On February 23, 2016 Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical company focused on re-engaging the body’s immune system to revolutionize the treatment of cancer, and Fred Hutchinson Cancer Research Center (Fred Hutch) reported the creation of a new, best-in-class clinical trials unit (CTU) dedicated to immuno-oncology (Press release, Juno, FEB 23, 2016, View Source [SID:1234509163]). Schedule your 30 min Free 1stOncology Demo! University of Washington, the Seattle Cancer Care Alliance (SCCA), Fred Hutch, and Juno are all investing in the CTU, and Juno will also provide research funds to Fred Hutch in support of pre-clinical and clinical research focused on the development of improved cancer immunotherapies.
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"Immuno-oncology, and in particular, T cell therapies are advancing at a rapid pace, and translational medicine and clinical care of patients need to move as quickly as the basic science," said Mark J. Gilbert, M.D., Juno’s Chief Medical Officer. "We are pleased to work with these world-leading institutions to accelerate the pace of learning for the field and the standard of care for patients. Our ongoing CAR T cell trials have highlighted the opportunity for strong translational medicine to improve our therapies and for dedicated clinical scientists to improve patient outcomes."
"Establishing this clinical trials unit is vital to accelerating our lifesaving research," said Fred Hutch President and Director Gary Gilliland, M.D., Ph.D. "We are on the precipice of multiple curative therapies, and the investment of Juno and the SCCA in our science will be catalytic in moving our discoveries into patients."
"Clinical trials are crucial steps in bringing safer, more effective cancer therapies to the patients who need them," said Fred Appelbaum, M.D., SCCA Executive Director and President. "The CTU will enable patients participating in clinical trials to get all of their care at a single site, with a team of dedicated surgeons, radiologists, pathologists and medical oncologists."
In addition to consolidating trial participants’ care into one location, the new unit will have dedicated space for research teams to handle specimens and collect trial data. The CTU is expected to be operational in mid-2016 and will be available for studies supported by Juno and other drugmakers.
Year: 2016
Medigene strengthens its DC platform with patent for treatment of stem cell or bone-marrow transplanted patients
On February 23, 2016. Medigene AG (MDG1, Frankfurt, Prime Standard), a clinical stage immune-oncology company focusing on the development of T cell immuno-therapies for the treatment of cancer, reported the grant of US patent 9,238,063 by the US Patent Office (USPTO) covering semi-allogeneic anti-tumour vaccines with HLA[1] haplo-identical antigen presenting cells (APCs) (Press release, MediGene, FEB 23, 2016, View Source [SID:1234509154]). Medigene holds an exclusive license to the patent that was issued to Helmholtz Zentrum München (German Research Center for Environmental Health). Schedule your 30 min Free 1stOncology Demo! Prof. Dolores Schendel, CEO and CSO of Medigene and co-inventor of this patent, explains: "This patent increases the applicability for Medigene’s DC vaccines and complements the IP portfolio for our DC vaccines already covered by granted patents in Europe, Australia and the US. It is highly relevant in the immunotherapy of stem cell or bone-marrow transplanted patients, who have received their transplants from parents, siblings or children."
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For a stem cell or bone-marrow donation without an available HLA-identical "sibling", healthy relatives of the patient are considered meanwhile as the best potential donors. Those donors are at least HLA haplo-identical with respect to the patient, which means that 50% of the MHC/HLA molecules of a donor are identical to the MHC/HLA molecules of the patient.
Currently, there are limited treatment options for patients with haematological malignancies who suffer disease relapse after a stem cell or bone-marrow transplantation. The patent US9,238,063 claims a method of treating a tumour disease in patients by using semi-allogeneic antigen presenting cells of an HLA haplo-identical donor. The APCs are modified to express and present tumour-specific antigens which are in turn recognised by the T cells of the patient resulting in an immune reaction directed against the patient’s residual tumour cells.
