On September 23, 2020 Athenex, Inc. (NASDAQ: ATNX), a global biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies for the treatment of cancer and related conditions, reported that the U.S. Food and Drug Administration (FDA) has allowed its Investigational New Drug (IND) application for TCRT-ESO-A2, an autologous T cell receptor (TCR)-T cell therapy targeting solid tumors that are NY-ESO-1 positive in HLA-A*02:01 positive patients (Press release, Athenex, SEP 23, 2020, View Source [SID1234573871]).

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TCRT-ESO-A2 is being developed by Axis Therapeutics Limited, a joint venture between Athenex and Xiangxue Life Sciences Limited ("XLifeSc"), a subsidiary of Xiangxue Pharmaceutical Co., Ltd. (Shenzhen Exchange: 300147). TCRT-ESO-A2 is similar to TAEST16001, an autologous cell-based therapy being developed simultaneously by XLifeSc for clinical application in China in that both therapies express the same affinity-enhanced TCR.

"The FDA’s allowance of this IND application for TCRT-ESO-A2 represents another important milestone for Athenex, as we further expand our oncology-focused pipeline in the field of T cell based cancer immunotherapy," stated Dr. Johnson Lau, Chairman and Chief Executive Officer of Athenex, and Chief Executive Officer of Axis Therapeutics. "We are extremely pleased by the allowance of this IND application, which represents the 10th IND allowed by the FDA for Athenex. We were also excited by the observed preliminary, positive clinical signals in pilot studies in China using TAEST16001 conducted by our partner, XLifeSc."

Mr. YongHui Wang, Chairman and Chief Executive Officer of Xiangxue Pharmaceutical, and Chief Executive Officer of XLifeSc, said, "This achievement with TCRT-ESO-A2 follows the IND allowance of TAEST16001 in China by the National Medical Products Association and represents the successful collaboration of our joint development team at Axis Therapeutics. XLifeSc has initiated a Phase I trial of TAEST16001 in China and we are excited to continue working with the team at Athenex to potentially bring a differentiated and valuable immunotherapy technology to cancer patients around the world."

Dr. Daniel Lang, President of Axis Therapeutics, added, "Our TCR-T cell therapy is based on the proprietary TAEST (T cell receptor Affinity Enhancing Specific T cell therapy) technology platform that provides high binding affinity of TCRs while reducing their off-target toxicity. We are encouraged by the preclinical and early clinical findings that indicate this TCR-T cell therapy technology could potentially be an effective treatment for multiple tumor types. We look forward to rapidly advancing the therapy into clinical development in the U.S."

On September 23, 2020 LifeArc, an independent medical research charity, reported a £3.0m co-investment in British biotech Avvinity Therapeutics alongside the UK government’s Future Fund (Press release, LifeArc, SEP 23, 2020, View Source [SID1234571031]). Lead investor LifeArc leveraged £1.5m of seed funding provided to Avvinity to secure matched funding of £1.5m from the Future Fund. The investment will help progress studies to validate first-in-class novel therapeutics as potential drug candidates for the treatment of solid tumours including gastric cancer, which is a historically intractable disease with limited treatment options.

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Dr David Holbrook, LifeArc’s Head of Seed Funds, said: "We are delighted to be backing Avvinity Therapeutics and its great science with the added endorsement of Future Fund. Alphamers are an entirely novel way to target disease that represent an exciting new approach to amplifying host immunity, and we look forward to translating this exciting and novel innovation towards benefits for patients with difficult to treat cancers."

Avvinity Therapeutics will focus on the development of novel immunotherapeutic molecules known as Alphamers, which harness a strong immune response to target and kill tumour cells. The proprietary Alphamer technology is a "plug-and-play" approach to enhance the performance of antibodies, or any other targeting moiety, so that multiple arms of the immune system are engaged specifically against cancer cells overexpressing the cell-surface targets of the antibodies. Avvinity’s most advanced project targets Epidermal Growth Factor Receptor (EGFR), which is overexpressed in a significant number of solid tumours including gastric tumours, head and neck, colon and lung cancers. Avvinity anticipates that by engaging the immune system Alphamers will have a far greater impact on treating these diseases than existing EGFR targeting agents. Alphamers also show potential in treating haematological cancers.

Avvinity’s patent portfolio exemplifies the use of antibodies, antibody fragments, RNA/DNA Aptamers and small molecules as targeting domains. When conjugated to these targeting agents, Avvinity’s Linker technology drives immune destruction of tumours or diseased tissue with minimal impact on healthy tissue.

