Anokion | October 19, 2022
Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease by restoring normal immune tolerance announced that Pfizer has made a $35 million equity investment in Anokion through the Pfizer Breakthrough Growth Initiative. In conjunction with the investment, Michael Vincent, M.D., Ph.D., senior vice president and chief scientific officer, Inflammation & Immunology, Pfizer, has joined the company’s scientific advisory board, which will be announced later this year, and Allison Kean, M.D., executive director, Worldwide Business Development, Pfizer has joined Anokion’s board of directors as an observer.
Separately, Anokion and Pfizer have entered into an agreement to leverage Pfizer’s development expertise and capabilities in support of the continued clinical development of KAN-101, Anokion’s lead candidate for the treatment of individuals with celiac disease.
“We are excited about these agreements with Pfizer as they provide us with important resources and expertise to advance our KAN-101 clinical program and our earlier-stage pipeline. People living with autoimmune diseases like celiac disease need additional treatment options, and we are excited to work with Pfizer to potentially develop these utilizing our immune tolerance platform. We also look forward to leveraging Pfizer’s insights and capabilities in support of our Phase 2 clinical program in patients with celiac disease.”
Deborah Geraghty, Ph.D., chief executive officer of Anokion
“We believe Anokion has a unique opportunity to develop potential durable and disease-modifying treatment options for people with celiac disease and other immune-mediated disorders, and we look forward to supporting them in the continued development of KAN-101,” said Dr. Vincent. “The agreements announced today are yet another example of our commitment to collaborating with biotechs to accelerate compelling external science that could lead to true breakthroughs for patients.”
Anokion intends to use a portion of the proceeds to fund its Phase 2 clinical program of KAN-101 for the treatment of individuals with celiac disease, a serious autoimmune disorder triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. Data from Anokion’s Phase 1 ACeD study (Assessment of KAN-101 in Celiac Disease) were presented at Digestive Disease Week (DDW) 2022, showing that treatment with KAN-101 was safe and tolerated, reduced T cell responses following gluten challenge, and demonstrated a dose-dependent inhibition of gluten-induced serum IL-2 (interleukin-2), a key disease biomarker that may correlate with the timing and severity of symptoms after gluten exposure in celiac disease. Based on favorable findings, Anokion is preparing to initiate patient dosing in a Phase 2 clinical trial in the second half of 2022, supported by Pfizer.
KAN-101 is an investigational therapy being evaluated as a treatment for individuals with celiac disease, a serious autoimmune disease triggered by ingestion of gluten, for which there are no approved therapeutic treatments available. KAN-101 is designed to induce tolerance to gliadin, a core component of gluten, through natural pathways in the liver. KAN-101 has been granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of celiac disease.
Anokion SA is a clinical-stage Swiss biotechnology company that aims to make a meaningful difference in the lives of patients suffering from autoimmune diseases by restoring normal immune tolerance. The company is focused on both prevalent and rare autoimmune diseases, including celiac disease, multiple sclerosis and type 1 diabetes. Anokion’s distinct approach leverages the company’s immune-based platform, which targets natural pathways in the liver to restore immune tolerance and address the underlying cause of autoimmune disease.
Emerald Health Pharmaceuticals | October 14, 2022
Emerald Health Pharmaceuticals Inc. a clinical-stage biopharmaceutical company developing a new class of medicines to treat neurodegenerative, autoimmune and other diseases, today announced the publication of a scientific article in the peer-reviewed Journal of Neuroinflammation highlighting additional data supporting the unique mechanism of action of EHP-101, the company’s first-in-class drug candidate for the treatment of systemic sclerosis and multiple sclerosis.
Titled “A cannabidiol aminoquinone derivative activates the PP2A/B55α/HIF pathway and shows protective effects in a mouse model of traumatic brain injury”, the paper was co-authored by Eduardo Muñoz, MD, PhD, EHP’s Chief Scientific Officer. The publication demonstrates that VCE-004.8, the active pharmaceutical ingredient of EHP-101, is a highly specific activator of the B55a subunit of the protein phosphatase, thus activating the hypoxia-inducible factor (HIF) pathway. This first-in-class activator of the HIF pathway via modulation of B55a provides a new mechanism to treat diseases where vascular integrity is compromised. Therefore, these findings support the use of EHP-101 for the treatment of SSc and MS, and illustrate the potential of VCE-004.8 for acute disorders including traumatic brain injury and stroke.