About Medigene’s DC vaccines: The platform for the development of antigen-tailored DC vaccines is the most advanced platform of the highly innovative and complementary immunotherapy platforms of Medigene Immunotherapies. Currently, Medigene evaluates its DC vaccines in a company-sponsored phase I/II clinical trial in acute myeloid leukaemia (AML). Further studies utilising Medigene’s DC vaccine technology include two ongoing clinical investigator-initiated trials (IITs): a clinical phase I/II trial for treating acute myeloid leukaemia (AML) at Ludwig Maximilians University Hospital Grosshadern, Munich, and a clinical phase II trial of a treatment for prostate cancer at Oslo University Hospital. Moreover, compassionate use patients are treated with DC vaccines at the Department of Cellular Therapy at Oslo University Hospital.
Dendritic cells (DCs) are the most potent antigen presenting cells of our immune system. Their task is to take up, process and present antigens on their cell surface, which enables them to activate antigen-specific T cells for maturation and proliferation. This way T cells can recognise and eliminate antigen-bearing tumour cells. Dendritic cells can also induce natural killer cells (NK cells) to attack tumour cells. The team of Medigene Immunotherapies GmbH’s scientists has developed new, fast and efficient methods for generating dendritic cells ex-vivo, which have relevant characteristics to activate both T cells and NK cells. The DC vaccines are developed from autologous (patient-derived) precursor cells, isolated from the patient’s blood, and can be loaded with tumour-specific antigens to treat different types of cancer. Medigene’s DC vaccines are in development for the treatment of minimal residual disease or use in combination therapies.
Further audio-visual education about Medigene’s DC-Vaccines at:
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Ignyta Announces Strategic Positioning that Focuses on Prioritized Pipeline
On February 23, 2016 Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, reported plans to prioritize certain "core" pipeline programs that have generated the most promising data to date, and to deprioritize certain "non-core" pipeline programs that have either generated less promising data or fall outside of Ignyta’s focus on molecularly targeted therapies (Press release, Ignyta, FEB 23, 2016, View Source [SID:1234509147]). Schedule your 30 min Free 1stOncology Demo! This strategic positioning prioritizes key research and development activities, improves efficiencies and reduces operating expenses.
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These plans include:
A renewed commitment to drive value from Ignyta’s core Rx/Dx business via molecularly targeted therapies by prioritizing the continued development of its entrectinib, taladegib, RXDX-105 and RXDX-106 programs in conjunction with complementary Dx development and laboratory operations;
Continued activities in furtherance of Ignyta’s immuno-oncology and cancer stem cell programs that relate to its current molecularly targeted pipeline (e.g., potential immunotherapy applications of the RXDX-105 and RXDX-106 programs, and potential molecularly targeted cancer stem cell applications of the taladegib and Spark programs); and
Cessation of all development activities relating to the company’s RXDX-107, RXDX-103 and RXDX-108 programs, and some of the Spark discovery programs.
"We continuously seek to develop targeted first-in-class and best-in-class product candidates for the benefit of cancer patients," said Jonathan Lim, M.D., Chairman and CEO of Ignyta. "After reviewing our pipeline and recent preclinical data for certain programs in light of this goal, and keeping in mind our obligation to be good stewards of our resources, we are undertaking this streamlining of our operations to focus on the key priorities and competencies that we believe are most likely to generate value for patients and stockholders."
Ignyta expects to provide further details regarding its strategic priorities during its upcoming March conference call to discuss its 2015 financial results. On Tuesday, February 23, 2016, Ignyta filed a Form-8-K with the U.S. Securities and Exchange Commission (SEC) containing a slide presentation detailing the company’s strategic positioning and prioritized pipeline. Ignyta’s SEC filings can be found on the company’s website at www.ignyta.com and on the SEC’s website at www.sec.gov.
