RedHill initiates phase 2 study of opaganib and darolutamide in advanced prostate cancer
- RedHill Biopharma has started a Phase 2 study to evaluate opaganib with darolutamide in metastatic castrate-resistant prostate cancer (mCRPC).
- The study is placebo-controlled, randomized, and involves 80 patients, with financial support from Bayer and Ramsay Hospital Research Foundation.
- Primary endpoint is improved 12-month radiographic progression-free survival (rPFS), using a companion lipid biomarker test (PCPro) for patient selection.
- The study aims to overcome resistance to standard androgen receptor pathway inhibition treatments.
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MAIA biotechnology announces positive efficacy updates for phase 2 THIO-101 trial in advanced non-small cell lung cancer
- MAIA Biotechnology reported positive data from its Phase 2 THIO-101 trial for advanced NSCLC.
- The trial showed a median overall survival of 16.9 months for patients treated with THIO and cemiplimab.
- This survival rate significantly exceeds the 5-6 months typically seen with standard chemotherapy.
- MAIA is considering accelerated FDA approval based on these promising results.
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Pyxis Oncology initiates new PYX-201 combination trial and cohort expansions
- Pyxis Oncology has launched a Phase 1/2 trial combining PYX-201 with Merck's KEYTRUDA for multiple solid tumors.
- The trial is part of a collaboration with Merck and targets advanced solid tumors, including head and neck cancer and breast cancer.
- An ongoing Phase 1 monotherapy trial for PYX-201 is expanding to include new cohorts for head and neck cancer.
- Both trials aim to explore PYX-201's potential as a breakthrough treatment for difficult-to-treat cancers.
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Auron Therapeutics receives FDA clearance for AUTX-703 and completes Series B financing
- Auron Therapeutics has received FDA clearance to initiate clinical development of AUTX-703 for hematologic malignancies.
- AUTX-703 is a first-in-class, oral KAT2A/B degrader, with preclinical data showing a survival advantage in acute myelogenous leukemia (AML).
- The $27 million Series B financing will fund AUTX-703's Phase 1 clinical proof-of-concept trial and explore KAT2A/B's potential in autoimmune diseases.
- The trial is set to begin patient enrollment in the first quarter of 2025, with plans to study AUTX-703 in solid tumors like neuroendocrine prostate and small-cell lung cancer.
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Vivos Inc. reports encouraging human clinical trial results and announces expansion plans
- Initial clinical trial results show safety of RadioGel Precision Radionuclide Therapy with no adverse events in the first five patients.
- A significant reduction in tumor size and metastatic activity was observed in a patient, indicating early signs of efficacy.
- Plans to expand the trial from 30 to 50 patients, including new deep injection technology for treating deeper-seated tumors.
- Collaboration with IsoTherapeutics to enhance production capacity and explore additional manufacturing partners for global expansion.
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Nuvectis Pharma announces proposed public offering of common stock
- Nuvectis Pharma has initiated an underwritten public offering of its common stock.
- The company plans to grant underwriters a 30-day option to purchase an additional 15% of shares.
- Proceeds will support development programs for NXP800 and NXP900, personnel hiring, and other corporate purposes.
- Lucid Capital Markets is the sole book runner for the offering.
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IO Biotech publishes preclinical data on IO112 cancer vaccine
- IO Biotech announced preclinical results for IO112, a cancer vaccine targeting arginase 1.
- The study showed IO112 enhances anti-tumor immunity by reprogramming tumor-associated macrophages.
- Arginase 1 is overexpressed in several cancers, contributing to immune suppression.
- An Investigational New Drug (IND) application for IO112 is expected to be submitted to the US FDA in 2025.
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Rakuten Medical completes technology transfer of IR700 manufacturing
- Rakuten Medical has completed the technology transfer for IR700 manufacturing from LI-COR Biosciences.
- IR700 is a light-activatable dye used in the Alluminox platform for photoimmunotherapy.
- The company now holds exclusive rights to manufacture and supply IR700, enhancing its business foundation.
- Rakuten Medical plans to pursue strategic partnerships to advance IR700-related therapeutic technologies.
