Partners
ActoGeniX’s goal is to become a leading fully integrated biopharmaceutical company, by building a top-class internal team and collaborating with experienced and high-quality partners including other (bio)pharmaceutical companies and academic institutions.
To accelerate its R & D activities and extend the potential applications of TopAct™ technology, ActoGeniX has established a worldwide network of collaborations with leading universities and clinical centers.
For the manufacture and development of ActoBiotics™ , ActoGeniX collaborates with several industrial partners worldwide. The Company intends to further expand this industrial network as it progresses towards commercialization of its products.
ActoGeniX intends to further develop its own ActoBiotics™ therapeutic programs and selectively enter into partnerships that could enhance value creation and support risk management.
AG013 in Oral Mucositis
Oral Mucositis
It is estimated that Oral Mucositis (OM) and its debilitating effects on patients receiving cancer treatment may increase due to the more frequent usage of newer chemotherapeutic agents. Oral mucositis related infections more frequently require hospitalization and in some cases lead to death. Eliminating oral mucositis symptoms would allow doctors to focus their full attention on the underlying cancer and health insurance companies would see the cost of care reduced significantly, as cancer patients avoid the need for oral mucositis-related medical intervention and hospitalizations.
AG013
AG013 has shown in a phase 1B clinical study that it is safe and well tolerated. Analysis of initial efficacy showed a 35% reduction of the percentage of days with ulcerative oral mucositis in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative oral mucositis.
Market
At the moment there are no prescription drugs available to treat or prevent OM, leaving an untapped global market that could reach $2 billion annually. AG013 has received an orphan drug status in EU and is scheduled to reach the market early 2017. In the US an orphan drug application has been filed and is currently under review.
Partnership
ActoGenix is currently looking for a partner to co-develop AG013 for any of the three major territories (US, EU, Asia). This partner would ideally have a marketing and sales force for hospital care products in the respective major territory, but not necessarily in the cancer supportive care space.
AG014 and IL-27 in Inflammatory Bowel Disease
Inflammatory Bowel Disease
Ulcerative colitis (UC) and Crohn's disease (CD), collectively known as inflammatory bowel disease (IBD), afflict over one million Americans and Europeans and produce symptoms that impair quality of life and ability to function. Progress in IBD management strategies has led to optimized approaches for achieving the two primary clinical goals of therapy: induction and maintenance of remission. There are a number of treatment options available for IBD patients that range from non-pharmacological treatments, such as diet, to pharmacological treatments and surgery. Nevertheless, there is still a high medical need for more effective and safer treatment options.
AG014
AG014 comprises an oral delivery of an anti-TNF antibody with a proven clinical efficacy in IBD. The advantage of AG014 compared to systemic administered anti-TNF antibodies is its local efficacy and overall safety, due to the local administration of the drug in the intestine.
IL-27
ActoGeniX is developing an ActoBiotic™ expressing and secreting the anti-inflammatory cytokine IL-27 for the treatment of inflammatory bowel disease and celiac disease. Positive efficacy data have been obtained with this product in an animal model of colitis. This groundbreaking work has been performed in collaboration with Professor Scott Durum at the National Cancer Institute (Frederick MD, US).
Market
Today, the IBD sales in the seven major markets are estimated at more than $3 billion, with anti-TNFs contributing to more than half of these sales. By delaying or replacing the use of costly and potentially unsafe anti-TNFs in the IBD treatment pathway, and pricing at between parity and a moderate discount to these therapies, AG014 and ActoBiotics™ IL-27 are commercially attractive products that are anticipated to have a significant impact on the treatment of IBD.
Partnership
ActoGeniX is looking for partners with an IBD focus to bring one or both products into clinic clinical development.
ActoBiotics™ for Celiac Disease
Celiac Disease
Celiac disease (CD), also known as celiac sprue or gluten-sensitive enteropathy, is a chronic systemic autoimmune disorder that develops from an immune response to specific dietary grains (wheat, barely and rye) that contain gluten. Currently, there is no treatment option for Celiac Disease, other than a life-long gluten-free diet.
ActoBiotics™ for Celiac Disease
ActoGeniX has demonstrated in a CD animal model that ActoBiotics™ delivering immunogenic antigens of gluten, results in an antigen-specific induction of immune tolerance. Co-delivery of ActoBiotics™ expressing tolerance promoting factors such as IL-10 enhances further this disease modifying approach.
