Mobility Bio and IAG, Image Analysis Group Partner to Develop Novel Osteoarthritis Drug Candidate.

Mobility Bio and IAG, Image Analysis Group Partner to Develop Novel Osteoarthritis Drug Candidate.

Mobility Bio and Image Analysis Group Partner to Objectively Assess Osteoarthritis Patient Response in a Proof of Concept Study using AI-Driven Imaging Biomarkers

Mobility Bio and Image Analysis Group Partner to Objectively Assess Osteoarthritis Patient Response in a Proof of Concept Study using AI-Driven Imaging Biomarkers

Mobility Bio, an emerging bio-pharma focused on the development of novel therapies for joint diseases and IAG, Image Analysis Group, a strategic bio-pharma imaging expert announce a partnership in the development of Mobility’s lead asset.

The IAG team has significant experience in using medical imaging to support drug development. IAG will use their proprietary AI-driven methodology for Dynamic Enhanced MRI Quantification (DEMRIQ) to acquire and analyse MRI images in Mobility Bio’s first in human clinical study of their novel therapeutic.

We are pleased to partner with Mobility and bring world-class imaging experts, who bring their expertise to maximise success in the clinic and help finding a solution for OA patients.’ said Dr. Olga Kubassova, IAG’s CEO.

We are delighted to work with IAG and leverage their advanced imaging capabilities as we study the potential of our lead product to benefit patients with osteoarthritis’ said Dr Tharak Rao, Mobility Bio’s Chief Medical Officer.

About Image Analysis Group (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

About Mobility Bio: 

Founded by Stanford physicians and scientists, Mobility is advancing treatments for osteoarthritis and other diseases that cause joint pain and disability. Osteoarthritis affects over 20 million people in the United States alone and lacks effective treatments to slow the progression of disease. Mobility’s new OA medicines are designed to reduce pain and discomfort, alleviate the underlying processes that lead to joint damage, and improve patients’ quality of life.

For more information, please reach out to: imaging.experts@ia-grp.com

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IAG Collaborates with Peter McCallum Cancer Center on bringing AI into Oncology Drug Development.

IAG Collaborates with Peter McCallum Cancer Center on bringing AI into Oncology Drug Development.

Why Targeted Drugs and Therapies Demand Novel Biomarkers for Assessing Tumour Burden

Cancer treatment is determined by the type of cancer and its stage. If caught at an early stage, treatment options include surgery or radiotherapy. Chemotherapy, drugs that potentially kill cancer cells, is necessary at a later stage when the cancer is more advanced or has spread. Chemotherapy is delivered systemically and acts with limited specificity in the body: cancer cells and healthy cells are affected and therefore, chemotherapy can result in severe side effects.

Today we see the rise of targeted cancer therapies and high-precision imaging

Over the last few decades several novel treatment modalities have become an important part in the fight against cancer.

Targeted cancer drugs work by ‘targeting’ differences of a cancer cell on a molecular level. Popular targets include those important for cancer growth and progression. Targeted drugs for example stop cancer cells from dividing, encourage the immune system to find and kill cancer cells or stop cancers from growing blood vessels. They are delivered systemically and can still have side effects, but, are generally less severe than chemotherapy.

Stereotactic ablative body radiotherapy (SABR) is a novel high-precision treatment modality. Radiotherapy beams originate from different positions around the body and are calibrated by medical imaging. As a result, the tumour receives a high dose and the surrounding tissues a lower dose. Careful treatment planning and the inherent high-precision of the technology allows that the radiotherapy field covers the tumour while avoiding healthy tissue as far as possible. This reduces the risk of side effects.

Effects to the Tumour Morphology

While novel cancer treatments are different in their delivery and mode of action, they share a common motivation and morphological tumour response.

Innovative therapies are specific by focusing on local control of the tumour and thus, lower the risk of side effects. Besides being effective in cancer cell death, they do not necessarily result in tumour morphological change: a residual non-viable tumour architecture can remain for a sustained period post-treatment.

