CS585: A selective IP agonist
The company’s third asset, CS585, is in the earlier stages of development and, while it has not yet been assigned a specific target indication, it is backed by preclinical research showing promise in thrombosis prevention without increased risk of bleeding. The candidate is an oral, selective and potent agonist of the prostacyclin receptor (IP).
During the CMD, the potential of CS585 to address rare disease was discussed by Dr. Michael Holinstat, associate professor at the University of Michigan Medical School and Cereno’s director of translational research. In the presentation, Dr. Holinstat highlighted how antiplatelet therapies have reduced the risk of morbidity and mortality by >26%, but noted that morbidity and mortality due to cardiovascular events remain unacceptably high. The challenge stems from novel antiplatelet therapies that need to decrease both platelet activation and thrombosis, while also limiting the risk of bleeding and intracranial haemorrhage. Notably, CS585 as an IP agonist has been shown to inhibit the aggregation of platelets from multiple pathways and, encouragingly, preclinical data have shown that this translates to the inhibition of clots (Exhibits 7 and 8). In addition, CS585 appears to target the IP receptor more selectively than existing IP agonists, according to Dr. Holinstat, who highlighted that these competitors are also challenged by short half-lives and by their utility in the blood, hindering their clinical application to indications such as pulmonary hypertension.

CS014: A ‘rare’ pivot
A key highlight of the CMD was Cereno’s announcement of its decision to pursue development of CS014, the second HDACi in its portfolio and a valproic acid (VPA) analogue (with a similar pharmacology profile to CS1), in the rare disease IPF, versus the broad label of thrombosis previously. We believe the decision was driven by a combination of factors, including clinical, commercial and strategic. Cereno recently presented encouraging preclinical data for CS014, which, although it related to a PAH model, demonstrated a robust, reversal of fibrosis and dose-dependent reverse remodelling of pulmonary vasculature, including plexiform lesions and small vessel-related fibrosis, which are also key pathological features of IPF. As part of the CMD, management also presented previously reported scientific publications and preclinical data. Preclinical data were also presented on CS014’s ability to reduce fibrosis and thrombosis (discussed in further detail below).

CS1: Advancing towards pivotal studies in PAH
CS1, Cereno’s lead asset, is a histone deacetylase HDAC inhibitor (HDACi), which aims to leverage the principles of epigenetic modulation to achieve disease modification in PAH. As part of the CMD presentation, Dr. Raymond Benza, system director of pulmonary hypertension at Mount Sinai Icahn School of Medicine, highlighted the epidemiology of PAH and the significant unmet need for safe, effective and disease-modifying treatments. This was followed by the Cereno team discussing the CS1 programme in PAH, the recently announced positive Phase IIa data and the forthcoming development plans for the asset.

https://www.biostock.se/2024/11/cereno-scientifics-vd-om-nya-behandlingar-for-sallsynta-sjukdomar/

BioStock: Cereno Scientifics vd om nya behandlingar för sällsynta sjukdomar
I dag kl. 08:34 ∙ Cision
BioStock träffade Cereno Scientifics vd Sten R. Sörensen på BioEurope. Cereno utvecklar nya behandlingar för sällsynta sjukdomar i syfte att förbättra och förlänga livet för patienter som har stor brist på tillräckliga behandlingsalternativ. I den här intervjun delar Sten med sig av insikter om bolagets aktuella projekt, deras mål på BioEurope och vad framtiden har att erbjuda. Se intervjun med Cereno Scientific på biostock.se:
https://www.biostock.se/2024/11/cereno-scientifics-vd-om-nya-behandlingar-for-sallsynta-sjukdomar/

Detta är ett pressmeddelande från BioStock - Connecting Innovation & Capital. https://www.biostock.se/

BioStock: Cereno Scientifics vd om nya behandlingar för sällsynta sjukdomar

https://www.youtube.com/watch?v=lQ3Y1yiYmQE

"Wrapping up the final day at BIO Europe 2024 in Stockholm! Our CEO Sten R. Sörensen, CMO & Head of R&D Dr. Rahul Agrawal, and Director of Business Development Julia Fransson have had an inspiring and productive experience filled with **meaningful discussions with potential partners, investors, and industry peers.**"

Cereno Scientific secures minimum 250 MSEK loan financing to reach set milestones into 2026

Cereno Scientific (Nasdaq First North: CRNO B), a pioneering biotech company developing innovative treatments for diseases with high unmet medical needs, today announced that the Company has entered into a financing agreement (the “Financing Agreement”) securing loan financing of at least 250 MSEK. The Financing Agreement includes a cash loan in two tranches totaling 175 MSEK as well as the issue of convertible loans of 75 MSEK with Fenja Capital II A/S and the US-based investor Arena Investors, LP (the “Financiers”). The Financing Agreement secures the financial runway for Cereno Scientific to reach its set milestones into 2026.

