On September 16, 2020 Menarini Ricerche, the R&D division of the Menarini Group, reported that a first patient in Europe has been treated in the cohort expansion phase of the DIAMOND clinical trial -01 (CLI24-001; NCT03008187), investigating SEL24 / MEN1703, a first-in-class dual oral PIM / FLT3 inhibitor, as a monotherapy agent in acute myeloid leukemia (AML) (Press release, Menarini, SEP 16, 2020, View Source [SID1234565260]). The patient has received the assigned treatment in the expansion phase of the cohort, which has been initiated after the end of the dose escalation phase of the trial, the results of which have been presented at the 25th annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper). The aforementioned cohort expansion phase began previously in the United States, with a first patient treated on July 21, 2020.

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DIAMOND-01 is a phase I-II trial, first administration to humans, in a dose escalation and cohort expansion design, to evaluate SEL24 / MEN1703,, in patients with recurrent or refractory AML, as well as patients who do not have been previously treated because they are not candidates for standard chemotherapy The expansion of the cohort, which has been implemented in various centers of excellence in oncology in the United States and Europe (Italy, Spain and Poland), will recruit patients with recurrent AML or refractory, and will evaluate the monotherapy activity and the safety profile of SEL24 / MEN1703 at the recommended dose, determined according to the results of the dose escalation phase.

On September 16, 2020 Amgen (NASDAQ:AMGN) reported that data from its oncology pipeline in solid tumors will be presented during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020, Sept. 19-21, 2020 (Press release, Amgen, SEP 16, 2020, View Source [SID1234565259]).

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Amgen will present new data for AMG 510 (proposed INN: sotorasib) and AMG 160 during two oral presentations. Data from the study of sotorasib, Amgen’s investigational KRASG12C inhibitor, will showcase Phase 1 clinical results on durability of clinical benefit in patients with non-small cell lung cancer (NSCLC). Additionally, data from Amgen’s bispecific T cell engager (BiTE) platform will feature preliminary safety and efficacy findings from the ongoing Phase 1 study of AMG 160, an investigational half-life extended BiTE immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). Abstracts will be released on Saturday, Sept. 19, and will be followed by oral presentations (sotorasib, Sunday Sept. 20 and AMG 160, Monday Sept. 21) that will highlight more recent data.

"During ESMO (Free ESMO Whitepaper), we will highlight our pioneering work in two key areas of oncology research – KRAS inhibition and BiTE therapies," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "Clinicians will be presenting updated data from the first and largest Phase 1 human clinical study of an investigational KRASG12C inhibitor, sotorasib — now the first KRASG12C inhibitor to advance to a Phase 3 study. In addition, early and encouraging data from our BiTE platform in the solid tumor setting will be presented. Our data at ESMO (Free ESMO Whitepaper) underscore our unique approach to harnessing the human biology of cancer to alter the course of cancer care for patients who need it most."

Learn more about Amgen’s development of innovative medicines for novel targets in difficult-to-treat solid tumors at AmgenOncology.com.

Key Clinical Abstracts and Presentation Times (Pipeline):

Durability of Clinical Benefit and Biomarkers in Patients (pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Treated With AMG 510 (sotorasib)*
Presentation #1257O, Proffered Paper Session, Sunday, Sept. 20, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Results From a Phase 1 Study of AMG 160, a Half-Life Extended (HLE), PSMA-Targeted, Bispecific T Cell Engager (BiTE) Immune Therapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Presentation #609O, Proffered Paper Session, Monday, Sept. 21, 2020, from 2:25 p.m. – 2:37 p.m. CEST / 5:25 a.m. – 5:37 a.m. PDT
Amgen Webcast Investor Call
Amgen will host two webcast calls for the investment community in conjunction with the ESMO (Free ESMO Whitepaper) Virtual Congress 2020. On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen’s clinical development team, will discuss the Phase 1 data being presented on the Company’s investigational half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA). 

