Partnership to Advance the Development of Berubicin in Primary and Metastatic Cancers of the Central Nervous System

IAG and CNS Pharmaceuticals Partner to Further the Development of Berubicin

IAG, a leading medical imaging company, will work closely with CNS during the Berubicin clinical trials to provide critical imaging services, its proprietary platform DYNAMIKA and imaging data analysis. IAG has deep expertise in partnering with biotech, and specifically oncology companies, to provide a centralized reading and analysis of patient responses in real time. IAG’s scientific and clinical imaging expertise in the field of glioblastoma multiforme (GBM) will be coupled with IAG’s proprietary AI and quantitative image-based assessments to allow CNS to review efficacy assessments, objective responses, and to thoroughly explore the advanced treatment manifestations. GBM therapies often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, inflammation, tumor necrosis and oedema which are often misinterpreted as tumor growth on traditional MRIs. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments.  IAG and CNS will be utilizing IAG’s advanced Artificial Intelligence (AI)-driven methodologies that provide reliable early efficacy readouts.

Adding IAG was a key step in preparation for the recently developed clinical trials in Berubicin,” commented John Climaco, CEO of CNS Pharmaceuticals. “IAG has an exemplary track record of partnering closely with companies in the biotech space to provide critical analysis of both efficacy and patient response, which we believe will be pivotal in advancing our Berubicin clinical trials. Furthermore, this was yet another key milestone achieved in our trial preparations as we continue to take all of the necessary steps to ensure a successful and timely launch of our Phase II trials. We look forward to leveraging IAG’s extensive expertise, as we plan to initiate our Phase II clinical trial of Berubicin in adults early next year.”

“We are excited to partner with CNS and bring our expertise to support the optimal trial design, efficient imaging data management and review. Use of the state-of-the-art and IAG’s AI driven methodologies for imaging data review will allow us to comprehensively explore Berubicin’s efficacy and build significant scientific evidence, while reducing the development costs, timelines and uncertainties,”  commented Dr. Olga Kubassova, IAG’s CEO and scientific founder.

Advanced imaging methods and computer aided image analysis is the key to successfully interpret treatment related changes in GBM and identify responders early,” stated Dr. Diana Dupont-RoettgerChief Scientific Alliance Officer at IAG. “We are excited to partner with CNS Pharmaceuticals in the development of Berubicin.

About CNS Pharmaceuticals, Inc.
CNS Pharmaceuticals is developing novel treatments for primary and metastatic cancers of the brain and central nervous system. Its lead drug candidate, Berubicin, is proposed for the treatment of glioblastoma multiforme (GBM), an aggressive and incurable form of brain cancer. CNS holds a worldwide exclusive license to the Berubicin chemical compound and has acquired all data and know-how from Reata Pharmaceuticals, Inc. related to a completed Phase 1 clinical trial with Berubicin in malignant brain tumors, which Reata conducted in 2006.  In this trial, 44% of patients experienced a statistically significant improvement in clinical benefit. This 44% disease control rate was based on 11 patients (out of 25 evaluable patients) with stable disease, plus responders. One patient experienced a durable complete response and remains cancer-free as of February 20, 2020. These Phase 1 results represent a limited patient sample size and, while promising, are not a guarantee that similar results will be achieved in subsequent trials. By the end of 2020, CNS expects to commence a Phase 2 clinical trial of Berubicin for the treatment of GBM in the U.S., while a sub-licensee partner undertakes a Phase 2 trial in adults and a first-ever Phase 1 trial in pediatric GBM patients in Poland.  Its second drug candidate, WP1244, is a novel DNA binding agent that has shown in preclinical studies that it is 500 times more potent than the chemotherapeutic agent daunorubicin in inhibiting tumor cell proliferation. https://cnspharma.com/

About IAG

Image Analysis Group (IAG) is a unique clinical development partner to life sciences companies.  IAG broadly leverages its proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development.

