On January 11, 2021 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide, reported a collaboration and license agreement with Novartis Pharma AG to develop, manufacture and commercialize BeiGene’s anti-PD-1 antibody tislelizumab in the United States, Canada, Mexico, member countries of the European Union, United Kingdom, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan (Press release, BeiGene, JAN 11, 2021, View Source [SID1234573851]). The Companies have agreed to jointly develop tislelizumab in these licensed countries, with Novartis responsible for regulatory submissions after a transition period and for commercialization upon regulatory approvals. In addition, both companies may conduct clinical trials globally to explore combinations of tislelizumab with other cancer treatments, and BeiGene has an option to co-detail the product in North America, funded in part by Novartis.

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Tislelizumab is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. It is approved and marketed by BeiGene in China in two indications, classical Hodgkin’s lymphoma (cHL) following at least two prior therapies and locally advanced or metastatic urothelial carcinoma (UC) with PD-L1 high expression. In addition, three supplemental new drug applications for tislelizumab have been accepted by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) and are under review. These indications are first-line treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) in combination with chemotherapy, first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and previously treated unresectable hepatocellular carcinoma.

"We are excited to collaborate with Novartis to further explore the potential of tislelizumab in multiple combinations and indications. Novartis is a well-recognized leader in oncology with a unique portfolio of cancer treatments and pipeline agents," said John V. Oyler, Co-Founder, CEO, and Chairman of BeiGene. "This important collaboration stands on a strong foundation of tislelizumab’s broad global development program, which has delivered two approvals in China, currently spans 15 potentially registration-enabling clinical trials, and has enrolled over 7,700 patients to date, including approximately 2,500 patients in more than 20 countries and regions outside of mainland China. We look forward to working with Novartis to fulfill the global opportunity of this potentially differentiated anti-PD-1 antibody."

Under the agreement BeiGene will receive an upfront cash payment of $650 million from Novartis. BeiGene is eligible to receive up to $1.3 billion upon the achievement of regulatory milestones, $250 million upon the achievement of sales milestones, and royalties on future sales of tislelizumab in the licensed territory. Under the terms of the agreement, BeiGene will be responsible for funding ongoing clinical trials of tislelizumab, Novartis has agreed to fund new registrational, bridging, or post-marketing studies in its territory, and each party will be responsible for funding clinical trials evaluating tislelizumab in combination with its own or third party products. Each party retains the worldwide right to commercialize its propriety products in combination with tislelizumab.

Closing of the transaction is subject to the expiration or early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act.

BeiGene Presentation at J.P. Morgan Healthcare Conference

The Company will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14 at 5:20 p.m. ET.

A live webcast of the conference call can be accessed from the investors section of BeiGene’s website at View Source or View Source An archived replay will be available after the event for 90 days.

About Tislelizumab

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug from BeiGene’s immuno-oncology biologics program and is being developed globally as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Tislelizumab received conditional approval from the China NMPA as a treatment for patients with cHL who received at least two prior therapies and for patients with locally advanced or metastatic UC with PD-L1 high expression whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. Complete approval for these indications may be contingent upon results from ongoing randomized, controlled confirmatory clinical trials.

In addition, three sNDAs for tislelizumab have been accepted by the CDE of the NMPA and are under review, for first-line treatment of patients with advanced squamous NSCLC in combination with chemotherapy, for first-line treatment of patients with advanced non-squamous NSCLC in combination with chemotherapy, and for previously treated unresectable HCC.

Currently, 15 potentially registration-enabling clinical trials are being conducted in China and globally, including 13 Phase 3 trials and two pivotal Phase 2 trials.

Tislelizumab is not approved for use outside of China.

About Tislelizumab Clinical Program

Clinical trials of tislelizumab include:

