Nouscom completes patient enrollment for phase 2 study of NOUS-209 in metastatic colorectal cancer
- Nouscom has completed patient enrollment for a Phase 2 trial evaluating NOUS-209 with pembrolizumab in dMMR/MSI metastatic colorectal cancer.
- The trial involves 69 patients and compares NOUS-209 plus pembrolizumab against pembrolizumab alone.
- Primary efficacy endpoint readout, focusing on Objective Response Rate (ORR), is expected in mid-2025.
- NOUS-209 is designed to activate immune responses by targeting MSI tumor-specific neoantigens.
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Curium completes enrollment early of phase 3 SOLAR-RECUR prostate cancer trial
- Curium has completed enrollment for its Phase 3 SOLAR-RECUR trial, focusing on the diagnostic performance of copper Cu 64 PSMA I&T PET/CT in men with suspected biochemical recurrence of prostate cancer.
- The trial is a multicenter, open-label study involving over 30 sites across the U.S.
- An additional Phase 3 trial, SOLAR-STAGE, is ongoing and will soon expand to Europe.
- The completion of enrollment marks a significant milestone in Curium's theranostic program for prostate cancer.
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ABK Biomedical receives FDA IDE stage 2 approval for Route90 study
- ABK Biomedical has received FDA approval to advance the Route90 study to Stage 2, based on interim safety outcomes from Stage 1.
- The pivotal study evaluates the safety and efficacy of Eye90 microspheres in patients with unresectable hepatocellular cancer (HCC).
- Co-primary endpoints include tumor response rates and duration of response, with additional endpoints for safety and post-treatment CT-dosimetry.
- Eye90 microspheres is the first imageable Y90 microspheres device, aiming to establish a new standard for HCC radioembolization.
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Theolytics doses first patient in phase I/IIa trial of THEO-260 in ovarian cancer
- Theolytics has initiated a Phase I/IIa trial for THEO-260, an oncolytic immunotherapy targeting advanced ovarian cancer.
- THEO-260 is designed to lyse cancer cells and cancer-associated fibroblasts, alleviating immune suppression.
- The trial aims to assess the safety and tolerability of THEO-260 and determine the recommended Phase II dose.
- Future plans include a study of THEO-260 via intraperitoneal delivery for advanced ovarian cancer patients.
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Merck announces phase 3 trial of subcutaneous pembrolizumab with berahyaluronidase alfa met primary endpoints
- Merck's Phase 3 MK-3475A-D77 trial evaluated subcutaneous pembrolizumab with berahyaluronidase alfa for metastatic non-small cell lung cancer (NSCLC).
- The trial met its dual primary pharmacokinetic endpoints, demonstrating noninferiority to intravenous KEYTRUDA.
- Secondary endpoints of efficacy and safety were consistent between subcutaneous and intravenous administration.
- Results will be presented at an upcoming medical meeting and shared with regulatory authorities worldwide.
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ImmunityBio completes ANKTIVA’s post-approval enrollment in NMIBC CIS trial
- ImmunityBio's QUILT 3.032 study treated 100 patients with BCG-unresponsive NMIBC CIS using ANKTIVA and BCG.
- The trial reported a 71% complete response rate, with some responses lasting up to 54 months.
- Data will be submitted to the EMA for a Marketing Authorization Application in the EU by Q4 2024.
- The study continues to monitor patients for response durability and overall survival outcomes.
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Lantern Pharma doses first patient in Japan for phase 2 trial of LP-300 in NSCLC
- Lantern Pharma has dosed the first patient in Japan for the expansion cohort of the Phase 2 HARMONIC trial.
- The trial targets never-smoker NSCLC patients who have progressed after tyrosine kinase inhibitor treatments.
- Conducted at five sites in Japan, the trial aims to address the high prevalence of never-smoker NSCLC in Asia.
- The trial evaluates LP-300 in combination with carboplatin and pemetrexed, with primary endpoints of progression-free and overall survival.
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AIM ImmunoTech publishes breast cancer data from Roswell Park study
- AIM ImmunoTech's drug Ampligen was evaluated in a Phase 1 study for early-stage triple-negative breast cancer (TNBC).
