On July 21, 2021 Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays and services, reported that it has received a positive final Local Coverage Determination (LCD) that expands Medicare coverage for use of its Target Selector assay to identify the HER2 biomarker from circulating tumor cells (CTCs) (Press release, Biocept, JUL 21, 2021, View Source [SID1234585030]). This coverage determination from the Centers for Medicare & Medicaid Services (CMS) Molecular Diagnostics Program (MolDx) was effective July 4, 2021.

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!

About 20% of breast cancers are HER2-positive, with metastatic cancers more likely to be HER2-positive and approximately 20% of HER2-positive patients experiencing recurrence each year. Given the efficacy of various anti-HER2 therapies, testing for HER2 is one of the most important sources of information used by oncologists in making treatment decisions for patients with breast cancer. As a result, guidelines for breast cancer recommend that all patients with new primary or newly metastatic breast cancer be tested for HER2. Traditionally, testing has been performed using tissue. However, adequate tissue from the original biopsy may not be available, and additional invasive biopsy procedures are often impractical and associated with complications.

"Target Selector is a highly sensitive assay for identifying HER2 status that is less invasive, more time-efficient and more cost-effective than tissue biopsy," said Michael Dugan, M.D., Biocept’s Senior Vice President, Chief Medical Officer and Medical Director. "Metastatic tumors often show genetic changes that are associated with disease progression and frequently have features of HER2 gene amplification that are not present in the primary tumor. Target Selector’s ability to both detect and characterize the tumor cells provides critical information to help identify patients who may benefit from advanced targeted therapies, with the potential to significantly improve patient outcomes."

The MolDx program was developed by CMS to identify and establish coverage and reimbursement for molecular diagnostic tests. To receive a favorable MolDx coverage determination, assays must demonstrate clinical utility, fulfill the CMS reasonable and necessary criteria, and meet analytical and clinical validity standards. The LCD, which includes other cancer biomarkers in addition to HER2, is posted on the CMS website and can be accessed here.

"This coverage determination for our Target Selector assay is important for physicians and patients, as it expands access to a test that can provide the opportunity to find answers that may otherwise not be available from traditional approaches," said Michael Nall, President and CEO of Biocept. "We are very pleased with this achievement and are excited to be making significant progress on a number of fronts that address critical needs in oncology and support public health efforts."

Biocept’s combined cell-based and cell-free liquid biopsy tests assess actionable cancer biomarkers from a patient’s blood and, uniquely, from cerebrospinal fluid (CSF) as well. Following the full commercial launch of its CSF assay, CNSide, Biocept submitted an initial application for Breakthrough Device Designation to the U.S. Food and Drug Administration (FDA). While the initial submission was recently denied, the company continues to pursue Breakthrough Device Designation for CNSide and is gathering data based on the feedback provided by the FDA to further support its submission. The test is currently marketed as a Lab Developed Test (LDT) in Biocept’s CLIA certified and CAP accredited lab. CNSide is designed to improve the clinical management of patients with suspected metastatic cancer involving the central nervous system.

The company also continues to provide COVID-19 testing services to help manage the impact of COVID-19 in long-term care facilities, schools and other public facilities it serves. Biocept has received more than 450,000 samples for SARS-CoV-2 testing since launching this service in June 2020. The samples are processed using Biocept’s RT-PCR-based technology at its CLIA-certified, CAP-accredited, high-complexity molecular laboratory in San Diego.

On July 21, 2021 Functional precision oncology innovator KIYATEC reported that it is initiating use of the 3D Predict Glioma test outside of its 3D-PREDICT clinical study (Press release, KIYATEC, JUL 21, 2021, View Source [SID1234585029]). Recently published peer-reviewed data demonstrated successful use of this test for patients with either newly diagnosed or recurrent high-grade gliomas, which includes glioblastoma (GBM).

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!

In choosing July 21, 2021, to announce the expanded use of its test, KIYATEC joins the country in shining a light on glioblastoma, which is the most common, treatment-resistant, and deadliest type of brain cancer. A recent bipartisan U.S. Senate resolution declared today as Glioblastoma Awareness Day in order to highlight the severity of GBM, and show support for individuals who are currently living with GBM, as well as caregivers and families. Additionally, the resolution encourages continued investment into glioblastoma research and treatments.