For more information please reach out to <imaging.experts@ia-grp.com> 

Partnership to Advance Connectivity and Interoperability in Clinical Trials of Rheumatic Diseases

ZiteLab Aps and IAG, Image Analysis Group Partner to Integrate IAG’s DYNAMIKA and the SAMRI Platforms to Advance Connectivity and Interoperability in Clinical Trials of Rheumatic Diseases

IAG, imaging expert company helps to accelerate novel drug development by using the right analytical tools and modern trial infrastructure. This includes bringing AI, Machine Learning and smart image analysis methods to ensure the speed and cost-effectiveness, while delivering true insights about your mechanism of action and patients’ response, in real-time. 

ZiteLab bridges the gap between patients, healthcare providers and the IT systems that have grown into an indispensable part of the healthcare experience. This includes long term partnerships with University Hospitals and other private and public research driven institutions. 

IAG and ZiteLab ApS have partnered to integrate IAG’s DYNAMIKA and the SAMRI platforms for scalable, intelligent and fast MRI data analysis for use in clinical trials of rheumatic diseases. 

DYNAMIKA, IAG’s cloud-based platform, greatly improves efficiencies and data control for management of all imaging components within clinical trials by combining state-of-the-art infrastructure with built-in AI-driven algorithms to generate robust trial endpoints. Its cloud architecture allows the seamless merge of real time quality control, review and reporting of image data with most commonly used scoring systems.  

SAMRI, ZiteLab’s platform has been developed in conjunction with rheumatology key opinion leaders and seamlessly integrates an intuitive interface for the scoring of the most complex of anatomies by radiologists, particularly in rheumatoid and psoriatic arthritis.  

The partners will integrate SAMRIs optimized scoring tools with DYNAMIKA’s image management and viewing functionality to provide a comprehensive platform for global multi-centre clinical trials, testing therapies for rheumatic diseases. This partnership will be a key driver for efficiency within clinical trials as well as building the foundation to understand better the analysis as performed by users for future improvements.   

 “This partnership will help bio-pharma companies developing novel therapeutics to tackle chronic diseases and diseases of aging. This modern trial infrastructure allows to deploy a wide range of novel imaging and scoring criteria in the trials. Thus, helping to accelerate clinical development of novel therapeutic agents and drive accuracy and speed of the patient response assessments“,  commented Jamshid Dehmeshki, Chief Technology Officer at IAG.

Ultimately, having the cloud infrastructure and novel methods for treatment efficacy assessment in once place  will lead to much more targeted R&D, reduced costs and timelines of clinical development, ” added Dr. Olga Kubassova, CEO of IAG.  

Such collaboration can truly be part of key drivers to operational efficiency. Our imaging experts’ and clinical collaborators’ data will be centralised and simultaneously available, therefore improving overall study transparency. We have the potential to provide a more comprehensive outlook on the factors influencing treatment efficacy evaluation, which in turn guarantees effective delivery of safe and efficacious treatments to patients.” added Romiesa Hagoug, Senior Clinical Project Manager at IAG. 

“We are proud of our work at the forefront of this exciting research and support the development of novel therapeutic agents,” Niels Steen Krogh, CEO of ZiteLab

 

About IAG: 

IAG, Image Analysis Group is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. 

About DYNAMIKA: 

IAG’s cloud platform for robust imaging data management in multi-centre trial setting and central review. One comprehensive software system to control trial progress, conduct central reads and use built-in AI for earlier read-outs and decision support. DYNAMIKA has powered  over 100 global clinical studies, from ph I-IV linking more than2000 sites, processing complex imaging data from thousands of patients. t can handle all types of imaging data, including MRI, CT, PET, SPECT and allows analysing it with state of the art or modern AI driven algorithms to generate trial endpoints. 

About ZiteLab ApS: 

ZiteLab bridges the gap between patients, healthcare providers and the IT systems that have grown into an indispensable part of the healthcare experience.  Diversity, multiculturalism, alongside the interdisciplinary expertise makes the strength of ZiteLab and their partners who have developed clinical trial and disease registry solutions that are in use on local, regional, national and international levels in several languages. ZiteLab is engaged in international research collaborations with focus on AI backed personalised treatment and screening. and new diagnostic classifications. All IT systems are based on the same IT-platform combining python, R and webtechnologies. 

For more information please reach out to <imaging.experts@ia-grp.com> 

Partnership to Validate Treatment Response in a Rare Paediatric Orthopaedic Condition

Novadip Biosciences and Image Analysis Group Partner to Objectively Assess Patient Response to a Novel Cell-Based Therapy for Osseous Non-Union Indications.

