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 daily.
- At 1200 mg daily, the objective response rate was 30% with a disease control rate of 80%.
- The study reported no dose-limiting toxicities, and the maximum tolerated dose was not reached.
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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 dose, supporting potential combination development.
- 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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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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Qurient launches clinical trial for acute myeloid leukemia treatment with adrixetinib
- Qurient has initiated a Phase 1 clinical trial for adrixetinib (Q702) after FDA IND clearance.
- The trial will assess safety and efficacy of Q702 alone 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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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 or overall survival were observed.
- UV1 maintained a positive safety profile, consistent with previous studies.
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Zymeworks presents new preclinical data on antibody-drug conjugate programs
- Zymeworks shared preclinical data for ADC candidates ZW220 and ZW251 at the EORTC-NCI-AACR Conference.
- ZW220 targets NaPi2b-expressing cancers, showing potential in NSCLC, ovarian, and uterine cancer models with a favorable toxicology profile.
- ZW251 targets glypican-3 in hepatocellular carcinoma, demonstrating strong anti-tumor activity and significant tolerability in preclinical models.
- IND submissions for ZW220 and ZW251 are planned for the first and second half of 2025, respectively.
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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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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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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 in healthy adults.
- MRX-5 was well tolerated with no serious adverse events; pharmacokinetics showed a linear profile.
- The company plans to develop an all-oral treatment strategy for nontuberculous mycobacterial infections.
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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, including cold urticaria and symptomatic dermographism, who were refractory 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 inducible urticaria in 2025.
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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 and secondary endpoints including overall survival and safety.
- This trial is part of a broader clinical development program by Merck and Moderna to explore mRNA-4157 in various cancer types and treatment settings.
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ENVISION trial results published in the Journal of Urology
- Phase 3 ENVISION study shows UGN-102 achieved an 82.3% 12-month duration of response in LG-IR-NMIBC patients.
- UGN-102 demonstrated a 79.6% complete response rate at three months post-treatment.
- UroGen completed NDA submission to the FDA for UGN-102, with a PDUFA date set for June 13, 2025.
- The trial reported mild-to-moderate treatment-emergent adverse events, similar to previous studies.
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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 begin a Phase 1 trial in MSI-High solid tumors.
- The trial will target tumors with high microsatellite instability, prevalent in endometrial, colorectal, and gastric cancers.
- 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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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 both companies' strengths to enhance precision medicine and treatment monitoring.
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Immutep to present new phase IIb data in PD-L1 negative head and neck cancer at ESMO Immuno-Oncology 2024
- Immutep will present new data from the TACTI-003 Phase IIb trial at the ESMO Immuno-Oncology Congress 2024.
- The trial focuses on first-line recurrent/metastatic head and neck squamous cell carcinoma patients with negative PD-L1 expression (CPS <1).
- The presentation will feature eftilagimod alpha (soluble LAG-3) combined with pembrolizumab.
- The poster with new data will be available on Immutep’s website after the presentation on December 12, 2024.
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