On May 25, 2021 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, and Clarity Pharmaceuticals, a clinical stage radiopharmaceutical company focused on the treatment of serious disease, reported the signing of a Master Supply Agreement for the therapeutic radioisotope copper-67 (Cu-67) (Press release, Clarity Pharmaceuticals, MAY 25, 2021, View Source [SID1234580503]). Under the agreement, NorthStar will supply Cu-67 exclusively to Clarity Pharmaceuticals as an active pharmaceutical ingredient used to support Clarity’s Targeted Copper Theranostics (TCT) programs.

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Cu-67 is a beta-emitting radioisotope with clinical applications as a radiopharmaceutical to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease.

"Previously, the lack of an effective copper chelating technology has limited the clinical development of Cu-67 products and subsequent commercial production of Cu-67," said Stephen Merrick, President and Chief Executive Officer of NorthStar Medical Radioisotopes. "Clarity Pharmaceuticals’ unique copper-chelating technology has enabled it to advance its product pipeline into a range of theranostic clinical trials that use copper-64 (Cu-64) for diagnostic imaging and Cu-67 as therapy. NorthStar is addressing the need for reliable Cu-67 radioisotope supply by advancing towards commercial-scale production. Our efforts use the proven expertise and innovative approach demonstrated in the successful development and commercialization of U.S.-produced, non-uranium molybdenum-99 (Mo-99) to generate technetium-99m. NorthStar is pleased to sign this agreement with Clarity Pharmaceuticals, and we look forward to supporting its plans for further clinical development and commercialization of Cu-67 based therapeutic radiopharmaceuticals to improve the lives of patients with serious disease."

"Consistent with other NorthStar production processes, the Cu-67 production process is also environmentally friendly and non-uranium based," said James T. Harvey, PhD, Senior Vice President and Chief Science Officer of NorthStar Medical Radioisotopes. "Cu-67 has an optimal half-life for a therapeutic radiopharmaceutical, is produced domestically in the United States without a nuclear reactor, has no long-lived contaminants or bi-products from the manufacturing process, and its starting material, zinc, is readily available. As opposed to other therapeutic isotopes in the market and under development, Cu-67 is ideally suited for commercial production to meet the growing demand for radiopharmaceuticals in large disease indications and we look forward to meeting Clarity’s anticipated future demands as it develops and commercializes its suite of products."

"Clarity leads the world in the development and commercialization of TCT," said Alan Taylor, PhD, Executive Chairman of Clarity Pharmaceuticals. "Access to large, commercial supply of Cu-67 at a suitable price-point enables us to apply our TCT approach not only to rare diseases such as neuroblastoma in children, but also other cancers with very large patient populations such as prostate and breast cancers. In essence, the availability of large scale production of Cu-67 in the United States will increase the speed of Clarity’s clinical trials across our SARTATETM, SAR-bisPSMA, SAR-Bombesin and discovery programs and will help us to achieve our ultimate goal of better treating children and adults with cancer."

About Copper-67 (Cu-67)

Copper-67 (Cu-67) is a short-range, beta-emitting radioisotope that is attractive for medical purposes due to its ability to carry sufficient radiation energy to cause cell death in targeted cells while having a sufficiently short half-life to limit unwanted radioactivity in patients. Cu-67 is being investigated for therapeutic purposes across a wide range of adult and childhood cancers. Potential radiotherapeutic targets include prostate cancer, breast cancer, neuroendocrine tumors (NETs), neuroblastoma, glioma, lymphoma, ovarian, and bladder cancers. A chelator, which strongly binds Cu-67 to the targeting agent, is required to develop safe and effective targeted therapies. Clarity has successfully developed a highly specific and highly stable chelator for copper isotopes and is progressing a range of radiopharmaceuticals based on its proprietary SAR Technology Platform. NorthStar is developing a proprietary process for commercial-scale production of Cu-67 to meet demand for clinical research and treatment purposes.

On May 24, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported it has signed a definitive agreement to sell Myriad RBM, Inc. to Q2 Solutions, a leading global clinical trial laboratory services organization, and a wholly owned subsidiary of IQVIA (Press release, Myriad Genetics, MAY 24, 2021, View Source [SID1234580517]). Q2 Solutions provides comprehensive testing, project management, supply chain, biorepository, biospecimen and consent tracking solutions. Myriad RBM, which specializes in contract research services for the pharmaceutical industry, will be added to the overall Q2 Solutions menu and offerings.

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"Our agreement with Q2 Solutions provides a good home for Myriad RBM teammates, delivers strong value, and provides significant capital for future growth," said Paul J. Diaz, president and CEO of Myriad Genetics. "The divestiture of Myriad RBM, along with other announced divestitures, allows us to accelerate the execution of our transformation plan and focus on advancing our core businesses in Women’s Health, Oncology and Mental Health."

