Hermed en gennemskrivning af spørgsmål/svar/noter fra dagens snak med Øystein Soug og Magnus Jaderberg. Bemærk at materialet er delvist engelsk, men jeg håber uanset, at der kommer ét eller andet budskab frem. Nedenstående svar skal ses som et “interleave” af udtalelser fra begge deltagere, hvor særligt Magnus Jaderberg kommenterede på de kliniske forhold.
… on to the questions that relate to the ASCO poster (phase 1/2 study of Durvalumab + interperitoneal ONCOS-102 for patients with OC/CRC) …
Q: While there appears to be general excitement around the (positive) preliminary findings of the clinical trial, especially the following (poster) conclusion appears to be contradicting said (positive) findings (again, given the conditions and outlook of the patients):
Preliminary analyses demonstrate evidence of biologic and clinical activity but no correlation between changes in immune infiltrates and clinical benefit
A: The primary objective (endpoint) of the study is to evaluate best dose (aka “dose escallation”); i.e. the primary investigator (PI) wasn’t initially expecting to be looking at efficacy (and neither did the company), however … they did it anyway. (aborum: one may speculate but I’m betting the PI saw more than an “initial signal of efficacy”)
It’s important (here) to note the wording of the conclusion; the word “correlation” has a different meaning in the language of statistics and I (MJ) would have rather liked to use the word “association”.
Basically the wording indicates that, from a statistical perspective, there not much immune data in the study … there are changes in the micro environments, but to talk about the clinical benefit and immune response you need more data.
…
Q: Is this statement based off the relatively low number of patients in the trial? (N = statistically insignificant)
A: (aborum: se svar vedr. tidligere spørgsmål … ØS og MJ besvarede flere spørgsmål ad hoc men for at parafrasere, så er antallet af patienter for lavt til at PI kan give en udtalelse der hviler på statistisk signifikante data)
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Q: While ONCOS-102 (generally) yields a favorable correlation of clinical benefit vs. stimulation, activation and infiltration of t-cells, is TRVX expecting the conclusion to change once the final data is produced (N = statistically significant) (as the results show some evidence of clinical benefit vs benchmark, it was somewhat of a surprise to find that the previous mode of action of ONCOS-102 wasn’t correlated with clinical benefit)
Følgende data blev fremsendt som underbyggende del af spørgsmålet:
Cohort A: N = 4: 0/4 0% DCR
Cohort B: N = 5: SD (OC) + PR (OC) 2/5 40% DCR
Cohort C: N = 8: SD (CRC) + SD (CRC) + SD/PR(OC) 3/8 37.5% DCR
CRC totalt alle cohorter N=7: 2/7 = 28% DCR
OC totalt alle cohorter N=9: 3/9 = 33 % DCR
DCR mål som må oppnåes i part 1 (med cohort C dosering)
for at gå videre til part 2:
Colorectal 1/13 = 7,6% (vs. aktuelt 28%)
Ovarie 5/18 = 27% (vs. aktuelt 33%)
A: As alluded to previously, the number of patients is quite low (as is usually the case for a dose escallation study); that said then …
- We’re very encouraged by about the clinical (signal of) efficacy observed so far - these are very sick patients (ØS).
- The early data are very good data (ØS).
…
Q: Is TRVX planning on issuing a press release tuesday morning to complement the ASCO poster?
A: (aborum: har skrevet om dette tidligere på dagen, men som udgangspunkt står selskabet i en situation der, grundet studiets sponsorer og generelle opsæt, kan gøre det problematisk at få tilladelse/finde detaljer, der kan formidles til markedet; selskabet er dog svært interesserede i at få feedback omkring forslag til, hvordan selskabets meldinger til markedet kan forbedres … jeg kan ikke vurdere, om der kommer en melding tirsdag morgen, men jeg tænker jungletrommerne aktuelt arbejder på at finde på ét eller andet)
Det fremgik endvidere af samtalen, at selskabet havde fået akkurat så stærke data som man havde håbet på, herunder en bekræftelse på, at det stærkeste kliniske “signal of efficacy” ses blandt patienterne i cohorte C (dvs. den største dosering af ONCOS-102), hvilket kan være retningsgivende for den kommende 2. cohorte for melanoma med 4x dosering af ONCOS-102.
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(følgende er en kommentar jeg tilføjede omkring selskabets IR aktiviteter; historisk set såvel som de kommende, som jeg har en særlig holdning til)
A general reflection:
I believe, from the IR perspective of a clinical biotech company, it’s of outmost importance to realize that a major part of the shareholders are retailers, i.e. aren’t clinically educated or have spent hours upon hours learning about the clinical terms, to fully understand - or comprehend - the nuances of clinical press releases.
However, they do represent as significant a part of the market to play an important part of the continuous price development in the market (i.e. stock price).
TRVX IR previously brought forward Magnus Jaderberg in a pre recorded screencast relaying the findings (read out/conclusions) of a clinical trial; this screen cast complemented the press release and gave the market an exemplary view of findings, benefits and outlook (clinically and financially) … in other words, a stroke of genious communication at the terms of an (important) part of the shareholder retailer base.
I therefore suggest that IR resorts to making much more use of Magnus Jaderbergs name, status and ability to relay complex clinical information to the average retailer in the market; put him forward and explain the clinical findings in a language that resonates with the average retailer. While this is likely a first for norwegian biotech, I see this as a necessary step to build more trust between management and investors.
TRVX should seriously consider sticking to a consistent plan of presentation each time a press release on clinical findings is isssued; take this opportunity and strong positive feedback from the previous screen cast to set a new standard in norwegian biotech.
ØS: “This feedback is of outmost importance to us and it’s definitely something we’ll take to heart. Also, do you think the tone of voice should be a bit more optimistic and upbeat”
(aborum: svaret her var, at jeg generelt ser de skriftlige meldinger som værende af høj kvalitet, men kunne godt savne mere synligt engagement - særligt under webcasts og referede endnu engang til forslaget om at synliggøre Magnus Jaderberg til at perspektivere på relevante kliniske data)
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Afslutningsvis kan jeg bidrage med at både Øystein Soug og Magnus Jaderberg fremstod svært engagerede i samtalen og gjorde opmærksom på, at de tager seriøst på alle henvendelser fra aktionærbasen.
Jeg er ikke helt klar over, hvad forventningen var til denne samtale, men for eget vedkommende finder jeg at ledelsen svarede glimrende for sig og at eventuelle uklarheder omkring konklussionen på ASCO posteren er blevet gennemlyst.
