On May 14, 2020 Recursion, a digital biology company industrializing drug discovery, reported it has entered into a global licensing agreement with Takeda Pharmaceutical Company Limited (Takeda) to gain rights to TAK-733, a clinical-stage MEK inhibitor, and develop it for the treatment of a hereditary cancer syndrome and related areas of oncology (Press release, Recursion Pharmaceuticals, MAY 14, 2020, View Source [SID1234558074]).

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"TAK-733 is a great example of the power of our approach to decode challenging and important areas of biology. By applying machine learning to images of cells, we capture cellular changes accompanying hundreds of unique biological perturbations, and even loss of just a single gene," said Chris Gibson, Ph.D., co-founder and CEO, Recursion. "Using our platform, we uncovered targeted areas of oncology where TAK-733 could be effective. And because our dataset is fully relatable, we then cross-referenced TAK-733 against hundreds of disease models we’ve developed already or will develop in the coming years."

TAK-733 was identified as a potential treatment for a hereditary tumor syndrome using Recursion’s approach to creating cellular models of diseases where genes are inactive. Using its automated drug discovery platform, Recursion discovered the potential of TAK-733 by testing more than 200 potential molecules from Takeda’s library against the most effective potential treatment for cancers carrying particular mutations.

"We’re making immense progress in oncology by understanding the genetic drivers of different tumor types and developing targeted therapeutics," said Ron Alfa, M.D., Ph.D., Senior Vice President, Translational Discovery. "Almost all available drugs today target a particular type of mutation that result in activated proteins — oncogenes. However, most tumors also harbor mutations that eliminate or deactivate proteins, tumor suppressors, and only a few of these pathways have been understood well enough to develop therapeutics. Recursion’s platform opens the door to discovering targeted therapeutics that are effective when these tumor suppressors are inactive."

Under the terms of the agreement, Recursion obtains exclusive worldwide rights to develop and commercialize TAK-733. For more information on Recursion, please visit www.recursionpharma.com.

On May 14, 2020 Nordic Nanovector ASA (OSE: NANO) reported that Betalutin (177Lu lilotomab satetraxetan) has received a positive opinion from the European Medicines Agency (EMA) on the application for orphan drug designation for the treatment of marginal zone lymphoma (MZL) (Press release, Nordic Nanovector, MAY 14, 2020, View Source [SID1234558090]). The positive opinion is expected to be adopted by the European Commission shortly.

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In the LYMRIT 37-01 Phase 1/2a trial, Betalutin showed a highly encouraging 78% overall response rate (ORR) and 44% complete response (CR) in the MZL patient group (n=9) – the highest response rates of any patient sub-population in this study. This followed a once-only administration of Betalutin in this heavily pre-treated group of patients with advanced disease.

MZL is a form of indolent (slow-growing) B-cell non-Hodgkin’s lymphoma (NHL) that accounts for approximately eight percent of all NHL cases. EMA orphan designation is designed to encourage the development of new treatments for life-threatening or chronically debilitating conditions that are rare (affecting not more than five in 10,000 people in the European Union). Medicines that meet the EMA’s orphan designation criteria qualify for several incentives to help support advancement.

Betalutin received Orphan Drug Designation for the treatment of follicular lymphoma in the US and Europe in 2014.

Lars Nieba, Interim Chief Executive Officer, commented "We are very pleased to receive a positive opinion on Orphan Drug Designation in the European Union for Betalutin in MZL. There is a clear need for new therapeutic options for MZL patients who no longer respond to anti-CD20 immunotherapy (rituximab), the current backbone of treatment in first and second-line patients. We look forward to receiving the final decision by the European Commission in the coming weeks."

