Parallellt med att Cereno Scientific förbereder starten av fas II-studien med huvudkandidaten CS1 i den sällsynta hjärt-kärlsjukdomen pulmonell arteriell hypertension, deltar bolaget i CVCT Forum – en konferens som samlar Key Opinion Leaders inom området. BioStock kontaktade Cerenos CMO Björn Dahlöf samt forumets ordförande och medgrundare, Dr Faiez Zannad, för att få veta mer om forumets betydelse, vad Cereno kommer bidra med under konferensen och hur bolaget kan gynnas av sitt deltagande.

Snart inleds årets prestigefyllda Global CardioVascular Clinical Trialists (CVCT) och därefter väntar fyra dagar av diskussioner kring de senaste kliniska studierna inom CVD-området. Det virtuella evenemanget samlar den globala expertisen inom hjärt- och kärlsjukdomar (CVD), inklusive forskare, industriaktörer, CROs, prestigefyllda forskningsinstitutioner, regulatoriska representanter, patientorganisationer och många andra.

Cereno Scientific samarbetar med KOLs inom CVD

Det svenska bioteknikbolaget Cereno Scientific, som utvecklar läkemedel för ett brett spektrum av CVDs, är en av deltagarna på årets CVCT Forum. Bolaget representeras av CMO Björn Dahlöf som kommer hålla presentationen “The Evolving Landscape Of Pulmonary Arterial Hypertension Phase 3 Trials Part 2- Redefining Clinically Meaningful Endpoints.” Dr Dahlöf kommer att diskutera ämnet ur ett branschperspektiv tillsammans med representanter från de globala life science-bolagen Merck och Abbott, där den senare är en av Cerenos samarbetspartners. Se hela CVCT-programmet här.

Genom bolagets vetenskapliga råd (SAB) har man ett nära samarbete med några av de viktigaste Key Opinion Leaders (KOLs) inom CVD-området, varav flera är involverade CVCT Forum. Två av dessa är forumets grundare och ordföranden, Dr Faiez Zannad och Dr Bertram Pitt.

»I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain [from the CVCT Forum] for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in context of the evolving field of PAH therapy and trials.« — Dr Björn Dahlöf, CMO Cereno Scientific

En annan KOL som deltar vid CVCT Forum, och som även han är medlem i Cerenos SAB, är Dr Raymond Benza. Dr Benza är särskilt framstående inom pulmonell arteriell hypertension (PAH), vilket även råkar vara Cerenos fokusindikation för den primära läkemedelskandidaten CS1. Faktum är att Cereno, efter att bolagets ansökan om läkemedelsprövning (Investigational New Drug, IND) godkänts av FDA, nyligen inledde en klinisk fas II-studie inom PAH med CS1.

Studien utvärderar en ny behandlingsmetod för PAH som är baserad på epigenetisk modulering genom HDAC (Histone DeACetylase)-hämning, och Cerenos studiedesign inkluderar ett antal experimentella utfallsmått. I studien kommer man dessutom – genom det ovan nämnda samarbetet med Abbott – använda CardioMEMS HF System, en apparat för övervakning av lungartärtryck. CardioMEMS HF-systemet har redan visat sig avsevärt reducera behovet av sjukhusinläggningar till följd av hjärtsvikt, och fi as II-studien med CS1 kommer enheten för första gången används i en klinisk PAH-prövning.

Dr Benza har varit en viktig rådgivare för Cerenos under utformningen av de kliniska delarna av den kommande fas II-studien, och han kommer även att vara studiens huvudprövare. Läs mer om Cerenos SAB inklusive en profil av Dr Benza här.

KOLs hjälper till att positionera Cereno i branschen

Att ha en nära relation med KOLs såsom Zannad, Pitt och Benza ger Cereno Scientific trovärdighet inom CVD-området. Detta är en viktig värdedrivare för bolaget, i synnerhet när man äntrar en ny fas av klinisk utveckling med CS1, parallellt med att man utökar sitt utvecklingsprogram med ytterligare kandidater med potential inom fler CVD-indikationer. Läs mer här.

