Uveal melanoma

Largest Prospective Study to Date Further Supports Performance of DecisionDx®-UM for Metastatic Risk Stratification in Uveal Melanoma and Utility of PRAME Biomarker for Refining Risk When Considered with DecisionDx-UM Class Result

Retrieved on: 
水曜日, 5月 8, 2024
Research, Genetics, Clinical Trials, Biometrics, Biotechnology, General Health, Health, Optical, Science, Oncology, Bascom Palmer Eye Institute, University, Risk, MFS, PRAME, Glomus tumor, Patient, Eye, Metastasis, Uveal melanoma, Annual general meeting, ARVO, UM, Medical imaging

Further, the study provides prospective validation data supporting Preferentially Expressed Antigen in Melanoma (PRAME) as a risk refinement tool when considered in the context of a Class 1 or Class 2 DecisionDx-UM test result.

Key Points: 
  • Further, the study provides prospective validation data supporting Preferentially Expressed Antigen in Melanoma (PRAME) as a risk refinement tool when considered in the context of a Class 1 or Class 2 DecisionDx-UM test result.
  • The data was presented at the Association for Research in Vision and Ophthalmology (ARVO) 2024 Annual Meeting in Seattle.
  • “The study data provides support for combining the reported expression status of the PRAME gene with the DecisionDx-UM class result to enhance metastatic risk prediction.
  • Patients with Class 2 tumors had considerably worse outcomes than those with Class 1 tumors, regardless of PRAME status; however, PRAME+ tumors fared worse within each GEP class (versus PRAME-).

Turnstone Biologics Corp. Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Recent Business Highlights

Retrieved on: 
木曜日, 3月 21, 2024
Administration, Head, TIL, Colorectal cancer, Immunotherapy, HNSCC, Takeda Oncology, Selection, Patient, G&A, Melanoma, TILS, Investment, CRC, Breast cancer, SITC, Research and development, Research institute, Turnstone, Uveal melanoma

SAN DIEGO, March 21, 2024 (GLOBE NEWSWIRE) -- Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX), a clinical-stage biotechnology company developing a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy, today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided recent business highlights.

Key Points: 
  • “2023 marked a transformative year for Turnstone Biologics in which we transitioned into a publicly traded company and continued to advance our pipeline through clinical development.
  • Recently, Turnstone expanded their trials to evaluate additional solid tumor types in addition to the existing indications of breast cancer and uveal melanoma.
  • Preclinical Data Presentations at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting Support Ongoing Clinical and Preclinical Efforts.
  • Cash, Cash Equivalents and Short-Term Investments: As of December 31, 2023, cash, cash equivalents and short-term investments were $94.8 million.

Immatics Announces Full Year 2023 Financial Results and Corporate Update

Retrieved on: 
木曜日, 3月 21, 2024
Ovarian cancer, Head, Uterine cancer, GSK, Patient, Dendreon, Commercial, Cancer, Bristol Myers Squibb, Neoplasm, Melanoma, TCR, Therapy, Research, MAGEA4, Sarcoma, GMP, Safety, Pharmacokinetics, Amgen, QC, CDMO, Development, Prevalence, Half-life, RECIST, Senior, FDA, Lung cancer, Administration, Conference, Entrepreneurship, Bank, Corr, Messenger, Protein, Pharmacology, Uveal melanoma, Pharmaceutical industry

“Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.

Key Points: 
  • “Immatics kicked off 2024 with a successful capital raise, providing significant financial runway and additional momentum to advance our ongoing clinical cell therapy and bispecific trials,” said Harpreet Singh, Ph.D., CEO and Co-Founder of Immatics.
  • For IMA203CD8 GEN2, Immatics cleared dose level 4a (DL4a, up to ~1.6x109 TCR-T cells) in December 2023, which is currently intended to be the target dose for further development.
  • A next data update for both Phase 1b cohorts with IMA203 GEN1 and IMA203CD8 GEN2 is planned for 2H 2024.
  • On September 11, 2023, Immatics announced a strategic multi-platform collaboration with Moderna, combining Immatics’ target and TCR platforms with Moderna’s cutting-edge mRNA technology.

