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
The world is more interconnected than ever. But our global network goes beyond humans: the health of all people on Earth is intimately dependent on the wellbeing of our ecosystems – our animals, plants, microbes, and the atmosphere that sustains us all. In this article, Belgian veterinary scientist Jan Spaas shares his thoughts on the ‘One Health’ approach from the WHO, and the bi-directional link between human and animal health.
by Amy LeBlanc
The health of our planet is strained. Stressed ecosystems and poor livestock conditions are leading to the emergence of new infectious diseases: over 30 novel human pathogens have been detected in the last three decades, of which 75% originated in wild or domestic animals (including COVID-19). Meanwhile, climate change is worsening the spread of disease vectors like mosquitos and ticks, impacting food systems, and threatening the safety of our communities via natural disasters like floods and fires.
In recognition of this interdependence between human, animal and environmental health, the World Health Organization (WHO) is encouraging an integrated, unified approach called ‘One Health’. The aim is to work together across sectors to improve the health of people, animals, and the environment to achieve a better planet for all.
A deep-rooted passion for animal health
Jan Spaas is a Belgian veterinarian and researcher in veterinary science, with many patents and entrepreneurial successes to his name. His deep care for animal health is rooted in his upbringing in the Belgian countryside, where his father was a horse breeder. “I was surrounded by horses from a very young age, and developed a passion for riding and showjumping,” Spaas says. In his youth, he won the bronze medal twice at the European Championship. But with his successes also came setbacks: “My horses often got injured and I grew frustrated with the lack of treatment options. It motivated me to pursue a veterinary degree at Ghent University, and a career dedicated to improving animal health.”
“I want to help improve the health of creatures that cannot speak for themselves.” – Jan Spaas
After his PhD, Spaas cofounded Global Stem cell Technology (GST) – a company developing regenerative therapies for horses and dogs. GST was eventually acquired by Boehringer Ingelheim – one of the world’s few major companies dedicated to both animal and human health – where Spaas went on to become the Global Head of Animal Health Research, before recently moving back home to Belgium. “These days I split my time between academic work as visiting professor at UGent, and research into treatments and supplements for horses at the Via Nova Equine Hospital, which I cofounded with my wife and is now part of the Altano group. After all this time, this is where my primary focus still lies – I want to help improve the health of creatures that cannot speak for themselves.”
More tools in the AMR toolbox
When asked about current threats to global health, Spaas has one clear challenge in mind: Antimicrobial Resistance (AMR). “Antibiotics are essential for both human and animal health. But their overuse, particularly in the livestock industry, is driving development of dangerous antibiotic-resistant pathogens which are causing deaths in both animals and people,” Spaas explains.
At Boehringer Ingelheim, Spaas was involved with research into antibiotic replacement options. “What brings me hope is that there is a rising awareness of the issue around the world – from European chicken farmers to South American cattle ranches, there is an increasing focus on animal welfare and a push for more responsible antibiotic use.”
“What brings me hope is that there is a rising awareness of the [AMR] issue around the world.” – Jan Spaas
Many companies are developing products to help farmers reduce and replace antibiotics without compromising the health of their animals. “We’re continuously adding more tools to our toolbox,” says Spaas. The industry is developing prophylactic options, like an E. coli vaccine for pigs, as well as more creative solutions for early-detection and prevention.
One such solution developed in Belgium is SoundTalks: an early-detection system for respiratory diseases in pigs. SoundTalks uses microphones in pigsties to collect and analyze the noise from the stalls, sending a phone alert to the farmer if it detects a persistent pig cough. “That way the farmer can isolate or treat the sick pig before it has a chance to spread the infection to the rest of the pigs in the stable, preventing them all from needing antibiotics,” says Spaas. “It’s a clever example of technology being integrated in stable management.”
Protecting pigs, people and planet
Spaas is currently involved in the development of another antibiotic alternative through his role as Chair of the Board of the Belgian biotech Animab – a VIB spin-off that was launched in 2020 with investor support from V-Bio Ventures. The company is developing oral antibodies to improve gut health, initially used to protect piglets from infections during their fragile post-weaning phase.
