1stOncology™: Cancer Intelligence Service – Page 12739 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Exact Sciences Extends Leadership In Advanced Cancer Diagnostics With Acquisitions Of Paradigm And Viomics

On March 3, 2020 Exact Sciences Corp. reported the completion of its acquisitions of Paradigm Diagnostics, Inc. and Viomics, Inc., two privately held companies based in Phoenix (Press release, Exact Sciences, MAR 3, 2020, View Source [SID1234555160]). Together, Paradigm and Viomics provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery, extending Exact Sciences’ lab testing and research and development capabilities.

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 addition of these companies and their talented team members to Exact Sciences is another step forward in extending our leadership in advanced cancer diagnostics," said Kevin Conroy, chairman and CEO of Exact Sciences. "Viomics’ research capabilities and the Paradigm therapy selection test and scalable clinical lab, combined with the powerful Exact Sciences commercial platform, allow us to provide patients with smarter, faster answers throughout the cancer continuum."

Paradigm currently offers a comprehensive genomic profiling test for patients with advanced, refractory, or recurrent cancer, allowing physicians to better understand a patient’s tumor profile and more effectively recommend targeted therapies or clinical trials. Palmetto GBA, a Medicare Administrative Contractor that assesses molecular diagnostic technologies under its MolDx program, recently covered the test under its existing local coverage determination for Next-Generation Sequencing for Solid Tumors. Differentiated from other tests by a design that requires smaller sample requirements and delivers faster results, the test is critical in supporting treatment decisions and builds upon the successful foundation of the Exact Sciences’ Precision Oncology team.

Viomics provides extensive sequencing capabilities and expertise in identifying unique biomarkers that indicate the presence of cancer in solid tissue and blood. The expertise of their team brings additional resources to Exact Sciences’ world-class research and development team, and any future biomarker discoveries may be used in Exact Sciences’ pipeline cancer tests. Sequencing will play a pivotal role in bringing tissue and blood-based advanced cancer diagnostics to patients and physicians.

Paradigm and Viomics will remain based in Phoenix. Financial terms of the transactions are not being disclosed. XMS Capital Partners served as advisor to Exact Sciences on these transactions.

Targovax Announces Completed Enrollment in the ONCOS-102 Trial in Anti-PD1 Refractory Melanoma

On March 3, 2020 Targovax ASA (OSE: TRVX), a clinical stage biotechnology company developing immune activators to target hard-to-treat solid tumors, reported that it has completed patient enrollment in the phase I trial with ONCOS-102 in combination with Keytruda (pembrolizumab) in patients with advanced anti-PD1 checkpoint inhibitor (CPI) refractory melanoma (Press release, Targovax, MAR 3, 2020, View Source [SID1234555157]).

In this trial, ONCOS-102 immune activation is being tested in patients with advanced, unresectable melanoma who have had disease progression on treatment with anti-PD1 CPI. This is a particularly challenging patient population, with few treatment alternatives available. In July 2019, Targovax reported encouraging results from part 1 of the trial – see link to press release here.

Part 2 of this trial is testing an extended ONCOS-102 dosing regimen with up to twelve injections compared to three injections in part 1. The enrollment of 12 patients into part 2 of the trial has now been completed. The last patients will complete their six months treatment and data on a total of 21 patients are expected in the second half of 2020.

The primary and secondary endpoints of the trial are to assess safety, immune activation and clinical responses of ONCOS-102 and Keytruda combination treatment. The main scientific aim is to test the hypothesis that ONCOS-102 can immune activate anti-PD1 refractory patients to respond to re-challenge with an anti-PD1 CPI.

Magnus Jäderberg, CMO of Targovax, said: "We are very pleased to have completed enrollment of our melanoma trial. ONCOS-102 is currently one of the most clinically advanced oncolytic viruses in this difficult to treat cancer, and therefore a high priority for us. With this trial also being a proof of concept trial, clinical and immune data from this study will not just indicate whether ONCOS-102 in combination with CPIs can help patients with hard to treat melanoma but potentially also other tumor indications. Supportive data could open the path for a registrational trial."

Bracco Diagnostics Inc. Signs the Shared Goal of Reaching 80% Colorectal Cancer Screening

On March 3, 2020 Bracco Diagnostics Inc., the U.S. subsidiary of Bracco Imaging S.p.A., a leading global company in the diagnostic imaging business, reported its commitment to achieve a colorectal cancer screening rate for its employees of at least 80% (Press release, Bracco Diagnostics, MAR 3, 2020, View Source [SID1234555156]).