"At the core of KIYATEC’s mission is the desire to improve cancer patients’ lives. We’re excited to take the next step in fulfilling this mission by expanding the use of our testing for patients with GBM, which is such an aggressive cancer with few treatment options," said Lillia Holmes, Chief Operations Officer at KIYATEC.

In a patient, the biological interaction between their live cancer cells and the administered therapy drives treatment outcomes. Measurement of this interaction, before prescribing a treatment plan, is not typically part of today’s cancer treatment paradigm. KIYATEC’s test results add this measurement into the information that informs oncologists’ treatment decisions for a given patient. This approach translated to patient benefit while demonstrating clinically relevant accuracy, as documented in the June Neuro-Oncology Advances publication.

The 3D Predict Glioma test is designed to work within the current framework of standard of care for high-grade glioma patients. Since live cells are required for the test, a patient’s oncologist must sync sample submission with the timing of the first surgery for newly diagnosed patients, or recurrent surgeries for relapsed patients. Oncologists interested in the potential use of the test to inform their decision-making, or requesting test kits to provide samples, should contact the company at [email protected].

"Our goal is to provide oncologists with a more effective decision-making tool, by combining individual patient’s cancer cells with potential treatment drugs," said Stephen Shuford, first author on the company’s recent Neuro-Oncology Advances publication.

The Senate resolution recognizes that:

The five-year survival rate for GBM patients is 7%,
The median length of survival is 8 months,
Approximately 13,000 Americans will be diagnosed with GBM in 2021,
Brain cancer has the highest per-patient initial cost of care, and
Despite being first described over a century ago, there are only four FDA approved drugs and one device for GBM.
KIYATEC aims to make a meaningful impact for patients who are facing this challenging cancer.

On July 21, 2021 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported it will release its second quarter 2021 financial results after the market closes on Wednesday, August 4, 2021 (Press release, Personalis, JUL 21, 2021, View Source [SID1234585028]). In conjunction with the release, the Company will host a conference call and webcast that day at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time to discuss its financial results and recent highlights.

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!

Interested parties may access the live call via telephone by dialing (866) 220-8061 for domestic callers or (470) 495-9168 for international callers, using conference ID: 8564509. The live webinar of the call may be accessed by visiting the Events section of the company’s website at investors.personalis.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On July 21, 2021 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported entering into its second clinical collaboration agreement with MSD (Merck & Co., Inc., Kenilworth, N.J. USA), to collaborate in the upcoming Phase 2 clinical trial of NOXXON’s NOX-A12 in combination with MSD’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), as second-line therapy in pancreatic cancer (Press release, NOXXON, JUL 21, 2021, View Source [SID1234585027]).

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!

This Phase 2 study will evaluate the safety and efficacy of NOX-A12, NOXXON’s anti-CXCL12 agent, in combination with KEYTRUDA and two different chemotherapy regimens in patients with microsatellite stable pancreatic cancer. The vast majority of pancreatic cancer patients have microsatellite stable tumors which are resistant to checkpoint inhibitor monotherapy. The study will enroll up to 70 patients and will contain an interim go/no-go in each arm in addition to usual safety and efficacy endpoints. MSD will provide pembrolizumab and expert advice for the study protocol, while NOXXON will sponsor the trial that will be conducted in clinical centers in the US and Europe.

The study will include two treatment arms to determine the most efficacious treatment combination to move forward into a registrational trial:

Arm 1: NOX-A12 + pembrolizumab + gemcitabine + nab-paclitaxel

Arm 2: NOX-A12 + pembrolizumab + nano-liposomal irinotecan + 5-fluorouracil + leucovorin

Dr. Jarl Ulf Jungnelius, Senior Medical Advisor at NOXXON, commented: "Checkpoint inhibitors have rapidly become first-line treatment options for many cancer types but have failed to demonstrate benefits in microsatellite stable pancreatic cancer as monotherapy or in combination with standard of care chemotherapy. We believe that tackling the microenvironment is a promising approach to deliver in pancreatic cancer the clinical benefits demonstrated by anti-PD-1 therapy in other tumor types."

