On September 11, 2018 Incyte Corporation (NASDAQ:INCY) and Foundation Medicine, Inc., reported that the companies have entered into an agreement for the development, regulatory support and commercialization of companion diagnostics (CDx), with an initial focus on CDx development for pemigatinib (INCB54828), Incyte’s selective FGFR1/2/3 inhibitor, in patients with cholangiocarcinoma (Press release, Incyte, SEPT 11, 2018, View Source [SID1234529385]). The initial CDx, which will include detection of activating FGFR2 translocations, is expected to be incorporated into FoundationOneCDx, Foundation Medicine’s FDA-approved comprehensive genomic profiling (CGP) assay and broad CDx platform.

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"There is an urgent need for a novel, biomarker-based, targeted therapeutic approach for patients with cholangiocarcinoma. The initial goal of this collaboration is to develop a companion diagnostic to enable testing at diagnosis of stage IV disease, with the aim of helping to reduce morbidity and mortality, and we are very pleased to be working with Foundation Medicine as we seek to improve outcomes for these patients," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Incyte is evaluating pemigatinib in patients with cholangiocarcinoma as part of the FIGHT clinical development program; initial data have been accepted for presentation at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in Munich this October."

"We’re committed to helping our biopharma partners bring biomarker-driven therapies to cancer patients. Partnerships with innovative biopharma companies, such as Incyte, who leverage our FDA-approved platform to help accelerate companion diagnostics development, are essential to achieving this mission," said Melanie Nallicheri, Chief Business Officer and Head of Biopharma at Foundation Medicine. "We’re proud to partner with Incyte to advance development of a potential new precision oncology treatment option for cholangiocarcinoma."

About FGFR and Pemigatinib (INCB54828)

Fibroblast growth factor receptors (FGFRs) play an important role in tumor cell proliferation and survival, migration and angiogenesis (the formation of new blood vessels). Activating mutations, translocations and gene amplifications in FGFRs are closely correlated with the development of various cancers.

Pemigatinib is a potent, selective, oral inhibitor of FGFR isoforms 1, 2 and 3 which, in preclinical studies, has demonstrated selective pharmacologic activity against cancer cells with FGFR alterations. Phase 2 studies investigating the safety and efficacy of pemigatinib monotherapy across several FGFR-driven malignancies are ongoing—the FIGHT (FIbroblast Growth factor receptor in oncology and Hematology Trials) clinical trial program currently comprises FIGHT-201 in patients with metastatic or surgically unresectable bladder cancer, including with activating FGFR3 alterations; FIGHT-202 in patients with metastatic or surgically unresectable cholangiocarcinoma who have failed previous therapy, including with activating FGFR2 translocations; and FIGHT-203 in patients with myeloproliferative neoplasms with activating FGFR1 translocations.

On September 11, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that quizartinib, an investigational FLT3 inhibitor, has been granted Orphan Drug designation by the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of FLT3-mutated acute myeloid leukemia (AML) (Press release, Daiichi Sankyo, SEP 11, 2018, View Source [SID1234529382]).

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"There is a critical need for new treatment options for patients with FLT3-ITD AML, especially given the poor prognosis associated with this subtype of AML," said Koichi Akahane, PhD, MBA, Executive Officer, Head of Oncology Function, R&D Division, Daiichi Sankyo. "Following the recent U.S. FDA Breakthrough Therapy designation for quizartinib, receiving Orphan Drug designation is another important regulatory milestone that will help accelerate the development of quizartinib in Japan. We look forward to working closely with the Japan MHLW to bring quizartinib to patients as quickly as possible."

The Japan MHLW Orphan Drug designation system is designed to promote research activities and support the development of orphan drugs for serious, difficult-to-treat diseases that affect fewer than 50,000 patients in Japan, and for which significant unmet medical need exists. An investigational compound can qualify for Orphan Drug designation if there is no approved alternative treatment option or if high efficacy or safety compared to existing treatment options is expected. Compounds receiving Orphan Drug designation qualify for several measures intended to support development, including, but not limited to, guidance and subsidies for research and development activities, priority consultation for clinical development and priority review of applications.