Phase 3 trial comparing tislelizumab to salvage chemotherapy in patients with relapsed/refractory classical Hodgkin Lymphoma (NCT04486391);
Phase 3 trial in patients with locally advanced or metastatic urothelial carcinoma (NCT03967977);
Phase 3 trial comparing tislelizumab with docetaxel in the second- or third-line setting in patients with NSCLC (NCT03358875);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced squamous NSCLC (NCT03594747);
Phase 3 trial of tislelizumab in combination with chemotherapy versus chemotherapy as first-line treatment for patients with advanced non-squamous NSCLC (NCT03663205);
Phase 3 trial of tislelizumab in combination with platinum-based doublet chemotherapy as neoadjuvant treatment for patients with NSCLC (NCT04379635);
Phase 3 trial of tislelizumab combined with platinum and etoposide versus placebo combined with platinum and etoposide in patients with extensive-stage small cell lung cancer (NCT04005716);
Phase 3 trial comparing tislelizumab with sorafenib as first-line treatment for patients with hepatocellular carcinoma (HCC; NCT03412773);
Phase 2 trial in patients with previously treated unresectable HCC (NCT03419897);
Phase 3 trial comparing tislelizumab with chemotherapy as second-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC; NCT03430843);
Phase 3 trial of tislelizumab in combination with chemotherapy as first-line treatment for patients with ESCC (NCT03783442);
Phase 3 trial of tislelizumab versus placebo in combination with chemoradiotherapy in patients with localized ESCC (NCT03957590);
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment for patients with gastric cancer (NCT03777657);
Phase 2 trial in patients with MSI-H/dMMR solid tumors (NCT03736889); and
Phase 3 trial of tislelizumab combined with chemotherapy versus placebo combined with chemotherapy as first-line treatment in patients with nasopharyngeal cancer (NCT03924986).

On January 11, 2021 With genetic sequencing at the forefront of precision medicine, Illumina (NASDAQ: ILMN) reported a portfolio of new and expanded oncology partnerships that further the company’s commitment to develop standardized, globally distributable tools for precision oncology (Press release, Illumina, JAN 11, 2021, View Source [SID1234573850]).

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Speaking today at the 39th Annual J.P. Morgan Healthcare Conference in San Francisco, California, Illumina CEO, Francis deSouza, announced a series of oncology partnerships that aim to expand the reach of its powerhouse comprehensive genomic profiling family of products, TruSight Oncology.

TruSight Oncology 500 (TSO 500) is a Research Use Only comprehensive pan-cancer assay designed to identify 523 known and emerging tumor biomarkers. TSO 500 utilizes both DNA and RNA from tumor samples to identify key somatic variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. Based on the content of TSO 500, Illumina will be adding an in vitro diagnostic (IVD) test to the TruSight Oncology product family. This comprehensive tumor profiling assay will have similar chemistry and analytics to TSO 500 and is currently undergoing review with regulatory authorities. It is expected to be launched in both the U.S. and Europe later this year.

"Cancer is a disease of the genome and treatment will increasingly leverage NGS-based tests, from early detection and diagnoses, to therapy selection and monitoring," said deSouza. "The continued expansion of our TruSight Oncology pipeline complements our planned acquisition of multi-cancer early detection company GRAIL."

Illumina is leveraging the content of its TSO 500 assay to develop companion diagnostics (CDx). The following partnerships demonstrate Illumina’s commitment to collaborating with industry leaders on cancer diagnostics and the advancement of precision oncology:

BRISTOL MYERS SQUIBB: Expanding on a collaboration that began in 2018, Bristol Myers Squibb will develop a microsatellite instability CDx, as well as develop a diagnostic based on the content of TruSight Oncology 500 ctDNA, Illumina’s first liquid biopsy assay. Both program expansions are planned for global use by Bristol Myers Squibb’s portfolio of cancer therapeutics.
KURA ONCOLOGY: Our partnership with Kura Oncology is focused on building a CDx claim for HRAS mutations in Head and Neck Squamous Cell Carcinomas.
Responding to the growing clinical use of PARP inhibitor drugs beyond BRCA-mutant cancers, and toward broader populations of patients with homologous recombination repair deficiency (HRD), Illumina is partnering to further expand the clinical utility of the TruSight Oncology portfolio.

MYRIAD GENETICS: Illumina is partnering with Myriad, with time-limited exclusivity in certain markets, to develop and commercialize distributed kits for the assessment of HRD and for Myriad to expand its HRD service offerings, through a combination of TruSight Oncology content and Myriad’s myChoice CDx test.
"The agreement between Myriad and Illumina combines clinically validated companion diagnostics and next-generation sequencing to advance comprehensive genomic profiling of tumor samples and drive improved outcomes for oncology patients," said Paul J. Diaz, President and CEO, Myriad Genetics. "We are pleased to collaborate with a high-caliber healthcare leader like Illumina to expand international access to the proprietary technology in Myriad’s myChoice CDx test and together bring innovative solutions to the oncology market."

MERCK: Additionally, Illumina and Merck are conducting a study focused on the expanded TruSight Oncology HRD offering.
"Illumina remains committed to innovating and diversifying our oncology product portfolio and partnerships. Together we can help rapidly deliver actionable insights to patients and physicians, by removing the empiric nature of therapy selection," said Joydeep Goswami, Senior Vice President of Corporate Business Development at Illumina. "With sequencing at the forefront of precision medicine, we are inspired by the opportunity that lies ahead with not just these partnerships, but others to come."

