Enhertu granted priority review in the US for HER2-low or HER2-ultralow metastatic breast cancer
- AstraZeneca and Daiichi Sankyo's sBLA for Enhertu has been accepted and granted Priority Review by the FDA.
- The application is based on positive results from the DESTINY-Breast06 Phase III trial, which compared Enhertu to chemotherapy.
- Enhertu reduced the risk of disease progression or death by 37% versus chemotherapy in the overall trial population.
- The FDA action date for the regulatory decision is anticipated during the first quarter of 2025.
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Alentis Therapeutics receives FDA IND clearance for ALE.P02, a novel CLDN1-ADC for the treatment of squamous cancers
- Alentis Therapeutics received FDA IND clearance for ALE.P02, an anti-CLDN1 ADC with a tubulin inhibitor payload.
- A Phase 1/2 clinical trial in patients with CLDN1+ squamous tumors is expected to start in Q1 2025.
- ALE.P02 targets squamous cancers with high CLDN1 expression, including head and neck, cervix, esophagus, and lung cancers.
- Alentis plans to initiate a first-in-human clinical trial for their second ADC program, ALE.P03, in 2025.
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Owkin partners with AstraZeneca to develop AI gBRCA pre-screen solution for breast cancer
- Owkin and AstraZeneca are collaborating to develop an AI-powered tool for pre-screening gBRCA mutations in breast cancer.
- The tool aims to accelerate and expand access to gBRCA testing, potentially identifying thousands more gBRCAm HR-positive early breast cancer patients by 2030.
- The solution leverages existing pathology slides and can identify high-risk patients in less than an hour, streamlining the diagnostic process.
- The gBRCA pre-screening solution is currently in development and undergoing validation.
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Volastra Therapeutics granted FDA fast track designation for novel KIF18A inhibitor in ovarian cancer
- Volastra Therapeutics' VLS-1488, a KIF18A inhibitor, received FDA Fast Track designation for treating platinum-resistant high-grade serous ovarian cancer (HGSOC).
- Fast Track designation aims to expedite the development and review of drugs for serious or life-threatening conditions.
- The Phase I/II trial for VLS-1488 is evaluating safety, tolerability, and preliminary efficacy in patients with advanced tumors, including HGSOC.
- Volastra's second KIF18A inhibitor, sovilnesib, also has Fast Track designation and is enrolling patients in early-phase studies.
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Maze Therapeutics initiates phase 1 trial for MZE782 in chronic kidney disease
- Maze Therapeutics has started a Phase 1 clinical trial for MZE782, targeting chronic kidney disease (CKD).
- MZE782 is an oral, small molecule targeting the solute transporter SLC6A19, potentially benefiting around five million CKD patients in the U.S.
- The trial is a randomized, double-blind, placebo-controlled study in healthy volunteers to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics.
- Initial results, including potential proof of mechanism, are expected in the second half of 2025.
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Genenta secures approval for innovative trial for metastatic renal cell cancer
- Genenta Science received approval from Agenzia Italiana del Farmaco (AIFA) for a Phase 1 clinical trial for metastatic renal cell cancer (mRCC).
- The trial will explore the use of Genenta’s flagship product, Temferon, which has shown promise in treating Glioblastoma Multiforme (GBM).
- The trial is set to commence in Q4 2024 and targets high-risk mRCC patients with a median overall survival of less than 2 years.
- Preclinical studies indicate that Temferon can reprogram the tumor microenvironment and activate the immune system, potentially improving outcomes for solid tumor patients.
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Kiromic BioPharma reports favorable 10-month follow-up results for the first patient treated in its Deltacel-01 clinical trial
- Kiromic BioPharma reports good safety and favorable efficacy results from the 10-month follow-up of the first patient in its Deltacel-01 Phase 1 trial.
- The trial evaluates Deltacel (KB-GDT-01), an allogeneic Gamma Delta T-cell therapy, in patients with stage 4 metastatic non-small cell lung cancer (NSCLC).
- The patient's tumor size reduced by approximately 27% with no new disease sites, achieving 10 months of progression-free survival without adverse events.
- Kiromic expects to report additional follow-up results from the fourth patient enrolled in this study in October.
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PreludeDx announces groundbreaking study results on HER2-positive DCIS patients
- PreludeDx's study in Clinical Breast Cancer shows significant advancement in personalized treatment for DCIS patients.
- The DCISionRT test identified HER2-positive patients with elevated residual risk after breast-conserving surgery and radiation therapy.
- Patients with the DCISionRT Residual Risk subtype had significantly higher in-breast recurrence rates (16.2% vs 1.6%, p=.01).
- The study suggests potential benefits of Trastuzumab for this subset of patients, as investigated in the NSABP-B43 trial.
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Papillon Therapeutics receives orphan drug designation from the U.S. Food and Drug Administration for PPL-002 for the treatment of Danon disease
- Papillon Therapeutics' PPL-002 has been granted Orphan Drug Designation by the FDA.
- PPL-002 is an experimental gene-modified CD34+ hematopoietic stem and progenitor cell (HSPC) therapy.
- The therapy aims to express functional Lamp-2 protein, which is deficient in Danon disease patients.
- Preclinical studies show PPL-002 improves disease phenotype in affected tissues.
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Cybin expands clinical team to support CYB003 phase 3 program
- Cybin Inc. has appointed Dr. Mirza Rahman as Senior Vice President, Patient Safety & Pharmacovigilance, and Dr. Marcelo Gutierrez as Vice President, Clinical Pharmacology.
- These appointments are in preparation for the Phase 3 pivotal trial of CYB003, a deuterated psilocin program for the adjunctive treatment of major depressive disorder (MDD).
- The Phase 3 program will consist of three studies across 12 different countries.
- Cybin aims to leverage the extensive experience of its new team members to advance its clinical operations and regulatory processes.
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