For en deilig nyhet med lån og konvertering på 6kr tallet når vi ligge på 5kr, og ikke 3 måneder seigpining med emisjon og tegning retter .

Insidehandel på nesten 140T aksjer til en verdi av ca 700tusen sek de siste dagene er beget bra. Ingen der som legger sparepengene sine i noe de ikke har tro på.

Cereno Scientific’s lead candidate CS1’s reverse vascular remodeling profile is accompanied by improvement of right-ventricular function in additional data from Phase IIa trial ­– webcast on March 4

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced additional Phase IIa trial data with drug candidate CS1 in pulmonary arterial hypertension (PAH) following the Clinical Study Report (CSR) completion. We see encouraging signs of reverse vascular remodeling effects of CS1, which are accompanied by measures of improved right-ventricular function of the heart, increasing impact over time on REVEAL 2.0 risk score and NYHA functional class as well as improved quality of life. An ongoing Extended Access Program (EAP) allowing patients to continue CS1 treatment will provide further insight into the long-term disease-modification effects of CS1. A larger placebo-controlled trial is being planned to confirm and expand upon these compelling findings. The combined preclinical and clinical data supports that the epigenetic modulating HDAC-inhibitor CS1 has a strong potential to transform the lives of PAH patients as a safe, well-tolerated oral therapy with disease-modifying effects. A webcast to present the Phase IIa data will be held on March 4, more details to come.

“We are pleased to have completed the Clinical Study Report, successfully concluding the Phase IIa trial and enhancing our understanding of CS1’s reverse remodeling effects. PAH is a progressive and fatal disease with pathological changes to the pulmonary vasculature and the right-heart. Despite the trial’s short duration, CS1 showed improvement of right-ventricular function signaling a disease-modifying effect by halting disease progression or through the reversal of pathological vascular remodeling. Based on these encouraging findings and the completed Clinical Study Report, we have now initiated a Type C meeting with the FDA to align the next development steps of CS1 and in parallel we are pursuing the publication of our scientific data,” said Rahul Agrawal, CMO & Head of R&D at Cereno Scientific.

The Phase IIa trial was conducted over 12 weeks with a total of 25 patients of which 21 were evaluated for efficacy parameters. The trial successfully met its primary endpoint of safety and tolerability, with no drug related serious adverse events. CS1 was also shown to have a positive impact on exploratory clinical efficacy parameters consistent with disease-modifying effects in PAH. Treatment with CS1 lowered patients’ REVEAL 2.0 risk score, a key predictor of clinical worsening and mortality, where 43% (9/21) showed an improved REVEAL 2.0 risk score and 71% (15/21) improved or had stable risk score after the 12-week treatment period. Patients reported functioning better in daily life when treated with CS1 as reflected in the 33% (7/21) of patients with improved NYHA functional class and 86% (18/21) of patients with improved or stable NYHA functional class after the treatment period. 67% (14/21) of the patients had sustained pressure reduction reflected in mean pulmonary arterial pressure (mPAP, AUC) when treated with CS1.

Further analysis conducted after the trial’s top-line reporting showed:

CS1 showed a significant improvement of right-ventricular Global Longitudinal Strain (RVGLS), a sensitive measure of right heart function and treatment response. The RVGLS is a highly predictive indicator of right-ventricular remodeling at early stages of disease and future mortality.
Alongside RVGLS, an improvement and/or stabilization in tricuspid regurgitation (TR)—a condition in which the valve fails to close completely during right ventricular contraction, leading to increased pressure—was also observed over the 12-week treatment period.
CS1 further demonstrated a gradual improvement over time on the REVEAL 2.0 risk score and the NYHA functional class in the 12-week treatment period.
CS1 also demonstrated a positive impact on quality of life (QoL) in patients with PAH as measured by PAH-SYMPACT and Minnesota Living with Heart Failure Questionnaire.
A sub-group of patients were identified being in the early stage of PAH disease who experienced marked improvement of pulmonary vascular resistance (PVR).
“All signs are pointing toward our epigenetic modulating HDACi CS1 having a real potential to be a disease-modifying game-changer in the treatment of PAH, a fatal rare disease with high unmet need. We are excited for the next part of the journey to further evaluate CS1’s transformative potential as a treatment for PAH. We view CS1 as a strong candidate for commercial partnering given the exciting preclinical and clinical data on reverse remodeling effects, good safety and tolerability, oral administration and market exclusivity of seven and ten years with an ODD in the US and Europe, respectively. In parallel with our regulatory and clinical preparations for further development, we foresee an even further increase in our partnering activities,” said Sten R. Sörensen, CEO of Cereno Scientific.

