On June 16, 2020 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing XCART, a personalized CAR T platform technology engineered to target patient- and tumor-specific neoantigens, reported it has entered into a master services agreement ("MSA") with PJSC Pharmsynthez to advance the development of the XCART technology for B-cell malignancies (Press release, Xenetic Biosciences, JUN 16, 2020, View Source [SID1234561137]). Under the terms of the MSA, Pharmsynthez will act as the primary contract research organization ("CRO") to assist in managing the collaboration with multiple academic institutions in Russia and Belarus.

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The initial stage of the collaboration will include an exploratory trial to evaluate and refine the XCART front-end process of target identification, screening and lead characterization, in a real-world clinical setting. This exploratory stage entails enrollment of NHL patients, obtaining tumor biopsies and then refining the XCART front-end methods. Subsequently the collaboration may be expanded to include development and qualification of manufacturing processes for producing autologous XCART T-cells. If successful, the Company has the potential to expand the clinical study component to dose a number of NHL patients in a Phase 1 dosing study.

"This agreement represents another significant milestone for the Company and provides access to a number of world-renowned academic institutions, researchers and clinical investigators in the area of oncology and hematology. Additionally, we are excited to again be working with the Shemyakin and Ovchinnikov Institute as they are intimately familiar with the XCART platform having been one of the primary inventors," commented Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Coupled with our recently announced collaboration with Scripps Research, we believe we are well-positioned to execute on our strategic development plan as we work to advance this innovative technology, which we believe has the potential to address a significant unmet need in NHL."

Alexander Gabibov, academic, Head of the Shemyakin and Ovchinnikov Institute of Bioorganic Chemistry RAS, commented, "The XCART platform was thoughtfully designed to target personalized, patient-specific tumor neoantigens and has demonstrated encouraging potential. Our team is uniquely positioned to carry out this important foundational work and, through this collaboration is able to leverage the additional expertise from the Belarus academic institutions. We are pleased to continue our collaboration with Xenetic through this agreement and look forward to helping to advance the XCART platform towards first-in-human dosing."

The XCART technology platform was designed to utilize an established screening technique to identify polypeptide domains that selectively bind to the unique B-cell receptor ("BCR") on the surface of an individual lymphoma patient’s malignant B-cell clones. This BCR-selective targeting domain is engineered into the antigen-binding domain of a chimeric antigen receptor ("CAR"), creating the possibility of a CAR T treatment that should only recognize a given patient’s malignant B-cell clones. An expected result for XCART is limited off-tumor toxicities, such as B-cell aplasia. Xenetic’s clinical development program will seek to confirm the early preclinical results, and to demonstrate a more attractive safety profile than existing therapies.

On June 16, 2020 Genprex, Inc. ("Genprex" or the "Company") (Nasdaq: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and diabetes, reported that it has expanded its program for the manufacture of TUSC2 (Tumor Suppressor Candidate 2) plasmid DNA for its lead drug candidate, Oncoprex immunogene therapy, by entering into a new agreement with manufacturing partner Aldevron, LLC, ("Aldevron") (Press release, Genprex, JUN 16, 2020, View Source [SID1234561135]). The new agreement provides for production of TUSC2 plasmid DNA, the active agent in Oncoprex, at full commercial scale. The Company’s manufacturing at this scale should also result in significantly lower costs per unit of product manufactured due to economies of scale.

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Genprex’s upcoming clinical trials include a Phase I/II trial of Oncoprex combined with osimertinib (marketed by AstraZeneca as Tagrisso) for non-small cell lung cancer (NSCLC), which received Fast Track Designation in January 2020 and is expected to be initiated in early 2021. A clinical trial of Oncoprex in combination with pembrolizumab (marketed by Merck as Keytruda) in NSCLC is also planned.

"We are pleased with continued progress in the scale-up of our manufacturing processes. This new agreement with Aldevron increases our manufacturing capabilities in support of our clinical trials utilizing Oncoprex immunogene therapy in combination with targeted therapies and immunotherapies against lung cancer," said Rodney Varner, Chairman and Chief Executive Officer of Genprex.

"Our team is excited about the expansion of our manufacturing agreement and elevation of our long-standing relationship with Genprex," said Michelle Berg, President of GMP Nucleic Acids at Aldevron. "Aldevron’s GMP facility and campus buildout ensures we can meet the future manufacturing demands of companies experiencing significant growth such as Genprex; thereby enabling our ultimate goal of impacting the lives of patients."

Oncoprex consists of TUSC2 plasmid DNA encapsulated in a lipid nanoparticle. The TUSC2 gene is the active agent in Oncoprex. Data indicate that the resultant product when transfected into cancer cells both induces cell signaling that triggers programmed cell death and modulates the immune system so that the cancer cells are more susceptible to treatment.

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.

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.