On April 1, 2021 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported it has completed the acquisition of Ipsen’s (Euronext: IPN; ADR; IPSEY) intellectual property and assets related to IPN-1087 (Press release, Fusion Pharmaceuticals, APR 1, 2021, View Source [SID1234577520]). IPN-1087 is a small molecule targeting neurotensin receptor 1 (NTSR1), a protein expressed on multiple solid tumor types. Fusion intends to use IPN-1087 to create an alpha-emitting radiopharmaceutical, FPI-2059, targeting solid tumors expressing NTSR1.

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Under the terms of the agreement, Fusion issued to Ipsen 600,000 shares of its common stock at the time of closing, including shares due upon the achievement of a patent-related milestone which occurred prior to closing. Such shares were issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended. Fusion will also be obligated to pay Ipsen up to an additional €67.5 million upon the achievement of certain development and regulatory milestones; low single-digit royalties on potential future net sales; and up to €350.0 million in net sales milestones, in each case, relating to products covered by the asset purchase agreement. Fusion will be responsible for paying to a third-party licensor up to €70.0 million in development milestone payments and mid-single to low-double-digit royalties on potential future net sales of products covered by the license agreement.

The closing of the acquisition was subject to the satisfaction of customary closing conditions, including the expiration of the waiting period under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976. Additional details regarding the financial terms can be found in Fusion’s Form 8-K filed with the Securities and Exchange Commission on March 2, 2021.

About FPI-2059
FPI-2059 will be a radioconjugate combining actinium-225 with IPN-1087, for development as a targeted alpha therapy for various solid tumors. The molecule targets NTSR1, a promising target for cancer treatment, that is overexpressed in multiple solid tumors. IPN-1087 was in Phase 1 clinical development as a lutetium-177-based radiopharmaceutical for pancreatic ductal adenocarcinoma, colorectal cancer and gastric cancers expressing NTSR1.

On April 1, 2021 Fresenius Kabi, a global health care company that specializes in lifesaving medicines and technologies for infusion, transfusion and clinical nutrition, reported it has signed an exclusive distribution agreement for the U.S. with Corvida Medical (Press release, Fresenius, APR 1, 2021, View Source [SID1234577519]).

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Under the terms of the agreement, Fresenius Kabi will be the exclusive U.S. distributor for the HALO Closed System Drug-Transfer Device (CSTD). The HALO system is an airtight and leak-proof CSTD that mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols and droplets. These are common challenges during the compounding and administration of hazardous drugs like chemotherapy.

"Fresenius Kabi is committed to offering solutions that provide the safe preparation and delivery of medications across the continuum of care," said John Ducker, president and CEO of Fresenius Kabi USA. "CSTDs play a critical role in protecting health care professionals from the risks of exposure to hazardous drugs during the preparation in the pharmacy and during patient administration by nurses. The combination of Fresenius Kabi freeflex/freeflex+ IV solution containers, oncology medicines and Corvida Medical’s HALO CSTD allows Fresenius Kabi to provide customers a broad range of products to assist with their oncology needs."

Mitch Moeller, CEO of Corvida Medical added, "We believe Fresenius Kabi is a great partner for the HALO Closed System Drug-Transfer Device. Their reputation for quality and patient focus along with their commercial infrastructure, distribution experience, customer relationships and extensive product portfolio will help our efforts to make HALO a leading CSTD option for U.S. customers. We are pleased that Fresenius Kabi recognized the design benefits, innovation and quality of the HALO product portfolio."

The distribution agreement may be expanded to other territories in the future. Financial terms of the agreement were not disclosed.

On April 1, 2021 Guardant Health, Inc. (Nasdaq: GH) announced that the New York State Department of Health Clinical Laboratory Evaluation Program (CLEP) has approved the Guardant Reveal liquid biopsy test for the detection and monitoring of minimal residual disease (MRD) in patients with early-stage cancer (stage II and III). Guardant Reveal is the first blood-only test able to detect, with 7-day turnaround time, a patient’s status for residual disease, without the need for a tissue biopsy.

