AM-Pharma, an Inventages portfolio company, raises €116m to conduct a pivotal Phase III Trial of recAP in Acute Kidney Injury

Proceeds to be used for the 1,400-patient international pivotal Phase III trial of recombinant human Alkaline Phosphatase (recAP) in patients with sepsis-associated acute kidney injury (SA-AKI) AKI is a devastating disease, with a high mortality rate and no approved pharmacological treatments   Bunnik, The Netherlands, – AM-Pharma B.V. (‘AM-Pharma, the Company’), a clinical stage biopharmaceutical company, leading in the development of a treatment for acute kidney injury (AKI) with its innovative recombinant human Alkaline Phosphatase therapeutic (recAP) today announces that it has raised €116m [$133m] from a European syndicate of new and existing investors. These new funds will be used to carry out a multi-national pivotal Phase III trial of recAP in 1,400 patients with sepsis-associated acute kidney injury (SA-AKI). Last year AM-Pharma reported promising results from its STOP-AKI Phase II clinical trial, which demonstrated significant improvements in survival and kidney function. AKI is a devastating disease, with a high mortality rate and no approved pharmacological treatments. The most important cause of AKI, which affects millions of patients worldwide, is sepsis. 1,2 AM-Pharma was awarded Fast Track designation by the US Food and Drug Administration in 2016 and recAP has the potential to be a first-in-class medicine for AKI. The results of AM-Pharma’s adaptive Phase II STOP-AKI study of recAP in 301 sepsis patients with AKI, demonstrated a significant relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. Whilst the primary endpoint – short term kidney function – was missed, long-term kidney function was significantly improved. Throughout the study, recAP was shown to be safe and well tolerated. These results were published... read more

China National Biotec Group (CNBG) and ImmunoBiology Ltd Enter Licensing Agreement to Co-Develop Next Generation Vaccine against Pneumococcal Disease in Greater China

ImmunoBiology Ltd (ImmBio), a Inventages portfolio company focused on vaccine R&D based at Babraham Research Campus near Cambridge UK, has recently signed a licensing agreement with LIBP (Lanzhou Institute of Biological Product) a subsidiary company under CNBG. “This reciprocal partnership will provide a more effective and convenient solution to the broad protection of pneumococcal related disease This partnership will enable ImmBio and LIBP to co-develop ImmBio’s proprietary PnuBioVax vaccine against pneumococcal disease and launch the pneumococcal vaccine in the Greater China area upon completion of successful clinical studies. This Sino-UK high-tech partnership deal has been possible as a result of the long-lasting successful relation between the companies and strong pre-clinical and Phase I clinical data obtained by ImmBio in the development of the pneumococcal vaccine to date. In addition to the multi-million milestone and royalty payment agreement, the licensing agreement provides a strategic alliance for ImmBio, allowing access to the partner’s strong technical ability and manufacturing capacity that could facilitate the development and commercialisation of the vaccine in the Rest of the World. Dr Enrique Tabares, CEO of ImmBio, commented: “We are excited to be working with such a prestigious organisation as CNBG and the value this partnership will bring to the development of the universal pneumococcal vaccine, PnuBioVax.” Dr. ZHANG Yuntao, Vice President of CNBG, said: “This reciprocal partnership will provide a more effective and convenient solution to the broad protection of pneumococcal related disease.” Pneumococcal disease, caused by the pathogenic bacteria Streptococcus pneumoniae, is a major cause of mortality with approximately 1.5 million deaths every year. This is higher than TB, HIV and malaria combined. It is... read more

