Den er avsluttet nå så er litt sent, men var ikke stort nytt som ble sagt. Gjennomgang av sliden som ligger på hjemmeside og et par spørsmål i etterkant. Et av spørsmålene var fra DNB hvor de spurte om 20 MBq/kg behandlingen var startet eller om de kun har kommet til rekrutteringen. Costa bekreftet at de har startet behandlingen på minst 1 pasient
Skulle det komme noe mer info senere idag/imorgen eller tar jeg feil?
Edit:
Er det bare jeg som reagerer på at etter en skikkelig god nyhet som ytterligere fjerner risiko “kun” løfter oss 6-7%, mens et høynet kursmål løfter oss det dobbelte? Etter denne meldingen må DNB endre LOA til 50% og kursmål til 161, noe annet vil være meget merkelig. Jeg sier ikke at jeg er misfornøyd med 7 kroner opp, jeg bare stusser litt på hvordan markedet tolker meldingene og info som har kommet.
Edit2:
Snakker om sola, her kom oppdatert analyse fra DNB, meget overrasket at de fortsatt har LOA til 40%! :
Nordic Nanovector released some new clinical data over the weekend in connection to the ASH meeting in San Diego. The company updated the clinical and safety outcomes from the ongoing phase I/II trial as well as gave safety data on the Arm 3 and Arm 4 dose findings. We believe that the data overall is very strong with excellent safety for the increased pre-dosing. When the company used 100mg/m2 of cold antibody, as pre-dosing they did not see any cases of Grade 3 or 4 haematological side effects. The ORR for the phase II proportion of patients came in at 69% with 38% CR and 31% PR.
Strong safety data from increased pre-dosing with cold antibody. The safety from the increased pre-dosing worked very well, especially the three first patients in Arm 4 (pre-dosed with 100mg/m2) of cold antibody. In this cohort, the company did not see any Grade 3 or Grade 4 haematological side-effects. We believe this was the main reason why the Safety Review Committee recommended the company to increase the dose of Betalutin to 20MBq/kg with the 100mg/m2 pre-dosing. These patients have passed the point where side-effects can be evaluated but only one of the patients was included in the efficacy evaluation. Another interesting data point was that the outcome in Arm 3 (where the pre-dosing was with 375mg rituximab) did not deliver the protection against haematological side effects as expected. All patients in Arm 3 had Grade 3 and Grade 4 haematological side-effects. This might not be that surprising given that rituximab bind to CD20 and Betalutin bind CD37. Arm 3 has since been discontinued.
Overall Response Rate (ORR) looks strong at 69% for the phase II patients. The ORR (Overall Response Rate) in Arm 1 (combining the phase I and the phase II part) was at c64% with a split of c36% CR (Complete Response) and c29% PR (Partial Response). When we look at the phase II patients in Arm 1 (16 patients in total) the data was even better with an ORR of 69% with a 38% CR rate and a 31% PR rate. These outcomes are very competitive we believe.
Median Duration of Response close to 21 months. The company commented on the duration of response for all patients in Arm 1 and stated that the median duration of response for all patients in Arm 1 was 20.7 months. This should be compared with a normal expected duration of response in this, late stage patient group of around 1 year. Hence duration of response seems clearly better than most other drugs on the market for late stage FL patients. One must also remember that this is in monotherapy setting making the duration of response even more impressive.
Next steps – finalising dose and initiate the pivotal phase II trial. Given the data presented and the fact that the Safety Review Committee has recommended the company to increase the dose in both Arm 1 and Arm 4 to 20MBq/kg with a pre-dosing of 100mg/m2 cold antibody we expect the company to finalise the dose for the pivotal phase II trial at the end of Q1 2017 and subsequently initiate the pivotal phase II trial in H2 2017 according to the timeframes given earlier.
We have a BUY recommendation and a NOK121 target price. We have a target price for the Nordic Nanovector share of NOK121 and this is based on a likelihood of approval of 40% in our model.