Lilotomab pre-dosing of NHL patients before Betalutin® therapy lowers haematological toxicity with no reduction in the tumor absorbed radiation dose
Findings published in two papers in The Journal of Nuclear Medicine
Oslo, Norway, 5 September 2016
Nordic Nanovector ASA (OSE: NANO) announces that two papers recently published in The Journal of Nuclear Medicine have shown that pre-dosing with the anti-CD37 antibody lilotomab (previously referred to as HH1), prior to injection with Betalutin® (177Lu-lilotomab) reduces haematological toxicity without adversely impacting the amount of radiation absorbed by the tumour. Betalutin® is a novel anti-CD37 antibody-radionuclide-conjugate (ARC) currently in Phase 1/2a. Two pre-dosing regimens have been investigated, one with 40 mg unlabeled lilotomab antibody (Arm 1) and one without (Arm 2). Data from eight patients were included in both papers.
The first paper 1) looked at the risk that pre-dosing with lilotomab could block the CD37 antigen on tumour tissues adversely impacting the amount of radiation absorbed by the tumour. The research shows that there was no difference in the tumour absorbed dose for patients in Arm 1 and Arm 2. The reduced distribution volume and clearance in Arm 1 might explain this finding as it implies that the concentration of Betalutin® in the blood was higher for Arm 1 patients than for Arm 2 patients, therefore increasing concentration counteracts any eventual blocking of CD37 on tumour tissue.
The second paper 2) looked at the radiation exposure of the red bone marrow (RM) which is often the primary organ at risk in radioimmunotherapy. Irradiation of the marrow may induce short and long-term haematological toxicity.
Researchers found that the RM radiation doses were significantly higher in the patients who did not receive pre-dosing. This difference indicates that pre-dosing with lilotomab has a protective effect for RM, most likely thanks to the unlabeled antibody, which blocks the binding to CD37 in the RM.
Jostein Dahle, Nordic Nanovector CSO, commented: “The results outlined in these two publications further support our hypothesis that pre-dosing with lilotomab provides a protective effect on healthy tissues when used prior to Betalutin® treatment and importantly that pre-dosing does not adversely impact the radiation absorbed by the tumor. These findings also support our development strategy for Betalutin®, where we are looking at different pre-dosing regimens in order to identify the optimal dose regimen of this novel antibody-radionuclide-conjugate to take into later stage clinical trials.”
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.
J Nucl Med Published August 4, 2016 as doi:10.2967/jnumed.116.173922
2) J Nucl Med Published September 1, 2016 as doi:10.2967/jnumed.116.180471
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.