On October 29, 2020 Lantheus Holdings, Inc. (the "Company") (NASDAQ: LNTH), parent company of Lantheus Medical Imaging, Inc. ("LMI"), a global leader in the development, manufacture and commercialization of innovative diagnostic imaging agents and products, reported a strategic collaboration with Insightec Ltd., a global healthcare company focused on the therapeutic power of acoustic energy (Press release, Lantheus Medical Imaging, OCT 29, 2020, View Source [SID1234569410]). Under the agreement, Lantheus’ microbubbles will be used in combination with Insightec’s investigational MR-guided Focused Ultrasound (MRgFUS) platform to evaluate treatment of glioblastoma and neurodegenerative conditions. The collaboration directly aligns with key Lantheus growth strategies of pursuing new applications for its microbubble franchise and expansion into oncology.

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Under the terms of the agreement, Lantheus’ microbubbles will be used together with Insightec’s MRgFUS platform designed to deliver ultrasound energy deep in the brain with no incisions. The microbubbles, combined with the application of focused ultrasound, are being investigated in the temporary disruption of the blood brain barrier to potentially allow for more effective delivery of chemotherapeutic agents in the treatment of glioblastoma patients. Glioblastoma is the most aggressive malignant primary brain tumor affecting 3.19 Americans per one hundred thousand and has a less than 5% five-year survival rate.1

Lantheus will supply its microbubbles and activation devices while Insightec will be responsible for future regulatory submissions and commercialization. The deal terms include a transfer price and royalties.

"We are thrilled to partner with Insightec to further expand our microbubble franchise within oncology and potentially neurodegenerative conditions," said Mary Anne Heino, President and Chief Executive Officer of Lantheus. "Our collaboration with Insightec could help change the paradigm in glioblastoma, an aggressive cancer for which patients and clinicians unfortunately have few options, and where the unmet medical need is truly significant."

"Focused ultrasound has strong potential to transform the treatment of diseases that currently have poor outcomes and few options. Partnerships, like this one with Lantheus, will help Insightec’s future customers push the boundaries of what is possible in providing care to patients with neurooncologic as well as neurodegenerative diseases," said Maurice R. Ferré MD, Chairman and CEO of Insightec.

About Glioblastoma

There are approximately 12,500 new cases of glioblastoma in the United States each year. Glioblastoma is the most commonly occurring primary malignant brain tumor, accounting for over 48% of all malignant tumors.2 Overall, median survival for glioblastoma patients is 12-15 months. Glioblastoma has a poor prognosis due to its high rate of tumor recurrence, which has been described clinically as inevitable.3 Worldwide, there are more than 240,000 estimated deaths from brain and central nervous system cancers each year, and glioblastoma represents one of the most common and lethal forms of these cancers.4

On October 29, 2020 Epic Sciences, Inc. and Predicine, Inc. reported they have entered into a global strategic partnership to offer biopharmaceutical companies access to both Predicine’s ctDNA-based testing and Epic’s CTC-based testing (Press release, Epic Sciences, OCT 29, 2020, View Source [SID1234569403]). Predicine’s lead offering is PredicineATLAS, the broadest CLIA-certified ctDNA-based assay that analyzes 600 cancer-related genes, using next generation sequencing. Epic’s CTC-based platform offers testing of AR-V7, AR-N term, PSMA, ER, PR and other phenotypic tests. The combination of both approaches allows pharmaceutical partners engaged in clinical trials to measure both genotypic and phenotypic markers from a single blood draw.

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Predicine is a California-based molecular insights company that has developed an NGS liquid biopsy technology to measure ctDNA and ctRNA genomic alterations in blood or urine. Predicine has launched its CLIA-certified 600-gene PredicineATLAS liquid biopsy assay for detecting cancer variants including single-nucleotide variants, indels, copy number variants (gain and loss), DNA fusions, microsatellite instability (MSI) and tumor mutational burden (TMB). Partnering with leading biopharmaceutical companies, Predicine provides harmonized liquid biopsy solutions and CDx development to support global clinical trials in US, EU, APAC region including China.

"From a single blood draw, Epic and Predicine’s partnership can now access Comprehensive Cancer Profiling that identifies CTCs with unmatched sensitivity, provides in-depth characterization of individual CTCs using genomic, proteomic and morphological tools and delivers a comprehensive genomic profile of the patient’s ctDNA that includes all known biomarkers and mutations associated with current cancer therapies," said Lloyd Sanders, President and Chief Executive Officer, Epic Sciences. "This molecular information is critical to understanding the current state of a patient’s disease and offers the ability to monitor the cancer status, mechanism of action, and their response to a specific therapy. The combination of CTCs and ctDNA is a comprehensive solution designed to meet the growing needs of our pharmaceutical partners as they seek to develop life-changing therapies."

