On July 30, 2020 AstraZeneca’s Tagrisso (osimertinib) reported that it has been granted Breakthrough Therapy Designation (BTD) in the US for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumour resection with curative intent (Press release, AstraZeneca, JUL 30, 2020, View Source [SID1234562536]).

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The Food and Drug Administration’s (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat a serious condition and address a significant unmet medical need. The new medicine needs to have shown encouraging early clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.

While up to 30% of patients with NSCLC may be diagnosed early enough to have potentially curative surgery, disease recurrence is common in early-stage disease and nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, experience recurrence within five years.1-6

José Baselga, Executive Vice President, Oncology R&D said: "Patients with early-stage EGFRm lung cancer often experience recurrence even after successful surgery and adjuvant chemotherapy, yet there are currently no approved targeted treatments to improve outcomes. The Phase III ADAURA trial with Tagrisso demonstrated an unprecedented level of clinical benefit in these patients, and we are working closely with the FDA to deliver this potentially curative treatment to patients as quickly as possible."

The FDA granted the BTD based on data from the Phase III ADAURA trial, which were also recently presented during the plenary session of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program.

In the trial Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the adjuvant treatment of Stage IB-IIIA EGFRm NSCLC patients, reducing the risk of disease recurrence or death by 79% (HR 0.21; 95% CI 0.16-0.28; p<0.0001) in a key secondary endpoint. In April 2020, an Independent Data Monitoring Committee recommended for the trial to be unblinded two years early based on its determination of overwhelming efficacy.

Tagrisso is approved for the 1st-line treatment of patients with locally advanced or metastatic EGFRm NSCLC and for the treatment of locally advanced or metastatic EGFR T790M mutation-positive NSCLC in the US, Japan, China, the EU and many other countries around the world.

Lung cancer

Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.7 Lung cancer is broadly split into NSCLC and small cell lung cancer, with 80-85% classified as NSCLC.8 The majority of all NSCLC patients are diagnosed with advanced disease while approximately 25-30% present with resectable disease at diagnosis.1-3 A significant portion of patients with resectable NSCLC eventually develop recurrence despite complete tumour resection and adjuvant chemotherapy. Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.9-11 These patients are particularly sensitive to treatment with EGFR-tyrosine kinase inhibitors (TKIs) which block the cell-signalling pathways that drive the growth of tumour cells.12

ADAURA

ADAURA is a randomised, double-blinded, global, placebo-controlled Phase III trial in the adjuvant treatment of 682 patients with Stage IB, II, IIIA EGFRm NSCLC following complete tumour resection and adjuvant chemotherapy as indicated. In the experimental arm, patients were treated with Tagrisso 80mg once-daily oral tablets for three years or until disease recurrence. The trial enrolled in more than 200 centres across more than 20 countries, including the US, in Europe, South America, Asia and the Middle East. The primary endpoint DFS in Stage II and IIIA patients and a key secondary endpoint is DFS in Stage IB, II and IIIA patients. The data readout was originally anticipated in 2022. The trial will continue to assess OS.

Tagrisso

Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with clinical activity against CNS metastases. Tagrisso 40mg and 80mg once-daily oral tablets have received approval in the US, Japan, China, the EU and many countries around the world for 1st-line EGFRm advanced NSCLC and EGFR T790M mutation-positive advanced NSCLC. Tagrisso is also being developed in the Stage III, unresectable setting (LAURA), in the neoadjuvant resectable setting (NeoADAURA), in combination with chemotherapy (FLAURA2) and in combination with potential new medicines to address resistance to EGFR-TKIs (SAVANNAH, ORCHARD).

AstraZeneca in lung cancer

AstraZeneca has a comprehensive portfolio of approved and potential new medicines in late-stage development for the treatment of different forms of lung cancer spanning different histologies, several stages of disease, lines of therapy and modes of action. AstraZeneca aims to address the unmet needs of patients with EGFRm tumours as a genetic driver of disease, which occur in 10-15% of NSCLC patients in the US and the EU and 30-40% of NSCLC patients in Asia, with the approved medicines Iressa (gefitinib) and Tagrisso, and its ongoing Phase III trials LAURA, NeoADAURA, and FLAURA2.9-11

