On May 14, 2025 Circio Holding ASA (OSE: CRNA), a biotechnology company developing powerful circular RNA technology for next generation nucleic acid medicine, today announces the presentation of new and strengthened in vivo data at the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper) annual meeting 2025 in New Orleans, USA (Press release, Circio, MAY 14, 2025, View Source [SID1234652961]).

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In the poster presentation, Circio is showcasing its latest in vitro and in vivo results for the circVec platform. circVec continues to demonstrate broad capability to significantly boost protein expression level and durability for both viral and non-viral gene and cell therapy.

Importantly, new results show that both viral and non-viral circVec vectors display tissue patterns that are distinct from equivalent mRNA-vectors. The pattern is hallmarked by increased protein expression in muscle, heart and spleen, and consistently low in liver. These surprising observations demonstrate a fundamental biological difference between circRNA and mRNA-based expression and show that the circVec platform has advantages that can open new therapeutic opportunities where current gene therapy approaches fall short.

"Circio is rapidly expanding the in vivo circVec data package, with several recent intriguing advances. It has become evident that circVec not only offers increased protein expression level and durability in general, but also that this effect is associated with a distinct tissue profile. These results provide a valuable roadmap to direct our R&D activities and develop a therapeutic strategy focused on areas that are not well served by existing gene therapy approaches." said Dr. Thomas B. Hansen, CTO of Circio. "We selected the prestigious ASGCT (Free ASGCT Whitepaper) meeting to present our latest results as it provided a great opportunity to showcase our technology to a broad life science audience and potential partners."

In addition, Circio is continuing to progress its circVec-AAV gene therapy development for muscular dystrophies and cardiomyopathies. Longitudinal in vivo data up to six months show a general overall advantage of circVec expression at low dose levels. Enhanced target tissue expression and reduced liver accumulation is also observable with circVec-AAV vectors, indicating that the circVec advantage is more pronounced in specific tissues and therapeutic settings. Follow-up analyses and testing of novel circVec-AAV variants are currently ongoing to further explore these observations and identify the most favorable opportunities for circVec-AAV gene therapy development.

Title of presentation:
CircVec: a powerful circular RNA expression platform to enhance viral and non-viral gene and cell therapies

Time and poster number:
13 May 2025, 18:00-19:30hrs CDT, poster #655

Location:
Ernest N. Morial Convention Center, New Orleans, Louisiana, USA

The poster is attached to this press release and is available on Circio´s webpage

On May 13, 2025 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported its decision to file an application for opening of insolvency proceedings with the local court of Mannheim in Germany.

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As previously reported, Affimed N.V. (the "Company") has been engaged in discussions with potential investors and partners with respect to potential strategic transactions to raise additional capital. Despite its continuous and ongoing fundraising efforts, the Company has not been able to raise sufficient additional funds to continue the operations of the Company and its controlled (and wholly owned) subsidiaries Affimed GmbH and Affimed Inc. Further, based on currently available information, the Company’s liquidity condition raises substantial doubt about the Company’s ability to continue as a going concern.

As a consequence, the members of the management board of the Company have determined in respect of the Company and the managing directors of Affimed GmbH have determined in respect of Affimed GmbH that the companies are overindebted (Überschuldung). The management of the Company and the management of Affimed GmbH have determined with regards to the respective company that they must file for insolvency under German law.

Following such determination, on May 13, 2025, the members the management board of the Company filed for the opening of ordinary insolvency proceedings over the assets of the Company and the managing directors of Affimed GmbH filed for the opening of ordinary insolvency proceedings over the assets of Affimed GmbH with the local court of Mannheim in Germany. There can be no assurance as to the outcome of any preliminary or formal insolvency proceedings with respect to the Company or Affimed GmbH or as to whether the companies will emerge from insolvency as a going concern. Further, the insolvency filing in respect of the Company and resulting preliminary and formal insolvency proceedings will also result in the Company’s common shares being suspended from trading on, and subsequent delisting from, The Nasdaq Global Market.

(Press release, Affimed, MAY 13, 2025, View Source [SID1234661338])

On May 13, 2025 Integra Therapeutics, a global leader in creating cutting-edge gene-writing tools to improve the efficacy, precision and safety of advanced therapies, reported it will be presenting new pre-clinical data at the 28th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) (Free ASGCT Whitepaper), taking place from May 13 to 17 in New Orleans (Press release, Integra Therapeutics, MAY 13, 2025, View Source [SID1234654550]).

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"The presentation at ASGCT (Free ASGCT Whitepaper) marks an important milestone in our work to develop safer and more capable cell engineering with our gene-writing platform with double digit editing efficiencies and multi gene integration for the next generation of cell therapies for oncological and autoimmune diseases" explains Dr Avencia Sánchez-Mejías, CEO and Co-Founder of Integra Therapeutics.

For the first time, the Integra Therapeutics’ technology has been used to created CAR-T cells, demonstrating the expression of more complex CARs (bispecific and with a kill switch) in a single DNA donor and simplifying the production process. The functionality of these CAR-T cells has also been shown compared to the methodology of market leaders and an improved ability to eliminate B-ALL tumoral cells and B cells from autoimmune diseases patients (i.e. lupus and rheumatoid arthritis) was demonstrated.

In addition, to the new FiCAT data for cell engineering, Integra Therapeutics will present results from CAR-T cells generated with novel CRISPR-Cas12l nucleases in combination with FiCAT, the result of the strategic agreement with Caszyme, which shows better efficiency than CRISPR-Cas9.

Presentation details

Title: Precise Gene Writing System for CAR-T cell therapy generation
Date & Time: May 14, 2025 / 5:30 pm-7:00 pm (local time)
Session Title: Gene Targeting and Gene Correction New Technologies
Location: Poster Session Hall I2
Published Abstract Number: 1140

Title: Development of viral-free FiCAT gene writing platform for liver-directed in vivo application
Date & Time: May 14, 2025 / 5:30 pm-7:00 pm (local time)
Session Title: Gene Targeting and Gene Correction New Technologies
Location: Poster Session Hall I2
Published Abstract Number: 1141

On May 13, 2025 GenScript reported financial results for the first quarter ended March 31, 2025 (Press release, GenScript, MAY 13, 2025, View Source [SID1234654246]).

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On May 13, 2025 Sumitomo Dainippon Pharma reported full year 2024 (April 1, 2024 to March 31, 2025) Financial Results and Reboot 2027 (Presentation, Sumitomo Dainippon Pharma, MAY 13, 2025, View Source [SID1234654016]).

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