On February 16, 2018 Immunomic Therapeutics (ITI), pioneering the study of investigational LAMP-based nucleic acid immunotherapy programs, reported that the company will participate at the 2018 BIO CEO & Investor Conference in two events (Press release, Immunomics, FEB 16, 2018, View Source [SID1234524030]):

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Monday, February 12, 2018, 7-9 p.m. EST, New York Marriott Marquis, Manhattan Ballroom

Scientific American Panel: "Hot Topics in Biotech: Cancer at a Crossroads"As new financing models become increasingly complex, immuno-oncology technologies present a promising, but complex landscape. Scientific American is hosting a salon conversation with leading industry experts like ITI focused on immuno-oncology.
Panel participants:
William Hearl, Ph.D., Founder & CEO, ITI
Jeremy Abbate, VP & Publisher, Scientific American
Andrew Marshall, Chief Editor, Nature Biotech
Barbara Ryan, Life Sciences Capital Markets & Strategy Advisor, Financial Communications, CNBC
Cliff Ransom, Executive Editor, Scientific American

Tuesday, February 13, 2018, 2:45 p.m. EST, Gilbert Room, New York Marriott Marquis

Corporate presentation: ITI’s Founder & CEO, William Hearl, Ph.D., will present an overview of the company and its LAMP-Vax technology.
About LAMP-Vax

ITI’s investigational LAMP-Vax platform is thought to work by encoding the Lysosomal Associated Membrane Protein, an endogenous protein in humans. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put LAMP-Vax technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. LAMP is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of LAMP in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for LAMP-Vax therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

On February 16, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that the company is scheduled to present at the 2018 RBC Capital Markets Healthcare Conference at 9:30 AM ET on Wednesday, February 21, 2018 in New York City (Press release, Pacira Pharmaceuticals, FEB 16, 2018, View Source;p=RssLanding&cat=news&id=2332988 [SID1234524038]).

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A live audio webcast of the Pacira presentation can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the presentation date.

Shire has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Shire, 2018, FEB 16, 2018, View Source [SID1234524050]).

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On February 16, 2018 The US Food and Drug Administration (FDA) reported the approval of apalutamide (Erleada, Janssen) for the treatment of patients with nonmetastatic prostate cancer who are at high risk for disease spread because treatment with hormone therapy is not effective and thus their disease is castration resistant (Press release, ChemDiv, FEB 16, 2018, View Source [SID1234524028]).

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Apalutamide.svg

This is the first FDA-approved treatment for nonmetastatic, castration-resistant prostate cancer. It is also the first time the FDA used metastasis-free survival (MFS) as the primary endpoint in its decision making.

"In the trial supporting approval, apalutamide had a robust effect on this endpoint. This demonstrates the agency’s commitment to using novel endpoints to expedite important therapies to the American public," said Richard Pazdur, MD, acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a press statement.

Apalutamide is an orally administered androgen-receptor inhibitor.

The FDA based its new approval on safety and efficacy data from the phase 3 SPARTAN (Selective Prostate Androgen Receptor Targeting With ARN-509) trial. Investigators randomly assigned 806 men to receive treatment with apalutamide (240 mg per day) and 401 to receive placebo; all participants also received hormone therapy, either gonadotropin-releasing hormone analogue therapy or surgical castration.
All of the men had also undergone previous definitive treatment, either surgery or radiotherapy, for prostate cancer, but their PSA scores doubled within 10 months or less following treatment, despite hormone therapy.

Median MFS, which was the primary endpoint, was 40.5 months in the apalutamide group as compared with 16.2 months in the placebo group (P < .001). That translated into a 72% reduction in the relative risk for metastasis or death with the new drug (hazard ratio, 0.28; 95% confidence interval [CI], 0.23 – 0.35).

In addition, the results with apalutamide were superior for all secondary endpoints compared to placebo, including time to metastasis, progression-free survival, and time to symptomatic progression; all were significantly longer with apalutamide (P < .001 for all comparisons).

Dova Pharmaceuticals has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, Dova Pharmaceuticals, 2018, FEB 16, 2018, View Source [SID1234527572]).

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