Melanoma, Cutaneous Malignant

ROTTERDAM, Netherlands and SAN DIEGO, April 5, 2024 /PRNewswire/ -- SkylineDx is pleased to announce two forthcoming scientific publications at the European Association for Dermato-Oncology congress, April 4-6, 2024. These publications show Merlin test's (CP-GEP model) ability to identify early-stage cutaneous melanoma patients at high risk for relapse. The first is a study led by researchers from Denmark, Weitemeyer, et al, that examined over 400 patients who underwent a sentinel lymph node biopsy (SLNB) between 2010 and 20151. All the biopsies were defined as negative for metastasis. The CP-GEP model was applied on the prospectively collected, archived tumor specimens and its outcome correlated with the patients' clinical data for 5 years following diagnosis (for both recurrence free survival and overall survival). The findings indicate that the model effectively stratifies node-negative patients in two groups: patients at low – and high risk for disease progression. In the high-risk group, 17.2% experienced a recurrence of the disease in the 5-year following diagnosis compared to 8% in the low-risk group. While a nodal assessment by means of the SLNB surgery remains the gold standard for clinical staging of cutaneous melanoma, not all eligible patients might undergo this invasive procedure. Node biopsies in the head and neck location may be challenging due to the regional course of nerves and lymphatic drainage2. The second study, led by Dr. Amaral from University of Tuebingen, Germany, assessed the performance of the CP-GEP model in a group of patients that did not undergo the SLNB procedure. More specifically, she focusses on a subgroup of melanoma patients with a primary tumor in the head and neck region. CP-GEP showed to be able to identify patients with a high risk for recurrence in this independent dataset. The authors concluded that the model demonstrates potential to risk stratify patients with early-stage melanoma3. "Both studies provide promising insights into CP-GEP's capacity to stratify patients based on their risk for disease progression and its potential value to support treatment and surveillance strategies for early melanomas." says Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx . About CP-GEP 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 identify cutaneous melanoma patients at low-risk for nodal metastasis who may forgo the sentinel lymph node biopsy (SLNB) procedure. 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 . 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 the access. In the United States, Tempus is commercializing 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™. About SkylineDx SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient's response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit . Footnotes: M. B.-M. Weitemeyer et al. Using a clinicopathologic and gene expression model to predict prognosis in stage I-II primary cutaneous melanoma: a multicenter Danish cohort study. Weitemeyer EADO 2024.pdf (falconprogram.com) Hieken et al. Head & neck primary cutaneous melanoma patients stratified by CP-GEP (Merlin Assay): risk of nodal metastasis and long-term survival outcome. SSO 2024. Abstracts SSO2024 Hieken.pdf (falconprogram.com). Amaral et al. Identification of patients at high risk for relapse by Merlin Assay (CP-GEP) in an independent cohort of melanoma patients (pts) that did not undergo sentinel lymph node biopsy: a H&N subgroup analysis. EADO 2024. Amaral EADO 2024.pdf (falconprogram.com) SOURCE SkylineDx

If choosing to use a molecular test to rule-out a sentinel lymph node biopsy (SLNB) in patients diagnosed with melanoma, it is important to show that patients foregoing an SLNB have low risk outcomes; Castle’s poster on DecisionDx-Melanoma shows that patients foregoing an SLNB due to a DecisionDx-Melanoma test result have low risk outcomes A second poster on DecisionDx-Melanoma shows that using the test’s results to guide clinical decision-making for patients with melanoma could result in 30% cost savings compared to care guided by American Joint Committee on Cancer (AJCC) stage alone A third poster on DecisionDx-SCC highlights the superior performance of the test compared to a nomogram based on clinical and pathological factors and the ability of the test to predict metastases in 70% of all patients included the study FRIENDSWOOD, Texas--(BUSINESS WIRE)-- Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, will share new data at the 20th European Association of Dermato-Oncology (EADO) Congress, being held April 4-6, 2024, in Paris, France, that demonstrate the ability of its DecisionDx-Melanoma and DecisionDx-SCC tests to improve clinical-decision making through precise risk-stratification of patients with cutaneous melanoma (CM) and squamous cell carcinoma (SCC). “Our DecisionDx-Melanoma test informs two questions: which patients can consider foregoing an SLNB, and what is the risk of recurrence so the most appropriate follow-up treatment plan can be implemented,” said Robert Cook, Ph.D., senior vice president of research and development at Castle Biosciences. “It is of high importance that when a test identifies patients with a low likelihood of a positive SLNB, and thus they could forgo this surgical procedure, the patients also have a low risk of metastatic outcomes. The data from our prospective, multicenter study show just that – SLNB-eligible patients who had a DecisionDx-Melanoma Class 1A (lowest risk) test result and made the decision with their physician to forego