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Illumina Appoints Bob Ragusa as Chief Executive Officer (CEO) of GRAIL

On October 15, 2021 Illumina, Inc. (NASDAQ:ILMN) reported that Bob Ragusa has been appointed as Chief Executive Officer of GRAIL, a healthcare company whose mission is focused on multi-cancer early detection, effective immediately (Press release, Illumina, OCT 15, 2021, View Source [SID1234591285]). GRAIL currently operates as a separate and independent unit of Illumina.

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"With over three decades of experience in genomics, Bob possesses the strategic vision and strong track record of execution to successfully scale GRAIL and bring its breakthrough early cancer detection test to billions around the world," said Francis deSouza, Chief Executive Officer, Illumina, Inc. "His extensive experience building and leading high-performing organizations, as well as his deep understanding of our industry, make Bob the perfect fit to lead GRAIL. I’d also like to thank Hans for his leadership and commitment to advancing multi-cancer early detection."

Hans Bishop, who has been Chief Executive Officer since June 2019, has chosen to step down and will serve as Advisor to Bob Ragusa through the end of 2021.

"Successfully bringing Galleri, GRAIL’s multi-cancer early detection test, to market has been one of the proudest achievements of my career," said Hans Bishop. "I am grateful to have led GRAIL over the last two and a half years. With Illumina, GRAIL’s world-class talent will advance innovation to further accelerate the development and commercialization of new diagnostic tools and services in the fight against cancer."

Ragusa is one of the most respected leaders in the industry with over 30 years of experience in genomics. As Illumina’s Chief Operations Officer, he was responsible for significantly scaling the business to serve over seven thousand customers in more than 140 countries. He was also responsible for Illumina’s Clinical Lab Services which processed millions of genomic samples per year. His organization included the global Manufacturing, Clinical Lab Services, Supply Chain, Quality, Life Cycle Management, Information Technology, and Global Facilities and Real Estate teams, all committed to ensuring high product quality and customer satisfaction.

Before joining Illumina in 2013, Ragusa was Executive Vice President of Engineering and Global Operations at Accuray, a radiation oncology company, where he and his team were responsible for the development, manufacturing and distribution of innovative precision treatment solutions. Ragusa served as Senior Vice President of Global Operations for Applied Biosystems, where he played an instrumental role in ramping up the availability of QPCR, as well as the sequencing systems that were used by the Human Genome Project.

"Leading GRAIL is the culmination of my career, including my work in genomics, oncology and scaling businesses to increase access to groundbreaking products that positively impact human health," said Ragusa. "I am honored to lead this talented team during a time of extraordinary growth and discovery with the express purpose of deploying innovation and cutting-edge science to help save lives."

Ragusa holds a Master of Science in Biomedical and Electrical Engineering from Carnegie Mellon University as well as a Bachelor of Science in Electrical Engineering and a Master of Business Administration from the University of Connecticut.

I-Mab Advances Late-stage Development of Its Differentiated CD38 Antibody Felzartamab (TJ202) in China

On October 15, 2021 I-Mab (the "Company") (NASDAQ: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that it has completed the patient enrollment of the phase 3 clinical trial of human CD38 antibody felzartamab (also known as TJ202) in combination with lenalidomide as a second-line therapy in patients with multiple myeloma (MM) (Press release, I-Mab Biopharma, OCT 15, 2021, View Source [SID1234591284]).

The phase 3 trial (NCT03952091) is a randomized, open-label, parallel-controlled, multi-center study to evaluate the efficacy and safety of the combination of felzartamab, lenalidomide (LEN) and dexamethasone (DEX) versus the combination of LEN and DEX in patients with relapsed or refractory MM who received at least one prior line of treatment. The primary endpoint of the study is to evaluate the progression-free survival (PFS) comparing the efficacy of felzartamab plus LEN/DEX versus LEN/DEX. Data from this study are expected to be the major package supporting Biologics License Application (BLA) submission for second-line treatment of MM in China.

"We are delighted to have completed the patient enrollment as planned under very challenging circumstances. The results will further support the clinical program towards registration to treat patients with multiple myeloma in China," said Dr. Joan Shen, CEO of I-Mab.

I-Mab has completed the single-arm registrational trial with felzartamab and DEX as a third-line therapy for MM patients in Greater China (NCT03860038). Topline data from the study has met the primary and secondary endpoints and confirmed its clinical advantages as estimated. BLA submission is on track in Q4 2021. Further, a new IND application is planned in Q4 2021 to initiate a clinical trial for combination of felzartamab with another I-Mab clinical asset as a potential first-line treatment for MM.

About Felzartamab

Felzartamab (TJ202/MOR202) is an investigational human monoclonal antibody derived from MorphoSys’ HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, which has been characterized as one of the most strongly and uniformly expressed antigens on the surface of malignant plasma cells. According to its suggested mode of action, the antibody recruits cells of the body’s immune system to kill the tumor through antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP). The antibody does not involve complement dependent cytotoxicity, or CDC, an additional immune mechanism involved in tumor cell killing. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential also in other cancers as well as autoimmune diseases. Based on a licensing agreement between MorphoSys and I-Mab signed in November 2017, I-Mab owns the exclusive rights for development and commercialization of TJ202/MOR202 in mainland China, Taiwan, Hong Kong and Macao.