Live audio of the conference call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

To learn more about Amgen’s innovative pipeline with diverse modalities and genetically validated targets, please visit www.AmgenOncology.com.

About CodeBreaK
The CodeBreaK clinical trial program for Amgen’s investigational drug sotorasib is designed to treat patients with multiple KRAS G12C-mutant solid tumors and address the longstanding unmet medical need for these cancers.

CodeBreaK 100, the Phase 1 and 2, first-in-human, open-label multicenter study, enrolled patients with KRAS G12C-mutant solid tumors. Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumor type and stage of disease. The primary endpoint for the Phase 1 study is safety, and key secondary endpoints include objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts: 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.

Amgen’s single-arm Phase 2 trials in both non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) (also part of CodeBreaK 100) are now fully enrolled. The potentially registrational Phase 2 trial in NSCLC is on track for data readout later in 2020 and a Phase 3 trial comparing sotorasib with docetaxel in NSCLC has begun recruiting. The Phase 2 CRC trial is expected to have a data readout in early 2021.

Amgen is currently enrolling six Phase 1b combination studies across various advanced solid tumors (CodeBreaK 101). In addition, a randomized global Phase 3 confirmatory study in NSCLC (CodeBreaK 200) has been initiated. Additional information about CodeBreaK clinical trials can be found at View Source

About BiTE Technology
BiTE (bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patient’s own T cells to any tumor-specific antigen, activating the cytotoxic potential of T cells to eliminate detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumor types through tumor-specific antigens. The BiTE platform has a goal of leading to off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumors, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential. To learn more about BiTE technology, visit www.AmgenBiTETechnology.com.

About Amgen Oncology
Amgen Oncology is searching for and finding answers to incredibly complex questions that will advance care and improve lives for cancer patients and their families. Our research drives us to understand the disease in the context of the patient’s life – not just their cancer journey – so they can take control of their lives.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we are driven by our commitment to transform the lives of cancer patients and keep them at the center of everything we do.

On September 16, 2020 Amgen (NASDAQ:AMGN) reported that it will host two webcast calls for the investment community in conjunction with the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Congress (Press release, Amgen, SEP 16, 2020, View Source [SID1234565258]). On Sunday, Sept. 20, 2020, at 11:00 a.m. PDT, David M. Reese, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team and clinical investigators, will discuss Phase 1 data being presented on the Company’s investigational KRASG12C inhibitor sotorasib (AMG 510). On Monday, Sept. 21, at 1:00 p.m. PDT, David M. Reese, M.D., along with members of Amgen’s clinical development team, will discuss the Phase 1 data being presented on the Company’s investigational half-life extended bispecific T-cell engager (BiTE) immuno-oncology therapy targeting prostate-specific membrane antigen (PSMA).

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Live audio of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

On September 16, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that data at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 showing that MammaPrint’s Ultra-Low risk threshold can identify postmenopausal breast cancer patients who will have an excellent prognosis with limited or no tamoxifen treatment (Press release, Agendia, SEP 16, 2020, View Source [SID1234565257]).

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The presentation, "Avoid systemic overtreatment of postmenopausal breast cancer patients with Ultralow MammaPrint result," can be found in the ESMO (Free ESMO Whitepaper) virtual exhibit.

Adjuvant anti-estrogen therapy is a widely-used therapy for estrogen receptor positive breast cancers, but as with many cancer treatments, may cause serious side effects. In this analysis, researchers sought to validate whether the MammaPrint Ultra-Low risk category can accurately identify postmenopausal, node-negative breast cancer patients who would have an excellent survival rate after surgery with no chemotherapy and a limited duration of or even no endocrine therapy.

This study confirms findings from the STO-3 Trial, previously published in 2017 in JAMA Oncology, and continues to show that the use of MammaPrint to stratify patient populations could help prevent the overtreatment of breast cancer patients.