AstraZeneca is committed to addressing tumour mechanisms of resistance through the ongoing Phase II trials SAVANNAH and ORCHARD which test Tagrisso in combination with savolitinib, a selective inhibitor of c-MET receptor tyrosine kinase, along with other potential new medicines. Enhertu (trastuzumab deruxtecan), a HER2-directed antibody drug conjugate (ADC) is in development for metastatic non-squamous HER2-overexpressing or HER2-mutated NSCLC including trials in combination with other anticancer treatments. In addition, DS-1062, a trophoblast cell-surface antigen 2 (TROP2)-directed ADC, is in early development for advanced NSCLC where TROP2 is overexpressed in the majority of patients.13

An extensive late-stage Immuno-Oncology programme focuses on lung cancer patients without a targetable genetic mutation which represents up to three-quarters of all patients with lung cancer.14 Imfinzi, an anti-PDL1 antibody, is in development for patients with advanced disease (Phase III trials POSEIDON and PEARL) and for patients in earlier stages of disease including potentially curative settings (Phase III trials MERMAID-1, AEGEAN, ADJUVANT BR.31, PACIFIC-2, PACIFIC-4, PACIFIC-5, and ADRIATIC) both as monotherapy and in combination with tremelimumab and/or chemotherapy. Imfinzi is also in development in the Phase II trials NeoCOAST, COAST and HUDSON in combination with potential new medicines from the early-stage pipeline including Enhertu.

AstraZeneca in Oncology

AstraZeneca has a deep-rooted heritage in oncology and offers a quickly growing portfolio of new medicines that has the potential to transform patients’ lives and the Company’s future. With seven new medicines launched between 2014 and 2020, and a broad pipeline of small molecules and biologics in development, the Company is committed to advance oncology as a key growth driver for AstraZeneca focused on lung, ovarian, breast and blood cancers.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers and Resistance, DNA Damage Response and Antibody Drug Conjugates – and by championing the development of personalised combinations, AstraZeneca has the vision to redefine cancer treatment and one day eliminate cancer as a cause of death.

On July 30, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord), reported that the European Commission (Zer) has Zercepac, a biosimilar trastuzumab for the treatment of certain patients with HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic stomach cancer (Press release, Henlius Biopharmaceuticals, JUL 30, 2020, View Source [SID1234562532]). The approval was based on a number of robust studies, including comparative quality studies as well as preclinical and clinical studies. The results confirmed the biosimilarity of Zercepac and showed an efficacy and safety comparable to the reference product Herceptin.

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The approval of the drug developed and manufactured by Henlius is an important milestone for both companies. Zercepac is the first monoclonal antibody (mAb) and third biosimilar marketed by Accord in Europe, and it is the first mAb developed by Henlius to be approved in the EU.

Dr. Scott Liu , co-founder and CEO of Henlius , said: "Henlius mission is to improve the lives of patients by providing them with high quality and affordable protein therapeutics through technical innovation and operational excellence. Approval of Zercepac in the EU is a major milestone in our global strategy, and this achievement demonstrates that our biological development and manufacturing capabilities have reached international standards. In the future, Henlius will continue to offer high quality biologicals as new treatments that will benefit patients worldwide. "

Paul Tredwell , VP Specialty Brands of Accord, EMENA, said: "This product is an exciting addition to our growing oncology portfolio that provides patients across Europe with access to more than 30 high quality, affordable oncology treatments. With Zercepac, our first mAb, we have firmly anchored our competence in the market launch of complex medications in order to guarantee an improved patient access and to offer cost-effective alternatives to the overloaded health systems ".

On July 30, 2020 Amplia Therapeutics Limited (ASX: ATX) ("Amplia" or the "Company") reported that it has received preliminary final results from the preclinical toxicology studies being conducted with its FAK inhibitor, AMP945 (Press release, Amplia Therapeutics, JUL 30, 2020, View Source;[email protected] [SID1234561580]). These data, together with those produced from the preclinical toxicology program to date, have not identified any toxicities that are likely to prevent a Phase 1 trial in healthy volunteers from progressing later this year as planned.

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The toxicology studies were conducted under a Good Laboratory Practice (GLP) quality framework and included repeat-dose administration of AMP945 in two species. Data from the repeat-dose studies allows the identification of a No Observed Adverse Effect Level (NOAEL) which can be used to determine the starting dose for the planned Phase 1 clincial trial. The Company is expecting to receive the consolidated report from these studies in late July.

Subject to approval from an independent Human Research Ethics Committee (HREC) and adequate funding, Amplia is planning to conduct the Phase 1 trial under the Australian Clinical Trials Notification (CTN) scheme. The aims of the trial will be to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of AMP945 when given as single and multiple doses.