Novadip Biosciences S. A., a biotech company focused on the development of novel stem cell-based therapies for regenerative medicine and IAG, Image Analysis Group, a strategic bio-pharma imaging expert announce a strategic alliance in the development of Novadip’s lead autologous stem cell therapy, NVD-003 

Novadip’s NVD-003 is a second-generation therapy improving bone healing in severe pathophysiological conditions including hypoxia, lack of mineralized callus formation, bone resorption and low osteogenicity. NVD-003 therapy supports the reconstruction and remodelling of large bone defects as may be found in different osseous non-union indications. To assess its safety and efficacy, CT and X-Ray images will be used.  

IAG’s team have significant experience in using medical imaging to support drug development.  

This partnership aims to design and validate imaging-based system for the assessment of radiological signs of bone formation in Congenital Pseudoarthrosis of the Tibia (CPT), a rare paediatric orthopaedic condition, and other non-union indicationsThe partner aim to bring a robust and validated system to support future development of NVD003 in application to CPT and other musculoskeletal conditions.  

Unique mechanism of action of NVD003 and patient healing process will be assessed using computer added radiological review of the imaging scans. Since CPT is a rare condition, we need to ensure that treatment response is assessed comprehensively and accurately. We are pleased to have on-board world-class imaging experts, who bring their expertise to maximise NVD-003’ success in the clinic and help finding a solution for CPT patients.’ said Dr. Olga Kubassova, IAG’s CEO.  

Novadip’s unique “3M3″ tissue regeneration technology platform, utilizing adipose-derived stem cells within a 3D extracellular matrix, is designed to transform the lives of patients with limited or no effective treatment options. This partnership will allow us comprehensively explore NVD003 efficacy and build solid scientific data while reducing the development costs, timelines and uncertainties. added Dr. Denis Dufrane, the founder and CEO of Novadip.  

About NVD-003: NVD-003 is an autologous stem cell therapy sourced from the stromal fraction of the patient’s adipose tissue. This 3-dimensional, malleable product is implanted at the non-union fracture site. The delivery of differentiated stem cells within their extracellular matrix in fractured pseudoarthrosis lesion(s) supplies factors and signalling molecules that can promote osteogenesis while providing appropriate mechanical stabilitytherefore providing the right milieu for tissue regeneration of large bone defects.  

About Novadip: Novadip is a Belgian biotech company founded in 2013, based on the scientific discoveries of Prof. Denis Dufrane, Novadip’s acting CEO and CSO. The company focuses on tackling unmet medical needs using their tissue regeneration technology platform, “3M3. Multiple product candidates, targeting different organs, arose from this platform including autologous, allogenic and miRNA / exosome-based therapies. Novadip possesses a promising pipeline tackling systemic and localised tissue defects by overcoming tissue reconstruction challenges. 

About IAG: IAG, Image Analysis Group is a unique clinical development partner to life sciences companies. We broadly leverage our proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development. www.ia-grp.com 

For more information, please reach to <imaging.experts@ia-grp.com>

Partnership to Maximize Chances of Success for IO Trials through the Use of Advanced Imaging Strategies

Cellsight Technologies, Inc. and IAG, Image Analysis Group Partner to Maximize Chances of Success for Immuno-Oncology Companies through the use of Advanced Imaging Strategies

SAN FRANCISCO, CA, USA and PHILADELPHIA, PA, USA – May, 4, 2020

IAG, Image Analysis Group and CellSight Technologies partner to bring advanced imaging into the development of novel therapeutic agents in immuno-oncology.

The partners will combine novel imaging strategies with quantitative image analysis methodologies to enhance drug development in Immunology and Oncology.

Today we see a number of expanding applications of immunotherapy from oncology to infectious and inflammatory diseases. Bio-pharma companies continue to develop novel or expand the scope of existing checkpoint inhibitors, CAR-T and monoclonal antibody therapies.

There is a growing need to employ advanced imaging techniques coupled with quantitative biomarker extraction methods.