On May 14, 2020 The Janssen Pharmaceutical Companies of Johnson & Johnson reported results from the final analysis of the pivotal Phase 3 SPARTAN study demonstrating ERLEADA▼ (apalutamide) in combination with androgen deprivation therapy (ADT) significantly improved overall survival (OS), compared to ADT alone, in patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who were at high risk of developing metastases.1 Results will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Programme (Abstract #5516) beginning on Friday 29th May.1 (Press release, Janssen Pharmaceuticals, MAY 14, 2020, View Source [SID1234558161])

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Findings from the study showed that apalutamide in combination with ADT prolonged median overall survival by 14 months and decreased the risk of death by 22 percent.1 Median OS was significantly longer, with 73.9 months for patients receiving treatment with apalutamide in combination with ADT compared to 59.9 months with patients receiving placebo in combination with ADT [HR=0.78; p=0.0161 (to reach statistical significance, a p-value of p<0.046 needed to be observed)].1 After the study met its primary endpoint of metastasis-free survival (MFS), the SPARTAN study was unblinded and patients on placebo were allowed to crossover to apalutamide. The OS results were achieved despite a crossover of 76 randomised placebo patients (19 percent) to apalutamide treatment.1 After adjusting for the cross-over of patients in the placebo arm, the treatment effect of apalutamide plus ADT exceeded median OS compared to placebo plus ADT with a difference of 21 months between the two arms (73.9 months vs 52.8 months, respectively, HR=0.69, p=0.0002). Additionally, treatment with apalutamide in combination with ADT significantly delayed patients’ time to cytotoxic chemotherapy compared to placebo in combination with ADT (HR=0.63; p=0.0002).1

"Treatment for patients with non-metastatic castration-resistant prostate cancer is primarily focused on delay of metastases and improvement of overall survival," said Eric Small, M.D., FASCO, Professor of Medicine, and Chief Scientific Officer at the Helen Diller Family Comprehensive Cancer Center at the University of California, San Francisco, and lead SPARTAN study investigator. "The final analysis of SPARTAN includes long-term data for each of these treatment parameters and helps to support the earlier use of apalutamide versus ADT alone."

Together with data from the primary analysis, the SPARTAN study has met all primary, secondary and exploratory endpoints. The primary endpoint of the study was MFS; the secondary endpoints were time to metastasis, progression-free survival (PFS), time to symptomatic progression, OS and time to initiation of cytotoxic chemotherapy; and the exploratory endpoints were second progression-free survival (PFS2), PSA responses and risk of PSA progression.1,2

"Our driving commitment to delay the onset of metastases and add years to life for prostate cancer patients has taken a significant step forward with today’s data," said Dr Joaquín Casariego, M.D., Janssen Therapeutic Area Lead Oncology for Europe, Middle East & Africa, Janssen-Cilag S.A. "The SPARTAN trial has successfully demonstrated that apalutamide improved overall survival by an average of 14 months, reinforcing the need to treat earlier in prostate cancer for the benefit of patients and their families. At Janssen, our vision is to pioneer new approaches to treating cancer by thinking differently about diagnosis and looking towards intercepting the disease before it can even take a hold."

Median treatment duration was nearly three times longer for patients treated with apalutamide plus ADT (33 months) compared with those treated with placebo plus ADT (12 months).1 Grade 3/4 treatment-emergent adverse events of special interest were rash (5.2 percent), fractures (4.9 percent), falls (2.7 percent), ischemic heart disease (2.6 percent), hypothyroidism (0 percent) and seizures (0 percent). Safety and tolerability of apalutamide is consistent and as reported previously.1,3

Initial results from the SPARTAN trial were presented at the 2018 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU) and simultaneously published in The New England Journal of Medicine.2,4 The study met its primary endpoint of MFS demonstrating a median MFS of more than two years (difference of 24.31 months) and a 72 percent reduction in risk of distant metastasis in patients with nmCRPC.4 OS data were not mature at the time of the final MFS analysis (24 percent of the required number of events). Updated results were presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Congress in 2019 and were simultaneously published in Annals of Oncology.5,6