“When I first learned of Animab’s solution I thought: Bullseye: this is it! It’s exactly the kind of alternative we need to reduce antibiotic use. Even better: the company has achieved a cost-effective method of production for these antibodies, which are usually expensive to create.” Affordability is particularly important in agrifood innovation, because profit margins for farmers are already extremely slim, meaning that any new products need to be cost-competitive with existing products. “For farmers, every cent counts,” Spaas acknowledges. “But that is why I think these types of creative and practical solutions are the future for animal health.”
Read this article to find out more about Animab’s oral antibody solutions!
By reducing the microbial burden of pathogens like E. coli or Salmonella in chickens, pigs and cows, we can reduce animal suffering, help farmers and combat the rise in AMR. But these efforts also have a positive downstream effect on the people who eventually consume the resulting animal products. “By treating livestock with biological therapies that don’t harm the environment, we can make sure that our meat, egg or dairy products are cleaner and healthier too. This is the One Health perspective; when we protect animals, we also protect people and the planet.”
“This is the One Health perspective; when we protect animals, we also protect people and the planet.” – Jan Spaas
Like owner, like dog
It’s not only animal health that affects people, but also the other way around. Many trends in human health are reflected in the wellbeing of our companion animals. There is currently a rise in the prevalence of allergies and inflammatory diseases in our pets, and around 60% of dogs and cats are now overweight or obese, often struggling with the usual health complications that accompany excess weight such as diabetes and osteoarthritis.
“Unfortunately, the health of our pets mirrors our own very closely,” says Spaas. “People have become more sedentary in their lifestyles, and our diets have become heavily loaded with fats and carbs. Both of these factors affect our companion animals, especially because we’re increasingly likely to view and treat pets as part of the family – keeping them with us as we’re watching TV or sneaking them scraps from the table.”
“When treating animals, there is a lot we can learn from human medicine.” – Jan Spaas
The good news is that human treatment techniques can also be used to develop veterinary solutions for our domestic animals. Stem cell therapy is one such innovative treatment method, which was initially developed for people but is now also being used for animals. Spaas personally helped develop a stem-cell therapy for horses and dogs with osteoarthritis during his time with GST.
Another success story is a new treatment for feline diabetes called Senvelgo, which is based on a similar mechanism of action as the human antidiabetic medication empagliflozin. “Senvelgo has been a huge breakthrough for pet owners, because before it was developed, the only treatment option was to administer an insulin injection to the cat twice a day. If you’ve ever had anything to do with a cat, you can imagine how painful that process is for both pet and owner! But this new product is orally administered; just a few drops on the cat’s food, and their diabetes can be kept under control for many years.”
“When treating animals, there is a lot we can learn from human medicine,” Spaas says. “My hope for the future is for better prevention, and for drugs to get to patients quicker and easier – whether that patient is a pig, pet or person. I think that better integration between human and animal health can help us achieve that.”
Image: Jan Spaas with a horse (©Laurien De Grande)
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
From initial discovery to market-ready product, biotech development is a complex multi-phase process, where strategic partnerships, continuous innovation and careful navigation of regulatory landscapes are crucial for long-term success. Despite this complexity (or perhaps because of it), entrepreneurs and VCs seldom take a step back to consider the full trajectory of this journey. In this article, we’ll explore the typical life cycle of a biotech startup, examining the key milestones and hurdles encountered along the way.
by Dennis Pedri
The American investor and philanthropist Warren Buffet once said: “No matter how great the talent or efforts, some things just take time. You can’t produce a baby in one month by getting nine women pregnant.”
The arduous biotech trek – from the inception of a groundbreaking idea to the successful launch of a product – reflects this concept. Some things simply can’t be rushed. Biotech companies face a long, highly-regulated and capital-intensive path to bring their innovations to life. However, the effort is incredibly worthwhile, as these innovations may have a profound and long-lasting impact on healthcare and human lives.
The journey of a biotech startup begins in the lab, often driven by academic research or cutting-edge discoveries in fields like molecular biology, genomics or bioengineering. At this early stage, scientists and researchers explore novel concepts such as identifying new drug targets, developing groundbreaking therapies or designing advanced diagnostic tools.
This research typically relies on grants from government institutions, universities or research foundations, as there is scant interest from private capital in financing research activities before ‘Proof of Concept (PoC)’ has been achieved. At this early point in the biotech life cycle, it’s vital for company founders to secure patents and IP protection – strong IP can be a cornerstone for attracting future investments and establishing a competitive edge.
