New breakthrough data from studies with Coave’s ALIGATER™-engineered AAV2-based capsid coAAV-CSF-01 (S01coAAV2) demonstrates improved brain tissue transduction and safety following intra-cerebrospinal fluid administration in non-human primates
Data selected for Late-Breaking Abstract at ASGCT 2025
Paris, France – May 9, 2025 – Coave Therapeutics (“Coave”), a company pioneering the future of genetic medicines, today announced the launch of coAAV-CSF-01, a novel CNS-targeted gene therapy capsid developed using its proprietary ALIGATER™ platform. New breakthrough data from studies evaluating the vector (research code S01coAAV2) have been selected for presentation as a Late-Breaking Abstract at the 2025 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting, to be held May 13-17, in New Orleans, LA, USA.
The data highlight the therapeutic potential of coAAV-CSF-01 (S01coAAV2) to transform central nervous system (CNS) gene therapy delivery. In non-human primate (NHP) studies, coAAV-CSF-01 was administered via intra-cerebrospinal fluid (intra-CSF) routes, including intracisternal magna (ICM) and intracerebroventricular (ICV). The results demonstrated higher transgene expression in targeted brain regions and a better safety profile using coAAV-CSF-01 compared to AAV9.
Key findings with coAAV-CSF-01 include:
“These exciting new data from coAAV-CSF-01 represent a major step forward in CNS gene therapy,” said Lolita Petit, CSO of Coave Therapeutics. “In non-human primates, the vector achieved robust brain transduction via intra-CSF delivery – a route long viewed as promising but historically constrained by limited efficacy and off-target effects. The enhanced biodistribution and improved safety demonstrated in these studies support its potential in developing new genetic medicines for neurodegenerative and neurodevelopmental CNS disorders.
“Furthermore, the vector was developed using our proprietary ALIGATER™ platform, enabling modular modification of AAV2 and other capsids to optimize tissue targeting and therapeutic performance – potentially opening the door to broader therapeutic applications. Together, the data position coAAV-CSF-01 as a potentially transformative advance in gene therapy delivery.”
coAAV-CSF-01 is part of Coave’s growing portfolio of proprietary AAV capsids engineered to optimize gene delivery in challenging therapeutic areas. The ALIGATER™ platform enables chemical conjugation-based modification of AAV vectors (coAAVs), offering a modular and scalable approach to enhance tissue targeting and transduction efficiency.
Late-Breaking Poster Presentation Details:
Coave’s abstract (#LBA78) can be viewed on ASGCT’s website (https://annualmeeting.asgct.org/).
Coave’s proprietary ALIGATER™ (Advanced Vectors-Ligand Conjugates) platform is a breakthrough technology addressing key limitations in the delivery of genetic payloads to extra-hepatic tissues, including limited tissue specificity, delivery efficiency and safety. ALIGATER™ enables conjugation of targeting ligands, such as small molecules, peptides, or antibody fragments, on AAV or non-viral vectors, offering superior delivery efficiency, tissue specificity and safety profile for a broad range of diseases. Importantly, the platform streamlines the manufacturing process by avoiding prior AAV capsid modifications. These capabilities will enable Coave to develop best-in-class gene therapies designed for specific indications.
Coave Therapeutics is a genetic medicine company pioneering the development of innovative solutions to enhance the precision, safety, efficacy and manufacturability of genetic medicines. With its proprietary ALIGATER™ platform, Coave is at the forefront of addressing challenges in gene therapy delivery to extra-hepatic tissues, creating a robust pipeline targeting CNS, neuromuscular and eye diseases.
Headquartered in Paris, France, Coave Therapeutics is backed by leading international life sciences investors. For more information about the science, pipeline, and people, please visit www.coavetx.com or follow us on LinkedIn.
Coave Therapeutics
Rodolphe Clerval, CEO
contact@coavetx.com
MEDiSTRAVA
Sylvie Berrebi, Mark Swallow
coavetx@medistrava.com
Tel: +44 203 928 6900
Antwerp, Belgium, May 6, 2025 – Agomab Therapeutics NV (“Agomab”) today announced late
breaking interim data from the ongoing STENOVA1 Phase 2a clinical trial for AGMB-129, an oral
gastrointestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-b RI or ALK5) developed for the
potential treatment of Fibrostenosing Crohn’s Disease (FSCD). The interim results were presented by
Florian Rieder, MD, at Digestive Disease Week® (DDW) 2025, taking place in San Diego on May 3-6,
2025.
STENOVA is a randomized, double-blind, placebo-controlled study in 103 patients with symptomatic
FSCD. Patients are randomized to receive one of two doses of AGMB-129 (200mg twice-daily or 100mg
once-daily) or placebo for 12 weeks on top of standard of care, including anti-inflammatory biologics.
The multi-center study is global with investigational sites in the USA, Canada and Europe.
The interim analysis was conducted on the first 44 patients after 12 weeks of treatment and indicated
that the primary endpoint of favorable safety and tolerability of AGMB-129 was met at both doses.
The severity and incidence of adverse events were similar among treatment arms, including placebo,
and there were no signs of cardiac toxicity, no pro-inflammatory effects, and no signals in safety labs,
vital signs, physical exams or ECGs.
The study also met its two predefined secondary endpoints of pharmacokinetics (PK) and target
engagement in the first 44 patients. The PK data indicated very low systemic exposure to AGMB-129
and high exposure to its inactive main metabolite MET-158. These results are consistent with prior
data in healthy subjects and support the gut-restricted profile of AGMB-129 in FSCD patients.
Target engagement, measured through transcriptomics in mucosal biopsies collected at the site of the
ileal strictures at screening and Week 12, showed significant downregulation of both fibrotic
(p=0.0036) and inflammatory pathways (p<0.0001) for the high dose cohort versus placebo.
