On January 14, 2020 Singapore-based precision oncology startup Lucence, reported on the heels of its series A funding, is sharing early data highlighting the capabilities of its liquid biopsy technology to detect somatic variants in patients with blood cancers, with excellent matching between bone marrow and blood (Press release, Lucence, JAN 14, 2020, View Source [SID1234553187]). Lucence’s amplicon-based sequencing technology, known as AmpliMARK, can provide high sensitivity mutation detection in blood for multiple solid tumor types. This new study data demonstrates the performance of AmpliMARK in hematological malignancies, and suggests that it can provide high resolution, target-rich insights for clinicians and patients to better, and less invasively, manage these diseases.

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Liquid biopsy aims to use blood as a platform for cancer screening, diagnosis, treatment, and monitoring. In the case of hematological malignancies like leukemia, current bone marrow-based tests for detecting and monitoring disease progression offer limited sensitivity and are highly invasive. Lucence’s findings suggest that a blood-based liquid biopsy test could be a compelling, highly sensitive clinical alternative to these tests.

Lucence’s poster highlighting their recent study results, Ultrasensitive Detection of Diverse Genomic Alterations in Hematological Malignancies using a Targeted Amplicon-based Sequencing Approach, will be presented Tuesday, January 14th at 4:15 pm Eastern Time at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Advances in Liquid Biopsies meeting in Miami. Based on a study of 65 patients with hematological malignancies, including acute myeloid leukemia, myelodysplastic syndromes, and multiple myeloma, the poster reports high sensitivity of AmpliMARK in detecting genomic alterations in blood and bone marrow samples. The study results show that AmpliMARK detects mutations at a sensitivity down to 0.1% variant allelic frequencies (VAF) and fusion genes like BCR-ABL1 down to 1% VAF. The results also show excellent concordance between bone marrow and blood, suggesting blood could be a viable medium of detection when marrow is challenging to obtain.

AmpliMARK uses a unique molecular bar-code and error correction technology that improves test sensitivity across multiple mutation types for single nucleotide variants and fusion genes. AmpliMARK is the foundational breakthrough technology in Lucence’s offering of blood-based tests for both profiling hematological and solid tumors.

Dr. Zi Yi Lim, senior consultant haematologist at the Centre for Clinical Haematology and study co-author, said, "Molecular diagnostics are an essential part of the workup and an important follow up tool in patients with blood cancers. Bone marrow assessments remain the gold standard investigation to evaluate the genomic disease profile of these patients. However, bone marrow assessments are costly, invasive and uncomfortable for the patient. The finding that Lucence’s technology can detect even low-level mutations in peripheral blood of patients with a high level of concordance to bone marrow is an exciting development. This could facilitate more convenient, cost-effective and regular disease assessments of such patients with a blood test."

Lucence is currently preparing to open their Silicon Valley laboratory to make their liquid biopsy tests more widely available to US clinicians and patients. While the Company’s initial focus in the US will be in profiling late-stage lung cancer patients for treatment selection, the data presented at the AACR (Free AACR Whitepaper) conference provides early validation of the core technology of Lucence’s liquid biopsy tests. Lucence announced their $20 million Series A led by IHH Healthcare, one of the world’s largest integrated private healthcare groups, in November 2019, and their executive team will be attending the upcoming 38th Annual J.P. Morgan Healthcare Conference in San Francisco.

On January 14, 2020 Celsee, Inc., a leading provider of single-cell isolation technology, and Kindstar Global, the largest medical esoteric testing service group in China, reported a purchase agreement to provide scientists at the Kindstar Laboratory System in China with Celsee’s Genesis System for monitoring circulating tumor cells (CTCs) in lung, breast, and bladder cancers as well as single-cell research (Press release, Celsee, JAN 14, 2020, View Source [SID1234553186]). In addition, Kindstar will become a distributor of Celsee’s products in China.

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For this cancer research, Kindstar scientists will use the BioINK kit, which was developed by IncellDx for CTC enumeration in therapeutic monitoring and is performed on Celsee’s Genesis System utilizing the Celselect Technology. Now, researchers will gain access to Celsee’s Genesis System, which has better capture efficiency and detection of CTCs compared to other CTC enumeration platforms.

"Kindstar Global is leading the way for oncology research and testing in China, and we are committed to implementing the most advanced tools for that work," said Dr. Shiang Huang, Founder and CEO of Kindstar. "We are truly impressed by the capabilities of Celsee’s single-cell isolation and enumeration technology and are eager to use it in our own laboratories as well as to make it available to scientists throughout China."

