2026 Q2 - tulosraportti
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Datan lähde: Quartr| Seuraava tapahtuma | |
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2026 Q4 - tulosraportti 15.4.2027 |
| Menneet tapahtumat | ||
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2026 Q2 - tulosraportti 1.9. | ||
2025 Q4 - tulosraportti 15.4. | ||
2025 Q2 - tulosraportti 28.8.2025 | ||
2024 Q4 - tulosraportti 10.4.2025 | ||
2024 Q2 - tulosraportti 29.8.2024 |
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- ·5 t sittenThanks Hulten for a professionally brilliant post. Circio (CRNA) – timeline ahead. 27.–30. October – ESGCT Hamburg - Presentation on next-generation circVec-based T-cell therapy. Circio has secured a slot for an oral presentation on circVec-based T-cell therapy, showcased to leading researchers and potential Big Pharma partners. New, strong data will validate the circVec platform.. H2 2026 – disease models: First efficacy data from AAV-circVec in relevant disease models, especially in wet AMD and cardiac. Also CNS data from the Big Pharma collaboration. Date unknown. 9.–11. November – BIO-Europe Second half of November – research update H2 2026 – ongoing triggers - Data in CNS, cardiac and wet AMD. - Possible new partnership agreements or updates from existing collaborations.
·6 t sittenCIRCIO AND CNS - SCIENTIFIC DEEP DIVE (PART 1/4) Results and why expression lasts Circio Holding has shown significantly higher gene expression with circVec in the heart, eye, and central nervous system (CNS). The CNS results are particularly interesting because gene therapy in the brain faces two distinct challenges: one must deliver a vector to the correct cell, and then produce enough functional protein over sufficient time. circVec addresses primarily the second challenge. A conventional AAV vector delivers DNA that normally expresses protein through linear mRNA. circVec instead utilizes a DNA-based expression system where the cell creates circular RNA: DNA → circular RNA → protein. Circular RNA lacks free ends and can be more stable against specific degradation mechanisms. This can provide more long-lasting and higher protein expression from a DNA construct that has already been delivered. However, circVec does not in itself make an AAV capsid more easily cross the blood-brain barrier or target specific neurons. FROM 4× IN 2025 TO UP TO 60× IN 2026 In the webcast on November 24, 2025, Circio showed around 4× higher reporter signal with circVec 2.1 than with conventional mVec after ICV injection in mice. The presentation simultaneously stated that testing of circVec 3.2 would start. In the webcast on September 1, 2026, the company presented three separate mouse experiments: - ICM (cisterna magna): 1 × 10¹¹ vg/mouse → approximately 10×. - ICV (brain ventricle): 9 × 10¹⁰ vg/mouse → approximately 30×. - IT (intrathecal): 1 × 10¹¹ vg/mouse → approximately 60×. The figures compare reporter expression from circVec against mVec within each experiment. They do not mean that IT is necessarily six times better than ICM as a delivery method. Nor can we straightforwardly interpret the increase from 4× in 2025 to 30× ICV in 2026 as an exact technology improvement: experimental design and timing must be fully compared. AN IMPORTANT VERSION DISCREPANCY The figure legends on page 10 in the September PDF are labeled circVec 3.2. On page 12, however, the CNS advantage is referred to as circVec 4.0. The Norwegian 26-page presentation also shows 3.2 at the three CNS graphs. This looks like a possible discrepancy in the summary, but the explanation is not confirmed. We should therefore not calculate a specific improvement from generation 3.2 to 4.0 based on these CNS figures. What is thus proven? A significant expression advantage in preclinical mouse experiments, following three administration methods. Not functional treatment of a neurological disease. THE DURATION MAY BE JUST AS IMPORTANT AS THE EXPRESSION LEVEL Perhaps the most interesting aspect of the CNS figures is not just the magnitude of the expression difference, but how the signals evolve over time. In the intrathecal experiment, mVec and circVec lie relatively close to each other early on. Later, the signal from the conventional construct declines, while the circVec signal remains higher and at times increases. Toward the end of the experiment, the difference is described as around 60×. Thomas Hansen describes the same development in the webcast on September 1: the mVec signal falls, while circVec is persistent and may increase somewhat. This fits the circVec mechanism. If the DNA cassette continues to make circular RNA and the RNA is simultaneously broken down more slowly, more RNA can accumulate and thereby provide a higher level of protein production. But this is an interpretation of the biology, not a complete mechanistic confirmation from the CNS experiment. Luminescence shows reporter signal, not direct RNA half-life, therapeutic enzyme activity, or the identity of all cells expressing the gene. Sources: Circio's original presentations from November 2025 and September 2026, as well as the webcast on September 1. All links in part 4.CIRCIO AND CNS – SCIENTIFIC DEEP DIVE (PART 2/4) Delivery methods, primate data, dose and DRG safety WHY THREE ADMINISTRATION METHODS? The blood-brain barrier makes it difficult for many gene therapies to reach the central nervous system via the bloodstream. Administration into the cerebrospinal fluid can bypass parts of the barrier: - ICM: injection into the cisterna magna at the transition between brain and spinal cord. - ICV: injection into the brain's ventricular system. - IT: injection into the intrathecal space, often via the spinal canal. All methods can provide CNS exposure, but they do not necessarily provide equal distribution to the cerebral cortex, deep brain areas, spinal cord, glial cells, and neurons. INDEPENDENT PRIMATE RESEARCH Okai and colleagues (2025) compared four AAV serotypes following ICM injection in non-human primates. They found no significant difference in biodistribution between the investigated serotypes. Delivery to the spinal cord and dorsal root ganglia was good, but distribution to deep brain regions was limited. The ICM procedure was well tolerated in this study. Amaral and colleagues (2026) investigated AAV9-GBA1. In primates, ICM resulted in significant expression in the spinal cord and dorsal root ganglia, but limited expression and enzyme activity in the brain. They also observed undesirable microscopic findings. Direct injection into brain tissue yielded a different distribution pattern, but also