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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.

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."

Atossa Genetics Provides Update on its Phase 2 Study of Fulvestrant Administered with its Microcatheter

On January 9, 2017 Atossa Genetics Inc. (NASDAQ: ATOS) reported that it is transferring the site of its Phase 2 study of fulvestrant administered with its patented microcatheters in patients with ductal carcinoma in situ or breast cancer who are scheduled for lumpectomy or mastectomy (Press release, Atossa Genetics, JAN 9, 2017, View Source [SID1234517340]). The study was initiated at Columbia University Medical Center Breast Cancer Programs (New York) and is now being transferred to Montefiore Medical Center in New York. This move comes about as the principal investigator, Dr. Sheldon M. Feldman, M.D., has relocated to Montefiore and is now Chief, Division of Breast Surgery & Breast Surgical Oncology, Director, Breast Cancer Services, and Professor, Department of Surgery, at the Montefiore Medical Center, The University Hospital for the Albert Einstein College of Medicine, Montefiore Einstein Center for Cancer Care.

Montefiore Health System consists of eleven hospitals; a primary and specialty care network of more than 180 locations across Westchester County, the lower Hudson Valley and the Bronx; an extended care facility; the Montefiore School of Nursing, and the Albert Einstein College of Medicine.

Dr. Steve Quay, President and CEO, commented, "We look forward to continuing our Phase 2 study at Montefiore, which is a nationally-ranked, top hospital. Although enrollment in the study has been slower than we expected, particularly as the study site is being moved, we expect that Montefiore’s large hospital system and leading breast cancer care center will facilitate faster enrollment, which we now anticipate completing by August 2017."

Adaptimmune confirms GSK Nomination of Second Adaptimmune Target under Strategic Multi-Target Collaboration

On January 9, 2017 Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in T-cell therapy to treat cancer, reported that GlaxoSmithKline plc (NYSE:GSK) (LSE:GSK) has nominated a second target, PRAME (preferentially expressed antigen in melanoma), under the strategic collaboration and licensing agreement between the companies (Press release, Adaptimmune, JAN 9, 2017, View Source [SID1234517335]). Adaptimmune will be responsible for PRAME preclinical TCR development and delivery of the IND package to GSK. The nomination of a second target meets a milestone set forth in the agreement.

Adaptimmune and GSK initially announced their strategic collaboration and licensing agreement in June 2014 for up to five programs, the first being the NY-ESO SPEAR T-cell therapy program, and the agreement was subsequently expanded in February 2016 to accelerate development of Adaptimmune’s NY-ESO SPEAR T-cell therapy toward registration trials in synovial sarcoma. Following the nomination of PRAME as a second target, Adaptimmune will take the program through preclinical testing to IND. GSK retains the right to nominate up to three additional targets, if GSK exercises its option on NY-ESO; however, this excludes targets on which work is already under way, including Adaptimmune’s proprietary MAGE-A10, MAGE-A4 and AFP programs.

"The nomination of this next target marks an important step forward for the collaboration," commented Helen Tayton-Martin, Adaptimmune’s Chief Operating Officer and responsible for the alliance. "The early clinical results we have seen in synovial sarcoma with our SPEAR T-cell therapy targeting NY-ESO-1, the first target nominated by GSK, have been promising thus far, and we are accelerating that program toward registration studies. The nomination of PRAME as GSK’s second target is further validation of our technology, and our goal is to deliver this IND package as expeditiously as possible."

Under the terms of the agreement, the potential development milestones Adaptimmune is eligible to receive solely in relation to the PRAME program could amount to approximately $300 million, if GSK exercises its option and successfully develops this target in more than one indication and more than one Human Leukocyte Antigen (HLA) type. Adaptimmune would also receive tiered sales milestones and mid-single to low double-digit royalties on worldwide net sales.

TG Therapeutics Announces Orphan Drug Designation for the Combination of TG-1101 and TGR-1202 for Treatment of Chronic Lymphocytic Leukemia

On January 9, 2017 TG Therapeutics, Inc. (NASDAQ:TGTX) reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation covering the combination of TG-1101 (ublituximab), the Company’s novel, glycoengineered anti-CD20 monoclonal antibody, and TGR-1202 the Company’s oral, next generation PI3K delta inhibitor, for the treatment of patients with chronic lymphocytic leukemia (CLL) (Press release, TG Therapeutics, JAN 9, 2017, View Source [SID1234517334]). The combination of TG-1101 and TGR-1202 is currently being evaluated in the UNITY-CLL Phase 3 Trial for patients with both frontline and previously treated CLL as well as the UNITY-DLBCL Phase 2b Trial for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).

"Receiving orphan drug designation for our proprietary combination of TG-1101 and TGR-1202 provides another layer of exclusivity protection on top of the composition of matter patents which were issued for TG-1101 and TGR-1202 last year and patents on the combination that have been filed and are pending approval," stated Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics. "Additionally, with enrollment into our UNITY-CLL Phase 3 trial currently exceeding our expectations, we expect to be able to commence a regulatory filing for the combination in 2018 and having orphan drug designation will provide certain cost saving advantages for us during the regulatory approval process."

ABOUT ORPHAN DRUG DESIGNATION

Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA

Chronic lymphocytic leukemia (CLL) is a type of cancer in which the bone marrow makes too many lymphocytes (a type of white blood cell). CLL usually gets worse slowly and is one of the most common types of leukemia in adults. It often occurs during or after middle age. It is estimated that there are approximately 20,000 new cases of CLL diagnosed each year in the United States.