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Efficacy of zenocutuzumab in NRG1 fusion-positive cancer published in NEJM
- The New England Journal of Medicine published results from the phase 2 eNRGy trial for zenocutuzumab, targeting NRG1 fusion-positive cancers.
- Zenocutuzumab is indicated for advanced pancreatic adenocarcinoma and NSCLC with NRG1 gene fusion, showing durable efficacy and a favorable safety profile.
- The trial involved 204 patients across 12 tumor types, with significant results in NSCLC and pancreatic adenocarcinoma.
- Merus has licensed commercialization rights in the U.S. to Partner Therapeutics for zenocutuzumab.
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Serplulimab approved in the EU for first-line treatment of extensive-stage small cell lung cancer
- Serplulimab, an anti-PD-1 monoclonal antibody, is approved by the European Commission for first-line treatment of ES-SCLC.
- The approval is based on the ASTRUM-005 Phase 3 study, which showed efficacy and safety of serplulimab with chemotherapy.
- Serplulimab has orphan drug designation in the EU, aiding its R&D and commercialization efforts.
- Henlius is conducting a bridging trial in the U.S. to support regulatory submission, comparing serplulimab with atezolizumab.
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Gradalis secures FDA RMAT designation for Vigil in advanced ovarian cancer
- Gradalis' Vigil, a personalized immunotherapy, received FDA's RMAT designation for advanced ovarian cancer.
- The designation is based on positive results from the Phase 2b VITAL study in HRP patients with high clonal tumor mutation burden.
- RMAT designation offers benefits like increased FDA interactions and potential expedited approval pathways.
- Gradalis aims to advance Vigil's development to address unmet needs in ovarian cancer treatment.
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Kura Oncology and Kyowa Kirin announce positive ziftomenib monotherapy trial and FDA feedback
- KOMET-001 trial in R/R NPM1-m AML achieved primary CR/CRh endpoint; NDA submission for ziftomenib expected in 2Q 2025.
- KOMET-017-IC and NIC Phase 3 trials to evaluate ziftomenib in combination with chemotherapy and venetoclax/azacitidine, respectively, starting 2H 2025.
- FDA feedback supports potential U.S. accelerated approval for ziftomenib in frontline AML treatment.
- Multiple clinical data presentations for ziftomenib and other pipeline programs anticipated throughout 2025.
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Erasmus Medical Center approves phase 2 study of Ampligen and Imfinzi for pancreatic cancer
- Erasmus Medical Center's Safety Committee approved the Phase 2 study of Ampligen and Imfinzi for late-stage pancreatic cancer.
- The approval follows positive Phase 1 safety data showing the combination therapy is well-tolerated with no severe adverse events.
- The Phase 2 study, named DURIPANC, is an open-label, single-center study in the Netherlands.
- Enrollment for Phase 2 is expected to begin soon, with up to 25 patients, including six from Phase 1.
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Akeso completes patient enrollment in phase III trial for sq-NSCLC treatment
- Akeso has completed patient enrollment for the Phase III HARMONi-6 trial comparing ivonescimab and tislelizumab for first-line treatment of sq-NSCLC.
- The trial evaluates ivonescimab, a PD-1/VEGF bispecific antibody, combined with chemotherapy against tislelizumab with chemotherapy.
- Ivonescimab is already approved in China for EGFR-TKI-resistant, non-squamous NSCLC and is under priority review for PD-L1-positive NSCLC.
- The trial is part of six global Phase III studies for ivonescimab, aiming to establish new standards in cancer immunotherapy.
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US patent granted for bifunctional compositions for cancer treatment
- Armaceutica, Inc. has been granted a US patent for bifunctional compositions using pyronaridine to treat various cancers.
- Pyronaridine, originally an anti-malarial drug, shows selective cytotoxicity against cancer cells while sparing healthy cells.
- Preclinical studies demonstrated reduced tumor volumes and increased longevity in mice and dogs with cancer.
- Armaceutica is seeking partners to develop pyronaridine as an approved cancer treatment, a process expected to take several years.
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