unique safety challenges. These studies are not trials with circVec. They demonstrate the delivery problems within which circVec must function. The main point: Higher protein expression alone cannot compensate for AAV failing to reach the correct target cell type. An important next milestone is therefore mapping where circVec DNA, RNA, and protein are actually located in the CNS. LOWER AAV DOSE – OPPORTUNITY AND SAFETY CHALLENGE One of Circio's most important hypotheses is that higher protein expression per vector genome can reduce the required AAV dose. This could potentially make gene therapy less burdensome and cheaper to produce. In heart models, Circio has demonstrated a significant dose-response advantage with a reporter protein. However, such findings do not yet document that one can administer a 10×, 40×, or 60× lower therapeutic dose in the brain. To prove this, an actual disease gene must be tested in a relevant CNS model: How low a dose provides sufficient correction, how long does it last, and what side effects occur? A 60× difference in light expression does not automatically mean a 60× lower treatment dose. The protein's function, the cells affected, the treatment threshold, and biodistribution determine how much the dose can actually be reduced. DRG TOXICITY – AN IMPORTANT CAVEAT The dorsal root ganglia (DRG) contain sensory nerve cells. These can be heavily exposed following AAV delivery to the cerebrospinal fluid, and neuronal and nerve fiber damage has been reported in several primate models. Grubor and colleagues (2025) found increased inflammation-related gene activity, cytokines, and immune cell infiltration prior to later DRG and nerve damage. Preventive immunosuppression with dexamethasone and tacrolimus reduced the damage in the investigated models. However, the researchers' introduction also highlights something particularly relevant for circVec: The expression of the AAV cargo itself is implicated in DRG toxicity, even if the underlying mechanisms are not fully understood. This creates an important two-part assessment: - A lower AAV dose could potentially mean fewer viral particles and lower total exposure. - Stronger transgene expression in undesired cells could potentially cause other problems, even at a lower dose. This is NOT proof that circVec is more toxic. It means one cannot declare the technology safer simply because it expresses more protein. Okai 2025 reported well-tolerated ICM administration in their experimental setup, while Amaral 2026 found undesirable findings following ICM delivery of a specific AAV9-GBA1 construct. The results show why one cannot generalize one safety study to all capsids, genes, doses, and administration routes. What do we need from Circio? Data on DRG, spinal cord, and peripheral organs; immune response; cell-type-specific expression level; and dose-response where therapeutic effect is weighed against actual toxicity. The potential strength of circVec is not "as much protein as possible", but the right amount of functional protein in the right cells with acceptable safety. Sources: Okai 2025, Amaral 2026, Grubor 2025, Chen 2023, and Circio's ASGCT/webcast material. Links in part 4.- ·16 t sittenCircVec and cardiac therapy – what is documented, and what does Circio need to prove? (Part 1/2) I have reviewed Circio's ASGCT data, webcast presentations and interviews, and compared with clinical AAV gene therapy. The first part concerns Circio's own data. Everything below is from preclinical experiments, not human treatment. 1. What do the mouse experiments show? AAV9-circVec 3.2 versus Circio's own mVec cassette, with the same heart-specific cTnT promoter and Firefly luciferase as a reporter. After intravenous dose of 5×10¹² vg/kg: - Up to 40× higher light signal in live mice, followed to day 71, and approximately 35× from isolated hearts. - RNAscope: 34–58× more reporter RNA in positive cells, and around 80 % of examined cardiomyocytes were RNA-positive. - RT-qPCR: approx. 96× more RNA in heart tissue, without statistically significant difference in the number of AAV vector copies. The ASGCT abstract also mentions up to 200× RNA in another analysis. This is not the same metric as 96× from the RT-qPCR figure, and should not be confused. The various measurement methods support increased expression after delivery, but some groups had only four mice. None of these numbers show better heart function. 2. Dose advantage – what does at least 10× mean? A separate mouse experiment investigated 5×10¹² to 1×10¹⁴ vg/kg. The dose curves indicated potential for comparable reporter expression at at least ten times lower AAV dose with circVec than mVec. This applies to measured gene expression in mice, not documented ten times lower dose to treat Danon or arrhythmogenic cardiomyopathy. PKP2 in the dose figure is an illustrative therapeutic reference level, not documented treatment effect from PKP2. 3. LAMP2B – an important step In September, Circio showed Western blot from mouse hearts on day 57. CircVec 3.2 gave clearly stronger LAMP2B bands than mVec. LAMP2B is relevant in Danon disease, but a precise fold improvement for this protein was not stated. The experiment also does not show correct localization, restored autophagy or improved function in a diseased heart. Danon is also not confirmed as the final clinical indication for Circio. 4. Liver and possible stress response CircVec gave lower unwanted reporter expression in the liver. But lower protein expression in the liver does not necessarily mean fewer AAV particles ended up there. An analysis of UPR-related genes as a group showed lower activation in circVec-treated mouse hearts than with mVec (p=0,003). This is an interesting early signal, not documented reduced immune risk or toxicity in humans. 5. CircVec 5.0 Circio has shown separate design improvements of around 90× and 170× expression versus mVec. These will be combined in Gen 5. In the BioHub interview, Erik Wiklund mentioned over 200× in vivo, while the written presentation describes the combined Gen 5 effect as potential. We need concrete combination data with a therapeutic gene before this can be considered confirmed. 200× expression does not mean 200× lower required treatment dose anyway. Sources part 1: Circio ASGCT poster: https://storage.mfn.se/21fac811-bd25-419d-ab49-20c47ecc5bfb/2026-asgct-poster.pdf Circio ASGCT presentation: https://storage.mfn.se/07a337af-de2b-49c6-ac87-670fbd9d1da4/260515-asgct-circio.pdf Webcast presentation 1.9.2026: https://www.circio.com/en/wp-content/uploads/sites/2/2025/06/260901-1h26-webcast-circio.pdf The BioHub: https://youtu.be/zrpuXDmCyWc
