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

On September 10, 2018 Boehringer Ingelheim reported that Dr Christopher Corsico, Senior Vice President, Corporate Division Medicine and Chief Medical Officer, will be leaving Boehringer Ingelheim to pursue his career outside of the company effective 31 December 2018 (Press release, Boehringer Ingelheim, SEP 10, 2018, View Source [SID1234529413]). Dr Thor Voigt, currently Medical Director Germany, has agreed to assume the leadership of the Corporate Division Medicine and to become Chief Medical Officer, effective October 1, 2018.

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Dr. Thor Voigt
Allan Hillgrove, Member of the Board of Managing Directors with responsibility for the Human Pharma Business Unit said: "We are grateful to Dr Corsico for his valuable contributions during many years of service for Boehringer Ingelheim. He has been instrumental for Boehringer Ingelheim’s drive for medical and patient focus. On behalf of the Board of Managing Directors I wish him all the best for the future." Allan Hillgrove further commented: "We are pleased to appoint Thor Voigt as Chief Medical Officer and Head of our Corporate Division Medicine. Dr Voigt is a highly respected and trusted leader who has taken multiple roles within Boehringer Ingelheim’s medical division in recent years."

Dr. Christopher Corsico
Christopher Corsico joined Boehringer Ingelheim in April 1998 as a Pharmacovigilance Physician, followed by the positions of US Pharmacovigilance Head, US Regulatory Head, and Regional Medical Director for North America. In 2012, he became Head of Corporate Division Quality, Regulatory, Pharmacovigilance and Epidemiology (QRPE) and Medicine, before he took over his current role in 2016.

Thor Voigt joined Boehringer Ingelheim in 1992 and was appointed to his current role in 2015. Prior to his current role, Thor was Medical Director in the Netherlands and the USA and Global Head of Clinical Operations. Thor holds a medical degree from University of Mainz, Germany.

Boehringer Ingelheim

Improving the health and quality of life of patients is the goal of the research-driven pharmaceutical company Boehringer Ingelheim. The focus in doing so is on diseases for which no satisfactory treatment option exists to date. The company therefore concentrates on developing innovative therapies that can extend patients’ lives. In animal health, Boehringer Ingelheim stands for advanced prevention.

Family-owned since it was established in 1885, Boehringer Ingelheim is one of the pharmaceutical industry’s top 20 companies. Some 50,000 employees create value through innovation daily for the three business areas human pharmaceuticals, animal health and biopharmaceuticals. In 2017, Boehringer Ingelheim achieved net sales of nearly 18.1 billion euros. R&D expenditure, exceeding three billion euros, corresponded to 17.0 per cent of net sales.

As a family-owned company, Boehringer Ingelheim plans in generations and focuses on long-term success. The company therefore aims at organic growth from its own resources with simultaneous openness to partnerships and strategic alliances in research. In everything it does, Boehringer Ingelheim naturally adopts responsibility towards mankind and the environment.

On September 10, 2018 ERYTECH Pharma (Euronext: ERYP – Nasdaq: ERYP), a clinical-stage biopharmaceutical company developing innovative therapies by encapsulating drug substances inside red blood cells, reported its financial results for the quarter ended June 30, 2018 (Press release, ERYtech Pharma, SEP 10, 2018, View Source;p=RssLanding&cat=news&id=2366796 [SID1234529397]).

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"In the first half of 2018, we completed our strategic transition towards solid tumor indications of high unmet medical need," said Gil Beyen, Chief Executive Officer at ERYTECH. "Specifically, we are excited that our pivotal Phase 3 trial with eryaspase in second line pancreatic cancer is open for enrollment. In addition, we are launching a Phase 2 trial in a first line triple-negative breast cancer, our second solid tumor indication and patient enrollment is expected to begin in the fourth quarter of this year. With both trials on track, we are expanding our teams and manufacturing capacity in Europe and the United States to support the anticipated clinical demand for product supply. Simultaneously, we are advancing our preclinical programs."

Business Highlights

Following the positive Phase 2b results with its lead product candidate eryaspase in second line metastatic pancreatic cancer and feedback from the U.S. Food and Drug Administration (FDA) and the Commission for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA), ERYTECH has initiated activities on a pivotal Phase 3 trial in the same indication during the first half of this year. The study, named TRYbeCA1, is on track for first patient enrollment before the end of the third quarter. Clinical trial authorizations and ethical committee approvals have been received in different European countries and the first clinical sites have been opened. Start of patient enrolment in the United States is expected early next year. The TRYbeCA1 trial is evaluating eryaspase in combination with standard chemotherapy (gemcitabine/paclitaxel or irinotecan-based regimen) compared to standard chemotherapy alone in approximately 500 patients at 120-130 sites within the United States and Europe. The primary endpoint is overall survival (OS). An interim analysis is foreseen when approximately two-thirds of events have occurred.

