Uveal melanoma

Kymera Therapeutics Announces Third Quarter 2023 Financial Results and Provides a Business Update

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星期四, 十一月 2, 2023
First grade, Research, HS, AD, PD, Food, Safety, Dana–Farber Cancer Institute, Disease, Abstract, Immunology, Cutaneous T-cell lymphoma, Uveal melanoma, STAT3, International, Physician, GDF15, Webcast, Atopic dermatitis, Therapy, Investment, CTCL, Patient, Administration, Cash, Plasma, Lymphoma, Conference, IRAK4, Development, TPD, ASH, Growth, DL2, Hypotension, DL, Solar cycle 4, Arm, AACR, Thrombocytopenia, Fast Track, PTCL, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, R, Society, SD, Hidradenitis suppurativa, MDM2, Recurrence, Blood, Peripheral T-cell lymphoma, Neutropenia, AML, Merkel-cell carcinoma, Pharmaceutical industry, Vaccine, Fine chemical, Medical device, Angela Merkel, Sanofi, Black Majesty

ET

Key Points: 
  • ET
    WATERTOWN, Mass., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing a new class of small molecule medicines using targeted protein degradation (TPD), today reported financial results for the third quarter ended September 30, 2023, and provided business updates on its pipeline of protein degraders.
  • Collaboration Revenues: Collaboration revenues were $4.7 million for the third quarter of 2023 compared to $9.6 million for the third quarter of 2022.
  • Net Loss: Net loss was $52.9 million for the third quarter of 2023 compared to a net loss of $43.0 million for the third quarter of 2022.
  • Cash and Cash Equivalents: As of September 30, 2023, Kymera had $435 million in cash, cash equivalents, and investments.

Late-Breaking Phase 1 Liver Metastasis Data from TriSalus Presented at SITC 2023 Supports Development of Innovative Immuno-oncology Approach for Liver and Pancreas Indications

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星期六, 十一月 4, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Survival, Patient, MDSC, Uveal melanoma, Fatigue, Nivolumab, T helper cell, DCR, Pancreas, PFS, Liver, Skin, FACS, SITC, NanoString Technologies, NK, Liver disease, Annual general meeting, Blood, TLR, Tumor microenvironment, University, Society, Progression-free survival, MD Anderson Cancer Center, Neoplasm, Society for Immunotherapy of Cancer, Medical imaging, Pharmaceutical industry, Immunotherapy, Cancer

The Progression-Free Survival (PFS), Disease Control Rate (DCR), and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are encouraging for UMLM and for other indications under development.

Key Points: 
  • The Progression-Free Survival (PFS), Disease Control Rate (DCR), and ctDNA molecular response data in PERIO-01 patients in combination with nivolumab are encouraging for UMLM and for other indications under development.
  • At the optimal biologic dose of SD-101 (2 mg) in combination with nivolumab (n=7), the median PFS was 11.7 months with an 81% DCR.
  • At the data cutoff as of September 29, 2023, 56 patients were enrolled, with each having received at least one dose of SD-101.
  • Dr. Katz added, “These data reflect additional validation of our innovative immunotherapy approach for liver and pancreas tumors.

Castle Announces Early Exploratory Study Data for Potential Development of a Complementary Test to Accompany DecisionDx®-UM That Could Aid in the Early Detection of Uveal Melanomas

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星期五, 十一月 3, 2023
Other Health, Research, General Health, Optical, Oncology, Medical Devices, Clinical Trials, Science, Biotechnology, Medical Supplies, Other Science, Health, University of Texas Southwestern Medical Center, Uveal melanoma, Biomarker, Ophthalmology, AAO, Malignancy, Risk, Eye, Patient, Pharmaceutical industry, Medical imaging

Harbour is a leading innovator in the treatment and study of uveal melanoma and the original developer of the DecisionDx-UM test, which he licensed to Castle in 2009.

Key Points: 
  • Harbour is a leading innovator in the treatment and study of uveal melanoma and the original developer of the DecisionDx-UM test, which he licensed to Castle in 2009.
  • “Unfortunately, this approach is highly subjective and can lead to both under- and over-treatment of patients.
  • The presentation details are as follows:
    Castle expects to share additional updates in 2024 on the ongoing exploratory study and potential development of a complementary test.
  • An excerpt from Schefler’s presentation regarding the study can be viewed here .

Immatics Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for ACTengine® IMA203 TCR-T Monotherapy

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星期二, 十月 24, 2023
FDA, Uveal melanoma, Regenerative Medicine Advanced Therapy, Center for Biologics Evaluation and Research, FDA Center for Devices and Radiological Health, Ovarian cancer, Disease, PRAME, Synovial sarcoma, Cancer, 21st Century Cures Act, Patient, BLA, Pharmaceutical industry, Research

IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.

Key Points: 
  • IMA203 is a TCR-T cell therapy targeting PRAME, a protein frequently expressed in a large variety of solid tumors.
  • “The FDA RMAT designation for multiple indications underscores the broad potential of IMA203 and the benefits it may provide for advanced-stage solid tumor patients.
  • This is an important regulatory milestone and a recognition of our clinical development progress for this program,” said Cedrik Britten, Chief Medical Officer of Immatics.
  • As of Sep 30, 2023, the U.S. FDA has received at least 238 requests for RMAT designations and granted 922.