On January 11, 2021 Agendia, Inc., a world leader in precision oncology for breast cancer, reported its participation in the 39th Annual J.P. Morgan Healthcare Conference, which will take place from Monday, January 11 through Thursday, January 14, 2021 (Press release, Agendia, JAN 11, 2021, View Source [SID1234573849]). Agendia Chief Executive Mark Straley will give a virtual presentation on Thursday, January 14 at 2:35 PM EST.

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A link to the live audio webcast of Mr. Straley’s presentation will be available by visiting the News & Updates section of Agendia’s website at View Source A replay of the webcast will be available for 90 days following the conclusion of the live presentation broadcast.

On January 11, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported it expects to introduce Galleri, its multi-cancer early detection blood test, in the second quarter of 2021 (Press release, Grail, JAN 11, 2021, View Source [SID1234573848]).

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In December, GRAIL completed the enrollment of PATHFINDER, a prospective, 6,600-participant multi-site interventional study conducted under a U.S. Food and Drug Administration Investigational Device Exemption application to evaluate the implementation of Galleri in clinical practice. PATHFINDER has completed its second planned independent Data and Safety Monitoring Board review. Presentation of initial results from PATHFINDER, and additional clinical validation data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) study, are expected in the first half of 2021. Together, these data are expected to support Galleri’s introduction as a laboratory developed test (LDT).

"Cancer remains the second-leading cause of death in large part because we lack recommended screening tests for the majority of deadly cancers. We are excited by the progress made in our mission to detect cancer earlier and what’s to come with the introduction of Galleri this year," said Hans Bishop, chief executive officer at GRAIL. "We are encouraged by the significant early interest in Galleri from health systems, medical practices, and self-insured employers."

GRAIL is conducting what it believes is one of the largest clinical study programs of its kind, with more than 134,000 participants enrolled to date. An earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests today — with a low false positive rate of less than 1%. When a cancer signal is detected, Galleri can determine where in the body the cancer is located with high accuracy, all from a single blood draw.

Galleri is available under investigational use in PATHFINDER, where it is being used to guide clinical care. Galleri is also expected to be offered to eligible patients in the United Kingdom (UK) starting in 2021 as part of a partnership with the UK National Health Service to support its Long Term Plan for earlier cancer diagnoses in an effort to transform cancer outcomes.

On January 11, 2021 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, reported collaborations with global biopharmaceutical companies Amgen (NASDAQ:AMGN), AstraZeneca (LSE/STO/Nasdaq: AZN), and Bristol Myers Squibb (NYSE: BMY) to evaluate GRAIL’s methylation-based technology for the detection of minimal residual disease (MRD) (Press release, Grail, JAN 11, 2021, View Source [SID1234573847]).

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Cancer MRD testing is used in clinical and research applications to detect the presence or absence of residual disease. Many MRD tests available today for solid tumors require tissue samples and development of patient-specific assays, which contributes to longer turnaround times and potential delay in treatment decisions. GRAIL’s targeted methylation platform could enable a blood-based MRD detection assay for solid tumors that perform comparably to bespoke tissue-based assays, while reducing complexity and processing times.

"GRAIL has developed and validated a novel approach to detect early cancer signals in blood and now we are excited to collaborate with leading companies Amgen, AstraZeneca, and Bristol Myers Squibb to evaluate the benefits of using our technology to find minimal residual disease after treatment or to detect early recurrent cancers," said Joshua Ofman, MD, MSHS, GRAIL chief medical officer and head of external affairs. "Cancer never quits, making the detection of residual disease and early recurrences critical to helping patients and care providers stay ahead of the disease."

"Amgen is pleased to partner with GRAIL to understand how this technology can provide deeper insights into tumor biology and a patient’s prognosis," said Narimon Honarpour, vice president, Translational Medicine, Amgen. "Achieving better clinical outcomes relies upon our understanding of cancer progression and the field needs more robust testing capabilities."

"Research has shown that we can improve outcomes across cancer types by treating patients as early as possible and intervening early if cancer recurs, which underpins our strategy," said Carl Barrett, vice president, Translational Science, Oncology R&D, AstraZeneca. "This collaboration with GRAIL will allow us to test a promising approach for monitoring MRD and detecting recurrence – tools that will provide critical information that we hope can optimize patient treatment plans."

"We are committed to leveraging the latest science and technologies to bring continued innovation to the healthcare community and patients we serve," said Sarah Hersey, vice president, Precision Medicine, Translational Medicine, Bristol Myers Squibb. "Our collaboration with GRAIL and other leaders in the industry will help enhance our ability to address the outstanding challenges of detecting and treating cancer head-on."