On October 29, 2019 Inivata, a leader in liquid biopsy, and the European Organisation for Research and Treatment of Cancer (EORTC) have reported a collaboration in which Inivata’s InVisionFirst-Lung liquid biopsy test will be used in a Phase II trial to screen and monitor ALK positive non-small cell lung cancer (NSCLC) patients initiating treatment with third generation ALK inhibitor therapy lorlatinib (Press release, EORTC, OCT 29, 2019, View Source [SID1234549947]).

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Although ALK positive NSCLC cancer patients are known to respond well to ALK inhibition therapies, such as lorlatinib, this has been limited in time by the emergence of drug resistance. Furthermore, the impact of acquired resistance on response to sequential therapies is unknown. The study has been designed to better understand resistance mechanisms and to analyze the correlation between ALK resistance mutational profile and response to lorlatinib.

Inivata’s InVisionFirst-Lung ctDNA test will be used initially to provide ‘real-time’ data for the pre-trial selection of patients through the detection of molecular resistance. The liquid biopsy test will also be used to provide data on ALK mutational profile in relation to each patient’s response to lorlatinib treatment at the point of disease progression and throughout the course of the study for those patients in whom new ALK mutations are detected.

Eighty-four patients will be involved in this Phase II study across 30 participating EORTC sites in Belgium, France, Italy, The Netherlands, Norway, Spain and the United Kingdom. EORTC, an independent, non-profit research organization in cancer, is the trial sponsor. The trial is being funded by Pfizer Inc., the marketing authorization holder of lorlatinib.

Clive Morris, Chief Executive Officer at Inivata, said: "This pharmaceutical company-backed collaboration highlights the value of our InVision platform in providing rapid and repeatable genomic profiling to enable new analyses of disease and benefit patient treatment. EORTC is a highly regarded leader in translation research and we look forward to working with them on this important study."

Dr Denis Lacombe, EORTC Director General, said: "Understanding the patterns of resistance and relapse is one of the most burning challenges in oncology. EORTC’s scientific strategy, being primarily patient centered, has developed, over the years, a specific focus on programs which address the entire course of the disease taking forward the challenges that patients face at recurrence. We are, therefore, particularly excited with this partnership which brings together the capacity of our organization and new technologies to address the applicability of liquid biopsy for longitudinal studies on this critical question. Better understanding of resistance will not only provide insight on how to design the next generation of treatment, but could also potentially suggest combination treatment to prevent the development of resistance."

"I would also like to add that this trial protocol was developed in the Methods in Clinical Research workshop (MCCR). This is a workshop to educate early career investigators on how to develop good clinical trial designs and we are delighted that we have been able to implement this protocol."

InVisionFirst-Lung is a ctDNA next generation sequencing liquid biopsy capable of testing 36 genes, including ALK, relevant to the care of patients with advanced NSCLC. The test is available world-wide for both commercial and research use. In the US, InVisionFirst-Lung is covered for Medicare patients with advanced (Stage IIIB/IV) NSCLC who meet specific clinical criteria.

On October 28, 2019 NeoTX Therapeutics, Ltd. reported the dosing of the first patient in its Phase 1b trial of naptumomab estafenatox (Nap) in combination with AstraZeneca’s checkpoint inhibitor IMFINZI (durvalumab) for the treatment of advanced or metastatic solid tumors (Press release, NeoTX, OCT 28, 2019, View Source [SID1234640359]). The company aims to establish the maximum tolerated dose in the dose-escalation Phase 1b study before advancing to a cohort expansion study.

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"The dosing of the first patient in our Phase 1b trial is a significant milestone for NeoTX, as it is our first clinical-stage molecule developed with our Selective T Cell Redirection (STR) platform," said Asher Nathan, Ph.D., chief executive officer of NeoTX. "Previous clinical studies have shown Nap to be well-tolerated, and preclinical work conducted by the NeoTX team supports its broad potential in treating advanced and metastatic tumors, especially in combination with checkpoint inhibitors. We’re looking forward to bringing this therapy to patients suffering from advanced cancers that have thus far been unresponsive to therapy with checkpoint inhibitors alone."

The open-label, multicenter, dose-finding Phase 1b trial (NCT03983954) will enroll patients with previously treated advanced or metastatic tumors. Patients will be treated with a combination of Nap and durvalumab.

About the STR platform
The STR platform leverages the body’s natural antibacterial immune response to selectively expand and redirect T cells to rapidly infiltrate and kill tumor cells, offering unique advantages in the field of T cell redirection. STR compounds induce the activation and expansion of specific T cells outside of the tumor microenvironment and redirect the T cells to attack the tumor cells.

