On February 12, 2019 Ascletis Pharma Inc. (Ascletis, 1672.HK) and 3-V Biosciences, Inc. (3-V Biosciences) jointly reported that Ascletis, through its subsidiary, and 3-V Biosciences have entered into an exclusive license agreement for 3-V Biosciences’ FASN (fatty acid synthase) inhibitor TVB-2640 (Ascletis code: ASC40), a first-in-class, Phase 2-ready drug candidate for non-alcoholic steatohepatitis (NASH), in Greater China (Press release, Ascletis, FEB 12, 2019, View Source [SID1234577322]).

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!

In conjunction with the license agreement, 3-V Biosciences raised US$18 million in a Series E financing led by new investor Ascletis, through its subsidiary. Ascletis is joined in this financing by new investor Qianhai Ark (Cayman) Investment Co. Limited and existing investors New Enterprise Associates, Inc. (NEA) and Kleiner Perkins (KP). All investors have committed to fund an additional US$7 million in a subsequent financing. 3-V Biosciences expects to use the proceeds of the financing to support the continued development of TVB-2640, including its Phase 2 trials for NASH in the United States and China.

Under the terms of the license agreement, 3-V Biosciences granted Ascletis an exclusive license to develop, manufacture and commercialize ASC40 (TVB-2640) and related compounds in Greater China. 3-V Biosciences is eligible to receive development and commercial milestones as well as tiered royalties on future net sales of ASC40 (TVB-2640).

"We are excited about this strategic collaboration with 3-V Biosciences. Results from the phase 1b trial showed significant decrease in liver fat synthesis and indicate that ASC40 (TVB-2640) may be a promising treatment for NASH," said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis, "There are no approved therapies today for NASH in China and globally. We’re thrilled to develop ASC40 (TVB-2640) for NASH in Greater China and support 3-V Biosciences’ Phase 2 multi-center trials in the United States and China."

"3-V Biosciences is excited about our partnership with Ascletis; Ascletis brings expertise and capabilities that can accelerate the advancement of TVB-2640 (ASC40) on a global scale for this important emerging disease," said George Kemble, PhD, CEO of 3-V Biosciences.

"The partnership with Ascletis, a leading expert in liver diseases, will accelerate the development of TVB-2640. We are delighted to welcome Dr. Wu to the board, and I look forward to working with him," said Beth Seidenberg, MD, board director of 3-V Biosciences and managing director of KP, an existing shareholder.

According to Dr. Rohit Loomba, MD of Univ. California San Diego, Director, NAFLD Research Center, and Principal Investigator of the upcoming Phase 2 study of TVB-2640, "I am excited to see the advancement of this compound; lipid synthesis is an important driver of NASH. This study will evaluate the impact of TVB-2640 on liver fat using advanced imaging techniques that are expected to predict the ability of this drug to address this unmet medical need."

"In 2016, there were approximately 243 million people in China with non-alcoholic fatty liver disease (NAFLD). By 2030, this is expected to increase to approximately 314 million people, of which 2.3 million will have cirrhosis," said Professor Wei Lai, MD, Director, Peking University Hepatology Institute, Chair, NAFLD and Alcoholic Liver Disease Special Interest Group (ALD SIG), Past-immediate President, Chinese Society of Hepatology of the Chinese Medical Association. "Inhibition of FASN is a promising mechanism of action for NASH. It is encouraging that Chinese biotech takes on the challenge to develop the first-in-class drug for such unmet medical need."

About TVB-2640 (ASC40).

TVB-2640 is an orally bioavailable, first-in-class inhibitor of FASN. FASN is a key enzyme in the de novo lipogenesis (DNL) pathway and catalyzes the biosynthesis of palmitate, which can then undergo further modifications into other fatty acids and complex lipids. Dysregulation of FASN activity is found in a number of different diseases, including liver diseases and cancer. NAFLD and the more advanced disease of NASH can progress to significant liver diseases, including cirrhosis and hepatocellular carcinoma.

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 A team led by Dr. Chi-Huey Wong, Distinguished Research Fellow at Academia Sinica in Taiwan, in collaboration with OBI scientists, has demonstrated in a recent study that the Globo-series glycosphingolipids (GSLs) antigens: Globo-H, SSEA-3, and SSEA-4 are specifically expressed on cancer cells and are found to correlate with tumor survival (Press release, OBI Pharma, FEB 12, 2019, View Source [SID1234533318]). This finding supports the basis of the anti-Globo series pipeline under development by OBI Pharma Inc.

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 article entitled "Signaling pathway of globo-series glycosphingolipids and β1,3-galactosyltransferase V (β3GalT5) in breast cancer" was published ahead of print on February 11, 2019 in the Proceedings of the National Academy of Sciences (PNAS)[1]. The study indicates that the GSL antigens can form a complex in membrane lipid raft with protein kinases such as caveolin-1 (CAV1), AKT, FAK and RIP. The reaction can trigger signaling pathways and promote tumor survival.

The study revealed that the expression of b3GalT5 is up-regulated in breast cancer and is highly correlated with tumor progression and poor survival in patients. On the other hand, knockdown of b3GalT5 in breast cancer cells can induce tumor apoptosis. Synthesis of SSEA-3 requires the presence of b3GalT5. SSEA-3 is the precursor of SSEA-4 and Globo H. When the expression of b3GalT5 decreases, expression of SSEA-3 also decreases. Subsequently, expression of SSEA-4 and Globo H are reduced.

When GSL antigens are unavailable or dysfunctional, protein kinases such as CAV1, AKT, FAK and RIP cannot signal to promote tumor survival. OBI’s anti-Globo series pipeline, such as OBI-888 (Globo H mAb) and OBI-898 (SSEA-4 mAb), targets high Globo H and SSEA-4 expressing cancers, suppressing or removing Globo H and SSEA-4 antigens to trigger tumor apoptosis. This study supports the scientific basis for OBI’s anti-Globo series pipeline and use of antibodies against the GSL antigens in treatment of breast and solid tumor cancers.

[1] "Signaling pathway of globo-series glycosphingolipids and β1,3-galactosyltransferase V (β3GalT5) in breast cancer." Proceedings of the National Academy of Sciences (PNAS), Published ahead of print February 11, 2019. View Source

On February 12, 2019 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Tuesday, February 19, 2019 at 5pm ET to discuss its financial results and corporate update for the fourth quarter and the year ended December 31, 2018 (Press release, Ultragenyx Pharmaceutical, FEB 12, 2019, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-fourth-quarter-and-full-year-3 [SID1234533266]).

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 live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or 262-912-6260 (International) and enter the passcode 6689186. The replay of the call will be available for one year.

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.