Tovecimig

Compass Therapeutics has shared promising results from a phase 2/3 study of its investigational bispecific antibody in biliary tract cancer (BTC). The ongoing COMPANION-002 trial has been evaluating the candidate, tovecimig (formerly CTX-009), alongside paclitaxel in adults with unresectable advanced, metastatic or recurrent BTC who have received one prior systemic chemotherapy regimen. The study met its primary endpoint, with tovecimig plus paclitaxel achieving a 17.1% overall response rate (ORR), including one complete response, compared to an ORR of 5.3% for paclitaxel alone. The tovecimig combination was also associated with progressive disease rates of 16.2% compared to 42.1% in patients on paclitaxel alone, and the safety profile of Compass’ drug was found to be consistent with prior studies. The pre-specified number of events required to inform the analyses of the study’s secondary endpoints, including progression free survival, overall survival and duration of response, have not yet been met and the company said it is expecting to report results for these endpoints in the fourth quarter of 2025. Thomas Schuetz, chief executive officer of Compass and vice chairman of the board of directors, said: “We believe these findings highlight the potential of tovecimig to provide a much-needed treatment option for the majority of patients with BTC who have limited alternatives after first-line therapy. We look forward to discussing this data with regulatory authorities.” Around 23,000 cases of BTC, a rare and aggressive cancer of the bile ducts, are diagnosed in the US every year. Nearly all patients develop progressive disease following first-line treatment with chemotherapy, Compass outlined, underscoring the need for safe and effective therapies in patients with advanced BTC. Tovecimig is designed to block both the Delta-like ligand 4 and vascular endothelial growth factor A signalling pathways, providing anti-tumour activity. “Patients currently have very limited treatment options, with the vast majority in the second-line setting having no approved therapeutic alternative whatsoever,” said Juan Valle, chief medical officer of the Cholangiocarcinoma Foundation. “Each investigative trial helps in this fight to advance new treatment options, and I look forward to following tovecimig’s continued progress.”

– ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases – Programs will leverage ABL Bio’s Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier – ABL Bio to receive up to £77 million in upfront and near-term payments SEONGNAM, South Korea I April 7, 2025 I ABL Bio Inc. (KOSDAQ: 298380), a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, announced a worldwide licensing agreement enabling GSK to develop novel medicines for neurodegenerative diseases by utilizing ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The agreement aims to develop multiple programs for novel targets across therapeutic modalities including antibody, polynucleotide or oligonucleotides, such as siRNA and ASOs, to address significant unmet medical needs of patients suffering from neurodegenerative conditions. The blood-brain barrier (BBB) serves as a protective barrier that restricts the entry of harmful substances and agents into the brain and is considered a significant obstacle in the development of treatments for neurological diseases. ABL Bio’s Grabody-B was developed to overcome the limitations of existing drugs that have difficulty crossing the BBB by targeting the Insulin-like Growth Factor 1 Receptor (IGF1R), facilitating drug penetration across the BBB and enabling efficient delivery into the brain. Under the terms of the agreement, ABL Bio will receive up to £77.1 million in upfront and near-term payments, including an immediate upfront payment of £38.5 million, research milestones and potential program expansion. In total, ABL Bio is eligible to receive up to £2.075 billion in research, development, regulatory and commercialization milestone payments across multiple potential programs. ABL Bio will receive tiered royalties on net sales if products are successfully commercialized. As part of the agreement, ABL Bio will transfer Grabody-B-related technology and know-how to GSK, while GSK will assume responsibility for preclinical and clinical development, manufacturing, and commercialization. Christopher Austin, SVP of Research Technologies, GSK, said “There is a critical need for new therapeutics to treat neurodegenerative brain diseases, which are rapidly increasing in prevalence due to the aging of the population. Many of the most promising new therapies are antibodies, which cannot efficiently reach the brain without a shuttle to get them across the BBB. This agreement reflects our commitment to innovative platform technologies to overcome the BBB and thus open entirely new opportunities for treating these devastating diseases, an important component of our emerging pipeline.” Sang Hoon Lee, CEO of ABL Bio said “This agreement underscores ABL Bio’s leadership in BBB technology and its commitment to advancing transformative therapeutics in neurodegenerative diseases through strategic partnership with global pharmaceutical leaders like GSK. Additionally, this agreement will serve as a great opportunity to strengthen ABL Bio’s position in the neurodegenerative disease treatment market through the potential commercialization of Grabody-B and to expand the modality areas where Grabody-B can be utilized. Given the increasing number of patients suffering from neurodegenerative diseases such as Alzheimer’s and Parkinson’s diseases, we hope this partnership will accelerate the development of innovative treatments and bring renewed hope to patients worldwide.” About ABL Bio ABL Bio is developing various clinical and non-clinical assets based on its bispecific antibody platform ‘Grabody’. Clinical projects for 7 pipelines, including ABL301, ABL001 (tovecimig), ABL111 (givastomig), ABL503 (ragistomig), ABL105, ABL202, and ABL103, are underway for different indications in various countries, including the United States, China, Australia, and Korea. In case of ABL001 (tovecimig), has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) to support the rapid development of this new drug candidate. In addition, ABL111 (givastomig), co-developed with I-Mab, is expected to disclose the top-line data from the Phase 1b clinical trial in 2025, evaluating the triple combination therapy with nivolumab and chemotherapy. Meanwhile, ABL Bio is preparing to initiate clinical trials for ABL104. In addition, ABL Bio is continuously researching and developing several other product candidates, including bispecific antibody-drug conjugates (ADCs). SOURCE: ABL Bio