On October 11, 2024 SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases reported that new clinical data on the efficacy of its Merlin test will be presented at the 21st International Congress of the Society for Melanoma Research (SMR) Annual Meeting 2024 in New Orleans (Press release, SkylineDx, OCT 11, 2024, View Source [SID1234647158]).

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The study, which assessed the clinical utility and performance of Merlin test in T1a melanoma patients, showed that it dramatically improves the ability to differentiate between low- and high-risk T1a patients. Merlin test identified 88% of patients as Low Risk, resulting in a post-test SLN positivity rate of only 1.5% among those classified as Merlin Low Risk. Conversely, 12% of patients were classified as High Risk, with a significantly higher SLN positivity rate of 15.8% among those identified as Merlin test High Risk. These findings highlight the test’s potential to reduce unnecessary SLNB surgeries, preventing overtreatment in the vast majority of patients while ensuring high-risk individuals receive appropriate care.

Alexander Meves, M.D., MBA, dermatologist at Mayo Clinic and principal inventor of the CP-GEP model, shared: "The intent is to help prevent undertreatment in seemingly low-risk early-stage melanoma patients who are actually at risk for nodal metastasis. By accurately identifying these at-risk individuals, we ensure that they receive the necessary interventions, even in the absence of traditional clinical risk factors."

For patients with at least one traditional adverse feature, such as age under 40, lymph vascular invasion, or a high mitotic rate, Merlin test identified 37 patients as Low Risk, all with a post-test SLN positivity rate of 0%. Additionally, among 104 patients without any adverse features, the Merlin test still identified 7 patients as High Risk, with a post-test SLN positivity rate of 14.3%. These results demonstrate that Merlin test effectively pinpoints high-risk individuals who might otherwise go untreated under traditional guidelines.

This latest data highlights the importance of Merlin test in transforming early-stage melanoma treatment. Merlin test provides clinicians with a robust, evidence-based tool to tailor SLNB surgery decisions, minimizing unnecessary surgeries while ensuring that high-risk patients receive appropriate care. With the ongoing advancements in genomic testing and personalized medicine, the Merlin test offers a new standard of care that has the potential to improve outcomes for countless melanoma patients.

About CP-GEP (Merlin test)

CP-GEP is a non-invasive prediction model for cutaneous melanoma patients that combines clinicopathologic (CP) variables with gene expression profiling (GEP). This model is able to stratify patients based on being high or low risk for metastasis and thereby categorize them in the appropriate surgical action categories listed in evidence-based cancer treatment, prevention and screening guidelines. The CP-GEP model was developed by Mayo Clinic and SkylineDx BV and it has been clinically validated in multiple studies. More information (including references) may be obtained at www.falconprogram.com and www.merlinmelanomatest.com. The test has been launched in the United States and Europe as Merlin test. SkylineDx collaborates with diagnostic service providers globally to bring this test to market and increase access. In the United States, Tempus is commercializing the Tempus Merlin test.
Quest Diagnostics launched their own LDT version of the CP-GEP model in the United States under the brand name MelaNodal Predict.

On October 11, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneLiquid CDx to be used as a companion diagnostic for Itovebi (inavolisib) in combination with palbociclib (Ibrance) and fulvestrant, a therapy developed by Genentech, a member of the Roche group, which has been contemporaneously approved for the treatment of adult patients with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, as detected by an FDA-approved test, following recurrence on or after completing adjuvant endocrine therapy (Press release, Foundation Medicine, OCT 11, 2024, View Source [SID1234647160]).

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Approximately 70% of all breast cancers are hormone-receptor positive, HER2-negative.1 PIK3CA is the most commonly mutated gene in hormone-receptor positive, HER2-negative breast cancer, with approximately 40% of patients harboring this mutation.2

"This approval reinforces the importance of testing for PIK3CA mutations at the time of diagnosis to help guide decision-making in the first-line setting for metastatic breast cancer patients," said Mia Levy, Ph.D., M.D., chief medical officer at Foundation Medicine. "Our high-quality liquid biopsy companion diagnostic relies on a routine blood draw to identify patients with PIK3CA mutations, enhancing broader access to genomic testing while allowing more patients to benefit from this new best-in-class first-line treatment regimen."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. From a routine blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With this approval, Foundation Medicine has seven companion diagnostic indications for breast cancer, the most of any comprehensive genomic profiling company.3 Foundation Medicine is the global leader in approved companion diagnostic indications with more than 60% of all approved U.S. companion diagnostic indications for next-generation sequencing (NGS) testing.

