City of Hope CAR T cell therapy for advanced prostate cancer demonstrates positive results in phase 1 clinical trial
- City of Hope conducted a phase 1 trial using CAR T cell therapy for metastatic castration-resistant prostate cancer (mCRPC).
- The trial involved 14 PSCA-positive patients, showing minimal side effects and promising therapeutic activity.
- Patients received a single infusion of 100 million CAR T cells without prior lymphodepletion chemotherapy.
- Four out of 14 patients had declines in PSA levels, with one patient showing a significant decline.
- Five out of 14 patients experienced mild or moderate cytokine release syndrome, a common side effect.
- A follow-up phase 1b trial aims to enroll up to 24 patients, combining PSCA-CAR T cell therapy with radiation.
Read more
Junshi Biosciences announces phase 3 study of toripalimab combined with bevacizumab for the first-line treatment of advanced hepatocellular carcinoma meets primary endpoint
- The phase 3 HEPATORCH study evaluated toripalimab combined with bevacizumab for first-line treatment of advanced hepatocellular carcinoma (HCC).
- The study met its primary endpoints of progression-free survival (PFS) and overall survival (OS).
- Toripalimab combined with bevacizumab significantly improved PFS and OS compared to sorafenib.
- The safety profile of toripalimab was consistent with known risks, with no new safety signals identified.
- Junshi Biosciences plans to submit a supplemental new drug application (NDA) for this indication to regulatory authorities.
- Further details will be presented at an upcoming international academic conference.
Read more
OBI Pharma announces phase 1/2 study initiation for OBI-992, a TROP2-targeted antibody-drug conjugate (ADC) for cancer therapy
- OBI Pharma has initiated a Phase 1/2 clinical trial for OBI-992, an ADC targeting TROP2.
- The trial will enroll patients with advanced solid tumors, including NSCLC, SCLC, and gastric cancer.
- Objectives include verifying the safety, pharmacokinetics, and preliminary efficacy of OBI-992.
- OBI-992 features high serum stability, excellent bystander effect, and potential to overcome drug resistance.
- The TROP2 targeting antibody was in-licensed from Biosion, Inc. in December 2021.
- OBI Pharma owns ex-China commercial rights for OBI-992.
Read more
KSQ Therapeutics announces first patient dosed in clinical development program for KSQ-001EX
- KSQ Therapeutics has dosed the first patient in the Phase 1/2 clinical study of KSQ-001EX, a CRISPR/Cas9 engineered TIL therapy.
- KSQ-001EX involves TIL with the SOCS1 gene inactivated, potentially enhancing T cell growth, survival, and differentiation.
- The Phase 1/2 trial is an open-label, safety lead-in study targeting melanoma, head and neck squamous cell carcinoma, and non-small cell lung cancer.
- Primary objectives include evaluating the safety and tolerability in Phase 1 and antitumor activity in Phase 2.
- Preclinical studies showed KSQ-001EX has enhanced anti-tumor activity, persistence, and memory formation in solid tumor models.
- The trial is being conducted at The University of Texas MD Anderson Cancer Center.
Read more
Laminar Pharmaceuticals completes recruitment for phase 2b/3 trial of idroxioleic acid in glioblastoma
- Laminar Pharmaceuticals has completed patient recruitment for the CLINGLIO phase 2b/3 trial.
- 140 patients have been enrolled across 21 hospitals in Spain, Italy, France, and the UK.
- The trial evaluates idroxioleic acid (LAM561) in combination with standard care for newly diagnosed glioblastoma.
- Interim analysis is expected in July 2024, with an unblinded readout by late 2024.
- Regulatory filings for conditional marketing authorization are planned for early 2025.
- The trial will continue until the final analysis of overall survival in 2026.
Read more
Prostate Cancer Foundation-funded research shows promising results against lethal form of prostate cancer
- City of Hope researchers, funded by the Prostate Cancer Foundation (PCF), report promising results from a phase 1 clinical trial using CAR T cell therapy for advanced prostate cancer.
