Intensity Therapeutics and Fractyl Health have recently provided updates on their clinical development programs, focusing on innovative treatments for cancer and metabolic diseases, respectively. Both companies are advancing key studies and anticipate important data readouts in the near future.
Intensity Therapeutics Advances INT230-6 in Clinical Trials
Intensity Therapeutics (INTS) reported its third-quarter 2024 financial results alongside a corporate update highlighting the progress of its lead candidate, INT230-6. The company has dosed the first patient in the INVINCIBLE-4 study, a Phase 2 randomized trial evaluating INT230-6 in presurgical triple-negative breast cancer (TNBC). This study aims to assess the pathological complete response (pCR) rate in the primary tumor and affected lymph nodes.
Additionally, Intensity Therapeutics is advancing the INVINCIBLE-3 study, a Phase 3 open-label, randomized trial testing INT230-6 as monotherapy compared to standard-of-care drugs in second and third-line treatment for certain soft tissue sarcoma subtypes. The study is expected to enroll 333 patients across multiple countries, with overall survival as the primary endpoint. According to Lewis H. Bender, Intensity Founder, President, and CEO, the company has received regulatory authorizations to initiate sites in eight countries for the Phase 3 sarcoma study and the Phase 2 breast cancer study.
INT230-6 is designed for direct intratumoral injection, comprised of cisplatin and vinblastine, and a penetration enhancer molecule (SHAO). The drug aims to kill tumors and stimulate an immune response, potentially offering clinical benefits for patients with high unmet needs in metastatic and local disease settings.
Fractyl Health Reports Progress in Metabolic Disease Therapies
Fractyl Health (GUTS) reported its third-quarter 2024 financial results and provided business updates on its Revita and Rejuva platforms. The company's REMAIN-1 pivotal study, evaluating Revita's efficacy in maintaining weight loss following discontinuation of GLP-1 therapy, is progressing rapidly. A mid-point data analysis is expected in Q2 2025. Fractyl is also enrolling patients in the REVEAL-1 open-label cohort of the REMAIN-1 study, with data expected to be reported beginning in Q4 2024.
Topline data from the REVITALIZE-1 pivotal study, which is evaluating Revita in patients with adequately controlled T2D on at least one glucose-lowering agent (GLA), is expected in mid-2025. Fractyl presented compelling weight maintenance data from both the Revita and Rejuva platforms at ObesityWeek 2024.
Fractyl is also advancing its Rejuva platform, with plans to submit a Clinical Trial Application (CTA) for RJVA-001 in T2D. If approved, a first-in-human study is planned for the first half of 2025. The company has also nominated RJVA-002, a smart GIP/GLP-1 pancreatic gene therapy lead candidate, for the treatment of obesity. RJVA-002 is designed to activate both GIP and GLP-1 receptors, which play crucial roles in regulating blood sugar and body weight.
Financial Highlights
Intensity Therapeutics reported research and development expenses of $2.2 million for the three months ended September 30, 2024, compared to $1.4 million for the same period in 2023. The increase was primarily due to preliminary work related to the INVINCIBLE-3 Study. As of September 30, 2024, cash and cash equivalents totaled $2.8 million, which the Company expects will be sufficient to fund operations into the first quarter in 2025.
Fractyl Health reported revenue of $14,000 for the quarter ended September 30, 2024, generated from its pilot commercial launch in Germany. Research and development expense was $19.0 million for the quarter ended September 30, 2024, compared to $9.4 million for the same period in 2023. As of September 30, 2024, Fractyl had approximately $84.7 million in cash and cash equivalents, which is expected to fund operations through key milestones into the fourth quarter of 2025.