Quizartinib is the first FLT3 inhibitor to prolong overall survival as an oral, single agent compared to chemotherapy in a randomized, phase 3 trial (QuANTUM-R) in patients with relapsed/refractory FLT3-ITD

AML. Results of QuANTUM-R were presented during the plenary program at the 23rd Congress of the

European Hematology Association in June 2018.

The safety profile observed in QuANTUM-R appears consistent with that observed at similar doses in the quizartinib clinical development program. Incidence of treatment-emergent adverse events was comparable between patients who received single agent quizartinib and those who received salvage chemotherapy. The most common adverse events (>30 percent, any Grade) in patients treated with quizartinib included nausea, thrombocytopenia, fatigue, musculoskeletal pain, pyrexia, anemia, neutropenia, febrile neutropenia, vomiting and hypokalemia.

About Quizartinib

Quizartinib, the lead investigational agent in the AML Franchise of the Daiichi Sankyo Cancer Enterprise, is an oral selective FLT3 inhibitor currently in phase 3 development for relapsed/refractory FLT3-ITD AML (QuANTUM-R) in the U.S. and EU and newly-diagnosed FLT3-ITD AML (QuANTUM-First) in the U.S., EU and Japan; and phase 2 development for relapsed/refractory FLT3-ITD AML in Japan.

In addition to Orphan Drug designation in Japan, quizartinib has been granted Breakthrough Therapy designation for the treatment of adult patients with relapsed/refractory FLT3-ITD AML and Fast Track designation for the treatment of relapsed/refractory AML by the U.S. Food and Drug Administration (FDA). Quizartinib also has received Orphan Drug designation by both the FDA and the European Medicines Agency (EMA) for the treatment of AML. Quizartinib is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.

About FLT3-ITD Acute Myeloid Leukemia
AML is an aggressive blood and bone marrow cancer that causes uncontrolled growth and accumulation of malignant white blood cells that fail to function normally and interfere with the production of normal blood cells.1 FLT3 gene mutations are one of the most common genetic abnormalities in AML.2 FLT3-ITD is the most common FLT3 mutation, affecting approximately one in four patients with AML.3,4,5,6 Patients with FLT3-ITD AML have a worse overall prognosis, including an increased incidence of relapse, an increased risk of death following relapse, and a higher likelihood of relapse following hematopoietic stem cell transplantation as compared to those without this mutation.7,8

On September 10, 2018 Oncoceutics, Inc. reported the receipt of a Small Business Innovation Research (SBIR) Phase IIB Bridge Award from the National Cancer Institute (NCI) (Press release, Oncoceutics, SEP 10, 2018, View Source [SID1234558366]). The NCI SBIR Bridge Award will allow Oncoceutics to expand and accelerate its clinical trials evaluating ONC201 in patients with a specific type of lethal brain cancer called H3 K27M-mutant glioma.

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The awarded project, "Adaptive Clinical Efficacy Evaluation of ONC201 in Recurrent High-Grade Glioma" (grant number 2R44CA192427-04), builds upon the work supported by previous NCI SBIR Fast-Track grant that supported Oncoceutics’ effort demonstrating the activity of ONC201 in high-grade gliomas, including those with the H3 K27M mutation that is commonly present in the midline region of the brain. Each year, the NCI’s SBIR Development Center presents the Phase IIB Bridge Award to a select number of companies based on NCI and external expert review of the scientific merits and commercial potential of the technology. Awardees are required to allocate third-party investment to match the Bridge funding prior to submitting the funding application which occurred in mid-2017. The NCI Bridge Award will provide $3 million to Oncoceutics to advance the clinical development of ONC201 over the next 3 years.

Patients with H3 K27M-mutant glioma often have significant neurological symptoms from their disease and lack proven therapeutic options other than palliative radiotherapy. However, emerging clinical results have shown that some patients treated with single agent ONC201 have stable disease, have had their tumor shrink, and/or have had improvements in neurological symptoms, such as paralyses of peripheral and cranial nerves. This has been observed in adults and children treated with ONC201, including children with diffuse intrinsic pontine glioma (DIPG), a type of high-grade glioma that almost uniformly (80-90%) harbors the H3 K27M mutation.

"We are extremely pleased to see continued support from the NCI for the ONC201 clinical program in H3 K27M-mutant gliomas based on the clinical activity observed in our Phase II study supported by the Fast-Track SBIR grant," said Patrick Wen, MD, Director, Center For Neuro-Oncology, Dana-Farber Cancer Institute.

