On october 29, 2018 LSK BioPharma (LSKB, Company) reported it has completed patient enrollment in its pivotal Phase 3 trial, ANGEL, which is evaluating the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer (Press release, LSK BioPharma, OCT 29, 2018, View Source [SID1234530520]). The ANGEL study is designed to support approval by the U.S Food and Drug Administration (FDA), the European Medicines Agency (EMA), Japanese Pharmaceuticals and Medical Devices Agency (PMDA), Korean Ministry of Food and Drug Safety (MFDS) and Taiwan Food and Drug Administration (TFDA).

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!

"Completion of enrollment in the ANGEL study is an important achievement and a critical milestone for our gastric cancer program and we appreciate all of the support from patients and investigators in accomplishing this global development milestone" said Dr. Sung Chul Kim, LSKB President, "Although rivoceranib has been approved in China, there is still no oral small-molecule angiogenesis inhibitor approved outside of China for gastric cancer. We believe it will be the first such drug for these patients worldwide."

The Company will now focus on follow-up of enrolled patients and preparation of the data for analysis with an expectation that the top-line, unblinded efficacy and safety data will be reported in the second half of 2019. The Company further expects to submit a New Drug Application for rivoceranib with the FDA in late 2019.

About the ANGEL Study

The ANGEL study is a prospective, randomized, double-blinded, placebo-controlled, multinational, multicenter, parallel-group, phase III study to evaluate the efficacy and safety of rivoceranib plus Best Supportive Care (BSC) compared to placebo plus BSC in patients with advanced or metastatic gastric cancer. A total of 459 patients have been randomized in the ANGEL study in 12 countries (in USA, EU, EEC, Japan, Korea and Taiwan). Details of the ANGEL Study can be found at the following link: View Source

About Rivoceranib (Apatinib)
Rivoceranib is the first successful oral 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.

On October 29, 2018 Infinity Pharmaceuticals, Inc. (NASDAQ: INFI) reported that it will host a conference call on Monday, November 5, 2018, at 4:30 p.m. ET to review its third quarter 2018 financial results and provide an update on the company (Press release, Infinity Pharmaceuticals, OCT 29, 2018, View Source [SID1234530275]).

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!

A live webcast of the conference call can be accessed in the Investors/Media section of Infinity’s website at www.infi.com. To participate in the conference call, please dial 1-877-316-5293 (domestic) or 1-631-291-4526 (international) five minutes prior to start time. The conference ID number is 8617458. An archived version of the webcast will be available on Infinity’s website for 30 days.

On October 29, 2018 Vical Incorporated (Nasdaq:VICL) reported financial results for the three months ended September 30, 2018 (Press release, Vical, OCT 29, 2018, View Source [SID1234530293]). Net loss for the third quarter of 2018 was $1.5 million, or $0.07 per share, compared with a net loss of $3.1 million, or $0.27 per share, for the third quarter of 2017. Revenues for the third quarter of 2018 were $0.1 million, compared with revenues of $3.2 million for the third quarter of 2017, reflecting a reduction in revenues from Astellas Pharma Inc. for services performed under ASP0113 collaborative agreements. Net loss for the third quarter of 2018 included a gain of $2.3 million related to the sale of the Company’s manufacturing assets and $0.7 million received from Astellas to cover close down costs related to the ASP0113 program.

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!

Vical had cash, cash equivalents, marketable securities and long-term investments of $52.7 million at September 30, 2018. The Company’s cash burn for the third quarter of 2018 was $1.6 million. The Company is updating its 2018 full year cash burn guidance to a range of between $15 million and $18 million, a reduction in cash burn from its previous forecast of between $20 million and $24 million. The Company anticipates ending 2018 with a minimum of $45 million in cash, cash equivalents, marketable securities and long-term investments.

Vical recently announced plans to explore a range of strategic options to enhance shareholder value. The company retained MTS Health Partners, L.P. to assist in the strategic review process. There is no set timetable for the review process and there can be no assurance that the process will result in a transaction.

Program updates include:

VL-2397 Antifungal Candidate

The multinational Phase 2 registration trial comparing VL‑2397 to standard first-line treatment for invasive aspergillosis in immunocompromised adults with acute leukemia or recipients of an allogeneic hematopoietic cell transplant is ongoing (ClinicalTrials.gov Identifier: NCT03327727). Vical expects to conduct the trial in approximately 40 major cancer and transplantation centers in North America, Europe and Asia. Centers are now open for enrollment in the US, Canada, Belgium, Germany, and will open shortly in South Korea. The FDA has advised that VL‑2397 would be eligible for a Limited Use Indication (LUI) approval for the treatment of invasive aspergillosis for patients with limited treatment options. The FDA has also granted Vical Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designations for VL‑2397 for the treatment of invasive aspergillosis. VL-2397 has a novel mechanism of antifungal action and could be the first therapeutic in a new class of antifungals.
VR-CHB01 Hepatitis B Virus (HBV) Therapeutic Candidate

The Company is pursuing preclinical development of a novel treatment for chronic HBV infection based on its DNA and lipid-delivery technologies. The initial aim of this program will be to demonstrate proof of concept for inhibiting HBV infection in an in vivo model. The Company expects to complete the initial stage of preclinical development in the fourth quarter of 2018

On October 29, 2018 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company developing novel cancer immunotherapies based on tumor-infiltrating lymphocyte (TIL) technology, reported that it will host a live webcast of its Melanoma Program Update event for Analysts and Investors on Friday, November 9, 2018 from 6:30 – 8:30pm ET during the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 33rd Annual Meeting in Washington, D.C (Press release, Iovance Biotherapeutics, OCT 29, 2018, View Source;p=RssLanding&cat=news&id=2373866 [SID1234530325]).

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!

Iovance’s leadership team will present an overview of the company’s immuno-oncology pipeline and the latest clinical data as well as the planned registration pathway for lifileucel, which was recently discussed with the U.S. Food and Drug Administration (FDA) and has received RMAT designation, the manufacturing progress leading to a commercial process and commercialization plans for lifileucel. Presentations will also be made by melanoma experts and key opinion leaders (KOLs) discussing updated clinical data from the C-144-01 study in metastatic melanoma.

The live webcast of this event will be accessible through the Investors section of Iovance Biotherapeutics’ website at View Source The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

On October 29, 2018 Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, reported that it has issued an additional $22.5 million aggregate principal amount of its 3.00% convertible senior notes due 2025 (the "notes") pursuant to the exercise in full of the option to purchase additional notes granted to the initial purchasers in Karyopharm’s previously announced private offering of $150 million aggregate principal amount of notes to qualified institutional buyers in reliance on Rule 144A under the Securities Act of 1933, as amended (the "Securities Act") (Press release, Karyopharm, OCT 29, 2018, View Source [SID1234530309]). The additional notes were sold on the same terms in all respects as the notes previously issued on October 16, 2018, and the terms of the additional notes are identical to those previously issued. The closing of the sale of the additional notes occurred on October 26, 2018. Following such closing, Karyopharm has issued a total of $172.5 million aggregate principal amount of notes.

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 notes were offered and sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of common stock issuable upon conversion of the notes, if any, have not been and will not be registered under the Securities Act or the securities laws of any other jurisdiction, and the notes and any such shares may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements. Any offer of the notes was made only by means of a private offering memorandum.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the notes or any other securities, nor shall there be any offer, solicitation or sale of the notes or any other securities (including the shares of Karyopharm’s common stock issuable upon conversion of the notes, if any) in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful.