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On May 12, 2021 Celyad Oncology SA (Euronext & Nasdaq: CYAD), a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T-cell (CAR T) therapies for cancer, reported that an abstract highlighting initial clinical data from the Phase 1 IMMUNICY-1 trial of CYAD-211 has been accepted for e-poster presentation at the upcoming European Hematology Association (EHA) (Free EHA Whitepaper) Virtual Congress 2021 (Press release, Celyad, MAY 12, 2021, View Source [SID1234579773])

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Filippo Petti, Chief Executive Officer at Celyad Oncology, commented, "We are very pleased with the initial results from the low dose cohort of our first shRNA-based allogeneic candidate, CYAD-211, which has showed preliminary signs of clinical activity, including a confirmed partial response, with no evidence of Graft-versus-Host-Disease. We are encouraged by the observed clinical activity at such a low dose level and the overall steady progress of the trial to date. Our team is intently focused on further assessing whether shRNA-mediated knockdown can generate safe, functional and clinically relevant allogeneic CAR T-cells for the treatment of cancer while offering an alternative technology platform with key advantages over gene-editing. We are excited for the opportunity to present the latest safety, clinical activity and cell kinetic data for the program next month at EHA (Free EHA Whitepaper) and look forward to future updates for the program throughout 2021 as we move towards our goal of establishing proof-of-concept for this dynamic platform."

CYAD-211 is an investigational, non-gene edited allogeneic CAR T candidate engineered to co-express a single hairpin RNA (shRNA) and a BCMA-targeting chimeric antigen receptor in development for the treatment of relapsed/refractory multiple myeloma (r/r MM). This non-gene editing technology, which does not permanently alter the genome integrity, is intended to decrease the potential safety risk associated with "off-target" genome modifications. This "All-in-One" Vector approach with one single transduction step avoids multiple genetic modifications and cost associated with additional GMP grade materials.

EHA 2021 ePoster Presentation Details:

The following abstract published today is now available on the EHA (Free EHA Whitepaper) 2021 website. Following the presentation at the meeting, the posters will be available in the Scientific Publications section of Celyad Oncology’s website.

Title: Objective response at low dose in the first-in-human IMMUNICY-1 trial evaluating non-gene edited allogeneic CYAD-211 anti-BCMA CAR T product in relapsed or refractory multiple myeloma

Presenter: Dr. Sébastien Anguille, Antwerp University Hospital (UZA), Edegem, Belgium

Topic: Gene therapy, cellular immunotherapy and vaccination—Clinical

Date and Time: e-Poster available starting Friday, June 11, 2021 at 9:00 a.m. CEST

Abstract Number: EP739

About CYAD-211

CYAD-211 is an investigational, shRNA-based allogeneic CAR T candidate for the treatment of r/r MM. CYAD-211 is engineered to co-express an anti-BCMA targeting chimeric antigen receptor and a single shRNA to knockdown the CD3zeta component of the T cell receptor complex.

About IMMUNICY-1 Phase 1 trial

The open-label, dose-escalation trial will evaluate the safety and clinical activity of CYAD-211 following cyclophosphamide and fludarabine preconditioning chemotherapy in patients with relapsed or refractory multiple myeloma. The trial will evaluate multiple dose levels of CYAD-211: 30×106, 100×106 and 300×106 cells per infusion. For more information, please visit www.clinicaltrials.gov, study identifier number NCT04613557.

On May 12, 2021 Kuraray reported that Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021) (Press release, Kuraray, MAY 12, 2021, https://pdf.irpocket.com/C3405/eq9A/Kj61/GizM.pdf [SID1234579789])

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1. Consolidated Financial Results for the First Quarter of the Fiscal Year Ending December 31, 2021 (January 1, 2021 to March 31, 2021)

(1) Consolidated Operating Results (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

(2) Consolidated Financial Position2. Dividends 3. Forecasts of Consolidated Financial Results for the Fiscal Year Ending December 31, 2021 (January 1, 2021 to December 31, 2021) (Percentage changes displayed for net sales, operating income, ordinary income and net income attributable to owners of the parent are comparisons with the corresponding period of the previous fiscal year.)

1. Qualitative Information regarding Business Results
1) Overview of Consolidated Business Results In the first quarter of fiscal 2021 (January 1, 2021–March 31, 2021), the world economy is still feeling the effects of the COVID-19 pandemic, and the outlook remains unclear. Amid these circumstances, the Group’s business results continued to recover owing to an increase in demand for at-home consumption due to the pandemic and an increase in automotive-related demand.

Consequently, consolidated operating results for the first quarter of fiscal 2021 are as follows: net sales rose ¥7,470 million, or 5.5%, compared with the previous fiscal year to ¥144,398 million; operating income increased ¥4,814 million, or 40.2%, to ¥16,786 million; ordinary income increased ¥4,962 million, or 43.9%, to ¥16,268 million; and net income attributable to owners of the parent decreased ¥1,422 million, or 21.2%, to ¥5,282 million. Furthermore, in the first quarter, we recorded a loss on litigation of ¥3,054 million related to a fire that occurred at our U.S. subsidiary in May 2018. We also recorded a disaster loss of ¥3,016 million due mainly to the suspension of production for some equipment at our U.S. subsidiary caused by a severe cold wave in the southern United States in February.