I have taken the liberty of sharing your post, just let me know if that's not okay :-) 
·1 päivä sittenTomorrow is a red day 😁
- ·1 päivä sittenCircVec in gene therapy for the eye – what do the mouse experiments show, and where can the technology provide an advantage? I have compared Circios eye data with clinical results from Opus Genetics and 4DMT. The question is not just how much circVec increases gene expression, but whether the technology can provide the same or better therapeutic effect at a lower AAV dose. 1. Circios eye data – mice only CircVec 4.0 was delivered with AAV2 by intravitreal injection in mice. - Up to 50 times higher reporter expression than Circios own mRNA-based control cassette (mVec). - Low-dose circVec (5 × 10⁸ vg/eye) gave up to 12 times higher signal than mVec at ten times higher dose (5 × 10⁹ vg/eye). - Expression was followed until day 63. This applies to a reporter in mice, not visual improvement or therapeutic effect. Differences in eye size, capsids and administration mean the doses cannot be compared directly with clinical studies. 2. Opus Genetics – LCA5 and BEST1 OPGx-LCA5 (AAV8): Six patients received the lowest planned dose, 1 × 10¹⁰ vg/eye. Three adults have maintained improvements in visual function through 24 months, and three adolescents have shown promising results through six months. Opus is proceeding with this dose in phase 3 without further dose escalation. Dosing start is expected in Q4 2026. Here, a dose problem that circVec would necessarily solve has not been documented. OPGx-BEST1 is interesting because Best disease is among the eye indications Circio has previously highlighted, along with wet AMD and retinitis pigmentosa. Five individuals received a low dose in Opus' BEST1 study. Of four who could complete retinal sensitivity examination, three showed improvement in a restricted area. Follow-up was three to six months. The high-dose group with 11 participants has been fully recruited. The results do not yet document that a higher dose gives a better effect. Circio has not publicly documented its own BEST1 candidate. 3. 4DMT – wet AMD 4D-150 is injected into the vitreous body and uses a specially developed AAV capsid (R100). The treatment produces both aflibercept and an RNA-based inhibitor of VEGF-C. In the PRISM phase 2b, 45 patients received either 1 × 10¹⁰ or 3 × 10¹⁰ vg/eye. The higher dose was chosen for phase 3. The company reported a sustained dose response in favor of this dose through two years. For the entire phase 2b group, meaning both doses combined, 4DMT reported a 78 % lower treatment burden: an average of 2.7 supplemental injections compared to 12.0 in a calculated standard course with aflibercept. This was not a concurrent randomized control group. Mild and transient intraocular inflammation was reported in 2 of 71 patients (2.8 %) in combined phase 1/2a and 2b data at the chosen phase 3 dose. This does not rule out rare or late side effects. Could circVec have provided sufficient protein production with fewer AAV particles? Possibly, but it has not been tested with 4D-150. Nor is it given that circVec can easily replace the cassette in a system with multiple treatment mechanisms. 4. CircVec 5.0 – possible further advantage Circio has shown separate design improvements and mentions a potential for over 200 times higher gene expression than a conventional control. The best elements are to be combined in circVec 5.0. It is not documented that the finished combination gives such an effect in the eye. Furthermore, 200 times higher expression does not mean 200 times lower therapeutic dose. Gen 5 can therefore provide further opportunities, but this must be investigated with relevant genes and eye cells. 5. Different diseases require different solutions In LCA5, a functioning gene must reach the photoreceptors. In BEST1, the retinal pigment epithelium (RPE) is central. Different BEST1 mutations may also require different treatment strategies. More protein in the wrong cell is not necessarily useful. In wet AMD, certain cells can produce and secrete a VEGF-inhibiting protein that acts locally. This can make increased gene expression interesting, but the protein amount must be safe and properly regulated. 6. What remains for Circio? CTO Thomas Hansen has discussed eye-specific AAV capsids, mapping of which cell types express circVec, and therapeutic constructs against wet AMD. Larger animal models are also on the milestone list. This is important because circVec can increase expression after the construct is delivered, but does not automatically solve the problem of reaching the correct cells. The central task will therefore be to test circVec against a relevant control with the same capsid and therapeutic gene, and investigate dose, therapeutic effect, and safety. My assessment CircVec 4.0 has shown a clear expression advantage in mouse eyes. Opus shows that conventional AAV can work well at a low dose in one disease, while 4DMT shows that dose and effective delivery can still be important in other programs. CircVec's greatest possible advantage perhaps lies where insufficient protein expression or high dose demand limits treatment. The decisive factor will be to show functional therapeutic protein in the correct cells and the same or better treatment effect at a lower AAV dose. Gen 5 is currently a possible extra advantage Kilder mld
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2026 Q2 - tulosraportti
47 päivää sitten
‧51 min
Uutiset
Tämän sivun uutiset ja/tai sijoitussuositukset tai otteet niistä sekä niihin liittyvät linkit ovat mainitun tahon tuottamia ja toimittamia. Nordnet ei ole osallistunut materiaalin laatimiseen, eikä ole tarkistanut sen sisältöä tai tehnyt sisältöön muutoksia. Lue lisää sijoitussuosituksista.
Foorumi
Liity keskusteluun Nordnet Socialissa
- ·5 t sittenThanks Hulten for a professionally brilliant post. Circio (CRNA) – timeline ahead. 27.–30. October – ESGCT Hamburg - Presentation on next-generation circVec-based T-cell therapy. Circio has secured a slot for an oral presentation on circVec-based T-cell therapy, showcased to leading researchers and potential Big Pharma partners. New, strong data will validate the circVec platform.. H2 2026 – disease models: First efficacy data from AAV-circVec in relevant disease models, especially in wet AMD and cardiac. Also CNS data from the Big Pharma collaboration. Date unknown. 9.–11. November – BIO-Europe Second half of November – research update H2 2026 – ongoing triggers - Data in CNS, cardiac and wet AMD. - Possible new partnership agreements or updates from existing collaborations.