Broadly speaking, novel therapies result in a complex tumour remnant that complicates the assessment of changes in tumour burden.

Cancer Therapy Validation

New drugs and therapies require a thorough validation showing treatment success. The Response Evaluation Criteria in Solid Tumours (RECIST) provides a validated and consistent methodology to evaluate the activity and efficacy of new cancer therapies in solid tumours: RECIST determines the tumour diameter on cross-sectional computed tomography (CT) or magnetic resonance imaging (MRI) scans to assess changes in tumour burden.

In January 2017, the RECIST working group has published on the continued relevance of RECIST guidelines and on the challenge to maintain RECIST as a standard for the assessment of tumour burden in clinical trials. The authors have acknowledged that “…maintaining the validity and relevance of RECIST as a standard evaluation approach is challenging, in particular to maintain a balance between its specificity and generalizability…” Furthermore, the authors noted that the RECIST linked data collection in clinical trials limits the utility of existing databases for the validation of new evaluation approaches to tumour response.

Modifications to Adjust to Novel Therapies

It is critical to note that RECIST version 1.1 remains the only general tool that provides harmonization of tumour response assessment.

However, the working group and a large body of research brings to light the acute need for new imaging modalities, assessment methodologies and updated criteria to support the development of the new classes of treatments. As a response to this need, the immune Response Evaluation Criteria in Solid Tumours for cancer immunotherapy trials (iRECIST) has been developed and validated.

Advanced Imaging and Analysis Methodologies

Recent research has shown that advanced imaging and Artificial Intelligence (AI)-powered analysis provide detailed insight into therapy related tumour microenvironmental changes and are able to predict RECIST outcomes.

MRI poses a promising alternative to evaluate tumour response and is currently rated as equivalent to CT by the American College of Radiology for solid tumours. Multi-parametric MRI (mpMRI) is a sequence of anatomical and functional MRI scans. Several solid tumour trials have successfully implemented mpMRI as an effective explorative endpoint; mpMRI’s ability to predict pathological response is considered as an important advantage over CT.

IAG, Image Analysis Group collaborates with Peter McCallum Cancer Center

IAG’s recent collaborative clinical trial in stereotactic ablative body radiotherapy (SABR) in renal cell cancer (RCC) has implemented a mpMRI protocol.

IAG’s expert team designed and deployed a dynamic contrast enhanced (DCE) MRI and diffusion weighted MRI (DWI) as part of a mpMRI imaging protocol to provide earlier evidence of response (Reynolds et al., 2018).

Resulting quantitative imaging biomarkers have shown to be predictive to RECIST-based assessments.

Together, with our scientific collaborators, IAG’s team brought forward novel imaging biomarkers that have shown significant correlations between the tumour volume change and changes in advanced perfusion imaging biomarkers.

The figure to this article shows colour coded parametric maps before and after therapy. More in the full article.

Full Article: Diffusion weighted and dynamic contrast enhanced MRI as an imaging biomarker for stereotactic ablative body radiotherapy (SABR) of primary renal cell carcinoma

About IAG, Image Analysis Group 

IAG, Image Analysis Group is a unique partner to life sciences companies, leading AI-powered drug development and precision medicine. IAG leverages expertise in medical imaging and the power of Dynamika™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner.  IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, radiological expertise via risk-sharing financing and partnering models.

Learn more:  www.ia-grp.com

Reach out: imaging.experts@ia-grp.com

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Vivacitas Oncology and IAG Partner in the Development of AR-67 for Patients with Recurrent Glioblastoma

Vivacitas Oncology and IAG Partner in the Development of AR-67 for Patients with Recurrent Glioblastoma

Vivacitas Oncology and IAG Partner to Integrate Novel Imaging Markers in the Development of AR-67 in Recurrent Glioblastoma Patients

WALNUT CREEK, CALIFORNIA, US AND LONDON, UK, April 28, 2021

– Vivacitas Oncology, Inc. (“Vivacitas”), a clinical stage biopharmaceutical company focused on tough to treat cancers,  and Image Analysis Group(“IAG”), a leading global medical imaging company, are collaborating  to apply Artificial Intelligence (AI) technology and advanced imaging strategies to further the development of AR-67, a third generation Camptothecin, in patients with recurrent glioblastoma multiforme (reGBM).

