On October 18, 2021 Avelas Biosciences, Inc. ("Avelas" or "the Company"), a clinical-stage drug-device company pioneering the field of fluorescence imaging for real-time cancer detection, reported that additions to its senior management team and Board of Directors and provides an update on the pegloprastide Phase III clinical program, due to start in 1H22 (Press release, Avelas Biosciences, OCT 18, 2021, View Source [SID1234591424]).

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Corporate Update

Avelas is pleased to announce it has strengthened its management team with the appointment of Ambareen "Amber" Sheriff as Vice President, Regulatory and Quality and further bolstered its Board of Directors with the appointment of Robin Stevens as a Non-Executive Director of the Company.

Ms. Sheriff is an expert in global regulatory strategies with more than 32 years of regulatory affairs and product development experience. Throughout her career, Ms. Sheriff has led US, EMEA and rest of the world regulatory and quality strategies supporting development and preparation of drug products, investigational studies and marketing authorisations. Prior to joining Avelas, Ms. Sheriff was the VP, Regulatory Affairs and Quality Assurance at Celerity Pharmaceuticals, where she obtained ten regulatory approvals in over six years in the role. Ms. Sheriff previously held roles at Marathon Pharmaceuticals, Winston Laboratories, Akorn, and Baxter Healthcare. Ms. Sheriff holds a B.S. in Pharmacy from the University of Karachi and a B.S. in Chemistry from Northeastern Illinois University.

Mr. Stevens has over 30 years’ experience advising private and public companies in a variety of functions, including corporate finance, capital markets and previously as an international audit partner, in a wide range of industries, operating in the UK and overseas. In addition to his role at Avelas, he is a Senior Advisor and Capital Markets Lead at MHA MacIntyre Hudson.

Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas, added: "As Avelas accelerates towards commencement of our Phase III clinical study for pegloprastide, I am delighted to be strengthening our team both at the management and Board level with the addition of Amber and Robin. We look forward to working closely with them."

Clinical Update

Avelas also announces that it is the Company’s intent to commence its registrational confirmatory Phase III trial for pegloprastide, its novel, best-in-class agent for visualizing breast cancer margins, in the first half of 2022, having received constructive and helpful feedback from the US Food and Drug Administration (the "FDA").

Avelas is developing pegloprastide (AVB-620), a novel fluorescent imaging agent used in combination with a fluorescence camera system, which has FDA Breakthrough Therapy Designation, for the intraoperative detection and visualization of positive margins during breast cancer surgery.

The goal of intraoperative image-guided surgery with pegloprastide is to increase the precision of cancer surgery and improve treatment outcomes for patients by fluorescently identifying cancer, in real-time during surgery, on the surfaces of excised tissue or residual cancer in the tumour bed not otherwise detected by surgeons and potentially left behind in a patient during an operation. Avelas has already demonstrated in prior studies that the use of pegloprastide, a fluorescent cancer marker, during surgery correctly identified cancer in up to 75% of patients who may have otherwise been candidates for a repeat (re-excision) surgery.

Through the benefits of Breakthrough Therapy Designation, Avelas has continued to collaborate with the FDA on the design of the Company’s registrational confirmatory Phase III trial. The design and protocol of the Phase III study will now be finalized in preparation for commencement of patient enrolment in the first half of 2022. Jay Lichter, Ph.D., Chairman, President, and Chief Executive Officer of Avelas said "We believe that pegloprastide is a best-in-class novel agent for visualising breast cancer margins in real time during surgery. Following this constructive dialogue with the FDA, we are excited to continue the clinical development of this exciting candidate."

On October 18, 2021 Roche (SIX: RO, ROG;OTCQX: RHHBY) reported that it has entered an agreement with Ibex Medical Analytics, a global leader in artificial intelligence (AI)-based cancer diagnostics (Press release, Hoffmann-La Roche, OCT 18, 2021, View Source [SID1234591406]). Under the agreement, the companies will jointly develop an embedded image analysis workflow for pathologists to seamlessly access Ibex’s AI algorithms, insights, and decision support tools using NAVIFY Digital Pathology, the cloud version of Roche’s uPath enterprise software. Collaborations with leading AI companies like Ibex are made possible through Roche’s Digital Pathology Open Environment, which allows pathologists to securely access third-party AI-powered technology alongside Roche’s growing menu of AI-based image analysis tools.