"The emerging clinical experience with ONC201 to treat gliomas at our institution and other leading cancer centers around the country is exciting," added said Yazmin Odia, MD MS, Lead Physician of Medical Neuro-Oncology, Miami Cancer Institute. "The dismal prognosis of midline gliomas and the dearth of therapeutic options means that this therapy could be practice-changing for neuro-oncology. We are eager to follow up on the radiographic and clinical improvements in biomarker-defined patients that we have seen with ONC201 as a single agent in our ongoing clinical trials. Future co-operative group efforts between NRG Oncology and the Children’s Oncology Group to test this drug in children and adults with newly diagnosed H3 K27M-mutant midline gliomas are in the planning process."

In addition to the support from the NCI, Oncoceutics has also received support from The Musella Foundation, a non-profit organization that helps brain tumor patients through education, advocacy, and financial support. The Musella Foundation has supported Oncoceutics’ development of ONC201 in high-grade gliomas for several years from bench to Phase II clinical trials. The Musella Foundation, in collaboration with Cancer Commons, Michael Mosier Defeat DIPG Foundation, The Cure Starts Now Foundation and xCures, has committed to contribute at least $1 million in hopes of accelerating the development of ONC201.

"Having represented and supported brain tumor patients’ interests for several decades, it has been frustrating to experience the failures of new treatments that have been developed to impact the outcome of this disease," said Al Musella, Founder and President of the Musella Foundation. "As highlighted in a recent ODAC meeting, the FDA, in collaboration with the NCI, is tasked with determining whether a molecular target is or is not considered substantially relevant to the growth or progression of pediatric cancer. We are excited to work with Oncoceutics that is developing a molecularly targeted agent, ONC201, that demonstrates the potential to advance the concept of Precision Medicine in patients that harbor the H3K27M mutation, a genetic aberration that is considered substantially relevant for the outcome of this disease. We are looking forward to contribute to making this drug available for as many patients as possible."

On September 10, 2018 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus turning cold tumors hot, reported a clinical collaboration with SOLTI, an academic research group dedicated to clinical and translational research in breast cancer (Press release, Oncolytics Biotech, SEP 10, 2018, View Source [SID1234529702]). This clinical collaboration, being sponsored by Oncolytics and facilitated by SOLTI, is a window of opportunity study (WOO) in the neoadjuvant setting for breast cancer. Patients will receive the appropriate standard of care for their cancer subtype plus pelareorep with or without the anti-PD-L1 cancer immunotherapy atezolizumab (Tecentriq). Patients are biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type, to support Oncolytics’ phase 3 study in metastatic breast cancer and is expected in mid 2019.

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"We are thrilled to enter into this collaboration with SOLTI and sponsor this window of opportunity study. We expect that this study will provide additional biomarker and immunological data to support our planned phase three study in metastatic breast cancer," said Matt Coffey, President and CEO of Oncolytics Biotech. "This data should confirm the findings of our phase two study and generate a robust biomarker plan designed to potentially enhance our phase three program. Importantly, it will also generate additional data demonstrating how the promotion of a virally induced inflamed phenotype should synergise with checkpoint inhibitors targeting PD-L1 like atezolizumab."

The study, facilitated by SOLTI, will be coordinated by Dr. Aleix Prat, Head of Medical Oncology at the Hospital Clínic of Barcelona, Associate Professor of the University of Barcelona and the Head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board. SOLTI has a network of more than 300 professionals, mostly medical oncologists, in over 80 hospitals in Spain, Portugal, France and Italy. Final study design and other details will be announced upon enrollment of the first patient, expected around the end of 2018 or very early 2019.

"It has been demonstrated that when reovirus infects a tumor, it promotes the release of immuno-stimulatory signals. This in turn results in the upregulation of PD-L1 on tumor cells and the recruitment of inflammatory immune cells like NK-cells and cytotoxic T-cells to the tumor, which are required prerequisites for checkpoint inhibitors to function effectively. In short, it turns cold tumors hot," said Dr. Prat. "We believe pelareorep can demonstrate the necessary inflamed tumor phenotype to prime tumors for PD-L1 blockade, which could potentially represent a promising form of cancer immunotherapy combination with atezolizumab. Results from this study will seek to establish the virus as an important immuno-oncology agent in breast cancer, which could ultimately support the expansion of pelareorep beyond metastatic breast cancer into first-line therapy."

