On April 5, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that it has initiated its rolling submission of a Biologics License Application (BLA) for SL-401 to the U.S. Food and Drug Administration (FDA) (Press release, Stemline Therapeutics, APR 5, 2018, View Source [SID1234532232]). SL-401 is a targeted therapy directed to CD123 that has been granted Breakthrough Therapy designation (BTD) by the FDA.

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Ivan Bergstein, MD, CEO of Stemline, commented, "The start of our rolling BLA submission is a major milestone for Stemline and the BPDCN patient community at large. If successful, SL-401 would be the first drug ever approved for BPDCN. Moreover, we believe that SL-401 may have a transformative impact on the outcomes of patients with this lethal malignancy of high unmet medical need. With this in mind, our clinical, regulatory, manufacturing, and commercial teams continue to work expeditiously to bring SL-401 to patients as quickly as possible."

On April 5, 2018 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF), a biotech company developing REOLYSIN (pelareorep), an intravenously delivered immuno-oncolytic virus creating an inflamed phenotype, reported that it will be presenting at the MicroCap Conference, being held at the Essex House in New York City on April 9 – 10, 2018 (Press release, Oncolytics Biotech, APRIL 5 2018, View Source [SID1234525207]). The Company’s presentation will be on April 10th at 8:30 am ET.

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Dr. Matt Coffey, President & Chief Executive Officer, will present a corporate overview, focusing on pelareorep’s mechanism of action and the Company’s lead program in HR+/HER2- metastatic breast cancer. The presentation will also describe Oncolytics’ pipeline expansion programs, focusing on combination therapies of REOLYSIN with other immuno-oncology drugs, including Merck’s Keytruda and targeted immunomodulatory drugs, including Celgene’s Revlimid and Imnovid.

The MicroCap Conference is an exclusive event for investors who specialize in small and microcap stocks. It is an opportunity for investors to be introduced to and speak with management at some of the most attractive small companies, learn from various expert panels, and mingle with other microcap investors.

A live audio link to the webcast session will be available on the Company’s website at View Source It is recommended that listeners log on 10 minutes in advance of a live session to register and download any necessary software. An audio replay will be accessible approximately two hours following the presentation on the Oncolytics website.

On April 5, 2018 Aeglea BioTherapeutics, Inc. (NASDAQ:AGLE), a clinical-stage biotechnology company that designs and develops innovative human enzyme therapeutics for patients with rare genetic diseases and cancer, reported that it will present Phase 1 dose escalation data regarding the use of the Company’s pegzilarginase in patients with advanced solid tumors at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) in Chicago, Illinois on Sunday, April 15 (Press release, Aeglea BioTherapeutics, APR 5, 2018, View Source [SID1234525187]).

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Title: Phase I Dose Escalation Trial of Pegzilarginase in Patients with Advanced Solid Tumors

Session Title: Phase I Clinical Trials 1

Session Date and Time: Sunday, April 15, 1:00 p.m. to 5:00 p.m. CT

Session Location: McCormick Place South, Hall A, Poster Section 42

Poster Board Number: 23

Permanent Abstract Number: CT030

An electronic version of the presentation will be available for download from the Presentations & Events section of the Company’s investor relations website after the poster presentation.

About Pegzilarginase (AEB1102) in Cancer
Pegzilarginase is an enhanced human arginase that enzymatically degrades the amino acid arginine. In some cancers, tumor cells stop producing specific amino acids and must acquire them from the blood, making the tumor cells susceptible to starvation through depletion of those amino acids. Aeglea is developing pegzilarginase to exploit vulnerabilities in some cancers that lead to an increased dependency on extracellular arginine. Pegzilarginase targets these arginine dependent cancers by depleting blood arginine levels to below the normal range. Preclinical data demonstrated that the resulting arginine starvation inhibits proliferation, induces cell death, increases turnover of cell components and promotes anti-tumor immune responses. The Company’s Phase 1 data in advanced solid tumors demonstrated that pegzilarginase was well tolerated at doses that produced marked and sustained reductions in blood arginine levels below the normal range.

On April 5, 2018 FORMA Therapeutics reported that it has successfully completed a critical objective under its strategic collaboration agreement with Celgene Corporation, triggering an undisclosed payment from Celgene (Press release, Forma Therapeutics, APR 5, 2018, View Source [SID1234525190]). Previously, FORMA and Celgene entered into a collaboration in the promising area of protein homeostasis to discover, develop and commercialize innovative drug candidates. This collaboration enables Celgene to evaluate select therapeutic candidates and programs in protein homeostasis during preclinical development.

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Jim Winkler, Ph.D., Vice President, Biology at FORMA Therapeutics said, "We are pleased with Celgene’s continued confidence in FORMA’s discovery research. This program represents a potential first-in-class therapeutic mechanism, by conferring both anti-tumor and immune-modulatory effects. We believe the field of protein homeostasis will deliver a promising pipeline of drugs, moving beyond cancer into immuno-oncology, inflammation and neurodegeneration."

About Protein Homeostasis

Protein homeostasis, which is important in oncology, neurodegenerative and other disorders, involves a tightly regulated network of pathways controlling the biogenesis, folding, transport and degradation of proteins. Exploring the maintenance and regulation of such competing, yet integrated, biological pathways using a chemical biology approach, should directly contribute to the understanding of diseases associated with excessive protein misfolding, aggregation and degradation

On April 5, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that it will report its first quarter financial results on Thursday, April 26, 2018 after the close of financial markets (Press release, Seattle Genetics, APR 5, 2018, View Source;p=RssLanding&cat=news&id=2341209 [SID1234525192]). Following the results announcement, company management will host a conference call and webcast discussion of the results and provide a general corporate update. Access to the event can be obtained as follows:

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LIVE access on Thursday, April 26, 2018

1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time

Telephone 800-263-0877 (domestic) or +1 646-828-8143 (international); conference ID 9171561
Webcast available at www.seattlegenetics.com in the Investors section
REPLAY access

Telephone replay will be available beginning at approximately 4:30 p.m. PT on Thursday, April 26, 2018 through 5:00 p.m. PT on Monday, April 30, 2018 by calling 888-203-1112 (domestic) or +1 719-457-0820 (international); conference ID 9171561
Webcast replay will be available on the Seattle Genetics website at www.seattlegenetics.com in the Investors section