Powered by Its Industry-Leading Comprehensive Multi-Omic Database, Caris Life Sciences to Showcase Research at ESMO 2023

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星期二, 十月 17, 2023
Congress, Diagnosis, Gene expression, ACTA2, Cancer, Nen language (Papuan), Medicine, MBA, Lung cancer, KRAS, Uveal melanoma, Abstract, Gastrointestinal cancer, Intelligence, Breast cancer, Multiomics, ASPS, AI, Therapy, POA, PIM1, DLL3, Patient, Oncology, ESMO, Immunotherapy, FACP, Database, GCN, European Society for Medical Oncology, Neoplasm, De novo, Prognosis, ABC, Research, SPARC, Pharmaceutical industry, Medical imaging, Vaccine

IRVING, Texas, Oct. 17, 2023 /PRNewswire/ -- Caris Life Sciences®(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, today announced that the company and collaborators within the Caris Precision Oncology Alliance™ (POA) will collectively present seven studies across a breadth of tumor types at the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain from October 20-24, 2023 (Booth #513). The findings demonstrate the power of Caris' comprehensive clinico-genomic database that enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment.

Key Points: 
  • The findings demonstrate the power of Caris' comprehensive clinico-genomic database that enable novel insights into cancer that could have profound effects on a patient's diagnosis, prognosis, care plan and response to treatment.
  • "The research being presented at this year's ESMO Congress is a testament to Caris' continued commitment to data-driven molecular innovation and large-scale collaboration to answer some of the pressing questions in precision oncology today," said Chadi Nabhan , M.D., MBA, FACP, Chairman of the Caris POA.
  • "The findings of these studies illustrate the power of comprehensive molecular profiling to identify underlying tumor biology setting the stage for therapeutics that improve patient outcomes.
  • Alongside our POA partners, we are pioneering new approaches to help deliver the right treatments to the right patients at the right time."

ZAP Surgical Announces Upcoming Installation of Next-Generation ZAP-X Gyroscopic Radiosurgery in Ankara, Turkey

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星期二, 九月 26, 2023
Radiology, Biotechnology, Surgery, Oncology, Health, Medical Devices, Hospitals, Other Health, SRS, Hacettepe University, Trigeminal neuralgia, Breast, Uveal melanoma, Multimedia, Brain, Radiation therapy, Radiosurgery, Teaching hospital, Lung, Chiari malformation, Stereotactic surgery, Management of prostate cancer, AVM, Patient, ZAP, Isotope, Medical imaging

ZAP Surgical Systems, Inc., a leading innovator in the field of surgical robotics, today announced that Hacettepe University Hospital in Ankara, Turkey is slated to install the novel ZAP-X® Gyroscopic Radiosurgery® platform before the end of the year.

Key Points: 
  • ZAP Surgical Systems, Inc., a leading innovator in the field of surgical robotics, today announced that Hacettepe University Hospital in Ankara, Turkey is slated to install the novel ZAP-X® Gyroscopic Radiosurgery® platform before the end of the year.
  • View the full release here: https://www.businesswire.com/news/home/20230926608561/en/
    ZAP-X Gyroscopic Radiosurgery platform.
  • For select indications, radiosurgery has proven to provide equivalent to superior outcomes compared to costly and potentially debilitating surgeries.
  • “With the addition of ZAP-X, they will further reinforce their reputation as global center of medical excellence.”

Turnstone Biologics Corp. Reports Second Quarter 2023 Financial Results and Provides Business Update

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星期五, 九月 1, 2023
Exercise, IPO, AACR, Moffitt, Investment, TIL, Cancer, American Association for Cancer Research, Uveal melanoma, Research, TILS, Takeda Oncology, Patient, Administration, Colorectal cancer, Melanoma, SAN, Glomus tumor, Research institute, Research and development, R, Breast cancer, Pharmaceutical industry, Cryptocurrency, Turnstone

The shares began trading on the Nasdaq Global Market on July 21, 2023, under the ticker symbol “TSBX”.

Key Points: 
  • The shares began trading on the Nasdaq Global Market on July 21, 2023, under the ticker symbol “TSBX”.
  • Cash, Cash Equivalents and Short-Term Investments: As of June 30, 2023, cash, cash equivalents and short-term investments were $49.2 million.
  • The Company expects that the combined cash, cash equivalents and short-term investments will be sufficient to fund its operations into the second quarter of 2025.
  • Net Loss: Net loss for the three months ended June 30, 2023, was $21.5 million, compared to net income of $11.6 million for the second quarter of 2022.

