On July 19, 2022 Persephone Biosciences Inc., a synthetic biology company reimagining patient and infant health through the development of microbiome-based medicines, reported that it has closed a $15 million seed financing round (Press release, Persephone Biosciences, JUL 19, 2022, View Source [SID1234616776]). The round was co-led by First Bight Ventures and Propel Bio Partners, and included investments from Y Combinator, Fifty Years, Susa Ventures, American Cancer Society’s BrightEdge Fund, Pioneer Fund, and ZhenFund among others.

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"This financing is a significant milestone for Persephone and the culmination of years of thoughtful engagement with forward-thinking investors and individuals who are committed to the vast potential of our platform and technology," said Stephanie Culler, CEO and Co-founder of Persephone Biosciences. "We plan to deploy this capital to further expand our research and clinical programs across a range of therapeutic areas, as well as pursue new collaborations. With our ARGONAUT study ramping up, it is an exciting time for us. We are grateful for the support of all our stakeholders and their commitment and confidence in our vision."

Persephone was founded to leverage a unique understanding of the microbiome as a therapeutic approach for a number of indications, including infant health and oncology. The company’s ARGONAUT trial (NCT04638751) is the largest study ever conducted in the U.S. to identify biomarkers for cancer treatment and prevention by mapping the gut-immune axis. In December 2021, Persephone announced that Janssen Biotech, one of Janssen Pharmaceutical Companies of Johnson & Johnson, would collaborate with the company on the colorectal cancer patient arm of ARGONAUT, and on an arm of additional healthy individuals with varying cancer risk. Then in April 2022, Persephone announced a collaboration with Ginkgo Bioworks to enable the synthetic biology tools needed to develop the next generation of microbial therapies.

On July 19, 2022 Fulgent Genetics, Inc. (NASDAQ: FLGT) ("Fulgent Genetics" or the "Company"), a technology-based genetic testing company focused on transforming patient care in oncology, infectious and rare diseases, and reproductive health, reported that it will release its second quarter 2022 financial results after the market closes on Thursday, August 4, 2022 (Press release, Fulgent Genetics, JUL 19, 2022, View Source [SID1234616775]). The company’s Chairman and Chief Executive Officer Ming Hsieh, Chief Financial Officer Paul Kim, Chief Commercial Officer Brandon Perthuis, and Chief Medical Officer Dr. Larry Weiss will host a conference call for the investment community the same day at 4:30 PM ET (1:30 PM PT) to discuss the results and answer questions.

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The call can be accessed through a live audio webcast in the Investors section of the company’s website, View Source, and through a live conference call by dialing (888) 221-3881 using the confirmation code 6448347. An audio replay will be available in the Investors section of the company’s website.

On July 19, 2022 NorthStar Medical Radioisotopes, LLC, a global innovator in the development, production and commercialization of radiopharmaceuticals used for therapeutic applications and medical imaging, reported the signing of a long-term supply agreement with Clovis Oncology, Inc. (NASDAQ: CLVS) for the therapeutic medical radioisotope, actinium-225 (Ac-225) (Press release, NorthStar Medical Radiostopes, JUL 19, 2022, View Source [SID1234616774]). Under terms of the agreement, NorthStar will provide Clovis with its environmentally preferred, high purity non-carrier-added (n.c.a.) Ac-225. Clovis plans to use NorthStar’s Ac-225 to radiolabel its lead peptide-targeted radionuclide therapeutic candidate currently in development, FAP-2286, which targets fibroblast activation protein (FAP), a promising theranostic target with expression across many tumor types.

