Basal Cell Neoplasms

The Company’s oncology aPKCi inhibitor is a novel, first in class drug candidate Jan. 15, 2025 -- Windtree Therapeutics, Inc. (“Windtree” or the “Company”) (NasdaqCM: WINT), a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases, today announced the issuance of a patent in Japan for “Inhibitors of atypical protein kinase C (aPKCi) and their use in treating hedgehog pathway-dependent cancers.” The patent number is 7603605 and expires in 2040. The aPKCi inhibitor platform is a novel, potential high-potency, specific, drug candidate with applications in oncology, particularly in hedgehog pathway-dependent cancers. Such cancers include basal cell carcinoma, medulloblastoma, rhabdomyosarcoma, small cell lung cancer and other malignant diseases. The asset platform includes two formulations (topical and oral) that have been in development in partnership with Cancer Research UK and top academic research centers. The claims also include combination therapies comprising use of the hedgehog pathway inhibitors along with an HDAC inhibitors enhancing anti-cancer efficacy. “Issuance of the new patent for our oncology preclinical aPKCi inhibitor pipeline is an important part of our development strategy,” said Jed Latkin, CEO of Windtree Therapeutics. “We will continue with our intellectual property work to expand our patent portfolio in key markets throughout the world.” The drug candidate is a novel, potential high-potency, specific, azaquinazoline ATP-competitive atypical PKC iota (aPKCi) inhibitor efficacy for the treatment of skin cancer and other rare malignant diseases. The asset platform includes two formulations (topical and oral) of the aPKCi inhibitor. Windtree Therapeutics also has an additional pending PCT application directed to crystalline forms of these inhibitors, also for use in cancer treatment. Windtree Therapeutics, Inc. is a biotechnology company focused on advancing early and late-stage innovative therapies for critical conditions and diseases. Windtree’s portfolio of product candidates includes istaroxime, a Phase 2 candidate with SERCA2a activating properties for acute heart failure and associated cardiogenic shock, preclinical SERCA2a activators for heart failure and preclinical precision aPKCi inhibitors that are being developed for potential in rare and broad oncology applications. Windtree also has a licensing business model with partnership out-licenses currently in place. The content above comes from the network. if any infringement, please contact us to modify.

January 17, 2025 Stamford has announced positive results for its ASN-002-003 multi-lesional clinical trial (NCT 04416516. Protocol No ASN-002-003) evaluating SP-002, an Adenovirus-5 replication deficient vector encoding human Interferon- in combination with vismodegib (a Hedgehog Pathway Inhibitor) in subjects presenting with multiple BCCs. “We are very pleased with these positive results from the Phase 2 study demonstrating the safety and efficacy of our gene therapy for patients with multiple nodular and superficial BCCs. We are particularly excited that the histopathologic criteria, which would allow responsive patients to be identified at screening and used for patient selection. This histopathologic criterion was first noted in the ASN-002-001 clinical study and has now been successfully reproduced in ASN-002-003. We believe this enables us to develop a useful treatment option for patients with nodular BCC and addresses the important need for a non-surgical option for those with BCCs in the H-zone or for those who are not ideal candidates for surgery.” Dr Clement Leong (PhD), CEO of Stamford Pharmaceuticals Press Release: Stamford announces positive results from Phase 2 Study of SP-002 in combination with 4-weeks of vismodegib in multi-lesional Basal Cell Carcinoma patients

Regeneron Pharmaceuticals has shared positive results from a late-stage trial of Libtayo (cemiplimab) in patients with high-risk cutaneous squamous cell carcinoma (CSCC) after surgery. The phase 3 C-POST trial has been comparing adjuvant treatment with the PD-1 inhibitor against placebo in patients with features associated with a high-risk of CSCC recurrence and who have completed surgery and post-operative radiation therapy. CSCC is the second most common type of skin cancer, with approximately 1.8 million cases diagnosed in the US every year. Libtayo is designed to block cancer cells from using the PD-1 pathway to suppress T-cell activation and already holds approvals to treat certain patients with advanced CSCC. C-POST met its primary endpoint of disease-free survival, with adjuvant Libtayo demonstrating a 68% reduction in the risk of disease recurrence or death in patients with high-risk CSCC after surgery compared to adjuvant placebo. The trial will continue for additional follow-up, Regeneron said, adding that it is planning to file a submission with US Food and Drug Administration for Libtayo in this indication in the first half of 2025. Israel Lowy, clinical development unit head, oncology, Regeneron, said: “Libtayo was the first PD-1 inhibitor approved for certain patients with advanced CSCC and has become a standard of care in this setting. With these results, Libtayo now has the potential to also transform the treatment of high-risk resectable CSCC with adjuvant treatment.” Lead C-POST investigator, Danny Rischin, the Peter MacCallum Cancer Centre, added: “With no currently approved options in the adjuvant setting, these landmark results demonstrate Libtayo could represent a major advance in delaying recurrence in these vulnerable patients.” Beyond CSCC, Libtayo is authorised to treat basal cell carcinoma, the most common type of skin cancer, as well as non-small cell lung cancer (NSCLC). Regeneron recently presented five-years results from the phase 3 EMPOWER-Lung 1 trial of Libtayo as a first-line treatment for advanced NSCLC in adults with at least 50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. According to the September announcement, a median overall survival of 26 months was seen in the Libtayo treatment group, compared to 13 months in the chemotherapy cohort, and median progression-free survival for Libtayo was eight months, compared to five months for chemotherapy.