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."

On January 11, 2021 Sensei Biotherapeutics, Inc., a clinical-stage cancer immunotherapy company, reported the successful closing of a $30 million Series B financing (Press release, Sensei Biotherapeutics, JAN 11, 2021, View Source [SID1234573846]). The financing was co-led by existing investor Apeiron Investment Group and new investor Catalio Capital Management. Additional investments included new investors Pura Vida Investments and several international family offices, as well as existing investors Cambrian Biopharma, Moore Strategic Ventures, Steve Jurvetson’s Future Ventures, and Presight Capital.

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"We believe Sensei’s ImmunoPhage platform represents the future of personalized cancer therapies. With our technology, once a patient’s cancer is genetically profiled we can have a personalized cocktail of ImmunoPhage delivered to that patient within a week. This is a critical improvement over the months it takes for existing personalized approaches in cancer, where every day matters for patients," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "I’m delighted to be working with this fantastic group of both new and existing investors to advance Sensei’s platform and provide life-changing therapies to more patients."

The ImmunoPhage platform uses genetically engineered viruses called bacteriophage to create robust immune responses to human cancer proteins and block key immunosuppressive pathways. ImmunoPhage are highly immunogenic and can be manufactured quickly, inexpensively, and at large scale. Sensei is expanding its proprietary Phortress library consisting of pre-manufactured, GMP-grade ImmunoPhage. Using the Phortress library, ImmunoPhage are selected and customized for each cancer patient using a personalized yet off the shelf cocktail approach to deliver a potent immunotherapy to the patient in a rapid and cost-effective manner.

Sensei’s lead ImmunoPhage product candidate, SNS‑301, is being evaluated in a Phase 1/2 trial for the treatment of locally advanced unresectable or metastatic squamous cell carcinoma of the head and neck (SCCHN) in combination with pembrolizumab. Promising interim results were published in Q4 2020, and topline results from this trial are expected by the end of 2021.

Sensei is also advancing two preclinical programs generated from its platform, including SNS-401, an ImmunoPhage cocktail for the treatment of merkel cell carcinoma, and SNS‑VISTA, a monoclonal antibody targeting V-domain Ig suppressor of T cell activation (VISTA), an immune checkpoint protein that inhibits the anti-tumor T cell response.

Christian Angermayer, founder of Apeiron Investment Group, said, "Sensei’s approach has the realistic potential to overcome the prior challenges of cancer immunotherapy and make advancements we previously couldn’t dream of. If a loved one got cancer today, I would want them to have access to a treatment that is both fast and personalized to their disease. And down the road, we might even be able to develop the therapy towards a real prophylactic cancer vaccination, so that we end cancer before it even starts."

"Sensei has the right mix of proprietary technology and experienced management to advance potentially game-changing therapeutic candidates in the cancer immunotherapy field," remarked George Petrocheilos, Co-founder and Managing Partner of Catalio Capital Management. "We look forward to collaborating again with Christian and working with the Sensei leadership team, as they advance a novel pipeline of cancer immunotherapy candidates and execute on their goal of transforming the treatment of cancer."