On November 8, 2019 A new study of 443 patients by Exact Sciences Corp. and its collaborators reported demonstrated 80% sensitivity at 90% specificity with a novel combination of six blood-based biomarkers for the most common type of liver cancer, hepatocellular carcinoma (HCC)i (Press release, Exact Sciences, NOV 8, 2019, View Source [SID1234550741]). The study also showed 71% sensitivity for early stage HCC at 90% specificity. The study compared performance to the alpha-fetoprotein (AFP) test, which demonstrated 45% sensitivity at 90% specificity for early stage HCC. Lead author Naga Chalasani, M.D., Associate Dean for Clinical Research at Indiana University School of Medicine and Director, Division of Gastroenterology and Hepatology, will present the findings Sunday, November 10th at the 2019 annual meeting for the American Association for the Study of Liver Diseases (AASLD) in Boston.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The data are included by AASLD’s Scientific Program Committee in The Best of The Liver Meeting, a distinction that recognizes abstracts for their rigorous scientific methodology and key insights for patient care and ongoing research. Exact Sciences’ HCC test has also been granted Breakthrough Device designation by the U.S. Food and Drug Administration. The agency’s Breakthrough Devices program expedites development, assessment, and review processes to provide patients and health care providers with timely access to new technologies.

Liver cancer is the number four cancer killer globally, and more than 42,000 Americansii and 780,000 people worldwide are diagnosed with the disease each yeariii. HCC alone accounts for approximately 90% of primary liver cancersiv. Clinicians and patients need more accurate, convenient testing options to help combat rising incidence rates, which have more than tripled since 1980i.

Current guidelines recommend at-risk patients undergo testing every six months using ultrasound (US) with or without the AFP blood testv. Combined, US and AFP have demonstrated 63% sensitivity for early stage cancersvi. Nearly half of Medicare patients tested for HCC receive only the AFP testvii, which in Exact Sciences’ Study was less sensitive for HCC detection than US and AFP combined. Three-year survival rates nearly double for patients who undergo regular testing compared to those who do not, yet fewer than one-third of patients adhere to current guidelinesv.

"A growing number of patients around the world are considered high risk for developing HCC," said Kevin Conroy, chairman and CEO of Exact Sciences. "A more sensitive and convenient blood-based test could help catch the disease earlier, which may lead to better outcomes. We are encouraged by the data presented at The Liver Meeting, as it shows an important advancement over the options currently available."

Exact Sciences’ multi-center, case-control study analyzed 443 blood samples, including 135 HCC cases and 308 age- and liver disease etiology-matched controls. The accuracies of both Exact Sciences’ HCC test and the AFP blood test were analyzed for all Barcelona Clinic Liver Cancer (BCLC) stages and for early stage HCC (stages 0 and A). With specificity set at 90%, Exact Sciences’ four methylated DNA markers and two protein markers detected 80% of HCC cases across all stages. The test demonstrated 71% sensitivity for early stage HCC, outperforming the AFP test, which detected 45% of early stage cancers and 62% of cancers across all stages in Exact Sciences’ study.

"There is a significant, worldwide unmet need for a blood-based, early detection diagnostic test for liver cancer in persons with elevated risk for the disease," said Dr. Chalasani. "The DNA methylation based liquid biopsy developed by Exact Sciences is timely and very promising for addressing this unmet demand."

Exact Sciences is finalizing its HCC test development and plans to make the test available in the second half of 2020. This will help generate real-world evidence to support guideline inclusion, broad reimbursement, and adoption of the test over time.

Note to editors: The full abstract (#109) can be found in the October 2019 supplement of Hepatology.

Media Contact:
Cara Connelly, [email protected], 614-302-5622

Investor Contact:
Megan Jones, [email protected], 608-535-8815

On November 8, 2019 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its board of directors declared a quarterly cash dividend of $0.19 per share (Press release, Thermo Fisher Scientific, NOV 8, 2019, View Source [SID1234550740]). The dividend will be paid on January 15, 2020, to shareholders of record as of December 17, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The board also authorized the repurchase of $2.5 billion of shares of its common stock in the open market or in negotiated transactions. The authorization has no expiration date. This replaces the company’s existing repurchase authorization, of which $500 million was remaining.

On November 8, 2019 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported that it will host a live conference call and audio webcast on Thursday, November 15, 2018 at 8:30 a.m. ET to report financial results for the third quarter ended September 30, 2018 and to provide a business overview (Press release, Bio-Path Holdings, NOV 8, 2019, View Source [SID1234550609]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

To access the live conference call, please call (844) 815-4963 (domestic) or (210) 229-8838 (international) at least five minutes prior to the start time and refer to conference ID 8564777. A live audio webcast of the call will also be available on the Events section of the Company’s website, www.biopathholdings.com. An archived webcast will be available on the Bio-Path website approximately two hours after the event.

