On April 8, 2019 Curis, Inc. (Nasdaq: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that it has begun dosing patients in the 5th cohort (200mg BID; total daily dose of 400mg) in the Phase 1 trial of CA-4948, an orally available small molecule inhibitor of IRAK4, for treatment of patients with non-Hodgkin lymphoma, including those with MYD88 alterations (Press release, Curis, APR 8, 2019, View Source [SID1234535043]).

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"This is an important milestone in the execution of our clinical program," said James Dentzer, the Company’s President and Chief Executive Officer. "Last fall, we re-organized the company to heighten focus on clinical execution and laid out an aggressive goal to advance to the 5th cohort (200mg BID) in time for a midyear 2019 release of initial data. We are pleased to announce that we have begun dosing the 5th cohort sooner than expected and we re-iterate our plan to report initial clinical data this summer."

About CA-4948, a Small-Molecule Inhibitor of IRAK4

Innate immune responses orchestrated through Toll-like receptors or certain interleukin receptors are important mediators of the body’s initial defense against foreign antigens, while their dysregulation is associated with certain inflammatory conditions. Toll-like receptor and interleukin receptor signaling through the adaptor protein MYD88, results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the transcription factor NFκB. More recently, components of this pathway are recognized to be genetically altered and have important roles in specific human cancers. MYD88 gene mutations are shown to occur in approximately 30% of Activated B-Cell (ABC) subtype of diffuse large B-cell lymphomas (DLBCL)1,2 and in over 90% of the B-cell malignancy Waldenstrom’s macroglobulinemia.3 Due to IRAK4’s central role in these signaling pathways, it is considered an attractive target for generation of therapeutics to treat these B-cell malignancies as well as certain inflammatory diseases.

1 Nature. 2011; 470(7332):115–119
2 Immunology and Cell Biology. 2011; 89(6):659–660
3 N Engl J Med. 30, 2012; 367(9):826–833

On April 8, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that the first patient has been treated in the AWARE-1 window of opportunity (WOO) study that is being conducted in collaboration with SOLTI, an academic research group dedicated to clinical and translational research in breast cancer (Press release, Oncolytics Biotech, APR 8, 2019, View Source [SID1234535041]). Patients will receive the appropriate intervention for their breast cancer sub-type, plus pelareorep, with or without Tecentriq (atezolizumab), followed by surgery.

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"We are pleased to have treated the first patient in our window of opportunity study that will yield important results confirming both our recently identified biomarker and pelareorep’s ability to prime an antitumor immune response," said Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech. "This short study could significantly de-risk our late-stage metastatic breast cancer program, resulting in a smaller, less expensive study with a higher likelihood of success. Beyond the biomarker data, the study will also inform whether we should add a checkpoint inhibitor arm to the phase three registration study. We look forward to initial data from this study in this highly-prevalent cancer indication later this year."

This study, which is being sponsored by Oncolytics and facilitated by SOLTI, is a WOO study in the early treatment setting for breast cancer. Patients will receive the appropriate intervention for their breast cancer sub-type plus pelareorep, with or without Tecentriq. Patients are biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their mastectomy. The study is being 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.

Pelareorep received FDA Fast Track Designation for the treatment of metastatic breast cancer in May 2017.

About Pelareorep
Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus 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 and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On April 8, 2019 4SC AG (4SC, FSE Prime Standard: VSC) reported preclinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2019 that confirm domatinostat’s mode of action in Merkel cell carcinoma (MCC) (Press release, 4SC, APR 8, 2019, View Source [SID1234535040]). The data were presented by Prof. Dr. Dr. Jürgen C. Becker, Department of Translational Skin Cancer Research at the University Hospital Essen, Germany, German Cancer Consortium (DKTK) and German Cancer Research Center (DKFZ), Heidelberg, Germany. The AACR (Free AACR Whitepaper) Meeting took place at the Georgia World Congress Center in Atlanta, USA, from 29 March to 3 April 2019.

