On December 12, 2018 Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company focused on the development and ultimate commercialization of drug candidates for both oncology and rare disease indications characterized by small, well-defined patient populations with serious unmet needs, reported that it plans to release an update on clinical data from the ongoing Phase 2 trial of the combination of intratumoral tilsotolimod and ipilimumab for unresectable or metastatic melanoma following failure of anti-PD-1 inhibitor treatment prior to the opening of the U.S. financial markets on Friday, December 14, 2018 (Press release, Idera Pharmaceuticals, DEC 12, 2018, View Source [SID1234532053]).

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The company will host a conference call and live webcast, Friday, December 14 at 10:00 A.M. EST to review the data being presented along with a questions and answers session.

Investor Webcast Details
To participate in the conference call, please dial (844) 882-7837 (domestic) and (574) 990-9824 (international). The webcast can be accessed live or in archived form in the "Investors" section of the company’s website at www.iderapharma.com. The company will be posting a slide presentation to the Idera corporate website in the "Investors" section which will be referenced during the conference call.

Live audio webcast of Idera’s presentations will be accessible in the Investors and Media section of Idera’s website at View Source Archived versions will also be available on the Company’s website after the event for 90 days.

On December 12, 2018 BerGenBio ASA (OSE:BGBIO) presented DNB Healthcare Conference 2018 (Presentation, BerGenBio, DEC 12, 2018, View Source [SID1234532110]).

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On December 12, 2018 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in France occurred recently, with the first French patients being dosed (Press release, Blue Earth Diagnostics, DEC 12, 2018, View Source [SID1234532031]). Axumin is a novel molecular imaging agent approved in the European Union for use in PET imaging to detect and localize prostate cancer in men experiencing suspected recurrence based on elevated blood prostate specific antigen (PSA) levels after primary curative treatment. Axumin is the first and only PET imaging agent approved by the European Commission for use in men with suspected recurrent prostate cancer in all European Union member states as well as in Iceland, Liechtenstein and Norway. Axumin is commercially available in France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

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Prostate cancer is a leading cause of cancer death in men. While most primary prostate cancer can be successfully treated, recurrence occurs in up to one-third of patients. Recurrent disease is typically detected by a rise in PSA levels but often the location and extent of the disease cannot be detected by conventional imaging. Of those who suffer biochemical recurrence, approximately one-third develop metastatic prostate cancer. Axumin was developed to target the increased amino acid transport that occurs in many cancers, including prostate cancer. It is labelled with the radioisotope (18F), enabling it to be visualized in the body with PET imaging.

Dr. Jonathan Allis, Chief Executive Officer of Blue Earth Diagnostics said, "Detection and localization of recurrent prostate cancer is a significant unmet medical need. Today’s announcement signifies Blue Earth Diagnostics’ commitment in maximizing access to Axumin for clinicians and their patients across Europe and a key milestone towards our goal."

On December 11, 2018 Athenex, Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer, reported that its global Phase 1b clinical trial of Oraxol (oral paclitaxel plus HM30181A) plus ramucirumab (monoclonal antibody to VEGF-R2) in gastric cancer patients who failed previous chemotherapies has completed the study of the second cohort of patients (Press release, Athenex, DEC 11, 2018, View Source;p=RssLanding&cat=news&id=2380209 [SID1234532013]). The results indicated strong positive signals of efficacy and the treatment was well tolerated.

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In the first cohort of six patients treated with a 200 mg/kg dose of Oraxol, partial responses were observed in 2/6 patients (33.3%) and stable disease observed in 1/6 patient (16.7%). There was one severe adverse event (SAE) of grade-4 neutropenia in one patient who had complete recovery from this event.

Athenex now reports that for the second cohort of six patients on an escalated Oraxol dose of 250 mg/kg, partial response, according to RECIST criteria, occurred in 3 patients (50%). There was one SAE of grade-3 vomiting in one patient, who elected to withdraw from the study and subsequently had complete recovery. The Oraxol dose is currently being further escalated to 300 mg/kg in the third cohort of patients and the study is ongoing.

"We are pleased by the strong positive signals of efficacy together with a good safety profile in this Phase 1b clinical trial of Oraxol plus ramucirumab in the second-line treatment of gastric cancer patients so far and look forward to further results from the continuation of this study. The results also echoed the strong positive signal that we have observed in other clinical studies of Oraxol as monotherapy for the treatment of metastatic breast cancer," stated Dr. Rudolf Kwan, Athenex’s Chief Medical Officer.

Oraxol is a novel oral formulation of paclitaxel currently in Phase 3 clinical trial in metastatic breast cancer.

Ramucirumab, as a single agent or in combination with paclitaxel, is FDA-approved for the treatment of patients with advanced or metastatic, gastric or gastroesophageal junction (GEJ) adenocarcinoma with disease progression on or after prior fluoropyrimidine- or platinum-containing chemotherapy. Ramucirumab is manufactured and marketed by Eli Lilly and Company under the name CYRAMZA.

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

PharmaEssentia Corp. licensed the Taiwan, Singapore and Vietnam rights of Oraxol from Athenex and is a partner in the development of Oraxol in the territory

On December 11, 2018 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported that the United States Patent and Trademark Office has issued a new method of use patent to Johns Hopkins University related to the Company’s E+E (T cell Enrichment and Enhancement) technology for which NexImmune holds an exclusive license from Johns Hopkins (Press release, NexImmune, DEC 11, 2018, View Source [SID1234554955]). This further enhances the company’s AIM technology intellectual property portfolio and provides broad intellectual property rights protecting key aspects of the company’s lead product AIM ACT, an adoptive T cellular therapy for the treatment of cancer.

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"Using our proprietary E+E technology to generate antigen-specific T cells represents a uniquely differentiated approach to expanding polyclonal T cells that are highly antigen-specific, highly polyfunctional and with a phenotypic composition optimized for anti-tumor cytotoxicity, proliferative capacity and long-term immunologic memory. We believe our AIM E+E generated T cell products have the potential to address some of the clinical limitations observed with currently available genetically modified T cell therapies. Our hope is that these differences translate into meaningful benefit for patients suffering from a variety of hematological malignancies," commented Scott Carmer, Chief Executive Officer of NexImmune. "Ensuring a robust intellectual property position around E+E is inherent to advancing the program and the claims granted in this patent exemplify the novel science behind this exciting technology."

U.S. patent 10,098,939 adds to previously issued U.S. and international counterpart patents and patent applications that form NexImmune’s AIM patent portfolio. Claims were granted on the ability of E+E to expand large numbers of antigen-specific T cells from the body’s endogenous T cell repertoire. Preclinical studies have demonstrated that cells generated using E+E have a large proportion of highly functional central and effector memory T cells which the company believes will provide both a potent immediate therapeutic benefit for cancer patients and an enhanced durability of response compared to currently approved adoptive T cell therapies. NexImmune plans to advance its AIM ACT platform into early phase clinical trials in 2019.