A First-in-human, Randomised Double-blind, Placebo-controlled 2-part Study to Evaluate the Safety, Tolerability, Immunogenicity and Pharmacokinetics of Single Ascending Doses of AX-202 in Healthy Subjects and Multiple Ascending Doses of AX-202 in Patients With Mild to Moderate Chronic Plaque Psoriasis.

The first-in-human study will be performed in healthy volunteers and patients with a chronic inflammatory skin disease. The primary objective is to evaluate the safety, tolerability and pharmacokinetics of increasing doses of AX-202 infusion.

Start Date25 Apr 2023

Sponsor / Collaborator

Arxx Therapeutics AS

NL-OMON35094 / CompletedNot Applicable

A Phase 1 Study to Compare the Pharmacokinetics of CAL-101 Capsules to Tablets in Healthy Male Subjects. - CAL-101 BE study.

Start Date09 Mar 2010

Sponsor / Collaborator

Calistoga Pharmaceuticals, Inc.

100 Clinical Results associated with AX-202

100 Translational Medicine associated with AX-202

100 Patents (Medical) associated with AX-202

Literatures (Medical) associated with AX-202

01 Aug 2024·The American Journal of Pathology

A Novel Role for the Phosphatidylinositol-4,5-Bisphosphate 3-Kinase Delta Isoform in Hepatocellular Proliferation

Article

Author: Stoops, John ; Cotner, Mary-Claire ; Martucci, Nicole J ; Bhushan, Bharat ; Orr, Anne ; Michalopoulos, George K ; Bowen, William ; Mars, Wendy M

The phosphatidylinositol-4,5-bisphosphate 3-kinase delta isoform (Pik3cd), usually considered immune-specific, was unexpectedly identified as a gene potentially related to either regeneration and/or differentiation in animals lacking hepatocellular Integrin Linked Kinase (ILK). Since a specific inhibitor (Idelalisib, or CAL101) for the catalytic subunit encoded by Pik3cd (p110δ) has reported hepatotoxicity when used for treating chronic lymphocytic leukemia and other lymphomas, the authors aimed to elucidate whether there is a role for p110δ in normal liver function. To determine the effect on normal liver regeneration, partial hepatectomy (PHx) was performed using mice in which p110δ was first inhibited using CAL101. Inhibition led to over a 50% decrease in proliferating hepatocytes in the first 2 days after PHx. This difference correlated with phosphorylation changes in the HGF and EGF receptors (MET and EGFR, respectively) and NF-κB signaling. Ingenuity Pathway Analyses implicated C/EBPβ, HGF, and the EGFR heterodimeric partner, ERBB2, as three of the top 20 regulators downstream of p110δ signaling because their pathways were suppressed in the presence of CAL101 at 1 day post-PHx. A regulatory role for p110δ signaling in mouse and rat hepatocytes through MET and EGFR was further verified using hepatocyte primary cultures, in the presence or absence of CAL101. Combined, these data support a role for p110δ as a downstream regulator of normal hepatocytes when stimulated to proliferate.

01 Jun 2024·Molecular Immunology

Inhibition of PI3K p110δ rebalanced Th17/Treg and reduced macrophages pyroptosis in LPS-induced sepsis

Article

Author: Wang, Yong ; Chen, Wenhao ; Jie, Yiyang ; Zhang, Shiyun ; Zhu, Minyi ; Mao, Kefan ; Zhang, Xian ; Wen, Yanting ; Shen, Jingwen ; Shan, Jiajia

Sepsis is a systemic inflammatory response syndrome caused by trauma or infection, which can lead to multiple organ dysfunction. In severe cases, sepsis can also progress to septic shock and even death. Effective treatments for sepsis are still under development. This study aimed to determine if targeting the PI3K/Akt signaling with CAL-101, a PI3K p110δ inhibitor, could alleviate lipopolysaccharide (LPS)-induced sepsis and contribute to immune tolerance. Our findings indicated that CAL-101 treatment improved survival rates and alleviated the progression of LPS-induced sepsis. Compared to antibiotics, CAL-101 not only restored the Th17/regulatory T cells (Treg) balance but also enhanced Treg cell function. Additionally, CAL-101 promoted type 2 macrophage (M2) polarization, inhibited TNF-α secretion, and increased IL-10 secretion. Moreover, CAL-101 treatment reduced pyroptosis in peritoneal macrophages by inhibiting caspase-1/gasdermin D (GSDMD) activation. This study provides a mechanistic basis for future clinical exploration of targeted therapeutics and immunomodulatory strategies in the treatment of sepsis.