CellSight is a San Francisco based clinical stage radiopharmaceutical development company with a PET/CT imaging agent (18F-FaraG) also known as VisAcT® that is specific to activated T cells. This imaging agent is useful for quantitative imaging of scans from patients undergoing immunotherapy for cancer (lung, melanoma, breast, brain and other solid tumors), various inflammatory diseases (such as Rheumatoid arthritis), and infectious diseases (such as HIV/AIDS or COVID-19).

IAG, Image Analysis Group is an imaging expert company working with biotech and pharmaceutical companies. IAG is leveraging its expertise in multiparametric MRI, ferumoxytol MRI, PET, CT and image analysis strategies (such as radiomics) to create high-impact synergies with applications in drug development for diseases in a wide range of therapeutic areas.

We are living in the era of immunotherapeutics, which have been game-changers for various inflammatory, oncologic and even infectious diseases. This collaboration between IAG and Cellsight allows us to visualize the interplay between the disease and the immune system. This is an extremely important tool for drug development of immunotherapeutic agents.” Commented Dr. Faiq Shaikh, IAG’s Head of Research & Enterprise.

“Immuno-Oncology drug development is in need for advanced imaging technologies to identify the right therapy for the right patient fast. This collaboration brings T-cell imaging and AI-based image analysis together to show treatment related changes in the tumor microenvironment and thereby to identify treatment responders, ” added Dr. Diana Dupont-Roettger, IAG’s Chief Scientific Alliance Officer.

“ We are excited to partner with IAG as we see great added value for our bio pharma partners in combining Cellsight’s immuno PET tracer capabilities with IAG’s deep knowledge based analysis. After all image interpretation and data extraction is key to any novel PET tracer but especially true when imaging the complex immune response.” Said Aruna Gambhir, CEO of Cellsight Technologies.

About IAG:

IAG, Image Analysis Group is a unique clinical development partner to life sciences companies. We broadly leverage our proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. We have years of experience in AI and Machine Learning as well as bespoke co-development business models that ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development.

For more information, please reach to <imaging.experts@ia-grp.com>

Multi-Omics-Based Machine Learning Models to Study Glioblastoma Multiforme

McMaster University’s Stem Cell and Cancer Research Institute and Image Analysis Group Partner to Develop Multi-Omics-Based Machine Learning Models to Study Glioblastoma Multiforme

HAMILTON, ON, CANADA and PHILADELPHIA, PA, USA – March 16, 2020

IAG, Image Analysis Group has partnered with the Singh Lab, led by Dr Sheila Singh to perform a multidisciplinary research project, involving researchers from Oncology and Neurosurgery to develop prognostication models for glioblastoma multiforme (GBM).

In this collaboration, the partners will pursue an entirely novel approach using radiomics (advanced quantitative image analysis), proteomics (large-scale study of proteins) and transcriptomics (DNA microarray assessment of gene expression) to evaluate the microstructural and functional bases for how glioblastomas, a very lethal type of brain tumor, behave in patients and how they can be stratified more accurately based on their aggressive potential.

““With a novel multi-omics approach we plan to discover new predictive biomarkers of recurrence patterns of the most common adult primary brain tumour, GBM. There is a whole spectrum of biological factors that contribute to how these cancers behave, such as the genes expressed, proteins secreted, and microstructural changes rendered. Studying these individually and incorporating them together allows us to classify these cancers. Thus, permitting to treat each patient based on the unique characteristics of their cancer and the pattern of their recurrence.”  Dr Singh commented.

This is a step towards precision medicine. The goal of this collaboration is to develop ways to harness the power of machine learning to develop genotypic-phenotypic biomarkers that allow stratify the risk and improve prognostication of GBM”, says Faiq Shaikh, M.D., IAG’s Head of Oncology & Radiomics. Dr Sotirios Bisdas, a senior Neuroradiologist at University College London is a co-investigator on this study.

 “We are excited to bring IAG’s advanced analytics into the field of neurobiology and work towards improving our understanding of diseases of the brain and accelerated way of drug development,“ added Dr. Kubassova, the CEO of IAG.

“While proteomics, genomics and radiomics have been leveraged individually in many of our studies, this is the first time a fully integrated multi-omics approach will be developed to support the understanding and management of a malignant disease,” commented Dr. Diana Dupont-Roettger, the Chief Scientific Alliance Officer, IAG.

