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 Boundless Bio, a company developing innovative new therapies directed to extrachromosomal DNA (ecDNA) in aggressive cancers, reported that scientific co-founder, Paul Mischel, M.D., will be lecturing on the foundational role that ecDNA plays in driving resistance to standard of care therapies at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting II, held June 22-24, 2020 (Press release, Boundless Bio, JUN 16, 2020, View Source [SID1234561148]).

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Track: Educational Session
Session: Overcoming Therapeutic Resistance: Challenges and Opportunities
Presentation Title: Tumor heterogeneity and the evolution of drug resistance
Date: Tuesday, June 23, 2020
Time: 3:30 p.m. – 4:00 p.m. EDT

About ecDNA

Extrachromosomal DNA, or ecDNA, are distinct circular units of DNA containing functional genes that are located outside cells’ chromosomes and can make many copies of themselves. ecDNA rapidly replicate within cancer cells, causing high numbers of oncogene copies, a trait that can be passed to daughter cells in asymmetric ways during cell division. Cancer cells have the ability to upregulate or downregulate oncogenes located on ecDNA to ensure survival under selective pressures, including chemotherapy, targeted therapy, immunotherapy, or radiation, making ecDNA one of cancer cells’ primary mechanisms of recurrence and treatment resistance. ecDNA are rarely seen in healthy cells but are found in many solid tumor cancers. They are a key driver of the most aggressive and difficult-to-treat cancers, specifically those characterized by high copy number amplification of oncogenes.

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 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX) a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported the successful completion of its capital increase by issuing new ordinary shares with exclusion of pre-emptive subscription rights via a private placement to European investors for approximately €1.3 million (Press release, NOXXON, JUN 16, 2020, View Source [SID1234561149]).

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"Having completed this capital increase, our cash balance is now over €10 million. To put this into context, cash consumption in the first five months of the year has been approximately €400k per month including the ongoing brain cancer trial. This strengthened financial foundation will enable us to consider and pursue additional opportunities for building value with NOXXON compounds, and ultimately facilitate the continued development of the company," said Aram Mangasarian, CEO of NOXXON.

On June 15, 2020 the Supervisory Board agreed to proceed with a capital increase excluding shareholders’ pre-emptive rights, in accordance with the delegation granted to it by the sixth resolution of the extraordinary general meeting of shareholders from January 02, 2019. All the subscriptions were received and the final completion of the capital increase was acknowledged by the Board of Directors at its meeting held on June 16, 2020.

The capital increase amounts to €1,302,000 and corresponds to the issue of 2,245,000 new shares at a subscription price of €0.58 per new share, i.e. a dilution rate of 5.7% of the capital after operation on a non-diluted basis. The subscription price of €0.58 per new share represents a discount of 10.4% on the average closing price of the shares over the seven trading days from June 4, 2020 to June 12, 2020.

Settlement of the transaction is planned to take place on June 17, 2020. The new shares will carry current dividend rights and will be admitted to trading on the Euronext Growth Paris market, on the same trading line as the existing shares, under ISIN code NL0012044762, as of June 18, 2020.

The company’s issued share capital, which is currently composed of 36,845,249 shares, will therefore be composed of 39,090,249 shares after the transaction. As an indication, the participation of a shareholder holding 1% of the company’s issued share capital prior to the capital increase (calculated on the basis of the number of shares of the company’s issued share capital as of June 12, 2020), would be, after the issuance of the 2,245,000 new shares, 0.94% of the capital. The issued share capital prior to this financing was €368,452.49 and will therefore become €390,902.49.

Detailed information about NOXXON, including information about its business, results and corresponding risk factors, was presented in the Annual Report 2019 and in the related press release dated April 22, 2020. The company’s press releases as well as other regulated information can be found on the company’s website (www.noxxon.com).

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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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"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.