On June 16, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported the publication of results highlighting the performance of the Oncotype DX Genomic Prostate Score (GPS) result in patients with unfavorable intermediate (UFI)-risk prostate cancer (Press release, Exact Sciences, JUN 16, 2020, View Source [SID1234561134]). Published in Urology, the new results demonstrate the GPS test is a strong independent predictor of critical outcomes in UFI-risk prostate cancer patients.

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"While men with very low-, low- and favorable intermediate-risk prostate cancer often choose between active surveillance and treatment, men with unfavorable intermediate-risk disease must make decisions about how aggressive their treatment plan should be," said Jennifer Cullen, Ph.D., M.P.H., lead author of the publication and Associate Director of Cancer Population Sciences at the Case Comprehensive Cancer Center in Cleveland. "These new findings, which demonstrate for the first time the GPS test as a strong predictor of critical endpoints in UFI-risk disease, indicate that Oncotype DX testing can aid physicians and UFI-risk prostate cancer patients in their decision-making process. The GPS score may help in decisions regarding treatment intensity and empower patients in their care choices."

For this new publication, additional statistical analyses were conducted of GPS results from two previously published cohort studies in men treated with radical prostatectomy. The study included 299 intermediate-risk patients, 175 of whom were classified as UFI-risk. Results showed that UFI-risk patients with a GPS test result >40 had outcomes consistent with high-risk disease and a poor prognosis, indicating they may benefit from more aggressive therapies. In contrast, UFI-risk patients with a GPS value <40 had outcomes similar to favorable intermediate-risk patients, suggesting less aggressive therapy may be needed.

The GPS test has been shown in multiple studies to be a strong independent predictor of several critically important outcomes in men with very low, low, and favorable intermediate-risk prostate cancer. Findings from these new analyses support guideline inclusion of the GPS test in the broader population of UFI-risk patients.1

"Men and families facing a prostate cancer diagnosis have many questions and tough decisions in determining the best course of treatment. Tools like the GPS test can help patients have confidence in navigating a treatment pathway," said Jamie Bearse, chief executive officer of ZERO – The End of Prostate Cancer. "This is an important step forward for expanding access and coverage for intermediate-risk prostate cancer patients, as they can use the GPS test to help best guide and determine their treatment."

About the Oncotype DX Genomic Prostate Score (GPS) Test
Developed by Genomic Health, a wholly-owned subsidiary of Exact Sciences Corp., and based on results from multiple studies led by Cleveland Clinic and the University of California, San Francisco, the Oncotype DX GPS test is the only genomic assay designed for men with clinically low-risk or favorable intermediate-risk cancer to help make treatment decisions at the time of diagnosis. The test analyzes 17 genes across four biological pathways from tumor tissue removed during biopsy to provide a GPS result with a score ranging from 0-100 that corresponds to the biologic aggressiveness of the tumor and the patient’s likelihood of prostate cancer metastasis and death at 10 years. The GPS test is included within NCCN Guidelines as a Category 2A molecular testing option for consideration in prostate cancer patients with clinically low-risk and favorable intermediate-risk disease and is covered by Medicare and multiple private insurance companies in the United States. To learn more about the Oncotype DX Genomic Prostate Score test, visit www.OncotypeIQ.com or www.MyProstateCancerTreatment.org.

On June 16, 2020 MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported the appointment of Stephen Eck, M.D., Ph.D. as Senior Vice President, Clinical Development & Chief Medical Officer, effective beginning July 1, 2020 (Press release, MacroGenics, JUN 16, 2020, View Source [SID1234561133]).

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"We are excited to announce the addition of Stephen Eck to the MacroGenics leadership team. Stephen is a hematologist/oncologist who brings to MacroGenics more than 20 years of broad pharmaceutical and biotech industry experience with proven leadership in the development and commercialization of oncology therapeutics," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Stephen will be a tremendous asset to our company."

Dr. Eck most recently served as chief medical officer of Immatics US, a company focused on TCR-based immunotherapies, and as president and chief executive officer of Aravive Biologics. Prior to these roles, Dr. Eck was Vice President and Global Head of Oncology Medical Sciences at Astellas Pharma, managing a portfolio of assets which included enzalutamide (Xtandi), erlotinib (Tarceva) and gilteritinib (Xospata). Dr. Eck has also held leadership positions in drug development as Vice President of Translational Medicine and Pharmacogenomics at Eli Lilly and as Head of Clinical Oncology at Pfizer. He began his professional career at Monsanto in cancer target discovery and later joined the University of Pennsylvania, where he was the Anne B. Young Assistant Professor of Cancer Research and the Director of the Cancer Gene Therapy Program. Dr. Eck currently serves as a director for Luminex Corporation and Circulogene, and on the boards of directors for the Personalized Medicine Coalition and the Central Pennsylvania Clinic. He is also a fellow of the American Association for the Advancement of Science.

Dr. Eck holds a B.A. from Kalamazoo College, an M.S. and a Ph.D. from Harvard University, and an M.D. from the University of Mississippi School of Medicine with Residency and Fellowship training at the University of Michigan.