About Dr Sheila Singh, Dr Fateme Salehi and McMaster Stem Cell and Cancer Research Institute

Dr Sheila Singh is a professor of Neurosurgery and the Canada Research Chair in human Brain Cancer Stem Cell Biology, at the McMaster Stem Cell and Cancer Research Institute. She is a renowned pediatric neurosurgeon and heads the Singh Lab at McMaster University. Dr Fateme Salehi, who will be a co-investigator on this study is the assistant professor of Radiology, and a neuroradiologist at the Faculty of Health Sciences, McMaster University.

About IAG, Image Analysis Group

IAG, Image Analysis Group brings cutting-edge advanced imaging technologies and supports drug development by leveraging expertise in AI and proprietary cloud-based platform DYNAMIKA. IAG serves as the imaging contract research organization (CRO) and  scientific expert company to design and execute trials in many therapeutic areas including neurology, oncology and autoimmune, rheumatic and musculoskeletal diseases. http://www.ia-grp.com/.

For more information, please reach to <eden.chrifi-alaoui@ia-grp.com>

Augmenting Clinical Decision Making with AI for Ulcerative Colitis Histopathological Image Analysis

IAG and Takeda Partner to Augment Clinical Decision Making with AI Driven Methodology for Ulcerative Colitis Histopathological Image Analysis

Image Analysis Group (“IAG”).today announced a partnership in the field of ulcerative colitis (UC) histopathological image analysis with Takeda Pharmaceutical Company Limited (“Takeda”).

The objective of the collaboration is to develop and validate an artificial intelligence (AI) powered tool that will potentially allow gastroenterologists to effectively incorporate histology (the study of the microscopic structure of tissues) in their real-life assessment of people suffering from UC.

In this collaboration, the parties will utilize an AI-driven approach to augment clinical decision making when assessing disease activity and the efficacy of treatments in UC. The parties will focus on the validation of the use of deep learning models and the use of IAG’s methodologies and platform DYNAMIKA in automating the assessment of UC histopathological images.

With support from the world’s leading clinical research opinion leaders and experienced pathologists, IAG will develop a seamless workflow to process and analyze the imaging data and provide expertise in using deep learning and AI and apply these models to the imaging data analysis.

Collaboration statements

Prof. Laurent Peyrin-Biroulet, Department of Hepato-Gastroenterology and Inserm U954, University Hospital of Nancy, the scientific lead on this project, said “The success of patient treatment with novel therapeutic agents highly depends on the efficient use of modern technologies and data-centric development approaches. In such a critical area as IBD, our patients will no doubt will benefit from the use of Artificial Intelligence to augment clinical decisions.“

“With results from recent clinical trials and emerging concepts of response to treatment such as disease clearence, there is a growing need to look at the disease through a different lens and ideally in a combined and holistic way. In real life, there are barriers in terms of access to trained IBD Pathologists. With its focus on automated quantitative imaging-driven analytics, this collaboration is a step towards putting assessment tools in the hands of practicing gastroenterologists, which will ultimately benefit patients“, added Dr. Andrea Stancati M.D., Vice President, Global Medical Franchise Head, Gastroenterology at Takeda

“We believe in demystifying AI and making it truly useful in the clinical decision making and clinical research”, said Dr. Olga Kubassova, CEO if IAG, “IAG is uniquely positioned to provide tools which could be a game-changer, particularly for the development and use of advanced therapies in complex areas such as IBD, ultimately supporting the goal of getting the right treatment to the right patients at the right time.”

 

About IAG, Image Analysis Group

IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com

 

About Takeda Pharmaceutical Company Limited

https://www.takeda.com

Partnership to Validate Predictive Imaging Markers for Treatment Response in Solid Tumors.

Soricimed and Image Analysis Group Partner to Validate Predictive Imaging Markers for SOR-C13 Treatment Response in Solid Cancer Tumors

TORONTO, CANADA and LONDON, UNITED KINGDOM / ACCESSWIRE / SEPTEMBER 6, 2019 – Soricimed Biopharma Inc. (“Soricimed”), a clinical-stage pharmaceutical company discovering and developing first-in-class targeted cancer therapeutics, today announced that it has entered into a strategic alliance with Image Analysis Group (“IAG”), a UK-based company with unique expertise in medical imaging and artificial intelligence (“AI”)-based image analytics, whereby the companies will join their efforts in the development of Soricimed’s lead anti-cancer drug candidate, SOR-C13, a first-in-class inhibitor of the TRPV6 calcium channel.