A consistent positive trend was also observed for the high dose versus placebo across several
exploratory endpoints, including stricturing patient-reported outcome (S-PRO) and disease severity in
centrally read Simple Endoscopic Score (SES-CD).
The STENOVA study is fully recruited, and on track to report results on 103 patients in the fourth
quarter of this year.
“Fibrostenosing Crohn’s disease is an area of high unmet medical need, and the interim STENOVA
results presented at DDW® show the potential of AGMB-129 as a novel drug candidate for patients.
The target engagement data point to the potential dual anti-inflammatory and anti-fibrotic effect of
AGMB-129, on top of standard of care. Moreover, the consistent trend observed for several of the
exploratory clinical endpoints after 12 weeks is very encouraging,” said Florian Rieder, MD, Vice-Chair
Department of Gastroenterology, Hepatology and Nutrition, Cleveland Clinic, OH.
“The positive interim data for the STENOVA Phase 2a clinical trial are an important step forward in the
development of our gut-restricted ALK-5 inhibitor AGMB-129 in patients with Fibrostenosing Crohn’s
disease,” said Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics. “The STENOVA study
is now fully recruited, and the swift enrollment underscores the high unmet medical need that exists
in this indication. We want to thank all patients and investigators for their participation in this landmark
study.”
AGMB-129 is an investigational drug and not approved by any regulatory authority. Its efficacy and
safety have not been established.
1 Study details | STENOVA – A Study to Evaluate Safety, Tolerability, PK and PD of AGMB-129 in Patients
With Fibrostenotic Crohn’s Disease | ClinicalTrials.gov
About AGMB-129
AGMB-129 is an oral, small molecule GI-restricted inhibitor of ALK5 (or TGF-b RI) currently in clinical
development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-b is a major driver of
fibrosis. AGMB-129 is specifically designed to inhibit ALK5/TGF-b in the GI-tract. Rapid first-pass
metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an
improved safety profile over systemically available inhibitors in this class. In a Phase 1 trial in healthy
subjects, single- and multiple-doses of AGMB-129 were generally well-tolerated at all doses tested. In
addition, the trial showed high local exposure to AGMB-129 in the ileum but no clinically relevant
systemic exposure, demonstrating that the GI restricted mechanism may operate efficiently in
humans. AGMB-129 has received U.S. FDA Fast Track Designation.
About Fibrostenosing Crohn’s Disease
Crohn’s disease is a chronic progressive disease of the gastrointestinal (GI) tract. It is estimated that
approximately 50% of patients with Crohn’s disease develop fibrosis of the GI tract, resulting in
stricture (stenosis) formation and intestinal obstructions, most frequently in the terminal ileum. These
strictures can cause obstructive symptoms such as nausea, vomiting and severe pain after meals,
leading to dietary change, malnutrition and surgery. Despite the large unmet medical need, there are
no approved pharmacological therapies for FSCD.
About Agomab
Agomab is focused on achieving disease modification by modulating inflammation and fibrosis in
chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do
this by targeting biologically validated pathways, including Transforming Growth Factor β, and by
applying specialized capabilities in organ-restricted small molecules. With a differentiated clinical
pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven
track-record and a strong investor base, Agomab is building a transformational company with the aim
to have a real impact on patients’ lives.
About Digestive Disease Week®
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and
academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.
Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American
Gastroenterological Association (AGA), the American Society for Gastrointestinal Endoscopy (ASGE)
and the Society for Surgery of the Alimentary Tract (SSAT), DDW is an in-person and online meeting
from May 3-6, 2025. The meeting showcases nearly 6,000 abstracts and 1,000 invited talks on the
latest advances in GI research, medicine and technology. More information can be found at
www.ddw.org.
Contacts
Investors
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
Media
Stephanie May or Eva Mulder
Trophic Communications
E-Mail: agomab@trophic.eu
Phone: +49 171 185 5682
Amsterdam, Netherlands, April 24, 2025 – Avidicure, a biotechnology company pioneering an entirely
new multifunctional antibody modality with broad applicability in oncology, today announced its launch
with a $50 million seed financing round, led by EQT Life Sciences with participation from Kurma Partners,
BioGeneration Ventures, BOM, Curie Capital, and V-Bio Ventures.
Avidicure is developing dual agonistic, multifunctional and avidity engineered antibodies, “AVC Boosters”,
that can safely deliver targeted and potent cancer monotherapy. AVC-Boosters unlock strong
and orchestrated immunological responses, harnessing the full power of both the innate and adaptive
immune system. The AVC-Booster design surpasses the best qualities of first-generation antibodies,
checkpoint inhibitors, T-cell engagers, and antibody-drug conjugates (ADCs).
“AVC-Boosters have the potential to change the treatment landscape for a wide range of cancers as first
in-class multifunctional antibody products that safely mobilize the full power of the immune system,”
said Arthur Lahr, Chief Executive Officer of Avidicure. “Our products drive targeted and potent immune
responses only in the tumor with reduced toxicity risk. We are eager to build a broad pipeline with our
unique platform and progress our lead oncology product, AVC-S-101, into clinical development for solid
tumors.”
Avidicure’s fully owned proprietary platform leverages decades of antibody engineering and in silico
protein design capabilities, and immunology expertise. Through the AVC-Booster plug-and-play
functionality, multiple products can be developed. Avidicure’s lead product, AVC-S-101, is a TROP2-
targeting booster that is being developed for non-small cell lung cancer and multiple other indications.
“Avidicure is taking an entirely new approach with broad clinical potential,” said Dr. Joern-Peter Halle,
former Chief Strategy Officer and Global Head of Research at Merck and Chairman of Avidicure’s
Scientific Advisory Board. “Avidicure’s multifunctional antibodies provide a novel treatment modality
with a unique, differentiated mode of action. These products are well-positioned to make a significant
impact in the treatment of cancer patients.”
