Uveal melanoma

Immatics Initiates Phase 1/2 Clinical Trial to Evaluate PRAME TCR Bispecific IMA402 in Patients with Advanced Solid Tumors

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木曜日, 8月 10, 2023

IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development.

Key Points: 
  • IMA402 is the second product candidate in Immatics’ TCER® pipeline of next-generation, half-life extended bispecific molecules to enter clinical development.
  • It targets an HLA-A*02:01-presented peptide derived from PRAME, a clinically established cancer target frequently expressed in a large variety of solid tumors.
  • The Phase 1/2 clinical trial ( NCT 05958121 ) investigates TCER® IMA402 in HLA-A*02:01-positive patients with PRAME-expressing recurrent and/or refractory solid tumors.
  • Immatics has implemented an adaptive design for the dose escalation with the goal of accelerating the clinical development timeline of IMA402.

Foghorn Therapeutics Provides Second Quarter 2023 Financial and Corporate Update

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金曜日, 8月 4, 2023

CAMBRIDGE, Mass., Aug. 04, 2023 (GLOBE NEWSWIRE) -- Foghorn® Therapeutics Inc. (Nasdaq: FHTX), a clinical-stage biotechnology company pioneering a new class of medicines that treat serious diseases by correcting abnormal gene expression, today provided a financial and corporate update in conjunction with the Company’s 10-Q filing for the quarter ended June 30, 2023. With an initial focus in oncology, Foghorn’s Gene Traffic Control® Platform and resulting broad pipeline have the potential to transform the lives of people suffering from a wide spectrum of diseases.

Key Points: 
  • “Foghorn made important progress across both our clinical and preclinical pipeline in the second quarter.
  • We are on track to initiate dosing in a combination study of FHD-286 in AML in the third quarter.
  • On June 28, 2023, Foghorn announced data from the Phase 1 dose escalation safety study of FHD-286 in metastatic uveal melanoma (mUM).
  • As of June 30, 2023, the Company had $284.3 million in cash, cash equivalents and marketable securities, which provides a cash runway into the second half of 2025.

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

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木曜日, 8月 3, 2023

“It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.

Key Points: 
  • “It was a productive quarter with positive updates for RP1 in anti-PD1 failed melanoma and RP2 in uveal melanoma presented at ASCO.
  • S,G&A Expenses: Selling, general and administrative expenses were $15.2 million for the first quarter ended June 30, 2023, as compared to $11.4 million for the first quarter ended June 30, 2022.
  • Selling, general and administrative expenses included $5.5 million in stock-based compensation expenses for the first quarter ended June 30, 2023.
  • Net Loss: Net loss was $49.6 million for the first quarter ended June 30, 2023, as compared to a net loss of $42.3 million for the first quarter ended June 30, 2022.

Provectus Biopharmaceuticals Announces Acceptance of PV-10 Poster Presentations at Society for Melanoma Research (SMR) 2023 Congress

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火曜日, 8月 1, 2023

KNOXVILLE, TN, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from ongoing clinical trials of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the combination therapy treatments of uveal melanoma metastatic to the liver (NCT00986661) and Stage III-IV cutaneous melanoma (NCT02557321) will be presented on two poster presentations at the Society for Melanoma Research (SMR) 2023 Congress (the SMR annual meeting) to be held in Philadelphia, PA from November 6-9.

Key Points: 
  • KNOXVILLE, TN, Aug. 01, 2023 (GLOBE NEWSWIRE) -- Provectus (OTCQB: PVCT) today announced that data from ongoing clinical trials of investigational cancer immunotherapy PV-10 (rose bengal sodium) for the combination therapy treatments of uveal melanoma metastatic to the liver (NCT00986661) and Stage III-IV cutaneous melanoma (NCT02557321) will be presented on two poster presentations at the Society for Melanoma Research (SMR) 2023 Congress (the SMR annual meeting) to be held in Philadelphia, PA from November 6-9.
  • The two accepted abstracts are:

Foghorn Therapeutics Announces Clinical Data from Phase 1 Study of FHD-286 in Metastatic Uveal Melanoma

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水曜日, 6月 28, 2023

At this time, the company does not plan to advance FHD-286 in uveal melanoma.

Key Points: 
  • At this time, the company does not plan to advance FHD-286 in uveal melanoma.
  • “The clinical data further support the safety and tolerability of FHD-286 and build on the previously disclosed AML/MDS data.
  • In the study, nine patients had stable disease and one patient had a durable partial response,” said Adrian Gottschalk, President and Chief Executive Officer of Foghorn.
  • Clinical data seen in the Phase 1 dose escalation study reinforced the safety and tolerability profile of FHD-286.