Immatics Announces Second Quarter 2023 Financial Results and Business Update

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星期四, 八月 17, 2023
Synovial sarcoma, MAGEA4, Paul Ehrlich Institute, Prevalence, Half-life, CRS, DL, Cohort, Clinical trial, Lung cancer, BRAF, Uveal melanoma, CTA, Head, Bristol Myers Squibb, Research, Cohort study, PRAME, TCR, Development, State Administrative Expenses, Sarcoma, ATM, Protein, Cytokine release syndrome, Patient, PEI, Administration, Melanoma, Corr, Entrepreneurship, Uterine cancer, Toxic shock syndrome toxin-1, Ovarian cancer, ORR, Safety, Breast cancer, Nivolumab, Pharmaceutical industry, Vaccine, Medical imaging, Cryptocurrency

“Beyond our recent IMA203 updates, we are pleased to report that we closed the second quarter with a cash position funding operations into late 2025.

Key Points: 
  • “Beyond our recent IMA203 updates, we are pleased to report that we closed the second quarter with a cash position funding operations into late 2025.
  • As per the latest data cut-off of April 4, 2023, ACTengine® IMA203 TCR-T monotherapy Cohort A showed a 67% confirmed objective response rate (cORR) in an interim clinical update announced on May 2, 2023.
  • Next update on Immatics’ IMA203 Phase 1b cohorts, including the projected clinical development path for PRAME-targeted TCR-T monotherapy towards registration-directed trials is planned for 4Q 2023.
  • TCER® IMA402 (PRAME) – Immatics submitted a clinical trial application (CTA2) to the Paul-Ehrlich-Institute (PEI) in April 2023.

Melanoma Research Alliance Statement on FDA Approval of Hepzato Kit for Patients with Uveal Melanoma with Liver Metastases

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星期二, 八月 15, 2023
Liver disease, Survival, MRA, Quality of life, Hope, Uveal melanoma, Doctor of Philosophy, Patient, Melanoma, Liver, Rare, FDA, Food, Metastasis, Medical imaging

WASHINGTON, Aug. 15, 2023 /PRNewswire/ -- The Melanoma Research Alliance (MRA) released the following statements from MRA Chief Science Officer Joan Levy, PhD and MRA Chief Executive Officer Marc Hurlbert, PhD on the Food & Drug Administration approval of Hepzato Kit for patients with uveal melanoma with liver metastases that cannot be surgically removed.

Key Points: 
  • WASHINGTON, Aug. 15, 2023 /PRNewswire/ -- The Melanoma Research Alliance (MRA) released the following statements from MRA Chief Science Officer Joan Levy, PhD and MRA Chief Executive Officer Marc Hurlbert, PhD on the Food & Drug Administration approval of Hepzato Kit for patients with uveal melanoma with liver metastases that cannot be surgically removed.
  • MRA Chief Science Officer Joan Levy, PhD: "This novel therapy delivers a chemotherapy drug directly to the liver and addresses an important unmet need for patients with uveal melanoma that has spread to the liver, the predominant organ of metastasis.
  • Further, it showcases the ingenuity and dedication of melanoma researchers who contributed towards its development and patients who participated in clinical trials testing this unique treatment approach.
  • MRA Chief Executive Officer Marc Hurlbert, PhD: "The approval of Hepzato Kit is the 16th treatment to earn FDA approval for melanoma since 2011 and the second approval specifically in uveal melanoma.

Delcath Systems, Inc. Announces FDA Approval of HEPZATO KIT™ for the Treatment of Adult Patients with Unresectable Hepatic-Dominant Metastatic Uveal Melanoma

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星期二, 八月 15, 2023
Neutropenia, Exercise, REMS, Genotype, US Foods, Radiation, EAP, Private investment in public equity, Liver disease, HLA, Mitigation, PIPE, DCR, RECIST, Delcath Systems, Uveal melanoma, National Comprehensive Cancer Network, Toxicity, Mum, Aplastic anemia, Vaccine, Lung, NCCN, HDS, PHP, Incidence, Overseas Private Investment Corporation, Bleeding, Dor, Patient, Lymph, Microsoft Access, Anemia, Liver, FDA, Melphalan, Liver failure, Death, Thrombocytopenia, ORR, Food, Medical imaging, Dietary supplement, Pharmaceutical industry

NEW YORK, Aug. 14, 2023 /PRNewswire/ -- Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, announced that today the US Food and Drug Administration (FDA) approved HEPZATO KIT (melphalan/Hepatic Delivery System) as a liver-directed treatment for adult patients with metastatic uveal melanoma (mUM) with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or lung that is amenable to resection or radiation.

Key Points: 
  • mUM is a rare and aggressive form of metastatic cancer with a US incidence of approximately 1,000 cases per year.
  • National Comprehensive Cancer Network (NCCN) guidelines recommend liver-directed therapies for mUM patients with liver metastases.
  • HEPZATO KIT is the only liver-directed therapy approved by the FDA for the treatment of mUM and percutaneous hepatic perfusion (PHP), the procedure enabled by HEPZATO KIT, is already included in the NCCN guidelines.
  • "FDA approval of HEPZATO KIT marks the beginning of a new chapter for Delcath and the culmination of the Company's commitment to bring this treatment option to patients suffering from metastatic uveal melanoma," said Gerard Michel, Delcath's Chief Executive Officer.