The partners will validate the use of advanced image assessment and AI-derived markers to predict patient treatment response in a Phase 1b investigator-initiated trial of late-stage pancreatic cancer patients. The trial will be conducted at one of the world’s most respected cancer research centers, The University of Texas MD Anderson Cancer Center.

IAG will bring its expertise in advanced imaging, Machine Learning and Radiomics to support conventional RECIST/iRECIST assessment and further validate methodologies for patient characterization and the development of predictive response markers.

“Immuno-oncology and advanced therapies demand novel response assessments,” stated Dr. Diana Roettger, Head of Therapeutic Innovation at IAG. “Standard diameter-based radiographic assessment (RECIST/iRECIST) of tumor size and response to treatment does not reflect the complexity of the tumor microenvironment. However, image analysis-based tumor markers that have the potential to predict treatment effects can enhance standard assessments by identifying which patients are most likely to respond to SOR-C13 treatment.”

“Traditionally, tumor shrinkage is used to measure treatment efficacy. However, when a tumor is invaded by cancer-fighting immune cells, it may stay the same size or even increase in size. IAG’s cloud-based software utilizes algorithms, methodologies and AI that provide a more detailed tumor image analysis, including quantitative measurements of tumor microenvironment characteristics,” explained Professor Jack Stewart, Chief Scientific Officer, Soricimed Biopharma Inc. “We are excited to partner with IAG to explore novel imaging markers in the development of our lead drug candidate, SOR-C13, and are confident that including predictors of early response will accelerate our clinical development program for targeted therapy.”

 About SOR-C13: SOR-C13 is a selective inhibitor of TRPV6, a calcium oncochannel over-expressed by solid tumor cancers. SOR-C13 binds with high affinity and selectivity and disrupts the function of TRPV6. TRPV6 plays a central role in a biochemical cascade that results in the upregulation of an array of pro-cancerous genes. TRPV6 is considered to be an important target for novel anticancer therapy. SOR-C13 is the first highly specific TRPV6 inhibitor to be identified and taken into clinical development.

 About Soricimed Biopharma: Soricimed is a private, clinical-stage company focused on developing first-in-class targeted cancer therapies. Their lead drug candidate, SOR-C13, was shown to be safe and well tolerated in a multi-center Phase 1 trial in late-stage solid tumor cancer. The U.S. FDA granted orphan-drug designation to SOR-C13 for the treatment of ovarian and pancreatic cancer. Soricimed is funded through private investors and various programs from the Governments of Canada and New Brunswick. www.soricimed.com

About IAG: IAG, Image Analysis Group is a unique clinical development partner to life sciences companies. We broadly leverage our proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development. http://www.ia-grp.com/.

For More Information

Julie A. Fotheringham
Partner, HAGEMAN Communication
Julie.fotheringham@hageman.ca
416.951.7988

Partnership to Advance Clinical Development of DPX-Survivac in the Treatment of Solid Tumors

IAG (Image Analysis Group) Partner with IMV to Advance Clinical Development of DPX-Survivac in the Treatment of Solid Tumors

London, UK, May 8th 2019 – IAG, Image Analysis Group, a strategic imaging partner for bio-pharma companies, announced they have entered into an collaboration with IMV’s to validate how advanced imaging techniques can help assess the tumor microenvironment in a subset of patients in IMV’s ongoing  phase 2 basket trial, which is evaluating DPX-Survivac in combination with pembrolizumab in multiple solid tumor indications.

Under the terms of the collaboration, IMV and IAG will use multi-parametric MRI (mpMRI) and IAG’s artificial intelligence imaging methodologies in an exploratory arm in IMV’s phase 2 multicenter basket study. This trial is assessing the combination of DPX-Survivac, pembrolizumab, and low dose cyclophosphamide in patients across five indications: ovarian cancer, hepatocellular carcinoma (HCCC), non-small-cell lung carcinoma (NSCLC), microsatellite instability-high (MSI-H) solid tumors, and bladder cancer.

