June 19, 2024 - 🧬 [nGram] Today’s Oncology Scoop: GenFleet's IND Approval, Golidocitinib's New Approval, Medivir's Phase 2b Study, Aethlon's Ethics Approval

1. GenFleet receives IND approval from China's NMPA for GFH375, an oral KRAS G12D (ON/OFF) inhibitor, in a phase I/II clinical trial treating advanced solid tumor patients with KRAS G12D mutation

   • GenFleet Therapeutics received IND approval from China's NMPA for GFH375, an oral KRAS G12D (ON/OFF) inhibitor.
   • The phase I/II clinical trial will target advanced solid tumor patients with KRAS G12D mutation.
   • GFH375 is designed to target both 'ON' (GTP-bound) and 'OFF' (GDP-bound) states of the KRAS G12D protein.
   • The trial will be conducted at approximately 40 hospitals, including Shanghai Chest Hospital.
   • Phase I will evaluate safety/tolerability and determine the recommended phase II dose (RP2D).
   • Phase II will assess efficacy in patients with pancreatic ductal adenocarcinoma (PDAC), colorectal cancer (CRC), and non-small cell lung cancer (NSCLC).
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2. Golidocitinib approved in China as first-in-class JAK1 only inhibitor for the treatment of relapsed or refractory peripheral T-cell lymphoma

   • Golidocitinib is the first JAK1 only inhibitor approved for relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).
   • Approval based on results from the multinational pivotal JACKPOT8B study.
   • The study showed an objective response rate (ORR) of 44.3% and a complete response rate of 23.9%.
   • Median duration of response (mDoR) was 20.7 months, with 53.8% of patients still responding.
   • Golidocitinib has been granted Fast Track Designation by the U.S. FDA and Priority Review by the CDE in China.
   • The drug has been acknowledged at international congresses and published in prestigious journals like The Lancet Oncology.
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3. Medivir selects global CRO partner for upcoming phase 2b study in HCC with fostrox + Lenvima and initiates study feasibility

   • Medivir has chosen a global CRO partner for its phase 2b study evaluating fostrox + Lenvima vs Lenvima alone in second line HCC.
   • The phase 2b study will be global, randomized, and aligned with recent FDA Type C interaction.
   • The study aims to become the first approved treatment alternative after current first line treatment for advanced HCC.
   • Patient enrollment will occur in the US, EU, and Asia, leveraging sites from the ongoing phase 1b/2a study.
   • Next steps include study feasibility to identify optimal sites and investigators, aiming for a study start in early 2025.
   • Fostrox is a liver-targeted inhibitor of DNA replication, showing promising efficacy and safety in ongoing studies.
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4. Aethlon Medical receives ethics committee approval for Hemopurifier cancer trial

   • Aethlon Medical received full ethics approval from the Human Research Ethics Committee (HREC) at Central Adelaide Local Health Network (CALHN).
   • The approval is for a safety, feasibility, and dose-finding study of the Hemopurifier in cancer patients with solid tumors not responding to anti-PD-1 antibodies.
   • The trial will be conducted at the Cancer Clinical Trials Unit, CALHN, Royal Adelaide Hospital, led by Prof. Michael Brown.
   • The primary endpoint of the trial is safety, with approximately 18 patients to be monitored for adverse events and lab test changes.
   • Next steps include submission to the Therapeutic Goods Administration, approval from the CALHN Research Governance Committee, and site initiation visits for patient enrollment.
   • The study aims to inform the design of a subsequent efficacy and safety Premarket Approval (PMA) study.
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