On June 22, 2022 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported the launch of a research test, codeveloped with Merck (known as MSD outside the United States and Canada) (Press release, Illumina, JUN 22, 2022, https://www.prnewswire.com/news-releases/illumina-launches-research-test-codeveloped-with-merck-to-unlock-deeper-insights-into-the-tumor-genome-301571457.html [SID1234616196]). The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology. The test adds assessment of a new genomic signature to the distributed, market leading TruSight Oncology 500 assay. It will be available globally, excluding the United States and Japan and will enable researchers to unlock deeper insights about the tumor genome by identifying genetic mutations used in the evaluation of homologous recombination deficiency (HRD).

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Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
Illumina, Inc. reported the launch of a research test, codeveloped with Merck. The research test builds upon Illumina’s commitment to broadly enable comprehensive genomic profiling and enhance research critical to realizing precision medicine in oncology.
"HRD status has emerged as an important biomarker in tumors that harbor high levels of DNA damage, such as ovarian, breast, prostate, and pancreatic cancers," said Phil Febbo, MD, chief medical officer at Illumina. "With one sample and one test, TruSight Oncology 500 HRD assay provides labs with comprehensive, accurate, sensitive results that can greatly enhance our understanding of the genomic nature of a tumor."

The Research Use Only TruSight Oncology 500 HRD test is a next-generation sequencing (NGS)–based assay that harnesses the power of Illumina NGS technology and validated HRD technology from Myriad Genetics (NASDAQ: MYGN), enabling labs to accurately detect genomic instability and analyze more than 500 genes simultaneously, including those relevant to HRD status. HRD is a genomic signature used to describe when cells are unable to effectively repair double-stranded DNA breaks. When this occurs, cells rely on alternative, error-prone DNA repair mechanisms, which may lead to genomic instability and, eventually, tumor formation.

The Molecular Pathology Diagnostic Unit at the Technical University of Munich participated in the TSO 500 HRD early access program in order to compare the results of Illumina’s prototype TSO 500 HRD assay to a validated reference standard, from Myriad Genetics.

"Our institution is delighted by the release of TruSight Oncology 500 HRD and we are very happy with our results from the early access program," said Nicole Pfarr, head of the Molecular Pathology Diagnostic Unit, Technische Universität München. "We look forward to using this assay routinely in our lab for future projects. Combining HRD assessment with TruSight Oncology 500 in one workflow will unlock the most comprehensive view of the tumor genome, while maintaining efficiency in the lab."

Large-cohort studies show that comprehensive genomic profiling (CGP) has the potential to identify relevant genetic alterations in up to 90% of samples. A single, comprehensive assay to assess a wide range of biomarkers uses less sample and returns results more quickly compared to multiple, iterative tests. As a kitted, distributable solution, this test helps to remove barriers for internalization of CGP and HRD testing, so that labs of all sizes can offer this powerful test.

"We are pleased to reach this first milestone with Illumina to commercialize an assay for HRD assessment that will aid in advancing clinical research and broaden access to clinical trials," said Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories.

The research test is expected to begin shipping globally (excluding the US and Japan) in August. In addition, as part of the partnership announced in September 2021, work is ongoing to develop a new HRD companion diagnostic (CDx) test for the EU and the UK to aid in the identification of ovarian cancer patients with positive HRD status.

This partnership expands on Illumina’s broad portfolio of oncology partnerships with industry leaders, with the united goal of advancing cancer diagnostics and precision medicine.

About TruSight Oncology 500
TSO 500 is a Research Use Only pan-cancer assay that enables Comprehensive Genomic Profiling. Designed to identify known and emerging tumor biomarkers across 523 genes, TSO 500 utilizes both DNA and RNA from tumor samples to identify key variants critical for cancer development and progression, such as small DNA variants, fusions, and splice variants. In addition, the assay assesses key immune-oncology biomarkers, such as Tumor Mutational Burden (TMB), Microsatellite Instability (MSI) and Homologous Recombination Deficiency (HRD). Due to its comprehensive biomarker content, labs can consolidate multiple single-gene or small-panel workflows into a single assay, saving biopsy specimen and time. Click here to learn more.

On June 22, 2022 Race Oncology Limited ("Race") reported to share further interim results from its preclinical melanoma research program (ASX announcement: 19 March 2021) (Press release, Race Oncology, JUN 22, 2022, View Source [SID1234616228]). The program’s objective was to explore the use of Zantrene (bisantrene dihydrochloride) in novel drug combinations for the treatment of drug and immunotherapy resistant melanomas using cell and animal models.