JAMA publishes Phase II recAP data for sepsis-associated Acute Kidney Injury

JAMA paper to be presented at ESICM conference in Paris New data on mode of action to be presented at ASN conference in San Diego AM‐Pharma B.V., a Inventages portfolio company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today publishes data in the prestigious Journal of the American Medical Association (JAMA) of its recently completed STOP-AKI Phase II study of recAP in the treatment of sepsis-associated Acute Kidney Injury (AKI). Simultaneously, the results will be presented at today’s European Society of Intensive Care Medicine in Paris. Additionally, new data on recAP’s mode of action will be presented tomorrow (October 25th) at the American Society of Nephrology Kidney Week in San Diego. Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the STOP-AKI study said: “Although the study did not meet its primary endpoint of short-term improvement in kidney function in the first 7 days, it did show long-term improvement in kidney function and very importantly a 40% relative reduction in mortality over placebo. In the absence of any drugs approved for this condition, these exciting clinical outcomes warrant further research to confirm these findings and to make this treatment available to patients.” Prof. Pickkers is presenting the results of the randomized clinical study at today’s Hot Topics session at ESICM in Paris at 16:40 CET. In addition, investigations at the institutions of Professor Mark D. Okusa and Professor Bruce Molitoris revealed more detail into recAP’s mode of action. Their research showed that protection from kidney injury is mediated by dephosphorylation by recAP of ATP to adenosine... read more


5 September 2018: Mundipharma has closed an asset purchase agreement with Vital Food Processors Limited,  an agricultural science company founded in New Zealand, for the global rights beyond New Zealand to commercialize Zyactinase™ – a clinically-proven gastrointestinal consumer health product. Zyactinase™ is a freeze-dried extract of Kiwifruit (Actinidia deliciosa) that has been developed as a constipation relief product as well as for long-term gut health. It contains a protease complex, fiber, pectin and fructo-oligosaccharides that stimulates increased bowel movements. Under the agreement, Mundipharma will initially focus on the commercializing Zyactinase™ to establish a foothold in the US and Canada markets, while continuing to supply existing partners. It will then look to expand its marketing and distribution footprint globally. This agreement will also enable the extension of the company’s Senokot® product range in the US, which is also an all natural, clinically proven digestive health supplement for the treatment of constipation. “We are delighted to have realized this opportunity to acquire a unique, clinically-proven differentiated formulation for commercialization on a global basis across our network,” said Mundipharma CEO, Raman Singh. “As well as providing a consumer pathway for a great product, this strategic acquisition also enables us to extend our depth and competitiveness in the digestive health category,” he added. Dr. Oliver Summerfield, Vital Foods CEO and Principal at majority investor Inventages Venture Capital, commented “We believe this deal recognizes the value created by Vital Foods’ technology platform and that Mundipharma is a strong partner for the global commercialization of the clinically-proven digestive health product developed by Vital Foods’ team” TM: ZYACTINASE is a trademark of Vital Food ®: SENOKOT... read more

AM-Pharma still on track with sepsis drug despite mixed phase 2 readout

The pharma industry doesn’t have a strong record when it comes to trying to find treatments for sepsis, but AM-Pharma has today reported what looks like a rare win. The Dutch biotech has just reported a greater than 40% reduction in mortality for its recombinant form of the enzyme alkaline phosphatase (recAP) compared to placebo in sepsis-related acute kidney injury (AKI). Kidney damage is a common early consequence of the havoc that results from the overblown immune response to infection that occurs in sepsis patients. AM-Pharma’s CEO Erik van den Berg told FierceBiotech that the intention now is to move the program into a phase 3 study in consultation with clinical investigators, regulators and, of course, Pfizer, which took out an option on the company back in 2015. In the trial, recAP—which has a fast-track designation from the FDA—was compared to placebo on top of standard therapy with antibiotics—still the primary treatment option for sepsis patients along with supportive care. The data isn’t a home run. The study in 301 patients—called STOP-AKI—missed its primary endpoint of showing an improvement in kidney function in the first week. However, it did show a “significant, progressive and sustained improvement” in renal function over the 28-day study period, without any major toxicity issues. Nevertheless, the mortality reduction coupled with renal function data suggests that the program remains on track in an indication that analysts have suggested could deliver blockbuster sales for a safe and effective product. Van den Berg said that the study “missed its primary endpoint … it met the primary objective of showing recAP could ameliorate kidney damage,” adding that it is actually more important to have... read more

AM-Pharma announces Phase II study results of recAP in sepsis-associated Acute Kidney Injury

