On December 7, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that it will host a hybrid event featuring key opinion leaders (KOLs) in multiple myeloma on Monday, December 13 at 8pm ET (Press release, Legend Biotech, DEC 7, 2021, View Source [SID1234596573]).

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The meeting will detail new and updated data from the CARTITUDE Clinical Development Program for ciltacabtagene autoleucel (cilta-cel). Cilta-cel is an investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell (CAR-T) therapy being studied for the treatment of patients with relapsed and/or refractory multiple myeloma. The meeting will follow the oral and poster presentations of the studies at the 63rd ASH (Free ASH Whitepaper) Annual Meeting & Exposition.

The event participants will include Ying Huang, PhD, CEO and CFO of Legend Biotech, and the following professionals in hematology and oncology:

Sundar Jagannath, MD, Professor of Medicine, Hematology and Medical Oncology, Mount Sinai School of Medicine; Director, Multiple Myeloma Program at Mount Sinai Hospital
Saad Usmani, MD, Professor of Medicine, Weill Cornell Medical College; Chief of Myeloma Service, Memorial Sloan Kettering Cancer Center of New York
This meeting will be available to investors and other interested parties by accessing the Legend Biotech website at Events and Presentations.

About Multiple Myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.1 Although treatment may result in remission, unfortunately, patients will most likely relapse.2 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory.3 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.4,5 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.6 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.7

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.

On December 7, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of synthetic DNA using its silicon platform, reported the launch of the Twist cfDNA Pan-cancer Reference Standards, a high-quality standardized control for use in the development and continuous monitoring of liquid biopsy tests to detect cancer from blood samples (Press release, Twist Bioscience, DEC 7, 2021, View Source [SID1234596571]).

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Liquid biopsy tests, which rely on NGS-based circulating tumor DNA (ctDNA) analysis, are a promising and growing area in clinical oncology. Liquid biopsy assays can accurately identify a single tumor variant in the presence of thousands of healthy cells. The most sought-after applications in the ctDNA field include early detection of disease, personalization of therapy, monitoring response to therapy, and monitoring for relapse of disease. Developing and standardizing these ultra-sensitive yet accurate ctDNA-based assays is paramount to ensure the resulting analysis from the test informs clinical decisions reliably.

"As the number of clinical validations of liquid biopsies increase, a true ctDNA pan-cancer reference standard, beyond the few variants that are widely available today, will increase liquid biopsies’ accuracy in detecting specific oncogenes and variants," said Florian Battke, director of development at CeGaT GmbH. "There is an obvious benefit of using a synthetic approach like the Twist ctDNA standards, as they are very high quality and closely mimic the properties of real samples without the instability."

The Twist cfDNA Pan-cancer Reference Standards material consists of synthetically designed variant sequences that mimic ctDNA combined with background DNA that is derived from, and closely mimics, human-derived cell-free DNA (cfDNA).

This reference standard can be used by researchers to assist in the development of liquid biopsy assays to establish the analytical limit of detection (LoD) for specific cancer variants and as a control to track the quality of an NGS assay workflow to ensure the fidelity of the assay process.

The Twist cfDNA Pan-cancer Reference Standards can be used within the liquid biopsy workflow, which includes Twist Library Preparation Kit and the Twist Mechanical Fragmentation Kit, for maximum efficacy and provides a large and diverse number of clinically relevant variants, combining best in class methods for variant synthesis with unrivaled control over the specific target allele frequencies in a format which closely mimics the size distribution and fragmentation profile of cfDNA. In contrast, traditional reference standards are limited in the number and variation of variants and typically use cell line-derived DNA which can carry unwanted sequence variations and variable fragment length.

Emily Leproust, CEO and co-founder of Twist Bioscience said, "Building on the success of our SARS-CoV-2 positive controls that are now used in COVID-19 tests worldwide, we believe having precise standard cancer reference controls that can be used in a validated workflow will be a gamechanger to confirm clinical insights from genetic information. While it is possible to create cell-based controls specific to each test, using a robust, precise control set that detects variation in test assays will be pivotal in both development and ongoing monitoring of a wide variety of liquid biopsy assays."

Applying the right reference materials is essential to benchmark the complexity and biological content of DNA found in liquid biopsy samples for assay development and validation. The Twist ctDNA reference material contains over 400 variants, including SNVs, indels, fusions and structural variants, as well as more than 140 clinically relevant variants. All variants are offered with a unique tiling design, which accurately mimics the pattern of naturally derived ctDNAs. All of these features make the Twist ctDNA reference a high-quality standard for the ctDNA variants that cancer liquid biopsy assays are designed to detect.

To demonstrate the limit of detection (LoD) of an ultra sensitive NGS-based liquid biopsy assay, using an accurately quantified ctDNA control is key. Twist’s silicon platform provides an advantage by specifically writing individual variants of interests, thus preventing any interference caused by contaminants derived from cell culture-based methods. Twist’s ctDNA reference material is also well-characterized and quantified, using industry-standard and proprietary methods (NGS, ddPCR, and fluorescence-based quantification).

