On February 18, 2020 Rheos Medicines, a biopharmaceutical company harnessing insights in immunometabolism to create a new class of therapeutics for patients with severe autoimmune disorders, inflammatory diseases and cancer, reported that Barbara S. Fox, Ph.D., the Company’s Chief Executive Officer, will present at the Cowen and Company 40th Annual Health Care Conference on Monday, March 2, 2020 at 10:00 a.m. EST (Press release, Rheos Medicines, FEB 18, 2020, View Source [SID1234554448]). The Conference will be held at the Boston Marriott Copley Place in Boston, MA.

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On February 18, 2020 Viracta Therapeutics, Inc. (the "Company"), a precision oncology company targeting virus-associated malignancies, reported that Ivor Royston, M.D., the Company’s President and CEO, will present an overview of Viracta’s approach in treating patients with Epstein-Barr Virus (EBV)-associated malignancies and data from the ongoing Phase 2 clinical trial in lymphoma (Press release, Viracta Therapeutics, FEB 18, 2020, View Source [SID1234554464]).

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It is estimated that there are over 200,000 new cases of EBV-associated cancers each year. Scientific research has worked to better understand these diseases and develop novel therapeutic approaches to address this global unmet need, however, there are no approved therapies targeting EBV-associated malignancies. Viracta has developed a novel approach to selectively target malignant cells associated with EBV that is applicable across many cancer types, which may also have utility in other virus-associated diseases.

Viracta is currently in a Phase 2 clinical study, evaluating its proprietary investigational drug, nanatinostat, in combination with valganciclovir as an oral combination therapy. The data from the Phase 1b portion of Viracta’s clinical study was presented in an oral session at the ASH (Free ASH Whitepaper) Annual Meeting in December 2019.

"We are honored that Viracta’s research and clinical findings have been recognized among the world-renowned leaders at the UCSD Moores Cancer Center," said Ivor Royston, M.D., President and CEO of Viracta. "We believe that our precision approach to treating virus-associated malignancies is truly unique and has the potential to provide the first non-toxic and effective therapeutic solution for these patients."

Viracta has received Fast Track Designation from the FDA for its proprietary investigational drug, nanatinostat, in combination with valganciclovir, in relapsed/refractory lymphomas, as well as Orphan Drug Designation for the treatment of post-transplant lymphoproliferative disorder, plasmablastic lymphoma, and angioimmunoblastic T-cell lymphoma.

Viracta aims to develop a new, highly targeted, non-toxic and non-immunosuppressive therapy which may be given on an out-patient basis for EBV-associated malignancies in hematological and solid tumors. If successful, this approach may be investigated as a possible treatment for additional virus-associated malignancies and other serious diseases.

UCSD Moores Cancer Center presentation details are as follows:

Title: "Precision Therapy of Relapsed/Refractory EBV+ Lymphomas Utilizing an Oral Inducer of Viral Kinases to Activate an Anti-tumor Prodrug"
Session: Hematology/Oncology
Date/Time: Thursday, February 20, 2020, 4 p.m. PST
Location: Moores Cancer Center at UCSD Health, San Diego, CA
About Nanatinostat

Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs which is key to activating latent viral genes in EBV-associated malignancies. The nanatinostat and valganciclovir combination is being investigated in EBV-associated lymphomas in an ongoing Phase 2 clinical trial [NCT03397706].

About EBV-Associated Cancers

Approximately 95% of the world’s adult population is infected with Epstein-Barr virus (EBV). Infections are commonly asymptomatic. Following infection, the virus remains latent in a small subset of lymphatic cells for the duration of the patient’s life. Under certain circumstances, such cells may undergo malignant transformation and become lymphoma. In addition to lymphomas, EBV is associated with a variety of solid tumors, including nasopharyngeal carcinoma and gastric cancer.

On February 18, 2020 Pharma Two B Ltd., a privately held company developing innovative therapeutics based on previously approved drugs for Parkinson disease, reported the appointment of David S. Tierney M.D. as Chief Executive Officer, effective immediately as well as the establishment of a fully owned U.S. subsidiary to serve as the marketing base of the Company’s activities (Press release, Pharma Two B, FEB 18, 2020, View Source [SID1234554416]).

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Pharma Two B’s main product, P2B001, is targeting patients with early stage Parkinson’s Disease. According to the Michael J. Fox Foundation for Parkinson’s Research (MJFF), Parkinson’s disease is estimated to affect nearly 1 million people in the United States and more than 6 million people worldwide. The Company estimates that approximately 15%-20% of these patients could be defined as early stage patients.

"We are excited to have David, a highly accomplished pharmaceutical executive with proven business development, medical and financial acumen, join Pharma Two B as CEO," said Ehud Marom, Chairman of Pharma Two B’s Board of Directors. "David has a successful track record in drug approvals, developing and executing plans of commercial organizations as well as raising equity capital raising from both private and VC investors, and the public markets, including the completion of an IPO."