Geron to Host a Virtual Investor Event in November

On October 15, 2021 Geron Corporation (Nasdaq: GERN) reported that it will host a virtual investor event on November 9 at 4:00 p.m. ET. Topics to be covered at the event, include (Press release, Geron, OCT 15, 2021, View Source [SID1234591283]):

The unmet medical needs in lower risk myelodysplastic syndromes and refractory myelofibrosis and the disease modification potential of imetelstat, Geron’s first-in-class telomerase inhibitor.
Expansion opportunities for imetelstat into new indications and in combination with other drugs.
A live physician panel discussion and question-and-answer session with:
Dr. Swaminathan Iyer, Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas
Dr. John Mascarenhas, Associate Professor of Medicine, Icahn School of Medicine at Mount Sinai, New York, New York
Prof. Uwe Platzbecker, Director, Clinic and Policlinic for Hematology, Cell Therapy and Hemostaseology, University Hospital, Leipzig, Germany
A live webcast of the presentation will be available through the Investor Relations section of Geron’s website under Events. Following the presentation, the webcast will be archived and available for replay for a period of 30 days.

Genmab Announces that Janssen has Received Positive CHMP Opinion for RYBREVANT® (amivantamab) for Patients with Advanced Non-small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations, After Failure of Platinum-based Therapy

On October 15, 2021 Genmab A/S (Nasdaq: GMAB) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended the granting of a conditional marketing authorization in Europe for Janssen’s amivantamab, a fully human bispecific antibody, for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) exon 20 insertion mutations, after failure of platinum-based therapy (Press release, Genmab, OCT 15, 2021, View Source [SID1234591282]). In July 2012, Genmab entered into a collaboration with Janssen Biotech, Inc. to create and develop bispecific antibodies using Genmab’s DuoBody technology platform. This is the first CHMP opinion for a product that was created using Genmab’s proprietary DuoBody technology platform.

"Following the U.S. FDA approval of RYBREVANT earlier this year, we are extremely pleased that the CHMP has granted Janssen a positive opinion for amivantamab, the first such opinion for a product created using Genmab’s DuoBody technology platform. We are hopeful that this opinion will lead to an approval and to the first treatment option for European patients with advanced NSCLC with activating EGFR exon 20 insertion mutations," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

For more information related to Janssen’s CHMP opinion for amivantamab, click here.

Roche announces PathAI collaboration for artificial intelligence-based digital pathology applications for improved patient care

On October 15, 2021 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that it has entered an agreement with PathAI, a global leader in artificial intelligence (AI)-powered technology for pathology (Press release, Hoffmann-La Roche, OCT 15, 2021, View Source [SID1234591281]). Under the development and distribution agreement, the companies will jointly develop an embedded image analysis workflow for pathologists. This workflow will allow PathAI image analysis algorithms to be accessed within NAVIFY Digital Pathology, the cloud version of Roche’s uPath enterprise software. This collaboration is now 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.

This agreement with PathAI is among the first to expand digital tools through the Roche open environment, and is one of the first for PathAI to distribute its AI-powered solutions via a third party platform.

"Working together, Roche and PathAI will bring the latest leading technologies to pathologists through our digital pathology solution. Expanded access to a menu of high medical value digital diagnostic tools will further ensure that patients are accurately diagnosed and receive the most effective treatment available," said Thomas Schinecker, CEO Roche Diagnostics.

Roche will initially distribute PathAI-developed research-use-only (RUO) algorithms through NAVIFY Digital Pathology, spanning multiple cancer types. The combined innovation will expand support for healthcare companies’ companion diagnostic and drug development programs.

"This collaboration brings together all of the components required to deliver and commercialise a differentiated AI-based digital pathology medical device including assay, scanner, image management system and algorithm. We believe this partnership will unlock the potential for digital pathology in the companion diagnostics setting, offering a differentiated service to biopharma sponsors and ultimately new opportunities to improve patient outcomes," said Dr. Andy Beck, CEO of PathAI.

About Roche Digital Pathology
As the leading provider of pathology lab solutions, Roche is delivering an 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.

Whole slide imaging combined with modern artificial intelligence (AI)-based image analysis tools have the potential to transform the practice of pathology. The use of AI and deep learning methods to interpret whole slide images in digital pathology enables pathologists to derive novel and meaningful diagnostic insights from tissue samples. AI-based image analysis automates quantitative tasks and enables fast, repeatable evaluation of information-rich tissue images that are sometimes difficult to interpret manually. AI-based image analysis uncovers aspects that are invisible to the human eye and reduces the risk of human error. Patients, whose tissue samples are analysed using AI-based image analysis, can benefit from a faster and more accurate diagnosis. The insights gained from these analyses can help pathologists determine the best treatment option for cancer patients.

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.