About naptumomab estafenatox (Nap)
Naptumomab estafenatox is the lead compound in NeoTX’s STR platform and is designed to target the 5T4 antigen that is present on many tumors.

Naptumomab estafenatox was licensed from Active Biotech in 2016. Active Biotech AB (publ) is a biotechnology company with focus on neurodegenerative/inflammatory diseases and cancer. Please visit www.activebiotech.com for more information.

About Durvalumab

Durvalumab (IMFINZI) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is approved for unresectable, Stage III non-small cell lung cancer (NSCLC) in more than 50 countries including the US, in the EU, and Japan based on the Phase III PACIFIC trial. Imfinzi is also approved for previously-treated patients with advanced bladder cancer in 10 countries, including the US.

As part of a broad development program, Imfinzi is also being tested as a monotherapy and in combination with tremelimumab, an anti-CTLA4 monoclonal antibody and potential new medicine, as a treatment for patients with NSCLC, small cell lung cancer, bladder cancer, head and neck cancer, liver cancer, cervical cancer, biliary tract cancer and other solid tumors.

On October 28, 2019 JSR reported that Consolidated Financial Results for the First Six Months of the Fiscal Year Ending March 31, 2020 (Press release, JSR, OCT 28, 2019, View Source net/doc/4185/ir_material_for_fiscal_ym3/72729/00.pdf [SID1234610438])

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1. Consolidated financial results for the first six months of the fiscal year ending March 31, 2020 (from April 1, 2019 to September 30, 2019)
(1) Consolidated operating results (Cumulative)
(2) Consolidated financial position

2. Cash dividends
3. Consolidated earnings forecasts for the fiscal year ending March 31, 2020 (from April 1, 2019 to March 31, 2020)

* Notes
(1) Changes in significant subsidiaries during the period (changes in specified subsidiaries resulting in the change in scope of consolidation): None
(2) Changes in accounting policies and changes in accounting estimates a. Changes in accounting policies required by IFRS: Yes b. Changes in accounting policies due to other reasons: None c. Changes in accounting estimates: None (3) Number of issued shares (ordinary shares) a. Total number of issued shares at the end of the period (including treasury shares)

* Quarterly financial results reports are not required to be subjected to quarterly reviews.
* Proper use of earnings forecasts, and other special matters Caution regarding forward-looking statements The forward-looking statements, including earnings forecasts, contained in these materials are based on information currently available to the Company and on certain assumptions deemed to be reasonable by the Company. These statements do not purport that the Company pledges to realize such statements. Actual business and other results may differ substantially due to various factors. How to obtain supplementary material on quarterly financial results The material on quarterly financial results is available on the Company’s website on Monday, October 28, 2019.

1. Qualitative Information on Quarterly Results
(1) Explanation of Business Results

Overview of the First Half of FY ending March 2020 (April 1, 2019 to September 30, 2019) JSR Group’s main customer industries have continued to face tough conditions since the second half of the previous fiscal year, given the U.S.-China trade conflict, the confusion surrounding the negotiations of the U.K.’s exit from the EU, and other factors, which are exacerbated by the growing economic slowdown in East Asia countries.

Under these circumstances, JSR Group has focused in the Elastomers Business on expanding global sales of products with advantages in technological competitiveness. In the Plastics Business, Techno-UMG Co., Ltd.

— in its second year since its merger — has aimed to realize synergy benefits through business consolidations and continued with integration of sales, development, and manufacturing. In the Digital Solutions Business, the Group has promoted expanded sales of semiconductor products applicable to cutting-edge technologies as well as greater sales of display materials in the Chinese market where strong growth is expected. In the Life Sciences Business, the Group has concentrated on enhancing consolidation of the structures undertaking endto-end biomedical drug discovery, production process development, and contract manufacturing obtained through active business acquisitions, in addition to enlarged sales of highly functional products, a company strength.

In the First Half of FY ending March 2020, the Company reported revenue of 240,149 million yen (down 2.3% year-on-year), operating profit of 18,999 million yen (down 15.2% year-on-year), and profit attributable to owners of parent of 13,472 million yen (down 19.4% year-on-year).

(i) Elastomers Business Segment Overall sales volume in the Elastomers Business segment decreased from the same period of the previous year and revenue was also down, despite satisfactory growth in SSBR sales volume. Operating profit dropped considerably, impacted by a contraction in price spreads due to lower sales prices caused primarily by lower raw material prices. Consequently, the Elastomers Business segment posted an operating loss of 278 million yen, down from an operating profit of 4,715 million yen in the same period of the previous year, on revenue of 91,007 million yen (down 8.4% year-on-year) in the First Half of FY ending March 2020.

