On November 2, 2018 Nordic Nanovector ASA (OSE: NANO) reported that the first patient has been dosed in the Archer-1 trial investigating Betalutin (177Lu-satetraxetan-lilotomab) in combination with rituximab (RTX) in second-line follicular lymphoma (2L FL) (Press release, Nordic Nanovector, NOV 2, 2018, View Source [SID1234530667]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
Rituximab is a CD20-targeting monoclonal antibody that is administered to patients with newly-diagnosed or relapsed FL as a single agent or in combination with chemotherapy. Over time, patients may develop resistance to RTX, thus alternative targets are important. In addition, developing novel "chemo-free" regimens for patients as an alternative to chemotherapy is desirable.
Archer-1 is a Phase 1b open-label, single-arm, multi-centre dose-escalation trial to assess the safety and preliminary activity of combining CD37-targeted Betalutin with CD20-targeted RTX in 20-25 patients with relapsed/refractory FL who have received one or more prior therapies. Starting doses of Betalutin and lilotomab are 10MBq/kg and 40mg, respectively, with the option for dose escalation. Following Betalutin dosing, patients will receive four weekly doses of RTX (375mg/m2). The primary endpoint is safety, and secondary endpoints include overall response rate, duration of response, progression free survival and overall survival.
The rationale for Archer-1 was provided by preclinical data recently published in the European Journal of Haematology in July 2018 (reference below). These data demonstrate that treatment with the combination of Betalutin and RTX significantly prolonged overall survival in a murine model of NHL compared to treatment with either agent alone, possibly by reverting downregulation of CD20 and resistance to RTX.
Eduardo Bravo, Nordic Nanovector CEO, commented: "Archer-1 presents an opportunity to investigate the potential of a novel dual CD37/CD20-targeting combination approach in 2L FL patients. If the preclinical results translate to patients, this may indicate a new way to administer biologic therapy in FL."
Reference
Repetto-Llamazares, A.H.V. et al. Combination of 177Lu-lilotomab with rituximab significantly improves the therapeutic outcome in preclinical models of non-Hodgkin’s lymphoma. Eur J Haematol. 2018 View Source
For further information, please contact:
IR enquiries
Malene Brondberg, VP Investor Relations and Corporate Communications
Cell: +44-7561-431-762
Email: [email protected]
International Media Enquiries
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44-207-638-9571
Email: [email protected]
About Betalutin
Betalutin is a tumour-seeking anti-CD37 antibody (lilotomab) conjugated to a low-intensity radionuclide (lutetium-177). It has shown promising efficacy and safety in the first part of the Phase 1/2 LYMRIT 37-01 clinical study in relapsed/refractory follicular lymphoma (R/R FL). A global, randomised Phase 2b trial, PARADIGME, in third line (3L) FL patients who are refractory to anti-CD20 immunotherapy (including rituximab, RTX) is currently on-going. Betalutin is also being investigated in the Phase 1b Archer-1 study in combination with RTX in second-line FL patients, and in the Phase 1 LYMRIT 37-05 study in patients with R/R diffuse large B-cell lymphoma (DLBCL), the most common form of non-Hodgkin’s lymphoma (NHL). Betalutin has been granted Fast Track designation in the US and Promising Innovative Medicine (PIM) Designation in the UK for the treatment of patients with R/R FL. Betalutin also received Orphan Drug designations for FL in both the USA and Europe in 2014. Betalutin is selective for CD37, which is highly expressed on the surface of B-cell non-Hodgkin’s lymphoma (NHL) cells. When bound to CD37 on tumour cells, Betalutin is internalised, causing DNA damage and cell death.