"MacroGenics has a rich pipeline of immuno-oncology programs," said Dr. Eck. "I look forward to working together with the MacroGenics team to advance these promising programs and bring new treatment options to patients."

Ezio Bonvini, M.D., Senior Vice President, Research and Chief Scientific Officer, who was overseeing MacroGenics’ clinical development and related functions on an interim basis will return to serving as the Company’s Chief Scientific Officer.

On June 16, 2020 Ona Therapeutics, which is focused on the discovery and development of therapeutic biologics to treat metastatic cancer, reported the closing of a €30 million Series A financing, with participation from existing investor Asabys Partners and new investors Alta Life Sciences, Bpifrance – InnoBio 2, Fund+ and Ysios Capital. (Press release, Ona Therapeutics, JUN 16, 2020, View Source [SID1234561132])

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Ona Therapeutics was founded in 2019 by IRB Barcelona, ICREA and research scientists Salvador Aznar-Benitah and Valerie Vanhooren, with backing from Asabys Partners – Sabadell Asabys, which was instrumental in putting together the Series A. Its approach is based on pioneering work from Dr Aznar-Benitah published in Nature in 2017 that validates Metastasis-Initiating Cells as therapeutic targets in metastatic cancer. The research shows that blocking the pathways that allow fat metabolism in animal models of cancer inhibits the cells that give rise to metastases, with the potential to not only prevent the development of these malignant growths, but also to eliminate existing ones. Importantly, this stands out as a common feature shared among various metastatic tumors, such as oral, breast, ovarian, gastric, bladder, prostate and melanoma.

The financing will allow Ona Therapeutics to complete the pre-clinical development in a variety of tumor types and to move its lead candidate into first clinical studies in patients with metastatic cancer in 2023.

Valerie Vanhooren, CEO and co-founder of Ona Therapeutics, commented: "We are very pleased to attract such a strong syndicate of investors which validates our approach to developing novel therapies with the potential to treat multiple types of metastatic cancer. Our research demonstrates that the survival of metastatic cells is linked to the intake of certain saturated fats and if we block the capacity for intake of these fats, we significantly reduce the cell’s metastatic potential."

Alexandra Tolia, Partner at Fund+, said: "Fund+ looks to invest in potential world class opportunities by backing great teams and ground-breaking science in areas of major unmet medical need. Metastasis remains an enormous challenge and the cause of over 90% of all cancer deaths worldwide. Ona Therapeutics is in a unique position to offer a promising new treatment to patients that otherwise have extremely limited options for recovery."

Joël Jean-Mairet, Managing Partner at Ysios Capital, said: "Ona Therapeutics is founded on world class science out of leading Barcelona research institutes. In the last year it has made exceptional progress in validating its scientific approach and we are very pleased to support this capital raise. Over the past years, we have evaluated around 600 companies active in oncology and Ona Therapeutics stands out for its singularity and potential impact in patients."

The investor syndicate will join the Ona Therapeutics Board which will consist of: Jose Mesa (Alta Life Sciences), Jean-François Morin (Bpifrance – InnoBio 2), Alexandra Tolia (Fund+) and Joël Jean-Mairet (Ysios Capital), and Interim Chair, Clara Campàs (Asabys Partners).

Bpifrance has invested through its InnoBio 2 fund which is focused on the development of the most promising biotechnology start-ups in Europe, and in France. Alta Life Sciences´ fund invests in highly innovative research business opportunities, such as Ona Therapeutics which is addressing large unmet medical needs such as metastasis.

On June 16, 2020 Blue Earth Diagnostics, a Bracco company focused on molecular imaging diagnostics, and PETNET Solutions Inc., a Siemens Healthineers company specializing in the manufacturing and distribution of positron emission tomography (PET) radiopharmaceuticals, reported the signing of a commercial manufacturing and distribution agreement (Press release, Blue Earth Diagnostics, JUN 16, 2020, View Source [SID1234561131]). Under the new multi-year agreement, PETNET will expand production and continue distribution of Axumin as well as commercially manufacture and distribute Blue Earth Diagnostics’ investigational radiohybrid Prostate-Specific Membrane Antigen-targeted agent, rhPSMA-7.3 (18F), pending its successful development and potential FDA approval. PETNET is currently a supplier of rhPSMA-7.3 (18F) for Blue Earth Diagnostics’ Phase 3 rhPSMA-7.3 (18F) clinical trials in newly diagnosed and recurrent prostate cancer (LIGHTHOUSE NCT04186819 and SPOTLIGHT NCT04186845, respectively). Axumin is a novel molecular imaging agent indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men who have elevated blood levels of prostate specific antigen (PSA) following prior treatment.

