On January 27, 2022 InnovHeart s.r.l., a developer of novel Transcatheter Mitral Valve Replacement (TMVR) systems for the treatment of mitral valve disease, reported the closing of its Series C financing with granting an exclusive licensing agreement to Grand Pharmaceutical Group Limited, (Grand Pharma) for its proprietary Saturn device in Greater China (Press release, China Grand Pharmaceutical, JAN 27, 2022, https://www.innovheart.com/innovheart-raises-55-million-in-series-c-financing-to-further-develop-the-trans-septal-saturn-transcatheter-mitral-valve-replacement-system/ [SID1234607467]).

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The transaction pulled in more than $55 million in equity, upfront licensing fees, milestone payments and structured royalties.

Series C equity round was led by Grand Pharma, together with the existing investors Genextra, Panakes Partners and Indaco Venture Partners confirming their ongoing support by joining this investment round. Under the license agreement, Grand Pharma is entitled to develop, manufacture and commercialize the Saturn device in Mainland China, Hong Kong, Macau and Taiwan.

‘Interventional treatment for mitral regurgitation is considered to be one of the most challenging areas in the field of structural heart disease, yet also represents huge market potential, estimated to reach $17.4 billion globally in future years. This strategic agreement will provide InnovHeart with resources that will accelerate the development of the trans-septal version of the Saturn system into First-in-Human clinical trials, as well as access to the dynamic Chinese structural heart market’, said Keith D. Dawkins MD, Chairman of InnovHeart Board of Directors.

Commenting on this new collaboration, Shawn Chen, Senior management of the Medical Device Division of Grand Pharma, said, ’We are very excited about this collaboration. The successful closing of this transaction demonstrates that Grand Pharma has completed the strategic layout in our cerebro-cardiovascular high-end medical devices sector. InnovHeart Saturn technology is one of the most promising TMVR technologies in the market. I am confident that with InnovHeart’s expertise in this field and Grand Pharma’s strong capability and resources, we will bring this innovative clinical solution to Chinese patients soon’.

’InnovHeart has already demonstrated excellent mid-term (>1 year) results with the trans-apical version. This low profile, adaptive valve design decreases the risk of LVOT obstruction and will be implanted transeptally in FIH in 2022’, said Paolo Denti MD, Cardiac Surgeon, San Raffaele University Hospital, Milan, Italy.

On January 27, 2022 Biogen Inc. (Nasdaq: BIIB) reported that they have entered into an agreement whereby Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion (Press release, Biogen, JAN 27, 2022, View Source [SID1234607484]).

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Biogen and Samsung Bioepis have built the industry leading anti-TNF portfolio in Europe1. Upon the acquisition of Biogen’s stake, the companies will continue with their exclusive agreements, including commercialization of their current portfolio. This includes marketed products BENEPALI (etanercept), a biosimilar referencing ENBREL, IMRALDITM (adalimumab), a biosimilar referencing Humira, and FLIXABI (infliximab), a biosimilar referencing Remicade. Additionally, Biogen will also retain commercial rights for BYOOVIZTM (ranibizumab-nuna), an approved biosimilar referencing LUCENTIS (ranibizumab), as well as an investigational biosimilar candidate in development, SB15 (aflibercept), a proposed biosimilar referencing EYLEA.

"We are thankful to Samsung Biologics for a productive collaboration since 2012," said Michel Vounatsos, Chief Executive Officer at Biogen. "We believe biosimilars are essential to help sustain healthcare systems and represent an important value creation opportunity for Biogen."

Samsung Biologics has agreed to pay Biogen up to $2.3 billion for its stake in the joint venture. Under the terms of this agreement, Biogen will receive $1 billion in cash at closing and $1.25 billion to be deferred over two payments of $812.5 million due at the first anniversary and $437.5 million due at the second anniversary of the closing of the transaction. Biogen is eligible to receive up to $50 million contingent upon achievement of certain commercial milestones. Closing of the transaction is contingent on the effectiveness of a securities registration statement filed by Samsung Biologics and satisfaction of certain regulatory and other customary closing conditions. Upon closing, Biogen will recognize a GAAP gain on disposal within other income (expense), net in its consolidated statement of income.

About Biosimilars
Biosimilars are biologic products that have been demonstrated to be similar in efficacy, safety and immunogenicity to the originator’s approved reference product, with the advantage that they can offer significant cost savings and increased patient access. Biosimilars may lower healthcare system costs broadly, creating headroom for innovation and could enable governments to potentially redirect savings to priorities such as increasing access to transformative therapies.

On January 26, 2022 Servier, an independent international pharmaceutical company, reported that it has partnered with French start-up Epigene Labs to develop an artificial intelligence-based application that prioritizes new cancer drug targets to determine the best therapeutic pathway to treat cancer patients (Press release, Servier, JAN 26, 2022, View Source;utm_medium=rss&utm_campaign=oncology-servier-collaborates-to-create-innovative-application-for-researchers [SID1234607399]). The application will be deployed within Servier R&D in the first quarter of 2022.