Dr Jon Moore, co-founder and Interim CEO of Avvinity Therapeutics said: "LifeArc has an excellent reputation in backing first-in-class therapeutics, and we look forward to working with its team of scientists to help progress Alphamers as important new immuno-oncology medicines."

On September 23, 2020 Sixfold Bioscience and Medicines Discovery Catapult reported that awarded Innovate UK grant to pursue ground-breaking project (Press release, Sixfold Bioscience, SEP 23, 2020, View Source [SID1234568060]).

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Sixfold Bioscience in partnership with Medicines Discovery Catapult, has been given the green light, through the award of an Innovate UK Smart Grant to test a pioneering system designed to deliver drugs directly to cancerous cells, without impacting the healthy cells around it.

Programmable Oligonucleotide Delivery System (PODS), developed by Sixfold Bioscience, is a versatile system which delivers short interfering RNA (siRNA) gene silencing cargo to specific cancer cells. This 18-month funded project with Medicines Discovery Catapult will focus on preclinical assessment, delivery system validation, and informing the clinical development strategy.

Drawing on the pre-clinical expertise and state of the art imaging facilities at Medicines Discovery Catapult, the project will accelerate the completion of a comprehensive preclinical data pack to pharmaceutical industry standards for rapid commercialisation and clinical advancement of Sixfold’s core platform technology.

Dr Anna Perdrix Rosell, co-founder and Managing Director of Sixfold Bioscience commented:

"We are thrilled to lead this collaborative project co-funded by Innovate UK. We are confident that by tapping into MDC’s unique drug development expertise and facilities, the collaboration will accelerate the preclinical development of our drug delivery system and its commercialisation. Our team’s ultimate goal is to unlock the true potential of siRNA therapeutics for cancer patients, and this collaboration takes us one step closer"

Professor Peter Simpson, Chief Scientific Officer at Medicines Discovery Catapult (MDC) added:

"We are delighted to work with Sixfold Bioscience on the validation and development of this innovative drug delivery system. Drawing on MDC’s strong track record of advancing drug delivery modalities and of complex medicines validation, this new partnership has the potential to rapidly progress this delivery modality towards commercial viability."

On September 23, 2020, Gilead Sciences, Inc. (the "Company") reported that it entered into an underwriting agreement (the "Underwriting Agreement") with Barclays Capital Inc. and Wells Fargo Securities, LLC, as representatives of the several underwriters listed in Schedule 1 thereto, relating to the issuance and sale by the Company of (a) $500,000,000 aggregate principal amount of the Company’s Floating Rate Notes due 2021 (the "2021 Floating Rate Notes"), (b) $500,000,000 aggregate principal amount of the Company’s Floating Rate Notes due 2023 (the "2023 Floating Rate Notes"), (c) $2,000,000,000 aggregate principal amount of the Company’s 0.750% Senior Notes due 2023 (the "2023 Fixed Rate Notes"), (d) $750,000,000 aggregate principal amount of the Company’s 1.200% Senior Notes due 2027 (the "2027 Fixed Rate Notes"), (e) $1,000,000,000 aggregate principal amount of the Company’s 1.650% Senior Notes due 2030 (the "2030 Fixed Rate Notes"), (f) $1,000,000,000 aggregate principal amount of the Company’s 2.600% Senior Notes due 2040 (the "2040 Fixed Rate Notes"), and (g) $1,500,000,000 aggregate principal amount of the Company’s 2.800% Senior Notes due 2050 (the "2050 Fixed Rate Notes" and, together with the 2021 Floating Rate Notes, the 2023 Floating Rate Notes, the 2023 Fixed Rate Notes, the 2027 Fixed Rate Notes, the 2030 Fixed Rate Notes and the 2040 Fixed Rate Notes, the "Notes") (Filing, 8-K, Gilead Sciences, SEP 23, 2020, View Source [SID1234567732]).

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Some of the underwriters and their affiliates have engaged in, and may in the future engage in, investment banking and other commercial dealings in the ordinary course of business with the Company or its affiliates. They have received, or may in the future receive, customary fees and commissions for these transactions. In particular, affiliates of certain of the underwriters for this offering are also lenders under the Company’s existing revolving credit facility and serve in various agency or other capacities under such facilities. In addition, affiliates of certain of the underwriters for this offering may become lenders under a new term loan facility that we may enter into to provide a portion of the financing in connection with the previously announced acquisition of Immunomedics, Inc. and may serve in various agency or other capacities under such facility.

