Evolveimmune Therapeutics Inc. has gained IND clearance from the U.S. FDA for EVOLVE-104, a novel trispecific T-cell engager for the treatment of solid tumors. The company will begin a phase I trial this year.
Lung cancer, which often occurs as lung adenocarcinoma, is the leading cause of cancer-related death worldwide. At least 70% of lung adenocarcinoma patients fail to show long-term benefit from immune checkpoint inhibitors, highlighting the need to identify in advance those more likely to benefit.
Endometrial cancer is the second most prevalent gynecological malignancy. Current standard treatments for endometrial cancer typically include a combination of surgery, radiation therapy and, in some cases, chemotherapy or hormonal therapy, depending on the tumor stage and molecular characteristics. However, the outcomes for metastatic and recurrent cases remain poor.
Prognosis is extremely poor for patients with head and neck squamous cell carcinoma (HNSCC), which accounts for around 90% of all head and neck cancer. Especially in the more aggressive subtype of HNSCC that is not associated with human papilloma virus infection, the natural killer cells that could fight HNSCC tumors are inhibited within the tumor microenvironment, in part because of the hypoxic conditions.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Immune checkpoint inhibitor therapy has proven effective against many types of solid tumors, but not many subtypes of ovarian cancer, including the rare subtype of ovarian clear cell carcinoma (OCCC). Now, researchers have identified a subtype of OCCC that involves inactivating mutations in the gene PPP2R1A and that responds well to immune checkpoint inhibitor therapy.
Radiopharm Theranostics Ltd. announced that the U.S. FDA has cleared the IND application for betabart (RV-01), its Lu177-B7H3 monoclonal antibody designed with strong affinity for the 4Ig isoform of B7-H3 that is highly expressed in tumors and not in healthy tissues.
Activating apoptosis of tumor cells by binding a soluble form of the membrane protein TRAIL to its surface receptors DR4 and DR5 on the tumor surface shows promise as a cancer therapy, but the ligand on its own has only a minutes-long half-life and does not strongly activate the receptors.
The U.S. FDA has cleared Zymeworks Inc.’s IND application for ZW-251, a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating the company’s proprietary topoisomerase 1 (TOPO1) inhibitor payload, ZD-06519, for the treatment of hepatocellular carcinoma (HCC).
Researchers at the Fred Hutchinson Cancer Research Center found that autoantibodies targeting the exoproteome reshaped checkpoint inhibitor responses and opened new avenues to enhance immunotherapy. In the study published in the July 23, 2025, issue of Nature, the authors set out to address a long-standing question in cancer immunotherapy: why patients with the same type of cancer, treated with the same immunotherapy, can experience such drastically different outcomes.
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