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Biogenera Advances BGA002 Toward Clinical Trials with Crowdfunding Support

Biogenera achieved two milestones for its anti-tumor drug BGA002: completing GMP-grade active ingredient production and launching a research collaboration with the University of Chicago. Using PNA technology via its MyGenera™ platform, BGA002 targets the MYCN gene in aggressive tumors. Clinical trials begin in 2026, with Biogenera planning to raise €35 million for development.

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Biogenera

Biogenera, a biotech company committed to the development of personalized DNA therapies, announces the achievement of two key milestones in the advancement of BGA002 , its anti-tumor drug.

On the one hand, it has completed the production of the active ingredient (API), which paves the way for the drug to enter clinical trials.

On the other hand, it has started a high-profile scientific collaboration with the University of Chicago, focused on preclinical research of the drug in models of neuroblastoma, one of the most aggressive pediatric tumors.

The importance of the two milestones for Biogenera’s future

These two milestones represent a significant acceleration in the clinical development of BGA002, a drug developed with PNA ( Peptide Nucleic Acid ) technology and the proprietary MyGenera™ platform, designed to selectively silence the MYCN gene, responsible for several aggressive pediatric and adult tumors.

To finance the project, which also includes the identification and testing of other molecules, as well as the creation of a production unit, Biogenera plans to raise 35 million euros over the next two years .

GMP Production of BGA002 API

Thanks to a new pharmaceutical process developed for large-scale production, BIOGENERA has successfully completed the production of the active ingredient (API) of BGA002 according to the highest Good Manufacturing Practice (GMP) standards, an essential requirement for clinical use in humans.

The substance is now ready for the fill-finish phase (filling in sterile solution), which will lead to the final formulation of the ready-to-use drug.

BGA002 will therefore be ready for the start of the first Phase I clinical study in pediatric patients affected by aggressive tumors resistant to conventional therapies, scheduled for the first quarter of 2026.

Collaboration with the University of Chicago

Strengthening the scientific and therapeutic value of BGA002 is the collaboration with the prestigious University of Chicago, which will involve two world-renowned experts in pediatric oncology.

Indeed, Professor Susan Cohn and Associate Professor Ami Desai, both widely recognized as Key Opinion Leaders (KOLs) in the field of Neuroblastoma research and treatment, will collaborate with Biogenera.

The goal is to conduct joint preclinical studies to further investigate the precision medicine efficacy of BGA002 in neuroblastoma models, with the aim of subsequently initiating clinical studies in children who do not respond to conventional therapies.

Massimiliano Cesarini, CEO of Biogenera: “These two results consolidate BIOGENERA’s vision: to offer new therapeutic options where effective solutions are currently lacking, especially in the field of pediatric rare diseases. BGA002 thus confirms its position as a cutting-edge project, capable of combining advanced research, precision medicine, and global collaboration to bring science to the service of hope.”

Biogenera has a solid patent portfolio

Biogenera is a pharma-biotech company specialized in the development, through its proprietary MyGenera™ platform, of a new class of antigen drugs based on PNA ( Peptide Nucleic Acid ) capable of directly targeting diseased genes at the DNA level, surpassing traditional approaches in terms of selectivity and efficacy.

It operates with a B2B model based on partnerships and licensing, supported by a solid patent portfolio (48 patents in 46 countries).

The pipeline includes 6 oncology drugs, including BGA002, the world’s first drug against the MYCN gene, which will enter the clinical phase in 2026, with orphan designations from the FDA and EMA.

Equity crowdfunding campaigns

The company has launched and successfully closed five equity crowdfunding rounds since 2017.

The first two rounds, in 2017 and 2018, were hosted by the now defunct platforms TwoHundred and Backtowork, raising just over $1 million in total.

In 2021, the campaign launched on Crowdfundme had raised 2.9 million euros from almost 650 investors, a campaign that was then extended on the 2Meet2Biz platform with another 235 thousand euros.

Last year (2024), Biognera finally raised nearly $1.6 million from over 500 investors, this time on Mamacrowd. After this latest round, the company’s valuation reached $81.9 million.

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(Featured image by Marek Studzinski via Unsplash)

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J. Frank Sigerson is a business and financial journalist primarily covering crypto, cannabis, crowdfunding, technology, and marketing. He also writes about the movers and shakers in the stock market, especially in biotech, healthcare, mining, and blockchain. In the past, he has shared his thoughts on IT and design, social media, pop culture, food and wine, TV, film, and music. His works have been published in Investing.com, Equities.com, Seeking Alpha, Mogul, Small Cap Network, CNN, Technology.org, among others.