"These data are particularly exciting because they continue to demonstrate utility for MammaPrint in the clinically low risk patient population. The study suggests that we may be able to de-escalate endocrine treatment for these patients," said William Audeh, MD, MS, Chief Medical Officer at Agendia. "We are pleased to present results that illustrate not only the potential of MammaPrint to identify which patients may be spared chemotherapy, but also to indicate patients who may not require five years, and certainly not ten years, of endocrine therapy. These data could be used to spare some women with ultra-low risk breast cancer from being over-treated."

Agendia is committed to providing immediate, actionable data points and furthering research that will allow for breast cancer patients and their care teams to confidently make the most personalized treatment decisions

On September 16, 2020 Canexia Health reported a new financing round from PacBridge Capital Partners (HK) Limited to propel the company’s long-term global growth and accelerate its roadmap to make cancer testing for treatment selection and monitoring accessible to all cancer patients (Press release, Contextual Genomics, SEP 16, 2020, View Source [SID1234565256]). The investment signals Canexia Health’s record-breaking growth in 2020 to date, with new customer collaborations and studies, product enhancements, and reimbursement progress.

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"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring"

Highlights include:

● New collaborations. In the first half of 2020, the company increased commercial partner agreements by 65%. One new collaborator is Genolife, a private clinic that provides access to personalized genetic tests and genetic counselling services. Genolife will offer Canexia Health’s circulating tumor DNA (ctDNA) assay, Follow It, in Quebec. Additional new commercial partner agreements include AstraZeneca Canada, the Eastern Ontario Regional Laboratory Association (EORLA), and Queen’s University. All are involved in Project ACTT, and EORLA and Queens University will adopt Canexia’s technology transfer model to bring ctDNA testing in-house. Project ACTT is a CAD $2.59M initiative led by Canexia Health and supported by Canada’s Digital Technology Supercluster to deploy and enhance Follow It for 2,000 patients during COVID-19 as an alternative to surgical tissue biopsies.

● Monitoring studies. Monitoring is a $15B market opportunity in the US alone. Adding to its portfolio of monitoring studies, Canexia Health is collaborating with Exactis Innovation, a pan-Canadian Networks Centres of Excellence comprising 14 oncology centers. The research study, led by Dr. Simon Turcotte at the Centre de Recherche Centre Hospitalier de l’Université de Montréal, will deploy Follow It to analyze ctDNA and investigate non-invasive early detection of treatment failure in patients with metastatic colorectal cancer who are undergoing systemic chemotherapy and liver resection. Following definitive surgery, disease recurrence is seen in 50-75% of patients within 2 years, highlighting the importance of recurrence risk prediction and disease monitoring in this patient population.

● Product enhancements. Canexia Health continues to expand the genomic content of its assays, including MSI and CNV content, as well as recently releasing updates to the Canexia Health Fusions panel. The company has also improved the sensitivity of its liquid biopsy assays for use in monitoring and leveraged tens of thousands of processed samples to improve its AI and machine learning algorithms.

● Reimbursement progress. Via partner Lab Genomics, Follow It has received a unique Z code, representing a key reimbursement milestone with the US Centers for Medicare and Medicaid.

● Corporate rebrand and growth. In July, the company rebranded from Contextual Genomics to Canexia Health to reflect the company’s deep focus on cancer patients and on building a community nexus to make precision oncology affordable and accessible. The company has also increased its full-time workforce by 35% since March 2020 with the addition of new hires in the laboratory, as well as in computational science, software, business development, and marketing.

"This has been a year of incredible growth for Canexia Health. Since the beginning of 2020, we have welcomed new customers and collaborators, and we are well on the path to democratize how oncologists gain information about cancer treatment selection and monitoring," said Michael Ball, CEO of Canexia Health. "Further, we have built a clinically focused molecular test specifically for those who want to bring this technology in-house. The faster you can get an individual on targeted therapy, the better their outcomes are likely to be. Building in-house capabilities and thus making cancer testing more accessible, that’s really the focus for our company moving forward."