The trial is expected to take 6-9 months from first patient enrolment to collection of final data, with completion expected by mid-2021. Data from the Phase 1 trial will support the progression of AMP945 into a Phase 2 clinical trial program in patients with various solid cancers and/or with fibrotic diseases, such as idiopathic lung fibrosis (IPF), expected to commence in late 2021.

Dr John Lambert, Amplia’s CEO and Managing Director commented "we are very pleased to receive the final piece of key data from the preclinical studies conducted to date. Achieving this milestone marks an important transition for Amplia as we transform the Company into a clinical-stage drug development company."

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics

On July 29, 2020 JSR Corporation reported that (Press release, JSR, July 29, 2020, View Source [SID1234575066])

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1. Consolidated financial results for the first three months of the fiscal year ending March 31, 2020 (from April 1, 2019 to June 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 Quarter of FY ending March 2020 (April 1, 2019 to June 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. 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 materials 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 end-to-end biomedical drug discovery, production process development, and contract manufacturing obtained through active business acquisitions, in addition to greater sales of highly functional materials, a company strength.

In the First Quarter of FY ending March 2020, the Company reported revenue of 119,501 million yen (down 2.3% year-on-year), operating profit of 10,035 million yen (down 12.6% year-on-year), and profit attributable to owners of parent of 7,291 million yen (down 18.4% 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 profit of 294 million yen (down 88.0% year-on-year) on revenue of 45,792 million yen (down 7.8% year-on-year) in the first three months 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 improved sales prices on higher 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 1,970 million yen (down 9.3% year-on-year) on revenue of 24,822 million yen (down 6.0% year-on-year) in the first three months 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 semiconductor and display materials 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 8,333 million yen (up 1.6% year-on-year) on revenue of 36,038 million yen (up 1.8% year-on-year) in the first three months 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 1,145 million yen (up 211.3% year-on-year) on revenue of 12,308 million yen (up 37.2% year-on-year) in the first three months of FY ending March 2020. (2) Explanation of Future Forecast Information, such as Forecast of Consolidated Business Results There are no changes in the forecast of consolidated business results for the first six-month period and the full term of FY ending March 2020, as announced in the "Consolidated Business Results for FY ended March 2019" on April 24, 2019(5) Notes on Condensed Quarterly Consolidated Financial Statements (Cautionary Notes regarding Assumptions of Going Concern) Not applicable (Significant Accounting Policies) The significant accounting policies that apply to the Group’s condensed quarterly consolidated financial statements are identical to the accounting policies applied to the consolidated financial statements pertaining to FY ended March 2019, apart from the matters stated below. Income tax expenses in the first three months of FY ending March 2020 have been calculated on the basis of the estimated annual effective tax rate.

The Group has applied the following standard from the First Quarter of FY ending March 2020. IFRS Summary of New / Revised Standard IFRS 16 — Leases Revision accounting related to lease contracts (Changes in Accounting Policy) The Group has applied IFRS 16 — Leases ("IFRS 16") from the First Quarter of FY ending March 2020. For the adoption of IFRS 16, the Group has employed a method recognizing the cumulative effect of the standard’s application, deemed to be a transitional measure, as the balance of retained earnings at the beginning of the current period at the date of initial application, without presenting a restatement of comparative information (modified retrospective approach). At inception of a contract, the Group assesses whether the contract is, or contains, a lease based on whether the contract conveys the right to control the use of an identified asset for a period of time in exchange for consideration. The Group elects not to recognize right-of-use assets and lease liabilities for short-term leases within12 months and leases of low-value assets. The Group recognizes a right-of-use asset and a lease liability at the lease commencement date when a contract is assessed to be, or contain, a lease. The lease liability of a lease transaction is measured at the discounted present value of the total unpaid value of lease payments at the lease commencement date.

The right-of-use asset is initially measured based on the initial measurement amount of the lease liability adjusted for any initial direct costs incurred or any lease payments made at or before the commencement date, plus any costs to restore the underlying asset or the site on which it is located and other related costs required in the lease contract. The right-of-use asset is periodically depreciated over the term of the lease. Lease payments are allocated to finance costs and an amortization component of the lease liability balance, in such a way as to apply a fixed interest rate to the lease liability balance. Finance costs are categorized and recorded as depreciation pertaining to the right-ofuse asset on the Condensed Quarterly Consolidated Statement of Profit or Loss.

