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Onconova Therapeutics Announces Participation in Two Upcoming International Conferences

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.

Monopar Therapeutics Receives Orphan Drug Designation from the European Commission for Camsirubicin in the Treatment of Soft Tissue Sarcoma

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]).

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.

MannKind Corporation to Hold 2019 Fourth Quarter and Full Year Financial Results Conference Call on February 25, 2020

On February 18, 2020 MannKind Corporation (NASDAQ:MNKD) reported that it will release its 2019 fourth quarter and full year financial results and its management will host a conference call to discuss the financial results and corporate updates at 9:00 AM (Eastern Time) on Tuesday, February 25, 2020 (Press release, Mannkind, FEB 18, 2020, View Source [SID1234554432]).

Presenting from the Company will be its Chief Executive Officer, Michael Castagna and Chief Financial Officer, Steven Binder.

To participate in the live call by telephone, please dial (800) 289-0438 or (323) 794-2423 and use the participant passcode: 1233728. Those interested in listening to the conference call live via the Internet may do so by visiting the Company’s website at View Source under News & Events.

A telephone replay of the call will be accessible for approximately 14 days following completion of the call by dialing (844) 512-2921 or (412) 317-6671 and use the participant passcode: 1233728. A replay will also be available on MannKind’s website for 14 days.

Kura Oncology to Report Fourth Quarter and Full Year 2019 Financial Results

On February 18, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that it will report fourth quarter and full year 2019 financial results after the close of U.S. financial markets on Tuesday, February 25, 2020 (Press release, Kura Oncology, FEB 18, 2020, View Source [SID1234554431]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

The live call may be accessed by dialing 877-516-3514 for domestic callers and 281-973-6129 for international callers and entering the conference code: 8077975. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

Heron Therapeutics to Present at the 9th Annual SVB Leerink Global Healthcare Conference

On February 18, 2020 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., President and Chief Executive Officer of Heron Therapeutics, will present at the 9th Annual SVB Leerink Global Healthcare Conference on Tuesday, February 25, 2020 at 1:00 p.m. ET at the Lotte New York Palace hotel (Press release, Heron Therapeutics, FEB 18, 2020, View Source [SID1234554430]).

A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.