On August 3, 2020 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported the launch of NeXT Liquid Biopsy, a high-performance, exome-scale, tumor-profiling platform that utilizes blood samples from advanced-stage solid tumor cancer patients (Press release, Personalis, AUG 3, 2020, View Source [SID1234562723]). NeXT Liquid Biopsy, paired with Personalis’ leading ImmunoID NeXT tissue profiling platform, enables a more comprehensive immuno-genomics view of the tumor that can now be monitored over time from blood samples. NeXT Liquid Biopsy monitors over twenty times more genes than the majority of liquid biopsy cancer panels on the market today. These capabilities will help biopharmaceutical companies advance their understanding of tumor biology, including resistance mechanisms, to aid the development of next-generation cancer therapies.

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!

Personalis CEO, John West, said, "Solid tumor biopsies and liquid biopsies complement each other, and it is important to utilize both in cancer research. Solid tumor biopsies can yield information about mutations, gene expression, the tumor microenvironment, and immune cells that have infiltrated the tumor, while liquid biopsies can track mutations and detect new mutations over time in response to treatment. By combining NeXT Liquid Biopsy with ImmunoID NeXT, researchers now have a powerful tool to address tumor heterogeneity, longitudinally monitor clonal and subclonal dynamics, identify acquired resistance mechanisms, and access key areas of tumor biology not typically included in targeted liquid biopsy panels. We strongly believe this will provide a powerful framework for translational research, and the development of next-generation cancer therapeutics to overcome therapy resistance and cancer progression."

Mr. West added, "Through our collaborations program, we are encouraged by our partners’ response to NeXT Liquid Biopsy. NeXT Liquid Biopsy represents a new capability in the market and we look forward to working closely with our first customers. This is just the first step in Personalis’ liquid biopsy product portfolio and we are excited for further developments in this area."

NeXT Liquid Biopsy is immediately available for order.

On August 3, 2020 Tyme Technologies, Inc. (NASDAQ: TYME), an emerging biotechnology company developing cancer metabolism-based therapies (CMBTs) reported that the U.S. Food and Drug Administration (FDA) has granted the company Orphan Drug Designation for its lead pipeline candidate, SM-88 (racemetyrosine), as a potential treatment for patients with pancreatic cancer (Press release, TYME, AUG 3, 2020, View Source [SID1234562721]).

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 FDA’s Office of Orphan Drug Products grants orphan status to support development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States. Orphan Drug Designation provides certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees and tax credits for qualified clinical trials.

"Receiving Orphan Drug Designation for SM-88 is another important milestone to emerge from our innovative pipeline of cancer metabolism-based compounds," said Steve Hoffman, Chairman and Chief Executive Officer of TYME. "We are pleased with the progress we are making in the clinic and believe that SM-88, which is now in multiple late-stage clinical trials offers the potential to play a significant role in establishing a new treatment paradigm for more than 57,000 patients who are diagnosed with pancreatic cancer annually within the United States."

About SM-88

SM-88 is an oral investigational modified proprietary tyrosine derivative that is believed to interrupt the metabolic processes of cancer cells by breaking down the cells’ key defenses and leading to cell death through oxidative stress and exposure to the body’s natural immune system. Clinical trial data have shown that SM-88 has demonstrated encouraging tumor responses across 15 different cancers, including pancreatic, lung, breast, prostate and sarcoma cancers with minimal serious grade 3 or higher adverse events. SM-88 is an investigational therapy that is not approved for any indication in any disease. Learn more.

About TYME-88-Panc Pivotal Trial

The TYME-88-Panc pivotal trial applies the latest advances in the field of cancer metabolism by evaluating the efficacy and safety of an oral investigational compound that targets the metabolic mechanisms of the disease at its source. A prospective, open label pivotal trial in metastatic pancreatic cancer for patients who have failed two lines of any prior systemic therapy. The trial is designed to evaluate the safety and efficacy of SM-88 used with MPS (methoxsalen, phenytoin and sirolimus) in advanced pancreatic cancer and will measure multiple endpoints, including overall survival, progression free survival, relevant biomarkers, quality of life, safety, and overall response rate. Learn more.

On August 3, 2020 UroGen Pharma Ltd. (Nasdaq:URGN), a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases, reported that it will report second quarter 2020 financial results on Monday, August 10, 2020, prior to the open of the market (Press release, UroGen Pharma, AUG 3, 2020, View Source [SID1234562720]). The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

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!

Audio Webcast

The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately two weeks.

On August 3, 2020 Sirtex Medical US Holdings, Inc. ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported the launch of SIROS, an innovative system for the delivery of SIR-Spheres Y-90 resin microspheres (Press release, Sirtex Medical, AUG 3, 2020, View Source [SID1234562719]).

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!

SIROS offers a visual, intuitive and versatile option for interventional radiologists to deliver SIR-Spheres to patients with liver cancer. With the system’s visually controlled administration, physicians can determine and adjust the precise quantity and speed of SIR-Spheres microspheres delivery. Additionally, the system is designed to be simple to use yet versatile enough to allow expanded options for patient-tailored delivery.

SIROS’ intuitive design features a peel-and-place tubing set, a proprietary needleless D-Vial specifically designed to suspend SIR-Spheres into a vortex that may allow for a more even distribution, and a locking cover to safely secure the microspheres during delivery. A three-step setup further provides quick and simple administration and disposal.

"SIROS brings world-class expertise and innovation together to provide interventional radiologists with the support and technology they need to treat patients with liver cancer," said Kevin R. Smith, Chief Executive Officer of Sirtex. "As established leaders in the industry for more than 20 years, we are pleased to add SIROS to our expanding portfolio of technology designed to advance patient care."

On August 3, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that it will host a live conference call and webcast at 8:00am ET on Friday, August 7, 2020 to discuss second quarter 2020 financial results and business progress, as well as provide an introduction to the newest members of its management team (Press release, Scholar Rock, AUG 3, 2020, View Source [SID1234562717]). Participating on the call will be Tony Kingsley (President and CEO), Ted Myles (CFO and Head of Business Operations), and Yung Chyung (Chief Medical Officer).

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!

Conference Call and Webcast
To access the live conference call, please dial 833-519-1308 (domestic) or 914-800-3874 (international), and refer to conference ID 5627485. A webcast of the call will also be available on the Investors & Media section of the Scholar Rock website at View Source An archived replay of the webcast will be available on the Company’s website for approximately 90 days following the presentation.