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 treatment was generally well tolerated, with common adverse events being mild GI-related toxicities and rash.
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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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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
- The Phase II FOCUS trial results were published on medRxiv, showing no clinical benefits in progression-free survival or overall survival with UV1 and pembrolizumab combination.
- The trial did not meet its primary and secondary endpoints but confirmed UV1's positive safety profile.
- The study involved 75 patients with head and neck squamous cell carcinoma, randomized to receive either UV1 with pembrolizumab or pembrolizumab alone.
- Next steps include further analysis of overall survival data, which will guide future development in this cancer indication.
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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 utilizes CRISPR-GNDM technology to modulate gene expression without altering DNA, 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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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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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 primary endpoint is disease-free survival, with secondary endpoints including overall survival and safety.
- Global recruitment has begun, with the first patients enrolling in Canada.
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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 and resolving.
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IDEAYA Biosciences receives IND clearance for IDE275 in MSI-High solid tumors
- IDEAYA's IDE275 (GSK959) has received IND clearance from the FDA for a Phase 1 trial in MSI-High solid tumors.
- The trial will target endometrial, colorectal, and gastric cancers, with MSI-High prevalence of 31%, 20%, and 19%, respectively.
- 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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Monte Rosa Therapeutics announces global license agreement with Novartis
- Monte Rosa Therapeutics has entered a global license agreement with Novartis for 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 royalties.
- Novartis will handle the development and commercialization of MRT-6160, starting with Phase 2 studies, while Monte Rosa completes the ongoing Phase 1 study.
- The agreement is subject to customary closing conditions, including regulatory clearance.
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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 by monitoring cfDNA with less than 1 mL of plasma.
- This collaboration leverages DELFI's advanced detection tools to enhance precision medicine in early clinical development.
- The trial focuses on Incendia's novel therapeutics that reprogram the tumor microenvironment.
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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 data from Cohort B of the TACTI-003 Phase IIb trial at ESMO I-O Congress 2024.
- The trial involves eftilagimod alpha and pembrolizumab in first-line recurrent/metastatic head and neck squamous cell carcinoma with CPS <1.
- Presentation by Dr. Martin Forster is scheduled for December 12, 2024, in Geneva, Switzerland.
- New data will be available on Immutep's website post-presentation.
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Shuttle Pharma completes clinical trial site enrollment for phase 2 of ropidoxuridine for treatment of patients with glioblastoma
- Shuttle Pharma has finalized agreements with six clinical trial sites for the Phase 2 trial of Ropidoxuridine in glioblastoma patients.
- The trial targets IDH wild-type, methylation negative glioblastomas, with patients currently being screened for enrollment.
- The study will randomize 40 patients into two dose groups to determine the optimal dose, with an additional 14 patients to be added for survival endpoint comparison.
- Completion of the trial is expected in 18 to 24 months, aiming to improve survival rates and quality of life for glioblastoma patients.
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