On October 21, 2020 Epsilogen Ltd, a global leader in the development of novel immunoglobulin E (IgE) antibodies to treat cancer, reported the award of a £1 million Smart Grant from the UK’s innovation agency, Innovate UK (Press release, Epsilogen, OCT 21, 2020, View Source [SID1234568793]). Epsilogen will collaborate with King’s College London and use the Smart Grant in a project to further develop the company’s novel cancer immunotherapeutic, EPS 201.

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The project directly follows and is founded upon the outputs from Epsilogen’s previous Biomedical Catalyst Primer grant, which sought to move the Company’s EPS 201 programme closer to the clinic. EPS 201 is a novel IgE-based therapeutic targeting HER2 positive (HER2+ve) solid tumours, harnessing the potent IgE-mediated immune response already showing promise clinically with Epsilogen’s lead drug MOv18-IgE.

EPS201 could address a large unmet need in breast cancer patients with HER2+ve cancers that fail to meet the HER2 expression level needed for Herceptin treatment. Currently, these patients have a five-year survival of less than 70%, which is much lower than that for HER2 negative patients.

Epsilogen’s share of the grant is £0.7m, with the remaining £0.3m being used by King’s to fund the research scientist and laboratory team working on the project.

Dr Tim Wilson, Chief Executive Officer of Epsilogen, commented: "We are proud to have been awarded another grant from Innovate UK for our pioneering work developing IgE-based therapeutics. It is a recognition of our progress to date and the potential that our therapies have in treating patients with cancer. We are looking forward to continuing our very successful collaboration with King’s College London and Professor Karagiannis, whose ground-breaking work is the foundation of the company we are today."

Dr Sophia Karagiannis, Professor of Translational Cancer Immunology and Immunotherapy from King’s College London, commented: "IgE therapies have a clear differentiation from IgG-based therapies, given their completely unique anti-cancer mode of action. Furthermore, EPS 201 has potential to address a large unmet need in breast cancer patients with HER2 positive cancers, making it an ideal candidate for further funding and investigation."

On October 21, 2020 Teneobio, Inc., a clinical-stage biotechnology company developing engineered bispecific antibodies to treat cancer, reported that it has entered into a research collaboration and commercial license agreement with ArsenalBio for the use of Teneobio’s UniDabs, single-domain, human heavy chain only antibodies in Chimeric Antigen Receptor (CAR) T-cell therapy (Press release, TeneoBio, OCT 21, 2020, View Source;utm_medium=rss&utm_campaign=arsenalbio [SID1234568789]).

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Under the terms of the agreement ArsenalBio will have commercial rights to UniDabs against therapy-guiding antigens for one of its proprietary immune cell therapy programs. Teneobio will receive an upfront payment, potential clinical and regulatory approval milestones as well as royalties on commercial sales world-wide.

Omid Vafa, CBO of Teneobio, said, "We are excited that ArsenalBio selected UniDabs as part of its efforts to advance immune cell therapies targeting solid tumors. We believe our UniDab platform for targeted cellular therapies offers unique advantages to support the work underway by the ArsenalBio team." Ken Drazan, CEO of ArsenalBio said, "We continue to make notable progress in our pipeline toward addressing the unmet need and suffering of patients with cancer by developing and advancing a new paradigm of human immune cell therapy design, manufacture, and clinical assessment. The UniDab platform will help contribute to this important work on behalf of patients."

On October 21, 2020 Ascentage Pharma (6855.HK), a globally focused, clinical-stage biotechnology company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, reported that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) has granted Guangzhou Healthquest Pharma Co., Ltd, a wholly-owned subsidiary of the company, priority review to its New Drug Application (NDA) for Olverembatinib (HQP1351) (Press release, Ascentage Pharma, OCT 21, 2020, View Source [SID1234568769]). The NDA of Olverembatinib was submitted based on results from two pivotal studies for the treatment of patients resistant to tyrosine kinase inhibitors (TKI) and with T315I-mutant chronic phase chronic myeloid leukemia and accelerated phase CML.