Avidicure is led by an experienced team with an established track record in drug discovery, development,
and commercialization. The founding management team consists of Arthur Lahr (CEO), Dirk De Naeyer
(COO), Robert Friesen (CSO), and Govert Schouten (CBO), who previously served as executive
management in Crucell, Ablynx and Kiadis, and played key roles in the acquisitions of these successful
European biotech companies. The Supervisory Board includes industry veterans Frank Verwiel (Intellia,
Aptalis, Bavarian Nordic, Merck), Martijn Kleijwegt (EQT-LS), Hunter Smith (Rhythm), and Helen Collins
(Five Prime, Enliven, Gilead, Amgen).
The company will be presenting preclinical data at the upcoming American Association for Cancer
Research (AACR) Annual Meeting in April, and at the American Society of Clinical Oncology (ASCO)
Annual Meeting in May.
About Avidicure
Avidicure is a biotechnology company pioneering an entirely new dual agonistic, multifunctional and
avidity engineered antibody modality, “AVC-Boosters,” designed to safely deliver targeted and potent
immune-modulating monotherapy for cancer patients. The AVC-Booster design surpasses the best
qualities of first-generation antibodies, checkpoint inhibitors, T-cell engagers, and antibody-drug
conjugates (ADCs). AVC-Boosters unlock strong and orchestrated immunological responses, harnessing
the full power of the innate and adaptive immune system. Avidicure is based in the Netherlands and is
supported by a syndicate of top-tier investors led by EQT Life Sciences. For more information, please visit
www.avidicure.com or follow the company on LinkedIn.
Contact:
Investor Relations
Christina Tartaglia
Christina.tartaglia@precisionaq.com
Media Relations
Colleen Ketchum
Colleen.Ketchum@precisionaq.com
Transforming disease control in piglets with an antibiotic-free monoclonal antibody
solution
Zwijnaarde, 23 April, 2025 – Animab (“the Company”), a leader in pioneering first-in-class oral
antibody solutions for unmet needs in production animals, today announces an exclusive
distribution agreement with Huvepharma® (“Huvepharma”), a global pharmaceutical company
specializing in the development, manufacturing and marketing of human and animal health and
nutrition products. Huvepharma and Animab will join forces to bring Nanoprotec®, Animab’s first
oral monoclonal antibody product, onto the European market.
Nanoprotec® targets enterotoxigenic Escherichia coli (ETEC) F4, a major cause of diarrhea in
piglets, leading to slow growth and mortality. Current disease control strategies for ETEC F4 rely
heavily on antimicrobials. Nanoprotec® provides an antibiotic-free approach that neutralizes
pathogens efficiently, enhancing both animal welfare and sustainable livestock management.
With over 60 million piglets affected annually in the EU, Animab’s novel antibody treatment will
set a new standard in disease control by providing immediate immunity, administered through
drinking water.
“We are delighted to partner with Huvepharma, whose strong commitment to innovative and
animal-friendly disease control solutions aligns with our vision, says Alain Wille, CEO of
Animab. “This collaboration will enable us to make a meaningful difference in livestock health
and productivity, meeting the evolving demands of sustainable animal production.”
“Nanoprotec® is designed to enhance animal welfare, improve productivity, and reduce reliance
on antibiotics in livestock farming, added Jan Spaas, Chairman of the Board of Animab. “With
Huvepharma’s extensive market reach and expertise, we are confident that our product will be
widely adopted, supporting both food safety and responsible farming practices. This partnership
marks a significant milestone in our mission to offer sustainable and responsible animal health
solutions.”
Eddy Piron, Vice President of Sales and Marketing and Wouter Depondt, Global Marketing
Director veterinary products at Huvepharma, commented: “Nanoprotec® is a valuable
addition to our portfolio, offering a targeted and antibiotic-free approach to managing weaning
diarrhea in piglets. It complements our existing E. coli enteritis solutions and reinforces our
commitment to innovative, sustainable animal health advancements.“
A Game-Changer in Animal Health
Founded in 2020 as a spin-off from VIB, University of Ghent (UGent) and Vrije Universiteit Brussel
(VUB), Animab has rapidly emerged as a leader in livestock disease control innovation. Backed
by a strong European investment consortium, the Company has secured over €12 million in
funding from Seventure Partners, VIB, PMV, AIF, V-Bio Ventures, and Qbic III.
Clinical trials of Nanoprotec® demonstrated a significant reduction in symptoms associated with
ETEC F4 infections. The monoclonal antibody prevents bacterial adhesion to the intestinal wall,
effectively blocking the bacteria from becoming pathogenic. Regulatory filing of Nanoprotec® to
the European Medicines Agency (EMA) is planned by the end of this year, with market launch
anticipated by the end of 2026.
Animab’s proprietary, scalable platform technology enables the cost-effective production of
orally administered monoclonal antibodies, designed to prevent intestinal infections, enhance
overall health, and optimize livestock productivity. The Company is committed to addressing
unmet needs in production animals and continues to expand its research and development
pipeline. Several novel oral antibody solutions are currently in development, targeting bacterial
and viral gastrointestinal infections in livestock.
ENDS
Notes to Editors
About Huvepharma
Our strong foundations, dynamic drive and clear business orientation have resulted in Huvepharma
being one of the top ten veterinary pharmaceutical companies operating around the world today.
Huvepharma is a privately-owned company, headquartered in Sofia, Bulgaria. Our manufacturing
subsidiary, Biovet, is headquartered in Peshtera, Bulgaria, and has independent manufacturing units
in various other locations. Large, modern fermentation plants provide capacity for producing major
molecules, purification and downstream processing and house extensive R&D, quality assurance and
packaged goods facilities.