Once a promising academic breakthrough has been made, there are many steps needed to turn that discovery into a viable product or therapeutic candidate. The first stage is usually preclinical development, which involves testing the concept in laboratory settings (typically through cell assays, animal models or patient sample studies), assessing the product’s safety, efficacy and mechanism of action.
A strong scientific team is pivotal at this stage to drive the company forward and handle the countless unforeseen issues that are inherently linked to a biotech project. It’s helpful for companies to have a clear ‘Target Product Profile (TPP)’, as it provides a roadmap for keeping the program on track and ensures the future product to be commercially viable.
Often, a startup will need to go through several optimization steps before it’s able to obtain a first proof of concept in a biological system that is relevant and predictive for patients. This is a critical step that validates the initial idea and attracts the interest of investors, including venture capital firms.
In parallel, many biotech startups also leverage government grants, academic partnerships and industry collaborations to obtain non-dilutive funding. Other key inflection points – often pursued in parallel – are the preparatory steps necessary for the approval of future human clinical trials, including ‘Chemistry, Manufacturing and Control (CMC)’, pharmacology and toxicology studies.
If a company is able to obtain an extensive data package in its preclinical phase, it can build on that strong foundation to move forward into clinical trials. This clinical stage is one of the most important milestones for a biotech startup. It involves human testing and is typically divided into three phases, each associated with a steep increase in costs:
At this advanced stage, regulatory affairs become critical for a biotech company, as it must secure approval for each clinical trial from the relevant regulatory body. A mistake might lead to significant trial delays and subsequent cash burn, which is especially problematic as clinical trials are already extremely expensive and typically take multiple years to complete.
Most of a company’s value inflection points happen during this critical stage. Despite having the lowest probability of success, Phase II is often regarded as the most significant value-adding step in a company’s journey, as it involves establishing ‘Human Proof of Concept’. If that is achieved, a company’s potential skyrockets, meaning that there is a huge opportunity for venture capital firms who are willing to take a risk and invest before this Phase II milestone. Most biotech merger and acquisition deals also take place around this time, as larger biotech or pharmaceutical companies make educated guesses on a startup’s chance of success.
If clinical trials are a success and the startup decides to proceed with its own in-house development, then the next step is to seek market approval for its product from regulatory authorities like the FDA (U.S.) or EMA (Europe). This process involves submitting extensive data to demonstrate that the product is safe and effective for its intended use. Companies that successfully navigate the regulatory approval process – especially in emerging therapeutic areas – can gain a first-to-market advantage, securing a significant market share and attracting further investments.
The next major step is bringing the product to market. Commercialization involves scaling up manufacturing, creating distribution channels and initiating marketing and sales. Market adoption requires extensive efforts to convince healthcare providers, patients and insurers that the new product will benefit them. As this is a tough challenge, the vast majority of startups choose to collaborate with larger pharmaceutical companies during this stage.
Finally, if the launch of its first product is a success, then the biotech company will need to look towards the future. To secure long-term success, it will need to expand its product pipeline – maintaining innovation through continuous R&D efforts and/or business deals – and continue to fuel its ambitious growth trajectory.
From lab to market, the life cycle of a biotech startup is a long, complex and capital-intensive process. However, the potential financial and societal rewards are significant. Biotech startups have a unique opportunity to transform healthcare through true innovation, addressing some of the world’s most pressing medical challenges.
At V-Bio, we strive to support our portfolio companies through the early stages of this complex endeavor, relying on our familiarity with the common patterns and pitfalls, to provide helpful guidance and advice. For both investors and entrepreneurs, a solid understanding of the biotech life cycle is fundamental to navigating the risks and seizing the best opportunities at each step of the biotech journey, working together to achieve long-lasting impact on global health.
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
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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.
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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.
In line with its stellar name, AstriVax Therapeutics is a rising star in Belgian biotech. The company launched in 2022 with €30 million – the largest seed round ever raised by a KU Leuven spin-out – and rapidly became a clinical-stage company, using its plug-and-play platform to fast-track development of vaccines and immunotherapies.