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Used at low concentrations, Zantrene was found to enhance cancer immunotherapy in three distinct and complementary ways: (1) direct killing of melanoma cells; (2) activation of immune cells targeting the tumour, and (3) reducing the expression of immune evasion genes in the tumour.

On June 22, 2022 Biomea Fusion, Inc. ("Biomea") (Nasdaq: BMEA), reported that the first patient has been dosed in the MM cohort of COVALENT-101, the company’s Phase I clinical trial evaluating BMF-219, Biomea’s covalent menin inhibitor, in patients with R/R AML, ALL, DLBCL, and MM (Press release, Biomea Fusion, JUN 22, 2022, View Source [SID1234616163]).

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"From the very beginning of our journey, we have been exploring and validating the broad potential of covalently inhibiting the scaffold protein, menin, in a host of liquid and solid tumors. Menin’s broad role in a variety of tumor types is rather striking. Based on the outstanding translational work of our team, we have seen compelling preclinical activity using BMF-219 in MM subtypes, especially those that are driven by MYC, a protein essential to the growth of numerous tumor types," said Steve Morris, MD, Chief Medical Officer of Biomea Fusion.

"Today, we have taken the first step to explore the clinical potential of BMF-219, a single-agent covalent menin inhibitor, in treating relapsed / refractory multiple myeloma patients. This represents the second cancer type, as well as the first cancer type outside of AML, to be studied with BMF-219. We are committed to delivering innovative medicine to patients in need, including those with R/R MM. I am incredibly proud of our team for their dedication as they continue to explore the boundaries of where science is leading us. Our mission is fundamentally driven by the wish to help cure patients of their disease. I would like to thank the entire Biomea team, including our participating clinical sites and wonderful collaborators, for their work quality and brilliance in achieving this very important milestone," said Thomas Butler, CEO, Chairman of the Board and Co-Founder of Biomea.

About COVALENT-101

A Phase I, open-label, multi-center, dose escalation and dose expansion study designed to assess the safety, tolerability, and pharmacokinetics / pharmacodynamics of once daily oral dosing of BMF-219 in patients with r/r acute leukemias —including subpopulations where menin inhibition is expected to provide a therapeutic benefit (e.g., patients with MLL1/KMT2A gene rearrangements or NPM1 mutations). The study has been expanded to include cohorts for patients with R/R multiple myeloma and R/R diffuse large B-cell lymphoma. Additional information about the Phase I clinical trial of BMF-219 can be found at ClinicalTrials.gov using the identifier NCT05153330.

About Multiple Myeloma (MM)

MM is a cancer of plasma cells, which make antibodies (immunoglobulins) and are mainly located in the bone marrow. As cancerous cells proliferate and migrate from the bone marrow, organ damage occurs due to excess immunoglobulins in bones and blood and the general weakening of bones. Approximately 35,000 people in the U.S. are diagnosed with MM each year and the 5-year relative survival rate is ~56% (Source: NCI SEER Data). The need is greatest among patients with relapsed or refractory disease, with overall survival as low as 6 months in some patients. Additionally, it is estimated that more than 60% of MM patients have menin dependent genetic drivers (MYC addicted or driven) and that these drivers are more common in the relapsed or refractory setting.

On June 22, 2022 The Menarini Group ("Menarini") and Radius Health, Inc. ("Radius") (NASDAQ: RDUS) (collectively, the "Companies") reported that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer (Press release, Radius, JUN 22, 2022, View Source [SID1234616179]).

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As part of the submission, the Companies have requested Priority Review with the FDA. If Priority Review is granted, the Companies anticipate that the FDA would conduct an 8-month review, incorporating a 6-month priority designation review.

The NDA submission is based on positive phase 3 data from the EMERALD study that was previously announced on October 20, 2021. EMERALD met both of its primary endpoints, which were progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup as compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.

Elacestrant is the first and currently only investigational oral SERD to show positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women, and men. Notably, these results showed elacestrant is also active in patients whose tumors harbor an ESR1 mutation, one of the key resistance mechanisms that develops in later treatment lines of metastatic breast cancer.