More information: https://www.huvepharma.com
About Animab
Animab is a biotech company founded in 2020 as a spin off from VIB, UGent and VUB, dedicated to
addressing the changing needs of livestock production. Leveraging proprietary research discoveries,
Animab focuses on targeting gastrointestinal infectionsin animals. Its interdisciplinary team integrates
cutting-edge research in animal science and biotechnology to advance product breakthroughs, cost
efficiency and sustainability in animal health. Led by experts in vaccines, biotechnology, business
management and international marketing, Animab is committed to offering safe and sustainable
solutions that enhance animal performance and well-being.
More information: www.animab.com
For more information, please contact:
Animab
Alain Wille, CEO of Animab
Phone: +32 467 06 00 91
Email: alain.wille@animab.com
Huvepharma
Veerle Hautekiet, Global Marketing Director
Phone: +32 491 37 31 81
Email : Veerle.Hautekiet@huvepharma.com
LEUVEN, Belgium – 24 March 2025 – Augustine Therapeutics NV (“Augustine” or “the
Company”), a biotechnology company focused on developing new therapies for neuromuscular,
neurodegenerative and cardio-metabolic diseases through the inhibition of the cytosolic Histone
DeACetylase 6 (HDAC6) enzyme, today announced it has successfully completed its Series A
financing round raising a total of EUR 77.7 million (USD 84.8 million). The oversubscribed
financing was co-led by Novo Holdings and Jeito Capital, supported by existing investors Asabys
Partners, who led an initial EUR 17.5 million closing in 2024, Eli Lilly and Company, AdBio partners,
V-Bio Ventures, PMV, VIB, Gemma Frisius Fund, the US-based Charcot-Marie-Tooth (CMT)
Research Foundation and Newton Biocapital.
HDAC6 is involved in neurodegeneration and tissue aging-related cellular processes, and
pharmacologic inhibition of HDAC6 is a promising approach in a number of diseases. Augustine
Therapeutics have designed a unique next-generation approach to selectively inhibit HDAC6
while preserving its beneficial non-catalytic functions. This novel non-hydroxamate, non-
hydrazine producing approach seeks to avoid the limitations of previous HDAC6i and has
significant potential in CMT, the most common hereditary disorder of the peripheral nervous
system, affecting approximately three million people worldwide. With additional independent
and differentiated programs focused on brain-penetrant and peripheral-restricted molecules,
Augustine’s pipeline of HDAC6 inhibitors has further potential in multiple diseases, including
neurodegenerative and cardio-metabolic disorders.
The Company’s scientific foundation originates from the ground-breaking research of Prof. Ludo
Van Den Bosch from the VIB-KU Leuven Center for Brain and Disease Research, who identified
HDAC6 inhibition as a promising approach for the treatment of CMT and other neuropathies.
Augustine was initially formed and seed-funded by V-Bio Ventures, AdBio Partners, VIB, PMV,
and Gemma Frisius Fund. The Company recently appointed experienced biopharma leader
Gerhard Koenig, PhD, who had served as Executive Chairman since June 2024, to lead the
Company as CEO in January 2025.
The proceeds will be used to advance Augustine’s lead candidate, AGT-100216, through a Phase
I/II proof-of-concept clinical trial in CMT. Beyond AGT-100216, Augustine has two other programs
in discovery targeting peripherally-restricted and blood-brain barrier-penetrant HDAC6i for
undisclosed neurodegenerative and cardio-metabolic indications.
Gerhard Koenig, PhD, CEO of Augustine said: “This significant financing is a testament to the
innovative medicinal chemistry that Augustine was founded on, which acts via a unique
mechanism of action. The therapeutic potential of HDAC6 is widely recognized in our industry,
but previous drug approaches have been sub-optimal, particularly for chronic diseases. At
Augustine, we believe we have solved these challenges with a novel non-hydroxamate, non-
hydrazide producing chemotype which is highly selective and avoids the typical limitations of
prior chemotypes, unlocking HDAC6 inhibition as a therapeutic approach. We now look forward
to rapidly advancing our lead candidate into clinical trials for the treatment of CMT, while
broadening the potential for our candidates to change treatment paradigms for neurological and
cardio-metabolic diseases. I would like to thank our new and existing investors for their
unwavering support as we continue to advance into clinical development.”
Emmanuelle Coutanceau, PhD, Partner, Seed Investments, Novo Holdings, commented: “Our
mapping of the HDAC6i landscape has made us confident that Augustine’s innovative and
rigorous approach to medicinal chemistry has yielded molecules with potential to be best-in
class. HDAC6 inhibition shows great promise in many indications, and we are enthused to start
our collaboration with Augustine’s top-tier management team. Additionally, Augustine will be
expanding its activities in Denmark, accessing a unique ecosystem and pool of talent which will
support the exploration of HDAC6i in cardio-metabolic diseases.”
Mehdi Ainouche, PharmD, Senior Principal, at Jeito Capital, said: “This investment illustrates
the potential of Augustine to bring exciting innovation in therapeutic areas where patients have
limited or no treatment options. We are delighted to co-lead this financing to realize Augustine’s
potential, which stands out for both the quality of its research and the expertise of Gerhard and
his team. We look forward to our future collaboration, which shares a common ambition: to
accelerate clinical development in order to bring these innovations to patients.”
Emmanuelle Coutanceau, PhD, Partner at Seed Investments, Novo Holdings, and Mehdi
Ainouche, PharmD, Senior Principal at Jeito Capital have joined Augustine Therapeutics’ Board of
Directors. Annette Clancy, Operational Investor at Jeito Capital, and Marie Schroeder, PhD, Vice
President at Seed Investments, Novo Holdings will join as Board Observers.
