August 6, 2024 - 🧬 [nGram] Today’s Oncology Scoop: Elevation, Lantern, SEED, Galvanize & More

1. Elevation Oncology announces promising initial data from Phase 1 trial of EO-3021

   • 42.8% confirmed ORR observed in Claudin 18.2-enriched subset of gastric and GEJ cancer.
   • EO-3021 demonstrated a differentiated safety profile with minimal MMAE-associated toxicities.
   • Advancing into dose expansion portion of Phase 1 trial; additional monotherapy data expected in 1H 2025.
   • Initiating dosing in combination portion of Phase 1 trial by year-end 2024.
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2. Lantern Pharma announces positive clinical update from ongoing phase 2 HARMONIC trial for never smokers with advanced NSCLC

   • Lantern Pharma reported an 86% clinical benefit rate in the initial patient cohort of the HARMONIC phase 2 trial.
   • The trial evaluates LP-300 in combination with pemetrexed and carboplatin in never smokers with advanced NSCLC.
   • Preliminary results showed a 43% objective response rate, with 3 patients having partial responses and 3 patients achieving stable disease.
   • The randomization and expansion phase is ongoing, with plans to enroll up to 80 additional patients.
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3. Salubris Biotherapeutics receives EMA approval for phase 1 trial of JK06 in solid tumors

   • Salubris Biotherapeutics has received EMA approval to initiate a Phase 1 clinical trial of JK06 in solid tumors expressing 5T4.
   • JK06 is a first-in-class quadrivalent, biparatopic ADC targeting 5T4 with an MMAE payload, showing robust efficacy and a clean safety profile in non-clinical studies.
   • The trial will be an open-label, dose-escalation and expansion study to assess safety, pharmacokinetics, and preliminary efficacy.
   • Phase 1 recruitment is expected to start in Q3 2024, with up to 155 subjects planned for enrollment.
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4. SEED Therapeutics enters into strategic research collaboration with Eisai

   • SEED and Eisai will collaborate to discover and develop novel molecular glue degraders for neurodegeneration and oncology.
   • SEED will receive up to $1.5 billion in upfront and milestone payments, plus tiered royalties.
   • Eisai will have exclusive rights to develop and commercialize compounds from the collaboration.
   • SEED concurrently launched Series A-3 financing, securing $24 million in the first close, with a second close targeted for Q4 2024.
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5. Galvanize Therapeutics completes enrollment in clinical trial evaluating Aliya pulsed electric field system for late-stage non-small cell lung cancer and metastasis to the lung

   • Galvanize Therapeutics has completed enrollment in the AFFINITY study for stage IV non-small cell lung cancer (NSCLC) or lung metastasis patients.
   • The 30-patient study examines the safety of adding Aliya PEF to standard care therapies and assesses immune stimulation and treatment effects.
   • Aliya PEF delivers high voltage, short duration electrical energy to induce non-thermal programmed cell death and potentially stimulate an immune response.
   • Results from the AFFINITY study are expected to be reported next year.
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6. First patient enrolled in the US phase 2 combination therapy of Akeso's ligufalimab with azacitidine for myelodysplastic syndrome

   • Akeso has enrolled the first patient in the US for its phase II trial of ligufalimab (AK117) combined with azacitidine for higher-risk myelodysplastic syndrome (HR-MDS).
   • Preliminary studies indicate that the combination therapy is safe and significantly effective, reducing anemia and transfusion needs.
   • The trial aims to expedite global approval and commercialization of AK117, a next-generation humanized IgG4 anti-CD47 antibody.
   • Additional phase II studies are evaluating AK117 in combination with venetoclax and AZA for AML patients and with other agents for solid tumors.
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7. First patient enrollment in the U.S. - A milestone for the global multi-center phase Ⅲ clinical trial of telitacicept for myasthenia gravis

   • RemeGen has enrolled the first patient in the U.S. for its global phase III clinical trial of telitacicept for generalized myasthenia gravis (gMG).
   • The trial is a multicenter, randomized, double-blind, placebo-controlled study aiming to recruit 180 patients worldwide.
   • Telitacicept targets BLyS and APRIL, reducing pathogenic antibodies and improving clinical status in gMG patients.
   • Previously, telitacicept received orphan drug and fast track status from the FDA and breakthrough therapy designation from China's NMPA.
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