Following the completion of EMERALD, data from the study was presented at the San Antonio Breast Cancer Symposium (SABCS) on December 8, 2021, published in the Journal of Clinical Oncology (JCO) on May 18, 2022, and further subset analyses were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on June 6, 2022.

Elcin Barker Ergun, the Chief Executive Officer of Menarini, commented, "We are excited about the potential for elacestrant to be approved for treatment of patients with advanced or metastatic ER+/HER2- breast cancer, which constitutes about 70% of breast cancer and remains an area of significant unmet medical need." Barker Ergun continued, "Elacestrant has shown statistically significant efficacy over current standard of care medications both for overall population and in patients whose tumors harbor an ESR1 mutation, one of the most difficult to treat mechanisms of acquired resistance that develops in the later stages of metastatic/advanced breast cancer."

Chhaya Shah, SVP of Clinical and Regulatory at Radius, commented, "We enrolled and completed the EMERALD trial in a high-quality manner, delivered positive topline results, and prepared the submission of the NDA to the FDA. The submission is a significant milestone for both companies, and we appreciate the strong, collaborative effort of many hard-working employees at Radius and Menarini, investigators, patients, and their families. Together we look forward to advancing elacestrant and providing the opportunity to benefit patients."

Nassir Habboubi, Global Head of Pharma R&D of Menarini Group, added, "The Menarini and Radius teams have done an excellent job working together since our partnership began in July of 2020." Habboubi continued, "We plan to test elacestrant in earlier treatment lines, combination trials, and metastatic breast cancer that has metastasized to the brain. These details are to be communicated by us throughout 2H 2022 and 1H 2023."

With the submission of the NDA, based on the original agreement of the Companies, Menarini takes over activities and will be responsible for registration and commercialization. Menarini plans to use its fully owned subsidiary in the U.S., Stemline Therapeutics, to commercialize elacestrant if approved by the FDA.

About Elacestrant (RAD1901) and EMERALD Phase 3 Study

Elacestrant is an investigational selective estrogen receptor degrader (SERD), out-licensed to Menarini Group, which is being evaluated for potential use as a once daily oral treatment in patients with ER+/ HER2- advanced breast cancer. In 2018, elacestrant received fast track designation from the FDA. Preclinical studies completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who have received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator’s choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR).

On June 22, 2022 Plus Therapeutics, Inc. (Nasdaq: PSTV), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, and Biocept, Inc. (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported a multi-year agreement to employ Biocept’s cerebrospinal fluid (CSF) assay CNSide1 in Plus Therapeutics’ ReSPECT-LM Phase 1/2a dose-escalation clinical trial of Rhenium-186 NanoLiposome (186RNL) for the treatment of patients with leptomeningeal metastases (LM), which is cancer in the membranes that surround the brain and spinal cord (Press release, Cytori Therapeutics, JUN 22, 2022, View Source [SID1234616164]).

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CNSide is an assay based on Biocept’s proprietary quantitative tumor cell capture method paired with advanced digital imaging and molecular markers used to detect, characterize and quantify tumor cells in CSF of patients with a variety of solid organ carcinomas and suspected LM, particularly breast and lung cancer which are leading causes of LM. CNSide provides a robust quantitative method to evaluate tumor status and response to treatment compared to conventional CSF cytology or radiologic monitoring.

"LM and the therapeutic response to 186RNL can theoretically be assessed through periodic sampling of tumor cells in the CSF," said Norman LaFrance, M.D., Chief Medical Officer and SVP of Plus Therapeutics. "Every LM patient in the ReSPECT-LM trial will have permanent access to the CSF via an intraventricular catheter placed in the cerebral ventricles before treatment, permitting medical staff to draw CSF as easily as blood. The CNSide technology is the most sophisticated and powerful technology available for monitoring tumor status and therapeutic response and can be seamlessly implemented into the ReSPECT-LM trial for the potential benefit of patients with LM."

"We see a significant opportunity for Plus Therapeutics to use our CNSide assay to monitor tumor burden in the CSF and response to treatment, and to profile specific cellular biomarkers which may inform their cancer radiotherapeutic drug development activities," said Michael Dugan, M.D., Biocept’s Chief Medical Officer and Medical Director. "CNSide has the potential to improve our understanding of therapy response in patients with LM treated with novel therapeutic approaches. This represents an area of very high unmet need in the care of cancer patients with certain forms of brain metastasis that are life-threatening."