On May 30, 2024 Alpha Fusion Co., Ltd. reported that its joint research partner, a research team led by Lecturer Naofumi Watanabe of the Department of Radiation Medicine at the Graduate School of Medicine, Osaka University, will begin a new physician-initiated clinical trial targeting standard treatment-resistant prostate cancer in June 2024 at the Department of Nuclear Medicine, Osaka University Hospital (Press release, Alpha Fusion, MAY 30, 2024, View Source [SID1234647193]).

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The astatine-labeled drug ([At-211]PSMA-5) used in a new alpha-ray therapy targeting prostate-specific membrane antigen (PSMA) expressed in prostate cancer, developed by Lecturer Watanabe’s research team, has been confirmed to have a long-lasting tumor regression effect after a single administration in a prostate cancer model mouse. Due to its strong effect in model mouse experiments, it is considered to be a particularly promising drug candidate compound.

[At-211]PSMA-5 has been selected for the Japan Agency for Medical Research and Development (AMED) Translational Support Research Program (Seeds F) "Project name: Conducting an investigator-initiated clinical trial for the practical application of an innovative alpha-ray therapy targeting prostate-specific membrane antigen (PSMA)" due to its usefulness, path to practical application, and the collaborative system between Osaka University and Alpha Fusion. Alpha Fusion will contribute to the practical application of this investigational drug as the world’s first prostate cancer treatment using astatine. This investigator-initiated clinical trial

is a phase I clinical trial to confirm the tolerability, safety, pharmacokinetics, and efficacy after administration of [At-211]PSMA-5 to patients with castration-resistant prostate cancer who have difficulty in implementing and continuing standard treatment. This is the first time that this investigational drug will be administered to humans in the world. The design is a dose-escalation design, starting with a low dose as an anticancer drug clinical trial and gradually increasing the dose.

[Study name] Phase I investigator-initiated clinical trial of a new alpha-particle nuclear medicine treatment for patients with castration-resistant prostate cancer.
・Subjects: Patients with castration-resistant prostate cancer for whom standard treatment is difficult to implement or continue
・Investigational drug: PSW-1025 (compound name: [At-211]PSMA-5)
・Period: June 2024 to March 2027 (planned)
・Planned number of cases: 15 cases
・Principal investigator: Naofumi Watanabe (Department of Nuclear Medicine, Osaka University Hospital)

On May 30, 2024 Oncopeptides reported its first quarter 2024 financial results (Presentation, Oncopeptides, MAY 30, 2024, View Source [SID1234644676]).

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On May 30, 2024 Incyte (Nasdaq:INCY) reported that it has completed its acquisition of Escient Pharmaceuticals, a clinical-stage drug discovery and development company advancing novel small molecule therapeutics for systemic immune and neuro-immune disorders (Press release, Incyte, MAY 30, 2024, View Source [SID1234643897]).

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"The acquisition of Escient and its first-in-class oral MRGPR antagonists bolsters our Inflammation and Autoimmunity portfolio and our commitment to creating innovative solutions that address the urgent needs of patients living with severe inflammatory diseases," stated Hervé Hoppenot, Chief Executive Officer, Incyte. "We are excited to continue the work started by the Escient team and accelerate the clinical development of these promising therapies."

Through this transaction, Incyte has added EP262 and EP547 to its portfolio. EP262 is a first-in-class, potent, highly selective, once-daily small molecule antagonist of Mas-related G protein-coupled receptor X2 (MRGPRX2). By blocking MRGPRX2 and degranulation of mast cells, EP262 has the potential to effectively treat multiple mast cell-mediated diseases including chronic inducible urticaria (CIndU), chronic spontaneous urticaria (CSU) and atopic dermatitis (AD). EP547 is a first-in-class oral MRGPRX4 antagonist with the potential to treat cholestatic pruritus and other conditions with severe pruritus.

"Over the past six years, Escient has pioneered the characterization of MRGPR biology and advanced two novel candidates, EP262 and E547, into clinical development," commented Joshua Grass, Chief Executive Officer of Escient Pharmaceuticals. "The close of this transaction represents the recognition of value of the innovation by the Escient team, and also represents an exciting transition to Incyte, a global biopharmaceutical company that is well positioned to advance these novel candidates to address the unmet needs of patients worldwide."