  Bunnik, The Netherlands, March 9th 2018. AM‐Pharma B.V., an Inventages portfolio company focused on the development of recombinant human Alkaline Phosphatase (recAP) for inflammatory diseases, today announced positive results from its adaptive Phase II study in 301 sepsis patients with Acute Kidney Injury (AKI), the largest therapeutic study in AKI to date. Professor Peter Pickkers, MD PhD, Chair of Experimental Intensive Care Medicine, Radboud University Medical Center, and principal investigator of the STOP-AKI study said: “Acute Kidney Injury affects millions of patients each year and comes with a substantial risk of mortality. The significant improvements demonstrated in survival and kidney function are very encouraging and strongly support further development of recAP.” The STOP-AKI study demonstrated a significant and dose-dependent relative reduction in mortality of more than 40% in the treatment group compared to the placebo group. While the addition of recAP to the standard of care did not affect kidney function in the first week of the study (the primary endpoint), it did show a significant, progressive and sustained improvement in renal function over the 28-day study period. Throughout the study, safety data were regularly reviewed by an independent Data Safety Monitoring Board (DSMB), without any observations of concern. The STOP-AKI data will be presented today by the principle investigator Professor Pickkers at the AKI & CRRT conference in San Diego and at the International Symposium on Intensive Care and Emergency Medicine (ISICEM) on March 21st in Brussels. Previously, the US Food and Drug Administration granted Fast Track designation to recAP for the treatment of sepsis-associated acute kidney injury. Acute Kidney Injury involves inflammatory processes in the kidney which can... read more

Phagenesis has successfully reached the first of two milestones in its staged acquisition agreement with Nestlé Health Science

Manchester, 4 October 2017 – Phagenesis announced today that by completing a key clinical study in Europe it has reached the first milestone in its staged acquisition agreement with Nestlé Health Science (NHSc). Under the terms of the agreement, Nestlé Health Science has acquired an additional stake in Phagenesis. Reinhard Krickl, CEO of Phagenesis, said: “We are very happy to have successfully closed a key clinical study demonstrating the clinical benefit of Phagenyx®* for the treatment of post-stroke dysphagia amongst tracheostomized patients. We are looking forward to having the study results published early 2018.” Phagenesis is a medical device company that has developed a new treatment for dysphagia, the inability to swallow safely. Dysphagia is a condition with high prevalence as well as high clinical and health economic burden. It is a debilitating condition, which frequently leads to life-threatening complications, including aspiration pneumonia, malnutrition and dehydration. Furthermore, patients with dysphagia experience a dramatic reduction in Quality-of-Life1. Oern Stuge, Chairman of Phagenesis, stated: “Nestlé Health Science’s increasing stake in Phagenesis will continue to foster a strong collaboration between Phagenesis and NHSc, allowing Phagenesis to accelerate its clinical programs demonstrating the benefit of Phagenyx for this significant unmet medical need.” Gunnar Weikert, Director of Phagenesis and Founder of Inventages Venture Capital commented: “As a long-term investor in Phagenesis we are pleased about this significant achievement and look forward to working more closely with NHSc.”  Currently, the management of neurogenic dysphagia is complex. Available options can improve the status and the symptoms, but few are treating the cause. Phagenesis has developed Phagenyx, a novel medical device designed to restore the neurological control... read more