Advanced imaging techniques could play a critical role in response assessment in developing new and innovative cancer therapies.

Multiparametric magnetic resonance imaging (mpMRI) provides quantitative non-invasive imaging markers of early therapy-related changes.

IAG is deploying its proprietary, cloud-based imaging approach to provide scientific evidence of early therapy response.

Tina Runk, Vivacitas co-founder and Executive Vice President of Clinical Operations stated,

“Working with IAG, we performed a retrospective analysis of imaging data from our Phase 2 clinical study of AR-67 activity in recurrent GBM, in which their  technology was applied to assess pseudoprogression from true progression of disease. This assessment capability demonstrates  the benefit of potentially including this technology in future pivotal clinical trials and treatment regimens to ensure patient retention based on more detailed and objective criteria.”

Dr. Diana Dupont-Roettger, the Chief Scientific Alliance Officer at IAG stated:

“We are excited to bring the latest and most impactful imaging strategies to Vivacitas to ensure a scientific excellence and efficient drug development process.”

ABOUT VIVACITAS ONCOLOGY:

Vivacitas Oncology is a private clinical stage biopharmaceutical company focused on combating those cancers that have proven to be frustratingly resistant to current treatment modalities. It originated with the vision of Dr. Joseph Rubinfeld (co-founder of Amgen) with the intent to improve upon well known chemotherapies with demonstrated effect, but which also possess challenges with potency, toxicity, stability, and other issues limiting their use.  Through an enduring spirit, Vivacitas continues to apply clarity, tenacity, and vision in our fight against intractable cancers and our pursuit of new treatment options for patients and their families worldwide.

For further information please visit www.vivaoncology.com or Elise@vivaoncology.com.

ABOUT IAG, Image Analysis Group 

IAG, Image Analysis Group is a unique partner to life sciences companies, leading AI-powered drug development and precision medicine. IAG leverages expertise in medical imaging and the power of Dynamika™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner.  IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, radiological expertise via risk-sharing financing and partnering models.

For further information please visit www.ia-grp.com or reach out to imaging.experts@ia-grp.com

Crescendo and IAG announce partnership in development of novel, targeted T cell enhancing immuno-oncology therapeutics

Crescendo and IAG announce partnership in development of novel, targeted T cell enhancing immuno-oncology therapeutics

Crescendo Biologics and IAG announce partnership in development of novel, targeted T cell enhancing immuno-oncology therapeutics.

Cambridge, UK and London, UK – 19 April 2021 – Crescendo Biologics Ltd (Crescendo), a clinical stage immuno-oncology company developing novel, targeted T cell enhancing therapeutics, and Image Analysis Group (IAG), a bio-pharma imaging expert, today announce a collaboration to employ advanced imaging techniques in the phase I clinical study of CB307, Crescendo’s Humabody® T cell enhancer.

IAG has significant expertise in medical imaging and proprietary image analysis methodologies to support drug development. The phase I clinical study of CB307, Crescendo’s lead programme, in patients with a range of PSMA positive tumour types is now open (NCT04839991), and IAG’s proprietary imaging data analytics will be used as part of the efficacy analyses in this trial.

CB307 is a unique, half-life extended Humabody® targeting PSMA and the potent co-stimulatory molecule CD137 (4-1BB). Monospecific monoclonal antibodies (mAbs) against CD137 have been shown to enhance T cell activity in clinical studies as cancer therapy but have also shown treatment-limiting hepatotoxicity. CB307 is designed to enable potent, tumour-specific T cell activation whilst avoiding the systemic toxicity associated with monospecific mAbs.

