Weizmann Institute of Science

ImPact Biotech to Present Promising Data on Padeliporfin VTP for UTUC and Prostate Cancer at AUA 2025

a month ago

• ImPact Biotech will present updated preliminary results from the ENLIGHTED Phase 3 study evaluating Padeliporfin VTP as a non-invasive treatment option for low-grade upper tract urothelial cancer at AUA 2025. • The company will also share 48-month follow-up data from the PCM-204 Phase 2b trial investigating Padeliporfin VTP for intermediate-risk prostate cancer, expanding on its established mechanism of action in low-risk disease. • Enrollment for the ENLIGHTED trial is expected to complete in the second half of 2025, with the study targeting up to 100 patients across more than 20 clinical sites globally.

RBX2660 Receives FDA Breakthrough Therapy Designation for Recurrent C. diff Infection

4 months ago

• RBX2660, a microbiota restoration therapy developed by Rebiotix and acquired by Ferring, has been granted Breakthrough Therapy Designation by the FDA for recurrent Clostridioides difficile infection. • The drug aims to restore gut microbiome balance by transplanting live, human-derived microbes into the intestinal tract, offering a potential alternative to antibiotic treatments. • Phase 3 trial data (PUNCH CD 3) demonstrated preliminary positive efficacy in reducing C. diff recurrence, positioning RBX2660 as a frontrunner in live microbiota-based therapies. • RBX2660 has already been granted orphan drug and fast-track status, potentially expediting its path to market for patients with limited treatment options.

Kadimastem and iTolerance Seek FDA Input for Novel Type 1 Diabetes Therapy, iTOL102

5 months ago

• Kadimastem and iTolerance have submitted a request for a Pre-IND meeting with the FDA for iTOL102, a novel treatment for Type 1 Diabetes. • iTOL102 combines allogeneic stem cell-derived pancreatic islets with an immunomodulator to potentially cure Type 1 Diabetes. • Preclinical studies of iTOL102 at the Diabetes Research Institute showed functional insulin release and disease reversal in animal models. • NLS Pharmaceutics anticipates its merger with Kadimastem will enhance its pipeline with valuable assets, pending shareholder approval.

Novel Alzheimer's Therapies Target APP, Tau, and ApoE4 in Early-Phase Trials

6 months ago

• Mivelsiran, an siRNA targeting APP, demonstrates durable reduction of APP metabolites in CSF and is being evaluated for cerebral amyloid angiopathy (CAA). • BIIB080, an antisense oligonucleotide, shows promising tau-PET trajectories, slowing tau accumulation across Braak regions in Phase 1 trial participants. • LX1001, a gene therapy delivering ApoE2, increases CSF ApoE2 levels and stabilizes tau deposition in ApoE4 homozygotes with MCI or mild to moderate AD. • Intranasal insulin combined with empagliflozin shows potential in improving cognition and reducing inflammation in MCI or early AD patients.

Hyperbaric Oxygen Therapy Shows Promise for Combat-Related PTSD in Veterans

6 months ago

• A randomized, sham-controlled trial reveals that hyperbaric oxygen therapy (HBOT) significantly reduces PTSD symptoms in veterans with combat-associated PTSD. • The study demonstrated a 68% treatment response rate in the HBOT group compared to 4% in the sham group, based on a 30% reduction in CAPS-5 scores. • Resting-state fMRI analysis showed improved brain connectivity within key networks, including the default mode, salience, and frontoparietal networks, in the HBOT group. • HBOT was well-tolerated, suggesting it could be a valuable therapeutic option for veterans with PTSD who have not responded to traditional treatments.

Padeliporfin VTP Shows High Complete Response Rate in UTUC Phase 3 Trial

6 months ago

• Interim Phase 3 data shows Padeliporfin VTP achieved an 86% complete response rate in patients with low-grade upper tract urothelial cancer (UTUC). • The ENLIGHTED study evaluates Padeliporfin VTP for low-grade UTUC, offering a potential alternative to invasive surgery. • Padeliporfin VTP demonstrates a favorable safety profile, with mostly Grade 1 or 2 adverse events that resolved quickly. • ImPact Biotech plans to complete enrollment by early 2025 and explore Padeliporfin VTP in other solid tumors like PDAC.

Padeliporfin VTP Shows High Complete Response Rate in Low-Grade UTUC

6 months ago

• ImPact Biotech's Padeliporfin VTP demonstrated an 85% complete response rate in patients with low-grade upper tract urothelial cancer (UTUC). • The ENLIGHTED Phase 3 trial evaluated Padeliporfin VTP, a vascular-targeted photodynamic therapy, for treating low-grade UTUC. • Treatment with Padeliporfin VTP was well-tolerated, with mostly Grade 1 or 2 adverse events that resolved within a week. • ImPact Biotech anticipates completing enrollment for the ENLIGHTED study by early 2025, with plans to explore the therapy in other solid tumors.

Padeliporfin VTP Shows High Complete Response Rate in Low-Grade UTUC

6 months ago

• Interim Phase 3 data shows Padeliporfin VTP achieved an 86% complete response rate in evaluable patients with low-grade upper tract urothelial cancer (UTUC). • The treatment maintains a consistent safety profile, with adverse events primarily being low-grade and resolving quickly, according to the ENLIGHTED study. • ImPact Biotech expects to complete enrollment in the ENLIGHTED study by early 2025, potentially leading to registration of Padeliporfin VTP for UTUC. • A Phase 1 study is planned to replicate the effect of Padeliporfin VTP in other unresectable solid tumors, starting with pancreatic ductal adenocarcinoma (PDAC).

ImPact Biotech to Present Phase 3 Data on Padeliporfin for Low-Grade UTUC at EMUC 2024

7 months ago

• ImPact Biotech will present interim Phase 3 results from the ENLIGHTED study of Padeliporfin VTP for low-grade upper tract urothelial cancer (UTUC). • The presentation will occur at the European Multidisciplinary Congress on Urological Cancers (EMUC) on November 9, 2024. • The ENLIGHTED study evaluates the efficacy and safety of Padeliporfin VTP, a minimally invasive treatment for unresectable solid tumors.

ImPact Biotech's Padeliporfin VTP Shows Promise in Phase 3 UTUC Trial

8 months ago

• ImPact Biotech's ENLIGHTED trial of Padeliporfin VTP for low-grade UTUC has reached 50% enrollment, marking a key milestone. • Interim results from the trial indicate a 77% complete response rate in response-evaluable patients after the induction treatment phase. • The ENLIGHTED trial is expected to complete enrollment by Q1 2025, with additional interim data anticipated in Q4 2024. • Padeliporfin VTP, administered intravenously with laser activation, is being evaluated as a potential novel treatment for UTUC.