On January 11, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported an update on the progress of its continued transformation and growth today at the virtual 39th Annual J.P. Morgan Healthcare Conference (Press release, Takeda, JAN 11, 2021, View Source [SID1234573854]). President and Chief Executive Officer, Christophe Weber, shared details on Takeda’s portfolio and pipeline strategy and financial outlook, including key programs expected to contribute to the company’s revenue growth over the next decade.

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"In 2020, Takeda demonstrated the resilience of our business model, the depth of our portfolio and the commitment of our employees as we continued to serve patients and communities globally while overcoming challenges posed by the COVID-19 pandemic," said Christophe Weber, Takeda president and chief executive officer. "As a values-based and R&D-driven biopharmaceutical company celebrating 240 years in 2021, we remain focused on bringing life-transforming treatments to patients worldwide by delivering on our highly innovative pipeline and our continued commitment to patients, our people and the planet."

Highly Innovative Pipeline Supports Sustained Growth

Takeda has built a world-class, state-of-the-art, externally-facing R&D engine and has generated an innovative and modality diverse pipeline of approximately 40 clinical-stage new molecular entities (NMEs). Takeda’s pipeline portfolio has the potential to contribute significantly to revenue growth and the company has a goal to reach JPY5 trillion ($47 billion) revenue by FY20301, representing 50% growth from FY2019.

The majority of revenue growth is expected to come from the company’s Wave 1 pipeline, which includes 12 unique NMEs, representing potential best-in-class/first-in-class therapies and its existing 14 global brands.

Takeda’s Wave 1 programs include five that have received a Breakthrough Therapy designation and three that were granted fast track designation by the U.S. Food and Drug Administration (FDA). In addition, one program was designated under the SAKIGAKE Designation System by the Japanese Ministry of Health, Labour and Welfare and another program was the first breakthrough designation granted by the Chinese Food and Drug Administration to a multinational biopharmaceutical company. Twelve pivotal milestones, including five pivotal data readouts, are expected through fiscal year 2022 with additional near-term development milestones expected across all Wave 1 programs.

Beyond the Wave 1 pipeline, Takeda’s research engine, which comprises internal research capabilities and more than 200 active partnerships, is rapidly advancing a steady stream of next-generation therapies in Wave 2 of our pipeline that will provide sustained growth in FY2025 and beyond. These Wave 2 early-clinical and preclinical programs are designed to provide transformative or curative potential for targeted populations with high unmet need across core therapeutic areas. They are based on targets with strong human validation, represent diverse modalities and leverage new platform capabilities in cell therapy, gene therapy and data sciences.

Key Wave 1 Pipeline Assets Have Significant Market Potential

TAK-003
Takeda’s tetravalent dengue vaccine candidate (TAK-003) has the potential to help address the massive global burden of dengue including key priorities for dengue control such as protection of seronegative individuals (persons not previously exposed to dengue) and prevention of hospitalization. TAK-003 is based on a live-attenuated dengue serotype 2 virus, which provides the genetic "backbone" for all four vaccine viruses. The TAK-003 development program includes the pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES), a double-blind, randomized, placebo-controlled trial evaluating the safety and efficacy of two doses of TAK-003 in the prevention of laboratory-confirmed symptomatic dengue fever of any severity and due to any of the four dengue virus serotypes in children and adolescents. The TIDES trial is continuing, and safety and efficacy will be assessed over a total of four and a half years. Dengue is the fastest spreading mosquito-borne viral disease and was recognized by WHO to be one of the top ten threats to global health in 2019. Approximately half of the world’s population now lives under the threat of dengue, which is estimated to cause 390 million infections each year.