#ENDS#

About the SPARTAN Study
SPARTAN (NCT01946204) is a Phase 3, randomised, registrational, double-blind, placebo-controlled, multicentre study that evaluated ERLEADA (apalutamide) in combination with ADT in men with nmCRPC with a rapidly rising PSA (PSA Doubling Time ≤10 months).2,7 The SPARTAN study enrolled 1,207 patients who were randomised 2:1 to receive either apalutamide orally at a dose of 240 mg once daily in combination with ADT (n=806) or placebo once daily in combination with ADT (n=401).4

About Non-Metastatic Castration-Resistant Prostate Cancer
Non-metastatic castration-resistant prostate cancer (nmCRPC) refers to a disease stage in which the cancer no longer responds to treatments that lower testosterone but has not yet been discovered in other parts of the body using a total body bone scan and/or CT/MRI scan.8 Features include: lack of detectable metastatic disease using conventional radiographic imaging and rapidly rising PSA while on ADT with serum testosterone level below 50 ng/dL.9,10 Ninety percent of patients with nmCRPC will eventually develop metastases, which can lead to pain, fractures and other symptoms.11 The relative five-year survival rate for patients diagnosed with a distant-stage prostate cancer is 31 percent.12 It is critical to delay the development of metastasis in patients with nmCRPC.

About ERLEADA
ERLEADA (apalutamide) is an androgen receptor (AR) inhibitor indicated for use in Europe for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease and in adult men for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT).7 In the U.S. apalutamide is indicated for the treatment of nmCRPC and mHSPC.13

Warnings and Precautions include ischemic heart disease, fractures, falls and seizure.2,3 In the SPARTAN study, the most common adverse reactions (≥10 percent) were fatigue, hypertension, rash, diarrhoea, nausea, weight decreased, arthralgia, falls, hot flush, decreased appetite, fracture and peripheral edema.1,4

On May 14, 2020 Kuraray reported that First Quarter of the Fiscal Year Ending December 31, 2020 (Press release, Kuraray, MAY 14, 2020, https://pdf.irpocket.com/C3405/yCGV/mXhw/evng.pdf [SID1234557964])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2020 (January 1, 2020 to March 31, 2020)

(1) Consolidated Operating Results

(2) Consolidated Financial Position

2. Dividends

3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2020 (January 1, 2020 to December 31, 2020) Regarding the full-year forecasts of consolidated financial results, due to the difficulty of reasonably calculating the impact of COVID-19 pandemic on the Group’s results from the third quarter onward, we have temporarily withdrawn the forecasts released on February 13, 2020 and it is to be determined. We will swiftly release a forecast once calculations become possible. [Reference]

(1) Changes in Important Subsidiaries during the Period (Changes in Special Subsidiaries Involving Changes in the Scope of Consolidation) Added: No companies Excluded: No companies

(2) Adoption of Special Accounting Practices in the Preparation of Quarterly Consolidated Financial Statements No

(3) Changes in Accounting Principles, Procedures and Presentation Methods in Connection with the Preparation of Quarterly Consolidated Financial Statements

1. Changes following revision of accounting standards:

No 2. Changes besides

1. above:

No 3. Changes in accounting estimates:

No 4. Restatement:

No (4) Number of Shares Issued and Outstanding (Common Shares)

1. Number of shares issued and outstanding (including treasury stock) as of the period-end: As of March 31, 2020 354,863,603 shares As of December 31, 2019 354,863,603 shares

2. Number of treasury shares as of the period-end: As of March 31, 2020 11,005,846 shares As of December 31, 2019 11,130,834 shares 3. Average number of shares for the period (cumulative): As of March 31, 2020 343,781,244 shares As of March 31, 2019 348,198,564 shares Note: It is not required that this type of earnings report be audited.

Cautionary Statement with Respect to Forecasts of Consolidated Business Results (Cautionary note regarding forward-looking statements) The results forecasts presented in this document are based upon currently available information and assumptions deemed rational. A variety of factors could cause actual results to differ materially from forecasts. Please refer to "

1. Qualitative Information regarding Business Results

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts" on page 4 of the Attachment for the assumptions used.