Media Contacts:
Augustine Therapeutics
Gerhard Koenig, CEO
E-mail: info@augustinetx.com
ICR Healthcare
Amber Fennell
E-mail: augustinetx@icrhealthcare.com
About Augustine Therapeutics
Augustine Therapeutics is a biotechnology company focused on the treatment of neuromuscular,
neurodegenerative and cardio-metabolic diseases through its next-generation approach to
selectively inhibit HDAC6. Augustine’s HDAC6 inhibitors have been purposefully designed to
selectively inhibit HDAC6 while preserving its beneficial non-catalytic functions. Augustine’s lead
program, AGT-100216, is the first selective HDAC6 inhibitor for long-term treatment of Charcot
Marie-Tooth (CMT) disease. With its novel non-hydroxamate, non-hydrazide producing
chemotype, Augustine’s HDAC6 approach is selective, avoids the limitations of other
chemotypes, and built for chronic diseases. With this novel approach, the Company will also be
targeting diseases beyond CMT, including neurodegenerative and cardio-metabolic diseases.
Augustine Therapeutics was founded on the ground-breaking research of Prof. Ludo Van Den
Bosch from the VIB-KU Leuven in Belgium. For more information visit www.augustinetx.com.
About Novo Holdings A/S
Novo Holdings is a holding and investment company that is responsible for managing the assets
and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve
people’s health and the sustainability of society and the planet by generating attractive long
term returns on the assets of the Novo Nordisk Foundation. Wholly owned by the Novo Nordisk
Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S
(Novozymes A/S) and manages an investment portfolio with a long-term return perspective. In
addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private
equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture,
Growth, Asia, Planetary Health and Principal Investments teams, Novo Holdings invests in life
science companies at all stages of development. As of year-end 2023, Novo Holdings had total
assets of EUR 149 billion. www.novoholdings.dk.
About Jeito Capital
Jeito Capital is a global leading Private Equity fund with a patient benefit driven approach that
finances and accelerates the development and growth of ground-breaking medical innovation.
Jeito empowers and supports managers through its expert, integrated, multi-talented team and
through the investment of significant capital to ensure the growth of companies, building market
leaders in their respective therapeutic areas with accelerated patients’ access globally, especially
in Europe and the United States. Jeito Capital is based in Paris with a presence in Europe and the
United States. For more information, please visit www.jeito.life or follow us on LinkedIn or X,
— AGMB-129 hit all primary and secondary endpoints in interim read-out from 44 patients after 12
weeks treatment —
— Detailed interim STENOVA results to be presented at future scientific conference —
— STENOVA clinical trial on track to report full results in the fourth quarter of 2025 —
— Open-label extension study initiated —
Antwerp, Belgium, March 10, 2025 – Agomab Therapeutics NV (‘Agomab’) today announced positive
interim results from 44 patients completing treatment in the ongoing STENOVA1 Phase 2a clinical trial
for AGMB-129, an oral gastro-intestinal (GI)-restricted small molecule inhibitor of ALK5 (TGF-β RI or
ALK5) for the potential treatment of Fibrostenosing Crohn’s Disease (FSCD).
STENOVA is a randomized, double-blind, placebo-controlled study in a total of 90 patients with
symptomatic FSCD. Patients are randomized to receive one of two doses of AGMB-129 or placebo for
12 weeks on top of standard of care, including biologics. The multi-center study is global with
investigational sites in the USA, Canada and Europe. The primary endpoints are the safety and
tolerability of AGMB-129 in FSCD patients. Secondary endpoints include the pharmacokinetics and
target engagement at the site of the ileal strictures as measured through transcriptomics. All primary
and secondary endpoints were met.
The company has also initiated the open-label treatment extension of the STENOVA study with AGM-
B129. Study participants who have completed the double-blind 12-week treatment period are eligible
to participate and can receive treatment for up to an additional 48 weeks.
“The positive interim data for the STENOVA Phase 2a clinical trial represent a significant milestone for
this program, and we look forward to presenting the detailed results at a scientific conference in the
near-term,” said Philippe Wiesel, Chief Medical Officer at Agomab Therapeutics. “We want to thank
all patients and investigators for participating in this trailblazing study, which aims to address the high
unmet medical need that exists in the field of Fibrostenosing Crohn’s disease.”
AGMB-129 is an investigational drug and not approved by any regulatory authority. Its efficacy and
safety have not been established.
About AGMB-129
AGMB-129 is an oral, small molecule GI-restricted inhibitor of ALK5 (or TGF-β RI) currently in clinical
development for the treatment of Fibrostenosing Crohn’s Disease (FSCD). TGF-β is a major driver of
fibrosis. AGMB-129 is specifically designed to inhibit ALK5/TGF-β in the GI-tract. Rapid first-pass
metabolism in the liver prevents clinically relevant systemic exposure, potentially delivering an
improved safety profile over systemically available inhibitors in this class. In a Phase 1 trial in healthy
subjects, single- and multiple-dose AGMB-129 was generally well-tolerated at all doses tested. In
addition, the trial showed high local exposure to AGMB-129 in the ileum but no clinically relevant
systemic exposure, demonstrating that the GI restricted mechanism may operate efficiently in
humans. Fibrostenosing complications occur in nearly 50% of Crohn’s disease patients and are the
leading cause of bowel resection surgery, however there are no approved specific therapies for FSCD.
AGMB-129 has received U.S. FDA Fast Track Designation.
About Agomab
Agomab is focused on achieving disease modification by modulating inflammation and fibrosis in
chronic indications such as Fibrostenosing Crohn’s Disease and Idiopathic Pulmonary Fibrosis. We do
this by targeting biologically validated pathways, including Transforming Growth Factor β, and by
applying specialized capabilities in organ-restricted small molecules. With a differentiated clinical
pipeline across several fibrotic disorders, end-to-end research and development capabilities, a proven
track-record and a strong investor base, Agomab is building a transformational company with the aim
to have a real impact on patients.