Dr. Tierney stated, "I am delighted to lead Pharma Two B at this pivotal time and believe there are substantial opportunities to create significant value by registering P2B001 and building the commercial infrastructure to launch the product in the U.S. in 2021. This plan will include securing the needed financial resources for a successful launch through quality financings with high quality investors that will prepare the Company for an IPO and or strategic combination."

P2B001 is a low dose, sustained release combination of pramipexole and resagiline. The drug is orally dosed once daily with no titration. P2B001 is near the end of the Phase 3 pivotal study and the Company is preparing for an NDA submission next year via the 505(b)(2) regulatory pathway. Dr. Tierney added, "I look forward to working with our team and board members, completing the ongoing Phase 3 study and building the infrastructure to support a successful launch, including marketing and collaboration with potential partners."

About David S. Tierney, M.D.

Prior to David’s appointment as CEO of Pharma Two B, he was President and CEO of BioPharmX Corp (NYSE American: BPMX) and of Icon Bioscience, Inc., where he led a team that in 2018 received U.S. FDA approval of its New Drug Application (NDA) for DEXYCU (dexamethasone intraocular suspension), a dropless, long-acting therapeutic for treating inflammation associated with cataract surgery. Icon was merged with EyePoint Pharmaceutical, Inc (NASDAQ: EYPT) in March 2018.

Dr. Tierney served as President and COO of Oceana Therapeutics, Inc., a specialty therapeutic company he co-founded in 2008. Oceana quickly established a global commercial network and by 2011 was acquired by Salix Pharmaceuticals. In 2000, David was appointed President & CEO of Hydro Med Sciences (HMS), a research firm with a promising drug delivery platform. Under his leadership, HMS emerged as Valera Pharmaceuticals, a fully integrated, commercial, specialty pharma company that successfully completed an initial public offering in 2005. Valera has since been merged into Endo Pharmaceuticals (NASDAQ: ENDP). In total, Dr. Tierney has over 30 years of experience in executive and management positions in the pharmaceutical industry. Dr. Tierney received his medical degree from Royal College of Surgeons in Ireland.

David Tierney is the recipient of two Ernst & Young Entrepreneur of the Year awards, first in 2005 and again in 2011, respectively, reflecting his accomplishments at Valera and Oceana. He was also featured in the inaugural 2010 Irish Life Science 50, an honor presented by the President of Ireland in conjunction the Irish Voice and Irish America Magazine. Additionally, in 2005, 2006, and 2011, PharmaVOICE 100 named David one of the most inspiring people in health sciences.

On February 18, 2020 Monopar Therapeutics Inc. (NASDAQ: MNPR) reported it has been granted Orphan Drug Designation from the European Commission for its drug candidate camsirubicin in the treatment of soft tissue sarcoma (STS), and the European Medicines Agency’s Committee for Orphan Medicinal Products has issued its public summary of opinion for the designation, which can be found on the Company’s website: View Source (Press release, Monopar Therapeutics, FEB 18, 2020, View Source [SID1234554433]).

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Orphan Drug Designation: is given to medicinal products that represent a significant benefit over existing treatments; are intended for the treatment, prevention or diagnosis of a disease that is life-threatening or chronically debilitating; and where prevalence of the condition in the European Union (EU) is less than 5 in 10,000 persons. Orphan Drug Designation benefits include protocol assistance, reduced EU regulatory filing fees and 10 years of market exclusivity. Designated orphan medicines are also eligible for conditional marketing authorization. Camsirubicin has already received orphan drug designation in the U.S. by the Food and Drug Administration (FDA), which provides for similar benefits such as fee reductions and 7 years of market exclusivity.

"We are pleased to receive Orphan Drug Designation from the European Commission as it is another important acknowledgement of the potential benefits of camsirubicin in the treatment of advanced soft tissue sarcoma (ASTS)," said Chandler Robinson, M.D., Chief Executive Officer of Monopar. "This designation complements our U.S. orphan drug designation already granted by the FDA. We look forward to initiating our previously announced Phase 2 clinical trial in ASTS in collaboration with our partner, Grupo Español de Investigación en Sarcomas (GEIS), in the first half of 2020."

Andrew Mazar, Ph.D., Chief Scientific Officer of Monopar added, "We are encouraged by camsirubicin’s potential demonstrated in its early clinical data to date. As a novel analog of doxorubicin, camsirubicin has been designed to reduce the irreversible heart damage generated by doxorubicin while retaining anti-cancer activity." Dr. Mazar continued, "Doxorubicin’s efficacy is highly dose dependent; however, higher cumulative doses have historically led to increased rates of irreversible heart damage. As a result, responding patients are pulled off treatment once a maximum lifetime cumulative dose has been reached. Disease progression and poor clinical outcomes in many patients is the unfortunate consequence of the maximum lifetime dose limitation. Camsirubicin offers the potential to administer drug without the risk of irreversible heart damage, thereby potentially improving efficacy by maintaining treatment in these patients as long as they demonstrate clinical benefit."