Dr Diana Dupont-Roettger, Chief Scientific Alliance Officer at IAG, commented:

“Targeted imaging methods are excellent tools to focus radiological response assessment. During the clinical study we will use highly specific, non-invasive biomarkers that specifically and quantitatively evaluate how tumours respond to CB307.  Imaging data analytics will further support the identification of treatment responders to this novel therapy.”

Dr Kenji Hashimoto, CMO of Crescendo Biologics, said:

“We are delighted to see CB307 progress into the clinic. Advanced imaging can provide insights into the molecular mechanism of a drug and its interaction with a cancer, which are critical for immunotherapeutic drug development. This collaboration is expected to help accelerate the clinical development of CB307 for patients with PSMA positive tumours.”

About Crescendo Biologics

Crescendo Biologics is a clinical stage immuno-oncology company developing novel, targeted T cell enhancing Humabody® therapeutics.

Leading its proprietary pipeline, Crescendo Biologics has developed CB307, a novel half-life extended CD137 x PSMA Humabody® for the selective activation of tumour-specific T cells exclusively within the tumour microenvironment. CB307 is designed to achieve a longer lasting anticancer effect whilst avoiding systemic toxicity.

The Company’s ability to develop multi-functional Humabody® therapeutics is based on its unique, patent protected, transgenic mouse platform generating 100% human VH domain building blocks (Humabody® VH). These robust molecules can be configured to engage therapeutic targets in such a way that they deliver novel biology and superior bio-distribution. This results in larger therapeutic windows compared to conventional IgG approaches. Humabody®-based formats can also be applied across a range of non-cancer indications.

Crescendo Biologics is located in Cambridge, UK, and is backed by blue-chip investors including Sofinnova Partners, Andera Partners, IP Group, Takeda Ventures, Quan Capital and Astellas.

For more information, please visit www.crescendobiologics.com and follow @HUMABODY.

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 about IAG: www.ia-grp.com/.

Crescendo Biologics

Kenji Hashimoto, CMO

+ 44 (0)1223 497140

info@crescendobiologics.com

Instinctif Partners

Melanie Toyne-Sewell, Dr Christelle Kerouedan

+ 44 (0)20 7457 2020

crescendo@instinctif.com

Image Analysis Group

Dr Diana Dupont-Roettger, Chief Scientific Alliance Officer

+44 7413 022053

contact@ia-grp.com

Genenta and IAG, Image Analysis Group Announce Partnership.

Genenta and IAG, Image Analysis Group Announce Partnership.

Genenta Imaging Partnership with IAG Optimizes Phase I/IIa Study of Temferon™ in Glioblastoma

Genenta Imaging Partnership with IAG Optimizes Phase I/IIa Study of Temferon™ in Glioblastoma

Genenta and IAG, Image Analysis Group Announce Partnership to Optimize Phase I/IIa Study of Temferon™ in Glioblastoma

MILAN (Italy) / LONDON (UK),  February, 2021 – Genenta Science srl (“Genenta”) a clinical-stage biotechnology company, pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon™), today announced a scientific partnership with Image Analysis Group (“IAG”) for its Phase I/IIa study (TEM-GBM) of Temferon in patients affected by glioblastoma multiforme (GBM).

Genenta Science is leveraging its Temferon™ technology platform to treat cancers using a novel immuno-gene therapy approach. The TEM-GBM study is evaluating the safety and efficacy of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-α2 in patients with GBM who have an unmethylated O-6-methylguanine-DNA methyltransferase gene promoter.

Carlo Russo, CMO & Head of Development of Genenta, said:

“Using IAG’s cutting edge non invasive technology provides Genenta with greater clarity in understanding how Temferon affects patients with glioblastoma. In particular, we can monitor how patients react to our treatment in real time while also differentiating between the effects of Temferon on the tumor and on surrounding tissues. This means we can fully explore the potential of this exciting drug candidate.”