- ·6 t sittenCIRCIO AND CNS - SCIENTIFIC DEEP DIVE (PART 1/4) Results and why expression lasts Circio Holding has shown significantly higher gene expression with circVec in the heart, eye, and central nervous system (CNS). The CNS results are particularly interesting because gene therapy in the brain faces two distinct challenges: one must deliver a vector to the correct cell, and then produce enough functional protein over sufficient time. circVec addresses primarily the second challenge. A conventional AAV vector delivers DNA that normally expresses protein through linear mRNA. circVec instead utilizes a DNA-based expression system where the cell creates circular RNA: DNA → circular RNA → protein. Circular RNA lacks free ends and can be more stable against specific degradation mechanisms. This can provide more long-lasting and higher protein expression from a DNA construct that has already been delivered. However, circVec does not in itself make an AAV capsid more easily cross the blood-brain barrier or target specific neurons. FROM 4× IN 2025 TO UP TO 60× IN 2026 In the webcast on November 24, 2025, Circio showed around 4× higher reporter signal with circVec 2.1 than with conventional mVec after ICV injection in mice. The presentation simultaneously stated that testing of circVec 3.2 would start. In the webcast on September 1, 2026, the company presented three separate mouse experiments: - ICM (cisterna magna): 1 × 10¹¹ vg/mouse → approximately 10×. - ICV (brain ventricle): 9 × 10¹⁰ vg/mouse → approximately 30×. - IT (intrathecal): 1 × 10¹¹ vg/mouse → approximately 60×. The figures compare reporter expression from circVec against mVec within each experiment. They do not mean that IT is necessarily six times better than ICM as a delivery method. Nor can we straightforwardly interpret the increase from 4× in 2025 to 30× ICV in 2026 as an exact technology improvement: experimental design and timing must be fully compared. AN IMPORTANT VERSION DISCREPANCY The figure legends on page 10 in the September PDF are labeled circVec 3.2. On page 12, however, the CNS advantage is referred to as circVec 4.0. The Norwegian 26-page presentation also shows 3.2 at the three CNS graphs. This looks like a possible discrepancy in the summary, but the explanation is not confirmed. We should therefore not calculate a specific improvement from generation 3.2 to 4.0 based on these CNS figures. What is thus proven? A significant expression advantage in preclinical mouse experiments, following three administration methods. Not functional treatment of a neurological disease. THE DURATION MAY BE JUST AS IMPORTANT AS THE EXPRESSION LEVEL Perhaps the most interesting aspect of the CNS figures is not just the magnitude of the expression difference, but how the signals evolve over time. In the intrathecal experiment, mVec and circVec lie relatively close to each other early on. Later, the signal from the conventional construct declines, while the circVec signal remains higher and at times increases. Toward the end of the experiment, the difference is described as around 60×. Thomas Hansen describes the same development in the webcast on September 1: the mVec signal falls, while circVec is persistent and may increase somewhat. This fits the circVec mechanism. If the DNA cassette continues to make circular RNA and the RNA is simultaneously broken down more slowly, more RNA can accumulate and thereby provide a higher level of protein production. But this is an interpretation of the biology, not a complete mechanistic confirmation from the CNS experiment. Luminescence shows reporter signal, not direct RNA half-life, therapeutic enzyme activity, or the identity of all cells expressing the gene. Sources: Circio's original presentations from November 2025 and September 2026, as well as the webcast on September 1. All links in part 4.CIRCIO AND CNS – SCIENTIFIC DEEP DIVE (PART 2/4) Delivery methods, primate data, dose and DRG safety WHY THREE ADMINISTRATION METHODS? The blood-brain barrier makes it difficult for many gene therapies to reach the central nervous system via the bloodstream. Administration into the cerebrospinal fluid can bypass parts of the barrier: - ICM: injection into the cisterna magna at the transition between brain and spinal cord. - ICV: injection into the brain's ventricular system. - IT: injection into the intrathecal space, often via the spinal canal. All methods can provide CNS exposure, but they do not necessarily provide equal distribution to the cerebral cortex, deep brain areas, spinal cord, glial cells, and neurons. INDEPENDENT PRIMATE RESEARCH Okai and colleagues (2025) compared four AAV serotypes following ICM injection in non-human primates. They found no significant difference in biodistribution between the investigated serotypes. Delivery to the spinal cord and dorsal root ganglia was good, but distribution to deep brain regions was limited. The ICM procedure was well tolerated in this study. Amaral and colleagues (2026) investigated AAV9-GBA1. In primates, ICM resulted in significant expression in the spinal cord and dorsal root ganglia, but limited expression and enzyme activity in the brain. They also observed undesirable microscopic findings. Direct injection into brain tissue yielded a different distribution pattern, but also unique safety challenges. These studies are not trials with circVec. They demonstrate the delivery problems within which circVec must function. The main point: Higher protein expression alone cannot compensate for AAV failing to reach the correct target cell type. An important next milestone is therefore mapping where circVec DNA, RNA, and protein are actually located in the CNS. LOWER AAV DOSE – OPPORTUNITY AND SAFETY CHALLENGE One of Circio's most important hypotheses is that higher protein expression per vector genome can reduce the required AAV dose. This could potentially make gene therapy less burdensome and cheaper to produce. In heart models, Circio has demonstrated a significant dose-response advantage with a reporter protein. However, such findings do not yet document that one can administer a 10×, 40×, or 60× lower therapeutic dose in the brain. To prove this, an actual disease gene must be tested in a relevant CNS model: How low a dose provides sufficient correction, how long does it last, and what side effects occur? A 60× difference in light expression does not automatically mean a 60× lower treatment dose. The protein's function, the cells affected, the treatment threshold, and biodistribution determine how much the dose can actually be reduced. DRG TOXICITY – AN IMPORTANT CAVEAT The dorsal root ganglia (DRG) contain sensory nerve cells. These can be heavily exposed following AAV delivery to the cerebrospinal fluid, and neuronal and nerve fiber damage has been reported in several primate models. Grubor and colleagues (2025) found increased inflammation-related gene activity, cytokines, and immune cell infiltration prior to later DRG and nerve damage. Preventive immunosuppression with dexamethasone and tacrolimus reduced the damage in the investigated models. However, the researchers' introduction also highlights something particularly relevant for circVec: The expression of the AAV cargo itself is implicated in DRG toxicity, even if the underlying mechanisms are not fully understood. This creates an important two-part assessment: - A lower AAV dose could potentially mean fewer viral particles and lower total exposure. - Stronger transgene expression in undesired cells could potentially cause other problems, even at a lower dose. This is NOT proof that circVec is more toxic. It means one cannot declare the technology safer simply because it expresses more protein. Okai 2025 reported well-tolerated ICM administration in their experimental setup, while Amaral 2026 found undesirable findings following ICM delivery of a specific AAV9-GBA1 construct. The results show why one cannot generalize one safety study to all capsids, genes, doses, and administration routes. What do we need from Circio? Data on DRG, spinal cord, and peripheral organs; immune response; cell-type-specific expression level; and dose-response where therapeutic effect is weighed against actual toxicity. The potential strength of circVec is not "as much protein as possible", but the right amount of functional protein in the right cells with acceptable safety. Sources: Okai 2025, Amaral 2026, Grubor 2025, Chen 2023, and Circio's ASGCT/webcast material. Links in part 4.