1. Qualitative Information regarding Business Results (1) Overview of Consolidated Business Results In the first quarter of fiscal 2020 (January 1, 2020–March 31, 2020), the world economy dramatically decelerated due to the serious impacts on consumption and production of the restrictions on economic activity to counter the global spread of COVID-19. Consequently, consolidated operating results for the first quarter of fiscal 2020 are as follows: net sales fell ¥4,719 million, or 3.3%, compared with the previous fiscal year to ¥136,927 million; operating income decreased ¥2,660 million, or 18.2%, to ¥11,971 million; ordinary income decreased ¥1,488 million, or 11.6%, to ¥11,306 million; and net income attributable to owners of the parent increased ¥619 million, or 10.2%, to ¥6,705 million.

The global spread of COVID-19 remains a serious issue with no end in sight regarding containment. In addition, it is expected to take a long time for economic activity to return to normal. Even amid this kind of environment, we will continue to supply needed products around the world. We realize the importance of the role that has been given to us, and we will maintain our business activities while thoroughly ensuring safety and working to prevent infection. The Group’s long-term vision, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." As we continue working to realize this vision, we will steadily take specific measures in line with the key management strategies underlined in the medium-term management plan "PROUD 2020" from a medium-to long-term perspective.

Through these efforts, we will also continue working to establish a new business portfolio. Results by Business Segment Vinyl Acetate Sales in this segment decreased 3.6% year on year to ¥63,866 million, and segment income fell 22.4% year on year to ¥8,387 million.

(1) The volume of PVA resin declined due to stagnant global demand. Due to the effect of an LCD panel inventory adjustment continuing from the second half of the previous fiscal year, shipments of optical-use poval film stayed level with the previous year. In addition, sales of PVB film remained weak, mainly for automotive applications. However, sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased for food packaging applications but sales for gas tank applications were weak due to a decline in the number of vehicles produced. Isoprene Sales in this segment decreased 3.4% year on year to ¥13,162 million, and segment income fell 16.0% year on year to ¥3,140 million.

(1) Shipments of isoprene chemicals declined, especially those to China. Sales of SEPTON thermoplastic elastomer struggled in Asia, but U.S. demand remained firm.

(2) The sales volume of GENESTAR heat-resistant polyamide resin increased due to anticipatory demand in China for electric and electronic device applications. Demand for connectors for automotive devices remained favorable. Functional Materials Sales in this segment increased 1.0% year on year to ¥30,766 million, and segment income grew 12.5% year on year to ¥1,268 million.

(1) Although the sales volume of methacrylic resins and sheets increased, the methacrylate business was affected by worsening market conditions.

(2) In the medical business, sales were steady in the first quarter due to anticipatory demand for dental materials, especially exports, but there are concerns about decelerating demand as many dental clinics have closed, mainly across the United States and Europe.

(3) As for Calgon Carbon, demand remained steady in North America, especially for drinking water applications while demand was sluggish in Europe. In the Carbon Materials business, sales of high value-added products increased. Fibers and Textiles Sales in this segment fell 12.5% year on year to ¥14,467 million while segment income decreased 18.1% year on year to ¥916 million.

(1) The sales volume of CLARINO man-made leather decreased due to stagnant demand in Asia and Europe.

(2) In fibers and industrial materials, the performance of KURALON for cement reinforcement use remained weak. Sales of products used in reinforcing rubber were negatively affected by a decline in vehicle production. However, sales results for VECTRAN were firm.

(3) In consumer goods and materials, sales of KURAFLEX were weak as demand for cosmetic and automotive applications fell despite an increase in sales for mask-related applications. Trading In fiber-related businesses, sales of sportswear-use products remained steady, but sales of resins and chemicals targeting Japanese and Chinese markets struggled. As a result, segment sales decreased 5.1% year on year to ¥29,771 million, and segment income rose 9.9% to ¥961 million. Others In other business, due to weak sales of domestic affiliates, segment sales declined 18.0% year on year to ¥11,661 million, and segment income fell 67.2% to ¥43 million.