- The study, conducted by Roswell Park Comprehensive Cancer Center, showed promising results in modifying the tumor microenvironment.
- Ampligen's chemokine modulation regimen attracted killer T-cells into TNBC tumors, similar to results seen in other cancers.
- The study will advance to Phase 2 to validate findings in a larger patient group.
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Pharmanovia signs biologic in-licensing agreement with Lindis Biotech for catumaxomab
- Pharmanovia has secured exclusive rights to commercialize catumaxomab, a trifunctional bi-specific monoclonal antibody, for malignant ascites treatment.
- Catumaxomab targets EpCAM-positive carcinomas and enhances the immune system to kill tumor cells.
- The drug was previously approved but withdrawn for commercial reasons; Pharmanovia aims to reintroduce it pending regulatory approval.
- A positive opinion from the EMA's CHMP was received, with EU marketing authorization expected by the end of 2024.
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Alpha Biopharma receives NMPA approval for Zorifertinib tablets
- Zorifertinib, developed by Alpha Biopharma, is approved by the NMPA for treating NSCLC with CNS metastases.
- The drug is the first EGFR-TKI designed to penetrate the blood-brain barrier, showing significant intracranial PFS benefits.
- The EVEREST trial demonstrated a 37% reduction in intracranial progression risk, with PFS reaching 17.9 months.
- Zorifertinib is expected to enhance patient care for lung cancer with brain metastases.
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Jazz Pharmaceuticals receives FDA approval for Ziihera in HER2-positive biliary tract cancer
- Ziihera, a dual HER2-targeted bispecific antibody, received accelerated FDA approval for HER2-positive biliary tract cancer (BTC).
- Approval was based on a 52% objective response rate and a median duration of response of 14.9 months from the HERIZON-BTC-01 trial.
- The ongoing Phase 3 HERIZON-BTC-302 trial will evaluate Ziihera in combination with standard-of-care therapy.
- Continued approval may depend on confirmatory trial results.
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CytoMed Therapeutics doses first patient in phase I trial of CAR-gamma delta T cell therapy
- CytoMed Therapeutics has dosed the first patient in its phase I ANGELICA Trial for advanced solid tumors or hematological malignancies.
- The trial evaluates allogeneic CAR-gamma delta T cells, which are derived from donors, potentially improving therapy accessibility.
- The trial is authorized by the Health Sciences Authority in Singapore and aims to assess safety and potential efficacy.
- This approach could reduce production costs and eliminate the need for donor-patient compatibility matching.
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Kura Oncology and Kyowa Kirin announce global strategic collaboration to develop and commercialize ziftomenib in acute leukemias
- Kura Oncology will receive a $330 million upfront payment and up to $1.2 billion in milestone payments.
- The collaboration involves a 50/50 profit share in the U.S., with Kura leading U.S. development and commercialization.
- Kyowa Kirin will have exclusive commercialization rights outside the U.S., with Kura receiving tiered double-digit royalties.
- The companies plan to launch multiple Phase 2 and Phase 3 studies of ziftomenib in AML and other hematologic malignancies.
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Nurix Therapeutics receives PRIME designation for NX-5948
- The European Medicines Agency (EMA) granted PRIME designation to NX-5948 for treating relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
- PRIME designation is given to medicines that address unmet medical needs and show potential benefits based on early clinical data.
- NX-5948 is a selective degrader of Bruton’s tyrosine kinase (BTK) and is currently in Phase 1 clinical trials.
- Pivotal trials for NX-5948 are planned to start in 2025.
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Pyxis Oncology announces favorable preliminary PYX-201 clinical phase 1 part 1 data
- PYX-201 achieved a 50% objective response rate (ORR) in heavily pretreated HNSCC patients, with a 100% disease control rate.
- A new clinical trial collaboration with Merck will evaluate PYX-201 in combination with KEYTRUDA, starting in Q1 2025.
- PYX-201 was generally well-tolerated, showing a favorable safety profile in the ongoing Phase 1 trial.
- Multiple data updates and expansion trials are expected in 2025, including monotherapy and combination studies.
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