Contacts
For Agomab Therapeutics
Sofie Van Gijsel
VP of Investor Relations
E-Mail: sofie.vangijsel@agomab.com
Phone: +1 781 296 1143
Media Requests for Agomab
Dr. Stephanie May
Trophic Communications
E-Mail: agomab@trophic.eu
Phone: +49 171 1855682
Ghent (Belgium), 4 March 2025 – Protealis, the specialist seed and seed technologies developer for high-performing legume crops in Europe, today announces the launch of three new soybean varieties, following five new registrations obtained in Belgium and Germany. One of the newly registered soybean varieties that received registration both in Belgium and Germany is PRO Denali, the first variety launched by Protealis in the 00 maturity group. These are tailored to grow in the more moderate regions in northern-central Europe. The launch marks the company’s rapid product portfolio expansion to 9 soybean varieties since its foundation in 2021, with the launch in the 00 soybean maturity group paving the way to commercial growth across new regions in central France, southern Germany, Austria, and Hungary.
Benjamin Laga, CEO of Protealis, commented: “We are very pleased to launch these three new soybean varieties, further showing our commitment to expand high-performance soybean cultivation in Europe. With the introduction of our first 00 category PRO Denali soybean, we have now moved into the field of the 00 maturity group that opens up vast acreages across Europe. As from now, farmers in these more temperate regions will be able to reap the benefits of high-performance soybean farming. Overall, our new varieties were selected as they consistently outperformed many of their peers in trials across multiple European regions. Together with our recently expanded sales & marketing team, we are now ready for the next wave of our commercial expansion.”
Protealis’ soybean varieties PRO Taranaki (000 group) and PRO Denali (00 group) were formally approved and registered in both Germany and Belgium. PRO Taranaki was already registered in Germany in 2024 but is now also registered in Belgium. The variety combines high yield with exceptional protein content and is well-suited for food applications. PRO Denali stands out with its excellent first pod height for efficient harvesting and delivers stable, high yields. Other approved and registered new soy varieties in Belgium include PRO Fogo (000 group), characterized by its high yield in drier conditions, and PRO Volcano (000 group), offering a great adaptability to northern climates, combined with a good yield-protein balance.
Protealis’ new soybean varieties, all suited for organic agriculture, respond to the rising demand for high-quality, non-GMO and locally grown soy for both food and feed applications in Europe. Historically, soybean cultivation struggled to gain traction in northern Europe due to a lack of high-performance varieties adapted to cooler climates. Today, cutting-edge breeding technologies, including AI-driven selection—one of Protealis’ core strengths—are changing the game in a soybean market in the EU-27 that is expected to grow by 13% by 2035[1]. While 000 varieties excel in areas like the UK, Belgium, and Germany, the newly introduced 00 group is ideal for central France, southern Germany, Austria, and Hungary.
To support its current product portfolio of now nine high-performance soybean varieties, Protealis recently grew its sales & marketing team with three new roles. A new sales agronomist will focus on German-speaking and rapidly growing Eastern European markets, while new roles in both Market and Business Development will focus on the expanding regional soy acreage and develop partnerships with the food and feed industry, increasingly demanding locally grown high-quality, high-protein legume crops.
[1] Source: Donau Soja, Non-GMO Soja Market report, January 2025
*** END ***
More information:
Renate Degrave
Head of Communications and Marketing Protealis
renate.degrave@protealis.com | +32 471 53 60 64
About Protealis
Protealis develops superior plant protein seeds and seed technologies, optimized for the European soil and climate. Being at the forefront of sustainable agriculture, Protealis aims to empower European farmers with sustainable and resilient alternatives to traditional protein sources by developing legume seed solutions with enhanced crop yield and protein levels, while at the same time minimizing the ecological footprint. By addressing the growing demand for more plant-based protein sources, the company is committed to contribute to more sustainable food systems. Today, Protealis is a commercial-stage company with nine early maturity soy varieties on the market and a yellow pea program in the pipeline. The company is headquartered in the biotechnology cluster in Ghent, Belgium. More info on www.protealis.com, LinkedIn or facebook.
Data protection is important to us. You are receiving this publication on the legal basis of Article 6 para 1 lit. f GDPR (“legitimate interest”). However, if you do not wish to receive further information about Protealis, email us at info@protealis.com and we will no longer process your details for this purpose. You can also find further details in our privacy statement on www.protealis.com.
Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Protealis’ (‘the Company’) or, as appropriate, the Company directors’ or managements’ current expectations and projections concerning future events such as the Company’s results of operations, financial condition, liquidity, performance, prospects, growth, strategies and the industry in which the Company operates. By their nature, forward-looking statements involve a number of risks, uncertainties, assumptions and other factors that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties, assumptions and factors could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward-looking statements contained in this press release regarding past trends or activities are not guarantees of future performance and should not be taken as a representation that such trends or activities will continue in the future. In addition, even if actual results or developments are consistent with the forward-looking statements contained in this press release, those results or developments may not be indicative of results or developments in future periods. No representations and warranties are made as to the accuracy or fairness of such forward-looking statements. As a result, the Company expressly disclaims any obligation or undertaking to release any updates or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based, except if specifically required to do so by law or regulation. Neither the Company nor its advisers or representatives or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.
• A seasoned Chief Executive, with over 20 years of distinguished leadership in medical biotechnology
• Poised to guide the Tanai team in advancing its groundbreaking, oral, first-in-class therapeutic targeting a genetically validated pathway for obesity treatment
Ghent, Belgium, 22 January 2025 – Tanai Therapeutics (“the Company” or “Tanai”), a VIB spin-off company developing a new therapeutic class of obesity treatments, today announces the appointment of Pieter Rottiers, as Chief Executive Officer (CEO) and Director.