TriSalus Reports Q4 and Full Year 2023 Financial Results and Business Update

Retrieved on: 
月曜日, 4月 1, 2024
Oncology, Health, Medical Devices, Other Health, Clinical Trials, Pharmaceutical, Biotechnology, HCPCS, Interest, Second Half, Patient, APC, Sale, Society, University, Bank statement, Investment, Therapy, Marketing, DCR, Webcast, Hepatocellular carcinoma, CMS, Abdominal ultrasonography, Vein, Disease, Opinion, Immunotherapy, Safety, Manuscript, Cholangiocarcinoma, Pancreas, PFS, FDA, Liver disease, HCC, OS, Uveal melanoma, MDSC, Growth, TACE, Commander, U.S. Pacific Fleet, Drug, MD Anderson Cancer Center, Data, Medicare, Liver, Pharmaceutical industry

TriSalus Life Sciences Inc., (Nasdaq: TLSI), today announced its financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.

Key Points: 
  • TriSalus Life Sciences Inc., (Nasdaq: TLSI), today announced its financial results for the fourth quarter and full year ended December 31, 2023, and provided a business update.
  • This new code, HCPCS 9797, has been assigned to the Ambulatory Payment Classification (APC) 5194 – Level 4 Endovascular Procedures.
  • The Company is working diligently to evaluate the materiality of the errors to determine whether any corrections for the third quarter financial results are required and to complete the Company’s year-end 2023 financial statements.
  • Operating losses were $14.1 million and $54.2 million, respectively, for the fourth quarter and full year ended December 31, 2023.

TriSalus Life Sciences Receives Approval from the World Health Organization and the American Medical Association’s Adopted Name Council for “Nelitolimod” as the Nonproprietary Drug Name for SD-101

Retrieved on: 
木曜日, 3月 7, 2024
Research, Medical Devices, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Liver, International, Neoplasm, Immunotherapy, Hepatocellular carcinoma, USAN, INN, Organization, World Health Organization, Tumor microenvironment, Patient, HCPCS, Cholangiocarcinoma, Publication, WHO, Cancer, Liver disease, Uveal melanoma

“The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.

Key Points: 
  • “The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.
  • This approach has the potential to enable more durable responses by patients to other immunotherapeutics, thereby facilitating better patient outcomes.
  • Information on nelitolimod will be posted on the USAN website ( www.ama-assn.org/go/usan ) and will be published in the Chemical Abstracts Service and in the U.S. Pharmacopeia.
  • Going forward, TriSalus will use the name in publications and public statements, at conferences and other forums, and in corporate-related materials.

Castle Biosciences Reports Fourth Quarter and Full-Year 2023 Results

Retrieved on: 
水曜日, 2月 28, 2024
Mental Health, Research, Clinical Trials, Biotechnology, Other Health, Health, Pharmaceutical, Science, Oncology, Well, Neoplasm, Psoriasis, DecisionDx-UM, Investment, News, Growth, Table, Uveal melanoma, Epidemiology, SCC, Webcast, Diagnosis, Mortality, Woman, Melanoma, Cohort (statistics), Recurrence, BWH, Overalls, Radiation, Metastasis, Mycosis fungoides, GAAP, Journal, Net, Depreciation, PSO, Major depressive disorder, Randomized controlled trial, Atopic dermatitis, Adjustment, Practitioner, ART, Castle, National Comprehensive Cancer Network, Survival, MDD, Workflow, Acquisition, MF, Risk, Medicare, NCCN, Patient, Pharmaceutical industry

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended Dec. 31, 2023.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced its financial results for the fourth quarter and year ended Dec. 31, 2023.
  • DecisionDx-SCC test reports delivered in the quarter were 3,530, compared to 1,845 in the fourth quarter of 2022, an increase of 91%.
  • DecisionDx-UM test reports delivered in the quarter were 405, compared to 432 in the fourth quarter of 2022, a decrease of 6%.
  • Castle Biosciences will hold a conference call on Wednesday, Feb. 28, 2024, at 4:30 p.m. Eastern time to discuss its fourth quarter and full-year 2023 results and provide a corporate update.

Delcath Systems Announces Healthcare Setting Locator for HEPZATO™ KIT (melphalan/Hepatic Delivery System)

Retrieved on: 
木曜日, 2月 22, 2024
Mum, Liver, Caregiver, Physician, Delcath Systems, Uveal melanoma, Lung, Locator, Radiation, Lymph, Health care, Patient

NEW YORK, Feb. 22, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that the Company has launched a Healthcare Setting Locator (Locator) on the hepzatokit.com website.

Key Points: 
  • NEW YORK, Feb. 22, 2024 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, today announced that the Company has launched a Healthcare Setting Locator (Locator) on the hepzatokit.com website.
  • Potential patients, caregivers, and healthcare providers may use the Locator to identify healthcare settings, offering treatment with the HEPZATO KIT.
  • Sites included on the Locator are accepting inquiries from patients or their physicians seeking potential treatment with HEPZATO KIT.
  • "The Healthcare Settings Locator is a great resource for metastatic uveal melanoma patients.

