Nordic Nanovector Announces First Patient Enrolled In The Last Cohort (Arm 4) Of Expanded Phase 1/2 Study Of Betalutin In NHL Patients
Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that the first patient has been enrolled into the second of the two new arms, and the last cohort, of its expanded Lymrit 37-01 clinical study with Betalutin®.
Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin’s lymphoma (NHL), including Follicular Lymphoma (FL).
The final cohort (Arm 4) is designed to investigate the safety and efficacy of Betalutin® in up to 12 patients with relapsed FL pre-dosed with high-dose unconjugated “cold” HH1 anti-CD37 antibody on Day 0, a few hours prior to the injection of Betalutin®.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to initiate the last arm in the Lymrit 37-01 study. The data so far shown for Betalutin® with low-dose HH1 pre-dosing (AACR April 2016) are highly encouraging for this group of patients. Arms 3 and 4 in the study are designed to investigate if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve an even stronger product profile with an even higher efficacy. We believe that this can be achieved using a regimen that ensures better control of haematological side effects and more specific tumour targeting with Betalutin®. With this last Arm, Betalutin’s clinical development plan for FL is in full execution mode according to our planned timelines.”
The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.
Data and analysis recently published at the American Association of Cancer Research annual meeting (16-20 April) confirmed that Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) and a 31.6% Complete Response (CR) in evaluable patients. Clinical responses observed were sustained, with Duration of Response exceeding 12 months in most responders in the 15 MBq/kg group who have been followed up for at least 12 months.
Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml “cold” HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016.
A decision to increase the dose of Betalutin to 17.5 MBq/kg in Arm 1 can be made based on the evaluation of the safety and efficacy data observed in the 15 patients treated with 15 MBq/kg. A decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other of Arms 3 and 4 can be made based on the evaluation of the safety and efficacy data observed in the first three patients of both cohorts.
Betalutin® is a novel anti-CD37 targeting Antibody Radionuclide Conjugate in development for the treatment of major types of non-Hodgkin’s lymphoma (NHL), including Follicular Lymphoma (FL).
The final cohort (Arm 4) is designed to investigate the safety and efficacy of Betalutin® in up to 12 patients with relapsed FL pre-dosed with high-dose unconjugated “cold” HH1 anti-CD37 antibody on Day 0, a few hours prior to the injection of Betalutin®.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to initiate the last arm in the Lymrit 37-01 study. The data so far shown for Betalutin® with low-dose HH1 pre-dosing (AACR April 2016) are highly encouraging for this group of patients. Arms 3 and 4 in the study are designed to investigate if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve an even stronger product profile with an even higher efficacy. We believe that this can be achieved using a regimen that ensures better control of haematological side effects and more specific tumour targeting with Betalutin®. With this last Arm, Betalutin’s clinical development plan for FL is in full execution mode according to our planned timelines.”
The Lymrit 37-01 study is a Phase 1/2 open label, single injection ascending dose study investigating three dose levels of Betalutin® and different pre-dosing regimens in patients with relapsed NHL with the aim of identifying an optimal dose regimen to take into the Phase 2 PARADIGME study, which is expected to start in 2H 2017.
Data and analysis recently published at the American Association of Cancer Research annual meeting (16-20 April) confirmed that Betalutin® was generally well tolerated and showed a 63.2% Overall Response Rate (ORR) and a 31.6% Complete Response (CR) in evaluable patients. Clinical responses observed were sustained, with Duration of Response exceeding 12 months in most responders in the 15 MBq/kg group who have been followed up for at least 12 months.
Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml “cold” HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016.
A decision to increase the dose of Betalutin to 17.5 MBq/kg in Arm 1 can be made based on the evaluation of the safety and efficacy data observed in the 15 patients treated with 15 MBq/kg. A decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other of Arms 3 and 4 can be made based on the evaluation of the safety and efficacy data observed in the first three patients of both cohorts.