Nordic Nanovector: Safety Review Committee Supports Dose Escalation in Lymrit 37-01 Trial

Nordic Nanovector ASA (OSE:NANO)(OSE:NANOO) 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.
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.
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