In the exploratory arm utilizing the mpMRI techniques, researchers will calculate advanced imaging biomarkers in support of RECIST1.1 and iRECIST assessment. mpMRI is designed to more clearly demonstrate the potential efficacy of immunotherapies and provide reliable assessments of tumor changes. The financial terms of the deal are not being disclosed.

 

“Artificial intelligence-driven methodologies applied to advanced imaging have the potential to transform the pharmaceutical industry and drug development. This partnership will allow us comprehensively explore DPX-Survivac’s mechanism of action and build solid scientific data, while potentially reducing the development costs, timelines, and uncertainties,” said Dr. Diana Roettger, Head of Therapeutic Innovation, IAG.

“The global pharmaceutical industry and major investors recognize the critical importance of deploying technological innovation in efficient drug development. We are excited to partner with IMV and support the success of their programs,” added Dr. Olga Kubassova, CEO of IAG.

 

Organizers of the 2019 Annual Society of Clinical Oncology (ASCO) Annual Meeting published an abstract highlighting the methodology on May 15, entitled “Early response assessment through multiparametric MRI based endpoints in a phase II multicenter study evaluating the efficacy of DPX-Survivac, intermittent low dose cyclophosphamide (CPA) and pembrolizumab combination study in subjects with solid tumors.”

 

About IAG

IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com

Collaboration in development of a combination therapy in Metastatic Melanoma

eTheRNA immunotherapies NV and IAG Collaborate to Facilitate the Clinical Development of a Combination Therapy in Patients with Metastatic Melanoma.

Niel, Belgium and London, UK July 01, 2019

eTheRNA immunotherapies NV, a clinical-stage Belgian company developing mRNA based immunotherapies for the treatment of cancer and IAG, a bio-pharma expert imaging company announced today a a collaboration aimed at facilitating the clinical evaluation of immuno-therapies based on eTheRNA’s proprietary mRNA-based TriMix platform with the use of IAG’s cloud based software DYNAMIKA.

eTheRNA is developing the mRNA-based immunotherapy ECI-006, which is a combination of TriMix (three mRNAs encoding dendritic cell maturation and activation proteins),  and mRNAs coding for 5 tumor-associated antigens. The primary objective of the product is to elicit an immune response against metastatic tumors.

IAG will leverage its proprietary software platform Dynamika for central imaging data logistics and analysis to facilitate the clinical development and standardize image assessment including RECIST 1.1 and iRECIST.

The use of innovative imaging data management and analysis platform DYNAMIKA will enable the partners to ensure that all imaging data is of high-quality as well as maintain control over trial progress.

Dr. Diana Roettger, Head of Therapeutic Innovation at IAG commented:

“Well-known image assessment issues in solid tumor clinical trials such as inter- and intra-reader reproducibility will be addressed through optimized workflows and increased transparency to quantitatively measure the treatment response in a fast turnaround.”

 

“Having clear and reliable early efficacy signals in our clinical program, which IAG is uniquely positioned to provide, can be a game-changer, particularly for immunotherapies like ECI-006,” stated Dr. Bertil Lindmark, CMO at eTheRNA, “Our work with IAG’s imaging expert team will help us better understand how ECI-006’s mechanism of action can affect the tumor development and, ultimately, support our goal of getting the right treatment to the right patients at the right time.”

 

About eTheRNA immunotherapies NV

eTheRNA immunotherapies NV is a clinical-stage company delivering innovative cancer immunotherapies from its proprietary mRNA-based TriMix platform. eTheRNA’s goal is to commercialise these immunotherapies to deliver long lasting clinical remission to cancer patients. eTheRNA was established in January 2013 as a spin-off from the VUB university in Belgium and is backed by international life science investors. www.etherna.be

 

About TriMix

The TriMix platform, on which eTheRNA’s immunotherapies NV are based, comprises three mRNAs encoding proteins (caTLR4, CD40L and CD70) that work synergistically to deliver optimal activation of dendritic cells. These cells behave as immune response mediators and mobilize the immune system to attack cancer cells through inducing a T-cell response. Clinical proof of concept for TriMix-based immunotherapies has been established through an extensive dataset demonstrating clear clinical benefits in advanced melanoma patients.

