Safety Review Committee Approves the Continued Evaluation of the 20 MBq/kg Betalutin® with 100 mg/m2 Lilotomab Regimen in Phase 2 Cohort in NHL
Oslo, Norway, 19 May 2017
Nordic Nanovector ASA (OSE: NANO) announces that the Safety Review Committee (SRC) for the ongoing LYMRIT 37-01 clinical trial of Betalutin® in non-Hodgkin’s Lymphoma (NHL) has reviewed safety data from the study and approved continued clinical evaluation of 20 MBq/kg Betalutin® administered after pre-dosing with 100 mg/m2 lilotomab.
Following the SRC’s recommendation, new patients will be enrolled into a Phase 2 expansion cohort of Arm 4 in Betalutin’s Phase 1/2 study LYMRIT 37-01, to continue the collection of safety and efficacy data of 20 MBq/kg Betalutin® after pre-dosing with 100 mg/m2 lilotomab. This will enable the company to build a robust database of clinical data to confirm the optimal dosing regimen for the pivotal Phase 2 PARADIGME study, which is on track to start in the second half of 2017.
Luigi Costa, Nordic Nanovector CEO, said: “This recommendation from the SRC represents another important milestone for the development of Betalutin®, in line with our strategy and established timelines. It supports the hypothesis that a higher pre-dosing regimen may enable the use of a higher dose of Betalutin®. The enrolment of new patients in Phase 2 provides the opportunity to collect additional safety and preliminary efficacy data to support the selection of the dosing regimen we will use in PARADIGME later this year.”
About LYMRIT 37-01
The LYMRIT 37-01 study is an ongoing Phase 1/2 open label, dose-escalation study with four treatment arms in patients with relapsed NHL to establish the recommended dosing regimen of single-dose Betalutin® for Phase 2. The study is investigating three doses of Betalutin® and different pre-dosing regimens with the aim of identifying an optimal dose regimen to take into a pivotal Phase 2 PARADIGME trial.
The most recent results were presented at the American Society of Hematology (ASH) annual meeting in December 2016 and showed:
• Significant anti-tumour activity observed: ORR of 62%, CR 38% in Arm 1 patients receiving 15MBq/kg; consistent for 16 patients treated in Arm 1/Phase 2 (ORR 69%, CR 38%)
• Durable responses observed: median duration of response of 20.7 months for patients in Arm 1
• Well tolerated with a predictable and manageable safety profile
Updated results from LYMRIT 37-01 have been accepted for presentation at the International Conference on Malignant Lymphoma (ICML), June 14-17 in Lugano, Switzerland.
For further information, please contact:
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 committed to develop and deliver innovative therapies to patients to address major unmet medical needs and advance cancer care. The company aspires to become a leader in the development of targeted therapies for haematological cancers.
Nordic Nanovector’s lead clinical-stage candidate is Betalutin®, a novel CD37-targeting Antibody-Radionuclide-Conjugates (ARC) designed to advance the treatment of non-Hodgkin’s Lymphoma (NHL). NHL is an indication with substantial unmet medical need, representing a growing market forecast to be worth nearly USD 20 billion by 2024.
The Company aims to rapidly develop Betalutin®, alone and in combination with other therapies, for the treatment of major types of NHL, targeting first regulatory submission in relapsed/refractory follicular lymphoma in 1H 2019. Nordic Nanovector intends to retain marketing rights and to actively participate in the commercialisation of Betalutin® in core markets.
The Company is also advancing a pipeline of ARCs and other immunotherapies for multiple 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.