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The Guardant Reveal blood test was introduced earlier this year and is Guardant Health’s first commercially available liquid biopsy for clinical use in the management of early-stage cancer. The test is focused first on one indication where the unmet medical need exists, early-stage colorectal cancer (CRC), with additional cancer types to follow. The Guardant Reveal blood test improves the management of CRC by detecting circulating tumor DNA (ctDNA) in blood after surgery to identify patients with residual disease who may benefit most from adjuvant therapy, and by detecting recurrence months earlier than current standard-of-care methods like carcinoembryonic antigen (CEA) tests or imaging.1-6

The test achieves industry-leading sensitivity (91 percent)7 for detecting ctDNA by simultaneously interrogating both genomic and epigenomic alterations. The test accurately reports genomic alterations down to allele frequencies of 0.01 percent and effectively filters out biological noise sources such as mutations caused by clonal hematopoiesis. The incorporation of biologically relevant epigenomic signatures has been essential to increasing the sensitivity of the test to detect residual disease in early-stage cancers including CRC.

"Securing New York State CLEP approval for Guardant Reveal means that oncologists in New York can now use the test to identify high-risk patients with colorectal cancer, our first indication, who may benefit from adjuvant therapy after surgery, and to detect recurrence earlier as part of regular surveillance," said, Helmy Eltoukhy, Guardant Health CEO. "This approval is consistent with our commitment to improving care for all cancer patients by expanding access to our tests by complying with appropriate clinical laboratory regulations."

There are over 1.5 million colorectal cancer survivors today in the U.S. and an estimated 10 percent to 30 percent of early-stage patients recur.8 An unmet medical need exists to offer new tests that can overcome the limitations of current tools.

On April 1, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will host a webinar featuring leading neuro-oncologists to discuss the use of the Company’s proprietary cerebrospinal fluid (CSF) assay for diagnosing and managing tumors that have metastasized to the central nervous system (CNS), including the brain or spinal column (Press release, Biocept, APR 1, 2021, View Source [SID1234577517]). Biocept’s CSF assay provides enhanced sensitivity compared with CSF cytology, the current standard of care, and has the added advantage of identifying actionable molecular targets for use in treatment decisions while providing quantitative information needed for assessing treatment response and monitoring disease progression.

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"Our goal is to establish our CSF assay as the new standard of care for the diagnosis of patients with suspected cancer metastasis to the CNS under National Comprehensive Cancer Network guidelines," said Michael Dugan, MD, Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "We have already gained substantial interest among neuro-oncologists and other cancer specialists from nearly two dozen leading academic institutions across the country. Most of these physicians have already ordered our CSF assay with many becoming repeat users.

"The CSF assay addresses a high unmet clinical need as current diagnostic tools for patients with brain metastases are inadequate or imprecise for assessing therapy response; however, many therapies are now available that offer substantial promise for improved survival and resolution of symptoms," Dr. Dugan added. "Between 10% and 30% of adult patients with cancer, depending on the type, will develop brain metastases. We estimate this market opportunity at more than $1 billion annually."

Amir Azadi, MD is a medical oncologist specializing in neuro-oncology and an Assistant Professor in the Department of Neurology at Barrow Neurological Institute. His expertise includes the diagnosis and treatment of brain tumors. He is board certified in internal medicine and medical oncology by the American Board of Internal Medicine, and is a member of the American College of Physicians, the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the Society of Neuro-Oncology. Dr. Azadi received his medical degree from Shahid Beheshti University of Medical Sciences in Tehran, Iran. He completed his residency in internal medicine at Banner – University Medical Center in Phoenix, and fellowships in hematology and oncology at the University of Louisville James Graham Brown Cancer Center and in neuro-oncology at Barrow Neurological Institute.