Pieter Rottiers, PhD, has a proven track record of leading start-ups and emerging biotechnology companies to success, demonstrating exceptional expertise in advancing innovative solutions. As CEO of Precigen ActoBio Inc., he spearheaded early-stage and clinical programs targeting gastrointestinal and autoimmune disorders. His prior senior roles at Intrexon Actobiotics NV, ActoGeniX NV, and VIB further highlight his leadership in driving breakthroughs in molecular biology and biotechnology.
“On behalf of Tanai’s Board of Directors, I am delighted to welcome Pieter Rottiers as the CEO of our Company,” said Sara Vandenwijngaert, Chair of Tanai. “With his exceptional leadership in biotech and drug development, Pieter is perfectly poised to guide our mission of pioneering innovative, first-in-class therapies for obesity. We are confident his expertise will drive meaningful progress for the Company.”
“I am honored to take on this important role at Tanai”, added Pieter Rottiers. “Tanai’s novel drug target holds immense potential in addressing obesity, a growing global challenge that is linked to numerous comorbidities. Backed by a strong investor syndicate and the deep scientific expertise of our team, Tanai is uniquely positioned to make transformative impact. I look forward to leveraging my experience and working alongside this talented team to drive the Company’s success.”
***ENDS***
Notes to Editors
Bio Pieter Rottiers, PhD
Dr. Pieter Rottiers is a seasoned executive with extensive expertise in medical biotechnology and drug development. He brings a wealth of experience from leadership roles in innovative biotechnology companies.
Prior to joining Tanai Therapeutics, Dr. Rottiers served as CEO and Director of Precigen ActoBio Inc. starting in 2018, where he successfully advanced a diversified portfolio targeting gastrointestinal and autoimmune disorders, including overseeing early-stage and clinical development programs. Under his leadership, the company made significant progress in advancing therapeutic candidates through various stages of clinical development. From 2015 to 2018, he was Vice President at Intrexon Actobiotics NV and served as Managing Director until 2024. Before that, he held senior roles at ActoGeniX NV, a VIB spin-off company acquired by Intrexon Corporation in 2015, and worked as Principal Investigator at the VIB-UGent Center for Inflammation Research.
Dr. Rottiers holds a PhD in Biotechnology from the University of Ghent and a postgraduate degree in Business Management from EHSAL Management School in Brussels.
About Tanai Therapeutics
Tanai Therapeutics is a Belgian biotech company pioneering a novel treatment for obesity. It was founded in 2023 as a spin-off from VIB and UGent with the support of V-Bio Ventures and Qbic. Its scientific foundation originates from the ground-breaking research of Prof. Savvas Savvides and Prof. Charlotte Scott from the VIB-UGent Center for Inflammation Research. Tanai Therapeutics is developing an oral, first-in-class therapeutic targeting a genetically validated pathway in obesity critical to energy expenditure. The company has raised over EUR 6 million in seed financing from a syndicate of investors, including V-Bio Ventures, Qbic, VIB, BioGeneration Ventures and Novo Nordisk.
For more information, please contact:
Tanai Therapeutics
Pieter Rottiers, CEO
E: Pieter.Rottiers@tanaitx.com
VIB Investor Relations
Lies Vanneste
E: IR@vib.be
M: +32 498 05 35 79
Montarnaud, France, 14 January 2025, 9AM CET Time – BIODOL Therapeutics (“Biodol”), a company
dedicated to discovering innovative pain treatments targeting FLT3, announced today that it has
entered into an option agreement with KYORIN Pharmaceutical (“Kyorin”), a major Japanese
pharmaceutical company focusing on the discovery and development of therapies for diseases with
significant unmet need. Pain has recently been identified as a strategic focus area for Kyorin, and the
two companies share a common vision regarding the potential of the FLT3 target.
Under the terms of the agreement, Biodol will receive an option fee, granting Kyorin the option to in
license BDT272 upon the successful completion of Phase 1 clinical trials. Upon exercise of the option,
Kyorin will be granted a license to develop and commercialize the compound in Japan and selected
additional territories in Asia (excluding China); in turn Biodol will receive upfront payment, milestone
payments tied to the progress of developing and commercializing BDT272, and royalties based on net
sales following its launch.
“We are proud to collaborate with Kyorin, a trusted and well-established partner with deep market
expertise and a proven track record in bringing therapies to patients. This agreement is a key milestone
for Biodol, as we join forces to deliver innovative pain treatments to address significant unmet medical
needs.” said Fabien GRANIER, CEO of BIODOL Therapeutics.
“Our company is focused on pain as one of our key strategic therapeutic areas for research and
development. Through this agreement, we anticipate that this innovative pain treatment candidate
will provide a new treatment option for patients suffering from pain conditions.” said Yutaka Ogihara,
President and CEO of KYORIN Pharmaceutical Co., Ltd.
About Kyorin Pharmaceutical
KYORIN Pharmaceutical Co., Ltd. was founded in 1923. Accelerating its evaluation and acquisition of
in-licensed products and establishing a presence in designated fields, Kyorin aims to contribute
broadly to people’s health by pursuing innovation in drug discovery, in order to strengthen drug
discovery capability and create high-value new drugs that meet medical needs.
About Biodol Therapeutics
Biodol Therapeutics (www.biodol.eu), founded in 2015, specializes in developing first-in-class
compounds for pain treatment. The company has identified the Receptor Tyrosine Kinase (RTK) FLT3
as a key driver in initiating and sustaining neuropathic pain (Nature Communications, 2018). Its
groundbreaking research has also demonstrated that inhibiting FLT3 signaling eliminates opioid
tolerance and hyperalgesia while preserving analgesic efficacy (Nature Communications, 2024). Biodol
Therapeutics is focused on developing allosteric inhibitors of the FLT3 receptor to address various
types of pain. The company holds exclusive rights to a portfolio of four patents and has received
support from BPI France, SATT AxLR, Inserm Transfert, Région Occitanie, the French National Research
Agency, SEMIA Incubator, and the Montpellier Business and Innovation Centre. Biodol was assisted by
MCE Carrel law firm, Alexandra Carrel and Luke Sampson, for this transaction.
