Nordic Nanovector announces an open Investigational New Drug application for new clinical study of Betalutin® in diffuse large B-cell lymphoma
Clinical development programme expected to start in 2H 2016
Oslo, Norway, 9 May 2016
Nordic Nanovector ASA (OSE: NANO), a biotechnology company focusing on the development of novel targeted therapeutics in haematology and oncology, announces that its Investigational New Drug (IND) application for a new Phase 1 clinical study of Betalutin® in a second non-Hodgkin lymphoma (NHL) indication is now open with the US Food & Drug Administration (FDA).
The Company plans to investigate Betalutin® in relapsed diffuse large B-cell lymphoma (DLBCL) patients who are ineligible for stem cell transplant. This represents the most prevalent relapsed DLBCL patient population and the one with the greatest unmet medical need.
The Phase 1 dose-finding study (Lymrit 37-05) has a classical 3+3 dose-escalation design and is expected to enrol up to 24 patients in the US and Europe. The study is designed to identify an optimal dose regimen of Betalutin® in patients pre-dosed with unconjugated “cold” HH1 anti-CD37 antibody to take into Phase 2.
In approving the IND, FDA requested that an additional 3+3 cohort be included at the start of the study to investigate a regimen involving an intermediate pre-dose of cold HH1 prior to Betalutin® injection in the DLBCL population.
The study protocol without the latest adjustments made to meet FDA’s requests has already been approved by the appropriate EU regulatory authorities, via the Voluntary Harmonisation Procedure.
Nordic Nanovector intends to adopt the FDA requested amendment also in Europe and plans to initiate the application process for the amended design with the relevant EU regulators as soon as possible. Pending approval of the amended design, the Company now expects the first DLBCL patient to be enrolled and treated in 2H 2016 compared to 1H 2016 as previously communicated.
Luigi Costa, Nordic Nanovector CEO, commented: “We are encouraged by FDA’s response to our IND, and intend to make the recommended amendment that will allow us to conduct our first study in DLBCL patients in both the US and Europe. We will work with EU regulators to expedite approval of the revised study design in Europe so that we can prepare and start patient recruitment in the second half of 2016. This is an important further step forward in the development of Betalutin®, data for which continue to highlight its potential to become a relevant new treatment of B-cell malignancies.”
DLBCL is an aggressive form of NHL that accounts for 36-43% of all NHL cases, making it the most common form of the disease (ref.1). It occurs most frequently in a population aged >50 years (average age 62 years). Immediate combination chemotherapy treatment is essential and the tumour is potentially curable.
The value of the DLBCL market (across all lines of therapy) in the seven major markets (US, EU-5 and Japan), exceeds USD 1.8 billion (mostly driven by sales of rituximab and chemotherapy drugs). The market is estimated to grow to USD 4.7 billion by 2024 as a result of novel immuno-oncology treatments and combination approaches in development in the relapsed setting (ref. 1).
Approximately 40% of DLBCL patients relapse following treatment with rituximab-chemotherapy (R-CHOP) in first line. In the seven key markets this equates to 21,200 patients. Only 30-40% of relapsed patients respond with subsequent high-dose chemotherapy followed by stem cell transplant (SCT) (ref. 2). Patients ineligible for SCT (12,720-14,840) have a very short life expectancy as available therapeutic options are limited and ineffective. This is one of the highest unmet medical need in Non-Hodgkin’s Lymphoma.
1. Non-Hodgkin’s Lymphoma (2015) Decision Resources
2. L.S. Raut and P. P. Chakrabarti: Management of relapsed-refractory diffuse large B cell lymphoma (2014) South Asian J. Cancer 3(1): 66–70
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.