John Stark, Chief Executive Officer of Celsee, commented: "We are very excited to announce the partnership with Kindstar and the opportunity to bring Celsee technology to the clinical research market in China. Our team has worked closely with IncellDx to develop workflows that combine our single-cell tools with their flow cytometry classification assays and BioINK assays for CTC enumeration to assess disease progression and response to therapy."

Celsee’s technology enables high-throughput analysis of single cells with industry-leading capture rates. The Genesis System supports two slide technologies. Celselect slides enrich and enumerate CTCs with high capture efficiency and detection rates. Celsingle slides use a gentle, gravity-based method to capture and isolate thousands of individual cells while maintaining viability and structural integrity for robust downstream analysis in both genomic and proteomic applications and improved sensitivity compared to other single-cell technologies.

On January 14, 2020 Takeda Pharmaceutical Company Limited (TOKYO:4502/NYSE:TAK) ("Takeda") reported that it will provide an update on the progress of its business transformation and priorities today at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Takeda, JAN 14, 2020, View Source [SID1234553185]). President and Chief Executive Officer, Christophe Weber, will share details on Takeda’s portfolio and pipeline strategy, financial outlook, and ongoing sustainability efforts, including its newly established commitment to carbon neutrality across its value chain.

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"Last year was an important and successful year for Takeda as we accelerated our transformation to become a leading global biopharmaceutical company," said Mr. Weber. "Our commitment to bringing better health and a brighter future to patients worldwide continues as we expand our global brands and advance our next-generation pipeline, driving sustainable growth. We also recognize that supporting our patients means we must commit to work on behalf of the broader global community – and one way to do this is by accelerating our environmental efforts."

Commercial Strategy and Innovative Pipeline

As highlighted at its recent R&D Investor Day event in November 2019, Takeda continues to generate significant opportunities through new indications and geographic expansion of its 14 global brands. By cultivating the best science through its research and development engine, comprised of internal capabilities and external partnerships, Takeda is quickly advancing a steady stream of next-generation therapies designed to provide transformative or curative potential for targeted populations with high unmet medical needs in its core therapeutic areas of oncology, rare diseases, neuroscience and gastroenterology.

Over the next several years, Takeda’s pipeline is projected to deliver value with a focus on the potential launches of 12 unique new molecular entities (NMEs) in 14 indications, which represent best-in-class or first-in-class therapies to advance patient standard of care, and that have the potential to deliver more than $10 billion (USD) in aggregate peak sales.

Takeda is confident in its ability to execute in the near-term and achieve sustainable growth through 2024 and beyond, with its portfolio of 14 global brands and additional anticipated product launches intended to fuel its growth trajectory while its next-generation platforms mature.

Additional Highlights include:

~40 NME clinical stage assets; 17 NMEs in Phase 2 and Phase 3
≥15 potential new launches within the next five years in China
8 potential best-in-class/first-in-class NMEs in pivotal studies
~50% of pipeline with orphan drug designation
Diversified modalities in research, including cell and gene therapies, small molecules and biologics
Financial Strength

Takeda is committed to maintaining investment grade credit ratings and remains on track towards its target of 2x Net Debt/adjusted EBITDA ratio within the fiscal years ending March 2022 to March 2024, with rapid de-leveraging driven by strong cash flow and proceeds from non-core asset divestitures. In the first six months of FY19, Takeda reduced its Net Debt/adjusted EBITDA ratio from 4.7x to 3.9x. In addition, four non-core asset divestitures were announced that, together with other potential divestments, are expected to reach $10 billion (USD).

Through expected cost synergies from the acquisition of Shire that are expected to reach a run rate of approximately $2 billion (USD) annually and operating expenditure efficiencies, Takeda is also driving towards its target of a mid-30% underlying core operating profit margin within the fiscal years ending March 2022 through March 2024. Takeda remains committed to shareholder returns with a well-established dividend policy of 180 yen per share annually.

