October 24, 2024 - 🧬 [nGram] Oncology Highlights (18th Oct - 24th Oct): Novartis' Kisqali® CHMP Nod, Evergreen's EU Trial, Nurix's Positive Results

1. Evergreen Theragnostics opens phase II small cell lung cancer trial in EU

   • Evergreen Theragnostics has launched the CCK2-VIEW Phase II trial for small cell lung cancer in the EU.
   • The trial uses 68Ga-EVG321, a radioligand imaging agent targeting CCK2R, highly expressed in SCLC.
   • This multi-center, open-label, non-randomized trial aims to quantify 68Ga-EVG321 radioactivity in patients.
   • The trial's success could lead to a theragnostic pair with 177Lu-EVG321, offering new treatment options.
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2. Novartis receives positive CHMP opinion for Kisqali to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

   • The European Medicines Agency's CHMP has given a positive opinion for Kisqali (ribociclib) for adjuvant treatment in HR+/HER2- early breast cancer at high risk of recurrence.
   • The recommendation is based on the Phase III NATALEE trial, which showed a 25% reduction in recurrence risk when Kisqali was added to endocrine therapy.
   • Kisqali was approved by the FDA in September 2024 for the same indication.
   • The European Commission is expected to make a final decision within two months.
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3. Keio University research reveals genomic insights for personalized cancer treatment

   • Keio University's study analyzed genomic data from 48,627 Japanese cancer patients, highlighting significant genomic differences between Asian and white populations.
   • The research identified a higher frequency of TP53 mutations in Japanese patients, suggesting racial differences in mutation prevalence.
   • Clinically actionable genetic alterations were found in 15.3% of the Japanese cohort, with the highest frequencies in well-differentiated thyroid cancer.
   • The study emphasizes the need for population-specific cancer treatment strategies to improve personalized therapies for Japanese patients.
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4. LaNova Medicines initiates phase 1 trial of LM-299 and completes $42 million financing

   • LaNova Medicines has started a Phase 1 clinical trial in China for LM-299, an anti-PD-1/VEGF bispecific antibody, targeting advanced solid tumors.
   • The trial follows promising preclinical results showing strong tumor growth inhibition and a well-tolerated safety profile.
   • An IND submission for LM-299 in the US is expected in the second half of 2024.
   • The $42 million Series C1 financing, led by Sino Biopharmaceuticals, will support the clinical development of LaNova's pipeline, including LM-299, LM-302, and LM-108.
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5. CHMP meeting highlights: October 2024

   • Ten new medicines recommended for approval, including Alhemo for haemophilia and Korjuny for malignant ascites.
   • Positive opinions for two influenza vaccines: Fluad for adults 50+ and Flucelvax for ages 2+.
   • Approval of biosimilars Absimky and Imuldosa for conditions like plaque psoriasis and Crohn’s disease.
   • CHMP confirmed refusal of conditional marketing authorisation for Masitinib for ALS treatment.
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6. Nurix Therapeutics presents positive results from the ongoing clinical trial of its BTK degrader NX-5948 in patients with relapsed/refractory Waldenstrom’s macroglobulinemia

   • NX-5948 showed robust clinical activity with a 77.8% objective response rate in evaluable patients.
   • The trial is in Phase 1a/1b, with data presented at the IWWM-12 in Prague.
   • The drug demonstrated a tolerable safety profile consistent with previous findings.
   • Next steps include advancing NX-5948 into the Phase 1b expansion cohort.
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