The clinical development plan for CS1 is to continue the evaluation of CS1 as a safe, well-tolerated oral therapy with disease-modifying effects in PAH. A larger placebo-controlled Phase IIb trial is being planned, and interactions with the U.S. Food & Drug Administration (FDA) has been initiated following the recent submission of a Type C meeting request.

kurs NÅ : 4,84

CS014’s progressing well with favorable safety and tolerability profile in part one of Phase I

We recently shared that the first part of two in the Phase I trial in healthy volunteers has been completed without any safety concerns. In the first part, CS014 was administered as a single ascending oral dose (SAD) and, in the second part that is now currently ongoing CS014 is administered as multiple ascending oral doses (MAD). The full Phase I trial is expected to be reported by mid-2025.

I am very pleased to see favorable clinical data consistent with what we have previously expected from the CS014’s safety and tolerability profile. Our HDACi CS014 is a new chemical entity that now has been tested for the first time in humans with initial positive results as a safe and well-tol­erated drug candidate. This is a major milestone in clinical development, especially for a new chemical entity drug (NCE). These positive safety and tolerability data is a strong initial validation and support further clinical development. We believe that the novel CS014 has the potential to be a safe, well-tolerated oral drug with disease-modifying capacity in the significant unmet need and market of IPF treatments.

Strengthened focus on rare cardiovascular and pulmonary diseases

We have strengthened the Cereno commitment to rare dis­eases when selecting the target indication idiopathic pul­monary fibrosis (IPF) for our novel HDACi CS014. The rare disease shares several of the disease mechanisms with PAH, our target indication for our lead program CS1, and both diseases are characterized by high unmet clinical needs de­spite today’s available treatments. Our safe, well-tolerated orally administered epigentic modulating HDACis, CS1 and CS014, hold promise to completely change the approach to how these rare diseases are treated with the ability to enhance and extend life for people affected.

New preclinical data of CS585 shared with the scientific community

We are excited that we have been invited to share new preclinical data on our promising novel prostacyclin (IP) re­ceptor agonist CS585 at several international conferences in the fourth quarter of 2024. At the ASH Annual Meeting and Exposition 2024, in December in San Diego, new pre­clinical data showed that through prolonged anti-thrombot­ic efficacy and high selectivity for the IP receptor, CS585 offers a promising new approach to anti-platelet therapy for thrombotic disease without bleeding.

Additionally, preclinical data presented at the ESC congress 2024 in August showed that CS585 inhibits platelet activa­tion and clot formation up to 24 hours post-administration. This data was later published in the esteemed medical jour­nal European Heart Journal (follow link to read).

Strengthening the Cereno Scientific promise

We have a razor-sharp focus on continuing dialogues with potential pharmaceutical partners and investors this spring. There are two exciting events in March where we will be presenting on stage as and have stakeholder meetings; BioEurope Spring is the leading partnering conference in Europe and the Nordic-American Healthcare Conference is the premier Nordics event in the US for life science in­novation, where we have been invited along with major players in the healthcare space. In parallel with the positive progress of our clinical programs, there have been sever­al relevant news announcements in the competitor realm which we operate and related to clinical study terminations as well as safety committee pausing a later stage clinical trial. These developments further underscore the important aspect to develop new drugs that are safe and well-toler­ated in this space. We believe we are well positioned to have a competitive advantage with our HDACi drugs in this regard in both PAH and in IPF.

When this report is published, we are just a few days from Rare Disease Day on February 28. I hope you join us in rais­ing awareness of these diseases and the high unmet clinical needs. I, on behalf of the Cereno Scientific team, am grate­ful for the continued support you show us as we are work­ing to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the fullest.

Thank you for your confidence.

Sten R. Sörensen, CEO

Her er det bare og handle hver gang man får frigjort midler :) For denne tenker jeg kommer til og bli fin og ha i skuffen sin fremover.