Bioteknikbolaget Cyxone publicerade nyligen sin rapport för fjärde kvartalet, en period med stort fokus på avancemang inom projektet med läkemedelskandidaten Rabeximod. Bolaget lämnade in nya patentansökningar, presenterade positiva resultat från toxikologistudier och erhöll godkännande om att starta fas II-studier i patienter med måttlig Covid-19. Under kvartalet stärkte bolaget även sin kassa, som kommer att finansiera alla planerade aktiviteter under 2021. BioStock tog kontakt med vd Tara Heitner för ytterligare kommentarer.

Nyligen presenterade Malmöbolaget Cyxone sin rapport för fjärde kvartalet 2020. Bolaget utvecklar sjukdomsmodifierande behandlingar för sjukdomar i immunsystemet, exempelvis ledgångsreumatism (RA), multipel skleros (MS) och för akuta respiratoriska sjukdomar som orsakats av virus. Bolaget rapporterade om ett händelserikt kvartal med en solid kassabehållning som kommer att finansiera alla planerade aktiviteter under 2021.

Stärkt kassa finansierar aktiviteter

Cyxone har en välfinansierad position att driva sina program framåt under 2021, med huvudfokus på Rabeximod och att genomföra den pågående fas II-studien samt att förbereda för en kommande RA-studie med kandidaten.

Resultatet under sista kvartalet 2020 redovisades till cirka -12 Mkr, jämfört med -9 Mkr under samma period 2019. Kassabehållningen på balansdagen uppgick till 56,1 Mkr jämfört med 61,7 Mkr vid utgången av 2019.

Dr Kalev Kask, upphovsmannen bakom patentet för det medicinska användandet i Covid-19, ingick tidigare under året ett samarbetsavtal med Cyxone om utveckling av en ny Covid-19-behandling med Rabeximod. Under kvartalet utnyttjade dr Kask optioner att teckna aktier enligt tidigare avtal och tillförde totalt 20 Mkr till bolaget utöver de 1,8 Mkr som han tecknade tidigare under året.

Teckningsoption med inlösen i maj

I november genomförde Cyxone även en riktad emission om 19 mkr till utvalda investerare och utfärdade samtidigt teckningsoptioner av serie TO4 med inlösen i maj 2021. Cyxone beslutade att emittera TO4 även till befintliga aktieägare, vilket innebär att teckningsoptionen potentiellt kan tillföra maximalt 42 Mkr till bolaget under våren.

Fas II med Rabeximod har inletts

I januari screenades den första patienten i Cyxones fas II-studie med Rabeximod. Studien har inletts i Polen med potential att utvidgas till fler länder. Bolaget väntar sig en preliminär resultatavläsning under Q3 2021. Läs mer.

VD kommenterar

BioStock tog kontakt med vd Tara Heitner för ytterligare kommentarer om vad som händer i bolaget just nu och hur förväntningarna ser ut för den närmaste tiden.

Tara, recently, clinical trial results with Roche’s RA antibody drug tocilizumab were presented, showing that the drug is cutting the risk of death among patients with severe Covid-19. What does this mean for your project with Rabeximod?

– This is good news for Rabeximod. It demonstrates that controlling inflammation similar to in RA, is helping patients that are struggling with Covid-19 where uncontrolled inflammation due to SARS-COV-2 is causing damage and mortality. So the fact that Rabeximod has shown efficacy in RA is a good sign for its potential in treating Covid-19 patients.

– Rabeximod like other RA drugs are being tested for Covid-19 because of a common pathology involving inflammatory cytokines and an imbalance of the immune system. Compared to tocilizumab and other RA drugs the preclinical data on Rabeximod suggests a broader action of Rabeximod on the cytokine suppression compared to anti-IL6 antibodies or JAK inhibitors that should make Rabeximod more effective and since Rabeximod is shown to be safe and well tolerated we can treat patients before they become severely ill (moderate Covid-19) to prevent them from progressing to a severe or acute stage of disease.

– Rabeximod is orally available as a capsule and thus has the potential to become a treatment that can be self-administered early it the disease, as opposed to tocilizumab which is an infusion which requires hospitalisation.

The first patient has been screened in your phase II trial with Rabeximod in patients with moderate Covid-19. How is the trial progressing?

– So far the trial is progressing with patients enrolled at sites in Poland with additional sites now opened in Poland. We have also received approval to open sites in Hungary and Slovakia which is great news. In addition, we are waiting for approvals in Romania, Ukraine and Latvia. With the possibility to open up all these additional sites, we strive to meet our patient enrolment goals.

In December you filed an IND with the FDA regarding Rabeximod as a therapy for Covid-19, what is the significance of the IND registration for Cyxone?

– First of all, the IND registration is a quality stamp for the Covid19 trial design and for Rabeximod. The feedback from the FDA allowed Cyxone the opportunity to optimise the trial for international acceptance. While this caused a slight delay in the execution of the Covid-19 trial we are happy that going forward we have incorporated the advice from the FDA.

– The IND enables Cyxone to seek ethical approvals to run trials in USA, and market and commercialise Rabeximod in USA which is today the most important market for RA with 70 percent market share. It also opens up for patent term extension in the USA. In sum, the IND increases the value of Rabeximod significantly for Cyxone and its shareholders.

Earlier plans were to initiate a phase II trial with Rabeximod in rheumatoid arthritis. Can you give us an update on those plans?

– We have engaged a number of world class advisors including our own SAB (Scientific Advisory Board) to assist with designing a trial which can better demonstrate the unique attributes and efficacy profile of Rabeximod to prepare for entry into a large but competitive RA market. At this stage we have an initial plan which is currently being fine-tuned. We are taking time to include the excellent input from our newly hired scientific and regulatory advisors.

You received funding through a directed share issue in November adding SEK 19 million. How will you use the proceeds?

– These funds are mainly being used to support the ongoing phase II Covid-19 trial such as expanding the Covid-19 trial sites if necessary, the design of the optimised RA trial and preparing the company for listing on the main market.

– In parallel we continue to progress non-clinical experiments to support new patents, exploring mechanisms of action of our compounds and in preparing T20K for non-clinical toxicology and safety studies with a new administration form.

 Speaking of T20K, your MS drug candidate, what can you tell us about this project?

– T20K is of course an earlier stage program and we have spent the past months increasing our understanding of how to best administer it clinically. We have also dedicated resources to planning the scale up and manufacturing which will be required for IND enabling studies and phase I studies. However, as a small company we are forced to focus our limited resources and indeed the focus for now is on Rabeximod.

Finally, what will be the most important events for Cyxone in the coming six months?

– The most important events for Cyxone will be the completion of enrolment of the Covid-19 trial, the finalisation of the RA trial design and start-up activities as well as a decision on the mode of administration of T20K. We have also ramped up our partnering activities and are actively seeking a strategic partner for Rabeximod.

– So we have a busy 6 months ahead and the whole team is working hard toward our goals. The team has achieved so much in the last 6 months and we’re all working together to achieve much more in the upcoming 6 months.

Innehållet i BioStocks nyheter och analyser är oberoende men BioStocks verksamhet är i viss mån finansierad av bolag i branschen. Detta inlägg avser ett bolag som BioStock erhållit finansiering från. 

Prenumerera på BioStocks nyhetsbrev