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.

On January 11, 2021 Akoya Biosciences, Inc., The Spatial Biology Company, reported that Brian McKelligon, the company’s Chief Executive Officer,reported to present at the J.P. Morgan 39th Annual Healthcare Conference on Wednesday, January 13, 2021 (Press release, Akoya Biosciences, JAN 11, 2021, View Source [SID1234573844]). Mr. McKelligon will provide a company overview of Akoya and its spatial phenotyping solutions.

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On January 11, 2021 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported a corporate update and highlighted priorities for 2021 (Press release, Scholar Rock, JAN 11, 2021, View Source [SID1234573843]).

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"2020 was a transformative year for Scholar Rock with significant progress made both clinically and operationally with positive interim data from the TOPAZ trial providing initial proof-of-concept of apitegromab’s potential in SMA and showing the potential benefit of inhibiting the latent forms of growth factors," said Tony Kingsley, President and CEO of Scholar Rock. "In 2021, we will further elucidate the potential of our product candidates through data from our TOPAZ Phase 2 trial in SMA and our DRAGON Phase 1 trial in cancer immunotherapy as well as build upon our scientific platform towards additional indications."

2021 Expected Milestones:

Apitegromab is a highly selective inhibitor of latent myostatin activation being developed as the potential first muscle-directed therapy for the treatment of spinal muscular atrophy (SMA).

Top-line Efficacy and Safety Data from TOPAZ Phase 2 Trial in SMA Anticipated in 2Q21. A total of 58 patients were enrolled across the three cohorts of the TOPAZ clinical trial with one discontinuation to date. Positive six-month interim analysis data were announced in October 2020, demonstrating apitegromab’s potential to improve motor function in patients with Type 2 and Type 3 SMA. The top-line 12-month efficacy and safety data are expected in the second quarter of 2021.
As of January 8, 2021, 56 patients have completed the 12-month study and all 56 have opted into the extension period.

Identification of Second Indication for Apitegromab Planned for 2021. With the demonstration of initial proof-of-concept from the TOPAZ interim analysis, Scholar Rock is actively evaluating multiple other disorders for which the selective inhibition of the activation of myostatin may offer therapeutic benefit.
SRK-181 is a potent and highly selective inhibitor of latent transforming growth factor beta 1 (TGFβ1) activation being developed with an aim of overcoming resistance to and increasing the number of patients who may benefit from, checkpoint inhibitor therapy.

Initial Clinical Response and Safety Data from the DRAGON Trial are Anticipated in the Second Half of 2021. SRK-181 is being evaluated in the two-part DRAGON Phase 1 trial in patients with locally advanced or metastatic solid tumors exhibiting primary resistance to anti-PD-(L)1 therapy. Dose escalation in Part A of the DRAGON trial is progressing with the highest planned dose of 2400 mg now being evaluated in Part A1 (SRK-181 as a single-agent) and the 800 mg dose being currently evaluated in Part A2 (SRK-181 in combination with an approved anti-PD-(L)1 therapy).
The DRAGON trial is anticipated to advance to Part B in the second quarter of 2021, which is expected to encompass multiple cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. Each cohort will enroll up to 40 patients with locally advanced or metastatic solid tumors for which they have been treated with an approved anti-PD-(L)1 therapy and have demonstrated primary resistance. Patients in Part B will be treated with SRK-181 in combination with an approved anti-PD-(L)1 therapy.

"We enter 2021 with positive momentum across our programs. We believe we’ve demonstrated the potential of our novel scientific approach to treating a wide array of disease areas for which growth factors play a critical role in disease progression," said Ted Myles, CFO and Head of Business Operations of Scholar Rock. "Our strong balance sheet, which can fund operations into 2023, provides flexibility as we continue to invest in developing important therapies for patients in need."

On January 11, 2021 Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK) ("Takeda") reported that it will present virtually at the 39th Annual J.P. Morgan Healthcare Conference at 5:20 p.m. ET on Monday, January 11, 2021 / 7:20 a.m. JT on Tuesday, January 12, 2021 (Press release, Takeda, JAN 11, 2021, View Source [SID1234573842]). Investors and the general public are invited to listen to the live webcast with Christophe Weber, president and chief executive officer, here. A replay of the webcast will also be archived at the same location. A link to the webcast and slides for download will also be available on Takeda’s website at View Source

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On January 11, 2021 EQRx, a company committed to developing and delivering important new medicines at lower prices, reported that it has raised $500 million in Series B financing (Press release, EQRx, JAN 11, 2021, View Source [SID1234573841]). Since launching a year ago, EQRx has raised approximately $750 million to advance its mission of bringing new medicines to treat life-threatening and chronic diseases to patients and healthcare systems around the world at prices that are a fraction of the cost of today’s leading therapies.

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The Series B financing includes participation from all Series A investors, life science specialists, world-class mutual funds and private equity funds, sovereign wealth and family offices, and market-leading payers and health systems that cover more than 20% of insured lives in the United States.

"There is an urgent need for change in the industry’s approach to drug pricing, and although challenging, changing the model is not only possible, it is critical," said Alexis Borisy, founder, chairman and chief executive officer of EQRx. "The price of a drug should never be the rate-limiting factor to patient access. EQRx is confronting this issue head-on by employing a disruptive, market-based approach to create true, sustainable access to great medicines at fair prices and reestablish trust and transparency between drug developers and the people who need these medicines."

EQRx is building a highly competitive pipeline of important new drug candidates to address diseases like cancer and inflammatory conditions that combined are projected to represent nearly 40% of the drug spend among the highest cost diseases globally by 2025. By leveraging proven druggable targets and a relentless focus on efficiency, together with deep strategic partnerships with health systems and payers, EQRx anticipates a higher probability of regulatory success, a lower risk-adjusted cost of drug development and a more streamlined access model. The Company estimates that its broad pipeline of innovative therapies has the potential to save the U.S. healthcare system between 50-70% of its current drug spend across the respective therapeutic areas.

In oncology, EQRx has disclosed several late-stage drug candidates currently in development that show promise in the treatment of some of the most common and devastating types of cancers globally—lung cancer, breast cancer and other solid tumors—including:

sugemalimab, a PD-L1 antibody with compelling phase 3 clinical data in non-small cell lung cancer (NSCLC), as well as potential additional applications in gastric cancers, esophageal cancers, and lymphomas. Notably, sugemalimab has received Breakthrough Drug Designation and Orphan Drug Designation from the United States Food and Drug Administration (FDA) for the treatment of certain lymphomas;
almonertinib, an EGFR inhibitor, to treat certain types of NSCLC, which is already approved in China and is in late-stage clinical trials;
EQRx’s PD-1 antibody (formerly known as CS1003), which has received Orphan Drug Designation from the FDA for a type of primary liver cancer; and
lerociclib, a CDK4/6 inhibitor, which targets HR+/HER2- breast cancer, the most common type of the disease.
EQRx’s business model drives cost savings both through the potential use of these medicines as monotherapies, and by enabling biopharma companies to create high-quality, lower-cost combination regimens including EQRx’s drugs through partnerships.

The Company has also entered several strategic collaborations with national and regional health plans and large integrated delivery networks and health systems. "EQRx is the ultimate convener, bringing healthcare stakeholders together in meaningful strategic partnerships to modernize traditional drug manufacturer-to-patient access models globally," added Melanie Nallicheri, co-founder, president and chief operating officer of EQRx. "Our shared goal is to enable effortless prescribing for providers and equal access to important new medicines for people by eliminating barriers, especially high drug costs. With this Series B financing, EQRx is well-poised to make sustainable drug pricing a reality for people, payers and health systems."