ICML BETALUTIN LYMRIT STUDY UPDATE JUNE 14 TH, 2017

Transcription

1 ICML BETALUTIN LYMRIT STUDY UPDATE JUNE 14 TH, 2017

2 Disclaimer This presentation 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 forwardlooking statements. 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. 2

3 Updated data continue to confirm Betalutin s promising clinical profile Growing clinical database Updated results based on 59 patients evaluable for safety, 47 patients evaluable for efficacy (cut-off May 6 th, 2017) Results confirm single-agent Betalutin is highly active in recurrent indolent NHL Overall efficacy: ORR = 64%, CR = 28% Relapsed FL : ORR = 70%, CR = 27% 87% of all evaluable patients had a reduction in tumour size Continued favourable safety profile Characterized primarily by reversible neutropenia and thrombocytopenia Safety data indicate higher lilotomab pre-dose (100 mg/m 2 ) may allow administration of a higher and potentially more efficacious dose of Betalutin 3

4 4 LYMRIT phase 1/2 study in recurrent inhl

5 Population of primarily elderly, heavily pre-treated patients with advanced stage disease All patients (n=59) FL* (n=44) Other** (n=15) Median age, years (range) 65, n (%) 69 (40 88) 43 (73%) 69 (40 80) 31 (70%) 68 (57 88) 12 (80%) Male/female 33 (56%)/26 (44%) 25 (57%)/19 (43%) 8 (53%)/7 (47%) Ann Arbor stage at diagnosis*** I/II III/IV Unknown/not reported 4 (13%) 19 (63%) 7 (23%) 4 (21%) 12 (63%) 3 (16%) 0 (0%) 7 (64%) 4 (36%) Prior regimens, median (range) 2 prior regimens 2 prior rituximab regimens Prior alkylating agent 3 (1-8) 40 (68%) 32 (54%) 48 (81%) 2 (1-8) 31 (70%) 24 (54%) 34 (77%) 3 (1-7) 9 (60%) 8 (53%) 14 (93%) Bulky disease >5 cm, n (%) 25 (42%) 22 (50%) 3 (20%) WHO performance status 0/1 35/24 29/15 6/9 *Follicular grades: I (n=16), II (n=23), IIIa (n=5) **Mantle-cell lymphoma (n=6), marginal zone lymphoma (n=9) *** Information collected for Phase 2 patients only (N: all=30; FL=19) 5 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

6 % of patients Single dose Betalutin is highly active in relapsed indolent NHL, especially in FL patients (ORR 70%; CR 27%) Response rates All (n=47) FL (n=33) ORR CR PR SD PD 6 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

7 Percentage change in tumor size (SPD)* 87% of all patients had a reduction in tumour size 100 ** Best percent change in tumour size from baseline (n=45) Patients * SPD= sum of the products of the diameters ** Change in size of target lesion is beyond the scale for this figure (n=2) Follicular Marginal zone Mantle cell 7 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

8 8 Betalutin as a single dose holds significant edge over existing and upcoming competitors in R/R FL

9 Betalutin is selective in tumour targeting Baseline FDG PET/CT scan showing tumour locations Day 5 SPECT/CT scan showing radioactivity uptake in tumours 9 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

10 Most common grade 3/4 toxicities are reversible neutropenia and thrombocytopenia Grade 3/4 treatment emergent AEs in 2 patients (n=59) Adverse event n (%)* Neutropenia 32 (54%) Leukopenia 29 (49%) Thrombocytopenia 28 (47%) Lymphopenia 24 (41%) Infection Urinary tract infection (1) Sepsis/neutropenic sepsis (2) Pharyngitis (1) Pneumonia (1) 5 (8%) Lymphoma progression 3 (5%) * 7 patients had not had hematologic recovery at the time of data cut-off 10 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

11 Platelet Count 10 9 /L Neutrophil Count 10 9 /L Data indicate a higher lilotomab pre-dosage mitigates the hematologic toxicity of Betalutin Mean platelet count by dose escalation cohort, Arms 1 and 4 Mean neutrophil count by dose escalation cohort, Arms 1 and mg llo + 15 MBq/kg Betalutin 40 mg llo + 20 MBq/kg Betalutin 100 mg/m 2 llo + 15 MBq/kg Betalutin 100 mg/m 2 llo + 20 MBq/kg Betalutin mg llo + 15 MBq/kg Betalutin 40 mg llo + 20 MBq/kg Betalutin 100 mg/m 2 llo + 15 MBq/kg Betalutin 100 mg/m 2 llo + 20 MBq/kg Betalutin Days after Betalutin Treatment Days after Betalutin Treatment 11 ICML 2017, Poster version of the Abstract 282, Prof. A Kolstad et al.

12 Betalutin has the potential to be a novel, safe and effective therapy for recurrent inhl Updated LYMRIT results show promising efficacy and safety Overall efficacy: ORR = 64%, CR = 28% Relapsed FL patients: ORR = 70%, CR = 27% Most common grade 3/4 AEs were reversible neutropenia and thrombocytopenia Safety data indicating higher lilotomab pre-dose (100 mg/m 2 ) may allow administration of a higher and potentially more efficacious dose of Betalutin Enrolment in the Phase 2 expansion cohort of Arm 4 is on-going Data on long-term efficacy outcomes will be reported at the next clinical update 12

13 Nordic Nanovector s mission is to extend and improve the lives of patients with haematological cancers by developing and commercialising innovative Antibody Radionuclide Conjugates (ARC) Nordic Nanovector ASA Kjelsåsveien 168 B, 0884 Oslo, Norway IR contact: tkvale@nordicnanovector.com