The Group’s long-term vision for its 100th anniversary coming up in 2026, Kuraray Vision 2026, is to become a "Specialty Chemical Company, growing sustainably by incorporating new foundational platforms into its own technologies." We will continue striving to optimize our business portfolio by steadily taking specific measures based on the three basic policies of Kuraray Vision 2026: pursuing competitive superiority, expanding new business fields and enhancing comprehensive strength of the Kuraray Group. We formulated a single-year management plan for fiscal 2021 and will focus on safe and stable operations amid the pandemic as well as thoroughly implement various measures decided on during the period of the previous medium-term management plan "PROUD 2020." At the same time, we will move ahead with formulating the next medium-term management plan, which is set to start in fiscal 2022. In the Functional Materials segment, due to an organizational reform on January 1, 2021, we integrated the Calgon Carbon Division and Carbon Materials Division, whose core products are activated carbon, into the Environmental Solutions Division. Results by Business Segment Vinyl Acetate Sales in this segment increased 13.0% year on year to ¥72,175 million, and segment income rose 59.9% year on year to ¥13,415 million

(1) Sales of PVA resin increased as global demand began to recover though overall business was affected by the U.S. cold wave. Sales of optical-use poval film were brisk due to an increase in demand for LCD panels, especially large displays, from the second half of the previous fiscal year. The sales volume of PVB film rose on the back of a recovery in demand for both construction and automotive applications. Sales of water-soluble PVA film steadily expanded for use in unit dose detergent packets, including for dish detergents, as more customers stay at home due to the COVID-19 pandemic.

(2) The sales volume of EVAL ethylene vinyl alcohol copolymer (EVOH resin) increased as food packaging applications remained firm and demand for gas tank applications recovered, but overall performance was affected by the U.S. cold wave. Isoprene Sales in this segment increased 13.2% year on year to ¥14,894 million, and segment income fell 3.0% year on year to ¥3,046 million.

(1) The sales volume of isoprene chemicals and SEPTON thermoplastic elastomer increased by a demand recovery mainly in China and the rest of Asia, but performance was affected by higher raw material and fuel prices.2) Sales of GENESTAR heat-resistant polyamide resin remained brisk for electric and electronic device applications and automotive applications amid growing demand. Functional Materials Sales in this segment decreased 1.5% year on year to ¥30,294 million, and segment income fell 16.3% year on year to ¥1,061 million.

(1) In the methacrylate business, sales for sign applications were weak despite an increase in sales of spatter-blocking barrier panels and displays.
(2) In the medical business, the dental materials business saw brisk sales, mainly in Europe and the United States.
(3) In the environmental solutions business, shipments decreased, especially for industrial applications. Fibers and Textiles Sales in this segment fell 5.2% year on year to ¥13,721 million while segment income decreased 52.4% year on year to ¥435 million

1) Sales of CLARINO man-made leather remained stable amid signs of a recovery in demand, especially for shoe applications in Asia and luxury good applications in Europe
2) In fibers and industrial materials, sales of KURALON were lower than the previous year despite a recovery in demand, which had fallen in the second half of the previous year
3) In consumer goods and materials, the sales volume of KURAFLEX decreased as 5 demand for counter cloths for the restaurant industry remained weak despite an increase in sales volume for mask-related applications.Trading In fiber-related businesses, sales stagnated, especially for sports clothing. Sales of resins and chemicals remained favorable due to an increase in demand in Japan and Asia, including China. As a result, segment sales increased 10.8% year on year to ¥32,972 million, and segment income rose 11.8% to ¥1,074 million

(2) Overview of Financial Position Total assets decreased ¥2,877 million from the end of the previous fiscal year to ¥1,048,707 million mainly because of a ¥30,184 million decrease in cash and cash deposits and a ¥5,794 million decrease in short-term investment securities, despite a ¥6,845 million increase in construction in progress, a ¥5,067 million increase in notes and accounts receivable-trade, a ¥4,615 million increase in inventories, a ¥4,608 million increase in machinery, equipment and vehicles, a ¥3,314 million in other current assets accompanying mainly an increase in other accounts receivable, and a ¥2,410 million increase in goodwill due to the effects of foreign exchange rates. Total liabilities decreased ¥25,709 million to ¥510,394 million due to factors that included the redemption of commercial paper totaling ¥20,000 million and a ¥11,684 million decrease in other current liabilities accompanying mainly a decrease in otheraccounts payable, despite a ¥3,626 million increase in notes and accounts payable–trade. Net assets rose ¥22,831 million to ¥538,312 million. Equity attributable to owners of the parent amounted to ¥520,151 million, for an equity ratio of 49.6%.