About Breast Cancer
Breast cancer is the most common cancer in women worldwide, with nearly 1.7 million new cases diagnosed in 2012, representing about 25 per cent of all cancers in women. Incidence rates vary widely across the world, from 27 per 100,000 in Middle Africa and Eastern Asia to 92 per 100,000 in Northern America. It is the fifth most common cause of death from cancer in women, with an estimated 522,000 deaths (6.4 per cent of the total).

Breast cancer starts when cells in the breast begin to grow out of control. These cells usually form a tumor that can often be seen on an x-ray or felt as a lump. The tumor is malignant (cancer) if the cells can grow into (invade) surrounding tissues or spread (metastasize) to distant areas of the body.

Genomic research has led to a better understanding of how genes and proteins classify breast cancer as hormone receptor positive, human epidermal growth factor receptor 2 negative (HR+/HER2-), hormone receptor positive, human epidermal growth factor receptor 2 positive (HR+/HER2+), hormone receptor negative, human epidermal growth factor receptor 2 positive (HR-/HER2+) or triple negative breast cancer (TNBC).

About Pelareorep
Pelareorep, is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus being evaluated for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers.

On September 10, 2018 Innate Pharma SA (the "Company" – Euronext Paris: FR0010331421 – IPH) reported that updated data from ongoing clinical trials evaluating first-in-class antibody, IPH4102, and lead asset, monalizumab, partnered with AstraZeneca/MedImmune, will be presented at the EORTC CLTF* 2018 Meeting in St Gallen, Switzerland, September 27-29, 2018 and at the ESMO (Free ESMO Whitepaper)** 2018 Congress in Munich, Germany, October 19-23, 2018, respectively (Press release, Innate Pharma, SEP 10, 2018, View Source [SID1234529424]). Moreover, Eric Vivier, Chief Scientific Officer, is invited to the ESMO (Free ESMO Whitepaper) Congress as speaker in the Early detection of cancer using minimally invasive biomarkers Special Symposium.

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EORTC CLTF 2018 for IPH4102:

Title: IPH4102 in relapsed/refractory cutaneous T cell lymphoma (CTCL): Results of the first-in-human multicenter phase 1 study
Date and time: September 29, 2018, 8:30 – 9:45
Presentation number: 078
Session: Oral presentation, Session 8 / Treatment and clinical cases
Presenter: Martine Bagot, Principal Investigator and Head of the Dermatology Department at the Saint-Louis Hospital, Paris, France
Location: Olma Messen Hall 9.2, St-Gallen, Switzerland

ESMO 2018 Congress for monalizumab:

Results of a Phase II study evaluating monalizumab in combination with cetuximab in previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN)
Date and time: October 20, 2018, 15:00
Presentation number: 1049PD
Session: Poster Discussion session – Head and neck
Presenter: Jérôme Fayette, Medical Oncologist at the Centre Léon Bérard Lyon, France
Location: Hall B3 – Room 23, ICM München, Munich, Germany
Title: Translational endpoints in patients with metastatic microsatellite-stable colorectal cancer (MSS-CRC) treated with Durvalumab plus Monalizumab (anti-NKG2A)
Date & time: October 20, 2018, 12:30
Presentation number: 1194P
Session: Poster Display session: Biomarkers, Gynaecological cancers, Haematological malignancies, Immunotherapy of cancer, New diagnostic tools, NSCLC – early stage, locally advanced & metastatic, SCLC, Thoracic malignancies, Translational research (ID 259)
Presenter: Jennifer R. Diamond, Associate Professor, Division of Medical Oncology at the Colorado University, Denver, US
Location: Hall A3, Poster Area Networking Hub, ICM München, Munich, Germany

Title: Changes in the innate immune system as early events in cancer
Date & time: October 22, 2018, 15:05 – 15:25
Session: Special Symposium Early detection of cancer using minimally invasive biomarkers
Presenter: Eric Vivier, Chief Scientific Officer of Innate Pharma, Marseille, France
Location: Hall A1 – Room 17, ICM München, Munich, Germany