By Amy LeBlanc
AstriVax Therapeutics’ technology originated at the KU Leuven Rega Institute with the academic work of Prof. Johan Neyts and Dr. Kai Dallmeier. CEO Hanne Callewaert – who co-founded the company after previous leadership positions with GSK Vaccines and Oxurion – explains: “There are several aspects that make our platform truly special. Firstly, our vaccines and immunotherapies are easy to produce, using a fermentation process similar to brewing and applicable to all products being developed on the platform. This allowing fast-track development. The resulting products are heat-stable for some time, meaning we are able to get shots from the factory to patients quickly and efficiently, even in tropical regions.”
The AstriVax Therapeutics’ platform uses plasmid-launched live attenuated viruses to create immunotherapy treatments that stimulate strong immune responses in the body, including the activation of T-cells. “This polyfunctional immune response results in broad and long-lasting protection against future infections (in the case of our prophylactics) and to treat infections (in our immunotherapies).”
The technology is also versatile: thanks to the plug-and-play nature of the platform, AstriVax Therapeutics is able to quickly develop a wide range of products for various infectious diseases, enabling rapid responses to new pathogens and evolving threats. “Our platform is able to address several significant global challenges in vaccines and therapeutics,” Callewaert states, proudly.
Less than two years after its creation, AstriVax Therapeutics graduated from academic spin-out to clinical-stage company. Its first-in-human clinical trial is simultaneously testing two different preventive vaccines – yellow fever and rabies – at two world-class clinical trial sites in Belgium: the Centre for Vaccinology (Ghent) and Vaccinopolis (Antwerp). “Given it’s the very first time the technology is administered to humans, this study is helping to clinically validate our platform, serving as a solid stepping stone for advancing the immunotherapies in our pipeline,” Callewaert says.
AstriVax Therapeutics is currently raising a new round of funds to support the clinical development of its first therapeutic products, using the same technology employed in its vaccines to create immunotherapies capable of clearing chronic viral infections. The company’s lead asset is a functional cure for Hepatitis B, Callewaert shares: “There are 250 million people worldwide affected by Hepatitis B, and over a million people die every year from resulting liver cirrhosis or cancer. At the moment, the only hepatitis B treatments available use antivirals to inhibit viral production, but they don’t clear the infection itself from the liver.”
This is where AstriVax Therapeutics’ technology can help, she says: “We can create an immunotherapy capable of being part of the combination treatment to achieve a functional cure by removing the infected cells, something which the current standard of care cannot do.” The company is planning to launch phase 1 of the clinical trial in five different European countries in 2025.
The company’s second immunotherapy is similarly aiming to achieve a cure in another chronic viral infection: human papillomavirus (HPV), the world’s leading cause of cervical cancer. About 15 years ago, an efficacious HPV vaccine was developed which has drastically reduced the incidence of cancer in the women who received it. But as Callewaert points out, this group is still a small minority: “Only about 18% of US women will have been vaccinated by 2030, and the figures are similar in many other countries. This is because the HPV vaccine has mainly been given to high-school girls, so most women over the age of thirty-five remain unprotected, resulting in a significant percentage of the global population still at risk of cervical cancer.”
Although the body’s immune system is often capable of clearing HPV, certain high-risk strains can result in persistent infections, causing lesions which may eventually turn cancerous. “In these intervening stages, there is often little doctors can do other than watch and wait,” Callewaert explains. “This leads to months of anxious uncertainty between HPV+ diagnosis for the women living with the knowledge that they may have a tumor growing within them. These are the women we’re hoping to help with our HPV immunotherapy.” AstriVax’ HPV program is currently still in a pre-clinical stage, but the company is confident it will enter the clinic by the end of 2026.
When asked about her dreams for AstriVax Therapeutcs’ future, Callewaert is ambitious: “Other companies have demonstrated that immunotherapies are capable of reducing the viral load of pathogens like Hepatitis B and HPV, but they have struggled to achieve truly effective results. We believe that – thanks to our vector’s unique dual ability to induce a T-cell response and neutralize antibodies – our technology can be best-in-class in clearing viruses and achieving a functional cure.” While raising funds for the clinical development of its current candidates, Callewaert is already thinking ahead to the vast potential possibilities for the company’s pipeline. “There are many indications on our wish list. We’re daring to dream big: by clearing infections and preventing cancer, we could help hundreds of millions of people around the world. That’s the kind of impact we are aiming
• 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.”
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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