Nicholas Blondin, MD is Assistant Professor of Clinical Neurology at Yale School of Medicine. His clinical expertise is in treating benign and malignant brain tumors, brain and spine metastasis, and neurological symptoms of cancer such as seizures, cognitive impairment, headaches, gait disturbance and weakness. Dr. Blondin is an active investigator for clinical trials for brain tumor patients through Yale Cancer Center. He received his Medical Degree from the University of Connecticut School of Medicine and completed his neurology residency at Yale New Haven Hospital, where he was Chief Resident in Neurology, followed by a fellowship in neuro-oncology at Yale New Haven Hospital.

Priya U. Kumthekar, MD is a United Counsel for Neurologic Subspecialties (UCNS)-certified neuro-oncologist from Northwestern University and is serving as the principal investigator for Biocept’s Four C clinical study. She is dedicated to patient care and moving the study of brain tumors forward primarily through her leadership on clinical trials. Dr. Kumthekar serves in leadership roles with the National Clinical Trials Network, particularly with the Alliance for Clinical Trials, and was named as the Alliance’s national Executive Officer of Neuro-Oncology in 2016. In this role, she oversees the conception and development of clinical trials from early phase through registration studies. Dr. Kumthekar is board certified in neurology and is a member of the American Board of Psychiatry and Neurology. She received her medical degree from Northeastern Ohio University. She previously was Chief Resident at Northwestern University, McGaw Medical Center.

On April 1, 2021 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs), reported the appointment of Jan M Van Tornout, MD, MSc, as acting Chief Medical Officer, effective April 1, 2021 (Press release, TYME, APR 1, 2021, View Source [SID1234577516]). Dr. Van Tornout will provide leadership and direction for all medical and related preclinical programs in development. He will be replacing Dr. Giuseppe Del Priore. "On behalf of the board of directors, we truly appreciate Giuseppe’s many contributions towards advancing our programs and we wish him continued success in his future endeavors," said Richie Cunningham, TYME’s CEO.

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Dr. Van Tornout brings over 25 years of medical experience in academia and industry, including over 15 years of global drug development in pharmaceutical and biotech settings and encompassing preclinical, IND, FIH, phase II-IV, (s)NDA, BLA, safety, medical affairs, clinical operations and regulatory experience. He has led clinical management and oncology teams at Natera, INOVIO Pharmaceuticals, Astellas Pharma, Bristol Myers Squibb and Amgen. Dr. Van Tornout has also served as a medical strategy consultant for various biotech companies including Cyclacel Pharmaceuticals, GlaxoSmithKline, Puma Biotechnology, Maverick Therapeutics, ERT, Huya Bioscience, and Gradalis.

Dr. Van Tornout previously held academic appointments at the University of Southern California (USC) with clinical appointments at Children’s Hospital Los Angeles as attending pediatric hematologist-oncologist. Dr. Van Tornout received his MD from the Katholieke Universiteit Leuven (KUL), Leuven, Belgium, an MS in classical philosophy from KUL, and a BS from the Faculté Notre-Dame de la Paix, Namur, Belgium. He obtained his certification as a paediatrician from the Gasthuisberg University Hospitals, KUL, and subsequently completed his training as a pediatric hematologist-oncologist at Children’s Hospital Los Angeles, USC. He earned an MSc. in applied biometry from USC and completed a post-doctoral fellowship in molecular epidemiology at USC. Subsequently his National Institutes of Health-sponsored laboratory focused on genetic epidemiology of childhood cancer (EWS) and the application of neural networks to the analysis of large pediatric cancer datasets.

"We are delighted and fortunate to be able to bring on an individual with Dr. Van Tornout’s vast experience at this important juncture for TYME. Jan has played an integral role in the approval of multiple drug candidates and has served as a key advisor in all facets of drug development. We will greatly benefit from his expertise on how best to advance our pipeline, as well as his guidance on the components that comprise high quality submissions to the FDA. We expect the end result to benefit both TYME and the patients we intend to help," said Richie Cunningham. Dr. Van Tornout stated, "I am excited to work with TYME and its leadership team during this pivotal period. TYME has multiple novel programs underway that have the potential to make a meaningful difference in the lives of many people with unmet medical needs. I am confident my background is very well-suited to help guide TYME in the next phase of clinical development across its various clinical and preclinical compounds."