"Given the high prevalence of PIK3CA mutations in hormone receptor-positive, HER2-negative breast cancer, the introduction of a new targeted treatment regimen in the first-line setting will have a profound impact on this patient population," said Jean A. Sachs, MSS, MLSP, chief executive officer at Living Beyond Breast Cancer. "Biomarker testing plays an important role in helping patients and their families make personalized treatment decisions based on their individual cancer, and we’re encouraged to see Foundation Medicine continue to expand its approved companion diagnostic indications in breast cancer."

On October 10, 2024 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported that its first patient with recurrent lung cancer has been treated, in a clinical trial at Hadassah Medical Center in Jerusalem, Israel (Press release, Alpha Tau Medical, OCT 10, 2024, View Source [SID1234647132]).

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The trial is designed to treat up to ten patients with recurrent tumors in the mediastinum area of the chest, and allows for the use of concurrent chemotherapy, targeted therapy, or immunotherapy, if indicated. The study will assess the safety and feasibility of delivering Alpha DaRT sources into the lung using an endobronchial ultrasound (EBUS) procedure, including by observing the rate of successful source placement and any treatment-related adverse events. In addition, the study will also assess the efficacy of Alpha DaRT for this indication by examining tumor response at one and three months after source insertion using RECIST criteria, as well as tumor coverage. Additional information about the trial can be found at View Source

According to the WHO’s International Agency for Research on Cancer, lung cancer is the leading cause of cancer-related deaths worldwide, with almost 2.5 million new cases detected each year, and is often only diagnosed at advanced stages, when treatment options are limited. In the U.S., lung cancer is the third most common cancer, according to the Centers for Disease Control and Prevention, with an estimated 210,000 new cases per year.

"Alpha Tau continues to forge ahead with the application of Alpha DaRT to a broader set of indications, particularly in tumors in visceral organs and other complex cases," said Alpha Tau Chief Executive Officer Uzi Sofer. "As we see continued clinician excitement and demand for use of the Alpha DaRT in an ever-increasing set of cancers, the ability to start treating patients in as terrible and widespread an illness as lung cancer is particularly meaningful."

"The Institute of Pulmonology of Hadassah Medical Center is excited to utilize this groundbreaking EBUS-guided implantable alpha radiation technology to treat a patient with lung cancer for the first time," noted Prof. Neville Berkman, MD, the study principal investigator and Director of the Institute of Pulmonology and Head of Adults and Invasive Pulmonology Unit, Hadassah Medical Center, who treated the patient. "The treatment makes use of bronchoscopic endobronchial ultrasound to insert the Alpha DaRT sources. We look forward to further examining the promise of what the Alpha DaRT treatment can offer lung cancer patients and their families."

"Treating the first lung patient with the Alpha DaRT is a very exciting moment. We have already demonstrated the advantages of the Alpha DaRT technology in a number of other tumor types, but examining its application to an organ such the lung, given its proximity to vital healthy organs, may hopefully open new doors to a global population of patients with otherwise poor treatment options," commented Alpha Tau Chief Medical Officer Robert Den, MD.

"Treating the first patient with lung cancer using Alpha DaRT marks a significant advancement, introducing a novel approach that combines the precision of alpha-emitting particles with the ability to selectively target and destroy tumor cells while minimizing damage to surrounding healthy tissues," added Dr. Philip Blumenfeld, study co-investigator and Senior Radiation Oncologist and Head of Thoracic Radiation Oncology Services at Hadassah Medical Center. "In this specific case, the patient had already undergone conventional radiation therapy to the lung and lymph nodes, and additional radiation would have posed a high risk of serious harm to nearby structures, particularly the esophagus and bronchus."

