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."

On September 16, 2020 The Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI-ABTS) in collaboration with US Medical Innovations, LLC (USMI) reported that Canady Helios Cold Plasma (CHCP) has been used as an effective inhibitor of cell viability in breast cancer molecular subtypes (Press release, JCRI-ABTS, SEP 16, 2020, View Source [SID1234565254]).

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JCRI-ABTS recently published in the journal of Clinical Plasma Medicine that in vitro testing demonstrated a 92–99% reduction of viability across seven breast cancer cell lines 48 hours after treatment with CHCP. (Access report here: Canady Cold Plasma Conversion System Treatment)

According to the American Cancer Society’s 2020 statistics, in the United States alone, an estimated 276,480 new cases of invasive breast cancer are expected to be diagnosed in women, and breast cancer deaths are projected to exceed 42,000. There are over 3.5 million women in the US currently living with breast cancer.

Dr. Canady commented, "We are very excited about the results of this new report, particularly the results pertaining to the Triple-Negative Breast Cancer (TNBC) cell lines. TNBC patients do not respond to endocrine therapies or HER2-targeted therapies, such as trastuzumab. Compared to other breast cancer phenotypes, TNBC has a significantly higher rate of death, recurrence and risk of metastatic spread to the lungs, liver, and brain despite adjuvant chemotherapy."

The JCRI-ABTS team has also just completed two additional milestones:

The first study demonstrates a 95-100% apoptosis (cell death) of all breast cancer cell lines.
The second study identifies a survival gene for breast cancer after CHCP treatment. Both studies will be submitted for publication this year.
As a result of this research, JCRI-ABTS is planning the development of the first plasma immunotherapy drug for solid tumors early in 2021, followed by animal studies and a phase I clinical trial in humans later next year.

JCRI-ABTS and USMI are currently conducting the first FDA-approved clinical trial (IDE #190165) to evaluate cold atmospheric plasma (Canady Helios Cold Plasma) for the treatment of stage IV recurrent solid tumors at Rush University Medical Center (Chicago, IL) and Sheba Medical Center (Ramat Gan, Israel). Prior to the Phase I clinical trial, human-use of Canady Helios Cold Plasma was limited to FDA approved Compassionate Use Cases (The most recent case is still tumor-free after 14 months). There have been no adverse events in the IDE clinical trial and compassionate use cases.

On September 16, 2020 Volastra Therapeutics, a biotechnology company developing novel therapies to treat and prevent the formation of metastatic disease, reported that it has named Charles Hugh-Jones, MD, FRCP, as its Chief Executive Officer (Press release, Volastra Therapeutics, SEP 16, 2020, View Source [SID1234565252]). Dr. Hugh-Jones brings a strong leadership background from across both multinational pharmaceutical organizations and smaller biotechnology companies. Over the course of his career, he has built extensive expertise in the development and commercialization of medicines.

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"We are incredibly fortunate that Charles is joining the team. His breadth of experience and scientific acumen will be vital in fulfilling our mission," said Volastra Executive Chair Sandra Peterson, former Group Worldwide Chairman of Johnson & Johnson, current Partner at Clayton, Dubilier, and Rice, and current board member of Microsoft.

Dr. Hugh-Jones, a board-certified physician, began his career at Schering AG, Enzon Pharmaceuticals and Sanofi, where he held various positions of increasing responsibility. He then joined Pfizer Oncology division as their Chief Medical Officer where he had medical oversight of all late-stage drug development and commercialization activities. Most recently, Dr. Hugh-Jones was global Chief Medical Officer of Allergan PLC, where he led complex interdisciplinary teams and supported the launch of novel medicines in multiple therapeutic areas.

"We are excited to have Charles at the helm as we tackle chromosomal instability, a pervasive feature of metastatic cancers," said Volastra Co-founder and Advisor Lewis Cantley, PhD, Professor of Cancer Biology in Medicine and Meyer Director of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medical College. "Our goal is to further uncover novel insights into chromosomal instability and its clear association with the formation, progression, and maintenance of metastasis to ultimately develop new therapies."

"I’m inspired by Volastra’s mission to bring new therapies to patients with metastatic solid tumors, which are notoriously among the toughest to treat with existing therapies," said Dr. Hugh-Jones. "There is a tremendous unmet need in this patient population, and Volastra’s novel research holds great promise. I look forward to working with the entire team to build upon the scientific discoveries of its founders and grow a pipeline of potential therapies that can make a difference in patients’ lives."

Volastra Therapeutics launched earlier this year with $20 million in financing. Polaris Partners led the financing with additional investment from Vida Ventures, ARCH Venture Partners, DROIA Oncology Ventures, and the Global Health Sciences (GHS) Fund (Quark Venture LP and GF Securities). As a cornerstone tenant in a new biotech development, the company recently secured 11,000 square feet of laboratory and office space in West Harlem, New York. Dr. Hugh-Jones will lead the growing team at this new location.