TAK-755
Takeda’s TAK-755 has the potential to be a transformative therapy for thrombotic thrombocytopenic purpura (TTP), a rare and life-threatening clotting disorder defined by low or absent circulating ADAMTS13 activity (an enzyme essential for regulation of normal blood clotting). There is very high unmet need for new therapies for both congenital and immune-mediated TTP, and TAK-755 is the first and only ADAMTS13 replacement therapy currently in development for both types of TTP. If approved, TAK-755 could be the only replacement therapy to rapidly and completely correct ADAMTS13 levels, and positively impact morbidity and mortality. If approved, TAK-755 has the potential to be first-in-class and the therapeutic choice for prophylaxis in congenital TTP, and a best-in-class therapy for the treatment of immune-mediated TTP. TAK-755 could simplify treatment, avoid adverse events related to plasma-derived therapy and plasma exchange, and provide the potential for at-home therapy. Data readouts are currently expected in 2021 for a phase 2 trial in immune-mediated TTP and in 2022 for a pivotal Phase 3 trial in congenital TTP.

TAK-007
Developed in collaboration with the University of Texas MD Anderson Cancer Center, Takeda’s TAK-007 is a chimeric antigen receptor (CAR) natural killer (NK) cell therapy ‘armored’ with IL-15 targeting CD19 positive B-cell malignancies. The vision is for TAK-007 to be an allogeneic therapy, meaning the NK cells are taken from a non-related healthy donor rather than the patient themselves. As a result, TAK-007 has the potential to be manufactured in advance and stored for off-the-shelf-use. MD Anderson’s CAR-NK CD19 is being studied in a phase 1/2 trial in patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). In the ongoing phase 1/2 trial, CAR-NK therapy has not been associated with the severe cytokine release syndrome (CRS) or neurotoxicity observed with existing CAR-T cell therapies and has the potential to be administered in an outpatient setting. A TAK-007 pivotal study is expected to begin enrolling patients with relapsed or refractory B-cell malignancies in 2021. There are currently no approved CAR NK therapies and no allogeneic cell therapies approved to treat cancer.

TAK-994 & TAK-925
TAK-994 is the first oral selective orexin 2 receptor agonist to enter clinical development for the treatment of narcolepsy type 1 (NT1), a rare neurologic condition characterized by excessive daytime sleepiness, cataplexy (signs and symptoms of the disease) and is due to a loss of orexin producing neurons. TAK-994 is currently being evaluated in an ongoing Phase 2 clinical trial in narcolepsy (SPARKLE-1501). If approved, TAK-994 may be the first treatment to address the underlying biology of the disease. TAK-925 (IV formulation) has published proof-of-concept data in NT1, narcolepsy type 2 (NT2), and shift work sleep disorder. Data for idiopathic hypersomnia and obstructive sleep apnea will be disclosed in the future.

Financial Strength
Takeda is committed to maintaining investment grade credit ratings and remains on track towards its medium-term target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years 2021 to 2023, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first half of FY2020, Takeda exceeded its $10B non-core asset divestiture target with 11 deals and up to ~$11.6 billion of non-core disposals announced since January 2019, while further de-leveraging in H1 FY2020 led to a 3.7x net debt/adjusted EBITDA ratio at the end of the period.

Takeda has solid growth momentum and potential for accelerated underlying growth over the medium term. Takeda is also on track to achieve our targeted annual run rate of $2.3 billion in cost synergies by the end of FY2021, further supporting margin performance to meet its medium-term underlying core operating profit margin target in the mid-30s. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.

Slides from the J.P. Morgan Healthcare Conference presentation and a link to the audio webcast can be accessed on Takeda’s website at: View Source

On January 11, 2021 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, reported that preliminary data from the ongoing dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab (anti-PD-1) and nab-paclitaxel plus gemcitabine (chemotherapy) in front-line metastatic pancreatic cancer will be presented in a poster session at the ASCO (Free ASCO Whitepaper) 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI) being held January 15th – 17th, 2021 (Press release, Arcus Biosciences, JAN 11, 2021, View Source [SID1234573853]).