Inaugural Award Poised to Advance Treatment Options for Uveal Melanoma Patients

Retrieved on: 
金曜日, 2月 16, 2024
Uveal melanoma, Liver, Melanoma, Research, Doctor of Philosophy, Schepens Eye Research Institute, HLA, Massachusetts Eye and Ear, MD, FDA, MRF, Friends, Food, CURE, Hope, Eye, Frustration, UM, Patient, Family, Disease, Tebentafusp, Education, Nursing

WASHINGTON , Feb. 16, 2024 /PRNewswire-PRWeb/ -- The Melanoma Research Foundation (MRF) recently announced the winners of the inaugural CURE OM Options Bring Hope Team Science Award: Bruce Ksander, PhD from the Schepens Eye Research Institute; Rizwan Haq MD, PhD from the Dana-Farber Cancer Institute and Margarete Karg, PhD from Massachusetts Eye and Ear Infirmary. The collaborative research project is titled, "Identification of molecular pathways that drive uveal melanoma metastasis." The goal of the team's research is to determine the main factors that drive uveal melanoma (UM) to spread and specifically target the liver, with the hope that this research may guide the development of effective therapeutic interventions. Uveal melanoma is a type of ocular melanoma (OM) and is the most common type of eye cancer in adults that constitutes around 5 of all melanomas. In about half of all UM cases, the disease will spread to other parts of the body. When this occurs, it is almost always fatal.

Key Points: 
  • The collaborative research project is titled, "Identification of molecular pathways that drive uveal melanoma metastasis."
  • Uveal melanoma is a type of ocular melanoma (OM) and is the most common type of eye cancer in adults that constitutes around 5 of all melanomas.
  • The CURE OM Options Bring Hope Team Science Award intends to support an interdisciplinary research team who is researching treatment options for metastatic UM patients not limited by HLA type.
  • To learn more about the CURE OM Options Bring Hope Team Science Award, read here .

OnKure Announces the Appointment of Samuel Agresta, M.D., as Chief Medical Officer

Retrieved on: 
木曜日, 2月 15, 2024
Breast cancer, Investigational New Drug, Agios Pharmaceuticals, FDA, Growth, Genentech, Myelodysplastic syndrome, Therapy, Patient, Sarcoma, Acute myeloid leukemia, HER, IND, Merrimack Pharmaceuticals, Uveal melanoma

BOULDER, Colo., Feb. 15, 2024 (GLOBE NEWSWIRE) -- OnKure, Inc. today announced the appointment of Samuel Agresta, M.D., M.P.H.

Key Points: 
  • BOULDER, Colo., Feb. 15, 2024 (GLOBE NEWSWIRE) -- OnKure, Inc. today announced the appointment of Samuel Agresta, M.D., M.P.H.
  • as Chief Medical Officer.
  • “Sam’s leadership experience and expertise in oncology drug development will be invaluable as we advance our portfolio,” said Nick Saccomano, Ph.D., Chief Executive Officer of OnKure.
  • Dr. Agresta also served as a Director and Chief Medical Officer at Infinity Pharmaceuticals, Inc. where he was responsible for the Phase 1 and 2 developments of the PI3Ky inhibitor, IPI-549.

Replimune Reports Fiscal Third Quarter 2024 Financial Results and Provides Corporate Update

Retrieved on: 
木曜日, 2月 8, 2024
Carcinoma, Neoplasm, Melanoma, NMSC, Merkel-cell carcinoma, REPL, Angiosarcoma, SITC, PFS, Clinical trial, Research, RECIST, Society, Hercules, Patient, CSCC, Type, FDA, Marketing, Investment, RP1, Food, MCC, Immunotherapy, Skin, Nivolumab, Uveal melanoma, Annual general meeting, BLA, RP2, Pharmaceutical industry

WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.

Key Points: 
  • WOBURN, Mass., Feb. 08, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (Nasdaq: REPL), a clinical stage biotechnology company pioneering the development of a novel class of oncolytic immunotherapies, today announced financial results for the fiscal third quarter ended December 31, 2023, and provided a business update.
  • We plan to submit a BLA for the treatment of patients with anti-PD1 failed melanoma in 2H 2024.
  • Selling, general and administrative expenses included $4.5 million in stock-based compensation expenses for the third quarter ended December 31, 2023.
  • Net Loss: Net loss was $51.1 million for the third quarter ended December 31, 2023, as compared to a net loss of $39.7 million for the third quarter ended December 31, 2022.