- ·16 t sittenCircVec and cardiac therapy – what is documented, and what does Circio need to prove? (Part 1/2) I have reviewed Circio's ASGCT data, webcast presentations and interviews, and compared with clinical AAV gene therapy. The first part concerns Circio's own data. Everything below is from preclinical experiments, not human treatment. 1. What do the mouse experiments show? AAV9-circVec 3.2 versus Circio's own mVec cassette, with the same heart-specific cTnT promoter and Firefly luciferase as a reporter. After intravenous dose of 5×10¹² vg/kg: - Up to 40× higher light signal in live mice, followed to day 71, and approximately 35× from isolated hearts. - RNAscope: 34–58× more reporter RNA in positive cells, and around 80 % of examined cardiomyocytes were RNA-positive. - RT-qPCR: approx. 96× more RNA in heart tissue, without statistically significant difference in the number of AAV vector copies. The ASGCT abstract also mentions up to 200× RNA in another analysis. This is not the same metric as 96× from the RT-qPCR figure, and should not be confused. The various measurement methods support increased expression after delivery, but some groups had only four mice. None of these numbers show better heart function. 2. Dose advantage – what does at least 10× mean? A separate mouse experiment investigated 5×10¹² to 1×10¹⁴ vg/kg. The dose curves indicated potential for comparable reporter expression at at least ten times lower AAV dose with circVec than mVec. This applies to measured gene expression in mice, not documented ten times lower dose to treat Danon or arrhythmogenic cardiomyopathy. PKP2 in the dose figure is an illustrative therapeutic reference level, not documented treatment effect from PKP2. 3. LAMP2B – an important step In September, Circio showed Western blot from mouse hearts on day 57. CircVec 3.2 gave clearly stronger LAMP2B bands than mVec. LAMP2B is relevant in Danon disease, but a precise fold improvement for this protein was not stated. The experiment also does not show correct localization, restored autophagy or improved function in a diseased heart. Danon is also not confirmed as the final clinical indication for Circio. 4. Liver and possible stress response CircVec gave lower unwanted reporter expression in the liver. But lower protein expression in the liver does not necessarily mean fewer AAV particles ended up there. An analysis of UPR-related genes as a group showed lower activation in circVec-treated mouse hearts than with mVec (p=0,003). This is an interesting early signal, not documented reduced immune risk or toxicity in humans. 5. CircVec 5.0 Circio has shown separate design improvements of around 90× and 170× expression versus mVec. These will be combined in Gen 5. In the BioHub interview, Erik Wiklund mentioned over 200× in vivo, while the written presentation describes the combined Gen 5 effect as potential. We need concrete combination data with a therapeutic gene before this can be considered confirmed. 200× expression does not mean 200× lower required treatment dose anyway. Sources part 1: Circio ASGCT poster: https://storage.mfn.se/21fac811-bd25-419d-ab49-20c47ecc5bfb/2026-asgct-poster.pdf Circio ASGCT presentation: https://storage.mfn.se/07a337af-de2b-49c6-ac87-670fbd9d1da4/260515-asgct-circio.pdf Webcast presentation 1.9.2026: https://www.circio.com/en/wp-content/uploads/sites/2/2025/06/260901-1h26-webcast-circio.pdf The BioHub: https://youtu.be/zrpuXDmCyWcI have taken the liberty of sharing your post, just let me know if that's not okay :-)
- ·1 päivä sittenTomorrow is a red day 😁
- ·1 päivä sittenCircVec in gene therapy for the eye – what do the mouse experiments show, and where can the technology provide an advantage? I have compared Circios eye data with clinical results from Opus Genetics and 4DMT. The question is not just how much circVec increases gene expression, but whether the technology can provide the same or better therapeutic effect at a lower AAV dose. 1. Circios eye data – mice only CircVec 4.0 was delivered with AAV2 by intravitreal injection in mice. - Up to 50 times higher reporter expression than Circios own mRNA-based control cassette (mVec). - Low-dose circVec (5 × 10⁸ vg/eye) gave up to 12 times higher signal than mVec at ten times higher dose (5 × 10⁹ vg/eye). - Expression was followed until day 63. This applies to a reporter in mice, not visual improvement or therapeutic effect. Differences in eye size, capsids and administration mean the doses cannot be compared directly with clinical studies. 2. Opus Genetics – LCA5 and BEST1 OPGx-LCA5 (AAV8): Six patients received the lowest planned dose, 1 × 10¹⁰ vg/eye. Three adults have maintained improvements in visual function through 24 months, and three adolescents have shown promising results through six months. Opus is proceeding with this dose in phase 3 without further dose escalation. Dosing start is expected in Q4 2026. Here, a dose problem that circVec would necessarily solve has not been documented. OPGx-BEST1 is interesting because Best disease is among the eye indications Circio has previously highlighted, along with wet AMD and retinitis pigmentosa. Five individuals received a low dose in Opus' BEST1 study. Of four who could complete retinal sensitivity examination, three showed improvement in a restricted area. Follow-up was three to six months. The high-dose group with 11 participants has been fully recruited. The results do not yet document that a higher dose gives a better effect. Circio has not publicly documented its own BEST1 candidate. 3. 4DMT – wet AMD 4D-150 is injected into the vitreous body and uses a specially developed AAV capsid (R100). The treatment produces both aflibercept and an RNA-based inhibitor of VEGF-C. In the PRISM phase 2b, 45 patients received either 1 × 10¹⁰ or 3 × 10¹⁰ vg/eye. The higher dose was chosen for phase 3. The company reported a sustained dose response in favor of this dose through two years. For the entire phase 2b group, meaning both doses combined, 4DMT reported a 78 % lower treatment burden: an average of 2.7 supplemental injections compared to 12.0 in a calculated standard course with aflibercept. This was not a concurrent randomized control group. Mild and transient intraocular inflammation was reported in 2 of 71 patients (2.8 %) in combined phase 1/2a and 2b data at the chosen phase 3 dose. This does not rule out rare or late side effects. Could circVec have provided sufficient protein production with fewer AAV particles? Possibly, but it has not been tested with 4D-150. Nor is it given that circVec can easily replace the cassette in a system with multiple treatment mechanisms. 4. CircVec 5.0 – possible further advantage Circio has shown separate design improvements and mentions a potential for over 200 times higher gene expression than a conventional control. The best elements are to be combined in circVec 5.0. It is not documented that the finished combination gives such an effect in the eye. Furthermore, 200 times higher expression does not mean 200 times lower therapeutic dose. Gen 5 can therefore provide further opportunities, but this must be investigated with relevant genes and eye cells. 