Colorectal cancer is a major public health problem. Colorectal cancer is the second leading cause of cancer death, and a cause of considerable suffering among more than 145,000 adults diagnosed with colorectal cancer each year. Colorectal cancer screening can reduce colorectal cancer death rates by both preventing the disease through the detection and removal of precancerous polyps and through detection at early more treatable stages.1

The National Colorectal Cancer Roundtable (NCCRT), established by the American Cancer Society (ACS) and the Centers for Disease Control and Prevention (CDC), has evolved their awareness campaign to increase Colorectal Cancer screening rates implementing the 80% in every community initiative in 2019.2

"Bracco Diagnostics Inc. is committed to the health and wellbeing of our employees, not only by taking the 80% screening rate pledge but also providing market leading products that are used in CT Colonography procedures. CT Colonography, also known as CTC or virtual colonoscopy, is a visual, patient-friendly colorectal screening test that can detect both precancerous and cancerous colorectal abnormalities," said Vittorio Puppo, President and CEO of Bracco Diagnostics Inc. "We have proudly supported for many years the great work of the NCCRT, other patient advocacy organizations and the American College of Radiology Colorectal Cancer Committee. At Bracco Diagnostics we are committed to the effort of eradicating colorectal cancer. Consequently, it is a logical step for Bracco Diagnostics to join the growing number of organizations in New Jersey and across the U.S. that make the 80% In Every Community pledge. I encourage other business leaders to join us in making this pledge for their organizations."

To find a location that performs CT Colonography procedures visit the American College of Radiology CT Colonography center locator at View Source

CNS Pharmaceuticals Announces Brain Cancer Patient from Berubicin Phase 1 Trial Remains Cancer Free

On March 3, 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 brain and central nervous system, reported as of February 2020, a patient from the Phase 1 clinical trial for the treatment of glioblastoma multiforme ("GBM"), conducted by Reata Pharmaceuticals, Inc., remains cancer free. GBM is an aggressive type of brain cancer and, currently, there are no effective therapies approved to treat this disease (Press release, CNS Pharmaceuticals, MAR 3, 2020, View Source [SID1234555155]).

In the Phase 1 trial, 44% of patients experienced a statistically significant improvement in progression-free survival. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response, which is defined by the National Cancer Institute as the disappearance of all signs of cancer in response to treatment. This initial trial was conducted in 2006 and as of February 2020, the patient has remained cancer free for over 13 years.

"We are delighted to provide this update on Berubicin’s potential capabilities given the unmet need for this aggressive disease," commented John M. Climaco, Chief Executive Officer of CNS Pharmaceuticals. "We are looking forward to initiating our Phase 2 clinical trial in the second half of this year with our partner, WPD Pharmaceuticals, Inc. In addition, we expect WPD Pharmaceuticals, Inc. to commence a first-ever Phase 1 trial in children later this year. As previously announced, the pediatric trial will be conducted at Children’s Memorial Health Institute, the largest pediatric hospital in Poland." WPD Pharmaceuticals, Inc. was founded by Dr. Waldemar Priebe, the founder of the Company.

About Berubicin
Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents. Anthracyclines are designed to utilize natural processes to induce deoxyribonucleic acid (DNA) damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation. Berubicin treatment of brain cancer patients appeared to demonstrate positive responses that include one durable complete response in a Phase 1 human clinical trial conducted by Reata Pharmaceuticals, Inc.

First Patient in Treatment for RhoVac’s Clinical Phase II Study in Finland

On March 3, 2020 RhoVac AB ("RhoVac") reported, on 3rd March 2020, that the first patient in Finland has started treatment in the company’s clinical phase IIb study in prostate cancer, a study entitled RhoVac-002 ("BRaVac") (Press release, RhoVac, MAR 3, 2020, View Source [SID1234555154]).

The first patient in Finland has now started treatment in the clinical study, called BRaVac. This clinical trial phase IIb-study is a randomized, placebo-controlled and double-blind study, with the primary objective of evaluating if treatment with the drug candidate RV001 can prevent or limit the development of advanced prostate cancer after curative treatment. The phase IIb study is an international, multicenter study, which will recruit over 175 patients in six European countries and the US. RhoVac has previously received approval to start phase IIb clinical trials in Denmark, Finland, Belgium, Germany and the US, and is awaiting final approval from the ethical committees in Sweden and the UK. The ambition is that all patients should be recruited by end of Q3 2020. The results report on active treatment part of the study is expected in H2 2021.