July 10, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Obsidian's FDA Fast Track, Curium's NDA, Prelude & Merck Collaboration

  1. Obsidian Therapeutics announces FDA fast track designation for OBX-115 for the treatment of advanced melanoma
    • The FDA has granted Fast Track Designation to OBX-115, an engineered T cell immunotherapy for advanced melanoma.
    • OBX-115 is designed for patients whose melanoma has relapsed after PD-1/PD-L1–based immune checkpoint inhibitors.
    • Fast Track Designation facilitates development and expedites review, potentially allowing for Priority and Rolling Review.
    • OBX-115 is currently being investigated in clinical trials for advanced melanoma and non-small cell lung cancer.
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  2. Curium submits new drug application for lutetium Lu 177 dotatate injection
    • Curium has submitted a 505(b)(2) New Drug Application to the FDA for Lutetium Lu 177 Dotatate Injection.
    • The drug is intended for the treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS).
    • Curium's formulation avoids infringement of any Orange Book listed patents, expediting its path to market.
    • Curium will work closely with the FDA through the review and approval process.
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  3. Intensity Therapeutics doses first patient in phase 3 study for metastatic soft tissue sarcoma
    • Intensity Therapeutics has dosed the first U.S. patient in its global Phase 3 study (INVINCIBLE-3) for metastatic soft tissue sarcoma.
    • The trial will compare INT230-6 monotherapy to standard-of-care chemotherapy in second or third-line metastatic, recurrent, or inoperable soft tissue sarcomas.
    • The study aims to enroll approximately 333 patients, with a primary endpoint of overall survival.
    • Regulatory documents have been filed to initiate the trial in Canada and Europe, with plans to start sites in eight countries over the next several months.
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  4. Monopar enrolls first patient in phase 1 trial for MNPR-101-Zr
    • Monopar Therapeutics has enrolled the first patient in its first-in-human Phase 1 trial for MNPR-101-Zr.
    • MNPR-101-Zr is a novel radiopharmaceutical imaging agent targeting the urokinase plasminogen activator receptor (uPAR).
    • The trial, led by Professor Rodney Hicks, aims to assess the safety and dosimetry of MNPR-101-Zr in up to 12 patients with advanced cancers.
    • This study is the first to evaluate a radiolabeled monoclonal antibody targeting uPAR in humans.
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  5. Elevar Therapeutics plans near-term resubmission of NDA for first-line treatment of unresectable hepatocellular carcinoma
    • Elevar Therapeutics to resubmit NDA for rivoceranib and camrelizumab as a first-line treatment for unresectable hepatocellular carcinoma (uHCC).
    • FDA confirmed resubmission can occur without delay, with potential additional GMP and BIMO inspections post-resubmission.
    • The resubmission will include data from the CARES-310 Phase 3 trial, showing a median overall survival of 23.8 months.
    • The original NDA was submitted in May 2023 and received a Complete Response Letter citing GMP deficiencies and incomplete BIMO inspections.
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  6. Prelude Therapeutics announces clinical collaboration with Merck to evaluate PRT3789 in combination with Keytruda in patients with SMARCA4-mutated cancers
    • Prelude Therapeutics and Merck have entered a clinical trial collaboration to evaluate PRT3789 with Keytruda in SMARCA4-mutated cancers.
    • The Phase 2 study will be sponsored by Prelude, with Merck providing Keytruda.
    • PRT3789 is a highly selective SMARCA2 degrader currently in Phase 1 clinical development.
    • Pre-clinical data showed enhanced anti-tumor immunity and tumor regressions with the combination therapy.
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  7. Expanded HyBryte treatment demonstrating positive outcomes in early-stage cutaneous T-cell lymphoma
    • Soligenix announced an interim update on the open-label study evaluating extended HyBryte treatment for up to 12 months in early-stage CTCL patients.
    • 75% of patients who completed at least 12 weeks of therapy achieved 'Treatment Success' with ≥50% improvement in their cumulative mCAILS score.
    • HyBryte appears to be safe and well-tolerated with no treatment-related adverse events reported to date.
    • The study is supported by a $2.6 million FDA Orphan Products Development Grant and aims to enroll up to 50 patients.
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  8. Remix Therapeutics attains near-term milestone from Roche collaboration
    • Remix Therapeutics has achieved a near-term milestone in its collaboration with Roche.
    • The collaboration focuses on discovering and developing small molecule therapeutics that modulate RNA processing using Remix's REMaster platform.
    • Remix received an upfront payment of $30 million and is eligible for up to $1 billion in milestone payments and royalties.
    • Roche will have exclusive rights to specific targets, with Remix handling discovery and preclinical activities, and Roche responsible for development and commercialization.
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