Senhwa Biosciences submits IND to US FDA for phase I/II study of Silmitasertib in pediatric solid tumors
- Senhwa Biosciences has submitted an IND to the US FDA for a Phase I/II study of Silmitasertib (CX-4945) in children and young adults with relapsed refractory solid tumors.
- The trial, conducted by Penn State Health Children's Hospital and the Beat Childhood Cancer Research Consortium, will focus on safety, dosage, and efficacy.
- Funding is provided by the Four Diamonds Foundation, with Senhwa supplying the investigational drug.
- Senhwa plans to apply for Orphan Drug Designation and Rare Pediatric Disease Designation for Silmitasertib in treating neuroblastoma.
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Revolution Medicines demonstrates anti-tumor activity of RAS(ON) inhibitors in preclinical models
- Revolution Medicines published research in Cancer Discovery showing robust anti-tumor activity of RAS(ON) multi-selective inhibitor RMC-7977 in KRAS-mutated NSCLC.
- The study highlighted enhanced anti-tumor effects when RMC-7977 was combined with RAS(ON) G12C-selective inhibitor RMC-4998.
- The combination therapy showed significant tumor regression and prolonged time to tumor doubling in preclinical models.
- Revolution Medicines is currently evaluating RMC-6236 in multiple clinical trials, including combinations with pembrolizumab and RMC-6291.
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Kolon TissueGene completes patient dosing in two pivotal US Phase III clinical trials for TG-C
- Kolon TissueGene has completed patient dosing in two US Phase 3 clinical trials for TG-C, targeting knee osteoarthritis.
- The trials involved 1,066 patients and will be followed by a two-year safety and efficacy assessment period.
- The company plans to submit a Biologics License Application (BLA) to the FDA after the follow-up period.
- Preparations for commercial production are underway in collaboration with Lonza.
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Immunotherapy approach shows potential in some people with metastatic solid tumors
- NIH researchers achieved tumor shrinkage in three of seven patients with metastatic colorectal cancer.
- The trial involved genetically engineering lymphocytes to produce receptors that recognize and attack specific cancer cells.
- Tumors shrank and were kept from regrowing for up to seven months in some patients.
- The study is ongoing and includes patients with different types of solid cancers.
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Immutep reports positive results in first line head and neck squamous cell carcinoma patients with negative PD-L1 expression
- Efti in combination with KEYTRUDA achieved a 35.5% response rate in evaluable patients (N=31) with CPS <1.
- High complete response rate of 9.7% with three patients showing a disappearance of cancer lesions post-treatment.
- Over 50% of patients received treatment for at least six months, with no new safety signals observed.
- Immutep will discuss the path forward with regulatory agencies based on these encouraging results.
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First patient dosed in phase I clinical trial of YOLT-201
- YolTech Therapeutics has dosed the first patient in the Phase I clinical trial of YOLT-201, an in vivo gene editing therapy for ATTR.
- The trial is a multicenter, open-label, single-dose study evaluating safety, tolerability, pharmacokinetics, and pharmacodynamics.
- YOLT-201 aims to knock down TTR protein levels in serum, potentially providing lifelong benefits to patients.
- The trial consists of two stages: dose-escalation to determine the optimal biological dose, followed by dose-expansion to assess safety and preliminary efficacy.
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Myeloma Investment Fund invests in Dynamic Cell Therapies to help fuel novel CAR-T-cell technologies
- Dynamic Cell Therapies (DCT) receives a $1M investment from the Myeloma Investment Fund (MIF).
- The investment aims to accelerate the development of novel CAR-T cell technologies for multiple myeloma.
- DCT's proprietary CAR-T cells have shown superiority to FDA-approved CAR-T cells in animal models.
- The technology platforms will improve the safety and efficacy of CAR-T cell therapies, with applications for hematological cancers.
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