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

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 9, 2018 Innovent Biologics (Innovent), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, reported that its IND application for IBI188, a fully human anti-CD47 monoclonal antibody (mAb) drug candidate, has been approved by the National Medical Products Administration (NMPA, formerly known as CFDA) for clinical trials (Press release, Innovent Biologics, SEP 9, 2018, View Source [SID1234529358]). Innovent will launch several clinical trials based on this mAb drug to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer. This is the fourth IND approval the company has received this year, including anti-CTLA-4 mAb, anti-RANKL mAb, anti-OX40 mAb and anti-CD47 mAb.

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As one of the key targets in the field of anti-tumor immunotherapy, CD47 is regarded by many experts to have the possibility of becoming the next "star" in the field of immuno-oncology following the ground-breaking success of PD1 / PD-L1 antibodies. The IND approval signals that Innovent’s discovery and development on CD47 has advanced IBI188 as a leading player for this target to enter into clinical development stage.

"Innovent, with a relentless focus on innovation and quality, has developed programs that are advancing into cutting edge drug development frontiers. We hope that through our efforts, we can advance the field of cancer treatment, provide better treatment options to increase patients’ survival rate and improve their quality of life," said Michael Yu, Founder, Chief Executive Officer and Chairman.

"Emerging data suggests that CD47 antibody in combination with other treatments, including anti-PD-1 monoclonal antibodies, could result in higher levels of anti-tumor efficacy. Innovent’s current rich pipeline will allow multiple drug combinations with IBI188 creating many opportunities to achieve breakthroughs in cancer treatment to meet more unmet patient needs in the future," said Dr. Kerry Blanchard, Chief Scientific Officer of Innovent.

CD47 is one of the most important targets in the field of immuno-oncology. The development of anti-CD47 monoclonal antibody has recently attracted much attention. Innovent will be among one of a few companies pursuing the development of an anti-CD47 antibody in the early clinical stage.

About IBI188

IBI188 is an anti-CD47 IgG4 monoclonal antibody developed by Innovent with independent intellectual property rights. Both in vitro and in vivo experiments showed that IBI188 can bind to the CD47 antigen on the surface of tumor cells, block the CD47-SIRPα signaling pathway, inhibit the "Don’t Eat Me" signal, and promote the phagocytosis of tumor cells by macrophages, thereby exerting an anti-tumor effect. It has stronger receptor blocking ability than similar drugs. Innovent will launch several clinical trials to assess its safety and efficacy for multiple tumor types, including non-Hodgkin’s lymphoma and ovarian cancer.

On September 9, 2018. Xspray Pharma reported positive data from a clinical bioequivalence study with the company’s lead product candidate HyNap-Dasa (Press release, Xspray, SEP 9, 2018, View Source [SID1234649534]). The study results confirmed its primary aim to show bioequivalence of an optimized formulation of HyNap-Dasa compared to Sprycel. The data will be instrumental in the design of the planned registration study for an ANDA application.
The completed clinical Phase I study examined HyNap-Dasa’s bioavailability compared to the dasatinib cancer drug, currently marketed as Sprycel for the treatment of chronic myeloid leukemia (CML). In the study, bioavailability of two different tablet formulations of HyNap-Dasa was tested in comparison with Sprycel tablets in 16 healthy subjects. The results are very positive and confirm the validity of Xspray’s patented formulation technology. The planned studies required to take HyNap-Dasa to final registration studies will now be performed as planned. The results also strengthen the potential for additional product candidates in the pipeline being developed with the same technology to reach the market.

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"I am happy to see that the data so strongly confirm our technology. The outcome of this study represents an important milestone for Xspray Pharma as it means that we now can initiate the preparation of the pivotal phase of the clinical program, taking us closer to a commercial launch of HyNap-Dasa. Furthermore, the results pave the way also for additional product candidates in our pipeline. It signifies a new and important step in our development as a company" said Per Andersson, CEO of Xspray Pharma.

The clinical results in summary:

The study compared the pharmacokinetic parameters Cmax and AUC for the originator product Sprycel and two different HyNap tablet formulations of dasatinib. Sixteen healthy volunteers received single doses of each product in a cross-over design. Although this study was not powered to demonstrate formal bioequivalence, an analysis of preliminary data indicate that bioequivalence with Sprycel was achieved for one of the HyNap formulations. The results demonstrate a high likelihood that formal bioequivalence will be achieved in an adequately powered study.

Sprycel is a registered trademark of Bristol-Myers Squibb.

On September 7, 2018 Amgen (NASDAQ : AMGN ) reported that it will present at the Morgan Stanley Global Healthcare Conference at 9:20 a.m. ET on Wednesday, Sept. 12, 2018, in New York City (Press release, Amgen, SEP 7, 2018, View Source [SID1234529359]). Robert A. Bradway, chairman and chief executive officer at Amgen, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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