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EXO Biologics secures up to EUR 16 million in Series A funding for exosome therapeutic development and clinical supply.
The funding will primarily strengthen EXO Biologics’ subsidiary ExoXpert®, the exosome specialist CDMO, support the first EMA approved MSC-derived exosome clinical trial, and fund the ongoing development of the ExoPulseTM platform to produce unmodified and RNA or drug-loaded exosomes.
Liège, Belgium April 24, 2024 – EXO Biologics, a clinical-stage biotech and a pioneer in developing exosome-based therapies, today announces the successful securing of a total of up to EUR 16 million in Series A funding. EXO Biologics will use the funds to support its ongoing and future clinical trials. It will also use funds to continue its manufacturing expansion, including upgrading its unique production platform, ExoPulse, and expanding partnerships to enable pan-market access to the platform and GMP clinical grade exosomes for faster access to clinical trials.
“By achieving this Series A funding in what remains a challenging time across the life science sector, EXO Biologics has received an endorsement from its founders, existing and new investors. This significant investment will support EXO Biologics in obtaining non-dilutive funding. It will also enable EXO Biologics to bring novel exosome therapies to patients with few alternative therapeutic options,” said Hugues Wallemacq, Chief Executive Officer (CEO) of EXO Biologics. “Having now launched the first clinical trial approved by the EMA to use MSC-based exosomes, EXO Biologics is now able to support the clinical development of these highly promising therapies globally. This significant funding will therefore enable EXO Biologics to accelerate development and commercial agreements with third parties worldwide.”
EXO Biologics initially raised EUR 9 million from investors, including Noshaq, Founders, and Belgian Family Offices. This support allowed EXO Biologics to add substantial additional funding in the form of subsidies from the Public Service of Wallonia (SPW) in Belgium, amounting up to a further EUR 7 million.
A significant portion (EUR 5.5 million) of the public subsidies has been granted via the Technological Innovation Partnership for Advanced Therapy Medicinal Products (ATMP-PIT) initiative. This three-year program has been launched by BioWin and the SPW under the Walloon Recovery Plan in Belgium. It involves 26 partners and will fuel collaborations between academia, research institutions, and businesses, driving forward the development and manufacturing of next-generation biomedicines.
EXO Biologics will direct the funding towards advancing transformative healthcare initiatives, including the enrolment in EVENEW, the first European Medicines Agency (EMA) authorized clinical trial involving MSC-based exosomes. This EVENEW study is a Phase 1/2 European clinical trial using EXO Biologics’ lead MSC-based exosome candidate EXOB-001. EXO Biologics is initially developing EXOB-001 to prevent Bronchopulmonary Dysplasia (BPD) in preterm newborns.
Directing resources toward enhancing the ExoPulse production platform will enable EXO Biologics to conduct further research into its longer-term aim of loading exosomes with therapeutic molecules such as RNAs, proteins, and chemical drug compounds.
In addition, EXO Biologics will use the funds to reinforce ExoXpert, EXO Biologics’ newly launched subsidiary and one of the first CDMOs specializing in exosomes, leveraging the clinically proven manufacturing platform ExoPulse. By offering access to ExoPulse, ExoXpert can accelerate and de-risk naive and loaded exosome drug development journeys for other companies.
About EXO Biologics
EXO Biologics is a biotech company committed to developing biopharmaceuticals using exosomes to treat rare diseases with unmet medical needs. Partnering with leading academic researchers, EXO Biologics aims to set the stage for future nanomedicines. The Company’s development strategy focuses on novel drug candidates for therapeutic applications in respiratory diseases, inflammatory bowel diseases, neurology, and oncology.
For additional information, please visit www.exobio.be and follow us on LinkedIn.
About Noshaq
Noshaq, headquartered in Liège, is an investment fund offering financial support for SMEs' growth and development in the Liège Region. Over the years, Noshaq has developed a range of financing vehicles that align with the market's needs, trends, and strategy. Each service offered by Noshaq (capital - loan - leasing) is always determined according to the demands and needs of the owner-investor. The objective is always to have a leverage effect on the company's development. Noshaq has a diversified portfolio of 477 companies, investing over 750 Million EUR in assets. Noshaq Immo is constructing a biotech-dedicated business park measuring 30.000m² in Liège (Montlegia Park).
www.noshaq.be
About BioWin
BioWin is the health cluster in Wallonia, Belgium, the regional reference for all stakeholders in health, biotech, and medtech research and innovation projects. It includes 250 members from the private, public, and academic sectors.
Biowin’s mission is to accelerate innovation to meet tomorrow’s public health challenges and develop the knowledge, employment, and competitiveness of all players in the health sector ecosystem. By bringing together all the innovation players in Wallonia’s life sciences field, BioWin aims to stimulate regional economic redeployment. The cluster also implements the sector’s industrial policy (industrial innovation and research, training, and support for business growth) to develop and anchor skills, knowledge, and jobs.
About EXOB-001
EXO Biologics has developed EXOB-001, a novel exosome-based drug candidate produced with ExoPulse. Exosomes, also known as extracellular vesicles (or EVs), are derived from cultured human umbilical cord mesenchymal stromal cells (hMSCs). Human MSCs are characterized by their ability to secrete growth factors and cytokines that modulate the immune system and promote tissue repair and regeneration. Exosomes are nanoparticles naturally released from these cells. Exosomes are expected to be a safer therapeutic alternative to MSCs as they eliminate the risk of emboli and an immune response. Since exosomes are nuclei-free, they eliminate the risk of malignant transformation and ectopic colonization. EXO Biologics has been granted Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA and ODD by EMA for EXOB-001 to prevent Bronchopulmonary Dysplasia (BPD) in preterm newborns.
About ENEVEW
EVENEW is a multi-center adaptive, seamless Phase 1/2 trial conducted by EXO Biologics. The trial assesses the safety and efficacy of intratracheal administration of EXOB-001 in preventing severe forms of Bronchopulmonary Dysplasia (BPD) in preterm newborns. Phase 1 is a single-arm, dose-escalating study to assess the safety of the intratracheal administration of EXOB-001, enriched with a historical nested case-control group to compare clinical outcomes for further evaluation. In this dose escalation part of the trial, a maximum of forty patients will be enrolled for up to three dose levels and two regimes. The second phase, triggered by a positive interim analysis, is a double-blind, randomized, placebo-controlled dose-finding study with efficacy evaluation of EXOB-001 on reducing BPD severity grade. Patients will be monitored up to the corrected age of two years (in hospital and outpatient).
Contact
Hugues Wallemacq – CEO
Anne-Lien Thys – CFO
0032 (0)468 27 07 96
About us
EXO Biologics mission is to provide affordable and accessible exosomes therapy to patients with unmet medical needs.