(2) Overview of Financial Position Total assets increased ¥1,950 million from the end of the previous fiscal year to ¥993,099 million mainly because of a ¥4,757 million increase in cash and cash deposits and a ¥4,515 million increase in inventory assets that offset a ¥3,716 million decrease in intangible fixed assets and a ¥4,204 million decrease in investment securities. Total liabilities increased ¥10,693 million to ¥463,297 million due to factors that included the issuance of commercial paper totaling ¥26,000 million and a ¥23,364 million increase in long-term loans payable, despite a ¥29,392 million decrease in accrued expenses. Net assets fell ¥8,742 million to ¥529,802 million. Equity attributable to owners of the parent amounted to ¥515,406 million, for an equity ratio of 51.9%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts Due to economic restrictions to combat the global spread of COVID-19, first quarter results for all segments were weak as demand for automobiles, electronic devices, displays and other mainstay Kuraray applications stagnated. Further deterioration in demand from the second quarter is unavoidable, and we need to respond accordingly with production adjustments and other measures. We expect this to have a large impact on our operating results. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2020 (January 1, 2020 to June 30, 2020) is as shown below. Furthermore, regarding the full-year forecasts of the consolidated financial results, due to the difficulty of reasonably calculating the impact of COVID-19 pandemic on the Group’s results from the third quarter onward, we have temporarily withdrawn the forecasts released on February 13, 2020 and it is to be determined. We will swiftly release a forecast once calculations become possible. In addition, although we recorded an extraordinary loss in fiscal 2019 related to the litigation over the fire at the U.S. subsidiary in May 2018, if it is determined that we need to revise our results forecasts in the course of future negotiations, we will make a swift announcement.

On May 14, 2020 Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported that topline data of the recently completed L-DOS47 dose escalation study in combination with pemetrexed and carboplatin in recurrent or metastatic non-squamous non-small cell lung cancer ("LDOS001") will be published at the ASCO (Free ASCO Whitepaper) 2020 Annual Conference (Press release, Helix BioPharma, MAY 14, 2020, View Source [SID1234557997]).

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The ASCO (Free ASCO Whitepaper) publication details are:

Abstract: e21680

Title: Phase I dose escalation study of immunoconjugate L-DOS47 in combination with pemetrexed/carboplatin in non-squamous non-small cell lung cancer ("NSCLC") patients.

Authors: Afshin Dowlati, Chandra Prakash Belani, George R. Simon, Heman Chao, Sarina Anne Piha-Paul; University Hospitals Case Medical Center, Cleveland, OH; Penn State Cancer Institute, Hershey, PA; Department of Thoracic and Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX; Helix BioPharma Corp, Aurora, ON; Department of Investigational Cancer Therapeutics (Phase I Program), The University of Texas MD Anderson Cancer Center, Houston, TX.

NCT Registration number: NCT02309892

Results: Fourteen (14) patients were enrolled across 6 dosing cohorts in the study. No dose limiting toxicities were observed. Of the twelve (12) patients evaluated for efficacy, 5 patients (41.7%) had a partial response ("PR"), 4 patients (33.3%) experienced stable disease ("SD") and 3 patients (25.0%) had progressive disease ("PD"). The objective response rate is 41.7%. The clinical benefit rate is 75.0%. L-DOS47, in combination with pemetrexed/carboplatin, appears to be well tolerated with promising anti-tumor activity against non-squamous NSCLC.

"I would like to thank the patients and their families who participated in our clinical study, as well as the principle investigators and associates who helped conduct the study," said Dr. Heman Chao, Helix’s Chief Executive Officer. "We are very optimistic with L-DOS47’s demonstrated excellent safety profile and encouraging efficacy data."