Nordic Nanovector: Single-dose Betalutin® shows promising efficacy, improved duration of response and favourable safety in relapsed NHL patients
Oslo, Norway, 4 December 2016 Nordic Nanovector ASA (OSE: NANO) presented today the updated results from its ongoing Lymrit 37-01 Phase 1/2 clinical trial of Betalutin® (177Lu-satetraxetan-lilotomab) in subjects with relapsed non-Hodgkin lymphoma (NHL) at the 58th Annual American Society of Hematology (ASH) meeting (San Diego, CA, USA). The updated data confirm Betalutin®’s promising efficacy and favourable safety profile as a single agent in 38 relapsed NHL patients, having failed multiple prior regimens and being eligible for assessments. The results, based on the data cut-off date of 31 October 2016, were presented by the study’s Principal Investigator Dr. Arne Kolstad from the Department of Oncology at the Oslo University Hospital, Radiumhospitalet. Key conclusions: • In the 35 patients evaluable for efficacy, the Overall Response Rate (ORR) was 63%, with 29% Complete Responses (CR) • The 21 evaluable patients in the study who received Betalutin® at the dose of 15 MBq/kg with 40 mg/m2 lilotomab pre-dosing had an ORR of 62% and a CR of 38%; of these, the 16 patients enrolled in the Phase 2 expansion of Arm 1, had an ORR of 69% and a CR of 38% • Durable responses have been observed with a median duration of response of 20.7 months for all patients in Arm 1 • Betalutin® is well tolerated, with a predictable and manageable safety profile: most adverse events are haematological in nature, and all have been transient and reversible • No dose-limiting toxicity (DLT) was reported in Arm 4 (15 MBq/kg Betalutin® plus 100 mg/m2 lilotomab pre-dosing) and this regimen demonstrated lower bone marrow toxicity than Arm 1, 2 and 3. Arm 4 is now enrolling patients to evaluate the higher dosing regimen of 20 MBq/kg Betalutin® plus 100 mg/m2 lilotomab. The Lymrit 37-01 study is a Phase 1/2 open label, dose escalation study investigating the optimal lilotomab pre-dosing and Betalutin® regimen in patients with relapsed NHL. Data from 38 patients are presented. Dr. Arne Kolstad, MD commented: “The results we are presenting today are very encouraging and continue to highlight the potential of Betalutin® to provide a new treatment option for NHL patients. These patients, particularly those who fail standard CD20-targeted immunotherapy and/or are too frail to receive chemotherapy, are desperately in need of alternative therapies that work through different and complementary mechanisms and are well tolerated. Betalutin® is showing exciting promise in an increasing number of NHL patients and we look forward to the results from future studies that will hopefully confirm its attractive profile.” Dr. Lisa Rojkjaer, MD Nordic Nanovector’s Chief Medical Officer, commented: “These new data confirm the promising results for Betalutin®, including durable responses in a number of patients, which were presented earlier this year at the AACR meeting, and continue to demonstrate an encouraging clinical profile as a single agent for treating patients with relapsed NHL. The results also support escalating to a higher dosing regimen in the final stages of this Phase 1/2 study that will allow us to decide an optimal dosing regimen for the pivotal Phase 2 study, PARADIGME, expected in Q1 2017.” The poster (abstract 1780) is available at: http://www.nordicnanovector.com/product-info/scientific-posters. Conference call details A conference call will take place on Monday 5 December at 11 am CET. Please make sure to dial in 5-10 minutes prior to scheduled conference call start time using the number and confirmation code below: Local – Norway +47 2350 0296Local – UK +44 (0)330 336 9411Local – USA and International +1 719 457 1036 Conference ID: 2949173 The conference call presentation will be available at www.nordicnanovector.com in the section: Investor Relations/Reports and Presentation/2016 from 10 am CET on Monday 5 December 2016. For further information, please contact: For Nordic NanovectorIR enquiries:Luigi Costa, Chief Executive OfficerCell: +41 79 124 8601Tone Kvåle, Chief Financial OfficerCell: +47 91 51 95 76Email: email@example.com Media enquiries:Mark Swallow/David Dible (Citigate Dewe Rogerson)Tel: +44 207 282 2948/+44 207 282 2949Email: firstname.lastname@example.org 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.