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Ibex’s Galen platform was recently granted Breakthrough Device Designation by the U.S. Food and Drug Administration (FDA) and is CE marked in Europe for breast and prostate cancer detection in multiple workflows. Through this alliance, customers using Roche Digital Pathology will gain access to Ibex’s innovative tools, such as algorithms that analyse prostate and breast biopsies, in addition to the AI tools already provided by Roche.

"With the addition of Ibex’s clinical-grade image analysis tools to our NAVIFY Digital Pathology menu, we can aid pathologists and providers in delivering value-based patient care by increasing their efficiency and accuracy for higher quality cancer diagnosis," said Jill German, Head of Roche Diagnostics Pathology Customer Area.

The clinical-grade AI algorithms and digital workflows included in this expanded menu of tools will enable pathologists to provide accurate, efficient and timely diagnoses for their patients and support them in the detection and grading of cancer, identification of important non-cancerous features, case reporting and more.

"Digital pathology provides the capability to introduce new, innovative ways for laboratories to improve quality and efficiency of cancer diagnosis. Together with Roche, we look forward to transforming pathology by delivering powerful AI-based tools to the fingertips of pathologists," said Joseph Mossel, CEO and Co-founder of Ibex Medical Analytics.

About Roche Digital Pathology

As the leading provider of pathology lab solutions, Roche is delivering the end-to-end digital pathology solution from tissue staining to producing high-quality digital images that can be reliably assessed using automated clinical image analysis algorithms. We minimise variables that can impact analysis, and it is this end-to-end development that produces the quality results healthcare providers and researchers can depend on. With the acceleration of immunotherapy and the development of more complex assays, Roche is moving these traditionally research-oriented tools into routine clinical practice and is committed to investing in and shaping the future of pathology.

Roche offers two deployment options for its uPath software: an on-premise solution and a cloud solution, marketed as NAVIFY Digital Pathology. The VENTANA DP 200 slide scanner and Roche uPath enterprise software are CE-IVD marked for in-vitro diagnostic use and are available in the U.S. for research use only (RUO). Image analysis algorithms developed by third-party entities and their utilisation are the responsibility of the third party provider.

On October 18, 2021 Mentice AB (publ) a leading supplier of high-technology solutions for simulation in the medical sector with focus on endovascular procedures, reported that it has through its fully owned subsidiary Mentice Inc entered into an agreement with ABBOTT Inc. to provide simulation solutions for training of interventional devices.

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The order covers systems that will be offered under a rental agreement for a 12-month term and the company will accordingly account for revenue under the same period.

The solutions will support ABBOTT’s CRM division in the work of rolling out new medical devices to the market in a safe and effective way.

The order will be accounted for in the order book for the segment Medical Device Industry during the fourth quarter 2021. The total value for the order amounts to SEK 7.0 million.

On October 18, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) and Accent Therapeutics (Accent) reported that they have signed an exclusive worldwide-collaboration agreement to research, develop, manufacture, and commercialize Accent’s pre-clinical stage METTL3 program (Press release, Ipsen, OCT 18, 2021, View Source [SID1234591402]).

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Acute myeloid leukemia (AML) is a difficult to treat cancer of the blood and bone marrow, accounting for a third of all new cases of leukemia in the US each year.1 Globally, the incidence of AML has been increasing year on year across the last 20 years.2 RNA modifying proteins (RMPs) are an emerging target class that control multiple aspects of RNA biology and represent a new approach for the potential treatment of various cancers. METTL3 is an RMP that has been validated pre-clinically as a novel therapeutic target for AML.1,3 This collaboration combines Accent’s expertise in RMP-targeting therapeutics with Ipsen’s capabilities and proven track record in Oncology medicine development and commercialization.