01 May 2024·Experimental Neurology

PI3Kδ inhibition alleviates the brain injury during cerebral ischemia reperfusion via suppressing pericyte contraction in a TNF-α dependent manner

Article

Author: Wang, Xiu-Ming ; Chen, Hui-Sheng ; Qiu, Jing ; Wang, Yi-Han

The pericytes (PCs) surrounding capillaries are vital regulators of capillary constriction. Persistent PC contraction results in the increased capillary constriction, therefore leading to the impaired cerebral blood flow (CBF) recovery after reperfusion and worsening the clinical outcomes in stroke patients. However, the potential determinants of PC functions during ischemia/reperfusion are poorly understood. Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit Delta (PIK3CD/PI3Kδ) is a crucial factor involved with neuronflammation during ischemic stroke. PI3Kδ has shown the expression in PCs, while its effect on PC functions has not been explored yet. In this study, a rodent ischemia/reperfusion model was established in C57BL/6 mice via transient middle cerebral artery occlusion and reperfusion (MCAO/R). The PI3Kδ expression in ischemic penumbra was remarkably upregulated following MCAO/R induction. PI3Kδ inhibitor CAL-101 improved the CBF recovery, ischemic brain injury, and suppressed capillary constriction in MCAO/R mice. Besides, the production of tumor necrosis factor alpha (TNF-α), an inducer for tissue injury, and the expression of transient receptor potential vanilloid type 2 (TRPV2), a channel protein permitting calcium (Ca²⁺) uptake, were significantly reduced in ischemic penumbra after CAL-101 treatment. In vitro, oxygen-glucose deprivation and reoxygenation (OGD/R) enhanced the expression of PI3Kδ and TRPV2 in primary mouse PCs. CAL-101 suppressed the TNF-α-induced TRPV2 expression in OGD/R-treated PCs, thus inhibiting the Ca²⁺ uptake and PC contraction. Collectively, this study suggests that PI3Kδ is a critical regulator of PC function during ischemic stroke.

News (Medical) associated with AX-202

23 Oct 2024

·pipelinereview.com

Calluna Pharma Successfully Completes Phase 1 Clinical Study of CAL101, a First-in-Class Therapeutic for Fibrotic and Fibro-Inflammatory Indications

OSLO, Norway I October 23, 2024 I Calluna Pharma AS (Calluna), a clinical stage biotechnology company pioneering first-in-class antibodies to treat inflammatory and fibrotic diseases, today announced the completion of Phase 1 clinical study for CAL101, Calluna’s lead product candidate. The study demonstrated a favorable safety, pharmacokinetic (PK) and immunogenicity profile for the mAb. CAL101 is a first-in-class mAb that targets S100A4, a damage-associated molecular pattern (DAMP) protein implicated in serious and life-threatening diseases, such as idiopathic pulmonary fibrosis and systemic sclerosis. Preclinical studies have demonstrated the ability of CAL101 to prevent and treat fibrosis and modify the disease-specific activation of fibroblasts – the key effector cells driving progression of fibrosis 1 . Jonas Hallén M.D., Ph.D., Co-Founder and Chief Medical Officer of Calluna Pharma, commented: “We are encouraged by the findings from the Phase 1 study. These results are an important step forward in the development of our lead asset, CAL101, particularly for fibrotic and fibro-inflammatory diseases where there remains a critical need for innovative therapeutic options. We are excited as we now move into the next phase of clinical development.” The first-in-human, randomized, double-blind, placebo-controlled Phase 1 study in 57 subjects was designed to evaluate safety, tolerability, immunogenicity and PK, and was led by Professor Dave Singh at the Medicines Evaluation Unit in Manchester, UK 2 . The study tested single ascending doses of CAL101 in healthy volunteers and multiple ascending doses in patients with mild to moderate chronic plaque psoriasis. Summary of key CAL101 Phase 1 study results: In early 2025, Calluna plans to advance CAL101 into Phase 2 studies in fibrotic and fibro-inflammatory indications. For more information about Calluna Pharma, please visit: www.callunapharma.com SOURCE: Calluna Pharma

