Nordic Nanovector announces first patient enrolled in Arm 3 of expanded Phase 1/2 study of Betalutin® in NHL patients
Oslo, Norway, 4 May 2016
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 one of the two new arms 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 new arm (Arm 3) is designed to investigate the safety and efficacy of Betalutin® in up to 12 patients with relapsed FL pre-dosed with standard anti-CD20 immunotherapy (rituximab) on Day 0, a few hours prior to the administration of Betalutin®.
Luigi Costa, Nordic Nanovector CEO, commented: “We are pleased to initiate the first of the two new cohorts in our ongoing clinical study, which represents a significant step forward in Betalutin’s development plan. Data we have seen to date suggest that we can achieve strong clinical efficacy with a regimen that controls haematological side effects. The two new arms are investigating if different pre-dosing regimens will allow the use of higher doses of Betalutin® to potentially achieve even higher efficacy than that so far observed, and therefore an even more compelling product profile.”
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 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.
Patient recruitment into the Phase 2 part of Arm 1 (15Mbq/kg plus 50mg/ml unconjugated “cold” HH1 anti-CD37 antibody) is progressing as planned with dose-escalation expected to begin in 2H 2016. Patient screening is also underway for the final arm in the expanded Lymrit 37-01 study (Arm 4), in which escalating doses of Betalutin® plus pre-treatment with a higher dose of cold anti-CD37 antibody than in Arm 1 will be evaluated in relapsed FL patients.
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.
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.
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 (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 announcement may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Nordic Nanovector’s business, financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”, “forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realised. Factors that could cause these differences include, but are not limited to, implementation of Nordic Nanovector’s strategy and its ability to further grow, risks associated with the development and/or approval of Nordic Nanovector’s products candidates, ongoing clinical trials and expected trial results, the ability to commercialise Betalutin®, technology changes and new products in Nordic Nanovector’s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Nordic Nanovector disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
This information is subject to a duty of disclosure pursuant to Section 5-12 of the Securities Trading Act.