“The results of Dr. Muñoz’s work, as published in this prestigious journal, validate EHP-101’s unique ability to address key disease factors associated with the complex pathophysiology of fibrotic and demyelinating diseases such as SSc and MS through complementary specific mechanisms of action,”
Alain Rolland, Pharm.D., Ph.D., COO of EHP
EHP is currently conducting a Phase 2a clinical study to evaluate the safety, tolerability, and preliminary efficacy of EHP-101 in SSc patients. The Company has also met the regulatory requirements to start a Phase 2 clinical trial of EHP-101 for MS.
About Emerald Health Pharmaceuticals Inc.
Emerald Health Pharmaceuticals is developing novel product candidates for the treatment of CNS, autoimmune, and other diseases. The Company has two families of patented new chemical entities that have been created through rational drug design to affect validated receptors and pathways in the body which are pertinent to targeted
diseases. Its first drug product candidate, EHP-101, is in a Phase 2a study for the treatment of systemic sclerosis, a severe form of scleroderma, and has met regulatory requirements to start a Phase 2 study for multiple sclerosis. EHP-101 has received Orphan Drug Designation in the US and EU, as well as Fast Track status by the US FDA for systemic sclerosis.
The Company’s second product candidate, EHP-102, is in non-clinical development with IND-enabling studies and is focused on treating Parkinson’s disease and Huntington’s disease. EHP-102 has received Orphan Drug Designation in the US and EU for Huntington’s disease.
BIOCORP and Merck KGaA, Darmstadt, Germany | October 11, 2022
BIOCORP a French company specialized in the design, development, and manufacturing of innovative medical devices, and Merck KGaA, Darmstadt, Germany, a leading science, and technology company, have entered into an agreement for the development and supply of a specific version of Mallya device as an accessory for one of Merck KGaA, Darmstadt, Germany's drug delivery devices.
Manufactured in Clermont-Ferrand Mallya is a Bluetooth enabled clip-on device for pen injectors that collects dose and time of each injection and transfers information in real time to a companion software. Mallya is the first in its category to receive the CE-mark and commercial versions for insulin pen injectors are already available and distributed in Europe and other geographies. Major agreements have already been signed by BIOCORP with Sanofi, Novo Nordisk and Merck KGaA, Darmstadt, Germany, to develop specific versions of the technology in the field of Insulin and Human Growth Hormone (HGH).
Healthcare companies BIOCORP and Merck KGaA, Darmstadt, Germany, will develop a new version of Mallya to help patients monitor their injection during their treatment. The device will automatically keep track of doses injected with timestamp and indicate that the product is administered properly, aiming to support patients with self-injections and to provide reassurance to patients.
Financial details of the partnership include payments from Merck KGaA, Darmstadt, Germany, up to 5 million € for the development of the product within the first three years of the collaboration. Additional revenues are estimated to reach up to 8 million € during the first 5 years after launch depending on commercial milestones and adoption of Mallya devices by Merck KGaA, Darmstadt, Germany patients with further upside potential in the subsequent years.
"We are delighted with this new partnership with Merck KGaA, Darmstadt, Germany, extending our collaboration to additional therapeutic areas. We had already announced that there is a great opportunity for our connected device Mallya in various therapeutic areas. As in diabetes, Mallya aims to reduce patients' stress and improve compliance with their treatments to optimize and secure the results “,
Éric Dessertenne, CEO of BIOCORP
Recognized for its expertise in the development and manufacture of medical devices and delivery systems, BIOCORP has today acquired a leading position in the connected medical device market thanks to Mallya. This smart sensor for insulin injection pens allows reliable monitoring of injected doses and thus offers better compliance in the treatment of patients with diabetes. Available for sale from 2020, Mallya spearheads BIOCORP's product portfolio of innovative connected solutions. The company has 74 employees. BIOCORP is listed on Euronext since July 2015.