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Founded in January 2019, French startup Epigene Labs has developed the mCUBE platform with augmented intelligence for aggregating and analyzing genomic data in oncology to derive biomarkers and prioritize new cancer drug targets.

Based on Epigene Labs’ mCUBE platform, the application is perfectly suited for oncology projects and Servier R&D users. The mCUBE platform allows users to cross-analyze clinical and molecular data (omics data) through a suite of dynamic dashboards, accelerating the decision-making process in the early phases of oncology projects.

Epigene Labs has developed this application based on specifications provided by Servier’s teams from several fields of expertise (Bioinformatics, IT/data, oncology, Digital Information and Data System – DIDS). The mCUBE platform is widely deployed among Servier R&D users. In order to ensure continuous improvement, users will regularly share their feedback with Epigene Labs teams.

According to Céline Lefebvre, Ph.D., who leads the computational medicine team at Servier R&D and who is in charge of this project: "Epigene Labs has delivered a solution that is perfectly adapted to Servier’s projects in the field of oncology and that is in line with Servier’s Data&IA R&D strategy. The mCUBE platform will accelerate our decision making. It is a great lever for improving our working methods for the benefit of cancer patients.

Akpéli Nordor, Pharm.D., Ph.D., co-founder and CEO of Epigene Labs, added, "Epigene Labs is pleased to work with Servier to demonstrate the utility of its tools. As oncologists, we have a unique understanding of the tools other oncologists need to accelerate data-driven drug discovery, biomarker identification and patient selection. We look forward to continuing our collaboration with Servier to rapidly deliver the best treatments to cancer patients."

The partnership with Epigene Labs illustrates Servier’s open and collaborative innovation dynamic, which aims to surround itself with a network of diversified partners to accelerate therapeutic innovation and offer patients innovative and personalized treatments.

Céline Triquel, Open Innovation Project Manager at Servier, concludes: "This project called for collaborative work methods, agility, courage and perseverance, with the objective of developing innovations for the patient. I would like to thank all the contributors to this project, which illustrates our willingness and ability to access and integrate cutting-edge technologies, driven by open innovation and supported by the startup@servier program. "*

* The startup@servier program aims to create value for the startup and Servier with the objective of accelerating therapeutic innovation for the benefit of patients. A first phase of joint work allows the startup to conduct a key study or pilot application of a technology, before entering into a classic collaboration.

On January 26, 2022 Aptus Clinical reported A new trial opens in Greater Manchester which is to test cutting-edge wearable technologies involving patients who have received cancer treatment (Press release, Aptus Clinical, JAN 26, 2022, View Source [SID1234607418]).

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The commercially-available health sensors and devices produce a digital fingerprint of vital signs that could allow doctors to assess the progress of their patients.

Called, EMBRaCE, (Enhanced Monitoring for Better Recovery and Cancer Experience), the trial is a collaboration between Manchester University NHS Foundation Trust, The Christie NHS Foundation Trust and The University of Manchester.

The trial opens initially for blood cancer, lung, and colorectal cancer patients and will run across Greater Manchester.

The technologies under investigation include:

a smart ring, worn on any finger made by the company Oura
the Withings ScanWatch, a hybrid smartwatch
the Isansys system, which is worn on the chest.
The technologies can assess a range of vital signs, including electrocardiogram (ECG), heart rate, temperature, physical activity levels and sleep.

Dr Anthony Wilson, Consultant in Anaesthesia and Critical Care at Manchester Royal Infirmary (MRI), part of MFT, is the clinical lead for the project.

He said: "Cancer places a huge burden on the lives of people everywhere. This study uses cutting-edge technology that can monitor people during their treatment, with devices that they can wear all the time.

"We hope that it will provide new insights into how people cope with cancer treatment and what we can do to improve their recovery."

Dr Michael Merchant, Senior Lecturer in Proton Therapy Physics, at The University of Manchester, said: "This trial will assess if the latest wearable technology has a role in cancer care.

"It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy.

"We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic.

"It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers."

Thomas Westworth, 70, is from South Lakeland in the Lake District. Now retired, he was self-employed within the building trade for 40 years, and has been receiving care for lymphoma at Manchester Royal Infirmary, part of Manchester University NHS Foundation Trust (MFT), for three months.

Mr Westworth will be taking part in the trial in the next couple of weeks when he receives his first infusion of CAR-T (Chimeric Antigen Receptor T-cell) therapy – a personalised medicine used to treat patients with certain types of leukaemia and lymphoma.

Mr Westworth said he is ‘fascinated by technology’, and was happy to consent to taking part in EMBRaCE when he was approached by the study team.

"I said if could be of any help I’d be happy to take part," said Mr Westworth.

"I think the actual idea behind the trial is fantastic, I think it should help people.

