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 indications. The 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 NVD–003 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 stability, therefore 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. 

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

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.

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.

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.

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.

For More Information

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

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.”

Image Analysis Group (IAG)

IAG, a pioneering imaging Clinical Research Organization (iCRO), seamlessly blends medical acumen, operational excellence, and cutting-edge AI to accelerate drug development. Since 2007, we’ve been the trusted partner for global biotech and pharma, expertly managing imaging across Phase I-III trials and real-world evidence studies in diverse therapeutic areas.

Our award-winning DYNAMIKA platform ensures unparalleled data integrity, while our innovative approach consistently unlocks and amplifies the value of novel therapies.

Partner with IAG to transform your clinical trials and maximize your therapeutic asset’s market potential.

Toronto, Houston and London, March 19, 2019 – Medicenna Therapeutics Corp., (TSX: MDNA, OTCQB: MDNAF) a clinical stage immuno-oncology company and IAG, Image Analysis Group, a strategic bio-pharma imaging expert partner, today announced an alliance to join their efforts in the development of Medicenna’s MDNA55, a first-in-class, Interleukin-4 Empowered Cytokine™ that specifically targets the Interleukin-4 Receptor (IL4R) for intra-tumoral treatment of recurrent glioblastoma (GBM) and other central nervous system tumors.

Immunotherapies such as MDNA55, often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, inflammation, tumor necrosis and oedema which are misinterpreted as tumor growth on traditional MRI’s. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments.  Thus, IAG and Medicenna will be deploying advanced Artificial Intelligence (AI)-driven methodologies that provide reliable early efficacy readouts.

IAG’s scientific and clinical imaging expertise in the field of GBM will be coupled with the latest AI driven methodologies to validate the impact of MDNA55 on brain tumours.

In Medicenna’s MDNA55 clinical program these advanced imaging protocol will aid fast response evaluation and identification of treatment related changes that can mask underlying tumour response. This is crucial for development of treatments with a substantial immune mediated component and for evaluating heterogenous tumour types such as GBM.

The use of novel image analysis methodologies will allow the partners to address complex issues such as pseudo-progression and quantitatively measure the treatment response, thus deploying a truly precision medicine approach to accurately monitor patient outcomes.

About Medicenna

Medicenna is a clinical stage immunotherapy company focused on oncology and the development and commercialization of novel, highly selective versions of IL-2, IL-4 and IL-13 Superkines and first in class Empowered Cytokines™ (ECs) for the treatment of a broad range of cancers. Medicenna’s wholly owned subsidiary, Houston-based Medicenna BioPharma, is specifically targeting the Interleukin-4 Receptor (IL4R), which is over-expressed by at least 20 different types of cancer affecting more than one million new cancer patients every year. Supported by a significant non-dilutive grant from CPRIT (Cancer Prevention and Research Institute of Texas), Medicenna’s lead IL4-EC, MDNA55 is being investigated in a Phase 2b clinical trial for rGBM, the most common and uniformly fatal form of brain cancer, at top-ranked brain cancer centres in the US. MDNA55 has completed three clinical trials in 72 patients, including 66 adults with rGBM, demonstrated compelling efficacy and obtained Fast-Track and Orphan Drug status from the FDA and FDA/EMA respectively. For more information, please visit www.medicenna.com.

About IAG

Image Analysis Group (IAG) 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.

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.

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.