Whether a contract is a lease or whether a contract contains a lease is determined based on the substance of the contract, even when the contract is not legally a lease-type contract. The lease payments associated with leases with a term concluding within 12 months and leases for which the underlying asset is of low value are recognized as an expense on a straight-line basis over the lease term. As a result of the transition to IFRS 16, right-of-use assets of 13,810 million yen have been incrementally recognized in Property, plant and equipment and lease liabilities of 13,678 million yen have been incrementally recognized in Other financial liabilities under current liabilities and non-current liabilities on the current Condensed Quarterly Consolidated Statement of Financial Position at the date of initial application. The weighted average incremental borrowing rate applied to lease liabilities recognized at the date of initial application of IFRS 16 was 3.0%. (Segment Information)

(1) Outline of Reportable Segments JSR Group reportable segments are components of the Group for which separate financial information is available. The Board of Directors determines the basis of business segments that are subject to regular reviews for decisions on the allocation of managerial resources and the evaluation of business results.

The Group has established divisions by product at its head office. Each division formulates comprehensive domestic and overseas strategies for its products and conducts business activities according to the strategies. Core Group companies take the initiative in working out comprehensive domestic and overseas strategies and conduct business activities according to the strategies. Thus, the JSR Group’s businesses consist of business segments by product based on divisions and core Group companies. JSR Group has four reportable segments: Elastomers Business, which consists mainly of the manufacture and sale of general-purpose synthetic rubber products for automobile tires, functional special synthetic rubber for automobile components, thermoplastic elastomers for modifying plastics, and synthetic rubber latex for coated paper; Plastics Business, which engages mainly in the manufacture and sale of ABS and other resins for automobiles, office equipment, and amusement applications; Digital Solutions Business, which conducts mainly the manufacture and sale of semiconductor materials, display materials, and products related to edge computing; and Life Sciences Business.

The Digital Solutions Business is a reportable segment comprising multiple segments based on the nature of the products and services, the nature of production processes, and similarity in markets and other economic characteristics. The accounting methods for reportable segments are the same as the methods adopted for preparation of consolidated financial statements.

On July 29, 2020 The Pancreatic Cancer Action Network (PanCAN) and GeneCentric Therapeutics, Inc. reported that they have entered into a collaborative research partnership for the advancement of RNA-based molecular signatures for pancreatic cancer disease progression and drug response (Press release, GeneCentric Therapeutics, JUL 29, 2020, View Source [SID1234564814]). The collaboration will combine GeneCentric’s single patient RNA-based report, including its Pancreatic Cancer Subtype Profiler (PurIST) for subtyping pancreatic ductal adenocarcinoma tumors (PDAC), with PanCAN’s extensive collection of patient molecular and outcomes data generated through its scientific and clinical programs.

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"GeneCentric is advancing promising molecular signatures of disease progression and drug response in pancreatic cancer based on tumor subtyping through next generation RNA sequencing of the tumor and tumor/immune microenvironment, and immunogenomics," said Dr. Lynn Matrisian, Chief Science Officer of PanCAN. "The collaboration, which will involve profiling and data analyses from our Know Your Tumor program and Precision PromiseSM adaptive clinical trial, is designed to advance our goals of improving treatment responses and survival of PDAC patients, accelerating the development of novel therapies and defining potential curative strategies for people diagnosed with this devastating disease."

"PanCAN, with its leading-edge, innovative research programs to accelerate new therapies to the clinic and dramatically improve treatment options for pancreatic cancer patients, is an ideal partner for GeneCentric," said Dr. Mike Milburn, President and CEO of GeneCentric. "We are honored to work with the PanCAN team and their renowned collaborators to advance and apply novel molecular signatures to support landmark initiatives such as the Precision Promise study as well as other pivotal research in the pursuit of cures for patients."

The collaboration will involve two research projects and is focused on GeneCentric’s single patient molecular report, including two PurIST defined PDAC subtypes, Basal (gemcitabine/nab-paclitaxel responsive) and Classical (FOLFRINOX responsive). One study, aimed at the molecular characterization of potential treatment response, will be a retrospective analysis of patient data from the Know Your Tumor Program at diagnosis and treatment outcome. The second initiative is in conjunction with PanCAN’s Precision PromiseSM clinical trial to assess molecular signatures of patients at enrollment and association with treatment responses. The three-year study will enable application of the range of GeneCentric’s current PDAC as well as pan-cancer tumor and immunogenomic signatures of treatment response, as well as exploration of novel PDAC-related signatures.