The deal is subject to customary closing conditions, and Myriad expects the transaction to close in the third calendar quarter.
Cowen is acting as exclusive financial advisor and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. is acting as legal advisor to Myriad Genetics.

On May 24, 2021 Scopus BioPharma Inc. (Nasdaq: "SCPS") reported the approval of an investigational new drug application ("IND") by the United States Food and Drug Administration ("FDA") for CpG-STAT3siRNA, the company’s distinctive immuno-oncology RNA therapy for the treatment of multiple cancers (Press release, Scopus BioPharma, MAY 24, 2021, View Source [SID1234580515]).

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A Phase 1 clinical trial for B-cell non-Hodgkin lymphoma will be initiated at City of Hope.

Scopus is a biopharmaceutical company developing transformational therapeutics based on groundbreaking scientific and medical discoveries. City of Hope is a world-renowned independent research and treatment center for cancer, diabetes and other life-threatening diseases near Los Angeles, California.

CpG-STAT3siRNA encompasses both RNA therapy and immunotherapy by synthetically linking siRNA to an oligonucleotide TLR9 agonist, creating the potential for targeted gene silencing with simultaneous TLR stimulation and immune activation in the tumor microenvironment. This highly-distinctive drug candidate was developed in the City of Hope laboratories of Hua Yu, Ph.D. and Marcin Kortylewski, Ph.D. Yu is co-leader of the Cancer Immunotherapeutics Program and Billy and Audrey L. Wilder Professor in Tumor Immunotherapy. Kortylewski is a professor in the Department of Immuno-Oncology.

On May 21, 2021 Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, reported that it has entered into a definitive agreement to acquire MagicMed Industries Inc. ("MagicMed"), a privately-held biotechnology company focused on creating a library of novel derivative psychedelic molecules such as psilocybin, N,N-dimethyltryptamine (DMT) and other molecular derivatives with applications across multiple indications, in an all-stock transaction (Press release, Enveric Biosciences, MAY 24, 2021, View Source [SID1234580514]).

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Through its extensive R&D capabilities at the state-of-the-art facility at the University of Calgary, MagicMed has focused on the discovery and early development of novel drug candidates, structurally related to psychedelics with vastly improved pharmaceutical characteristics and commercial potential for the treatment of neurological and psychological indications. The Psybrary is MagicMed’s library of novel psychedelic derivatives developed through the combination of synthetic biology and traditional chemistry techniques. MagicMed has 13 patent applications filed for derivatives of psilocybin and DMT, 2 patent applications filed for derivatives of mescaline and MDMA with further intellectual property protection for mescaline, MDMA, ibogaine and LSD in process.

The acquisition of MagicMed will expand and complement Enveric’s current pipeline of naturally occurring compounds, which is primarily focused on cannabinoids, to now include a robust portfolio of psychedelic-derived molecules. Enveric intends to continue to develop patient-centric support care therapies in oncology and central nervous system (CNS) indications. Upon closing, Enveric intends to commence drug discovery and development for treatment of cancer-related Post Traumatic Stress Disorder (PTSD) patients who are currently in treatment for cancer and those who are in remission. It is anticipated that the PTSD drug development program holds the potential to be expanded in the future beyond cancer-related applications to include other patient populations, such as military veterans.

"Our proposed acquisition of MagicMed underscores the core fundamental mission of Enveric to form a drug discovery and clinical stage biotechnology company with a focus on bringing forward nature-originated therapies to improve the standard of care and serve unmet needs in oncology and CNS indications," said David Johnson, Chairman and CEO of Enveric Biosciences. "Psychedelics and cannabinoids, in our opinion, have extensive patient benefits for the mind and body. We welcome MagicMed’s world class research and development team led by Dr. Joseph Tucker, who not only have experience in psychedelic drug discovery, but also research experience in cannabinoids, as well. Patients who are currently being treated for cancer or are in remission are forced to face debilitating physical and mental side effects with very few treatment options available to alleviate their pain. PTSD, for example, is a significant unmet need for this patient population. Together, with the MagicMed team, following the closing of the acquisition, we plan to commence the discovery and development of psychedelics-derived therapies."

Once closing is complete, Dr. Joseph Tucker will be appointed Chief Executive Officer of the Company and David Johnson, current Chief Executive Officer and Chairman, will be appointed Executive Chairman.

Dr. Joseph Tucker is a seasoned executive who has built several publicly traded biotechnology companies. Dr. Tucker was a founder and chief executive officer of Stem Cell Therapeutics, which was acquired by Trillium Therapeutics in 2013. Dr. Tucker has also held the position of co-founder and CEO of Epimeron Inc., a University of Calgary start-up acquired in the creation of Willow Biosciences Inc. At Willow, Dr. Tucker served as Executive Chairman and COO. Prior to founding these companies, Dr. Tucker was a healthcare analyst with two investment banks and has also worked in technology commercialization for a university technology transfer office. Dr. Tucker received his Ph.D. in Biochemistry and Molecular Biology from the University of Calgary.