an SLNB had excellent outcomes during the follow-up period. We believe it is this kind of evidence that should be required in order for clinicians to safely adopt a molecular test that rules out an SLNB surgical procedure. “Our second DecisionDx-Melanoma poster shows that the clinical use of our test is also associated with a 30% cost savings improvement … a win-win situation.” Castle will present the following posters at EADO: DecisionDx-Melanoma Title: Patients who forego sentinel lymph node biopsy after 31-GEP testing are not harmed: A prospective, multicenter analysis Abstract: A-262 Summary: This study shares data from Castle’s prospective, multicenter study of patients with T1-T2 CM tumors who were being considered for an SLNB. Within a median follow-up time of two years, none of the patients with low-risk DecisionDx-Melanoma test results (Class 1A) who decided to forego SNLB based on their results had a tumor recurrence. These study data support use of the DecisionDx-Melanoma test to inform SLNB decisions and show that it can identify patients at low risk of sentinel lymph node (SLN) positivity who may safely forego the SLNB procedure, reducing healthcare costs and procedure complications. Title: The health economic impact of the 31-gene expression pro for treatment and surveillance management plans in patients with cutaneous melanoma Abstract: A-223 Summary: The DecisionDx-Melanoma test has been validated to predict individual risk of SLNB positivity and five-year risk of recurrence and metastasis for patients with CM. This study explored the cost-savings impact of using the DecisionDx-Melanoma test to guide risk-aligned clinical decision-making versus using the current melanoma staging standard, a patient’s AJCC stage. Costs of National Comprehensive Cancer Network (NCCN) guideline-recommended practices for patients with melanoma that were evaluated in the study included: SLNB, clinical visit schedules, imaging surveillance and adjuvant treatment for eligible patients. The study determined that using DecisionDx-Melanoma test results to guide decision-making could save commercial payers more than $3 million (30% cost savings per one million plan members over five years) compared to care guided by AJCC stage, with 95% of such potential cost savings occurring during the first year post-diagnosis (year one projected savings of approximately $2.5 million). DecisionDx-SCC Title: Evaluating the performance of a clinicopathological prognostic nomogram and utility of the 40-gene expression profile (40-GEP) test in refining risk of metastasis in high-risk cutaneous squamous cell carcinoma (HR-cSCC) patients Abstract: A-128 Summary: The DecisionDx-SCC test uses a patient’s tumor biology to independently predict risk of regional or distant metastasis in patients with high-risk SCC. The test has also been shown to improve the accuracy of risk predictions when used with other risk assessment approaches, including NCCN guidelines. This study evaluated the performance of a risk-stratification nomogram developed in Europe (Rentroia-Pacheco, et al, 2023) in a U.S. cohort of high-risk SCC patients (n=760) and the additional prognostic value provided by the DecisionDx-SCC test. In the study, the nomogram misclassified nine out of 10 tumors that metastasized as low risk. When the same tumors were tested using DecisionDx-SCC, 42% of those that the nomogram classified as low risk of metastasis were classified as high risk by the test, as well as 70% of all tumors that metastasized. These data demonstrate that DecisionDx-SCC improves the accuracy of risk assessment based solely on clinicopathological risk factors, leading to more appropriate risk-aligned management plans for patients with high-risk SCC. Castle’s abstracts can be found in the digital Book of Abstracts available for download on the EADO website. About DecisionDx®-Melanoma DecisionDx-Melanoma is a gene expression pro stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of SLN positivity and a patient's personal risk of melanoma recurrence and/or metastasis. By integrating tumor biology with clinical and pathologic factors using a validated proprietary algorithm, DecisionDx-Melanoma is designed to provide a comprehensive and clinically actionable result to guide risk-aligned patient care. DecisionDx-Melanoma has been shown to be associated with improved patient survival and has been studied in more than 10,000 patient samples. DecisionDx-Melanoma’s clinical value is supported by 50 peer-reviewed and published studies, providing confidence in disease management plans that incorporate the test’s results. Through Dec. 31, 2023, DecisionDx-Melanoma has been ordered more than 150,000 times for patients diagnosed with cutaneous melanoma. About DecisionDx®-SCC DecisionDx-SCC is a 40-gene expression pro that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), Class 2A (higher) or Class 2B (highest) risk category, predicts individual metastatic risk to inform risk-appropriate management. Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management. About Castle Biosciences Castle Biosciences (Nasdaq: CSTL) is a leading diagnostics company improving health through innovative tests that guide patient care. The Company aims to transform disease management by keeping people first: patients, clinicians, employees and investors. Castle’s current portfolio consists of tests for skin cancers, Barrett’s esophagus, mental health conditions and uveal melanoma. Additionally, the Company has active research and development programs for tests in other diseases with high clinical need, including its test in development to help guide systemic therapy selection for patients with moderate-to-severe atopic dermatitis, psoriasis and related conditions. To learn more, please visit and connect with us on LinkedIn, Facebook, X and Instagram. DecisionDx-Melanoma, DecisionDx-CMSeq, DecisionDx-SCC, MyPath Melanoma, DiffDx-Melanoma, TissueCypher, IDgenetix, DecisionDx-UM, DecisionDx-PRAME and DecisionDx-UMSeq are trademarks of Castle Biosciences, Inc. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. These forward-looking statements include, but are not limited to, statements concerning: the ability of DecisionDx-Melanoma test results to (i) result in 30% cost savings compared to care guided by AJCC stage, (ii) inform SLNB decisions and identify patients at low risk of SLN positivity who may safely forego the SLNB procedure and (iii) reduce healthcare costs and procedure complications; the ability of DecisionDx-SCC to (i) predict metastases, (ii) improve the accuracy of risk predictions when used with other risk assessment approaches, including NCCN guidelines and (iii) improve the accuracy of risk assessment based solely on clinicopathological risk factors. The words “believe,” “can,” “could,” “potential” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. These forward-looking statements involve risks and uncertainties that could cause our actual results to differ materially from those in the forward-looking statements, including, without limitation: subsequent study or trial results and findings may contradict earlier study or trial results and findings or may not support the results obtained in these studies, including with respect to the discussion of our tests in this press release; actual application of our tests may not provide the aforementioned benefits to patients; and the risks set forth under the heading “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, and in our other filings with the SEC. The forward-looking statements are applicable only as of the date on which they are made, and we do not assume any obligation to update any forward-looking statements, except as may be required by law. View source version on businesswire.com: Contacts Investor Contact: Camilla Zuckero czuckero@castlebiosciences.com Source: Castle Biosciences Inc. View this news release online at:

European Patent 3,823,617 Issued on March 6, 2024 HADDONFIELD N.J., April 2, 2024 /PRNewswire/ -- Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics, today announced that on March 6, 2024, the European Patent Office (EPO) issued EP patent 3,823,617 ('617 patent) covering the pharmaceutical composition of matter for the company's lead compound, LNS8801. Linnaeus's patent disclosure is directed toward the pharmaceutical composition of matter of LNS8801 and embodies (1) an enantiomerically purified compound SRR G-1, or a derivative thereof, including specific crystal forms, salts, and co-crystals, that modulates G protein-coupled estrogen receptor activity; (2) pharmaceutical and cosmetic compositions comprising an enantiomerically purified SRR G-1, or a derivative thereof; and (3) methods of treating or preventing disease states and conditions and cosmetic conditions mediated through these receptors and related methods thereof in humans and animals. "We are extremely pleased that the EPO has issued this composition of matter patent," commented Patrick Mooney, MD, CEO of Linnaeus. "We are thrilled to have these issued claims in both the US and Europe, and we believe that they will provide critical market protection for LNS8801 into the 2040s. As we continue to collect very promising data from our clinical trials with LNS8001, we will continue to prosecute the claims in this patent worldwide." Linnaeus is currently conducting an open-label phase 1/2 study assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy in patients with advanced cancer, including cutaneous melanoma. Based on promising data from the phase 1/2 study, Linnaeus plans to initiate a potentially pivotal, randomized controlled trial in patients with metastatic cutaneous melanoma who have had confirmed progression on immune checkpoint inhibitors. The study will enroll 135 patients who will be selected based on a predictive biomarker and then randomized to receive LNS8801 alone, LNS8801 and pembrolizumab, or physician's choice therapy. Key endpoints will include an analysis of progression-free survival and overall survival between the treatment groups. Over 25 comprehensive cancer centers in the United States are eager to participate in this study. About LNS8801 LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory. In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and durable clinical benefit in patients with advanced cancers, and a predictive biomarker has been identified. About Metastatic Cutaneous Melanoma Although there has been progress in the treatment of metastatic cutaneous melanoma, most patients will progress on standard-of-care therapies and need further treatment. According to the American Cancer Society, almost 8000 patients die each year in the United States, highlighting the need for safe and effective therapies in the treatment-refractory setting. About Linnaeus Linnaeus Therapeutics, Inc. is a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small molecule oncology therapeutics that target G protein-coupled receptors. The company was formed and launched in partnership with the UPstart incubator at the University of Pennsylvania's Penn Center for Innovation (PCI).