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"We are pleased to work in conjunction with PETNET Solutions, the leading supplier of PET radiopharmaceuticals in the United States, to continue to expand Axumin production and distribution in the United States," said Jonathan Allis, D. Phil., CEO of Blue Earth Diagnostics. "Axumin launched as the first FDA-approved 18F imaging agent for recurrent prostate cancer in 2016, and is now available at more than 1,100 imaging centers across the United States. Based on Blue Earth Diagnostics’ success in using its extensive radiopharmacy network for U.S. Axumin production and distribution, we chose PETNET as a clinical trial manufacturer of rhPSMA-7.3 (18F) for our Phase 3 clinical trials. Under this new agreement, PETNET will also provide commercial production and distribution of rhPSMA-7.3 (18F) pending its successful development and potential FDA approval. We believe that the complementary mechanisms of action of Axumin and rhPSMA-7.3 (18F) may ultimately allow physicians and their patients flexibility in selecting the diagnostic agent most appropriate to each specific clinical situation. The new agreement expands Axumin production in 2021, so that physicians and patients may have more convenient access to the product."

"We are proud to continue working with Blue Earth Diagnostics as the U.S. commercial supplier in making Axumin available to imaging centers and their patients, and we are pleased that PETNET Solutions has been selected to manufacture and distribute rhPSMA-7.3 (18F)," said Barry Scott, Head of PETNET Solutions Inc. "PETNET’s broad national network of radiopharmacies enables us to increase access to 18F PET radiopharmaceuticals to help healthcare providers address society’s most challenging diseases."

About Axumin (fluciclovine F 18)

Axumin (fluciclovine F 18) injection is a novel product indicated for use in positron emission tomography (PET) imaging to identify suspected sites of prostate cancer recurrence in men. Recurrence of prostate cancer is suspected by an increase in prostate specific antigen (PSA) levels following prior treatment. PET imaging with Axumin may identify the location and extent of such recurrence. Axumin was developed to enable visualization of the increased amino acid transport that occurs in many cancers, including prostate cancer. It consists of a synthetic amino acid that is preferentially taken up by prostate cancer cells compared with surrounding normal tissues and is labeled with the radioisotope F 18 for PET imaging. Fluciclovine F 18 was invented at Emory University in Atlanta, Ga., with much of the fundamental clinical development work carried out by physicians at Emory University’s Department of Radiology and Imaging Sciences. Axumin was approved by the U.S. Food and Drug Administration in May 2016, following Priority Review, and is the first product commercialized by Blue Earth Diagnostics, which licensed the product from GE Healthcare. The molecule is being investigated by Blue Earth Diagnostics for other potential cancer indications including neuro-oncology.

About rhPSMA

rhPSMA-7.3 (18F) is an investigational imaging agent that consists of a radiohybrid Prostate-Specific Membrane Antigen (PSMA)-targeted receptor ligand which attaches to and is internalized by prostate cancer cells, and is labeled with the 18F radioisotope for PET imaging. rhPSMA compounds can also be labeled with radioisotopes such as 177Lu and 225Ac for therapeutic use. Blue Earth Diagnostics acquired exclusive, worldwide rights to rhPSMA imaging technology from Scintomics in 2018, with an option to therapeutic rights. rhPSMA originated from the Technical University of Munich, Germany, and has been utilized clinically under German legislation at the Department of Nuclear Medicine there for the diagnostic imaging of men with both primary and recurrent prostate cancer. rhPSMA compounds have not received regulatory approval.

NOTE: Axumin (fluciclovine F 18) injection is FDA-approved for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

This press release is intended to provide information about Blue Earth Diagnostics’ business in the United States and Europe. Please be aware that the approval status and product label for Axumin varies by country worldwide. For EU Axumin product information refer to: View Source;mid=WC0b01ac058001d124.

U.S. Indication and Important Safety Information about Axumin

INDICATION

Axumin (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
Adverse reactions were reported in ≤ 1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.
To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On June 16, 2020 Perrigo Company plc ("Perrigo" or the "Company") (NYSE; TASE: PRGO), a leading global provider of Quality, Affordable Self-Care Products, reported that Perrigo Finance Unlimited Company, an indirect wholly-owned finance subsidiary of Perrigo (the "Issuer"), commenced a registered public offering of senior notes (the "Notes") (Press release, Perrigo Company, JUN 16, 2020, View Source [SID1234561130]). The Notes will be fully and unconditionally guaranteed on a senior unsecured basis by the Company. The exact terms and timing of the offering will depend upon market conditions and other factors.

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Perrigo intends to use the net proceeds of the Notes offering to fund the redemption of the Issuer’s 3.500% Senior Notes Due March 15, 2021 and 3.500% Senior Notes Due December 15, 2021, with the balance, if any, for general corporate purposes, which may include the repayment or redemption of additional indebtedness.

BofA Securities, J.P. Morgan and Wells Fargo Securities are the joint book-running managers in the offering.

The offering is being made pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission. The offering will be made only by means of a prospectus supplement relating to the offering and the accompanying base prospectus, copies of which may be obtained by contacting: BofA Securities, Inc. at [email protected] or toll-free at (800) 294-1322; or by calling J.P. Morgan Securities LLC collect at (212) 834-4533; or by calling Wells Fargo Securities, LLC toll-free at (800) 645-3751 or emailing [email protected].