July 22, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Nuvalent Doses First Patient, Zymeworks FDA Clearance, TME Pharma Strategy

1. Nuvalent announces first patient dosed in HEROEX-1 Phase 1a/1b clinical trial of NVL-330

   • Nuvalent has initiated the HEROEX-1 Phase 1a/1b clinical trial for NVL-330, a novel HER2-selective inhibitor.
   • The trial targets pre-treated patients with HER2-altered non-small cell lung cancer (NSCLC), including those with HER2 exon 20 mutations.
   • HEROEX-1 is a multicenter, open-label, dose-escalation and expansion trial to evaluate the safety, tolerability, and preliminary anti-tumor activity of NVL-330.
   • The trial aims to determine the recommended Phase 2 dose (RP2D) and characterize the pharmacokinetic profile of NVL-330.
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2. Zymeworks announces FDA clearance of investigational new drug application for ZW191

   • FDA has cleared the IND application for ZW191, a novel folate receptor-⍺ targeted topoisomerase I inhibitor antibody-drug conjugate.
   • ZW191 targets FR⍺-expressing tumors, including ovarian and other gynecological cancers, as well as non-small cell lung cancer (NSCLC).
   • The drug incorporates a novel antibody and drug-linker for improved efficacy and targeting lower levels of FR⍺.
   • Zymeworks plans to file applications for regulatory authorization to initiate clinical studies for ZW191 in non-US jurisdictions in the second half of 2024.
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3. TME Pharma announces strategic plan to externalize and monetize second clinical stage asset NOX-E36

   • TME Pharma plans to externalize and monetize NOX-E36, an L-stereoisomer RNA aptamer inhibiting the CCL2 chemokine.
   • NOX-E36 has shown potential in addressing unmet medical needs in ophthalmic diseases impacted by fibrosis.
   • The compound has been administered to 175 clinical trial participants, demonstrating excellent safety and tolerability.
   • Fibrosis is a significant cause of treatment failure in eye diseases like diabetic retinopathy, age-related macular degeneration, and primary open angle glaucoma.
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4. GC Cell and Lukas announce strategic cooperation agreement to jointly tap into the innovative cell therapy market

   • GC Cell and Lukas Biomedical have signed an international strategic cooperation agreement.
   • The collaboration aims to expand patient access to autologous T cell therapy and other innovative cell treatments.
   • GC Cell's Immuncell-LC therapy, approved by the MFDS in 2007, has treated over 10,000 patients in Korea.
   • Lukas's LuLym-T cell therapy aligns with Taiwan's new Regenerative Medicine Act and is set for a five-year conditional approval.
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