Christelle Huguet, Senior Vice President, Head of Research, External Innovation and Early Development, Ipsen, said "Oncology is a key focus area for Ipsen as we grow our pipeline. We are delighted to partner with Accent to progress the METTL3 program as we continue our expansion into hematologic oncology. Our teams are steadfast in our commitment to areas of high unmet medical need including rare cancers, so this collaboration is strongly aligned with Ipsen’s mission and strategy for growth."

Shakti Narayan, Chief Executive Officer of Accent Therapeutics said "This collaboration blends Ipsen’s commitment to developing and commercializing transformative oncology medicines with Accent’s leading expertise in the field of RNA modification. As we focus on developing our rich pipeline of novel RMP-targeted therapies, we are pleased to entrust our METTL3 program to the innovative team at Ipsen to bring this novel investigational therapy to patients in need."

Under the agreement, Ipsen will pay up to $446m, comprising upfront payment as well as pre-clinical, clinical, regulatory, and sales-based milestone payments, plus tiered sales royalties ranging from mid-single digits to low-double digits.

ENDS

METTL3 program

One of the most prevalent modifications within mRNA is the methylation of the adenine base at the N6 position, resulting in N6-methyladenosine (m6A). This modification is catalyzed by the methyltransferase enzyme complex METTL3/METTL14. m6A is involved in several aspects of mRNA stability and turnover, controls translation of oncogenes that confer growth advantage and migratory behavior and has emerged as a key mRNA modification implicated in hematological cancers. Knockout of METTL3 and/or METTL14 promotes AML differentiation and apoptosis and has been shown to be important for both in vitro and in vivo growth for AML. Accent Therapeutic’s novel investigational small molecule inhibitors of METTL3 seek to treat specific sub-types of AML with high unmet medical need.

On October 17, 2021 CytoImmune Therapeutics, Inc. ("CytoImmune"), a clinical-stage immunotherapy company, reported that believes its strategic plan not affected by the recent developments around Allogene Therapeutics’ AlloCAR T (Press release, CytoImmune Therapeutics, OCT 17, 2021, View Source [SID1234591776]). CytoImmune’s approach to NK cell immunotherapy does not involve lentiviral transduction or gene editing.

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On October 7th 2021, Allogene Therapeutics reported an FDA clinical hold on its AlloCAR T trials based on a single patient case in its ALPHA2 trial. Assessment of a patient with low blood counts showed a clonal chromosomal abnormality in ALLO-501A CAR T cells of unclear clinical significance. ALLO-501A is an anti-CD19 AlloCAR T which entered Phase 1/2 study in June 2020. ALLO-501A is a T cell product that has undergone lentiviral transduction for expression of its chimeric antigen receptor (CAR) and two rounds of gene editing to knock out the T-cell receptor as well as expression of CD52. The cause of the chromosomal abnormality found in the patient’s ALLO-501A CAR T cells is currently under investigation.

In contrast, CytoImmune is developing a novel class of allogeneic, off-the-shelf natural killer (NK) cell-based immunotherapies engineered to eliminate cancer cells using well-established retroviral transduction technology without the use of gene editing technologies. Our NK cell engineering platform builds on our founders 54 years of collective laboratory investigation of NK cells, their treatment of over 1,000 patients with therapies modulating NK cells in man, and their extensive history of transducing human NK cells to assess gene function.

Our current platforms include proprietary technologies that enable us to: (1) generate an abundant supply of potent human CAR NK cells to treat multiple patients from a single umbilical cord blood product, (2) undertake highly efficient retroviral transduction of the CAR and/or secreted bispecific killer cell engagers into human NK cells, (3) improve the persistence of these CAR NK cells for sustained activity once infused into the body, (4) freeze, store and thaw our CAR NK cells to be infused as an unmatched, allogeneic off-the-shelf treatment of cancer.

CytoImmune continues to advance its NK cell-based platform toward the clinic with patient safety as our highest priority.