5. Different diseases require different solutions In LCA5, a functioning gene must reach the photoreceptors. In BEST1, the retinal pigment epithelium (RPE) is central. Different BEST1 mutations may also require different treatment strategies. More protein in the wrong cell is not necessarily useful. In wet AMD, certain cells can produce and secrete a VEGF-inhibiting protein that acts locally. This can make increased gene expression interesting, but the protein amount must be safe and properly regulated. 6. What remains for Circio? CTO Thomas Hansen has discussed eye-specific AAV capsids, mapping of which cell types express circVec, and therapeutic constructs against wet AMD. Larger animal models are also on the milestone list. This is important because circVec can increase expression after the construct is delivered, but does not automatically solve the problem of reaching the correct cells. The central task will therefore be to test circVec against a relevant control with the same capsid and therapeutic gene, and investigate dose, therapeutic effect, and safety. My assessment CircVec 4.0 has shown a clear expression advantage in mouse eyes. Opus shows that conventional AAV can work well at a low dose in one disease, while 4DMT shows that dose and effective delivery can still be important in other programs. CircVec's greatest possible advantage perhaps lies where insufficient protein expression or high dose demand limits treatment. The decisive factor will be to show functional therapeutic protein in the correct cells and the same or better treatment effect at a lower AAV dose. Gen 5 is currently a possible extra advantage Kilder mld
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- ·5 t sittenThanks Hulten for a professionally brilliant post. Circio (CRNA) – timeline ahead. 27.–30. October – ESGCT Hamburg - Presentation on next-generation circVec-based T-cell therapy. Circio has secured a slot for an oral presentation on circVec-based T-cell therapy, showcased to leading researchers and potential Big Pharma partners. New, strong data will validate the circVec platform.. H2 2026 – disease models: First efficacy data from AAV-circVec in relevant disease models, especially in wet AMD and cardiac. Also CNS data from the Big Pharma collaboration. Date unknown. 9.–11. November – BIO-Europe Second half of November – research update H2 2026 – ongoing triggers - Data in CNS, cardiac and wet AMD. - Possible new partnership agreements or updates from existing collaborations.
- ·6 t sittenCIRCIO AND CNS - SCIENTIFIC DEEP DIVE (PART 1/4) Results and why expression lasts Circio Holding has shown significantly higher gene expression with circVec in the heart, eye, and central nervous system (CNS). The CNS results are particularly interesting because gene therapy in the brain faces two distinct challenges: one must deliver a vector to the correct cell, and then produce enough functional protein over sufficient time. circVec addresses primarily the second challenge. A conventional AAV vector delivers DNA that normally expresses protein through linear mRNA. circVec instead utilizes a DNA-based expression system where the cell creates circular RNA: DNA → circular RNA → protein. Circular RNA lacks free ends and can be more stable against specific degradation mechanisms. This can provide more long-lasting and higher protein expression from a DNA construct that has already been delivered. However, circVec does not in itself make an AAV capsid more easily cross the blood-brain barrier or target specific neurons. FROM 4× IN 2025 TO UP TO 60× IN 2026 In the webcast on November 24, 2025, Circio showed around 4× higher reporter signal with circVec 2.1 than with conventional mVec after ICV injection in mice. The presentation simultaneously stated that testing of circVec 3.2 would start. In the webcast on September 1, 2026, the company presented three separate mouse experiments: - ICM (cisterna magna): 1 × 10¹¹ vg/mouse → approximately 10×. - ICV (brain ventricle): 9 × 10¹⁰ vg/mouse → approximately 30×. - IT (intrathecal): 1 × 10¹¹ vg/mouse → approximately 60×. The figures compare reporter expression from circVec against mVec within each experiment. They do not mean that IT is necessarily six times better than ICM as a delivery method. Nor can we straightforwardly interpret the increase from 4× in 2025 to 30× ICV in 2026 as an exact technology improvement: experimental design and timing must be fully compared. AN IMPORTANT VERSION DISCREPANCY The figure legends on page 10 in the September PDF are labeled circVec 3.2. On page 12, however, the CNS advantage is referred to as circVec 4.0. The Norwegian 26-page presentation also shows 3.2 at the three CNS graphs. This looks like a possible discrepancy in the summary, but the explanation is not confirmed. We should therefore not calculate a specific improvement from generation 3.2 to 4.0 based on these CNS figures. What is thus proven? A significant expression advantage in preclinical mouse experiments, following three administration methods. Not functional treatment of a neurological disease. THE DURATION MAY BE JUST AS IMPORTANT AS THE EXPRESSION LEVEL Perhaps the most interesting aspect of the CNS figures is not just the magnitude of the expression difference, but how the signals evolve over time. In the intrathecal experiment, mVec and circVec lie relatively close to each other early on. Later, the signal from the conventional construct declines, while the circVec signal remains higher and at times increases. Toward the end of the experiment, the difference is described as around 60×. Thomas Hansen describes the same development in the webcast on September 1: the mVec signal falls, while circVec is persistent and may increase somewhat. This fits the circVec mechanism. If the DNA cassette continues to make circular RNA and the RNA is simultaneously broken down more slowly, more RNA can accumulate and thereby provide a higher level of protein production. But this is an interpretation of the biology, not a complete mechanistic confirmation from the CNS experiment. Luminescence shows reporter signal, not direct RNA half-life, therapeutic enzyme activity, or the identity of all cells expressing the gene. Sources: Circio's original presentations from November 2025 and September 2026, as well as the webcast on September 1. All links in part 4.CIRCIO AND CNS – SCIENTIFIC DEEP DIVE (PART 2/4) Delivery methods, primate data, dose and DRG safety WHY THREE ADMINISTRATION METHODS? The blood-brain barrier makes it difficult for many gene therapies to reach the central nervous system via the bloodstream. Administration into the cerebrospinal fluid can bypass parts of the barrier: - ICM: injection into the cisterna