On August 20, 2018 Pfizer Inc. reported that it invites investors and the general public to view and listen to a webcast of a conference call with investment analysts on Monday, August 27, 2018 at 9:00 a.m. EDT (Press release, Pfizer, AUG 20, 2018, View Source [SID1234529034]). The purpose of the call is to review the Tafamidis data presentation at the ESC Congress 2018 organized by the European Society of Cardiology.

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To view and listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can also listen to the conference call by dialing either (855) 895-8759 in the United States and Canada or (503) 343-6044 outside of the United States and Canada. The password is "ESC".

Visitors to www.pfizer.com/investors will be able to view and listen to an archived copy of the webcast of the conference call.

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 20, 2018 Immunocore Limited, a leading T Cell Receptor (TCR) biotechnology company, focused on delivering first-in-class biological therapies that have the potential to transform the lives of people with serious diseases, reported that it has dosed the first patient in a Phase I study, part of an ongoing collaboration with GlaxoSmithKline (GSK) (Press release, Immunocore, AUG 20, 2018, View Source [SID1234528999]).

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The study, the first programme under Immunocore’s collaboration with GSK to proceed into clinical development, will assess the safety and tolerability of IMCnyeso, an ImmTAC molecule, in patients with non-small cell lung cancer (NSCLC), bladder cancer, melanoma and synovial sarcoma, positive for NY-ESO-1 and/or LAGE-1A. The start of the study has triggered an undisclosed milestone payment to Immunocore.

Under the terms of the collaboration entered into in 2013, Immunocore is responsible for all pre-clinical development and for the initial clinical trial in patients for each of the first two target programmes. Upon exercise of each programme option, GSK would be responsible for the remaining development and commercialisation activities for that target.

Joseph Dukes, Director and Head of Biology at Immunocore, commented: "We are delighted that our world-leading science has delivered a second ImmTAC into the clinic. This is the first partnered programme to commence dosing in patients, representing a critical milestone in our collaboration. It puts this promising programme onto a clinical development path, which we hope will ultimately result in a new treatment option for patients with some of the most difficult-to-treat tumours."

James Smothers, Vice President and Head of Immuno-Oncology DPU at GSK, said "At GSK we are focussed on delivering transformational medicines for cancer patients and we are excited to investigate the scientific promise of ImmTAC technology. The start of this phase I study is another marker of success in our productive collaboration with Immunocore."

On August 20, 2018 Aravive Biologics, Inc. reported that the U.S. Food and Drug Administration has granted Fast Track Designation to AVB-S6-500 as a potential treatment for platinum-resistant recurrent ovarian cancer (Press release, Aravive Biologics, AUG 20, 2018, View Source [SID1234529000]).

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"Gaining Fast Track Designation is an important recognition of the potential that AVB-S6-500 has to offer to meet a critical unmet medical need for patients with recurrent ovarian cancer," said Ray Tabibiazar, M.D., Executive Chairman of Aravive Biologics. "We look forward to initiating the Phase 1b portion of our planned Phase 1b/2 study combining AVB-S6-500 with standard-of care therapies in patients with platinum-resistant ovarian cancer before the end of the year."

The FDA’s Fast Track Designation is intended to facilitate development and expedite review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier.

"We are very pleased that the FDA has granted Fast Track status to AVB-S6-500," said Gail McIntyre Ph.D., DABT, Senior Vice President of R&D at Aravive. "This important designation is based on the promising safety and activity observed to-date with AVB-S6-500, and we look forward to working closely with the FDA as we advance its development in ovarian cancer."

About AVB-S6-500

AVB-S6-500 is a novel high-affinity, soluble Fc-fusion protein designed to block the activation of the GAS6-AXL signaling pathway by intercepting the binding of GAS6 to its receptor AXL. Research has shown GAS6-AXL signaling to be a key molecular pathway that promotes tumor growth and metastases, as well as immune evasion and resistance to other anticancer agents. AXL and GAS6 expression correlate with poor prognosis in cancer. Results of a Phase 1 study of AVB-S6-500 in healthy volunteers showed a favorable safety profile, with no reported serious or dose-limiting adverse events. Moreover, results of that trial showed a dose-related reduction of circulating free GAS6, a measurement that Aravive anticipates will be highly useful as a biomarker to better monitor the therapeutic responses and potentially to better select responder patient populations. A reduction in this biomarker has correlated to anti-tumor activity in preclinical animal studies. In preclinical studies, GAS6-AXL inhibition has shown activity, whether achieved by a single agent (including AVB-S6-500) or through combinations of a variety of anticancer therapies including radiation therapy, immuno-oncology agents, and drugs that affect DNA replication and repair. GAS6/AXL inhibition has also shown potential as a strategy for the treatment of certain fibrotic diseases.

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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"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.