June 12, 2024 - 🧬 [nGram] Today’s Oncology Scoop: City of Hope CAR T Cell Therapy, Junshi Biosciences Phase 3 Success, OBI Pharma's New Study

  1. 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.
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  2. 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.
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  3. 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.
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  4. 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.
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  5. 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.
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  6. 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.
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  7. 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.
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  8. 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.
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  9. 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.
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  10. 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.
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