magna at the transition between brain and spinal cord. - ICV: injection into the brain's ventricular system. - IT: injection into the intrathecal space, often via the spinal canal. All methods can provide CNS exposure, but they do not necessarily provide equal distribution to the cerebral cortex, deep brain areas, spinal cord, glial cells, and neurons. INDEPENDENT PRIMATE RESEARCH Okai and colleagues (2025) compared four AAV serotypes following ICM injection in non-human primates. They found no significant difference in biodistribution between the investigated serotypes. Delivery to the spinal cord and dorsal root ganglia was good, but distribution to deep brain regions was limited. The ICM procedure was well tolerated in this study. Amaral and colleagues (2026) investigated AAV9-GBA1. In primates, ICM resulted in significant expression in the spinal cord and dorsal root ganglia, but limited expression and enzyme activity in the brain. They also observed undesirable microscopic findings. Direct injection into brain tissue yielded a different distribution pattern, but also unique safety challenges. These studies are not trials with circVec. They demonstrate the delivery problems within which circVec must function. The main point: Higher protein expression alone cannot compensate for AAV failing to reach the correct target cell type. An important next milestone is therefore mapping where circVec DNA, RNA, and protein are actually located in the CNS. LOWER AAV DOSE – OPPORTUNITY AND SAFETY CHALLENGE One of Circio's most important hypotheses is that higher protein expression per vector genome can reduce the required AAV dose. This could potentially make gene therapy less burdensome and cheaper to produce. In heart models, Circio has demonstrated a significant dose-response advantage with a reporter protein. However, such findings do not yet document that one can administer a 10×, 40×, or 60× lower therapeutic dose in the brain. To prove this, an actual disease gene must be tested in a relevant CNS model: How low a dose provides sufficient correction, how long does it last, and what side effects occur? A 60× difference in light expression does not automatically mean a 60× lower treatment dose. The protein's function, the cells affected, the treatment threshold, and biodistribution determine how much the dose can actually be reduced. DRG TOXICITY – AN IMPORTANT CAVEAT The dorsal root ganglia (DRG) contain sensory nerve cells. These can be heavily exposed following AAV delivery to the cerebrospinal fluid, and neuronal and nerve fiber damage has been reported in several primate models. Grubor and colleagues (2025) found increased inflammation-related gene activity, cytokines, and immune cell infiltration prior to later DRG and nerve damage. Preventive immunosuppression with dexamethasone and tacrolimus reduced the damage in the investigated models. However, the researchers' introduction also highlights something particularly relevant for circVec: The expression of the AAV cargo itself is implicated in DRG toxicity, even if the underlying mechanisms are not fully understood. This creates an important two-part assessment: - A lower AAV dose could potentially mean fewer viral particles and lower total exposure. - Stronger transgene expression in undesired cells could potentially cause other problems, even at a lower dose. This is NOT proof that circVec is more toxic. It means one cannot declare the technology safer simply because it expresses more protein. Okai 2025 reported well-tolerated ICM administration in their experimental setup, while Amaral 2026 found undesirable findings following ICM delivery of a specific AAV9-GBA1 construct. The results show why one cannot generalize one safety study to all capsids, genes, doses, and administration routes. What do we need from Circio? Data on DRG, spinal cord, and peripheral organs; immune response; cell-type-specific expression level; and dose-response where therapeutic effect is weighed against actual toxicity. The potential strength of circVec is not "as much protein as possible", but the right amount of functional protein in the right cells with acceptable safety. Sources: Okai 2025, Amaral 2026, Grubor 2025, Chen 2023, and Circio's ASGCT/webcast material. Links in part 4.
- ·16 t sittenCircVec and cardiac therapy – what is documented, and what does Circio need to prove? (Part 1/2) I have reviewed Circio's ASGCT data, webcast presentations and interviews, and compared with clinical AAV gene therapy. The first part concerns Circio's own data. Everything below is from preclinical experiments, not human treatment. 1. What do the mouse experiments show? AAV9-circVec 3.2 versus Circio's own mVec cassette, with the same heart-specific cTnT promoter and Firefly luciferase as a reporter. After intravenous dose of 5×10¹² vg/kg: - Up to 40× higher light signal in live mice, followed to day 71, and approximately 35× from isolated hearts. - RNAscope: 34–58× more reporter RNA in positive cells, and around 80 % of examined cardiomyocytes were RNA-positive. - RT-qPCR: approx. 96× more RNA in heart tissue, without statistically significant difference in the number of AAV vector copies. The ASGCT abstract also mentions up to 200× RNA in another analysis. This is not the same metric as 96× from the RT-qPCR figure, and should not be confused. The various measurement methods support increased expression after delivery, but some groups had only four mice. None of these numbers show better heart function. 2. Dose advantage – what does at least 10× mean? A separate mouse experiment investigated 5×10¹² to 1×10¹⁴ vg/kg. The dose curves indicated potential for comparable reporter expression at at least ten times lower AAV dose with circVec than mVec. This applies to measured gene expression in mice, not documented ten times lower dose to treat Danon or arrhythmogenic cardiomyopathy. PKP2 in the dose figure is an illustrative therapeutic reference level, not documented treatment effect from PKP2. 3. LAMP2B – an important step In September, Circio showed Western blot from mouse hearts on day 57. CircVec 3.2 gave clearly stronger LAMP2B bands than mVec. LAMP2B is relevant in Danon disease, but a precise fold improvement for this protein was not stated. The experiment also does not show correct localization, restored autophagy or improved function in a diseased heart. Danon is also not confirmed as the final clinical indication for Circio. 4. Liver and possible stress response CircVec gave lower unwanted reporter expression in the liver. But lower protein expression in the liver does not necessarily mean fewer AAV particles ended up there. An analysis of UPR-related genes as a group showed lower activation in circVec-treated mouse hearts than with mVec (p=0,003). This is an interesting early signal, not documented reduced immune risk or toxicity in humans. 5. CircVec 5.0 Circio has shown separate design improvements of around 90× and 170× expression versus mVec. These will be combined in Gen 5. In the BioHub interview, Erik Wiklund mentioned over 200× in vivo, while the written presentation describes the combined Gen 5 effect as potential. We need concrete combination data with a therapeutic gene before this can be considered confirmed. 200× expression does not mean 200× lower required treatment dose anyway. Sources part 1: Circio ASGCT poster: https://storage.mfn.se/21fac811-bd25-419d-ab49-20c47ecc5bfb/2026-asgct-poster.pdf Circio ASGCT presentation: https://storage.mfn.se/07a337af-de2b-49c6-ac87-670fbd9d1da4/260515-asgct-circio.pdf Webcast presentation 1.9.2026: https://www.circio.com/en/wp-content/uploads/sites/2/2025/06/260901-1h26-webcast-circio.pdf The BioHub: https://youtu.be/zrpuXDmCyWcI have taken the liberty of sharing your post, just let me know if that's not okay :-)