"We are excited to partner with Epic Sciences by offering the capabilities of Predicine’s proprietary liquid biopsy technology," said Shidong Jia, Founder and CEO of Predicine. "Combining ctDNA and CTC from a single blood draw offers a complementary, multi-technology approach in comprehensive cancer profiling, monitoring therapy efficacy/disease burden and assessing minimal residual disease. We are very pleased to provide this unique liquid biopsy solution to our pharma partners in support of global clinical trials."

About Comprehensive Cancer Profiling

Epic Sciences’ Comprehensive Cancer Profiling provides a multi-technology approach to liquid biopsy from a single blood draw to complete several types of analyses. The company leverages its proven and proprietary CTC capabilities. Our enrichment-free approach reveals both genotypic and phenotypic insights and minimizes the risk of CTCs being missed. By combining CTC technology with ctDNA and immune cell analysis we enable a comprehensive analysis that is both minimally invasive and highly accurate.

On October 29, 2020 ITM Medical Isotopes GmbH and Isogen reported that signed a formal supply arrangement to provide a reliable supply of Lutetium-177 to the world’s health care system using Bruce Power reactors as a key supply source (Press release, ITM Isotopen Technologien Munchen, OCT 29, 2020, View Source [SID1234569401]).

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ITM Medical Isotopes GmbH, based in Munich, Germany, is a subsidiary of the biotechnology and radiopharmaceutical group of companies Isotopen Technologien München AG (ITM), and Isogen is a joint venture between nuclear companies Framatome and Kinectrics. The arrangement was made possible through Isogen’s partnership with Bruce Power, Canada’s only private sector nuclear energy generator, in combination with ITM’s know-how in the development of medical isotopes, and will ensure reliable, consistent supply of medical isotopes for use in targeted therapies for cancer patients around the world for the next 15 years.

The agreement, which follows the signing of a Memorandum of Understanding (MOU) in November 2019, defines the use of the new Isotope Production System (IPS) to be deployed in conjunction with ongoing Life-Extension work at the Bruce Power site. The IPS, designed and manufactured in Ontario by Isogen, offers functional flexibility, and will support the future production of other isotopes in addition to Lutetium-177, providing the world’s health care system with a stable supply of isotopes for decades.

The unique international partnership among the three companies brings together a wealth of knowledge in nuclear engineering, operations, and radiopharmaceutical production and development.

Vic Fedeli, Minister of Economic Development, Job Creation and Trade, praised the partnership.

"Ontario continues to position itself as a world leader in the production of life-saving medical isotopes," said Minister Fedeli. "The innovation of Ontario companies, and international partnerships are critical to ensuring Ontario’s economic recovery from the COVID-19 outbreak. Today’s announcement is further proof that Ontario is open for business, open for jobs and open for investment."

Medical isotopes are increasingly being used in innovative applications such as targeted therapies in the treatment of cancers, as well as a tool in the sterilization of medical equipment to help protect frontline health care workers in their battle against the COVID-19 pandemic.

"This is an exciting day as we move into the next phase of our isotope program," said Mike Rencheck, Bruce Power’s President and CEO. "Bruce Power is proud of its role as supplier of critical medical isotopes, including 40 per cent of the world’s Cobalt-60, which has been essential in the fight against COVID-19.

"As we look towards the future, the Isotope Production System is a game-changer that will allow us to access a key neutron source in our reactors, and create unprecedented capacity and redundancy of isotope production to improve global access to these innovative tools in the fight against cancer. Today’s announcement is a big step forward in achieving our goal of long-term, sustainable, and flexible production of medical isotopes at the Bruce Power site."

Production of Lutetium-177 at Bruce Power is expected to start in 2022, following regulatory and other approvals. Lutetium-177 is produced by irradiating Ytterbium-176. The process involves placing Ytterbium-176 source material in special sealed containers that are then conveyed into one of the Bruce Power reactors using the proprietary Isotope Production System (IPS). The Ytterbium-176 is then irradiated for about one week and the resulting intermediate Lutetium-177 is then sent to ITM for further processing into highly pure pharmaceutical grade Lutetium-177 for subsequent distribution to health care facilities worldwide.

Development of the IPS is currently in its final phase of engineering, testing, and design at the state-of-the-art Framatome engineering facility in Kincardine, Ontario.

"This is a landmark day for Isogen and we are thrilled to finalize our agreement with ITM," said John D’Angelo, President of Isogen. "Through the combination of Isogen’s proprietary production technology, the reliability and capacity of the Bruce Power reactors, and ITM’s patented processing technology and industry-leading supply network, we have set the stage to create the largest, most secure supply of Lutetium-177 in the world. This will be a benefit to our pharma partners, and to cancer patients now and in the future, knowing they can rely on a stable supply of isotope for decades to come."

