On August 20, 2018 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:00 a.m. (Eastern Time) on Thursday, September 13th, to review its Pharmaceutical Business (Press release, Johnson & Johnson, AUG 20, 2018, View Source [SID1234528998]). Joaquin Duato, Vice Chairman of the Executive Committee; Jennifer Taubert, Executive Vice President, Worldwide Chairman, Pharmaceuticals; Mathai Mammen, Global Head, Janssen Research & Development and Lesley Fishman, Senior Director Investor Relations will host the call.

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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

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Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on September 21, 2018. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13681049.

On August 19, 2018 Lion TCR Pte. Ltd., a Singapore-based Biotech company reported that it has receives approval from Health Sciences Authority (HSA), Singapore, for its Phase I/II multicentre clinical study of its product candidate (LioCyx) for treatment of relapsed liver cancer post-liver transplantation (Press release, Lion TCR, AUG 19, 2018, View Source [SID1234528981]). The first such trial in Singapore and for the region that uses precision T cell receptor (TCR) immune cell therapy to target Hepatitis B virus (HBV)-related liver cancer, which forms at least 80% of liver cancers in Asia. 80% of the 800,000 new liver cancer cases in the world yearly are diagnosed in Asia Pacific, including China, Vietnam, Thailand, Indonesia, South Korea and Singapore. Liver cancer is the world’s third most deadly cancer with very limited treatment options and poor treatment outcome. There is currently no effective treatment available for liver cancer relapsed patients post-liver transplantation.

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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

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LioCyx is developed by Lion TCR’s scientific founder, Prof. Antonio Bertoletti, a world-renowned HBV-liver cancer clinician scientist. Several Investigator-sponsored trials of LioCyx in Singapore and China have showed results of good safety profile and encouraging signs of efficacy. "We are very delighted with the approval of Phase I/II clinical trial of our LioCyx, the first engineered TCR-T cell therapy for treatment of liver cancer in Singapore. It is an utmost encouragement on the recognition of innovative therapy for patients in need. Singapore HSA has been very efficient, transparent and professional in reviewing our application for the clinical trial of this innovative immunotherapy", said Dr. Victor Li Lietao, founder and CEO of Lion TCR.

Patients recruitment for the Phase I/II clinical trial will begin with National University Hospital (NUH), Singapore. Lion TCR is in the midst of including more medical centres in Singapore and China into the trial.

On August 19, 2018 Harbour BioMed reported it has entered into an exclusive strategic partnership with Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (Kelun-Biotech) to develop and commercialize A167, an anti-PD-L1 antibody in Phase 2 clinical development, worldwide outside of the Greater China region (Press release, Harbour BioMed, AUG 19, 2018, View Source [SID1234528980]). The companies will also collaborate in developing combination therapies of A167 with other agents for commercialization in their respective territories. The potential value of the partnership exceeds $350 million in addition to royalties.

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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

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"Anti-PD-L1 therapy has been validated in many clinical trials in the Immuno-Oncology area. A167 has significant potential as a single agent and as the foundation for combination therapy with other innovative drugs. We are delighted to advance A167 globally and work closely with Kelun-Biotech to achieve its therapeutic potential," said Dr. Jingsong Wang, Harbour BioMed’s founder, Chairman and Chief Executive Officer. "We plan to conduct A167-based combination trials globally by ourselves, including with innovative compounds we are developing, or in collaboration with our partners, to find better therapeutic options against a wide range of tumor types." Dr. Wang noted that the partnership with Kelun-Biotech, Harbour’s first global development alliance, is an important step that accelerates our plan to build a highly innovative, clinical-stage portfolio for worldwide markets.

"A167 is one of the important compounds in our portfolio," said Dr. Tongtong Xue, Chief Executive Officer of Kelun-Biotech. "We are glad to enter this collaboration with Harbour BioMed which is based on trust in our partner’s capabilities and expertise. The Harbour team brings extensive global clinical development experience that will accelerate clinical trials with A167, especially in the area of combinational therapies." Dr. Xue noted that the collaboration is the second alliance Kelun-Biotech entered with Harbour this year. "We entered a strategic partnership with Harbour to co-discover, co-develop and commercialize antibodies against innovative targets, based on Harbour’s leading fully human antibody discovery platforms. We have made significant progress in our joint discovery programs against multiple targets in oncology and immunological diseases."

A167 is an immune-oncology investigational antibody developed by Kelun-Biotech. It binds to immune checkpoint protein PD-L1 and reactivate T cells in the body against cancer cells. The antibody has potential usage in a broad range of solid tumor and hematological malignancies in monotherapy and in combination with other agents. A167 is currently in multiple Phase 1 and Phase 2 clinical trials in China targeting lymphoma and solid tumors.

Under the agreement, Kelun-Biotech will receive upfront, development and regulatory milestones, and commercial milestones based on preset goals, with a potential value of more than $350 million, in addition to royalties based on annual net sales. Harbour will have exclusive rights to develop, manufacture and commercialize A167 in regions outside of Greater China. Both companies will share data generated from their own research and clinical trials to support mono and combination therapies of A167 with other agents for both parties’ development and registration.

