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.

On February 18, 2020 Synlogic (Nasdaq: SYBX) reported that Aoife Brennan, M.B., B.Ch., Synlogic’s president and chief executive officer, will participate in the following upcoming investor conferences (Press release, Synlogic, FEB 18, 2020, View Source [SID1234554465]):

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9th Annual SVB Leerink Global Healthcare Conference on Tuesday, February 25 at 1:00 pm ET in New York
Cowen 40th Annual Health Care Conference on Monday, March 2 at 2:10 pm ET in Boston
Live webcasts of the presentations can be accessed under "Event Calendar" in the Investors & Media section of the Company’s website. Archived webcast recordings will be available on the Synlogic website for approximately 30 days after each event.

On February 18, 2020 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a Phase 3-stage biopharmaceutical company discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported that the Company will be participating in two upcoming international conferences (Press release, Onconova, FEB 18, 2020, View Source [SID1234554434]):

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1. RAS-Targeted Drug Discovery Summit/Europe
February 25-27
Vienna, Austria

Presentation Details:

Title: Rigosertib is a Unique Small Molecule RAS Antagonist: Scientific & Clinical Studies
Date/Time: Thursday, February 27th, 9:00 AM Central European Time
Venue: Hilton Vienna Plaza
Presenter: Steven M. Fruchtman, M.D., President & CEO of Onconova

About RAS and Rigosertib:

There is a high frequency of RAS mutations in cancer that leads to the belief that mutations of the RAS Pathway provide a proliferative advantage and thus are involved in the pathogenesis of cancer. As a result, targeting the RAS pathway has been the objective of scientific research for decades. As published in the journal Cell in 2016, and now under investigation in a pivotal Phase 3 Trial, rigosertib targets the mutated RAS pathway by its interaction with RAS effector proteins containing the RAS Binding Domain. The RAS-Targeted Drug Discovery Summit provides an opportunity to showcase the potential for rigosertib in MDS and in other RAS-driven cancers, such as KRAS-mutated lung cancer and colorectal cancer, and RAS-driven pediatric cancers as well. Onconova will review its INSPIRE Trial for which the Company anticipates reporting top-line data for second-line, higher-risk MDS patients in the first half of this year, following full enrollment and 288 death events. Dr. Fruchtman looks forward to joining colleagues at the Summit to discuss advancements in rigosertib’s development as well as the progress the Company and others have made in targeting RAS.

2. 2nd Regional Symposium on MDS
March 5-6
Tel Aviv, Israel

"We are pleased to participate in the MDS Conference in Tel Aviv where experts from around the globe will be presenting new data on the diagnosis and management of MDS," said Dr. Steven Fruchtman.

On February 18, 2020 Eureka Therapeutics, Inc., a clinical stage biotechnology company developing novel T cell therapies to treat solid tumors, reported that its Director of Strategy and Business Development, Dr. Jingyi Xiang, will be presenting at CAR-TCR Summit Europe being held at the Novotel London West, London, United Kingdom on February 25, 2020 (Press release, Eureka Therapeutics, FEB 18, 2020, View Source [SID1234554450]).

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Presentation Details

Title:

Novel Antibody-TCR Platform (ARTEMIS T cells) Combines Fab-based Antigen Recognition with gamma/delta-TCR Signalling for Favorable Safety and Efficacy Profile in T Cell Immunotherapy

Speaker:

Dr. Jingyi Xiang

Event Program:

Translation Track

Date:

Tuesday, February 25, 2020

Time:

5:30 p.m. GMT