 

About IAG

IAG, Image Analysis Group is a unique clinical development partner to life sciences companies. We broadly leverage our proprietary image analysis methodologies, power of our cloud platform DYNAMIKA, years of experience in AI and Machine Learning as well as bespoke co-development business models to ensure higher probability for promising therapeutics to reach the patients. Our independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development, www.ia-grp.com .

Accelerating Development of Novel Therapies for Patients with IBD

Image Analysis Group Announces Collaboration with Eli Lilly and Company and Robarts Clinical Trials, Inc. to Accelerate Development of Novel Breakthrough Therapies for Patients with Inflammatory Bowel Disease

London, UK, May 8th, 2019 – IAG, Image Analysis Group , a strategic imaging partner for bio-pharma companies, announced they have entered into an collaboration with Eli Lilly and Company and Robarts Clinical Trials to validate how advanced imaging and artificial intelligence (AI) driven methodologies can accelerate the clinical development of novel breakthrough therapies and enable parties to bring novel effective treatments to patients with inflammatory bowel disease (IBD).

The companies will assess MRI data from patients with Crohn’s Disease, a form of IBD, and then develop targeted strategies for the development of efficient treatments using state-of-the-art and innovative methodologies.

IAG will bring scientific and clinical imaging expertise in the field of inflammatory diseases, which will be coupled with IAG’s proprietary methodologies for identifying more specific and sensitive imaging biomarkers for inflammatory driven diseases.

Robarts Clinical Research, a global clinical research organization focused on IBD, will provide clinical expertise, patient-focused insights, and data.

Lilly, a research-based company that develops, manufactures, markets, and sells pharmaceutical products, will provide imaging and clinical expertise specifically focused at bringing innovation to the development of new therapies.

We believe that use of the right imaging and quantitative methodologies has the potential to accelerate early drug development by providing greater precision than conventional assessments, which heavily rely on subjective visual scoring of inflammation in images,” said Olga Kubassova, Ph.D., Chief Executive Officer, IAG.  “Smart ways of using data will enable the life sciences industry to increase the speed and quality of innovation, while saving costs.

The future of successful clinical R&D of novel therapeutic agents is dependent on the efficient use of modern technologies and data-centric development approaches. While artificial intelligence is already optimizing drug development in many therapeutic areas, quantitative imaging-driven analytics of treatment responses as well as radiographic patient phenotyping are considered future game changers for pharmaceutical R&D. This collaboration will help advance understanding in these areas.

We are excited to bring together novel methodologies and years of scientific expertise to generate meaningful and actionable data,” said Ajay Nirula, M.D., PhD, vice president, Immunology, Lilly. “Our hope is this collaboration will produce new insights and tools that will ultimately benefit people living with IBD.

As more of such data and innovation become available to the community of physicians and scientists, the more chances we have to make fast objective decisions and develop personalised treatments for individuals with luminal and fistulizing CD,”Brian Feagan, CSO of  Robarts Clinical Trials.

 

About IAG

IAG is a strategic partner to bio-pharmaceutical companies developing new treatments to improve patients’ lives. Our dynamic Strategy, Trial Solutions and Bio-Partnering divisions work closely to meet critical needs of biotechnology companies: funding, clinical development and monetization of their assets. We fuse decades of therapeutic insights, risk-sharing business model and agile culture to accelerate novel drug development. IAG broadly leverages its core imaging expertise, proprietary technology platform DYNAMIKA and capabilities to support an objective early go no/ go decision and drive excellence for tomorrow’s innovative therapeutic agents with speed. www.ia-grp.com

 

About Robarts Clinical Trials

Robarts Clinical Trials Inc. (RCTI) is a global research organization providing clinical trial and central image management solutions (CIMS) to the pharmaceutical and biotechnology industries. Its unique model combines the efforts of leading internationally recognized academic researchers with operational experts to offer integrated solutions to its pharmaceutical and biotechnology partners. Over the past 20 years, RCTI has become recognized as an expert in clinical trial design, execution, outcome development, precision medicine and image management for drug development in Inflammatory Bowel Disease. Robarts Clinical Trials Inc. provides services in over 55 countries worldwide, collaborates with leading academic research institutions across the globe and partners with many of the leading pharmaceutical and biotechnology organizations to bring new and improved treatment options to patients.  www.robartsclinicaltrials.com