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Priority review status accelerates research and development of innovative drugs with significant clinical advantages and for which there is an urgent medical need. According to the Provisions for Drug Registration (SAMR Order No. 27) and Working Procedures for Priority Review and Approval of Drug Marketing Authorization (Interim) (No. 82 of 2020) implemented on July 1, and July 7, 2020, respectively, the regulatory authority will prioritize the review process and evaluation resources for applications with expected shorter review timelines, which helps accelerate the market access of these innovative drugs.

CML is a hematologic malignancy of the white blood cells. BCR-ABL TKI have significantly improved the clinical management of CML. However, despite clinical benefits offered by the first-generation BCR-ABL inhibitor imatinib (GLEEVEC), and several second-generation TKIs, acquired resistance to TKIs remains a major challenge in the treatment of CML. BCR-ABL tyrosine kinase mutations represent a key mechanism of acquired drug resistance; T315I, which is the most common drug-resistant mutation, occurs in about 25% of patients with drug-resistant CML. Patients with T315I-mutant CML are resistant to both first- and second-generation BCR-ABL inhibitors, presenting an urgent unmet medical need for effective treatment.

Olverembatinib is a novel, orally active, potent third-generation BCR-ABL inhibitor designed to effectively target BCR-ABL mutants, including T315I, and the first China-developed third-generation BCR-ABL inhibitor targeting drug-resistant CML. In July 2019, HQP1351 was cleared by the US Food and Drug Administration (FDA) to enter a Phase Ib clinical study. In May 2020, Olverembatinib was granted an Orphan Drug Designation and a Fast Track Designation for treating CML with specific genetic characteristics by the FDA.

"Olverembatinib is the drug candidate of Ascentage Pharma’s first NDA submission, which will become the first third-generation BCR-ABL inhibitor therapeutics in China," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "This priority review granted to Olverembatinib will help expedite the approval process, hopefully soon changing the current treatment options for patients with CML in China who cannot be effectively treated by currently available TKIs. We hope Olverembatinib will soon be approved to benefit more patients."

On October 21, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the company’s MRIdian Linac MRI-guided radiation therapy system will be featured at the 2020 Annual Meeting of the American Society for Radiation Oncology (ASTRO), being held virtually October 24 to 28, 2020 (Press release, ViewRay, OCT 21, 2020, View Source [SID1234568767]). The meeting will feature presentations that showcase the MRIdian system, including how clinicians use this cutting-edge Stereotactic MRI-Guided Adaptive Radiation Therapy (SMART) technology to tackle both tough-to-treat and ubiquitous cancer, expand clinical experience with the device, and impact patient outcomes.

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At this year’s virtual ASTRO meeting, nearly 40 scientific session presentations/posters will highlight the important role of MRIdian in cancer care, including data bolstering its clinical value in the treatment of pancreas, prostate and tough-to-treat tumors such as oligometastases and renal cancer. With the clarity provided by MRIdian’s real-time imaging and automatic beam gating, physicians are equipped to account for anatomical changes and motion caused by respiration or other bodily processes to personalize treatment to the patient’s unique needs.

Acibadem Maslak Hospital will present its data on MRIdian treatment for low- to intermedia-risk prostate cancer patients. This study complements the Amsterdam University Medical Centers studies on patients with intermediate- to high-risk prostate cancer, where no fiducials were required and which resulted in fewer grade 2 toxicities than published data*.
Wednesday October 28, 2:00 PM – 3:00 PM ET
PV 07 – Poster Q&A – Session 7 4130
Weill Cornell/NewYork-Presbyterian, the Miami Cancer Institute (MCI), and the Moffitt Cancer Center are among the institutions presenting on their experiences using SMART for pancreas cancer. Findings are expected to strengthen the current body of literature, with SMART helping clinicians drive positive patient outcomes and new insights on volumes and survivability.
Monday, October 26, 11:45 AM – 11:50 AM ET
QP 12 – GI 02 – Hypofractionation in GI Cancers
Monday, October 26, 2:00 PM – 3:00 PM ET
PV 04 – Poster Q&A – Session 4 3426, 3363, & 3325
Amsterdam University Medical Centers and MCI will share data on utilization of SMART for tough-to-treat tumors, including renal cancer and abdominal oligomets, treated with radiation therapy and immunotherapy.
Monday, October 26, 2:00 PM – 3:00 PM ET
PV 04 – Poster Q&A – Session 4 4407, 2405
As part of ASTRO’s Innovation Hub, a dedicated space within the virtual platform to highlight new technologies and innovations, ViewRay will host two brief Innovation Hub presentations on MRIdian’s capabilities and a presentation on workflow and efficiency by Justin Rineer, M.D., Radiation Oncologist at Orlando Health UF Health Cancer Center. The company will also host an Industry Expert Theater presentation featuring experts from the Dana -Farber/Brigham Women’s Cancer Center discussing their MRIdian clinical experience:

Innovation in Action: What’s next for MRIdian
Sunday, October 25, 12:00 – 12:15 pm ET
Innovation in Action: Real-Time, On-Table Adaptive
Tuesday, October 27, 11:30 – 11:45 am ET
Innovation in Action: MRIdian Solutions for Streamlining Workflow and Improving Efficiency
Monday, October 26, 10:30 – 11:30 am ET
Industry Expert Theater: Maximizing Clinical Value of MRIdian, featuring Dana -Farber/Brigham Women’s Cancer Center
Tuesday, October 27, 11:00 am – 12:00 pm ET
To visit ViewRay’s virtual booth and for a full schedule of the MRIdian-focused presentations at ASTRO 2020 please visit View Source ViewRay’s booth will feature information including:

Experience MRIdian: Treat and Prove what Others Can’t (Demo and more)
The Patient Experience: Latest Videos
Innovation Value: See What’s New with Technology and Treatment
Clinical Value: See the Results
MRIdian in Action: Learn More About our Customer Experience
The Economic Value of MRIdian: The Financial Benefits of Introducing a New Service Line
Additionally, ViewRay will host a physician-led webinar for investors and analysts on Tuesday, October 27, 2020 at 11:00 am ET. Registration is required to attend and will close an hour prior to the start. Please register at View Source

Currently 40 MRIdian systems are installed at hospitals around the world, where they are used to treat a wide variety of solid tumors and are the focus of numerous ongoing research efforts. MRIdian has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. More than 10,000 patients have been treated with MRIdian. For a list of treatment centers, please visit: View Source

* Dearnaley D, Syndikus I, Mossop H, et al. Conventional versus hypofractionated high-dose intensity modulated radiotherapy for prostate cancer: 5-year outcomes of the randomised, non-inferiority, phase 3 CHHiP trial. Lancet Oncol. 2016 Aug;17(8):1047-10.

On October 21, 2020 Samsung Biologics (KRX: 207940.KS) reported that financial results for its fiscal 2020 third quarter ending September 30, demonstrating confident execution of its ongoing business operations (Press release, Samsung BioLogics, OCT 21, 2020, View Source [SID1234568766]).

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The Company recorded strong revenues of KRW 274.6 billion despite the economic impact and slowdown in the global market amid the COVID-19 pandemic. Furthermore, the Company posted an operating profit of a solid KRW 56.5 billion reflecting the Company’s accelerated plans for expansion as part of its long-term strategy. Operating profit margin remained firm at a 20% level, and net income improved to KRW 56.1 billion quarter-on-quarter.

Compared to Q3 of last year, Samsung Biologics improved its revenues by KRW 89.8 billion at 49% as a result of continuous increase in sales volume across all plants. Operating profit increased by KRW 32.9 billion at 139% year-on-year. Gross and operating profit margin rates both improved by 5%p and 8%p respectively.

Samsung Biologics holds a solid financial position with third quarter assets of KRW 6.1 trillion, KRW 4.5 trillion in equity, and KRW 1.6 trillion in liabilities, with a debt ratio of 36.4% and borrowings ratio of 13.2%.

The strong Q3 financial results reaffirm the continuing execution of the Company’s accelerated business strategy, further bolstered by its recent announcements for Plant 4 construction and the opening of its first global expansion with the R&D Center in San Francisco. Both Plant 4, dubbed the "Super Plant" and the new R&D facility are expected to elevate Samsung Biologics’ global competitiveness and client satisfaction to the next level.