Alkermes to Host Conference Call to Discuss First Quarter 2021 Financial Results

On April 21, 2021 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:00 a.m. ET (1:00 p.m. BST) on Wednesday, Apr. 28, 2021 to discuss the company’s first quarter 2021 financial results (Press release, Alkermes, APR 21, 2021, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-first-quarter-2021-financial-results-301274155.html [SID1234578317]). Management will also provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Wednesday, Apr. 28, 2021, through Wednesday, May 5, 2021, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay access code is 13718854.

Personalis to Report First Quarter 2021 Financial Results on May 5, 2021

On April 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its first quarter 2021 financial results after the market closes on Wednesday, May 5, 2021 (Press release, Personalis, APR 21, 2021, View Source [SID1234578315]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 6587766. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

City of Hope Scientists Develop a Novel, Noninvasive Liquid Biopsy Test for Identification of Lymph Node Metastasis in Early-Stage T1 Colorectal Cancer

On April 21, 2021 Scientists at City of Hope, a world-renowned independent research and treatment center for cancer and diabetes, reported that have developed a novel, noninvasive liquid biopsy test for detecting lymph node metastasis in individuals with high-risk T1 colorectal carcinoma (Press release, City of Hope, APR 21, 2021, View Source [SID1234578314]). Research on the development of the blood test was reported in a new study published in Gastroenterology, a journal of the American Gastroenterological Association.

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This blood-based test is an example of the theranostic (a term that combines "therapeutic" and "diagnostic") approach at City of Hope, whose goal is to help every patient receive personalized treatment appropriate for their specific disease. Development of blood-based biopsies to detect and monitor tumors is one of the leading-edge technologies under investigation to help patients with cancer.

Most individuals suspected of having T1 colorectal cancer with lymph node metastasis undergo radical surgery to remove affected parts of the colon. Unfortunately, only 5-10% of these individuals actually had lymph node metastasis after final examination of the removed colon, indicating that surgery was not necessary for the majority of these people.

"Since radical surgery dramatically reduces quality of life for patients, improving the success rate of identification of high-risk individuals with lymph node metastasis remains the challenge in T1 colorectal cancer diagnosis," said Ajay Goel, Ph.D., M.S., chair of the Department of Molecular Diagnostics and Experimental Therapeutics at City of Hope, and the study’s senior author. "In the future, we hope to improve our confidence in identifying which individuals truly have lymph node metastasis via this novel biomarker-based liquid biopsy test for T1 colorectal cancer, in combination with clinical and pathological criteria."

The publication by Goel and colleagues focused on translating their previous findings of identifying lymph node metastasis with T1 colorectal cancer in a tissue-based assay into a blood-based assay. After refining and validating the panel of RNA biomarkers, the blood test was found to accurately identify lymph node metastasis with high sensitivity (83.3%; a higher value means fewer cases of disease are missed), and specificity (76.2%; a higher value means the test can accurately identify those without disease).

"Obtaining results with more than 80% accuracy (sensitivity) in finding lymph node metastasis in the blood was a completely unexpected finding and is a complete game changer," Goel said.

City of Hope researchers are excited about the potential of this new liquid biopsy test to complement current risk assessment for lymph node metastasis for individuals with early stage T1 colorectal cancer. The technology is patent pending.

Goel indicated that further work will be done to optimize the blood-based assay to improve sensitivity and continue to validate the assay in prospective clinical trials. "There are several steps between where we are now and where we want to go — detecting lymph node metastasis in colon cancer from a blood sample — but without doubt this is an encouraging first step."

Support for this study was provided by grants from the National Cancer Institute, and the National Institutes of Health (CA72851, CA181572, CA184792, CA202797 and CA187956).

Biocept Announces Full Commercial Launch of CNSide™ Cerebrospinal Fluid Assay to Address Unmet Needs for Patients with Metastatic Brain Cancer

On April 21, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported the full commercial launch of CNSide, its cerebrospinal fluid (CSF) assay designed to better detect and manage treatment of metastatic cancers involving the central nervous system (CNS) (Press release, Biocept, APR 21, 2021, View Source [SID1234578313]). The assay, initially introduced in January 2020, has the ability to offer a timely and accurate method to diagnose disease, identify actionable biomarkers, and assess response to therapy, potentially impacting life expectancy and quality of life.

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CNSide is based on Biocept’s proprietary quantitative tumor cell capture and detection method paired with assays to identify actionable molecular treatment targets. The assay answers three key questions: Is there involvement by tumor? Is there a target for treatment? Is there a trend with respect to treatment response?

The CNSide assay addresses a high unmet clinical need, as the current standard of care, CSF cytology, has limited sensitivity for detecting brain metastasis and assessing therapy response, and does not provide quantitative results. Between 10% and 30% of patients with cancer, depending on cancer type, will develop brain or spinal cord metastasis. Overall survival expectancy is low, and many patients are not diagnosed early enough for therapeutic intervention. However, the use of newer targeted therapies for lung and breast cancer with intracranial metastasis can often extend survival for a year or more, resolving symptoms and substantially improving quality of life.

"Simply stated, patients diagnosed with advanced cancer and their physicians need better tools to diagnose brain metastasis earlier, more accurately, and to assess response to therapy in a timely, quantitative fashion so that patients can benefit from the remarkable advances in cancer therapies available today," said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "These patients do not have time to waste on inaccurate or uncertain diagnostic tests."

