Lilly to Participate in J.P. Morgan Healthcare Conference

On January 2, 2020 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the 38th Annual J.P. Morgan Healthcare Conference on Tuesday, January 14, 2020 (Press release, Eli Lilly, JAN 2, 2020, View Source [SID1234552655]). David A. Ricks, Lilly’s chairman and chief executive officer, will participate in a fireside chat at 5:30 p.m. Eastern time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s Investor website at View Source A replay of the presentation will be available on this same website for approximately 90 days.

BioNTech Announces Publication of Preclinical Data for first-in-kind CAR-T Cell Therapy Approach Targeting Solid Tumors in Science

On January 2, 2020 BioNTech SE (NASDAQ: BNTX, "BioNTech" or "the Company"), reported a publication in Science on the company’s novel CAR-T therapeutic approach for solid tumors which utilizes a CAR-T Cell Amplifying RNA Vaccine, or CARVac (Press release, BioNTech, JAN 2, 2020, View Source [SID1234552654]). The report entitled "An RNA vaccine drives expansion and efficacy of claudin-CAR-T cells against solid tumors" provides preclinical proof-of-concept data for BioNTech’s first CAR-T product candidate BNT211, an autologous CAR-T cell therapy targeting the oncofetal antigen Claudin 6 (CLDN6), and outlines CARVac as a broadly applicable RNA vaccine approach to improve therapeutic efficacy of CAR-T cell therapies.

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Although CAR-T cell therapy has shown significant clinical efficacy in blood cancers, it still faces major challenges in solid tumors, including a limited number of identified cancer-specific solid tumor targets, inefficient infiltration of CAR-T cells into solid tumors and insufficient CAR-T cell persistence. BioNTech aims to overcome these hurdles by targeting CLDN6, a novel tumor specific antigen expressed in multiple solid tumors, in combination with an RNA vaccine promoting the amplification and persistence and efficacy of CAR-T cells in vivo.

In the published study, a second generation CLDN6-CAR-T therapy with a 4-1BB costimulatory domain (BNT211) was evaluated both in vitro in tumor cell lines and in vivo in mice with human ovarian cancer transplants. In mice, CLDN6-CAR-T cell therapy demonstrated complete tumor regression of transplanted large human tumors within two weeks after treatment initiation. Furthermore, the combination with CARVac achieved improved engraftment, proliferation and expansion of CAR-T cells in vivo, resulting in tumor regression even at sub-therapeutic CAR-T doses. CARVac was also successfully applied for CAR-T cells targeting the pan-cancer antigen CLDN18.2 and CD19, the target of approved CAR-T cell therapies. The combination of CAR-T cell therapy with CARVac underlines the value of cross-platform synergies to address key development challenges in the treatment of cancer.

BioNTech intends to initiate a first-in-human Phase 1/2 clinical trial for BNT211 this year in solid tumors, including ovarian, testicular, uterine and lung cancer. Manufacturing to support clinical trials of BNT211 will be conducted in-house at BioNTech’s state-of-the-art GMP certified cell therapy manufacturing

facility in Idar-Oberstein, Germany, which has been in operation since 1999. BioNTech initiated a multi-year capacity expansion at the facility in 2018 which it expects to complete in 2020.

AMGEN COMMENCES STRATEGIC COLLABORATION WITH BEIGENE TO EXPAND ONCOLOGY PRESENCE IN CHINA

On January 2, 2020 Amgen (NASDAQ:AMGN) reported the successful closing of the transaction to enter into a strategic collaboration with BeiGene that will significantly accelerate Amgen’s plans to expand its oncology presence in China, the world’s second-largest pharmaceutical market (Press release, Amgen, JAN 2, 2020, View Source [SID1234552653]). BeiGene is a commercial-stage research-based oncology company with an established and highly experienced team in China, including an approximately 900-person commercial organization and an approximately 600-person clinical development organization.

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"There continues to be substantial unmet medical need in China, particularly for patients with cancer," said Robert A. Bradway, Amgen’s chairman and chief executive officer. "We have been impressed with what BeiGene has accomplished, particularly in research, clinical development and commercialization, and we look forward to working together to advance new oncology therapeutics for patients in China and around the world."

As previously announced, the terms of the collaboration are:

Amgen has acquired a 20.5% stake in BeiGene for approximately $2.8 billion in cash. This represents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019, the day prior to the signing of the agreements. In addition, Anthony C. Hooper, former executive vice president of Global Commercial Operations at Amgen, has been elected to BeiGene’s board of directors, effective today.

BeiGene will commercialize XGEVA (denosumab), KYPROLIS (carfilzomib) and BLINCYTO (blinatumomab) in China, during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products returned to Amgen. XGEVA was launched in China in September 2019; New Drug Applications for KYPROLIS and BLINCYTO have been filed in China.

Amgen and BeiGene will collaborate to advance 20 medicines from Amgen’s innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on the sales of these products outside of China, with the exception of AMG 510, Amgen’s first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors. Amgen anticipates utilizing data from clinical trials conducted in China to advance the development of its oncology portfolio globally.

Of the 20 oncology medicines in development, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen. Amgen and BeiGene will share profits in China equally on these products until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.

Amgen will continue to commercialize its non-oncology product portfolio in China. Last year, Amgen launched its first-ever product in China, Repatha (evolocumab), an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.

XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in Amgen’s oncology pipeline, will be manufactured at Amgen’s existing facilities.

Since 2011, Amgen has expanded its geographic presence from approximately 50 to 100 countries, enabling the company to play a growing role in serving the rapidly increasing demand for better healthcare around the world. The pharmaceutical market in China is expected to grow briskly as access to new medicines continues to improve. With approximately four million people diagnosed with cancer annually and 2.3 million deaths from the disease each year, the need for new oncology treatments in China is particularly acute and the oncology market is one of the fastest-growing segments of the overall pharmaceutical market there.

For more information about Amgen’s products, including important safety information, please visit www.xgeva.com, www.kyprolis.com, www.blincyto.com, www.repatha.com, and www.prolia.com.

Abbott Hosts Conference Call for Fourth-Quarter Earnings

On January 2, 2020 Abbott (NYSE: ABT) reported that it will announce its fourth-quarter 2019 financial results on Wednesday, Jan. 22, 2020, before the market opens (Press release, Abbott, JAN 2, 2020, View Source [SID1234552652]).

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The announcement will be followed by a live webcast of the earnings conference call at 8:30 a.m. Central time (9:30 a.m. Eastern), and will be accessible through Abbott’s Investor Relations website at www.abbottinvestor.com. An archived edition of the call will be available later that day.

Merck to Present at the 38th Annual J.P. Morgan Healthcare Conference

On January 2, 2020 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that Kenneth C. Frazier, chairman and chief executive officer, and Dr. Roger M. Perlmutter, president, Merck Research Laboratories, are scheduled to participate at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Jan. 13, 2020 at 4:30 p.m. PST (7:30 p.m. EST) (Press release, Merck & Co, JAN 2, 2020, View Source [SID1234552651]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source