(ii) Plastics Business Segment Sales volume, especially sales to overseas destinations, in the Plastics Business segment slipped from the same period of the previous year and revenue also fell. Despite better price spreads supported by lower cost prices on declining raw material prices, operating profit declined due to the significant impact of the sales volume slump. Consequently, the Plastics Business segment posted an operating profit of 3,635 million yen (down 7.9% year-on-year) on revenue of 48,962 million yen (down 6.9% year-on-year) in the First Half of FY ending March 2020.

(iii) Digital Solutions Business Segment Revenue improved in the Digital Solutions Business segment from the same period of the previous year, on the back of sales volume growth in edge computing materials and a good showing by semiconductors in spite of tough conditions in customer markets. Operating profit also rose slightly, driven by revenue growth. Consequently, the Digital Solutions Business segment posted an operating profit of 17,048 million yen (up 2.6% year-on-year) on revenue of 73,731 million yen (up 3.0% year-on-year) in the First Half of FY ending March 2020.

(iv) Life Sciences Business Segment The Life Sciences Business segment saw a sizable jump in revenue from the same period of the previous year, supported by expanded sales in biomedical drug discovery, production process development, and contract manufacturing as well as in diagnostic reagents. The segment’s operating profit increased due to a rise in profits concurrent with expanded revenue. Consequently, the Life Sciences Business segment posted an operating profit of 1,992 million yen (up 376.0% year-on-year) on revenue of 25,080 million yen (up 30.2% year-on-year) in the First Half of FY ending March 2020.

(2) Explanation of Future Forecast Information, such as Forecast of Consolidated Business Results JSR Group revised its forecast of consolidated business results for the full-year of FY ending March 2020 from those announced on July 29, 2019. While the Life Sciences Business has been going strong, sales volume declines and sluggish market conditions in the Elastomers and Plastics Businesses, and the slowdown in customer demand for display materials in the Digital Solutions Business depress the forecast and it is expected to fall below the previous forecast. For detailed numerical information, please refer to "Supplemental Data" published on October 28,2019.

On October 28, 2019 JSR Corporation reported that (Press release, JSR, OCT 28, 2019, View Source [SID1234575065])

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1. Consolidated financial results for the first six months of the fiscal year ending March 31, 2020 (from April 1, 2019 to September 30, 2019)

(1) Consolidated operating results (Cumulative)
(2) Consolidated financial position

2. Cash dividends
3. Consolidated earnings forecasts for the fiscal year ending March 31, 2020 (from April 1, 2019 to March 31, 2020)1. Qualitative Information on Quarterly Results (1) Explanation of Business Results Overview of the First Half of FY ending March 2020 (April 1, 2019 to September 30, 2019) JSR Group’s main customer industries have continued to face tough conditions since the second half of the previous fiscal year, given the U.S.-China trade conflict, the confusion surrounding the negotiations of the U.K.’s exit from the EU, and other factors, which are exacerbated by the growing economic slowdown in East Asia countries. Under these circumstances, JSR Group has focused in the Elastomers Business on expanding global sales of products with advantages in technological competitiveness. In the Plastics Business, Techno-UMG Co., Ltd. — in its second year since its merger — has aimed to realize synergy benefits through business consolidations and continued with integration of sales, development, and manufacturing. In the Digital Solutions Business, the Group has promoted expanded sales of semiconductor products applicable to cutting-edge technologies as well as greater sales of display materials in the Chinese market where strong growth is expected. In the Life Sciences Business, the Group has concentrated on enhancing consolidation of the structures undertaking endto-end biomedical drug discovery, production process development, and contract manufacturing obtained through active business acquisitions, in addition to enlarged sales of highly functional products, a company strength. In the First Half of FY ending March 2020, the Company reported revenue of 240,149 million yen (down 2.3% year-on-year), operating profit of 18,999 million yen (down 15.2% year-on-year), and profit attributable to owners of parent of 13,472 million yen (down 19.4% year-on-year).

(i) Elastomers Business Segment Overall sales volume in the Elastomers Business segment decreased from the same period of the previous year and revenue was also down, despite satisfactory growth in SSBR sales volume. Operating profit dropped considerably, impacted by a contraction in price spreads due to lower sales prices caused primarily by lower raw material prices. Consequently, the Elastomers Business segment posted an operating loss of 278 million yen, down from an operating profit of 4,715 million yen in the same period of the previous year, on revenue of 91,007 million yen (down 8.4% year-on-year) in the First Half of FY ending March 2020.

(ii) Plastics Business Segment Sales volume, especially sales to overseas destinations, in the Plastics Business segment slipped from the same period of the previous year and revenue also fell. Despite better price spreads supported by lower cost prices on declining raw material prices, operating profit declined due to the significant impact of the sales volume slump. Consequently, the Plastics Business segment posted an operating profit of 3,635 million yen (down 7.9% year-on-year) on revenue of 48,962 million yen (down 6.9% year-on-year) in the First Half of FY ending March 2020.

