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."

On January 11, 2021 Resolution Bioscience, Inc. reported a companion diagnostic agreement with Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage targeted oncology company (Press release, Mirati, JAN 11, 2021, View Source [SID1234573845]). As part of the agreement, Resolution’s ctDx liquid biopsy technology will be used to help identify non-small cell lung cancer (NSCLC) patients who may benefit from Mirati’s investigational KRAS G12C inhibitor therapy. The fast and non-invasive assay was designed to detect actionable NSCLC mutations, such as KRAS G12C.

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Cancers stemming from RAS mutations account for nearly a quarter of all human cancers and contribute to 1 million deaths per year worldwide. Among the RAS family of oncogenes, KRAS gene mutations are the most common, making up to 85% of all RAS mutations. Mirati’s investigational drug candidate adagrasib (MRTX849) is an orally available small molecule that potently and selectively inhibits the G12C substitution mutation. The Resolution assay will be used to identify patients whose cancers are driven by this KRAS variant.

"We are excited to join forces with Mirati to address this large unmet medical need and to further drive adoption of our innovative liquid biopsy diagnostic tests," said Mark Li, CEO of Resolution Bioscience. "Our mission is to provide critical, actionable information to improve care and clinical outcomes for cancer patients worldwide."

About Resolution Bioscience’s Liquid Biopsy Technology

The Resolution liquid biopsy assays are powered by the company’s patented cell-free DNA (cfDNA) analysis platform, which includes proprietary targeted capture next-generation sequencing (NGS) biochemistry and tightly coupled, cloud-based bioinformatics. The liquid biopsy assays are designed to provide rapid and accurate tumor genotyping, all without an invasive tissue procedure. Now covered by Medicare and private payors, Resolution’s technology has been recognized as novel by the FDA and cited in several important scientific publications and presentations. For example:

97% clinical response was seen for NSCLC patients who received plasma-directed therapy selection from Resolution’s assay as reported in a publication with Memorial Sloan Kettering Cancer Center and the Northern Cancer Institute of Sydney. With more than 1,000 patients enrolled, the ongoing study is the largest prospective study of stage II, III, or IV NSCLC aimed at demonstrating clinical response and outcomes based upon plasma-directed therapy selection.
A recent study by the Dana-Farber Cancer Institute found that the Resolution ctDx Lung assay identified more actionable gene fusion mutations than Guardant Health’s Guardant360 test.
Resolution was the first to demonstrate the detection of all four major types of mutations in a blinded clinical study led by scientists at Dana-Farber Cancer Institute. The team determined the assay has the potential to be implemented broadly for patient care and translational research.
Resolution was also the first company to demonstrate gene deletion detection in cfDNA in a study led by scientists at Vanderbilt University in small cell lung cancer. The team determined that cfDNA sequencing allows for improved monitoring of disease burden, depth of response to treatment, and timely warning of disease relapse in patients.
The Resolution HRD assay was granted Breakthrough Device Designation by the US Food and Drug Administration.
In a recent AstraZeneca publication, Resolution had the highest positive predictive value and the lowest false positive rate among four leading NGS liquid biopsy companies in a blinded comparison study.