"All the staff here at Manchester Royal Infirmary and other hospitals where I have been cared for have been fantastic, everyone is absolutely brilliant."

EMBRaCE is funded by the GM Cancer Digital Innovation Fund, UK Research and Innovation and the National Institute for Health Research (NIHR) in collaboration with Aptus Clinical and Zenzium Ltd.

This trial will assess if the latest wearable technology has a role in cancer care. It will help us to identify ways that clinical staff can individualise treatment before, during, and after therapy. We will find out if 24/7 data from these wearable sensors can be used to support patient recovery and provide accurate measurement outside clinic. It could even support the development of new cancer treatments by developing a digital platform for clinical trials in cancer involving wearable devices or fitness trackers.
Dr Michael Merchant

Steve McConchie, CEO of Aptus Clinical, a clinical contract research organisation based in Alderley Park, Cheshire, said: "We are delighted that the clinical data collection and curation infrastructure we initially created to support an important piece of exploratory research into COVID-19 is being expanded to assess the utility of patient wearables to improve the care of cancer patients across Manchester.
"We look forward to continuing this collaboration with our partners at MFT , The Christie, and Zenzium and are pleased to be supporting research with the potential to make a real difference to patient’s care."

EMBRaCE is partnered with the health and biomedical data science company Zenzium Ltd to harness the power of Artificial Intelligence (AI) to analyse and identify key patterns within patient data.

Anthony D. Bashall, Managing Director of Zenzium, said: "We firmly believe the future of healthcare will be driven by continuous rather than episodic measurements to improve patient outcomes on an individual basis.

"We are excited to be part of this ground-breaking collaboration with some of the best entities in the field, which gives us the opportunity to bring our technology, knowledge and expertise in wearable devices enabled by AI to potentially make a real difference in the lives of patients."

Mr Steve Sweeney, cancer survivor and chair of the group of patients who have advised the project commented: "A cancer diagnosis is fraught with a variety of challenges for patients, way beyond the clinical treatment pathway itself.

"We know patients have anxiety around ongoing monitoring and the gap between GP and hospital cancer care, issues with fatigue and sleep disturbance, problems maintaining fitness and the need for greater psychological support.

"The EMBRaCE programme addresses these challenges head on, allowing participants to take more proactive control of their cancer journey through wearables and the data they provide clinicians. These patient pioneers will help shape the future of cancer care in the UK."

Professor Dave Shackley, Director of Greater Manchester Cancer Alliance and the Senior Responsible Officer for Cancer in Greater Manchester said: "We are delighted in Greater Manchester to have such a fantastic study taking place. The smart use of digital technology is going to be pivotal for high quality, personalised cancer care for our patients. We look forward to hearing the outcomes of this exciting research project and in particular implementing any key findings."

On January 26, 2022 CellCentric, a clinical stage, private biotechnology company pioneering small molecule inhibition of p300/CBP to treat cancer, reported it has received funding from BrightEdge, the impact venture capital fund of the American Cancer Society (Press release, CellCentric, JAN 26, 2022, View Source [SID1234607400]). The funding will be used to further progress the clinical development of its ground-breaking, targeted treatment, inobrodib (formerly known as CCS1477) and are accompanied by additional significant investment from existing lead investor, Morningside Investments Limited.

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Inobrodib is a first-in-class small molecule inhibitor that impacts twin regulatory proteins p300 and CBP and thus affects a number of established, yet elusive to treat oncogenes (including Myc, IRF4 and the Androgen Receptor). The orally bioavailable drug is transitioning into Phase II clinical trials in multiple indications; castration resistant prostate cancer (mCRPC), haematological malignancies as well as specifically targeted tumours driven by genomic alterations.

CellCentric recently received confirmation from the World Health Organisation for inobrodib as a new International Non-proprietary Name (INN) for CCS1477. The -brodib suffix represents the new class of drug; p300/CBP bromodomain inhibitors. Any subsequent follower drugs with a similar mechanism of action will bear the same novel drug class stem, -brodib.

Alice Pomponio, Managing Director of the American Cancer Society’s BrightEdge said: "We are delighted to be supporting CellCentric’s mission to bring a novel targeted therapy to people with cancer. At BrightEdge we invest in ground-breaking cancer research with the goal to translate them into commercially accessible solutions that put patients front and centre."

Jason Dinges of Morningside Technology Advisory, and CellCentric Board member, added: "We are proud to continue our support of CellCentric and its mission to bring the first p300/CBP inhibitor to patients. At Morningside we are committed to investing in companies with strong teams and clear plans to deliver on their goals."

Will West, Chief Executive Officer of CellCentric, commented: "We are very pleased to welcome BrightEdge, alongside our cornerstone investor Morningside, as we continue to pioneer targeted cancer treatment through inhibiting p300/CBP. We now know that our drug can be well tolerated and deliver clear signals of efficacy. The task ahead is to build on that, maximising its impact as a monotherapy and in combination with existing standard of care agents, to treat specific cancer types."