(iii) Digital Solutions Business Segment Revenue improved in the Digital Solutions Business segment from the same period of the previous year, on the back of sales volume growth in edge computing materials and a good showing by semiconductors in spite of tough conditions in customer markets. Operating profit also rose slightly, driven by revenue growth. Consequently, the Digital Solutions Business segment posted an operating profit of 17,048 million yen (up 2.6% year-on-year) on revenue of 73,731 million yen (up 3.0% year-on-year) in the First Half of FY ending March 2020.

(iv) Life Sciences Business Segment The Life Sciences Business segment saw a sizable jump in revenue from the same period of the previous year, supported by expanded sales in biomedical drug discovery, production process development, and contract manufacturing as well as in diagnostic reagents. The segment’s operating profit increased due to a rise in profits concurrent with expanded revenue. Consequently, the Life Sciences Business segment posted an operating profit of 1,992 million yen (up 376.0% year-on-year) on revenue of 25,080 million yen (up 30.2% year-on-year) in the First Half of FY ending March 2020.

(2) Explanation of Future Forecast Information, such as Forecast of Consolidated Business Results JSR Group revised its forecast of consolidated business results for the full-year of FY ending March 2020 from those announced on July 29, 2019. While the Life Sciences Business has been going strong, sales volume declines and sluggish market conditions in the Elastomers and Plastics Businesses, and the slowdown in customer demand for display materials in the Digital Solutions Business depress the forecast and it is expected to fall below the previous forecast. For detailed numerical information, please refer to "Supplemental Data" published on October 28,2019.

On October 28, 2019 Ziopharm Oncology, Inc. ("Ziopharm" or "the Company") (Nasdaq:ZIOP), and The University of Texas MD Anderson Cancer Center reported a new research and development agreement relating to Ziopharm’s Sleeping Beauty immunotherapy program to use non-viral gene transfer to stably express and clinically evaluate neoantigen-specific T-cell receptors (TCRs) in T cells (referred to as TCR-T) (Press release, Ziopharm, OCT 28, 2019, View Source [SID1234552231]).

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"We are delighted to deepen our relationship with MD Anderson, which provides treatment to a large and diverse population of cancer patients with solid tumors," said Laurence Cooper, M.D., Ph.D., Chief Executive Officer of Ziopharm. "This new agreement is a launch point to expand our TCR library and execute two new clinical trials; a trial for utilizing TCRs from the library targeting hotspot mutations in KRAS, TP53 and EGFR, and a second trial for personalized TCRs targeting patient-specific neoantigens."

"Cell-based immunotherapies have emerged as a powerful new option for treating patients with hematological cancers, but we have not yet had the same success for patients with solid tumors," said Ferran Prat, Ph.D., J.D., senior vice president for Research Administration and Industry Ventures at MD Anderson. "We are pleased to be working with Ziopharm to advance a new generation of cell therapies, and we are hopeful they can one day be effective in treating a broader group of our patients."

Under the terms of the new agreement, Ziopharm commits to fund an additional $20 million for this expanded work in the TCR-T program through 2023, as well as certain milestone payments for clinical development or regulatory approval in the U.S., European Union, Japan and the rest of the world. The funding for this new agreement was included within the budget forecast provided by Ziopharm in its second quarter 2019 financial results news release and webcast commentary.

MD Anderson will receive low, single-digit royalties on net sales in the U.S. and international markets, as well as warrants for Ziopharm common stock which vest upon achievement of clinical milestones. According to institutional guidelines, MD Anderson has implemented an Institutional Conflict of Interest Management and Monitoring Plan to manage this research.

This new agreement expands the relationship between Ziopharm and MD Anderson, established under a 2015 research agreement related to CD19-specific CAR-T. Earlier this month, the Food and Drug Administration cleared an IND application for a phase 1 clinical trial to evaluate CD19-specific CAR-T, manufactured and infused within two days of gene transfer using Ziopharm’s rapid personalized manufacture (RPM), as an investigational treatment for patients with relapsed CD19+ leukemias and lymphomas. Ziopharm has approximately $20 million of pre-funded R&D at MD Anderson under the prior agreement, which may now be used under the new agreement, for both the CAR-T or TCR-T initiatives.

In addition to the new research and development agreement, Ziopharm has entered a lease agreement with MD Anderson through which the company accesses additional laboratory and office space within the institution’s campus. This new facility will serve as home for Ziopharm’s expanded Houston office, under the direction of Eleanor de Groot, Ph.D., EVP, GM Cell Therapy and Drew Deniger, Ph.D., head of Ziopharm’s TCR-T cell therapy program.