As previously disclosed, under the terms of the agreement, Incyte has acquired Escient and its assets for $750 million plus Escient’s net cash remaining at the close of the transaction, subject to customary adjustments.

Centerview Partners LLC and Goldman Sachs & Co. LLC advised Escient on the transaction, and Fenwick & West LLP acted as legal counsel for Escient. Covington & Burling LLP acted as legal counsel for Incyte.

About EP262

EP262 is a potent, highly selective once-daily small molecule antagonist of MRGPRX2, a receptor expressed on mast cells that is activated by numerous ligands, including many peptides released from sensory neurons as well as other cell types. In response to MRGPRX2 activation, mast cells release histamine, tryptase, chymase, chemokines and cytokines, which can cause itchy hives, angioedema, type 2 inflammation (through engagement of the adaptive immune system) and chronic pruritus and pain. Preclinical data demonstrate that, by blocking activation of MRGPRX2, EP262 has the potential to effectively treat a broad range of mast cell-mediated conditions, with an initial focus on chronic urticarias and atopic dermatitis.

About EP547

EP547 is a potent, highly selective antagonist that blocks the activation of MRGPRX4 by various bile acids, bilirubin and urobilin. By virtue of this disease-specific mechanism of action, EP547 has the potential to be a highly targeted and efficacious treatment for cholestatic and uremic pruritus.

On May 30, 2024 OncoNano Medicine, Inc. ("OncoNano"), a clinical-stage biotechnology company pioneering the development of polymeric micelles encapsulating anti-cancer payloads, reported that it will present a Trials in Progress poster at the upcoming 2024 American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place in Chicago, Illinois, May 31st–June 4th, 2024 (Press release, OncoNano Medicine, MAY 30, 2024, View Source [SID1234643896]).

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The poster will highlight the study objectives and design of the ongoing ON-5001 study, a phase 1/1b, multicenter, open label, non-randomized dose escalation and dose expansion to examine the safety, tolerability and optimal dosing of ONM-501, a dual-activating STING (STimulator of INterferon Genes) agonist, as a monotherapy and in combination with cemiplimab (Libtayo) in patients with advanced solid tumors and lymphomas (NCT06022029).

Details for the ASCO (Free ASCO Whitepaper) Annual Meeting Trials in Progress poster presentation are as follows:

Presentation Overview:

TITLE: A phase 1 dose-escalation and expansion study of an intratumorally administered dual STING agonist (ONM-501) alone and in combination with cemiplimab in patients with advanced solid tumors and lymphomas.

PRESENTER: Julia Foldi, M.D., Ph.D., Assistant Professor of Medicine, Oncology, University of Pittsburgh Medical Center

SESSION: Developmental Therapeutics—Immunotherapy

POSTER: Poster Board #160a; Abstract TPS2693

DATE/TIME: June 1, 2024; 9:00 AM-12:00 PM CDT

Once presented the poster will be made available on the OncoNano website at Publications — OncoNano (www.onconano.com/publication).

About ONM-501

ONM-501 is a next generation dual-activating STING (STimulator of INterferon Genes) agonist currently in phase 1 development for the treatment of solid tumors. STING activation mediates a multifaceted type-1 interferon response that is critical in the activation of innate and adaptive immunity against infection and, potentially, cancer. ONM-501 is a pH-sensitive polymer, PC7A, carrying a cyclic guanosine monophosphate–adenosine monophosphate (cGAMP) payload, that together induce prolonged STING activation. In preclinical models, when delivered to the tumor microenvironment, ONM-501 produces dendritic cell maturation and cytotoxic T cells priming, while demonstrating antitumor efficacy. ONM-501 is currently being evaluated in a phase 1, multicenter, open label, non-randomized dose escalation and dose expansion trial to examine the safety, pharmacokinetics, pharmacodynamics, and early activity of ONM-501 as a monotherapy and in combination with an anti-PD-1 checkpoint inhibitor, cemiplimab, in patients with advanced solid tumors and lymphomas. The trial is open in the United States and planned to open in Australia in 2H2024; visit clinicaltrials.gov (NCT06022029) for more details. ONM-501 development has been supported in part by a grant from the Cancer Prevention and Research Institute of Texas.