- The trial involved 14 patients with metastatic castration-resistant prostate cancer (mCRPC) treated with PSCA-directed CAR T cells.
- Patients' T cells were reprogrammed to target the PSCA protein on cancer cells and then infused back into the patients.
- Four patients showed declines in PSA levels, a biomarker for prostate cancer progression, with one patient experiencing a 95% decrease.
- Mild to moderate cytokine release syndrome was observed in five patients, a common side effect of CAR T cell therapy.
- A phase 1B trial is planned to address the persistence of CAR T cells and enhance anti-tumor activity through repeat dosing and combination with radiation.
Read more
Processa Pharmaceuticals announces positive efficacy results from preliminary evaluation of Phase 1b dose-escalating trial with NGC-Cap in gastrointestinal cancer
- Eight of 12 evaluable patients (66.7%) had progression-free survival (PFS) ranging from 5 to 11 months.
- At the highest NGC-Cap dose, all three evaluable patients had PFS with two partial responses (PR) and one stable disease (SD).
- For all NGC-Cap doses, 5-Fluorouracil (5-FU) exposure was greater and fluoro-beta-alanine (FBAL) exposure was lower with a better or similar side-effect profile than monotherapy capecitabine.
- The trial defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap.
- These dosage regimens will be further evaluated in a Phase 2 trial in breast cancer patients to determine the optimal dosage regimen for the pivotal trial.
- Processa is starting to initiate sites for the Phase 2 study to identify the optimal dosage regimen for NGC-Cap in various cancers.
Read more
TRACON announces publication of phase 2 clinical data for TRC102 in recurrent glioblastoma patients
- TRACON Pharmaceuticals published Phase 2 clinical data for TRC102 in Clinical Cancer Research.
- The study evaluated TRC102 in combination with Temodar in 19 patients with recurrent glioblastoma.
- Extended survival observed in two patients with progression-free survival ≥ 17 months and overall survival > 32 months.
- The study confirms the safety and feasibility of TRC102 with Temodar and suggests further evaluation in biomarker-enriched trials.
- TRC102 is also being studied in a Phase 2 trial for stage III non-squamous non-small cell lung cancer, sponsored by the NCI.
- TRC102 was granted orphan drug designation by the US FDA for the treatment of malignant glioma in 2020.
Read more
Foundation Medicine announces partnership with Repare Therapeutics to provide genomic profiling services
- Foundation Medicine collaborates with Repare Therapeutics to support the Phase I/Ib MYTHIC study of lunresertib.
- The partnership aims to develop FoundationOne CDx as a companion diagnostic for lunresertib.
- Lunresertib is a first-in-class, selective oral small molecule inhibitor of PKMYT1, targeting specific genetic alterations in solid tumors.
- Initial Phase 1 data shows positive safety and anti-tumor activity for lunresertib alone and in combination with camonsertib.
- FoundationOne CDx test analyzes over 300 cancer-related genes and has more than 35 companion diagnostic indications.
- Foundation Medicine leads in companion diagnostic approvals, holding approximately 60% of all U.S. approvals for next-generation sequencing testing.
Read more
Eilean Therapeutics joins The Leukemia & Lymphoma Society's Beat AML master clinical trial
- Eilean Therapeutics has joined The Leukemia & Lymphoma Society's Beat AML Master Clinical Trial.
- The trial will evaluate lomonitinib, Eilean's precision therapy for FLT3 mutated relapsed/refractory acute myeloid leukemia (AML).
- Lomonitinib is a pan-FLT3/IRAK4 inhibitor targeting FLT3 mutations and escape pathways.
- This is Beat AML's first phase 1 sub-study and its first precision medicine study for relapsed/refractory AML.
- Beat AML is a collaborative trial sponsored by a nonprofit, showing superior survival rates and better quality of life.
- The trial aims to advance AML treatment by matching targeted therapies to genetic mutations.
Read more