Immunotherapies such as Temferon may lead to the phenomenon of pseudo-progression in GBM, an inflammatory response which could be misinterpreted as tumor growth using traditional and routine clinical MRI assessments. IAG’s advanced AI-driven non invasive methodologies allow accurate measurement of tumor volume within brain tissue, providing reliable early efficacy readouts.

Dr. Diana Dupont-Roettger, Chief Scientific Allicance Officer at IAG commented,

“We are excited to partner with Genenta in this Phase I/II study and beyond. Advanced imaging and AI based analysis allow for quantitative assessment of the tumour volume and are therefore able to identify early treatment related changes in GBM. This information is vital in cases where conventional criteria such as RANO overestimate the tumour burden.”

During the partnership, IAG, a leading medical imaging company, will work closely with Genenta to provide critical imaging services, using 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 GBM will be coupled with IAG’s proprietary AI and quantitative image-based assessments to allow Genenta to review efficacy assessments, objective responses and to thoroughly explore the advanced treatment manifestations.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for cancer. Temferon™ is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes – TEMs). TemferonTM, which is under investigation in a Phase I/IIa clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno-oncology. Based in Milan, Italy, and New York, USA, Genenta has raised more than €33.6 million (~$40 million) in three separate rounds of financing.

About Image Analysis Group

IAG, Image Analysis Group is a unique partner to life sciences companies, leading AI-powered drug development and precision medicine. IAG leverages expertise in medical imaging and the power of Dynamika™ – our proprietary cloud-based platform, to de-risk clinical development and deliver lifesaving therapies into the hands of patients much sooner.  IAG provides early drug efficacy assessments, smart patient recruitment and predictive analysis of advanced treatment manifestations, thus lowering investment risk and accelerating study outcomes. IAG bio-partnering takes a broader view on asset development bringing R&D solutions, operational breadth, radiological expertise via risk-sharing financing and partnering models.

For further information please visit www.ia-grp.com or reach out to imaging.experts@ia-grp.com

Genenta Investor Relations

Stefania Mazzoleni, PhD: Italy

Stefania.mazzoleni@genenta.com

+39 339 7095931

Mary-Ann Chang, CFA: US & Europe

mchang@lifesciadvisors.com

+44 7483 284 853

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

WPD Pharmaceuticals, Inc. & IAG, Image Analysis Group will Deploy AI and Quantitative Imaging to Advance New GBM Treatment

WPD Pharmaceuticals, Inc. & IAG, Image Analysis Group will Deploy AI and Quantitative Imaging to Advance New GBM Treatment

WPD Pharmaceuticals to Collaborate With IAG to Deploy Artificial Intelligence and Quantitative Imaging to Assess the Effects of Berubicin

Vancouver, British ColumbiaJanuary 06, 2020WPD Pharmaceuticals Inc. (CSE: WBIO)(FSE: 8SV1) (the “Company” or “WPD”) a clinical-stage pharmaceutical company, is pleased to announce that it has engaged Image Analysis Group (“IAG”), a leading medical imaging company, to provide important critical imaging services during the Berubicin phase 2 clinical trials which are scheduled to start in February 2021.

IAG has deep expertise in partnering with global biotech companies to provide centralized reading and analysis of patient responses in real time. IAG’s scientific and clinical imaging expertise in the field of glioblastoma multiforme (“GBM”), coupled with IAG’s proprietary Artificial Intelligence (AI) powered platform DYNAMIKA will allow WPD and its partners to review efficacy assessments, objective responses, and to thoroughly explore Berubicin’s effect in patients with GBM.

Advanced cancer therapies often lead to pseudo-progression, a local tissue reaction resulting from immune cell infiltration, causing inflammation, tumor necrosis and oedema which are often misinterpreted as tumor growth on traditional MRIs. Under the arrangement, IAG will utilize its advanced AI-driven methodologies that provide reliable early efficacy readouts. Pseudo-progression is difficult to distinguish from disease progression using routine clinical MRI assessments, and having IAG’s advanced technology will be crucial for early detection and progression.