"CNSide, with Target Selector technology, provides information well beyond what we can obtain from current diagnostics—specifically, it provides insights to help us select the right treatment for our patients, as well as insights on duration of therapy," said Priya Kumthekar, MD, Associate Professor of Neurology and Oncology, Northwestern University Feinberg School of Medicine, during a recent key opinion leader webinar. "I see CNSide as a way to improve diagnosis and monitoring of CNS involvement in a patient population that represents a very high unmet need, and a population that appears to be growing."

"The full sales force launch of our CSF assay, along with new branding, is an exciting next step toward our goal of establishing CNSide as a new standard-of-care diagnostic test for cerebrospinal fluid," said Michael Nall, Biocept’s President and CEO. "Initial acceptance by neuro-oncology early-adopters has been highly encouraging as physicians from nearly two dozen leading academic institutions have ordered CNSide—with many becoming repeat users. This represents a significant market opportunity that we estimate at more than $1 billion annually in the United States for breast and lung cancers that have metastasized to the central nervous system."

In 2020, Biocept presented highly favorable results from pilot studies with the assay at three major scientific meetings.1-3 The studies showed that in approximately 80% of the cases of suspected CNS involvement, tumor cells were detected using the CNSide assay, compared with about 50% of cases examined by CSF cytology. The assay is currently validated to identify metastatic cancers originating in the lung and breast. Biocept plans to expand its CSF testing menu for additional tumor types and biomarkers in the future.

A recent webinar hosted by Biocept featured leading neuro-oncologists discussing the use of the CNSide assay for diagnosing and managing tumors that have metastasized to the CNS. The webinar can be viewed here.

Humanigen Appoints Dr. Adrian Kilcoyne to the role of Chief Medical Officer

On April 21, 2021 Humanigen, Inc. (Nasdaq: HGEN) ("Humanigen"), a clinical-stage biopharmaceutical company focused on preventing and treating an immune hyper-response called ‘cytokine storm’ with its lead drug candidate, lenzilumab, reported the appointment of Adrian Kilcoyne, MD, MBA, MPH, to the newly-created role of Chief Medical Officer, effective immediately, reporting to Dr. Cameron Durrant, CEO of Humanigen (Press release, Humanigen, APR 21, 2021, View Source [SID1234578312]).

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Dr. Kilcoyne brings to Humanigen strong leadership experience from multinational pharmaceutical and biotechnology companies and a strong clinical background in both Internal Medicine and Public Health Medicine. His most recent leadership role was in AstraZeneca, where he served as Vice President of Oncology Global Medical Affairs, Head of Evidence Generation and External Alliances, and previously as Vice President and Head of US Medical Affairs and Health Economics and Outcomes Research. Dr. Kilcoyne oversaw the development and delivery of the fully integrated global evidence strategy across the company’s complete oncology portfolio, including managing development of real-world evidence, epidemiology, biostatistics and data sciences, health economics and outcomes research, payer evidence, medical affairs sponsored research, and investigator research. He also led Global Oncology External Alliances, building strong scientific partnerships to advance patient care.

"Humanigen is delighted to welcome Dr. Kilcoyne," said Dr. Durrant. "His experience and knowledge in multiple areas, including COVID-19, CAR-T and other oncology clinical development areas, medical affairs, regulatory affairs, evidence generation, health economics, and partnering gives him a unique insight that can be leveraged towards Humanigen’s COVID-19, acute GvHD, CAR-T and other oncology programs with lenzilumab and ifabotuzumab. In addition, Adrian’s leadership in the external alliances arena will be instrumental in helping guide the progress of Humanigen’s pipeline and potential commercialization."

During his tenure at AstraZeneca, Dr. Kilcoyne oversaw multiple launches of innovative therapies in oncology, including acalabrutinib, a Bruton’s tyrosine kinase inhibitor, in the US (marketed as CALQUENCE) which has also been investigated in two Phase 2 studies in COVID-19 patients. Previously, Dr. Kilcoyne held several leadership positions at Celgene Corporation, a subsidiary of Bristol Myers Squibb, including Executive Medical Director, Global Lymphoma Program Lead, Clinical Research and Development overseeing the development of lenalidomide in Diffuse Large B-Cell Lymphoma (DLBCL). He was also the US lymphoma CAR-T lead supporting the clinical development and launch preparation of lisocabtagene maraleucel (or liso-cel, marketed as Breyanzi) for the treatment of adults with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy. Prior to this, Dr Kilcoyne held Medical Affairs and Clinical Development leadership roles in Sanofi Pasteur MSD, Roche and Eli Lilly.

Dr. Kilcoyne’s responsibilities as Humanigen Chief Medical Officer include the clinical development and regulatory strategy for lenzilumab across its varied potential therapeutic indications including CAR-T, acute GvHD, CMML and COVID-19. Additionally, Dr. Kilcoyne will be responsible for the clinical development and regulatory strategy for ifabotuzumab in solid tumors. Dr. Kilcoyne will also be responsible for medical affairs, real-world evidence generation, health economics and outcomes and participate in external alliance evaluation.

"I am excited to join the Humanigen team at this time and look forward to the opportunity to contribute to the company’s strategic long-term growth. I am honored to have the opportunity to deliver on the promise that Humanigen’s innovative portfolio offers to patients with significant unmet medical need," said Dr. Kilcoyne.

Dr. Kilcoyne graduated from Trinity College, Dublin and holds a MSc in Public Health from the London School of Hygiene and Tropical Medicine, along with a MSc in Business Administration from the Warwick Business School. He is the co-author of Pharmaceutical Medicine, a textbook published by Oxford Specialist Handbooks in 2013, edition 2 now being finalized.