Tuesday, July 16, 2024

Market Authorization Application for Nidlegy™ Validated by EMA

Similar articles

Market validation of the Marketing Authorization Application (MAA) for Nidlegy™ was announced by Philogen S.p.A. and Sun Pharmaceutical Industries Limited on July 4, 2024, after its finalization on June 3rd and subsequent validation by the European Medicines Agency (EMA) on June 20th. “The validation of the dossier by EMA represents the first important milestone for the MAA review process,” commented Dario Neri, CEO and Chief Scientific Officer at Philogen. “Our group is committed to working with EMA throughout the review process with the goal of making Nidlegy™ available to patients in need.”

Nidlegy™ is a biopharmaceutical product developed by Philogen for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and mixed prior to intralesional administration. The L19 antibody is specific to the Extra Domain B of Fibronectin, a protein expressed in tumors but absent in most healthy tissues.

Market Validation for Nidlegy™: Pro-Inflammatory Cytokines IL2 and TNF Show Promise in Advanced Melanoma

Interleukin 2 (IL2) and Tumor Necrosis Factor (TNF) are pro-inflammatory cytokines with potent anti-tumor activity. Nidlegy™ is currently under investigation in two Phase III clinical trials for the treatment of locally advanced melanoma and Phase II trials for High-Risk Basal Cell Carcinoma and other non-melanoma skin cancers.

The Phase III PIVOTAL study is an international, multi-center, randomized, comparator-controlled, parallel-group trial evaluating the efficacy and safety of intratumoral injections of Nidlegy™ as a neoadjuvant treatment, followed by standard-of-care treatment (surgery), versus standard-of-care treatment alone in melanoma patients with locally advanced, fully resectable cutaneous, subcutaneous, or nodal metastases accessible to intratumoral injection. The trial enrolled 256 patients across 22 clinical centers in Germany, Italy, France, and Poland. The data from the Phase III trial are expected to be published in a peer-reviewed scientific journal in 2024.


Market Need for Neoadjuvant Melanoma Treatment: Addressing Uncontrolled Melanocyte Growth

Melanoma is a skin tumor originating from uncontrolled melanocyte growth. Locally advanced melanoma is a metastatic cancer where lesions spread to regional lymph node drainage areas and can present as micrometastases, satellite/in-transit metastases, or lymph node metastases. Currently, patients with resectable disease undergo surgery, possibly followed by approved adjuvant systemic therapies. There is no approved drug for treating locally advanced fully resectable melanoma in the neoadjuvant setting.

Philogen is an Italian-Swiss biotechnology company focused on developing innovative cancer treatments. Their therapeutic strategy involves using ligands to selectively deliver potent payloads (pro-inflammatory cytokines, drugs, or radionuclides) to tumor masses, sparing healthy tissues.

Philogen has developed monoclonal antibody and small molecule-based ligands with high affinity to numerous tumor-associated antigens. The company is headquartered in Siena, Italy, with a subsidiary and research center in Zurich, Switzerland. Besides oncology, Philogen is also developing novel treatments for chronic and debilitating conditions.

The partnership between Philogen and Sun Pharma, focused on the treatment of skin cancers in Europe, New Zealand, and Australia, marks a significant milestone with the EMA validation of the Nidlegy™ MAA. This collaboration aims to bring innovative therapies to patients, enhancing their quality of life and addressing unmet clinical needs in oncology.

You can follow our news on our Telegram and LinkedIn accounts.


Resource: Sun Pharma, July 04, 2024

Subscribe to our newsletter

To be updated with all the latest news, offers and special announcements.

Latest article