In addition, in the ordinary course of their business activities, the underwriters and their affiliates may make or hold a broad array of investments and actively trade debt and equity securities (or related derivative securities) and financial instruments (including bank loans) for their own account and for the accounts of their customers. Such investments and securities activities may involve securities and/or instruments of the Company or its affiliates. If any of the underwriters or their affiliates have a lending relationship with the Company, certain of those underwriters or their affiliates routinely hedge, and certain other of those underwriters or their affiliates may hedge, their credit exposure to the Company consistent with their customary risk management policies. Typically, these underwriters and their affiliates would hedge such exposure by entering into transactions which consist of either the purchase of credit default swaps or the creation of short positions in the Company’s securities, including potentially the Notes. Any such credit default swaps or short positions could adversely affect future trading prices of the Notes. The underwriters and their affiliates may also make investment recommendations and/or publish or express independent research views in respect of such securities or financial instruments and may hold, or recommend to clients that they acquire, long and/or short positions in such securities and instruments.

On September 23, 2020 Accenture (NYSE: ACN) reported that it has built a data and analytics approach to manage and derive insights from pediatric acute myeloid leukemia (AML) genomic data (Press release, Accenture, SEP 23, 2020, View Source [SID1234567721]). Working in collaboration with researchers and clinicians from Fred Hutchinson Cancer Research Center (Fred Hutch), and the Target Pediatric AML (TpAML) computational working group, a large-scale research project which supplied the data, this new approach aims to enable pediatric oncology physicians and researchers — specifically those focused on pediatric AML — to better analyze patient clinical trial and genetic data, with the potential to improve precision medicine.

In collaboration with the TpAML investigators, led by Dr. Soheil Meshinchi at Fred Hutch, Accenture data scientists aggregated and standardized anonymized genomic and clinical data from over 2,000 children with AML, treated in clinical trials. RNA data alone, one of the most critical indicators of treatment outcomes in precision medicine, amounts to over 48,000 columns per patient if managed in a standard table format. Combined with other relevant data points — such as patient demographics, clinical treatment arm, and prognosis — the sheer volume and variety of combinations presents a significant hurdle to comparing patient profiles and outcomes at scale.

"The Accenture data scientists who worked with the TpAML team had the clinical and genomic background knowledge to hit the ground running. We model this type of collaboration in all of our engagements so that we’re able to anticipate challenges and navigate them with speed," said Joe Depa, a managing director for Accenture Applied Intelligence. "In this case particularly, I am pleased that we were able to leverage the power of data and analytics to make this information more accessible to researchers, potentially advancing precision medicine and helping improve people’s lives."

Through this engagement, TpAML investigators provided access to the sequencing data and guidance on key data points — including genetic markers, clinical trial treatment details, and clinical outcomes — that can define a patient’s response to a particular treatment at the time of diagnosis (prior to the start of chemotherapy). These insights could help inform the recommended course of treatment, giving patients and physicians a more robust view of likely clinical success and side effects with standard therapy, based on an individual patient’s genetic makeup and medical history. This approach may provide a more informed pathway to more effective precision medicine for pediatric AML, where therapy might be modified based on patients’ predicted response to standard therapy – i.e., high-risk patients may be allocated to bone marrow transplantation or targeted therapies.

"Integration of genomic and clinical data and getting it into a usable, accessible format is a significant challenge in precision medicine," said Dr. Meshinchi. "This collaborative effort between TpAML investigators and Accenture data scientists provides a mechanism to more informed analysis of clinical and genomic data, and could help identify patients at high risk of failure with conventional treatments. Validation of these findings can help modify patients’ treatments based on their relapse risk."

By applying data science and engineering tools, such as Alteryx and Python, and machine learning libraries like scikit-learn, to this corpus of information, Accenture was able to create a code base that clinicians are using to model, understand and potentially predict how patients may respond to specific treatments. Data was made further accessible and consumable using Unity 3D visualization, offering a more interactive way to view the data in a game-space environment, laying a foundation for advanced, dynamic visualizations and VR experiences which could help clinicians potentially identify anomalies, or which they could use as an interface to present findings.

"For years, patients diagnosed with a disease often received the same treatment. And for some people, that treatment worked. However, for others, it did not work – or did so only marginally, or with serious side effects. With genome mapping, in combination with new analytical, scientific and technological advances, it is possible to develop targeted, more precise, personalized treatments for individuals or similar patient populations," explained Stuart Henderson, global Life Sciences lead for Accenture. "Precision oncology is delivering on the promise of better patient care and health outcomes in remarkable ways and we look forward to seeing more projects like this TpAML investigation."

This project builds on Accenture research underscoring the importance of data management and sharing to drive precision oncology, and the role of data and genomics in biopharmaceutical development.

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