On November 7, 2019 OSE Immunotherapeutics (ISIN: FR0012127173; Mnémo: OSE), reported a new licensing deal with Chong Kun Dang (CKD) Pharmaceutical Corporation for Tedopi, a combination of neoepitopes selected and optimized from five tumor antigens shown to generate a specific response of cytotoxic T cells versus cancer cells expressing at least one of these tumor associated antigens and an associated T-helper cell response, for potential registration and commercialization in Korea (Press release, OSE Immunotherapeutics, NOV 7, 2019, View Source [SID1234648650]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We are pleased to announce the licensing of Tedopi to such a strong partner as CKD, one of the industry leaders in Korea," said Alexis Peyroles, Chief Executive Officer of OSE Immunotherapeutics. "This partnership allows us to make a difference for Korean non-small cell lung cancer patients after previous checkpoint inhibitor treatment failure, a population for which there is great unmet medical need. This licensing agreement is an example of our commitment to making Tedopi available to the broadest audience globally and maximizing its potential."

Financial terms of the contract include both upfront and short-term milestone payments of €1.2 million with total milestones payments of €4.3 million, as well as royalties on sales and transfer price in the high twenties. The deal applies specifically to development and licensing of Tedopi in the Korean market which accounts for approximately 1% of the total global oncology market.

"It is indeed interesting times as cancer immunotherapies are dramatically transforming the landscape of cancer treatment. However, there is a large population still devastated from checkpoint inhibitor failures," said Young-Joo Kim, Chief Executive Officer of Chong Kun Dang Pharmaceutical Corp. "We are excited to add a promising product to help an underserved patient population to our portfolio and look forward to working with the outstanding team at OSE to help bring Tedopi to the Korean market."

Tedopi is currently being evaluated in an open-label Phase 3 trial (called Atalante 1) in advanced non-small cell lung cancer (NSCLC) for HLA-A2 positive patients after failure from previous treatment with PD-1/PD-L1 checkpoint inhibitors. Results from the first step of this ongoing Tedopi Phase 3 trial in NSCLC are expected end of Q1 2020.Tedopi is also being studied in an ongoing Phase 2 trial in patients with pancreatic cancer.

On November 7, 2019 NBE-Therapeutics AG and SOTIO a.s. reported that SOTIO has elected a second target for the development of a next generation antibody-drug conjugate (ADC) under their existing license and collaboration agreement. NBE and SOTIO will collaborate on the discovery, non-clinical development and manufacturing of this second undisclosed target (Press release, NBE Therapeutics, NOV 7, 2019, View Source [SID1234573380]). The development will be based on NBE’s proprietary antibody drug conjugate platform, including NBE’s site-specific SMAC-technologyTM conjugation and its new, highly potent anthracycline toxin platforms. SOTIO will take global responsibility for clinical development, registration and commercialization of the ADC products.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

NBE-Therapeutics’ new iADCTM platform creates highly potent and safe immune-stimulatory ADCs with an anthracycline payload, inducing a long-lasting immunological anti-tumor effect. It has shown unprecedented preclinical data in efficacy, as well as safety, in multiple pipeline programs. Its lead program NBE-002 against the ROR1 target has successfully passed the GLP tox study and is in the final stages of CMC. It is expected to begin its first
in-human study by mid-2020 for triple negative breast cancer and lung cancer, as well asother cancer indications.

NBE is eligible for the option exercise fee, as well as milestone payments and royalties based on global net product sales. In addition, NBE will be reimbursed for its R&D expenses incurred in connection with product development in collaboration with SOTIO.

Dr. Ulf Grawunder, CEO of NBE-Therapeutics commented: "We are very enthusiastic that SOTIO has nominated a second ADC program under the existing collaboration agreement between SOTIO and NBE, confirming the high quality of our ADC platform. We have now created a robust and scalable ADC platform that enables us to leverage iADC development in clinical studies for multiple programs. The collaboration with SOTIO over the past years has further strengthened our technology and we are very proud to have them on board for a second iADC development program."

"Based on the very encouraging data from our first collaboration target with NBE and the SO-N102 program, as well as the data of NBE’s proprietary program NBE-002, we have now exercised the second target option in the collaboration," mentions Dr. Radek Spisek, CEO of SOTIO. "NBE’s product platform addresses the key issues of today’s antibody-drug conjugates and has the potential to provide new and superior treatment options for cancer patients."