"Our mission at MagicMed has always been focused on unlocking the full potential of psychedelic-derived medicines for the treatment of neurological and psychological indications," added Dr. Joseph Tucker, Chief Executive Officer of MagicMed. "Complementing our R&D capabilities, working together with Enveric will allow us to leverage the company’s clinical team, all of whom are focused on advancing our extensive pipeline of molecules through the clinic to help serve the millions of patients who are suffering with mental health issues around the globe. Through this acquisition – in the best interest of each of our respective teams – we have bolstered our pipeline, bringing together a seasoned team of experts with the leadership skills and knowledge that is crucial to creating a platform that aims to address large unmet total addressable markets (TAM)."

The transaction is structured as an amalgamation under the Business Corporations Act (British Columbia). At the closing, a recently formed subsidiary of Enveric will amalgamate with MagicMed, with the resulting corporation being an indirect wholly owned subsidiary of Enveric. Under the terms of the amalgamation agreement and other related agreements , Enveric will issue the shareholders of MagicMed an aggregate of 9,946,969 shares of common stock of Enveric, as well as warrants, options and restricted stock units to acquire an additional 9,039,882 shares of common stock of Enveric. The current Enveric shareholders will own approximately 63.4% of the combined company’s common stock, as calculated on a fully diluted basis, and current MagicMed shareholders will own approximately 36.6% of the combined company’s common stock, as calculated on a fully-diluted basis. The agreement is subject to customary closing conditions and the approval of Enveric’s and MagicMed’s shareholders and is expected to close during the second half of 2021. Additionally, as part of the closing of the transaction, Enveric will receive approximately $4 million (CAD) in cash from the MagicMed Treasury.

David Johnson and Dr. Joseph Tucker will host a conference call to discuss the transaction today, May 24th at 8:30 a.m. ET.

On May 24, 2021 Veriskin, Inc., a start-up medical device company, reported that it has invented and is developing novel technology for skin cancer diagnostics and screening (Press release, Veriskin, MAY 24, 2021, View Source [SID1234580511]). Veriskin has received FDA Breakthrough Device Designation for its TruScore device in July, 2020. Development of this innovative technology is being supported by grant funding from the National Cancer Institute and seed-round capital from private investors. Veriskin has completed two IRB-approved clinical studies. The Company is initiating a third clinical study, preparatory to designing the clinical trial needed to obtain FDA approval to market its device.

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Skin cancer is the most common form of cancer in the United States, accounting for just under half of all cancer diagnoses. The American Cancer Society predicts that 106,110 new melanoma cases will be diagnosed and 7,180 people are expected to die of malignant melanoma in 2021. It is estimated that approximately 5.4 million basal and squamous cell carcinomas are diagnosed each year, affecting 3.3 million people and leading to more than 15,000 lives lost. Skin cancers are very difficult for non-specialists, such as primary care practitioners, to differentiate from non-malignant skin abnormalities. Uncertainty in initial diagnosis can lead to 1) failure to detect cancer at an early, more treatable stage, 2) hundreds of malpractice claims due to missed cancers, and 3) many unnecessary referrals to specialists and unwarranted biopsies. Fortunately, the majority of skin cancer cases can be cured when detected early. "Development of an accurate diagnostic device for use by frontline practitioners provides a significant opportunity for saving lives and reducing healthcare costs," said Veriskin CEO, Mirianas Chachisvilis, PhD.

Veriskin’s TruScore is a proprietary, non-invasive, low-cost, hand-held device that aids non-expert users to rapidly and objectively determine whether a suspicious skin lesion is cancerous. It works on both pigmented and non-pigmented skin lesions and produces a quantitative score. Use of the device can potentially reduce the number of missed cancers and unnecessary biopsies. Veriskin’s patented technology is based on a novel, orthogonal approach: active perturbative hemodynamic measurements combined with a proprietary machine-learning algorithm. The device detects both structural and functional vascular abnormalities associated with pathological angiogenesis (a well-established, early hallmark of cancer). The resultant diagnostic information content is significantly higher than provided by competing imaging-based technologies. IRB-approved clinical studies performed in multiple dermatology clinics in California and Arizona have demonstrated sensitivity of greater than 99% and specificity of 94% in a set of 125 biopsy-verified lesions. "Veriskin anticipates that TruScore will help primary care practitioners and dermatologists to detect potentially dangerous skin cancers earlier and with higher accuracy," said the CEO.

Veriskin’s development of its innovative technology has been supported by multiple grants from the National Cancer Institute (totaling $3.9 million with opportunities for additional funding). Recently, Veriskin raised over $1M in a seed-round co-led by Pasadena Angels and Ariel Savannah Angel Partners, with participation from Frontier Angels and TiE SoCal Angels. "We are delighted to be able to support Veriskin in the commercialization of its innovative technology," said Kevin Herzberg, Vice Chairman of Pasadena Angels.