On May 30, 2024 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that it will present new data related to its DecisionDx-Melanoma and DecisionDx-UM tests at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held May 31-June 4, 2024, in Chicago (Press release, Castle Biosciences, MAY 30, 2024, View Source [SID1234643895]).

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"Harnessing the biology of tumors through our DecisionDx family of gene expression profile tests can help guide decision-making about the most appropriate cancer treatment pathway for patients aligned to their risk of metastasis," said Derek Maetzold, president and chief executive officer of Castle Biosciences. "The findings we are presenting at ASCO (Free ASCO Whitepaper) demonstrate the clinically meaningful risk stratification provided by our tests and support their utility in helping inform risk-aligned treatment and care for patients diagnosed with cutaneous and uveal melanoma to improve cancer outcomes."

Castle’s presentations at ASCO (Free ASCO Whitepaper) will take place during the Melanoma/Skin Cancers poster session on Saturday, June 1 from 1:30-4:30 p.m. Central time in Hall A.

DecisionDx-Melanoma

Title: The 31-GEP identifies patients with localized cutaneous melanoma at the highest risk of metastasis to the central nervous system
Abstract: 9530
Poster Bd #: 314
Key take-aways: Cutaneous melanoma (CM) metastasis to the central nervous system (CNS) has a poor prognosis; however, patients generally experience better outcomes if CNS metastases are detected and treated earlier when the patient is still asymptomatic. CNS imaging is not routinely recommended for patients with early-stage CM (American Joint Committee on Cancer 8th edition (AJCC8) stage I–II), yet approximately 14% of patients with stage II melanoma will develop CNS metastases. This study demonstrated that the DecisionDx-Melanoma test can identify patients with earlier-stage melanoma who have a higher risk of CNS metastasis within the first three years post-diagnosis. These higher-risk patients may benefit from more frequent imaging surveillance to identify CNS metastases earlier to improve patient survival. Patients with Class 2B (highest risk) DecisionDx-Melanoma test results had higher rates of CNS metastases and lower five-year recurrence free survival than patients with Class 1A (lowest risk) or Class 1B/2A (increased risk) test results (p<0.001). Further, the study showed that a Class 2B (high risk) DecisionDx-Melanoma test result was the only significant predictor of CNS metastasis in multivariable analyses that included clinicopathologic-based risk factors considered in AJCC8 staging (HR (95% CI) 9.21 (2.72-31.19); p<0.001).
DecisionDx-UM

Title: The 15-gene expression profile test is independent from PRAME and 7-gene next-generation sequencing: Results from 3,267 clinically tested uveal melanomas
Abstract: 9598
Poster Bd #: 382
Key take-aways: This study is the largest to date to describe the combined performance of Castle’s comprehensive suite of UM tests, which includes the prognostic DecisionDx-UM test and two ancillary tests: Preferentially Expressed Antigen in Melanoma (PRAME) status (DecisionDx-PRAME) and DNA mutation status (DecisionDx-UMSeq). The study explored associations across test results and found that neither PRAME expression status nor the presence of mutations in putative prognostic genes (BAP1, SF3B1 and EIF1AX) to be adequate surrogates for the DecisionDx-UM Class result. Given the extensive data supporting DecisionDx-UM as the most accurate predictor of metastatic outcomes, including recently presented data from the largest prospective performance study of DecisionDx-UM to date, which included more than 1,500 patients from 26 centers, study authors recommend that PRAME and DNA mutation status be considered in the context of a DecisionDx-UM result to further refine metastatic risk and inform risk-aligned treatment plans.
The full abstracts outlined above can be found at the ASCO (Free ASCO Whitepaper) website here.

About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile risk stratification test. It is designed to inform two clinical questions in the management of cutaneous melanoma: a patient’s individual risk of sentinel lymph node (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 March 31, 2024, DecisionDx-Melanoma has been ordered more than 164,000 times for patients diagnosed with cutaneous melanoma. More information about the test and disease can be found here.

About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma (UM). DecisionDx-UM is the standard of care in the management of newly diagnosed UM in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for UM include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommend differential surveillance regimens based on a Class 1A, 1B and 2 result. DecisionDx-UM is currently the only prognostic test for UM that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type. It is estimated that nearly 8 in 10 patients diagnosed with UM in the United States receive the DecisionDx-UM test as part of their diagnostic workup. More information about the test and disease can be found here.