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Ac-225 is a high energy alpha-emitting radioisotope of increasing interest for clinical studies investigating the use of targeted radiopharmaceutical therapy (RPT), which combines select molecules with therapeutic radioisotopes, such as Ac-225, to directly target and deliver therapeutic doses of radiation to destroy cancer cells in patients with serious disease. Ac-225 carries sufficient radiation to cause cell death in a localized area of targeted cells, while its half-life limits unwanted radioactivity in patients. Clinical research and commercial use of Ac-225 are severely constrained by chronic short supply due to limitations of current production technology. NorthStar is positioned to be the first commercial-scale producer of Ac-225 for advancing clinical research and commercial radiopharmaceutical products. NorthStar will use its environmentally preferred electron accelerator technology to produce n.c.a. Ac-225, that is free of long-lived radioactive contaminants and byproducts associated with other production methods, which pose regulatory and waste management challenges for contract development and manufacturing organizations, hospitals, health systems and academic institutions.

"We are very pleased to enter this Ac-225 supply agreement with Clovis Oncology, and we look forward to working with them moving forward," said Stephen Merrick, Chief Executive Officer of NorthStar Medical Radioisotopes. "Our companies share a vision of developing and delivering innovative technology and compounds to drive research and ensure clinical availability of targeted radiopharmaceutical therapies for patients with cancer. NorthStar is applying the same development expertise to rapidly advance large-scale production of n.c.a. Ac-225 that has positioned us at the forefront of U.S. radioisotope production as the only commercialized producer of the important medical radioisotope molybdenum-99 (Mo-99). Construction is now underway on our dedicated, state-of-the-art Actinium-225 Production facility, with initial production of radiochemical grade Ac-225 planned for late 2023, and a Drug Master File to be submitted in 2024, which, upon acceptance by the FDA, will allow NorthStar to provide cGMP grade Ac-225."

"As part of Clovis Oncology’s commitment to developing peptide-targeted radionuclide therapeutic and imaging compounds, we recognize the importance of working with partners like NorthStar, whose knowledge and expertise can support our strategic goals," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "Our lead compound, FAP-2286, offers the potential to address a variety of solid tumors, as monotherapy and in combination, and working with NorthStar enables us to explore different modalities in this emerging class of cancer therapeutics."

On July 19, 2022 Pillar Biosciences, the leader in Decision Medicine, which develops and distributes next-generation sequencing (NGS) tests to localize testing and reduce time to treatment initiation and overall testing costs, reported that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s Premarket Approval (PMA) supplement application for its Pan-cancer oncoReveal CDx (Press release, Pillar Biosciences, JUL 19, 2022, View Source [SID1234616773]). The supplement, if approved, will expand the label/indication of Pillar Bioscience’s oncoReveal Dx Lung & Colon Cancer Assay to include actionable targets for eight additional cancer types, bringing the total detectable cancers to ten.

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"We are pleased to take the next step towards expanding the clinical utility of the oncoReveal Dx, which is the first FDA-approved multi-cancer IVD launched in the market," said Randy Pritchard, CEO of Pillar Biosciences. "With our innovative technology platform, we built an assay with extraordinary sensitivity, simple workflow, and fast turnaround time to enable localized testing that can be performed in any NGS lab, whether hospital-based or a commercial reference laboratory. This localized approach demonstrates our commitment to bringing highly accurate and actionable NGS testing to clinical laboratories and biopharmaceutical companies in order to help improve treatment decisions and outcomes that are accessible to everyone, everywhere.

The Pan-cancer oncoReveal CDx is developed for tumor profiling and therapy selection, and includes actionable targets on ten of the most common cancer types. The panel provides comprehensive genomic results, covering 22 clinically relevant genes in one multiplex reaction, and has a fully automatable workflow that can be performed by any clinical laboratory with a sample-to-report time of as little as 48 hours.

The PMA supplement application follows the original PMA approval of oncoReveal Dx Lung & Colon Cancer Assay in July 2021.

On July 19, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus on lung disease, reported that it will release financial results for the second quarter ended June 30, 2022 before the open of trading on Thursday, August 4 (Press release, Biodesix, JUL 19, 2022, View Source [SID1234616772]). Biodesix’s management will host a conference call and webcast to discuss its financial results and provide a general business update at 8:00 a.m. Eastern Time on the same day.

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