October 31, 2024 - 🧬 [nGram] Oncology Highlights (25th Oct - 31st Oct): IDEAYA, Merck & Moderna, Trinity Biotech, Celldex


  1. IDEAYA announces positive interim phase 1 expansion data of IDE397 in MTAP-deletion urothelial and lung cancer
    • IDEAYA presented positive interim data for IDE397 in MTAP-deletion urothelial cancer (UC) and non-small cell lung cancer (NSCLC) at ENA 2024.
    • The study showed a 33% overall response rate (ORR) with 1 complete response and 8 partial responses among 27 evaluable patients.
    • No drug-related serious adverse events were observed at the 30 mg once-a-day expansion dose.
    • IDEAYA plans to expand the Phase 1/2 study of IDE397 in combination with Trodelvy in MTAP-deletion UC in Q4 2024.
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  2. Qurient launches clinical trial for acute myeloid leukemia treatment with adrixetinib
    • Qurient has initiated a Phase 1 clinical trial for adrixetinib (Q702) after receiving IND clearance from the U.S. FDA.
    • The trial will assess the safety and preliminary efficacy of Q702 as a single agent and in combination with venetoclax and azacitidine for relapsed/refractory AML.
    • Adrixetinib is a selective inhibitor of AXL/MER/CSF1R kinases, showing promise in enhancing chemo-sensitivity and immune response.
    • The study aims to establish a recommended Phase 2 dosage and explore further clinical collaborations.
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  3. Revolution Medicines presents initial data from RMC-9805 monotherapy study in patients with advanced pancreatic ductal adenocarcinoma
    • Revolution Medicines shared preliminary data for RMC-9805, a RAS(ON) G12D-selective inhibitor, showing promising safety and antitumor activity in PDAC patients.
    • The Phase 1/1b study involved 179 patients with KRAS G12D mutations, testing doses from 150-1200 mg QD and 300-600 mg BID.
    • At 1200 mg daily, the objective response rate was 30% with a disease control rate of 80%, and the treatment was generally well tolerated.
    • No dose-limiting toxicities were observed, and the maximum tolerated dose was not reached, indicating potential for further development.
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  4. Trinity Biotech enters oncology space with acquisition of prostate cancer focused EpiCapture
    • Trinity Biotech acquires EpiCapture, a company developing a non-invasive test for aggressive prostate cancer.
    • The EpiCapture test uses epigenetic analysis to detect DNA methylation patterns, reducing the need for invasive biopsies.
    • Trinity Biotech plans to commercialize the test in the US and explore regulatory pathways for other markets.
    • The acquisition deal includes an initial consideration of $3 million, with an additional $0.5 million contingent on future milestones.
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  5. Ultimovacs publishes phase II FOCUS trial results
    • Ultimovacs announced the publication of Phase II FOCUS trial results on medRxiv.
    • The trial evaluated UV1 with pembrolizumab in head and neck squamous cell carcinoma.
    • No clinical benefits in progression-free survival or overall survival were observed.
    • UV1 maintained a positive safety profile, similar to previous studies.
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  6. Zymeworks presents new preclinical data on antibody-drug conjugate programs at EORTC-NCI-AACR conference
    • Zymeworks showcased preclinical data for ADC candidates ZW220 and ZW251 at the EORTC-NCI-AACR Conference.
    • ZW220 targets NaPi2b-expressing cancers and shows potential for IND submission in 1H 2025.
    • ZW251 targets glypican-3 in hepatocellular carcinoma, with IND submission expected in 2H 2025.
    • Both ADCs demonstrate strong preclinical activity and favorable tolerability profiles in animal studies.
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  7. Modalis Therapeutics receives orphan drug designation for MDL-101
    • Modalis Therapeutics has been granted Orphan Drug Designation by the FDA for MDL-101, targeting congenital muscular dystrophy type 1A (LAMA2-CMD).
    • MDL-101 uses CRISPR-GNDM technology to modulate gene expression, aiming to activate the LAMA1 gene to compensate for LAMA2 deficiency.
    • LAMA2-CMD is a severe genetic disorder with no current approved treatments in the U.S., highlighting the high unmet medical need.
    • The designation supports the development of MDL-101, potentially offering a one-time, durable treatment for LAMA2-CMD patients.
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  8. ImPact Biotech to present updated interim phase 3 data from ENLIGHTED study of padeliporfin VTP in low grade UTUC at EMUC 2024
    • ImPact Biotech will present interim results from the ENLIGHTED Phase 3 study at EMUC 2024 in Lisbon.
    • The study focuses on the efficacy and safety of Padeliporfin VTP for treating low-grade upper tract urothelial cancer (UTUC).
