Summit Therapeutics Announces Initial Indications for Clinical Trials for Ivonescimab (SMT112)

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1. Summit Therapeutics announces initial indications for Phase III clinical trials for ivonescimab, a potential first-in-class bispecific antibody.

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2. The trials will focus on non-small cell lung cancer (NSCLC) patients.

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3. Summit held multiple meetings with the FDA in Q1 2023 to plan the clinical program.

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4. Ivonescimab will be combined with chemotherapy for EGFR-mutated, locally advanced, or metastatic non-squamous NSCLC patients (HARMONi trial).

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5. Ivonescimab will also be combined with chemotherapy for first-line metastatic squamous NSCLC patients (HARMONi-3 trial).

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6. The first patient in the HARMONi trial is expected to be dosed in Q2 2023, while the first patient in the HARMONi-3 trial will be dosed in H2 2023.

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7. Ivonescimab, or SMT112, combines immunotherapy and anti-angiogenesis effects into a single molecule, targeting both PD-1 and VEGF in tumor tissue.

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8. Over 750 patients have been dosed with ivonescimab in clinical studies in China and Australia.

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9. Summit's Q1 earnings call will be held on May 11, 2023, at 9:00 am ET.

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10. Ivonescimab is not yet approved for use by any health authority, and its efficacy and safety have not been established.

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