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"While recent cancer breakthrough therapies, most notably anti-PD-1 antibodies, have led to dramatic improvements in outcomes in many cancer settings, this is not the case for pancreatic cancer, which remains a devastating diagnosis for patients. We are highly encouraged by the preliminary data from our Phase 1 trial for AB680 in combination with anti-PD-1 therapy and chemotherapy, in which we have seen promising clinical activity in these difficult to treat patients. Importantly, this experimental regimen has been well tolerated, and early safety data indicate that this AB680 combination regimen appears to have a side effect profile similar to that of anti-PD-1 therapy and chemotherapy," said Bill Grossman, M.D., the Chief Medical Officer of Arcus. "We look forward to presenting updated data from the Phase 1 portion of this trial at ASCO (Free ASCO Whitepaper) GI on January 15th, wherein we will report more mature safety and clinical response data, including those from the 100mg dose cohort."

The clinical activity and safety profile observed to date with AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy support its recent advancement into the ongoing Phase 1b expansion portion of the study, as well as plans to open a randomized control arm for the Phase 1b expansion. Dosing of AB680 100mg I.V. every two weeks has been selected for this portion of the study.

Full details of the presentation are as follows:

Abstract/Poster Title: ARC-8: Phase I/Ib study to evaluate safety and tolerability of AB680 + chemotherapy + zimberelimab (AB122) in patients with treatment-naive metastatic pancreatic adenocarcinoma (mPDAC)
Abstract No: 404
Poster Session: Pancreatic Cancer
Available Date: January 15, 2021
Time: 5:00 a.m. PT

In addition to the presentation on AB680, Arcus will also highlight the design of the recently initiated ARC-9 randomized Phase 2 study to advance etrumadenant in late-line colorectal cancer:

Abstract/Poster Title: ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC)
Abstract No: TPS150
Trials in Progress Poster Session: Colorectal Cancer
Available Date: January 15, 2021
Time: 5:00 a.m. PT

Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States1 and the seventh leading cause of cancer-related deaths worldwide2.

Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent neoplastic disease of the pancreas, with high metastatic potential, accounting for more than 90% of all pancreatic malignancies and is a highly devastating disease with poor prognosis and rising incidence.3,4

Few treatment options exist for metastatic pancreatic cancer, and response rates to the standard of care therapy of gemcitabine/nab-paclitaxel remain very low. Based on the FDA approved label for nab-paclitaxel in combination with gemcitabine, the phase 3 registrational trial demonstrated overall and complete response rates in patients with metastatic pancreatic cancer that were 23% and <1%, respectively. 1,5

To date, addition of anti-PD-1 antibodies to gemcitabine/nab-paclitaxel in controlled clinical trials in this setting has shown no added benefit when compared to that obtained with the chemotherapy alone.6,7

About ARC-8 Study

ARC-8 is a Phase 1/1b study to evaluate safety and tolerability of AB680 + zimberelimab (AB122) + chemotherapy in patients with treatment-naive metastatic pancreatic adenocarcinoma.

For additional information on this trial (NCT04104672), please visit www.clinicaltrials.gov.

About AB680

AB680 is an extremely potent and selective small-molecule CD73 inhibitor designed to provide differential benefits relative to monoclonal antibodies, such as greater inhibition of CD73 enzymatic activity (both soluble and cell-bound) and deeper tumor penetration. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types, including pancreatic cancer. 8 By effectively eliminating CD73-derived adenosine, AB680 may improve the efficacy of treatment approaches expected to elicit anti-cancer immune responses (e.g., platinum-based chemotherapy with/without anti-PD-1 therapy). AB680 was the first small-molecule CD73 inhibitor to enter the clinic and demonstrated a favorable safety profile with a long half-life in a healthy volunteer study. AB680 is currently in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer.

On January 11, 2021 Omeros Corporation (Nasdaq: OMER) reported that Gregory A. Demopulos, M.D., chairman and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference this week (Press release, Omeros, JAN 11, 2021, View Source [SID1234573852]). This conference is being held as a virtual conference this year. The presentation is scheduled for Wednesday, January 13, 2021 at 10:50 a.m. EST.

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The presentation will be webcast. The live and archived webcasts can be accessed on the investor relations section of the company’s website at www.omeros.com under "Events." The archived webcast will be available for 30 days.

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."