    • The presentation will be part of the EMUC24 Networking and Abstract Discussion Session on November 9, 2024.
    • Padeliporfin VTP is a minimally invasive therapy being evaluated for various solid tumors, including high-grade UTUC, PDAC, and NSCLC.
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  9. MicuRx completes phase 1 trial of MRX-5 in Australia
    • MicuRx successfully completed a Phase 1 clinical trial of MRX-5, an oral antibacterial agent, in Australia.
    • The trial assessed safety, tolerability, pharmacokinetics, and food effect of MRX-5, showing it was well tolerated with no serious adverse events.
    • MRX-5 demonstrated a linear pharmacokinetic profile, unaffected by food intake, supporting further development for NTM infections.
    • Future plans include exploring an all-oral treatment strategy for NTM infections, leveraging MRX-5's high specificity and favorable safety profile.
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  10. Celldex announces barzolvolimab met all primary and secondary endpoints in phase 2 study for chronic inducible urticaria
    • Barzolvolimab showed positive results in a Phase 2 trial for chronic inducible urticaria (CIndU), meeting all primary and secondary endpoints.
    • The study involved 196 patients with CIndU, focusing on cold urticaria and symptomatic dermographism, who were unresponsive to antihistamines.
    • Barzolvolimab demonstrated significant improvements in critical temperature and friction thresholds, with a favorable safety profile.
    • Celldex plans to advance barzolvolimab into Phase 3 development for CIndU in 2025.
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  11. Merck and Moderna initiate phase 3 trial evaluating adjuvant V940 (mRNA-4157) in combination with Keytruda after neoadjuvant Keytruda and chemotherapy in patients with certain types of non-small cell lung cancer (NSCLC)
    • Merck and Moderna have started a Phase 3 trial, INTerpath-009, to evaluate V940 (mRNA-4157) with Keytruda as adjuvant treatment for resectable Stage II, IIIA, or IIIB (N2) NSCLC.
    • The trial targets patients who did not achieve a pathological complete response after neoadjuvant Keytruda and platinum-based chemotherapy.
    • The study will enroll 680 patients globally, with a primary endpoint of disease-free survival (DFS).
    • Secondary endpoints include overall survival, distant metastasis-free survival, and safety.
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  12. ENVISION trial results show promising response for UGN-102 in bladder cancer
    • Phase 3 ENVISION trial results published in the Journal of Urology show an 82.3% 12-month duration of response for UGN-102 in LG-IR-NMIBC patients.
    • UGN-102 achieved a 79.6% complete response rate at three months, with durability estimates of 80.9% at 15 and 18 months.
    • UroGen Pharma has submitted a New Drug Application to the FDA, with a PDUFA goal date set for June 13, 2025.
    • The trial demonstrated a favorable safety profile, with common adverse events being mild-to-moderate.
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  13. IDEAYA Biosciences receives IND clearance for IDE275 in MSI-High solid tumors
    • IDEAYA Biosciences has received IND clearance from the FDA for IDE275 (GSK959), a Werner Helicase inhibitor, to initiate a Phase 1 trial in MSI-High solid tumors.
    • The trial will focus on endometrial, colorectal, and gastric cancers, where MSI-High prevalence is significant.
    • IDEAYA will receive a $7 million payment for IND acceptance, with potential future milestones up to $950 million.
    • GSK will sponsor the trial, covering 80% of global R&D costs, while IDEAYA will handle 20%.
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  14. Monte Rosa Therapeutics announces global license agreement with Novartis
    • Monte Rosa Therapeutics has entered a global license agreement with Novartis to advance VAV1-directed molecular glue degraders, including MRT-6160.
    • Monte Rosa will receive a $150 million upfront payment and is eligible for up to $2.1 billion in milestone payments and tiered royalties on ex-U.S. sales.
    • Novartis will handle the development and commercialization of MRT-6160 starting from Phase 2, while Monte Rosa completes the ongoing Phase 1 study.
    • The agreement is subject to customary closing conditions, including regulatory clearance.
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  15. Delfi diagnostics partners with Incendia therapeutics for phase 1 trial
    • DELFI Diagnostics' DELFI-TF Monitoring assay will be used in Incendia Therapeutics' Phase 1 clinical trial (NCT05753722).
    • The assay aims to evaluate treatment response and disease progression in patients with advanced solid tumors.
    • DELFI-TF requires less than 1 mL of plasma, beneficial for early clinical studies with large blood volume needs.
    • The collaboration leverages DELFI's precision monitoring to enhance Incendia's novel therapeutics development.
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