Values-Driven Commitment to ESG (Environment, Social, Governance)

Recognizing that climate change poses a risk to human health, including the spread of infectious diseases, Takeda has made environmental efforts a priority. To date, Takeda has met and exceeded its previously established 2020 environmental goals ahead of schedule, including reducing its CO2 emissions by 33.7% compared to 2005 levels. Furthering the Company’s commitment to the environment, today Takeda will unveil its new 2040 targets to achieve carbon neutrality across its value chain. Takeda intends to do this by eliminating all greenhouse gas (GHG) emissions from its operations (Scopes 1 and 2), working with its suppliers to significantly reduce their emissions (Scope 3), and addressing remaining Scope 3 emissions through verified carbon offsets. Beginning with FY19 GHG emissions, the Company commits to carbon neutrality (Scopes 1, 2, and 3) through the purchase of renewable energy and verified carbon offsets, while simultaneously working to reduce emissions from its operations and suppliers.

In addition to Takeda’s environmental efforts, its overall commitment to ESG – including the Access to Medicines Strategy and Global Corporate Social Responsibility (CSR) Program – has been recognized by multiple benchmark ESG indices. Since 2014, Takeda has risen 15 spots to No. 5 in the latest Access to Medicines Index, which measures commitment and achievements in the field of patient access to medicine and treatment globally. Takeda is proud to have provided access to innovative and potentially life-saving treatments to more than 125,000 patients. In addition, its CSR Program has committed over $100 million (USD) to organizations that work to prevent diseases and improve health outcomes around the world. Takeda is proud that employees are engaged and select the organizations that the CSR Program supports. Takeda’s 2019 Sustainable Value Report provides additional details on the its commitment to ESG.

On January 14, 2020 Distributed Bio, a global leader in computational optimization of fully human monoclonal antibody libraries, is reported a multi target research collaboration with John DiPersio, MD, PhD, Chief of the Division of Oncology at Washington University School of Medicine and Deputy Director of the Alvin J. Siteman Cancer Center in St. Louis (Press release, Distributed Bio, JAN 14, 2020, View Source [SID1234553184]). Distributed Bio will use its proprietary SuperHuman antibody discovery and engineering platform to discover and optimize therapeutics in collaboration with Dr. DiPersio.

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"We are delighted to collaborate with Dr. DiPersio on antibody discovery," says Jacob Glanville, Co-Founder and Chief Executive Officer of Distributed Bio. "The SuperHuman Platform represents the culmination of a decade of our research in computational library design. From analyzing thousands of human immune systems with our machine learning AbGenesis platform, we have harvested from nature the rules of making exceptional therapeutic repertoires. The result is a library of 76 billion antibodies that contains over 5,000 hits against any antigen, thermostable, non-immunogenic, pre-screened by human blood and therapeutically developed in advance to avoid engineering delays downstream. This is an order of magnitude more molecules than can be generated by other technologies, and enables our partners to search for ultra-specific, species-cross reactive therapeutic antibodies at unprecedented speeds. The libraries overcome many of the limitations of other monoclonal generation technologies that have resulted in a unique engineering opportunity: a library that can generate unique and developable hits against every antigen tested, enabling routine success against targets that used to be nearly insurmountable – GPCRs, Ion Channels, pMHC complexes, broadly-neutralizing antibodies against HIV, therapeutic anti-idiotypic antibodies, bi-epitopic antibodies, and mouse/NHP/human cross-reactive antibodies."

Under the terms of the collaboration, Distributed Bio will use its SuperHuman antibody library to discover novel therapeutic antibodies to targets selected by Dr. DiPersio and will also use its Tumbler technology to optimize clones that he already has identified. The lead clones will then be further developed by Dr. DiPersio.

On January 14, 2020 NOXXON Pharma N.V. (Paris:ALNOX) (Euronext Growth Paris: ALNOX), a biotechnology company focused on improving cancer treatments by targeting the tumor microenvironment (TME), reported that following discussions with investors it has received commitments for an investment of €0.5 million through a private placement (Press release, NOXXON, JAN 14, 2020, View Source [SID1234553182]).

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"We are pleased with the ongoing support of the investment community, in particular the long-term investors from Europe and the US who continue to support NOXXON’s strategy and also invested in the capital increases last year. This investment provides additional capital for the company and allows us to advance the Phase 1/2 trial of NOX-A12 in combination with radiotherapy as a 1st line treatment in brain cancer patients, which is one of the key clinical goals for NOXXON. As with the previous private placement, for which we have attracted long-term equity investors, there are no warrants or other option-like instruments attached to this financing," said Aram Mangasarian, CEO of NOXXON.

The price agreed with investors of €0.51 per share represents a 26% discount on the average closing price of the shares over the seven trading days from December 31, 2019, to January 9, 2020. As such, it is anticipated that 980,389 new shares will be issued in the context of this financing. Closing and settlement of this transaction is expected within the next seven days.