Phase 1

23 Jan 2024

·www.biospace.com

Calluna Pharma Launches and Announces EUR 75 Million Series A Financing to Develop Novel Therapies for Inflammatory and Fibrotic Diseases

Clinical stage company formed from the merger of Oxitope Pharma and Arxx Therapeutics Calluna Pharma has a pipeline of selective antibodies targeting immunological diseases New company to complete multiple clinical proofs-of-concept, across programs Series A led by Forbion, with participation from Norwegian investors Sarsia, p53, and Investinor NAARDEN, The Netherlands & OSLO, Norway--(BUSINESS WIRE)-- Oxitope Pharma (Oxitope) and Arxx Therapeutics (Arxx), companies with a shared goal of leveraging the innate immune system to discover and develop disease modulating therapies, today announced their merger to form Calluna Pharma Inc. (Calluna). Calluna has raised EUR 75 million in a series A financing and is backed by Oxitope and Arxx’s existing lead investors, Forbion, Sarsia, p53, and Investinor. The new company will combine expertise in the field of innate immunity, based on damage-associated molecular patterns (DAMPs), with a pipeline of selective antibodies that target inflammatory and fibrotic indications, including several first-in-class clinical candidates. Calluna is developing novel therapies that harness the transformative potential of the body's immune system. The Company’s unique approach involves precision targeting of upstream innate immune amplifiers, enabling disruption of a comprehensive range of disease-associated downstream signaling pathways while maintaining a favorable safety profile. As a result, Calluna has developed a robust pipeline of selective antibodies, targeting immunological diseases. These include novel therapeutic candidates that fulfil unmet clinical needs across a spectrum of diseases, driven by acute or chronic inflammation and non-resolving tissue fibrosis. Calluna has four promising therapies in its pipeline. Its clinical stage lead program, CAL101, is a monoclonal antibody that neutralizes the bioactivity of S100A4, a DAMP protein implicated in serious and life-threatening diseases such as idiopathic pulmonary fibrosis, chronic kidney disease, systemic sclerosis, rheumatoid arthritis, and severe (steroid insensitive) asthma. Of particular interest is another of its programs, CAL102, a monoclonal antibody neutralizing oxidized phospholipids – these play a significant role in onset and progression of a wide range of acute and chronic inflammatory and fibrotic diseases. CAL102 demonstrated efficacy in several preclinical disease models. John Montana, PhD., Chief Executive Officer of Calluna Pharma, commented: “In joining forces, these two key players in the innate immunology space have created an exciting new clinical company that has four promising therapies in its pipeline with excellent preclinical proof-of-concept data. By innovating beyond traditional treatment strategies, Calluna offers clinical candidates with superior efficacy, improved patient tolerance, and minimal adverse side effects which have real potential to redefine patient outcomes.” Antoine Boulanger, PhD., Principal at Forbion, added: “The merger of Oxitope Pharma and Arxx Therapeutics to create Calluna Pharma is a prime example of our Forbion Ventures Fund’s strategy where we both build new and enable existing companies. As a result, we recognized the strength of combining these two companies’ pioneering approaches to disrupt the treatment of inflammatory and fibrotic diseases, the complementarity of management skills, and the resulting robust clinical pipeline. We look forward to continuing our support of potentially life changing clinical assets moving into the next phases of clinical development.” Sveinung Hole, MBA, Managing Partner at Sarsia (ex-Chair at Arxx Therapeutics) and Susanne Stuffers MD, PhD, Managing Partner at p53, commented: “Sarsia and p53 strive to bring cutting edge ideas and therapies from early-phase to clinical development and beyond to benefit patients and transform people’s lives. Calluna Pharma epitomizes this, and we are enthusiastic to join forces with Forbion and to contribute to the success of this new entity.” The company’s board of directors will include John Montana, Operating Partner (Forbion), as Chief Executive Officer, Antoine Boulanger, Principal (Forbion), Susanne Stuffers (p53), Farzad Abdi-Dezfuli General Partner (Sarsia), and Marco Boorsma, General Partner (Forbion) as Chairman. The Company is raising further financing to develop its pipeline to multiple key clinical milestones over the next 2.5 years. For more information about Calluna Pharma, please visit: View source version on businesswire.com: Contacts Source: Calluna Pharma View this news release online at:

AcquisitionImmunotherapy

23 Jan 2024

·www.pharmaceutical-technology.com

Newly launched Calluna raises $81m to advance monoclonal antibody pipeline

Calluna will use the funding to develop four immunotherapy candidates. Credit: Maria Dryfhout via Shutterstock. European biotechs Oxitope Pharma and Arxx Therapeutics have merged to form Calluna Pharma, raising €75m ($81m) in a Series A funding round. Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. 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Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address. Thank you. You will recieve your mail in sometime.So, please check your email to download the Report. Go deeper with GlobalData Reports LOA and PTSR Model - Monoclonal Antibody Conjugate 3 To Target Egfr For Oncology in Malignant Mes... Reports LOA and PTSR Model - Monoclonal Antibody Conjugate 3 To Target Egfr For Oncology in Non-Small Cel... Premium Insights The gold standard of business intelligence. Find out more Related Company Profiles Boehringer Ingelheim International GmbH GSK plc View all Led by existing lead investors Forbion, Sarsia, p53, and Investinor, the funding from the round will go towards a pipeline of monoclonal antibodies targeting immunological diseases. Calluna’s lead candidate CAL101 is a monoclonal antibody (mAb) designed to neutralise S100A4, a damage-associated molecular pattern (DAMP) protein. When released in excess or at the wrong time, DAMPs can contribute to the development and progression of diseases involving inflammation and tissue damage such as rheumatoid arthritis, steroid-insensitive asthma, chronic kidney disease, and idiopathic pulmonary fibrosis. CAL102, a monoclonal antibody that neutralises oxidised phospholipids, is another therapy in development by Calluna. It acts by disrupting the underlying pathways associated with conditions characterised by inflammation and fibrosis. The company has two other candidates, CAL103 and CAL104, which are both in the discovery phase. Netherlands-based Oxitope launched in 2020, a few years after Norway-based Arxx in 2018, with both startups focusing energy on therapeutic antibodies. It’s already been a big year for immunotherapies. Earlier this month, pharma giant Boehringer Ingelheim teamed up with 3T Biosciences in a deal totalling $538.5m to advance cancer immunotherapies, using 3T’s T-Cell Receptor Antigen and Cross-Reactivity Engine (TRACE) discovery platform to discover and develop the immunotherapies. This development comes after GSK purchased Aiolos Bio in a large $1.4bn acquisition , granting GSK access to Aiolos’ monoclonal antibody AIO-001. The candidate, soon to be investigated in a Phase II study, targets a cytokine thought to play a role in asthma and other inflammation diseases. In the announcement accompanying the funding round, Calluna chief executive officer John Montana said: “In joining forces, these two key players in the innate immunology space have created an exciting new clinical company that has four promising therapies in its pipeline with excellent preclinical proof-of-concept data.” Free Report How is the Biopharmaceutical industry evolving? 2021 was a year of continued innovation and change in the Biopharmaceutical industry. As the COVID-19 pandemic continues to take its toll on businesses worldwide, it’s time to look for new ways to create value, prepare for the future, and remain competitive in the ever-changing landscape. GlobalData’s expansive report examines the business environment and trends that shape the Biopharmaceutical industry. We highlight the most impactful emerging technologies, as well as the industry, regulatory, and macroeconomic factors that influence growth prospects. Access the report to: Benchmark the impact of major themes on the Biopharmaceutical industry. Gain a deeper "on the ground" perspective through exclusive opinions and analysis from industry respondents. Evaluate the effects of COVID-19 on the sector. Download the full report to understand what to expect and how to align your strategies for success. 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ImmunotherapyPhase 2Acquisition

100 Deals associated with AX-202

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Indication	Highest Phase	Country/Location	Organization	Date
Plaque psoriasis	Phase 1	GB	Arxx Therapeutics AS	25 Apr 2023
Fibrosis	Phase 1	-	Calluna Pharma, Inc.	-
Scleroderma, Systemic	Phase 1	-	Arxx Therapeutics AS	-

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