- ·1 päivä sittenTomorrow is a red day 😁
- ·1 päivä sittenCircVec in gene therapy for the eye – what do the mouse experiments show, and where can the technology provide an advantage? I have compared Circios eye data with clinical results from Opus Genetics and 4DMT. The question is not just how much circVec increases gene expression, but whether the technology can provide the same or better therapeutic effect at a lower AAV dose. 1. Circios eye data – mice only CircVec 4.0 was delivered with AAV2 by intravitreal injection in mice. - Up to 50 times higher reporter expression than Circios own mRNA-based control cassette (mVec). - Low-dose circVec (5 × 10⁸ vg/eye) gave up to 12 times higher signal than mVec at ten times higher dose (5 × 10⁹ vg/eye). - Expression was followed until day 63. This applies to a reporter in mice, not visual improvement or therapeutic effect. Differences in eye size, capsids and administration mean the doses cannot be compared directly with clinical studies. 2. Opus Genetics – LCA5 and BEST1 OPGx-LCA5 (AAV8): Six patients received the lowest planned dose, 1 × 10¹⁰ vg/eye. Three adults have maintained improvements in visual function through 24 months, and three adolescents have shown promising results through six months. Opus is proceeding with this dose in phase 3 without further dose escalation. Dosing start is expected in Q4 2026. Here, a dose problem that circVec would necessarily solve has not been documented. OPGx-BEST1 is interesting because Best disease is among the eye indications Circio has previously highlighted, along with wet AMD and retinitis pigmentosa. Five individuals received a low dose in Opus' BEST1 study. Of four who could complete retinal sensitivity examination, three showed improvement in a restricted area. Follow-up was three to six months. The high-dose group with 11 participants has been fully recruited. The results do not yet document that a higher dose gives a better effect. Circio has not publicly documented its own BEST1 candidate. 3. 4DMT – wet AMD 4D-150 is injected into the vitreous body and uses a specially developed AAV capsid (R100). The treatment produces both aflibercept and an RNA-based inhibitor of VEGF-C. In the PRISM phase 2b, 45 patients received either 1 × 10¹⁰ or 3 × 10¹⁰ vg/eye. The higher dose was chosen for phase 3. The company reported a sustained dose response in favor of this dose through two years. For the entire phase 2b group, meaning both doses combined, 4DMT reported a 78 % lower treatment burden: an average of 2.7 supplemental injections compared to 12.0 in a calculated standard course with aflibercept. This was not a concurrent randomized control group. Mild and transient intraocular inflammation was reported in 2 of 71 patients (2.8 %) in combined phase 1/2a and 2b data at the chosen phase 3 dose. This does not rule out rare or late side effects. Could circVec have provided sufficient protein production with fewer AAV particles? Possibly, but it has not been tested with 4D-150. Nor is it given that circVec can easily replace the cassette in a system with multiple treatment mechanisms. 4. CircVec 5.0 – possible further advantage Circio has shown separate design improvements and mentions a potential for over 200 times higher gene expression than a conventional control. The best elements are to be combined in circVec 5.0. It is not documented that the finished combination gives such an effect in the eye. Furthermore, 200 times higher expression does not mean 200 times lower therapeutic dose. Gen 5 can therefore provide further opportunities, but this must be investigated with relevant genes and eye cells. 5. Different diseases require different solutions In LCA5, a functioning gene must reach the photoreceptors. In BEST1, the retinal pigment epithelium (RPE) is central. Different BEST1 mutations may also require different treatment strategies. More protein in the wrong cell is not necessarily useful. In wet AMD, certain cells can produce and secrete a VEGF-inhibiting protein that acts locally. This can make increased gene expression interesting, but the protein amount must be safe and properly regulated. 6. What remains for Circio? CTO Thomas Hansen has discussed eye-specific AAV capsids, mapping of which cell types express circVec, and therapeutic constructs against wet AMD. Larger animal models are also on the milestone list. This is important because circVec can increase expression after the construct is delivered, but does not automatically solve the problem of reaching the correct cells. The central task will therefore be to test circVec against a relevant control with the same capsid and therapeutic gene, and investigate dose, therapeutic effect, and safety. My assessment CircVec 4.0 has shown a clear expression advantage in mouse eyes. Opus shows that conventional AAV can work well at a low dose in one disease, while 4DMT shows that dose and effective delivery can still be important in other programs. CircVec's greatest possible advantage perhaps lies where insufficient protein expression or high dose demand limits treatment. The decisive factor will be to show functional therapeutic protein in the correct cells and the same or better treatment effect at a lower AAV dose. Gen 5 is currently a possible extra advantage Kilder mld
Yllä olevat kommentit ovat peräisin Nordnetin sosiaalisen verkoston Nordnet Socialin käyttäjiltä, eikä niitä ole muokattu eikä Nordnet ole tarkastanut niitä etukäteen. Ne eivät tarkoita, että Nordnet tarjoaisi sijoitusneuvoja tai sijoitussuosituksia. Nordnet ei ota vastuuta kommenteista.
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Viimeisimmät kaupat
| Aika | Hinta | Määrä | Ostaja | Myyjä |
|---|---|---|---|---|
| 1 | - | - | ||
| 743 | - | - | ||
| 535 | - | - | ||
| 1 332 | - | - | ||
| 2 212 | - | - |
Huomioi, että vaikka osakkeisiin säästäminen on pitkällä aikavälillä tuottanut hyvin, tulevasta tuotosta ei ole takeita. On olemassa riski, että et saa sijoittamiasi varoja takaisin.
Rahastot ja ETF:t, joilla on osaketta
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