On February 12, 2019 Alligator Bioscience reported that it will publish its report for the year ended 31 December 2018 (Press release, Alligator Bioscience, FEB 12, 2019, https://alligatorbioscience.se/en/alligator-bioscience-to-host-conference-call-to-provide-year-end-report-2018-business-update/ [SID1234538670]). All interested parties are invited to participate in a telephone conference, which will include a presentation of the Year-end Report, on the same day at 09:00 a.m. CET. The event will be hosted by CEO Per Norlén and the presentation will be held in English.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

When: 09:00 a.m. CET Thursday 14 February 2019

Listen to the presentation: View Source

To participate in the telephone conference, please use the dial in details shown below:
SE: +46856642692
UK: +443333009266
US: +18338230590

The conference call will be made available on the company’s website after the call: View Source

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

On February 12, 2019 Yuhan Corporation (000100.KS; Yuhan) and Sorrento Therapeutics (Nasdaq: SRNE) reported that ImmuneOncia, a joint venture formed in September 2016, has completed a private equity financing of $40 million USD at a pre-money valuation of $95 million USD, which was led by Paratus SP (Private Equity Fund) (Press release, Sorrento Therapeutics, FEB 12, 2019, View Source [SID1234533284]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The proceeds of the transaction will be utilized to advance ImmuneOncia’s Phase I and II clinical studies of IMC-001, a PD-L1 monoclonal antibody, as well as to support its earlier stage programs. As a result of this financing, ImmuneOncia is expected to be sufficiently funded in preparation for an initial public offering, which is expected to occur in 2021.

This investment from Paratus SP was made in recognition of ImmuneOncia’s R&D capabilities, strong management team and its growth potential based on the market trends in the global immuno-oncology landscape.

"Our R&D and clinical studies have been progressing on schedule. This cash infusion allows us to move IMC-001 forward to the next stage of development," said Yun Jeong Song, M.D., CEO of ImmuneOncia Therapeutics, Inc.

"We are pleased with the continued progress made by our joint venture over the past year," added Dr Henry Ji, Chairman and CEO of Sorrento Therapeutics. "This latest $40 million USD investment by Paratus SP validates the potential of our antibody therapies in international markets."

As of the closing of the financing, equity stakes in ImmuneOncia include Yuhan at 36.1%, Sorrento at 34.6% and Paratus SP at 29.3%.

About IMC-001 (PD-L1 monoclonal antibody)

IMC-001 is a fully human anti-PD-L1 monoclonal antibody (mAb) immune checkpoint inhibitor. The mAb blocks the interaction of PD-L1 protein with its receptor PD-1, then suppressing the inhibition of PDL1 signal to T cells and enhancing the killing effect of T cells on tumors. This antibody also kills cancer cells through traditional antibody-dependent cell-mediated cytotoxicity (ADCC) recruiting natural killer (NK) cells and other effector cells against the tumor and potentially further strengthening the anti-tumor effect of the antibody.

On February 12, 2019 Dynavax Technologies Corporation (NASDAQ: DVAX), a fully-integrated biopharmaceutical company focused on discovering and developing novel vaccines and immuno-oncology therapeutics, reported that will report its fourth quarter and full year 2018 financial results on Tuesday, February 26, 2019, after the U.S. financial markets close (Press release, Dynavax Technologies, FEB 12, 2019, View Source [SID1234533267]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Dynavax will host a conference call and live audio webcast on Tuesday, February 26, 2019, at 4:30 p.m. (ET)/1:30 p.m. (PT).

The live audio webcast may be accessed through the "Events &Presentations" page in the "Investors" section of the company’s website at www.dynavax.com. Alternatively, participants may dial (877) 423-9813 (domestic) or (201) 689-8573 (international) and refer to conference ID 13687416.

The archived conference call will be available on Dynavax’s website beginning approximately two hours after the event and will be archived and available for replay for at least 30 days after the event.

On February 12, 2019 Blue Earth Diagnostics, a leading molecular imaging diagnostics company, reported that the first commercial production of Axumin (fluciclovine (18F)) in Italy occurred recently, with the first Italian patients being dosed (Press release, Blue Earth Diagnostics, FEB 12, 2019, View Source [SID1234533250]). 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 Italy, France, Norway, the Czech Republic, The Netherlands, United Kingdom and Austria with further European countries set to follow soon.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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, and Blue Earth is committed to maximizing access to Axumin to clinicians and their patients across Europe. Today’s announcement is key milestone towards our goal."

On February 12, 2019 BioPharma (LSKB, Company) reported it has reached the pre-specified number of events required for unblinding and analysis of the primary endpoint of overall survival in the ANGEL study, a global Phase III clinical trial, which is evaluating the safety and efficacy of rivoceranib (also known as apatinib) in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, FEB 12, 2019, View Source [SID1234533268]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Reaching the primary completion date in our global pivotal trial is an important milestone in the development of rivoceranib" said Scott Houston, Vice President of Clinical Development, "Outside of China, where apatinib is marketed, there is no small-molecule angiogenesis inhibitor approved for gastric cancer. We believe it will be the first such drug available for these patients worldwide."

The Company, which has conducted pre-submission meetings with FDA and EMA in the last month, will now focus on completion of database lock activities and subsequent data analysis with an expectation that the top-line, unblinded safety and efficacy data will be reported in the middle of this year. LSKB further expects to complete preparations in the second half of this year for filing marketing authorizations applications in several territories worldwide, including the US.

About Rivoceranib (Apatinib)
Rivoceranib is the first successful small-molecule angiogenesis inhibitor in gastric cancer. Rivoceranib acts by inhibiting angiogenesis, a critical process in cancer growth and proliferation. Specifically, rivoceranib selectively inhibits VEGFR-2 which mediates the primary pathway for tumor-mediated angiogenesis. It was approved in China (advanced gastric cancer, Dec 2014) where it is marketed by the Chinese-territory license-holder Jiangsu Hengrui Medicine Co., Ltd. LSK BioPharma holds the global rights (ex-China). The Company is currently conducting a global (12 countries including US, Japan, Korea, Italy, Germany, and Russia) Phase 3 clinical trial of rivoceranib in advanced or metastatic gastric cancer patients. Rivoceranib has been clinically tested in over 1,000 patients worldwide and has demonstrated efficacy in numerous cancers including gastric cancer, CRC, HCC, NSCLC, esophageal cancer, thyroid cancer, mesothelioma, and neuroendocrine tumors. It has also shown potential to significantly improve clinical outcomes in combination with chemotherapeutics and immunotherapy, as well as for maintenance therapy. LSKB has received notification designating rivoceranib as an orphan medicinal product for the treatment of gastric cancer from the European Commission in the European Union, the US FDA, as well as the MFDS in South Korea.