On September 11, 2020 Sumitomo Dainippon Pharma Oncology, Inc., a developer of novel cancer therapeutics, reported that new data evaluating the oral investigational agent dubermatinib (TP-0903), an AXL kinase inhibitor, will be presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2020 Virtual Annual Congress, being held September 19-21, 2020 (Press release, Sumitomo Dainippon Pharma, SEP 11, 2020, View Source [SID1234565037]). Data will be shared during the Developmental Therapeutics Mini-Oral Presentation and include findings from a Phase 1 study evaluating the safety, pharmacokinetics, pharmacodynamics and clinical activity of dubermatinib in patients with advanced solid tumors.

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"We are pleased to present these new data to the scientific community at ESMO (Free ESMO Whitepaper) 2020, which build upon our growing understanding of dubermatinib and the potential role of AXL kinase inhibition in oncology," said David J. Bearss, Ph.D., Chief Scientific Officer and Global Head of Research, Sumitomo Dainippon Pharma Oncology (SDP Oncology). "Furthermore, we look forward to sharing the findings from the expansion arms of the Phase 1 study evaluating the role dubermatinib may play in the treatment of specific tumor types. These data also represent SDP Oncology’s commitment to advancing purposeful science in emerging areas of oncology research that aims to positively impact outcomes for patients with cancer."

Below are the details for the SDP Oncology presentation:

Abstract Title

Details

Presenter

A Phase 1, First-in-human, Safety, Pharmacokinetic, and Pharmacodynamic Study of Oral Dubermatinib (TP-0903) in Patients with Advanced Solid Tumors

Presentation #536MO

Friday, September 18 at 9:56 a.m. CEST

Mini-Oral Presentation

John Sarantopoulos, M.D., UT Health San Antonio

About Dubermatinib (TP-0903)

Dubermatinib is an investigational oral AXL receptor tyrosine kinase (RTK) inhibitor under evaluation in a Phase 1a/b study in patients with advanced solid tumors (NCT02729298) and an ongoing study in collaboration with the Leukemia & Lymphoma Society as part of the Beat AML Clinical Trial (NCT03013998). SDP Oncology is exploring parallel clinical development paths for dubermatinib in both solid and hematologic malignancies.

About AXL Kinase

AXL belongs to the TAM (Tyro3, AXL and Mer) family of receptor tyrosine kinases and is overexpressed in many human cancers.1 It plays a key role in tumor cell proliferation, survival, metastasis, cellular adhesion, and avoidance of the immune response. The overexpression of AXL is associated with a poor patient prognosis and drug resistance.2

On September 11, 2020 Targazyme Inc., a late clinical-stage biopharmaceutical company developing novel fucosyltransferase enzyme technologies and products to improve clinical efficacy, safety, and cost of care outcomes for immuno-oncology and stem cell transplantation, reported that it has recruited cancer immunotherapy industry veteran James Caggiano to be the CEO, focused initially on its oncology business (Press release, Targazyme, SEP 11, 2020, View Source [SID1234565036]).

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A former US Army Officer, Jim Caggiano brings nearly 30 years of immuno-oncology, pharmaceutical, and medical device experience at successful companies such as TAP Pharmaceuticals, Allergan, Abbott Laboratories, Valeant, and Dendreon. As President at Valeant, Caggiano led the successful business turnaround of Dendreon, doubled the value of Dendreon by selling it to Sanpower Group for $820M, and became its CEO. Under his leadership, Dendreon earned over $100M in EBIT in 2018 and 2019.

"We welcome Jim Caggiano to our Targazyme team and look forward to his leadership with advancing our oncology assets to making a life-changing difference for cancer patients and their families worldwide," said Lynnet Koh, Targazyme’s Founder and Executive Chairman of Targazyme. "Caggiano brings a track record of delivering major shareholder value through successful execution of sell-side deal transactions and driving major commercial revenue growth. His military leadership skills positions the company for consistently delivering on key milestones on time and on budget."

"I’m honored to join Targazyme at this exciting and pivotal time in its history," said Caggiano. "I look forward to working with the team here to capitalize on the impressive results of the past and to move these very promising, life-saving therapies forward, ultimately enhancing the lives of cancer patients."

On September 11, 2020 CNS Pharmaceuticals, Inc. (NASDAQ: CNSP) ("CNS" or the "Company"), a biopharmaceutical company specializing in the development of novel treatments for primary and metastatic cancers of the central nervous system, reported that CEO, John Climaco, will present virtually at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on Wednesday, September 16th, 2020 at 9:30 AM EDT (Press release, CNS Pharmaceuticals, SEP 11, 2020, View Source;co-22nd-annual-global-investment-conference-301128132.html [SID1234565035]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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H.C. Wainwright 22nd Annual Global Investment Conference:

Date:

Wenesday, September 16th, 2020

Time:

9:30 AM EDT

Link:

View Source

A replay of the presentation will be available on the Company’s website for 90 days following the event. Members of management will hold 1-on-1 virtual investor meetings at the conference. Investors attending the conference virtually who are interested in meeting with Company management should contact their H.C Wainwright representatives.

On September 11, 2020 Regulus Therapeutics Inc. (Nasdaq: RGLS), a biopharmaceutical company focused on the discovery and development of innovative medicines targeting microRNAs ("Regulus"), reported that Jay Hagan, President and Chief Executive Officer of Regulus, will present at the H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15, 2020 at 11:00 AM EDT (Press release, Regulus, SEP 11, 2020, https://www.prnewswire.com/news-releases/regulus-therapeutics-to-present-at-the-hc-wainwright-22nd-annual-virtual-global-investment-conference-301128135.html [SID1234565034]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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A live webcast of the presentation will be available through the investor relations section of the Company’s website at www.regulusrx.com.

On September 11, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that Noridian, the Medicare Administrative Contractor (MAC) for Northern California, has finalized a final local coverage article (LCA) to provide Medicare benefits for serial use of the Signatera molecular residual disease (MRD) test in patients with a history of colorectal cancer (Press release, Natera, SEP 11, 2020, View Source [SID1234565033]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The Noridian article is in line with the positive coverage determination issued by the CMS Molecular Diagnostics (MOLDX) program last week via Palmetto GBA and shares the same effective date of October 18th, 2020.