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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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).

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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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.

On April 21, 2021 EdiGene, Inc. ("Company", or "EdiGene"), reported the successful completion of an RMB 400 million (approximately USD 62 million) Series B Plus financing (Press release, EdiGene, APR 21, 2021, View Source [SID1234578311]). Loyal Valley Capital led the round and other new investors included BioTrack Capital and Sherpa Healthcare Partners, along with continued support by existing investors including IDG Capital, Lilly Asia Venture, 3H Health Investment, Huagai Capital, Sequoia Capital China, Alwin Capital and Kunlun Capital. EdiGene is a biotech company develops genome editing technologies to accelerate drug discovery and develop novel therapeutics for a broad range of diseases. Previously the company completed a Series B Financing of an RMB 450 million (approximately USD 67 million) in October 2020. Proceeds from the financing will be used to advance the company’s pipeline into clinics and to scale up the business operation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Andy Lin, Founding Partner of Loyal Valley Capital commented: "Gene-editing, as one of the most exciting technologies in life science, has showcased huge potential in treating or curing various diseases in recent years and may fundamentally transform the current ways of disease treatment in the future. As the leading company in China in translating gene-editing technologies into innovative therapies, EdiGene has assembled a team of world-class researchers and experienced drug developers to develop and commercialize such assets, with full scientific rigor and quality. With their lead product receiving the first gene-editing therapy IND application approval in China, their pipeline addresses serious unmet medical needs with innovative and creative approaches. Investing in EdiGene fits very well with our value of ‘investing in and fostering leaders that make the world a better place’. We are honored to lead the round and join force with EdiGene and other investors to bring effective and accessible innovative therapies to patients in China and globally. We look forward to supporting the company in financing, scaling up development capabilities, linking up key resources upstream and downstream and collaborating with global partners, helping the company to become a global player in research and translation of gene editing technologies."

"We are delighted to add these top tier investors and are grateful for the continuous support from the current investors," said Dong Wei, Ph.D.，CEO of EdiGene, "The company is speeding up portfolio advancement and scaling up business footprints. Adding to our existing Beijing R&D center and Guangzhou Clinical Application Center, we have opened our Clinical Development Office in Beijing, Business Development Office in Shanghai and launched a R&D center in Cambridge, Massachusetts, USA. The round enables us to continue our efforts in translating gene-editing technologies into therapeutics and further grow the company in terms of scale, global competitiveness and business development. With these efforts, we strive to bring innovative therapies to patients in need sooner."

"We are grateful for the investors’ support, which enables us to move forward in R&D, company scale and globalization and propel the company to a brand new stage," said Wensheng Wei, Ph.D., Scientific Founder of EdiGene, "We will continue to translate genome editing technologies into transformative therapies, bringing new hope and new options to patients in China and around the world."

In January 2021, the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA) has approved EdiGene’s Investigational New Drug (IND) application for ET-01, an investigational CRISPR/Cas 9 gene-editing therapy for patients with transfusion dependent β-thalassemia. It marks the first gene-editing therapy and the first hematopoietic stem cell therapy IND application approval in China. The Company is preparing to initiate ET-01’s Phase I clinical trial, and furthermore, is advancing other assets including allogeneic CAR-T therapy, in vivo therapies based on RNA base editing technology LEAPER, as well as novel targeted therapies discovered through high-throughput genome-editing screening.

On April 21, 2021 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that Manuel Litchman, M.D., President and Chief Executive Officer, and Knut Niss, Ph.D., Chief Technology Officer, will participate in Chardan’s 5th Annual Genetic Medicines Manufacturing Summit, taking place virtually on April 26 and 27, 2021 (Press release, Mustang Bio, APR 21, 2021, View Source [SID1234578310]). The company will participate in a fireside chat on Monday, April 26, 2021, at 3:15 p.m. ET and will also participate in one-on-one meetings during the conference. A webcast of the company’s fireside chat will be available on the Events page of the Investor Relations section of Mustang’s website, www.mustangbio.com, for approximately 30 days after the meeting.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!