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) 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 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 to Optimize 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

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

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

Image Analysis Group (IAG) is a unique clinical development partner to life sciences companies.  IAG broadly leverages it’s 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 see www.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

Dual-Energy CT for Suspected Radiographically Negative Wrist Fractures: A Prospective Diagnostic Test Accuracy Study.

In this prospective study, dual-energy CT and MRI had a similarly high sensitivity and specificity in helping detect radiographically negative wrist fractures. Dual-energy CT had a high sensitivity and a moderate specificity in the detection of bone marrow edema of the wrist. Dual-energy CT had high sensitivity and specificity in depicting fractures of the wrist in patients with suspected wrist fractures and negative findings on radiographs.

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