On November 16, 2020 Danaher Corporation (NYSE: DHR) reported that Executive Vice President and Chief Financial Officer, Matt McGrew, will be presenting at the Wolfe Research Healthcare Conference on Thursday, November 19, 2020 at 12:00 p.m. ET (Press release, Danaher, NOV 16, 2020, View Source [SID1234571174]). The audio will be simultaneously webcast on www.danaher.com.

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On November 16, 2020 KDx Diagnostics, Inc. (KDx), and Lister Hospital (East and North Hertfordshire NHS Trust), Stevenage, UK,reported a joint publication describing how KDx’s URO17 test performed in patients with hematuria (blood in urine) (Press release, KDx Diagnostics, NOV 16, 2020, View Source [SID1234571173]). URO17 test, based on an exciting new bladder cancer marker, is urine-based and non-invasive and was able to detect the presence of bladder accurately in hematuria.

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There are over 197,000 newly diagnosed cases of bladder cancer in Europe, and 430,000 globally, with 81,000 cases in the US alone. Accurate detection of new bladder cancer is currently very difficult and expensive, requiring invasive camera-based testing methodology. Excitingly, the data showed KDx’s URO17 test had 100% sensitivity and 92.6% specificity in detecting new bladder cancer in patients with hematuria in this study.

"Previously, we have shown that the URO17 test exhibited 100% sensitivity and 96% specificity in detecting recurrent bladder cancer from urine samples (Babu et. al., 2018). This study confirms the accuracy of URO17 in detecting bladder cancer in the same matrix (non-invasive urine samples), but importantly expands on the previous findings by demonstrating that URO17 test can be reliably used to detect new bladder cases in patients with hematuria," said Nam W. Kim, Ph.D., KDx’ CEO, and CTO.

"We are delighted with this publication, which documents our successful collaboration with Mr. Nikhil Vasdev in this important study. Together with our recent CE Marking for the URO17-IVD test, this publication and our collaboration position us to bring this important test to patients in UK and Europe," said Sholeh Jahanfard, President and COO of KDx.

Mr. Nikhil Vasdev – Consultant Urological Surgeon at Lister Hospital and Associate Medical Director for cancer services at East and North Hertfordshire NHS Trust, which runs the hospital – is the chief investigator and the lead author of the study. "We are pleased to be the first group in Europe to report on the high accuracy of URO17 test in detecting the presence of bladder cancer in patients who have not been previously diagnosed with the disease," said Mr. Vasdev, who is also a Senior Clinical Lecturer at the University of Hertfordshire. "Our ability to detect bladder cancer simply, accurately, and non-invasively using URO17 will greatly improve detection at an early stage when it can be treated most effectively," he added.

Dr. Michael Chilvers, Medical Director at East and North Hertfordshire NHS Trust and also a co-author of the URO17 publication, said: "I am extremely proud of our urology department being at the forefront of this groundbreaking publication in Europe. URO17 shows real promise in improving bladder cancer patient care."

On November 16, 2020 Bristol Myers Squibb (NYSE: BMY) reported that the U.S. Food and Drug Administration (FDA) has informed the company that its review of the Biologics License Application (BLA) for lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after at least two prior therapies will not be completed by the Prescription Drug User Fee Act (PDUFA) action date of November 16, 2020 (Press release, Bristol-Myers Squibb, NOV 16, 2020, View Source [SID1234571170]).

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The FDA was unable to conduct an inspection of a third-party manufacturing facility in Texas during the current review cycle due to travel restrictions related to the COVID-19 pandemic. Therefore, the FDA is deferring action on the application until the inspection can be completed. The application remains under review. The FDA did not provide a new anticipated action date.

"Bristol Myers Squibb continues to work closely with the FDA to support the ongoing review of the BLA for liso-cel," said Samit Hirawat, M.D., executive vice president, chief medical officer, global drug development, Bristol Myers Squibb. "We are committed to bringing liso-cel to patients with relapsed or refractory large B-cell lymphoma who still have significant unmet need."

