On February 4, 2019 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported that it would present at the 21st Annual BIO CEO & Investor Conference (Press release, Oncolytics Biotech, FEB 4, 2019, View Source [SID1234533035]). The presentation, by Dr. Matt Coffey, President & CEO of Oncolytics, will take place at 2:30 pm ET, on Monday, February 11, 2019, in the Herald/Soho Room at the New York Marriott Marquis.

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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 the 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 February 4, 2019 Exicure, Inc. (OTCQB: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that its CEO, Dr. David Giljohann, will present at the Immuno-Oncology 360° Conference (IO360°) being held February 6-8, 2019 at the Crowne Plaza Times Square in New York City (Press release, Exicure, FEB 4, 2019, View Source [SID1234533037]). Dr. Giljohann’s presentation titled "Innate Immune System Activation with Spherical Nucleic Acids" will occur on Thursday, February 7, 2019 at 4:30 pm EST during the Translational Science & Emerging Biomarkers Part II track.

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On February 4, 2019 Syntrix Pharmaceuticals reported that it has been awarded a three-year grant worth $3.4 million from the National Heart Lung and Blood Institute of the National Institutes of Health to assess its investigational CXCR1/2 inhibitor SX-682 in patients with low- and high-risk myelodysplastic syndrome (MDS) who had progression or were intolerant to prior therapy (Press release, Syntrix, FEB 4, 2019, View Source [SID1234553882]). The phase 1/2 clinical trial will be carried out in collaboration with researchers at the Moffitt Cancer Center led by Dr. Rami Kamrokji.

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"Patients with low-risk MDS have an expected median survival measured in years, but suffer from hematologic deficits and related symptoms that lead to transfusion dependence," said Syntrix’s President John Zebala. "Patients with high-risk MDS have debilitating cytopenias and borderline leukemia, and can have expected survival measured in months."

Only three drugs have received regulatory approval for MDS treatment, all with suboptimal response rates (<50%) and of limited durability (1-2 years). Once these agents fail in patients, there is no second-line treatment. Prognosis after failure is dismal, with median survival estimated at <6 months for higher-risk patients, and <18 months for lower-risk patients.

The Phase 1/2 clinical trial of SX-682 builds on groundbreaking discoveries by investigators at the Moffitt Cancer Center and the Albert Einstein College of Medicine who showed CXCR1/2 is pivotal in MDS and that its inhibition is a therapeutic strategy against the disease.

This Phase 1/2 trial in MDS patients will test the hypothesis that targeting CXCR1/2 with SX-682 will be efficacious in the disease by eliminating the MDS stem cells and bone marrow MDSCs. The FDA approved the protocol for the study in an IND sponsored by Syntrix.

ABOUT SX-682: SX-682 is a clinical-stage oral allosteric small-molecule inhibitor of CXCR1 and CXCR2 (CXCR1/2). Inhibiting both human receptors is believed essential. CXCR1/2 are a combined "master switch" of the immunosuppressive tumor microenvironment. Clinical studies in melanoma, breast, ovarian, prostate and colon cancer have shown a direct correlation between serum levels of CXCR1/2 ligands and disease progression. SX-682 has been validated in all major solid tumor models, where it exhibits mono-agent anti-tumor activity, blocks metastasis, depletes immunosuppressive myeloid cells, activates tumor killing by effector cells, reverses chemo-resistance, and potently synergizes with anti-CTLA-4 and anti-PD1. SX-682 is also being evaluated in solid tumors supported by the National Cancer Institute.

On February 4, 2019 INmune Bio, Inc. ("INmune" or the "Company"), an immunotherapy company focused on developing therapies that harness the patient’s innate immune system to fight disease, reported that the Company’s common stock is expected to commence trading on The Nasdaq Capital Market, on Monday, February 4, 2019 under the ticker symbol "INMB" (Press release, INmune Bio, FEB 4, 2019, View Source [SID1234533090]).

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On February 1, 2019, INmune closed its initial public offering ("IPO") of 1,020,560 shares of its common stock at of $8.00 per share for a total of $8,166,560 in gross proceeds before placement agent fees and offering expenses.

Univest Securities, LLC served as the lead placement agent for the IPO. WallachBeth Capital, LLC and WestPark Capital, Inc. were co-placement agents.

A registration statement relating to this U.S. offering was filed with the Securities and Exchange Commission ("SEC") and was declared effective by the SEC as of December 19, 2018. The offering of the securities was made only by means of a prospectus, forming a part of the registration statement. Copies of the final prospectus relating to the U.S. offering may be obtained from Univest Securities, LLC. 375 Park Avenue Unit 1502, New York, NY 10152, by telephone at +1 212 343 8888 or email at [email protected]. In addition, a copy of the prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On February 4, 2019 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs directed against tumor metabolism and tumor immunology targets for the treatment of cancer, reported that it has completed patient enrollment in the ongoing Phase 2 ENTRATA trial. ENTRATA is a randomized clinical study of the glutaminase inhibitor CB-839 combined with everolimus versus placebo with everolimus for the treatment of advanced renal cell carcinoma (RCC) (Press release, Calithera Biosciences, FEB 4, 2019, View Source [SID1234535231]). CB-839 now has the International Nonproprietary Name (INN) telaglenastat, as recommended by the World Health Organization.

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"The ENTRATA trial is the first randomized trial evaluating the glutaminase inhibitor telaglenastat. There is ample evidence demonstrating the potential of glutaminase inhibition to block growth and survival of cancer cells," said Susan Molineaux, PhD, President and Chief Executive Officer of Calithera. "We are pleased that patient enrollment is now complete and look forward to learning more from ENTRATA about how this promising mechanism could help heavily pre-treated patients with advanced renal cancer."

The ENTRATA trial (NCT03163667) is a Phase 2 randomized, double blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with everolimus versus placebo with everolimus in patients with advanced clear cell RCC who have been treated with at least two prior lines of systemic therapy, including a VEGFR-targeted tyrosine kinase inhibitor. The trial enrolled 69 patients at multiple centers in the United States. The primary endpoint of ENTRATA is progression-free survival (PFS). Calithera plans to report efficacy and safety data from the trial in the second half of 2019.

Telaglenastat is an investigational, novel glutaminase inhibitor specifically designed to block glutamine consumption in tumor cells. RCC tumors commonly exhibit metabolic alterations that increase their dependence on glutamine. In preclinical studies, telaglenastat produced synergistic antitumor effects when used in combination with standard-of-care RCC therapies.

Telaglenastat is also being investigated in the CANTATA trial, which will enroll approximately 400 patients and is designed with registrational intent. It is a global, randomized, double-blind trial designed to evaluate the safety and efficacy of telaglenastat in combination with cabozantinib versus placebo with cabozantinib in patients with advanced clear cell RCC who have been treated with one or two prior lines of systemic therapy. The primary endpoint is PFS by blinded independent review, and a key secondary endpoint is overall survival.