TG Therapeutics, Inc. Announces Issuance of Composition of Matter Patent for TGR-1202 in the United States
On February 23, 2016 TG Therapeutics, Inc. (Nasdaq:TGTX) reported that the United States Patent and Trademark Office (USPTO) has issued a patent for the composition of matter of TGR-1202, the Company’s orally available PI3K delta inhibitor (Press release, TG Therapeutics, FEB 23, 2016, View Source [SID:1234509146]). Schedule your 30 min Free 1stOncology Demo! The patent, U.S. Patent No. 9,150,579 specifically covers TGR-1202, pharmaceutical compositions containing TGR-1202, and its use for treating various forms of leukemia, including chronic lymphocytic leukemia (CLL). The patent was issued to Rhizen Pharmaceuticals SA and is exclusively licensed to TG Therapeutics pursuant to the Company’s existing license agreement with Rhizen Pharmaceuticals. The issuance affords patent protection for TGR-1202 in the US through July of 2033, exclusive of patent term extensions, which have the potential to extend beyond this date. TGR-1202 is currently in Phase 3 clinical development.
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"We are happy to report the issuance of the first U.S. patent for TGR-1202 which provides composition of matter patent protection until at least 2033 and possibly longer with patent term extensions. We believe this issuance strengthens our intellectual property position and should provide substantial market exclusivity for TGR-1202," stated Michael S. Weiss, the Company’s Executive Chairman and Interim CEO. Mr. Weiss continued, "We look forward to continuing to strengthen our intellectual property position through the issuance of additional patents for our portfolio products both individually and in combination in the US and abroad."
Myriad Genetics Expands Strategic Research Collaboration With AbbVie
On February 23, 2016 Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular diagnostics and personalized medicine, reported an expanded companion diagnostics (CDx) research collaboration with AbbVie, Inc. to support the development of AbbVie’s investigational PARP inhibitor, veliparib (Press release, Myriad Genetics, FEB 23, 2016, View Source [SID:1234509141]). Schedule your 30 min Free 1stOncology Demo! Under the terms of the agreement, AbbVie will use Myriad’s CDx portfolio — myChoice HRD and new tumor tests — to help identify patients with non-small cell lung cancer who are likely to respond to treatment with the combination of veliparib and chemotherapy. Other terms of the deal were not disclosed.
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"As a company committed to innovation in the field of oncology, this collaboration with AbbVie enables us to use our proprietary companion diagnostics to advance care for patients with lung cancer," said Jerry Lanchbury, chief scientific officer, Myriad Genetics. "If we are successful, our companion diagnostics will identify more patients who may benefit from treatment with the combination of veliparib and chemotherapy."
This expanded agreement builds on an existing companion diagnostic research collaboration established in November 2014, in which Myriad has been working with AbbVie to support Phase 3 clinical studies of veliparib for patients with breast cancer or ovarian cancer.
About Veliparib (ABT-888)
Veliparib is an investigational oral poly (adenosine diphosphate [ADP]—ribose) polymerase (PARP) inhibitor being evaluated in multiple tumor types. PARP is a naturally-occurring enzyme in the body involved in the repair of DNA damage to cells. Veliparib is being investigated in combination with DNA-damaging therapies like chemotherapy or radiation. Veliparib is currently being studied in multiple cancers and tumor types, including Phase 3 studies in advanced non-small cell lung cancer and breast cancer. Veliparib is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.
About myChoice HRD
Myriad’s myChoice HRD is the first homologous recombination deficiency test that can detect when a tumor has lost the ability to repair double-stranded DNA breaks, resulting in increased susceptibility to DNA-damaging drugs such as platinum drugs or PARP inhibitors. High myChoice HRD scores reflective of DNA repair deficiencies are prevalent in all breast cancer subtypes, ovarian and most other major cancers. In previously published data, Myriad showed that the myChoice HRD test predicted drug response to platinum therapy in certain patients with triple-negative breast and ovarian cancers. It is estimated that 1.8 million people in the United States and Europe who are diagnosed with cancers annually may be candidates for treatment with DNA-damaging agents.