Atonomics announces CE marking of Trace Lipids Test Panel

Atonomics announces CE marking of Trace Lipids Test Panel Trace is a rapid, lab accurate self-testing device for measuring wellness and disease biomarkers Trace Lipids panel measures cholesterol markers from a finger prick of blood with quantitative lab standard results provided within minutes Lipids panel and app can assist in monitoring cardiovascular risk without need to send blood samples to central lab Atonomics A/S, a consumer medical diagnostics company providing personal central lab standard data, announced today the CE marking of its first commercial product, a Lipids test panel on its proprietary Trace platform.  Trace, a personal biomarker device, is a disruptive self-testing platform for accurate, low-cost, and easy-to-use diagnostics. The Lipids Panel determines total cholesterol, HDL (high density lipids), LDL (low density lipids) and triglycerides levels from a finger prick of blood with quantitative lab standard results provided within minutes. The simple cartridge test can be used to monitor the effectiveness of diet, lifestyle changes and medication to lower cholesterol which is a key marker of cardiovascular risk. The device will be linked to an app for convenient read-out and tracking. “We are delighted to launch our first product after having demonstrated that we can achieve central lab accuracy in a small and user friendly format ideally suited for point-of-care applications.  While the initial CE mark is for in-vitro diagnostics (IVD) professional use, a CE mark for self-testing is targeted for later this year, which will enable us to market Trace directly to consumers for home use,” said Thomas Warthoe, CEO. The company plans to roll out a range of prevention and disease marker tests with pipeline products... read more

AM-Pharma completes patient recruitment of recombinant human Alkaline Phosphatase

Recruitment of 301 patients in STOP-AKI adaptive Phase II trial marks largest ever therapeutic study in AKI AM‐Pharma B.V., an Inventages portfolio company focused on the development of recombinant human Alkaline Phosphatase (reCAP) for inflammatory diseases, announced completion of recruitment in the adaptive Phase II trial to treat sepsis patients with Acute Kidney Injury (AKI). The trial, titled A Safety, Tolerability, Efficacy and QoL Study of Human recAP in the Treatment of Patients With SA-AKI (STOP-AKI), completed recruitment with 301 patients, which makes it the largest interventional clinical study in AKI to date. The STOP-AKI adaptive Phase II trial is being conducted in two parts. First, data from 131 patients were evaluated to select the most effective dose of recAP. Second, an additional 170 patients were recruited into two arms, receiving either the optimal dose of recAP identified initially, or placebo. The study was conducted in more than 50 intensive care units (ICU) in Western Europe and North America. Erik van den Berg, CEO of AM-Pharma said: “We are pleased to announce that we have enrolled the last patient in the STOP-AKI trial. I would like to express my appreciation to all staff in the investigating ICUs for their dedication and diligence in supporting the trial. We will now enter a new and exciting phase of patient follow-up, data analysis and discussions with our scientific advisors. We anticipate publishing and presenting results from the trial in early 2018.” In May 2015, Pfizer Inc. (NYSE:PFE) acquired a minority equity interest in AM-Pharma and secured an exclusive option to acquire the remaining equity in the company. The option becomes exercisable upon... read more

Accera Appoints Dr. Judith Walker as Chief Medical Officer

Accera, Inc., an Inventages portfolio company, today announced the appointment of Judith Walker, M.D., F.R.C.P.(C), as Chief Medical Officer. Dr. Walker joins Accera from QuintilesIMS where she held the position of Vice President of Product Development, providing leadership for the global clinical development of drugs in the areas of neurology and pain. “Dr. Walker brings to Accera over 20 years of experience in the global biopharmaceutical industry,” said Accera’s president and CEO, Charles Stacey, M.D. “Her wealth of expertise in neurology drug development will be invaluable as we advance our metabolic approach to the treatment of Alzheimer’s disease into the final stage. Dr. Walker will lead the progression of our newly formulated lead compound in Alzheimer’s and help build out our pipeline of drugs in the CNS space.” Prior to QuintilesIMS, Dr. Walker served as Senior Director of Medical Affairs at Teva Neuroscience, a division of Teva Pharmaceuticals. Before Teva Neuroscience, Dr. Walker held leadership roles in global product and global clinical development in neurology at Serono International (Merck KGaA). Dr. Walker continues to serve on the boards of Great Lakes Neuroscience and the pharmaceutical advisory board of the non-profit Accelerated Cure Project. A Fellow of the Royal College of Physicians and Surgeons of Canada, Dr. Walker received her medical degree from the University of Montréal and completed her residency in neurology at the University of Western Ontario. “Accera has one of the few drugs in late-stage development for Alzheimer’s disease which addresses a differentiated and well-validated target,” said Dr. Walker. “I am delighted to be joining Accera at this exciting time in the program.” About Accera Accera, Inc.... read more