On August 17, 2018 ITUS Corporation (NASDAQ: ITUS) reported that CEO, Dr. Amit Kumar, will be presenting at the Next Generation Dx Summit in Washington, D.C., being held on August 20th-24th (Press release, Anixa Biosciences, AUG 17, 2018, View Source [SID1234530492]). Dr. Kumar’s presentation, "Liquid Biopsy based on Flow Cytometry and Artificial Intelligence to Detect the Existence of a Solid Tumor," is scheduled at 2:50 PM EDT, Wednesday, August 22nd. Dr. Kumar will discuss ITUS’s latest data on its Cchek diagnostic development, including studies on breast cancer and prostate cancer, as well as data from the collaborative study with Memorial Sloan Kettering and Serametrix.

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"This conference is focused on a number of diagnostic technologies including liquid biopsy and early cancer detection. This is the first commercial conference where we will be presenting our technology to a concentrated audience of industry players," stated Dr. Kumar. "We are pleased with the scientific progress achieved thus far with Cchek, and we remain confident that we will begin preliminary regulatory discussions with the FDA by the end of the year," added Dr. Kumar.

Dr. Kumar further stated, "With both of our programs–Cchek cancer diagnostic and CAR-T treatment for ovarian cancer—heading toward initial FDA discussions by the end of the year, we are excited about the impact we could have on the fight against cancer. Any day now, we are expecting to hear back from the FDA regarding the request, by us and our partner Moffitt Cancer Center, for a pre-IND meeting about our CAR-T therapy. We believe that the next few months will be a very exciting period for the Company, for our shareholders, and for cancer patients."

On August 17, 2018 Taiho Pharmaceutical Co., Ltd. reported that it applied to the Japanese Ministry of Health, Labour and Welfare for an additional indication for unresectable advanced or recurrent gastric cancer for its anticancer agent LONSURF combination tablet T15, T20 (trifluridine and tipiracil) (Press release, Taiho, AUG 17, 2018, View Source [SID1234529758]).

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This application is based on the results of a Phase III TAS-102 Gastric Study (TAGS) trial that compared trifluridine/tipiracil plus best supportive care (BSC) versus placebo plus BSC, in patients with previously treated metastatic gastric cancer refractory to standard therapies.

In the TAGS trial, the primary endpoint of overall survival (OS) was extended significantly with trifluridine/tipiracil compared to placebo, and no new safety signals were observed with the study drug.

Taiho Pharmaceutical anticipates that, if approved, LONSURF will provide a new oral treatment option for patients with gastric cancer.

About Gastric Cancer
In Japan, gastric cancer is the most common cancer by site, with 131,893 people newly diagnosed per year (2013)*1 and 45,531 people losing their lives to it in 2016*2. Gastric cancer is the fifth most common cancer worldwide and the third most common cause of cancer-related deaths (after lung and liver cancer), with an estimated 723,000 deaths annually*3. In recent years, the outcome for gastric cancer has improved remarkably, and survival has increased dramatically over the past 10 years. As gastric cancer progresses, treatment options become limited as numerous complications can restrict the usable drugs and preclude intensive chemotherapy. Accordingly, new therapeutic drugs which prolong survival and relieve symptoms in late-stage treatment of metastatic gastric cancer are considered valuable in the treatment of the disease.

About TAGS
The TAGS (TAS-102 Gastric Study) trial is a Taiho-sponsored pivotal Phase III multinational, randomized, double-blind study evaluating LONSURF (trifluridine and tipiracil), plus best supportive care (BSC) versus placebo plus BSC in patients with metastatic gastric cancer refractory to standard treatments. The primary endpoint in the TAGS trial was overall survival (OS), and secondary endpoint measures included progression-free survival (PFS), and safety and tolerability, as well as quality of life. The TAGS trial enrolled 507 adults 18 years and older with metastatic gastric cancer who had previously received at least two prior regimens for advanced disease. Amongst other locations, the TAGS trial was conducted in Japan, North America, Europe, Russia and Turkey.

Please see ClinicalTrials.gov for additional details regarding the TAGS trial.
View Source

About LONSURF
LONSURF is an oral anticancer drug, which utilizes the combination of trifluridine (FTD) and tipiracil (TPI), whose dual mechanism of action is designed to maintain clinical activity and differs from conventional fluoropyrimidines. FTD is an antineoplastic nucleoside analogue, which is incorporated directly into the DNA, thereby interfering with the function of DNA. The blood concentration of FTD is maintained via TPI, which is an inhibitor of the FTD‐degrading enzyme, thymidine phosphorylase.

In Japan, Taiho Pharmaceutical has been marketing LONSURF for the treatment of metastatic advanced or recurrent colorectal cancer since 2014. In the United States, beginning in 2015, Taiho Oncology, Inc., a U.S. subsidiary of Taiho Pharmaceutical, began marketing the drug for the treatment of patients with mCRC who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. In June 2015, Taiho Pharmaceutical and Servier entered into an exclusive license agreement for the co-development and commercialization of LONSURF in Europe and other countries outside of the United States, Canada, Mexico and Asia. In parts of Asia outside of Japan, Jeil Pharmaceutical and TTY Biopharm, which are Taiho Pharmaceutical’s business