to regulation of the immune system. Utilizing these biological discoveries to identify new immune regulatory pathways Rise develops immune modulatory drugs for therapy of autoimmunity, inflammatory disease, and cancer. With its proprietary Tripartite X (TPX) platform, Rise can deliver these first-in-class biological therapies orally. For more information about Rise Therapeutics, please visit www.risetherapeutics.com.
ABOUT VIRTICI, LLC

Founded in 2011, Virtici is a privately held product-development company headquartered in Seattle, Washington. Virtici’s mission is to improve quality of life and save lives, and is primarily developing products to improve the way we treat cancer, autoimmunity, and cardiovascular/metabolic diseases. Virtici, working closely with our affiliates Celdara Medical and MBV, partners with inventors and their research institutions, bringing the business and finance expertise to accelerate product development. Working with its partners in the pharmaceutical industry, Daiichi Sankyo and Grunenthal Group, Virtici connects the entire product development lifecycle by improving innovation, enhancing discovery and increasing product development efficiencies. For more information about Virtici, please visit www.virtici.com.
ABOUT CELDARA MEDICAL, LLC

Celdara Medical was founded by Drs. Jake Reder and Michael Fanger in 2008. CM has locations outside of Boston in Lebanon, NH, in New York, NY, and in Washington, DC. Celdara Medical builds academic and early-stage innovations into high-potential medical companies, identifying discoveries of exceptional value at the earliest stages and moving them toward the market. Celdara Medical partners with inventors and their institutions, providing the developmental, financial, and business acumen required to bridge discovery and profitability. With robust funding options, a diverse and high impact Programmatic pipeline, and partnerships with world-class academic institutions and industry leaders, Celdara Medical navigates all aspects of a complex industry, accelerating science to improve human health. For more information about Celdara Medical, see www.celdaramedical.com or write to [email protected].
ABOUT MBV, LLC

MBV, LLC was founded in 2015 to help inventors leverage their discoveries to improve human health. MBV partners with scientists to develop their ideas commercially by providing expertise in pre-clinical/clinical development, financing, intellectual property, licensing, and business development. MBV leverages a variety of funding sources and both internal and external expertise to develop products and partnerships in the biotechnology, medical device and pharmaceutical industries. Located in Indianapolis, IN, MBV has partnered with Celdara Medical and Virtici, providing decades of development experience on both coasts while working to develop the best from a large pool of under-accessed assets in the Midwest. For more information about MBV, please visit www.mononbioventures.com.

MabVax Therapeutics Files Investigational New Drug Application for Novel Radioimmunotherapy Agent MVT-1075

On January 9, 2017 MabVax Therapeutics Holdings, Inc. (Nasdaq: MBVX), a clinical-stage oncology drug development company, reported the filing an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for MVT-1075 (177Lu-CHX-A″-DTPA-HuMab5B1), the Company’s novel fully human antibody radioimmunotherapy (RIT) (Press release, MabVax, JAN 9, 2017, View Source [SID1234517341]). Subject to receiving FDA authorization to proceed, MabVax plans to initiate the phase I clinical trial in patients with recurrent pancreatic cancer and other CA19-9 positive malignancies early in 2017. This is the third IND filed by MabVax that builds on the tumor targeting characteristics of the HuMab-5B1 antibody discovered from immune responses of cancer patients vaccinated with the Company’s proprietary cancer vaccines.

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The MVT-1075 RIT agent combines the targeting specificity of the HuMab-5B1 antibody for an antigen overexpressed on pancreatic cancer and other CA19-9 positive cancers with 177Lutetium to target delivery of therapeutic radiation to cancer cells. Preclinical studies have demonstrated marked suppression and in some instances regression in xenograft animal models of pancreatic cancer, potentially making it an important new therapeutic agent in the treatment of pancreatic cancer and other cancers expressing the same antigen, CA19-9.

In this initial phase I trial the Company plans to evaluate the safety, dosimetry, and pharmacokinetics of MVT-1075. Patients enrolled in the study will have been diagnosed with recurrent locally advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) or other CA19-9 positive malignancies. Patient disease status will be evaluated based on tumor measurements using RECIST 1.1 criteria. The investigative sites will include Memorial Sloan Kettering Cancer Center in New York City.

In November 2016, MabVax reported positive interim results from two phase I trials. The first trial is evaluating the Company’s therapeutic antibody MVT-5873, in which safety was reported to have been established at three incremental dose levels by treating 16 patients at three clinical sites. Patients continue to be recruited to establish the recommended phase II dose (RP2D). The second trial is evaluating the Company’s Immuno-PET diagnostic agent MVT-2163. The Company reported that phase I trial results demonstrated acceptable interim safety, pharmacokinetics, and biodistribution in the initial two cohorts of patients: the first cohort was administered MVT-2163 alone; and the second cohort was given MVT-2163 following administration of MVT-5873. Target specificity was demonstrated by correlation with lesions identified by conventional computerized tomography (CT) scans and patients are actively being recruited to this trial.

David Hansen, MabVax’s President and Chief Executive Officer, said, "Following the positive interim data readout from our two ongoing phase I trials, we are excited to take this next step forward in our development strategy. Subject to receiving FDA authorization to proceed, we plan on expanding the HuMab-5B1 program to include delivery of a potent new radiotherapy agent. We are hopeful that this approach will provide a new treatment option for these difficult-to-treat cancers."