Aram Mangasarian, CEO of NOXXON commented: "We are excited to continue our successful collaboration with MSD, a key global player in the immuno-oncology space. We expect this upcoming Phase 2 to confirm the excellent safety and more clearly define the clinical benefits that NOX-A12 can provide in combination with KEYTRUDA to patients suffering from highly aggressive cancers, such as pancreatic cancer."

About NOX-A12

NOXXON’s lead compound NOX-A12 is a highly selective inhibitor of CXCL12, a critical tumor microenvironment chemokine that shields the tumor from the immune system and promotes vasculogenesis, significantly reducing cancer treatment efficacy and promoting tumor growth. NOX-A12 acts by two potential mechanisms of action:

Reducing the CXCL12 shield around the tumor, leading to an improved access of immune effector cells like T lymphocytes to the tumor;
Blocking tumor blood vessel rebuilding by vasculogenesis post radiotherapy.
NOX-A12 is currently developed in second-line pancreatic cancer in combination with Keytruda and in glioblastoma in combination with radiotherapy.

About KEYTRUDA

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA

On July 21, 2021 Eureka Therapeutics, Inc., a clinical-stage biotechnology company developing novel T cell therapies to treat solid tumors, reported the initiation of a Phase I/II clinical trial of ECT204, a GPC3 targeting ARTEMIS T-cell therapy for the treatment of hepatocellular carcinoma (HCC), the predominant type of liver cancer. The Phase I portion of the ARYA-3 study is now open for enrollment (Press release, Eureka Therapeutics, JUL 21, 2021, View Source [SID1234585026]).

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!

Glypican 3 (GPC3) is a promising target for HCC therapies and is found in more than 70% of HCC cells. The GPC3 protein is also expressed in other solid tumors including ovarian and lung cancer. During the ECT204 ARYA-3 investigational study, a patient’s T cells will be collected, engineered to express Eureka’s proprietary ARTEMIS cell receptors targeting GPC3, and infused back into the patient’s body to target and kill GPC3-expressing cancer cells.

The ARYA-3 trial is being run in parallel with Eureka’s ongoing ET140203 ARYA-1 trial. With ET140203, the ARTEMIS receptor targets an alpha fetoprotein (AFP)-peptide/HLA-A2 complex found on liver cancer cells using a TCR-mimic antibody. With ECT204, since the antibody directly recognizes GPC3 and does not require the patient to be HLA-A2 positive, the therapy is potentially available to a larger liver cancer patient population.

"We look forward to working with City of Hope on our ARYA-1 and ARYA-3 clinical trials," said Dr. Cheng Liu, President and CEO of Eureka Therapeutics. "ECT204 and ET140203 ARTEMIS T cells were engineered with our proprietary tumor infiltration and controlled cytokine release technologies that we believe can improve on the performance of engineered T cell therapies in solid tumors. Effective treatment for HCC is a highly unmet medical need, and we are committed to bringing our therapies to patients faster."

"We are excited to provide City of Hope patients with both GPC3 and AFP targeted therapy options to treat HCC," said Dr. Daneng Li, Program Lead of the Hepatobiliary Tumor Program and principal investigator of the trial at City of Hope, a comprehensive cancer center near Los Angeles. "Engineered T-cell therapy is a novel approach, and it has the potential to transform how solid tumors will be treated in the future."

The ARYA-3 study is an open-label, dose escalation, multi-center, Phase I/II clinical trial of ECT204 ARTEMIS T cell therapy to initially assess the safety and determine the recommended phase II dose (RP2D) in adult patients with advanced GPC3-positive HCC. Additional information about Eureka’s Phase I/II study may be found at ClinicalTrials.gov, using Identifier NCT: NCT04864054.

Patients, caregivers, and healthcare professionals interested in Eureka’s clinical trials and technology can find more information by visiting eurekaconnectme.com.

Liver cancer is the fourth leading cause of cancer death worldwide, accounting for an estimated 782,000 deaths in 2018. About 43,000 new cases, and 30,000 deaths from liver cancer are expected to occur in the U.S. in 2020. The rate of liver cancer diagnosis has more than tripled since 1980, according to the American Cancer Society. Patients with advanced HCC have a poor prognosis and limited treatment options.