About Camsirubicin

Camsirubicin is a proprietary doxorubicin analog that is selective for topoisomerase-IIa. It has been investigated in ASTS patients in a Phase 1 and a single arm Phase 2 clinical trial. In these studies, no camsirubicin-treated patients developed the irreversible cardiotoxicity common to doxorubicin. The most common adverse event observed in the Phase 1 study was neutropenia, which was mitigated in the Phase 2 study through the use of prophylactic G-CSF. Based on encouraging clinical results to date, Monopar has entered into a clinical trial partnership with Grupo Español de Investigación en Sarcomas (GEIS), an internationally renowned non-profit organization focused on the research and development of drugs for sarcoma cancers. GEIS will be conducting a multi-country, randomized, open-label Phase 2 clinical trial in the 1st line setting evaluating camsirubicin head-to-head against doxorubicin in patients with ASTS. Enrollment for the trial is expected to begin in the first half of 2020 and will include approximately 170 ASTS patients. The primary endpoint of the trial will be progression-free survival, with secondary endpoints that include overall survival.

On February 18, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early, when it can be cured, reported the initiation of the PATHFINDER Study (Press release, Grail, FEB 18, 2020, View Source [SID1234554449]). A prospective, multi-center study, PATHFINDER marks the first time GRAIL’s test results will be returned to healthcare providers and communicated to participants to help guide appropriate diagnostic workup for more than 50 cancer types.

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Initial PATHFINDER health system partners include Dana-Farber Cancer Institute, Intermountain Healthcare, Mayo Clinic, Oregon Health & Science University, and Sutter Health with plans to expand to additional partners. The first participants have been successfully enrolled.

Today, the majority of deadly cancers do not have U.S. guideline-recommended screening paradigms, and as a result, many cancers are not detected until they have progressed to late stages when chances of survival are lower. Data from previous clinical studies demonstrate GRAIL’s multi-cancer early detection test is able to detect more than 50 cancer types across all stages, with a very low false positive rate of less than one percent, through a single blood draw. When a cancer signal is detected, GRAIL’s test is also able to identify where in the body the cancer is located with high accuracy. Identifying a cancer’s tissue of origin will enable healthcare providers to efficiently guide PATHFINDER participants with a cancer "signal-detected" test result through the appropriate care pathway to arrive at a diagnostic resolution.

"GRAIL is at the forefront of transforming early cancer detection as we bring our multi-cancer test into clinical practice through our first interventional study," said Hans Bishop, Chief Executive Officer at GRAIL. "We are partnering with leading healthcare systems to gain important real-world insight into the clinical use of our multi-cancer early detection test, an important step on our path toward commercialization."

"GRAIL set out to develop a true multi-cancer early detection test, and we believe we have built the world’s largest methylation database that’s enabled machine learning rooted in fundamental insights into the biology of cancer signals in the blood," said Alex Aravanis, Chief Scientific Officer and Head of R&D, and a Founder of GRAIL. "Building on our foundational investments in science and technology, we developed a high performing test for the detection of over 50 types of cancer, and we are excited to evaluate its ability to inform clinical care."

The PATHFINDER Study is conducted under an investigational device exemption (IDE) to evaluate GRAIL’s multi-cancer early detection test. GRAIL believes that its IDE application is the first approved by the Food and Drug Administration (FDA) for a return-of-results study involving a multi-cancer next-generation sequencing-based blood test.

About the PATHFINDER Study

The PATHFINDER Study is evaluating the implementation of GRAIL’s investigational multi-cancer early detection test in clinical practice, and marks the first time GRAIL’s test will be used to return results to people. PATHFINDER will enroll approximately 6,200 participants across several health systems and is sponsored by GRAIL. PATHFINDER is being conducted under an FDA approval of an IDE application for GRAIL’s multi-cancer early detection blood test.

GRAIL’s test is not yet available for use outside of this investigational study. It is not meant to replace the cancer screening tests healthcare providers may recommend, such as colonoscopy or mammography. For more information, visit www.grail.com/clinical-studies/pathfinder-study/.

‎About GRAIL’s Multi-Cancer Early Detection Test

GRAIL’s multi-cancer early detection test is designed to detect cancers in early stages, when the chance of survival is higher than if cancer is detected after symptoms appear. Clinical data have shown the ability of this technology to detect more than 50 cancer types with a very low false positive rate of less than one percent. GRAIL’s test was designed to minimize false positives in order to limit associated harms, including patient anxiety and unnecessary diagnostic workups. When a cancer signal is detected, the test has been able to identify where in the body the cancer is located with high accuracy, an important step to guiding diagnostic next steps and care.

GRAIL’s methylation-based technology preferentially targets the most informative regions of the genome and is designed to use its proprietary database and machine-learning algorithms to both detect the presence of cancer and identify the tumor’s tissue of origin. GRAIL believes its sequencing database of cancer and non-cancer methylation signatures is the largest of its kind.