About Alpha DaRT

Alpha DaRT (Diffusing Alpha-emitters Radiation Therapy) is designed to enable highly potent and conformal alpha-irradiation of solid tumors by intratumoral delivery of radium-224 impregnated sources. When the radium decays, its short-lived daughters are released from the sources and disperse while emitting high-energy alpha particles with the goal of destroying the tumor. Since the alpha-emitting atoms diffuse only a short distance, Alpha DaRT aims to mainly affect the tumor, and to spare the healthy tissue around it.

On October 10, 2024 Oncoinvent, a clinical stage, radiopharmaceutical company developing innovative treatments for solid cancers, reported that the first patient has been dosed in its Phase 2 study of Radspherin in patients with peritoneal carcinomatosis from ovarian cancer (Press release, Oncoinvent, OCT 10, 2024, View Source [SID1234647148]). Radspherin is a novel alpha-radiation therapy candidate designed for targeted, local treatment of cancers that have spread to body cavities. The Phase 2 trial is a randomized controlled study designed to assess progression-free survival (PFS) in primary advanced ovarian cancer patients treated with Radspherin following complete surgical resection and pre-operative chemotherapy.

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"We are pleased to announce the dosing of the first patient in our Phase 2 study of Radspherin in ovarian cancer patients, representing another pivotal achievement that underscores the potential of our clinical program," said Oystein Soug, Chief Executive Officer of Oncoinvent. "This milestone builds upon the highly encouraging data from our Phase 1/2a trials in ovarian and colorectal cancer patients, where Radspherin demonstrated promising safety and efficacy. This follows the FDA’s recently granted Fast Track designation, bringing us closer to demonstrating the therapeutic potential of Radspherin. We look forward to advancing this clinical study as part of our mission to improve outcomes for patients suffering from peritoneal carcinomatosis."

The Phase 2 trial (NCT06504147) is a randomized controlled study assessing the efficacy and safety of Radspherin in patients with peritoneal metastasis from ovarian cancer. The primary objective is to compare PFS between patients who receive Radspherin after complete surgical resection following pre-operative chemotherapy, and patients who only undergo pre-operative chemotherapy and surgery. The study is being conducted at six centers in the US, UK, Norway, Spain and Belgium. Positive Phase 1/2a data from the safety interim analysis demonstrated that Radspherin was well tolerated with no dose-limiting toxicity observed at the recommended dose of 7MBq.

On October 10, 2024 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage biopharmaceutical company focused on precision oncology through synthetic lethality, reported that four abstracts have been accepted for poster presentation at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics, to take place in Barcelona, Spain, October 23 – 25, 2024 (Press release, Aprea, OCT 10, 2024, View Source [SID1234647133]). Details on the posters are below.

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"We are very pleased to have these posters featured at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium, showcasing the ongoing progress in our oncology pipeline of DNA damage response (DDR) inhibitors," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "This symposium provides a great opportunity to share updates on our two clinical stage candidates, APR-1051 and ATRN-119, with the international oncology community."

Poster Details

Clinical:
Title: Safety and Preliminary Efficacy of APR-1051, a WEE1 Inhibitor, in a Phase 1 Study of Patients with Cancer-Associated Gene Alterations (ACESOT-1051)
Session date/ time: Wednesday, October 23rd, 12:00 – 19:00 CET
Location: Exhibition Hall
Poster #: 77

Title: ATRN-119, a Novel Macrocyclic ATR Inhibitor, in Patients with Advanced Solid Malignancies: A Phase 1/2a Trial (ABOYA-119)
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster#: 348

Preclinical
Title: The novel WEE1i, APR-1051, does not substantially off-target PLK1, PLK2, or PLK3 and exhibits favorable in vivo characteristics for treating CCNE1-overexpressing cancers
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster #: 335

Title: Development and testing of a first-in-class series of macrocyclic ATR inhibitors for cancer treatment
Session date/ time: Friday, October 25th, 09:00 – 15:00 CET
Location: Exhibition Hall
Poster #: 336

Copies of the posters will be available on the "Investor Resources" page of the Aprea corporate website at the conclusion of the meeting