Nordic Life Science 1
PHASE I FIRST PATIENT DOSED WITH ALLIGATOR’S ATOR
-1017 This is a Phase I study with the wholly owned 4-1BB antibody ATOR-1017, currently being developed for the treatment of metastasized cancer. HE STUDY IS a dose escalation study in patients with advanced cancer and this is Klaas Bakker, CMO, Oncopeptides the first time ATOR-1017 has been evaluated in humans. The study will be conducted at three different clinics in Sweden and will include up to 50 patients. The primary objective of the study is to assess the safety and tolerability of ATOR-1017 and to determine the recommended dose for the subsequent Phase II studies. ATOR-1017 activates 4-1BB Data from the company’s ongoing Phase 2 ANCHOR triple combination study has been presented. N THE DATA from the study melflufen and dexamethasone demonstrated positive efficacy in combination with daratumumab or bortezomib in patients with relapsed/refractory multiple myeloma (RRMM). Preclinical data supporting clinical development of melflufen in AL amyloidosis was also presented for the first time. “The ANCHOR data is truly encouraging and supports the future development of melflufen in triplet regimens. The ORR of 76% and median PFS of 14.3 months in the daratumumab arm, while immature, are among the highest reported in this patient population. This further validates the foundation for our next randomized Phase 3 study LIGHTHOUSE (OP-108), in which we will compare subcutaneous daratumumab with or without melflufen. We expect to enroll the first patient in early 2020 and are excited to embark on this next journey with melflufen in multiple myeloma,” says Klaas Bakker, Chief Medical Officer, Oncopeptides. “Based on our very positive preclinical data around AL amyloidosis and our experience of melflufen in a clinical setting, we are excited to initiate our first study with melflufen in patients with Immunoglobulin Light Chain (AL) amyloidosis. This lays the foundation for the use of melflufen in another indication with a high unmet medical need,” adds Bakker. receptors, which increases the ability of the immune system to detect and kill tumor cells. This makes 4-1BB an attractive target for cancer immunotherapy. ATOR-1017 has a unique profile related to the fact that its immune-stimulatory function is stronger in areas where immune cells are abundant, notably in tumors. This creates an opportunity for a strong immune activation that can increase efficacy and reduce side effects for the patient. “In the preclinical studies, ATOR-1017 has shown a strong and long-lasting immune response, and even created immunity to cancer, while minimizing the side effects through tumor-directed immune activation,” says Per Norlén, CEO of Alligator Bioscience. NORDICLIFESCIENCE.ORG 33