5TH ANNUAL MOVE FOR MELANOMA AIMS TO RAISE $75,000 TO HELP CANADIAN MELANOMA AND SKIN CANCER PATIENTS REACH TREATMENT

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木曜日, 6月 22, 2023

Raising Funds and Awareness: The 5th Annual Move for Melanoma Event Aims to Support Canadian Melanoma, Non-Melanoma Skin Cancer and Ocular Melanoma Patients

Key Points: 
  • Raising Funds and Awareness: The 5th Annual Move for Melanoma Event Aims to Support Canadian Melanoma, Non-Melanoma Skin Cancer and Ocular Melanoma Patients
    VANCOUVER, BC, June 22, 2023 /CNW/ - Save Your Skin Foundation will host the 5th annual MOVE FOR MELANOMA event over the weekend of September 23 – 24, 2023.
  • while raising funds for Canadians touched by melanoma, non-melanoma skin cancer, and ocular melanoma.
  • Move for Melanoma is an annual event hosted by Save Your Skin Foundation, the only organization in Canada that supports skin cancer patients financially when they need it most.
  • Kathleen Barnard, President and Founder of Save Your Skin Foundation, and stage IV melanoma survivor, is also available for interviews.

TriSalus Life Sciences Presents Additional Data for SD-101 Delivered by the Proprietary PEDD™ Method with the TriNav™ Device for Uveal Melanoma Liver Metastases at the ASCO 2023 Annual Meeting

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月曜日, 6月 12, 2023

PERIO-01 is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.

Key Points: 
  • PERIO-01 is evaluating whether this platform approach can improve the performance of systemic checkpoint inhibitors in patients with UMLM.
  • PERIO-01 is an open-label, first-in-human Phase 1 trial of SD-101, administered by hepatic arterial infusion with TriNav using PEDD in UMLM.
  • The study consists of dose-escalation cohorts of SD-101 (2, 4, or 8 mg) alone or with immune checkpoint inhibition.
  • The data were also selected for presentation at the Developmental Therapeutics - Immunotherapy Poster Discussion Session on June 3, 2023 at 3:00pm CT.

Replimune Presents RP1 Data from the IGNYTE anti-PD1 Failed Melanoma Cohort and RP2 Data in Uveal Melanoma at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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土曜日, 6月 3, 2023

WOBURN, Mass., June 03, 2023 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of a novel class of tumor-directed oncolytic immunotherapies, today announced updated data from the first 75 patients in the anti-PD1 failed melanoma cohort of the IGNYTE clinical trial along with data from the ongoing Phase 1 trial of RP2 combined with nivolumab in patients with uveal melanoma are being presented at the ASCO annual meeting. The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.

Key Points: 
  • The anti-PD1 failed melanoma cohort of the IGNYTE clinical trial evaluating RP1 (vusolimogene oderparepvec) in combination with nivolumab is registration-directed.
  • The anti-PD1 failed melanoma cohort is registration-directed and completed enrollment earlier in the year with 141 patients enrolled.
  • These updated data include the first 75 patients from the anti-PD1 failed melanoma cohort combined with the 16 anti-PD1 failed melanoma patients from the prior all comers 30 patient melanoma cohort (n=91 in total).
  • Data in uveal melanoma patients from the Phase 1 clinical trial evaluating RP2 in combination with nivolumab was presented.

Castle Biosciences to Share New Data on DecisionDx®-Melanoma and DecisionDx®-UM at the 2023 ASCO Annual Meeting

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土曜日, 6月 3, 2023

Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that new data on DecisionDx®-Melanoma and DecisionDx®-UM will be shared during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6.

Key Points: 
  • Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, today announced that new data on DecisionDx®-Melanoma and DecisionDx®-UM will be shared during the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2-6.
  • DecisionDx-Melanoma is the Company’s genomic risk-stratification test for patients with cutaneous melanoma, and DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States.
  • Details regarding Castle’s accepted abstracts are as follows:
    Abstract #6601: Integrating the 31-gene expression profile test into clinical decision-making to guide risk-aligned care decisions for patients with stage I-III cutaneous melanoma: NCI-SEER Analysis.
  • First Author: David Hyams, M.D., F.A.C.S., director of Desert Surgical Oncology in Rancho Mirage, California
    Abstract #e21574: Long-term outcomes in a population-based cohort of 2,967 uveal melanoma patients clinically tested with the 15-gene expression profile: A collaborative study with the National Cancer Institute (NCI) Surveillance, Epidemiology, and End Results (SEER) Program Registries.

Immunocore presents additional ctDNA data from the KIMMTRAK Phase 3 trial at ASCO

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土曜日, 6月 3, 2023

“We have shown that KIMMTRAK can deliver significant OS benefit to patients with metastatic uveal melanoma, regardless of best RECIST response.

Key Points: 
  • “We have shown that KIMMTRAK can deliver significant OS benefit to patients with metastatic uveal melanoma, regardless of best RECIST response.
  • We have now validated ctDNA reduction as an early surrogate for OS in two separate clinical trials,” said Koustubh Ranade, Vice President of Translational Medicine at Immunocore.
  • Patients will be randomized to one of three arms including tebentafusp, as monotherapy or in combination with an anti-PD1, and a control arm.
  • Title: A Phase 2/3 trial in progress on tebentafusp as monotherapy and in combination with pembrolizumab in HLA-A*02:01+ patients with previously treated advanced, non-uveal melanoma