Processing and global distribution of pharmaceutical grade Lutetium-177 by ITM is enabled through the company’s global network of radiopharmaceutical production facilities. The partnership’s primary goal is to guarantee the supply of pharmaceutical grade Lutetium-177 and meet the medical community’s growing demand for this important isotope.

"We are very pleased to further strengthen our partnership with Bruce Power and Isogen by signing this exclusive agreement which ensures us a consistent and reliable irradiation service for critically needed radioisotopes for the next 15 years," said Steffen Schuster, CEO of ITM. "This partnership will further increase the scalability of our production and thus ensure a steady supply of no-carrier-added Lutetium-177 on a global scale, further increasing the availability of this promising treatment option to cancer patients worldwide."

The advancement of the Lutetium-177 project further cements Ontario as a hub of nuclear innovation and isotope production, and matures Canada’s status as a leader among the international medical isotope community.

"Canada has always been looked to as a leader in the development and production of medical isotopes, and the advancement of this unique partnership is yet another example of innovation by Canadian companies in the isotope industry," said James Scongack, Chair of the Canadian Nuclear Isotope Council, and Bruce Power’s Executive Vice President, Corporate Affairs & Operational Services. "We are proud of the innovative work being done by Canadian companies to remain at the forefront of the global isotope market, and we look forward to expanding Canada’s leadership role in the growing global medical isotope supply chain as we fight the ongoing battle against cancer."

On October 29, 2020 Advanced Chemotherapy Technologies, Inc., a clinical-stage drug delivery company, reported that it has closed a $5.5 million Series A investment round led by Khosla Ventures (Press release, Advanced Chemotherapy Technologies, OCT 29, 2020, View Source [SID1234569399]). The capital will be used to fund initial clinical development of the company’s ACT-IOP-003 local chemotherapy system for the treatment of locally advanced non-resectable and borderline resectable pancreatic cancer.

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For pancreatic cancer, the ACT-IOP-003 system will be used to deliver the chemotherapy drug, gemcitabine, through the dense tumor microenvironment, directly to the tumor, while also minimizing the systemic toxicity commonly associated with chemotherapy treatments for pancreatic cancer. This approach offers three major advantages over traditional systemic chemotherapy: (1) Superior delivery of chemotherapy to the tumor cells, greatly increasing the amount of drug to treat the tumor, (2) Tumor shrinkage that can enable surgical resection, the only curative treatment for pancreatic cancer, and (3) Greatly decreased systemic toxicity so that the patient can remain in treatment.

This novel implantable drug delivery system uses a mild electrical current (iontophoresis) and can deliver a wide range of drugs directly to the local tumor. The system was developed in the laboratories of Jen Jen Yeh, MD, and Joseph M. DeSimone, PhD, at the University of North Carolina (UNC) at Chapel Hill. In preclinical studies, 100% of pancreatic cancer tumors treated with the device using gemcitabine shrunk by an average of 40%, while tumors treated with intraveneously delivered gemcitabine grew an average of 240%.

"ACT has made remarkable progress leveraging their seed investment and NIH grants to advance their first product, ACT-IOP-003, into the clinic," said Vinod Khosla, founder of Khosla Ventures. "ACT brings a skilled team and unique approach to drug delivery and precision medicine and we are excited to build on this momentum."

"We are excited to have the support of such an outstanding Venture Capital firm in Khosla Ventures," said Tony Voiers, CEO of Advanced Chemotherapy Technologies. "We are now poised to move our lead product into the clinic, where we will have the opportunity to treat pancreatic cancer, one of the deadliest of all cancers, and to continue to develop new applications for our novel drug delivery approach."

"We at the UNC Lineberger Comprehensive Cancer Center are thrilled to see our research endeavors, initially funded by the Unversity Cancer Research Fund, move into the clinic," said Shelley Earp, MD, director of UNC Lineberger. "Through the cancer center’s collaborative ethos, Joe’s engineering prowess found a terrific clinical partner in Jen Jen Yeh, a pancreatic cancer surgeon with a passion to translate ideas from her lab to the clinic. Together, they did the hard but necessary work to test, develop and publish their promising findings in top notch journals. The results impressed all and with this new investment, it has the potential to help so many people in our state and beyond with hard to treat cancers."

In conjunction with the financing, company CEO, Tony Voiers, and company founders, DeSimone and Yeh, will continue to serve on the Board of Directors.

On October 29, 2020 The Board of Directors of McKesson Corporation (NYSE:MCK)reported a regular dividend of 42 cents per share of common stock (Press release, McKesson, OCT 29, 2020, View Source [SID1234569397]). The dividend will be payable on January 4, 2021, to stockholders of record on December 1, 2020.

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