On December 7, 2021 Xcovery Holdings, Inc., an oncology focused bio-pharmaceutical company, reported the acquisition of a majority and controlling stake in Meryx Inc., a clinical stage immuno-oncology company based in Chapel Hill, North Carolina developing TKIs in a range of hematologic and solid malignancies, including lung cancer (Press release, Xcovery, DEC 7, 2021, View Source [SID1234596570]). The partnership and synergies between Xcovery and Meryx will accelerate and enhance both Xcovery’s and Meryx’s missions to develop small molecule oncology drugs for patients all over the world. A new leadership and board of directors reflecting the new ownership will be established in the coming weeks.

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"We are thrilled to partner on a global level with Meryx, a firm with whom we already have an out-licensing collaboration in China," said Lieming Ding, M.D., Chairman of the Xcovery Board and Chairman of Betta Pharmaceuticals, a major Chinese pharma company. "Meryx has done a remarkable job of developing an innovative cutting-edge oncology pipeline. We are looking forward to building on this impressive track record and collaborating closely with its team to advance the clinical trials of these promising drug candidates."

"Xcovery is at a very exciting juncture in its history," stated Dr. Giovanni Selvaggi, Xcovery’s CEO and CMO. "We are well positioned to accelerate and further strengthen all Meryx’s ongoing R&D projects, both at clinical and pre-clinical level. Jointly with Meryx, and with the support of Betta, we are building a global company to benefit cancer patients worldwide through innovation and precision," added Dr Selvaggi.

Dr. Stephen Frye, Meryx’s CEO also stated, "Through the new collaboration with Xcovery and with our longstanding collaboration with Betta, Meryx will have the opportunity to advance our exciting clinical-stage and preclinical pipeline at a faster pace to improve cancer patients’ care."

Details of the transaction have not been disclosed.

On December 7, 2021 Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) ("Takeda") reported that it will present a total of 23 company-sponsored abstracts at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting being held December 11-14, 2021 in Atlanta, Georgia (Press release, Takeda, DEC 7, 2021, View Source [SID1234596569]). Takeda’s latest research in hematologic diseases focuses on optimizing patient care, while advancing novel approaches for patients with limited or ineffective treatment options.

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Takeda Oncology will present data in multiple myeloma, lymphoma and leukemia from the company’s marketed products as well as provide early insights into the potential of therapies leveraging the innate immune system. In hematology, Takeda will present prospective, post-hoc and real-world data across a range of hematological disorders, aimed at addressing the breadth of needs within the bleeding disorders community, while investigating potentially transformative treatment options.

"At Takeda Oncology, improving patient care is the foundation for all we do," said Christopher Arendt, Ph.D., Head of Oncology Cell Therapy and Therapeutic Area Unit of Takeda. "At this year’s ASH (Free ASH Whitepaper), we look forward to showcasing our deep legacy and leadership in the treatment of hematologic cancers by sharing data that will help to inform the optimal use of our established medicines and presenting research from two pipeline programs designed with the potential to drive potent and effective immune attacks against cancer. While early-stage, we continue to explore these new treatment pathways as we seek to outsmart cancer."

"The hematological data we are highlighting at ASH (Free ASH Whitepaper) this year demonstrates our commitment to furthering personalized care strategies, and leading scientific innovation to address unmet needs within the global bleeding disorders community," added Neil Inhaber, Head of Global Medical Affairs, Rare Genetics and Hematology. "In addition to developing our promising pipeline of investigative molecules, which may have transformative potential for multiple rare and life-threatening hematological conditions, we remain focused on expanding the use of our current portfolio to benefit more people living with rare bleeding disorders."

A full list of company-sponsored abstracts can be found here.

rADAMTS13 (TAK-755), modakafusp alfa (TAK-573), and subasumstat (TAK-981) are investigational compounds that have not been approved for use by the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), or any other regulatory authorities.

Takeda’s Commitment to Oncology

Our core R&D mission is to deliver novel medicines to patients with cancer worldwide through our commitment to science, breakthrough innovation and passion for improving the lives of patients. Whether it’s with our hematology therapies, our robust pipeline, or solid tumor medicines, we aim to stay both innovative and competitive to bring patients the treatments they need. For more information, visit www.takedaoncology.com.

Takeda’s Commitment to Hematology

Takeda is a leader in hemophilia with the longest heritage and market-leading portfolio, backed by established safety and efficacy profiles with decades of real-world experience. We have 70+ years driving innovation for patients and a broad portfolio of 11 products across multiple bleeding disorders. Our experience as a leader in hematology means we are well prepared to meet today’s needs as we pursue future developments in the care of blood disorders. Together with the hematology community, we are raising expectations for the future, including earlier diagnosis, earlier and full protection against bleeds, and more personalized patient care.

On December 7, 2021 Immunome, Inc. (Nasdaq: IMNM), a biopharmaceutical company that utilizes its human memory B cell platform to discover and develop first-in-class antibody therapeutics, reported that members of management will participate in a fireside chat hosted by Cantor Fitzgerald Analyst Brian Cheng on Wednesday, December 8, 2021 at 1:00 p.m. ET (Press release, Immunome, DEC 7, 2021, View Source [SID1234596567]).

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The live call is reserved for institutional clients of Cantor Fitzgerald. A replay of the webcast can be accessed from the Investor Relations section of the company’s website at www.immunome.com. The webcast replay will be available at the conclusion of the live presentation for approximately 30 days.