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Merkel cell carcinoma – tumor cells hide from the immune system

MCC is a rare, highly aggressive skin cancer often caused by either infection with Merkel cell polyomavirus or extensive UV exposure. Patients suffer from rapidly enlarging nodules that are between 0.5 and 5 cm in diameter, while the tumor aggressively spreads through the blood vessels to lymph nodes and many organs.

Although immune checkpoint inhibitors have shown compelling clinical activity in MCC, in some patients the tumor cells are very adept at evading the immune system. The tumor cells and its microenvironment prevent immune cells from entering the tumor and limit the presentation of tumor-signals on their surface. For these patients, refractory to or relapsing on checkpoint inhibitor therapy, currently no further treatment options are available.

Prof. Dr. Dr. Jürgen C. Becker explained: "In previous experiments we demonstrated that the immune escape mechanisms of MCC cells were epigenetically reversible1. Therefore, we were highly interested in testing the effect of 4SC’s domatinostat, an orally available, epigenetically active small molecule inhibitor targeting histone deacetylases class I, on MCC cell lines.

"Our new data demonstrate that domatinostat increased the presentation of tumor signals on the cells’ surface, stopped MCC cells from dividing and even induced cell death. All these effects were specific for MCC cell lines and did not occur in healthy control cells."

Frank Hermann, M.D., Chief Development Officer of 4SC, said: "We thank our collaborators for the dedication and energy devoted to their research with domatinostat. The fact that domatinostat counteracts the immune escape of MCC at different levels suggests that the combination of domatinostat with checkpoint inhibitors is potentially a promising therapeutic strategy in MCC and we plan to initiate a potentially pivotal clinical trial later this year."

Abstract ID 2368: Domatinostat increases apoptosis, G2M cell-cycle arrest and immunogenicity of Merkel cell carcinoma

The poster is available on 4SC’s website.

Reference:

1 Epigenetic priming restores the HLA class-I antigen processing machinery expression in Merkel cell carcinoma. C. Ritter, K. Fan, A. Paschen, S. Reker Hardrup, S. Ferrone, P. Nghiem, S. Ugurel, D. Schrama, and J. C. Becker. Sci Rep. 2017 May 23;7(1):2290. doi: 10.1038/s41598-017-02608-0

On April 8, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company plans to release its first-quarter 2019 financial results after the close of the U.S. financial markets on Apr. 30, 2019 (Press release, Exact Sciences, APR 8, 2019, View Source [SID1234535039]). Following the release, company management will host a webcast and conference call at 5 p.m. ET to discuss financial results and business progress.

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First-Quarter 2019 Webcast & Conference Call Details

Date:

Tuesday, Apr. 30, 2019

Time:

5 p.m. ET, 4 p.m. CT

Webcast:

The live webcast can be accessed at www.exactsciences.com

Telephone:

Domestic callers, dial 877-201-0168
International callers, dial +1 647-788-4901
Access code for both domestic and international callers: 4989449

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4989449. The webcast, conference call and replay are open to all interested parties.

On April 8, 2019 Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, reported that the company is scheduled to present an update on the company’s programs and progress at the following upcoming conferences (Press release, Trillium Therapeutics, APR 8, 2019, View Source [SID1234535037]):

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Investor Conferences:

H.C. Wainwright Global Life Sciences Conference

Presenter: Dr. Niclas Stiernholm, Chief Executive Officer

Date and Time: April 9, 2019 at 3:10 p.m. BST

Location: Grosvenor House, London

18th Annual Needham Healthcare Conference

Presenter: Dr. Bob Uger, Chief Scientific Officer

Date and Time: April 10, 2019 at 12:00 p.m. ET

Location: Westin Grand Central Hotel, New York City

A live audio webcast of the H.C. Wainwright Global Life Sciences Conference presentation will be available under the investor relations section of Trillium’s website at www.trilliumtherapeutics.com.