iTeos Therapeutics to Present at William Blair Biotech Focus Conference 2021

On July 8, 2021 iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage biopharmaceutical company pioneering the discovery and development of a new generation of highly differentiated immuno-oncology therapeutics for patients, reported that Michel Detheux, PhD, President and Chief Executive Officer, will participate in a panel discussion at the upcoming William Blair Biotech Focus Conference 2021 titled: "Developing Therapies for the Next IO Targets" on Wednesday, July 14, 2021 at 2:10 p.m. ET (Press release, iTeos Therapeutics, JUL 8, 2021, View Source [SID1234584721]).

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A live webcast of the presentation will be available on the Investors section of the company’s website at View Source An archived replay will be available for approximately 30 days following the presentation.

Novocure to Report Second Quarter 2021 Financial Results

On July 8, 2021 Novocure (NASDAQ: NVCR) reported that it will report financial results for the second quarter 2021 on Thursday, July 29, 2021, before the U.S. financial markets open (Press release, NovoCure, JUL 8, 2021, View Source [SID1234584722]). Novocure’s management will host a conference call and webcast to discuss its financial results for the three and six months ended June 30, 2021, at 8 a.m. EDT on Thursday, July 29, 2021. Analysts and investors can participate in the conference call by dialing 855-442-6895 for domestic callers and 509-960-9037 for international callers, using the conference ID 1926805.

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The webcast, earnings slides presented during the webcast and the corporate presentation can be accessed live from the Investor Relations page of Novocure’s website, www.novocure.com/investor-relations, and will be available for at least 14 days following the call. Novocure has used, and intends to continue to use, its investor relations website as a means of disclosing material non-public information and for complying with its disclosure obligations under Regulation FD.

Can-Fite Gears Up to Initiate Pivotal Phase III Liver Cancer Study FDA Granted Namodenoson Orphan Drug and Fast Track Status

On July 8, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has completed preparatory work ahead of the anticipated initiation of patient enrollment for its pivotal Phase III registration trial of Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, JUL 8, 2021, View Source [SID1234584691]).

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Can-Fite has received agreement from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) on the protocol and plans to submit it for Institutional Review Board (IRB) approvals in the coming weeks. Namodenoson has Orphan Drug status with both the FDA and EMA, as well as Fast Track Status with the FDA for the treatment of HCC. A compassionate use program has been ongoing in Israel.

The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival. Other oncology trial efficacy outcomes such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

The Company plans to conduct an interim analysis by an Independent Data Monitoring Committee (IDMC) after 50% of enrolled patients are treated. Namodenoson will be evaluated as a 2nd or 3rd line treatment for CPB7 patients in whom other approved therapies have not been or are no longer effective.

"We are eager to commence this study, as there is a dire need for a safe and effective treatment for patients with advanced liver disease, defined as CPB7, where Namodenoson has an advantage with its liver protective effect," stated Can-Fite CEO Dr. Pnina Fishman.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson was evaluated in Phase II trials for two indications, as a second line treatment for hepatocellular carcinoma, and as a treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.

Xilis Raises $70 Million Series A Financing to Advance Diagnostic and Drug Discovery and Development Platform Leveraging Proprietary MicroOrganoSphere™ Technology

On July 8, 2021 Xilis, Inc., a pioneering company using its MicroOrganoSphere (MOS) technology to guide precision therapy for cancer patients and accelerate drug discovery and development, reported the close of a $70 million Series A financing (Press release, Xilis, JUL 8, 2021, View Source [SID1234584723]). The round was led by Mubadala Capital, joined by new investors including GV (formerly Google Ventures), LSP (one of Europe’s largest healthcare investment firms), Catalio Capital Management, and Duke Angel Network. Current investors Felicis Ventures, Two Sigma Ventures, Pear VC, KdT Ventures, and Alix Ventures also participated.

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Founded in 2019 by Dr. Xiling Shen, Dr. David Hsu, and Dr. Hans Clevers, Xilis is based on decades of biomedical, oncology, and stem cell research by its three co-founders. Dr. Clevers, a Breakthrough Prize winner, is the inventor and pioneer of the organoid technology. Dr. Shen and Dr. Hsu are accomplished engineering and medical professors at Duke University and experts in precision medicine. They have developed the scalable MOS technology to analyze patients’ own tumors in their native microenvironment – a breakthrough achievement.

"Our vision is to transform cancer care in diagnostics and reshape drug development by providing a technology for rapid therapeutic profiling," said Xiling Shen, PhD, Founder and Chief Executive Officer of Xilis. "The support provided by these world-class investors is an important milestone for our journey to transform cancer care and dramatically improve patient survival by enabling personalized precision oncology and bringing transformative medicines to patients faster and with higher success rates," added Dr. Shen.

Hans Clevers, MD, PhD, Scientific Co-Founder, venture partner at LSP and Principal Investigator at the Hubrecht Institute, Netherlands, stated, "Since my lab invented organoids a dozen years ago, we provided proof-of-concept for many applications, yet the technology remained slow, complex, and expensive. Together with LSP, I have been looking for enabling technology to unlock the full potential, and Dr. Shen and Dr. Hsu’s invention of the MOS technology has torn down those hurdles and will accelerate its use both in the clinic and for drug discovery and development."

Xilis’ MOS has been proven to have broad applications:

Leveraging MOS and AI-driven algorithms, Xilis is developing its Precision Oncology Platform to accurately predict therapeutic responses to help clinicians prioritize cancer treatment strategies for each patient. The entire process from patient biopsy to results takes less than two weeks, enabling extensive clinical application.
The MOS technology enables high-fidelity pharmaceutical drug discovery and development. Drug developers can use this versatile platform at multiple stages of R&D, including early discovery, preclinical toxicity and efficacy, bioanalytical testing, and clinical trials.
MOS is a revolutionary technology for immunotherapy development, which requires the patient’s immune microenvironment.
Proceeds from the Series A funding will further advance Xilis’ proprietary MOS technology, expand its AI-driven capabilities, fund clinical studies for diagnostic development, and validate the use of MOS technology with biopharma partners.

"There is a critical need for technologies that can help clinicians determine the most optimal therapy for their individual patients," Mubadala Capital’s Ayman AlAbdallah added. "Patients will benefit greatly from Xilis’ precision medicine assays by avoiding time spent on treatment cycles that are ineffective, and instead, receive therapies with the greatest potential of success quickly and efficiently. The Xilis Precision Oncology Platform is a cost-effective, outcomes-driven advancement that will help reduce the global burden of oncology costs."

"Genetic approaches to cancer diagnostics continue to be impactful, and Xilis is creating meaningful pathways for its Precision Oncology Platform to improve cancer care for a broader set of patients," said GV Managing Partner Krishna Yeshwant, MD, MBA. "Xilis brings together experts in the fields of organoid development and precision medicine, and I’m excited to work with this impressive team as they continue to develop a breakthrough approach."

Thermo Fisher Scientific Declares Quarterly Dividend

On July 8, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported that its Board of Directors has authorized a quarterly cash dividend of $0.26 per common share, payable on October 15, 2021, to shareholders of record as of September 15, 2021 (Press release, Thermo Fisher Scientific, JUL 8, 2021, View Source [SID1234584758]).

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