The BLA is based on the safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating liso-cel in 268 patients with R/R large B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), high-grade lymphoma, primary mediastinal B-cell lymphoma and Grade 3B follicular lymphoma. TRANSCEND NHL 001 is the largest study of CD19-directed CAR T cells to support a BLA to date.

For Holders of Contingent Value Rights (CVR), Ticker BMY-RT

U.S. FDA approval of liso-cel by December 31, 2020 is one of the required remaining milestones of the Contingent Value Rights issued upon the close of the Celgene acquisition in the fourth quarter of 2019. The other is U.S. FDA approval of Idecabtagene Vicleucel (ide-cel) by March 31, 2021. The company is committed to working with the FDA to progress both applications to achieve the remaining regulatory milestones required by the CVR.

Bristol Myers Squibb: Creating a Better Future for People with Cancer

Bristol Myers Squibb is inspired by a single vision — transforming people’s lives through science. The goal of the company’s cancer research is to deliver medicines that offer each patient a better, healthier life and to make cure a possibility. Building on a legacy across a broad range of cancers that have changed survival expectations for many, Bristol Myers Squibb researchers are exploring new frontiers in personalized medicine, and through innovative digital platforms, are turning data into insights that sharpen their focus. Deep scientific expertise, cutting-edge capabilities and discovery platforms enable the company to look at cancer from every angle. Cancer can have a relentless grasp on many parts of a patient’s life, and Bristol Myers Squibb is committed to taking actions to address all aspects of care, from diagnosis to survivorship. Because as a leader in cancer care, Bristol Myers Squibb is working to empower all people with cancer to have a better future.

On November 16, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported its participation in the Piper Sandler 32nd Annual Virtual Healthcare Conference, which takes place November 30 – December 3, 2020 (Press release, Agendia, NOV 16, 2020, View Source [SID1234571168]). Agendia Chief Executive Mark Straley will be accompanied by Agendia Chief Financial Officer Brian Dow for one-on-one Investor meetings on Monday, November 30; meetings may be requested exclusively through Piper Sandler. Additionally, a recorded company presentation will be available via the Piper Sandler conference site from November 23 to December 3, and on the Agendia website at View Source

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On November 16, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, reported its first multi-system contract with Integrated Proton Solutions (IPS), a provider of turn-key proton therapy programs in the United States (Press release, RefleXion Medical, NOV 16, 2020, View Source [SID1234571166]). The multi-year, multi-site contract will create centers that house both of these advanced approaches to external beam radiotherapy (EBRT) for treating malignant tumors.

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"IPS looks forward to adding biology-guided radiotherapy to our armamentarium of therapeutic offerings, as we expect it to bring the efficacy of radiotherapy so often seen in early-stage cancer to late-stage or metastatic disease," said Jeff Bordok, CEO of Integrated Proton Solutions. "Other radiotherapy machines cannot efficiently treat multiple, moving tumors on one patient, and then be used for single-tumor treatment on the next patient. This eventual flexibility of the RefleXion machine makes it a clear winner in our view."

The RefleXion X1 machine with BgRT is designed to overcome the technical limitations that restrict radiotherapy to one or two tumors. Instead, it will one day allow radiotherapy to reach more tumors during the same treatment session, even those tumors that move due to patient motion, such as breathing or digestion.

"This agreement with IPS is another step in realizing an important pillar of our value proposition, which is to provide leading-edge cancer treatment at the community level so that patients are treated close to their homes and to their support systems," said Todd Powell, president and CEO of RefleXion. "We are thrilled to engage with a partner like IPS that shares this philosophy as they work to establish these treatment centers throughout the United States."

BgRT uses emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope, known as a PET tracer, to guide EBRT. As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine design integrates PET arcs with a linear accelerator to detect these emissions and then immediately direct radiotherapy to each tumor.

Integrated Proton Solutions develops proton therapy centers featuring the most advanced proton therapy equipment in facilities that optimize workflow for clinicians and provide an environment sensitive to the needs of those undergoing cancer treatment. The first center offering both BgRT and proton therapy is expected to open in mid-2021.