Experterna delger sina insikter

BioStock ville veta mer om vikten för Cereno att delta i CVCT Forum och ha ett så nära samarbete med ledande KOLs inom CVD, särskilt med tanke på bolagets fortsatta tillväxt, både inom teamet och inom dess kliniska utvecklingsprogram. Vi kontaktade därför bolagets CMO, Dr Björn Dahlöf, samt CVCTs ordförande och medgrundare Dr Zannad.

»The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year’s edition. You can almost say that the CVCT Forum a gathering of “Who is Who” within cardiovascular diseases.« — Dr Faiez Zannad, Medlem av Cereno Scientifics vetenskapliga råd och medordförande i CVCT Forum

Dr Dahlöf, Cereno is once again attending the CVCT Forum where CVD clinical trials come front and centre. What will the company gain the most from attending this year?

– I have been part of the CVCT community for several years in my capacity as Principal Investigator of major mortality and morbidity studies in cardiovascular disease prevention. Now, being CMO of Cereno Scientific brings another interesting dimension to cardiovascular trials and I also have the privilege to present our innovative phase II trial to the community. The gain for me and the company will be the interaction and networking with leading thought leaders from all aspects of cardiovascular trials, gaining further knowledge and inspiration, and putting our phase II trial in context of the evolving field of PAH therapy and trials.

You will be contributing at CVCT with a presentation alongside representatives from Merck and Abbott. What will this presentation focus on?

– My presentation will focus on the innovative and cost-effective design of our phase II trial in PAH, which is of utmost importance for future development of CS1 with Cereno being a small biotech company. Firstly, I will introduce the key features of the CS1 PAH program with a focus on the potential of epigenetic modulation in PAH, the smart formulation of CS1 and the unique combination of CS1’s four efficacy pillars which are anti-proliferation/anti-fibrosis, anti-inflammation, pulmonary pressure reduction and anti-thrombosis. Secondly, I will highlight other key elements of the trial including remote monitoring of pulmonary pressure by the CardioMEMS technique in collaboration with Abbott and the long list of secondary exploratory objectives. In combination, we hope to have all we need for the next clinical trial, including safety and tolerability which is the primary objective of the phase II trial, the right dose(s), exploratory efficacy, and pharmacokinetics.

The company is currently searching for a Head of Clinical Development and a Head of Research and Preclinical Development. What are the overall implications of these additions?

– Yes, we have recently experienced rapid growth with an expanded pipeline and the initiation of our first phase II program. To support this, as well as the future growth of the company, we are continuously assessing the need to build out our organization. We have already strengthened our team with key roles within clinical trial execution and are currently looking for additional experts to lead our clinical research as well as preclinical development work. The new additions will enable us to successfully deliver on the ongoing development programs as they continue to progress, together with our collaboration partners.

Dr Zannad, as chair of CVCT, what is the main goal of the Forum?

– The key purpose of the Global CVCT Forum is to bring together expert stakeholders from various backgrounds to discuss key recent and future clinical trials within cardiovascular, cardiorenal and cardiometabolic diseases in depth, both individually and in context. CVCT is the only global meeting that brings together the most authoritative stakeholders to discuss clinical trials in detail and I am very much looking forward to this year’s edition. You can almost say that the CVCT Forum a gathering of “Who is Who” within CV.

And as a member of Cereno’s SAB, how do you hope this year’s Forum will contribute to the company’s clinical development?

– I hope that Cereno will be able to both connect with, and take inspiration from, all the other stakeholders present at the CVCT and gain an expanded view on the different elements of clinical development. I am also looking forward to Cereno’s contributions to the sessions focused on the evolving landscape of PAH trials. I think it will be interesting for the community to learn more about the innovative elements of their phase II trial.

Finally, what are your expectations for Cereno’s phase II trial within PAH?

– It has been a pleasure to follow Cereno’s journey so far, and I am impressed with the progress made by the team up to this point. CS1 is showing promising characteristics that fit very well with the pathogenesis of PAH, so I am excited to see the clinical evidence as it unfolds.

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