Mariusz Olejniczak, CEO of WPD commented, “We are very pleased to partner with IAG to collaborate on the upcoming Berubicin trials and other studies including WPD101, if possible in the future. IAG has a strong track record of working with leading biotech companies to provide critical imaging collection, analysis, and assessment which is a very important part of our Berbucin phase 2 trials. We look forward to working with them leading up to and in preparation of the commencement of the these Trials.”

Olga Kubassova, CEO of IAG commented, “We are pleased that IAG’s unique focus on the use of quantitative imaging and AI will help accelerate WPD’s development programs while reducing R&D costs, timelines, and uncertainties. This work will support the field of advanced cancer drug development as a whole and provide much needed treatment options to patients with glioblastoma.”

 Diana Dupont-Roettger, Chief Scientific Alliance Officer of IAG commented, “The integration of advanced imaging and AI driven image analysis will prevent a false response assessment in patients experiencing pseudo-progression and thereby enhance the efficacy read out of Berubicin, avoid early patient drop-out and save costs. IAG is excited to collaborate with WPD and to support the clinical development with optimal imaging trial design, efficient imaging data management and response assessment.”

 

About Image Analysis Group

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. IAG’s independent Bio-Partnering division fuses risk-sharing business models and agile culture to accelerate novel drug development. 

About WPD Pharmaceuticals

 WPD is a biotechnology research and development company with a focus on oncology and virology, namely research and development of medicinal products involving biological compounds and small molecules.  WPD has licensed in certain countries 10 novel drug candidates with 4 that are in clinical development stage. These drug candidates were researched at medical institutions, and WPD currently has ongoing collaborations with Wake Forest University and leading hospitals and academic centers in Poland.

WPD has entered into license agreements with Wake Forest University Health Sciences and sublicense agreements with Moleculin Biotech, Inc. and CNS Pharmaceuticals, Inc., respectively, each of which grant WPD an exclusive, royalty-bearing sublicense to certain technologies of the licensor. Such agreements provide WPD with certain research, development, manufacturing and sales rights, among other things.  The sublicense territory from CNS Pharmaceuticals and Moleculin Biotech includes for most compounds 30 countries in Europe and Asia, including Russia.

 Cautionary Statements:
 Neither the Canadian Securities Exchange nor the Investment Industry Regulatory Organization of Canada accepts responsibility for the adequacy or accuracy of this release.
This press release contains forward-looking statements. Forward-looking statements are statements that contemplate activities, events or developments that the Company anticipates will or may occur in the future. Forward-looking statements in this press release include that IAG’s technology will enhance our analysis of the effects of Berubicin, that we may partner with IAG regarding our other compounds and that WPD’s drugs could be developed into novel treatments for cancer. These forward-looking statements reflect the Company’s current expectations based on information currently available to management and are subject to a number of risks and uncertainties that may cause outcomes to differ materially from those projected. Factors which may prevent the forward looking statement from being realized is that the IAG technology may not provide the benefits expected and we may not engage them further; competitors or others may successfully challenge a granted patent and the patent could be rendered void; that we are unable to raise sufficient funding for our research; that we may not meet the requirements to receive the grants awarded; that our drugs don’t provide positive treatment, or if they do, the side effects are damaging; competitors may develop better or cheaper drugs; and we may be unable to obtain regulatory approval for any drugs we develop. Readers should refer to the risk disclosure included from time-to-time in the documents the Company files on SEDAR, available at www.sedar.com. Although the Company believes that the assumptions inherent in these forward-looking statements are reasonable, they are not guarantees of future performance and, accordingly, they should not be relied upon and there can be no assurance that any of them will prove to be accurate. Finally, these forward-looking statements are made as of the date of this press release and the Company assumes no obligation to update them except as required by applicable law.

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

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

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

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

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

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>