Safety Review Committee supports dose escalation with Betalutin® in Lymrit 37-01 trial pending safety data from cohort receiving higher pre-dosing
Dose-escalation of Betalutin® accompanied by increase in lilotomab pre-dosing could further improve efficacy while maintaining a favourable safety profile
Oslo, Norway, 23 September 2016
Nordic Nanovector ASA (OSE: NANO) announces that the independent Safety Review Committee (SRC) for the ongoing Lymrit 37-01 clinical trial of Betalutin® in follicular lymphoma (FL) has given its support to the continuation of the trial potentially at a higher dose of Betalutin® and increased pre-dosing with lilotomab, as soon as safety data from Arm 4 of the same study become available. FL is one of the most prevalent forms of non-Hodgkin lymphoma (NHL).
Lymrit 37-01 is a Phase 1/2 open label, single injection dose-ascending study investigating different 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.
After a planned review of the interim safety data from the Phase 1 and 2 parts of Arm 1 of Lymrit 37-01, based on 15 patients with relapsed/refractory FL treated with 15 MBq/kg Betalutin® and pre-dosed with 40 mg lilotomab*, the SRC concluded the following:
• The regimen of 15 MBq/kg Betalutin® administered after pre-dosing with 40 mg lilotomab is safe and the safety profile observed to date supports a possible dose escalation of Betalutin®
• The efficacy profile is promising compared to other candidates in development, particularly with regard to complete responses
• The limited safety data available to date from the first cohort of three patients in Arm 4 (receiving 15 MBq/kg Betalutin® and pre-dosed with 100mg/m2 lilotomab**) is encouraging and appears to show that an increase in pre-dosing with lilotomab improves the safety profile of Betalutin®
• Safety and dosimetry data from Arm 4 should confirm if and to what level the doses of Betalutin® and lilotomab in Phase 2 can be increased to further improve the risk/benefit profile seen so far.
The company does not expect any impact to previously communicated timelines, neither for the dose definition date (Q1 2017) nor the planned pivotal PARADIGME trial, which is scheduled to start in 2H 2017.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased with the conclusions of the SRC meeting, which provide us with further confidence that we are closing in on the optimal dose regimen.”
*Lilotomab is a murine anti-CD37 antibody, previously referred to as HH1. The way the dose of lilotomab is referred to has been changed (from 50 mg/patient to 40mg/patient) following further characterisation of lilotomab, which has determined the actual absorbance factor of lilotomab reference standard (1.74 vs. the previous estimate of 1.4). The absorbance factor is used to measure the concentration of lilotomab drug product.
**The change in dose units for lilotomab from mg to mg/m2 is because a more accurate way of calculating the administered concentration of antibody is now being applied, as described in previous footnote.
For further information, please contact:
Luigi Costa, Chief Executive Officer
Cell: +41 79 124 8601
Tone Kvåle, Chief Financial Officer
Cell: +47 91 51 95 76
Mark Swallow/David Dible (Citigate Dewe Rogerson)
Tel: +44 207 282 2948/+44 207 282 2949
About Nordic Nanovector:
Nordic Nanovector is a biotech company focusing on the development and commercialisation of novel targeted therapeutics in haematology and oncology. The Company’s lead clinical-stage product opportunity is Betalutin®, the first in a new class of Antibody-Radionuclide-Conjugates (ARC) designed to improve upon and complement current options for the treatment of non-Hodgkin Lymphoma (NHL). NHL is an indication with substantial unmet medical need and orphan drug opportunities, representing a growing market worth over $12 billion by 2018.
Betalutin® comprises a tumour-seeking anti-CD37 antibody, lilotomab (previously referred to as HH1), conjugated to a low intensity radionuclide (lutetium-177). The preliminary data has shown promising efficacy and safety profile in an ongoing Phase 1/2 study in a difficult-to-treat NHL patient population. The Company is aiming at developing Betalutin® for the treatment of major types of NHL with first regulatory submission anticipated in 1H 2019.
Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets, while exploring potential distribution agreements in selected geographies. The Company is committed to developing its ARC pipeline to treat multiple selected cancer indications.
Further information about the Company can be found at www.nordicnanovector.com
This information is subject to the disclose requirements pursuant to section 5-12 of the Norwegian Securities Trading Act.