For more information, please contact:
Biodol Therapeutics
contact@biodol.eu
Paris, France, January 9, 2025 – Coave Therapeutics (‘Coave’), a company pioneering the future of genetic medicines, today announces the successful raising of €32 million ($33 Million) in Series A financing. The financing was co-led by Novo Holdings A/S and Bpifrance, with participation from Invus and UI Investissement, alongside existing investors Seroba Life Sciences, Fund+, Kurma Partners, Omnes Capital and Turenne Capital.
The financing will enable Coave to advance its proprietary ALIGATER™ (Advanced Vectors-Ligand Conjugates) platform, a breakthrough technology addressing key limitations in the delivery of genetic payloads to extra-hepatic tissues, including limited tissue specificity, delivery efficiency and safety. ALIGATER™ enables conjugation of targeting ligands, such as small molecules, peptides, or antibody fragments, on AAV or non-viral vectors, offering superior delivery efficiency, tissue specificity and safety profile for a broad range of diseases. Importantly, the platform streamlines the manufacturing process by avoiding prior AAV capsid modifications. These capabilities will enable Coave to develop best-in-class gene therapies designed for specific indications.
The funding will also enable Coave to advance its lead preclinical assets towards clinical development, with a primary focus on the central nervous system (CNS), neuromuscular and eye diseases. Coave plans to move two development candidates to CTA/IND-enabling studies in 2026.
“We are delighted to welcome this group of top-tier investors who share our vision for the ALIGATER™ platform. This funding is a critical milestone for Coave as we work to develop a new generation of targeted, safer, and more efficacious gene therapies,” said Rodolphe Clerval, CEO of Coave. “It also reinforces our ability to expand collaborations with pharma and biotech partners, driving innovation in the field of genetic medicines for a broad range of diseases.”
Emmanuelle Coutanceau, Partner at Seed Investments, Novo Holdings, commented: “Coave’s unique technology platform, strong proof-of-concept data, and experienced team, positions it as a leader in developing new generations of gene therapies. We are excited to see Coave acquiring one of our stealth-mode companies, broadening their international presence in Denmark.”
“Coave, with its ALIGATER™ platform for creating a new class of targeted gene therapies, has the potential to deliver groundbreaking new treatments to patients in need,” said Jean-François Morin, Investment Director at Bpifrance – InnoBio Funds. “With this Series A financing and a top tier team, Coave will be able to progress its pipeline of internal programs.”
In connection with the financing, Emmanuelle Coutanceau from Novo Holdings and Jean Francois Morin from Bpifrance will join Coave’s Board of Directors.
Coave Therapeutics is a genetic medicine company pioneering the development of innovative solutions to enhance the precision, safety, efficacy and manufacturability of genetic medicines. With its proprietary ALIGATER™ platform, Coave is at the forefront of addressing challenges in gene therapy delivery to extra-hepatic tissues, creating a robust pipeline targeting CNS, neuromuscular and eye diseases.
Headquartered in Paris, France, Coave Therapeutics is backed by leading international life sciences investors. For more information about the science, pipeline, and people, please visit coavetx.com and follow us on LinkedIn.
Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.
Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Principal Investments, Planetary Health Investments and Asia teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk
Bpifrance is the French national investment bank: it finances businesses – at every stage of their development – through loans, guarantees, equity investments and export insurances. Bpifrance also provides extra financial services (training, consultancy) to help entrepreneurs meet their challenges (innovation, export).
InnoBio funds are investment funds dedicated to life sciences, managed by Bpifrance, which is also one of the LPs alongside pharmaceutical companies and institutional investors. These funds aim to invest in companies developing innovative products, close to or in early clinical development, with the objective of bringing them to clinical proof of concept. InnoBio funds take minority equity stake in companies and can lead or co-lead the investment rounds. For more information, please visit: www.bpifrance.com
Founded in 1985, Invus makes equity investments in both private and public companies. The firm is active across a range of industries including consumer products, technology and healthcare. Invus has offices in New York, Paris, Hong Kong and Singapore with over $10Bn under management composed of committed capital which enables it to invest with a long-term horizon.. Learn more at www.invus.com.
UI Investissement is an independent, specialized company in the development of companies with €1.5 billion under management. For over 50 years, UI Investissement has been supporting the leaders of startups, SMEs, and growing companies to help them become economically and sustainably successful businesses, with a focus on three key sectors: healthcare, agrobusiness, and business services.
With its expertise, UI Investissement provides support to companies in the health sector at all stages of their development and plays a central role in the ecosystem. It is through the Majycc Innovation Santé fund that UI Investissement supports entrepreneurs who aim to be the architects of tomorrow’s health. The roots of Majycc Innovation Santé are deeply connected to the DNA of several private clinic groups, nursing home groups, and mutual health insurance companies, representing entrepreneurship, health and human values, respect for corporate culture, and the projects of the individuals who build them.
www.ui-investissement.com
www.linkedin.com/company/ui-investissement
Coave Therapeutics
Rodolphe Clerval, CEO
contact@coavetx.com
MEDiSTRAVA
Sylvie Berrebi, Mark Swallow
coavetx@medistrava.com
Novo Holdings, Public Relations
Marie-Louise Jersin
maj@novo.dk
Bpifrance, Media Relations
Juliette Fontanillas
juliette.fontanillas@bpifrance.fr