Market
Celiac disease affects 1% of the Western population, which means that at least 3 million people in the US suffer from this disease. As the only treatment option is a gluten-free diet, a number of gluten-free foods have been developed in the last decades. It is estimated that gluten-free industries revenues were $1.7 billion in 2010.
Partnership
ActoGeniX is looking for partners to bring this ActoBiotic™ into clinic clinical development.
ActoBiotics for Type 1 Diabetes
Type 1 Diabetes (T1D)
Formerly called juvenile diabetes or insulin dependent diabetes mellitus (IDDM), T1D accounts for 5% of diabetic cases. Patients can no longer produce their own insulin either as a result of the destruction of the patient’s β-islet cells of the pancreas by autoreactive T-cells or due the the neutralizing effect of auto-antibodies directed against insulin. The only treatment option today is insulin replacement.
ActoBiotics for Type 1 Diabetes
ActoGeniX developed an ActoBiotic™ capable of delivering pro-insulin and IL10 in the gut, showing a restoration of antigen-specific, long-term tolerance and reversal of diabetes in NOD mice, combined with low-dose anti-CD3. Mechanistically, this intervention approach increases local regulatory T-cell frequencies which proliferate in the pancreatic islets and suppress the auto-immune reaction in an antigen-specific way.
Market
The worldwide prevalence for T1D was 194 million patients in 2003 and will rise to an estimated 330 million people by 2025. In 2007, the global anti-diabetes drug market accounted for $24.1 billion and is expected to have 15-20% growth in the future. The ActoBiotics™ approach developed by ActoGeniX could potentially be the first intervention for newly diagnosed T1D patients, resulting in a complete reversal of the disease.
Partnership
ActoGeniX is looking for partners with a focus on diabetes to bring this product into clinic clinical development.
ActoBiotics™ for Clostridium difficile associated enteropathy
Clostridium difficile associated enteropathy (CDAE)
Clostridium difficile (C. difficile) is the leading cause of hospital-acquired diarrhea in the United States. Current treatment consists of the discontinuation of the offending antibiotic as well as the administration of metronidazole or vancomycin. Although both antibiotics are effective at inhibiting C. difficile, they only kill the active form of C. difficile, not the resistant, long-lived spores it produces. As a result, about 20% of the patients will have recurrent C. difficile infection after cessation of antibiotic treatment. With these problems and limitations of today’s antibiotic therapy, there is a clear need to develop more selective and effective alternatives to combat CDAE.
ActoBiotics™ for CDAE
ActoGeniX is constructing ActoBiotics™ secreting antibody fragments to neutralize the C. difficile toxins A and B. Passive immunization by oral delivery of toxins-neutralizing antibodies in the colon lumen is an entirely novel approach and a more effective way to address the disease compared to systemic administration of the antibodies. This approach further represents a non-antibiotic treatment strategy that is designed to block the harmful effects of the toxins from the intestinal luminal side while allowing the colon to heal naturally and become repopulated with normal gut flora. More importantly, it may also serve as preventive therapy in the case of hospital outbreaks of CDAE.
Market
CDAE represents an increasing burden to the health care system, totaling more than $1 billion per year in the United States alone. ActoGeniX expects that its novel approach to neutralize C. difficile toxins in the gut is more effective for recurrent infections of C. difficile than other treatment options. Due to its low COGS, even a first line treatment could be considered.
Partnership
ActoGeniX is looking for partners specialized in hospital care products to bring this ActoBiotic™ into clinical development or to develop novel ActoBiotics™ producing a proprietary anti-toxin A/B of the respective partner.
ActoBiotics platform
Platform
The Topact™ platform allows for the engineering of ActoBiotics™ with single or multigenic polypeptides. More than 1600 different ActoBiotics™ producing complex proteins, cytokines, antibody fragments, growth factors and antigens have been developed so far. The advantages of the platform are a superior safety and efficacy profile through local targeting and further represents the only economically viable way to deliver biotherapeutics to the GI tract.
Partnership
ActoGeniX is seeking partners with proprietary proteins or peptides to develop novel ActoBiotics™ for local delivery to the GI tract.
For more information on the partnering opportunities with ActoGeniX, you are kindly requested to contact ActoGeniX’s Director Business Development, Emil Pot.