In February, the Company selected triple-negative breast cancer (TNBC) as the next solid tumor indication for the development of eryaspase. A Phase 2 proof-of-concept clinical trial, TRYbeCA2, has been designed. The TRYbeCA2 trial will evaluate eryaspase in combination with gemcitabine and carboplatin, compared to chemotherapy alone, in approximately 65 previously untreated patients with metastatic TNBC in Europe and the United States. The primary endpoint will be objective response rate. Set up activities are ongoing and start of patient enrollment is expected around year end.

In order to ensure adequate supply of eryaspase for its planned clinical trials, as well as the anticipated initial commercial needs of eryaspase, if approved in these larger indications, the Company is establishing a manufacturing facility in the United States (Princeton, New Jersey) and is also expanding its manufacturing capacity in Lyon, France.

In May, the Company announced the expansion of its executive management team with the addition of Alex Dusek as VP of Commercial Strategy to lay the groundwork for planned commercial launch and ensure commercial product preparedness, primarily in the United States. He brings over 25 years of experience including commercial strategic roles at Argos Therapeutics, Bayer and United Therapeutics.

In June, the Company announced that it would cease the development of eryaspase in acute lymphoblastic leukemia (ALL) and confirmed its strategic shift to solid tumors. The resources that become available as a result of this decision will be utilized to broaden the development in selected solid tumors where metabolic pathways are activated, including in other settings in pancreatic cancer. ERYTECH believes that the solid tumor indications being pursued represent a significantly larger market opportunity than ALL.

Several preclinical programs, all leveraging the Company’s proprietary ERYCAPS encapsulation platform, are ongoing. The Company’s next product candidate, erymethionase, methionine-gamma-lyase encapsulated in red blood cells, is also targeting solid tumor indications. Erymethionase recently completed non-clinical development and activities in support of initiating a Phase 1 clinical trial are ongoing. ERYMMUNE, the Company’s immuno-oncology program, and ERYZYME, the encapsulation of enzymes used in therapies to treat metabolic diseases, are also progressing.
Financial Highlights

Net loss for the six-month period ended June 30, 2018 was €19.0 million, compared to €14.1 million in the same period of 2017. The €4.9 million increase was primarily attributable to:
An increase in R&D expenses by €4.7 million, mostly related to the Company’s intensified clinical and regulatory activities (€2.9 million), as well as the continued increase (€1.7 million) in preclinical research activities.
An increase in G&A expenses by €3.5 million, reflecting the continued structuring of the company (€2.5 million) and the increased costs associated with becoming a public company in the U.S. (€1.0 million).
The accounting of a €2.9 million financial income, as the Company’s cash position denominated in euros was impacted by the positive currency exchange variation in the period of the U.S. dollar against the euro in the overall period.

As of June 30, 2018, ERYTECH had cash and cash equivalents totaling €165.4 million, compared with €185.5 million as of December 31, 2017. The €20.1 million decrease in total cash and cash equivalents in the six-month period comprised a total net cash utilization of €22.5 million for operating, investing and financing activities, and a €2.4 million favorable foreign exchange impact on the Company’s cash position denominated in U.S. dollars, related to the appreciation of the U.S. dollar against the Euro in the first half of 2018. The company expects an increase in cash utilization in the second half of 2018, associated with the execution of the clinical plan and the related manufacturing capacity investments.
Key Upcoming Milestones

First patient in the pivotal Phase 3 clinical trial in second-line pancreatic cancer in Europe and the United States

First patient in the Phase 2 proof-of-concept clinical trial in TNBC

Completion of CMC activities with erymethionase in preparation of the start of a Phase 1 clinical trial
Second Quarter Results 2018 Conference Call Details

As a reminder, ERYTECH management will hold a conference call and webcast on Tuesday, September 11, 2018 at 02:30pm CET / 08:30am EDT to discuss business highlights and financial results for the second quarter of 2018. Gil Beyen, Chairman and CEO, Eric Soyer, CFO and COO and Iman El-Hariry, CMO will host a brief presentation, followed by a Q&A session.

The call is accessible via the below teleconferencing numbers, followed by the Conference ID#: 4983808#

USA/Canada: +1 (833) 818-6807 France: +33 176748988
International Dial-In Number: +1 (409) 350-3501 United-Kingdom: +44 2031070289
The webcast can be followed live online via the link: View Source

An archived replay of the call will be available for 7 days by dialing + 1 800 585 8367, Conference ID: 4983808#.

2018 Financial Calendar:

Business Update and Financial Highlights for the third quarter of 2018: November 12, 2018 (after U.S. market close), followed by a conference call and webcast on November 13, 2018 (2:30pm CET/8:30am ET)
Upcoming Investor Conferences:

Morgan Stanley Healthcare Conference, September 13, New York

BoursoCap, September 18, Paris

Midcap Event Paris, October 9, Paris

Jefferies Healthcare Conference, November 14-15, London

Actionaria, November 22-23, Paris