(3) Basis for the Revision in Forecasts, Including Consolidated Operating Results Forecasts In the consolidated first quarter, shipments in many of Kuraray’s businesses increased due to growth in demand, including for mainstay applications for automobiles, displays, and electronic and electric devices. We assume that demand will remain firm in the second quarter as well. Based on these circumstances, the forecast of consolidated operating results for the second quarter of fiscal 2021 (January 1, 2021 to June 30, 2021) is as shown below. The revised cumulative consolidated operating results forecast for the second quarter of the fiscal year ending December 31, 2021 (January 1, 2021 to June 30, 2021) is as follows.

Furthermore, although we recorded an extraordinary loss in the consolidated first quarter related to the litigation over the fire at the U.S. subsidiary, the litigation is still ongoing.

On May 12, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported abstracts on new analyses from the previously completed SIMPLIFY-1 and SIMPLIFY-2 studies have been accepted into the program for the 2021 Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) (Press release, Sierra Oncology, MAY 12, 2021, View Source [SID1234579805]). An abstract highlighting the association between transfusion independence and improved overall survival in myelofibrosis patients treated with momelotinib has been selected for oral presentation.

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"Overall survival remains the gold standard benchmark for oncology therapies. We are excited to showcase these new analyses in an oral presentation demonstrating a strong correlation between achieving or maintaining transfusion independence at Week 24 and overall survival for momelotinib patients in SIMPLIFY-1. A similar trend was seen in SIMPLIFY-2," said Barbara Klencke, MD, Chief Development Officer of Sierra. "Higher rates of transfusion independence at Week 24 were observed in anemic patients receiving momelotinib, regardless of the degree of baseline anemia, and in all subgroups of patients when analyzed either by baseline platelet count or baseline transfusion status as we describe in a separate accepted poster. Together, these data support the potential long-term benefit of achieving or maintaining transfusion independence by inhibiting ACVR1 / ALK2 in addition to JAK1 and JAK2 with momelotinib in myelofibrosis patients, regardless of baseline platelet count, transfusion status or degree of anemia. We look forward to the presentation of the full data sets at the EHA (Free EHA Whitepaper) annual meeting next month."

Transfusion Independence is Associated with Improved Overall Survival in Myelofibrosis Patients Receiving Momelotinib

Efficacy data examining the association between transfusion independence and overall survival for momelotinib patients from SIMPLIFY-1 (JAKi-naïve) and SIMPLIFY-2 (JAKi-exposed) will be presented in an oral presentation by Ruben Mesa, MD, Director of the Mays Cancer Center, UT Health San Antonio, MD Anderson Cancer Center.

Previously published data from both SIMPLIFY studies demonstrate robust overall survival for momelotinib-treated patients (median not yet reached in SIMPLIFY-1 and 34.3 months in SIMPLIFY-2). Additionally, previously reported week 24 transfusion independence rates were higher in the momelotinib arms of SIMPLIFY-1 (67% vs. 49%) and SIMPLIFY-2 (43% vs. 21%). The new analyses suggest JAKi-naïve patients receiving momelotinib who maintain or achieve transfusion independence at week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2.

Presentation Details

Abstract: S202
Title: Transfusion Independence is Associated with Improved Overall Survival in Myelofibrosis Patients Receiving Momelotinib
Presenter: Ruben Mesa, MD, Director of the Mays Cancer Center, UT Health San Antonio, MD Anderson Cancer Center
Session Title: Novel Therapies and Targets in MPN
Virtual Presentation Available: Friday, June 11, 2021 beginning at 9:00 am CEST
Live Q&A Discussion: Wednesday, June 16, 2021, 4:00 – 4:45 pm CEST

Improved Transfusion Independence Rates for Momelotinib vs. Ruxolitinib in Anemic JAKi Naïve Myelofibrosis Patients Independent of Baseline Platelet or Transfusion Status

Progressive anemia is a common occurrence in myelofibrosis, with nearly all patients requiring transfusions as their disease advances. As described above, the analyses in Abstract S202 show that JAKi-naïve patients receiving momelotinib who maintain or achieve transfusion independence at week 24 have favorable overall survival compared to non-responders, with a similar trend observed in SIMPLIFY-2. Therefore, it is important to understand which patients are most likely to achieve transfusion independence at week 24.

Abstract EP1081 will highlight new analyses from SIMPLIFY-1 to demonstrate that the prognostically important week 24 transfusion independence rates in JAK inhibitor-naïve myelofibrosis patients were consistently higher in anemic patients receiving momelotinib compared to ruxolitinib, regardless of the platelet count, transfusion status or degree of anemia at baseline. Data to be featured further support the potential benefits of inhibiting ACVR1 / ALK2 in addition to JAK1 and JAK2 in myelofibrosis patients, and will be presented by Jean-Jacques Kiladjian, MD, PhD, Professor of Clinical Pharmacology, Paris Diderot University; Consultant Hematologist, Head, Clinical Investigation Center, Saint Louis Hospital, Paris, France.

Presentation Details

Abstract: EP1081
Title: Improved Transfusion Independence Rates for Momelotinib vs. Ruxolitinib in Anemic JAKi Naïve Myelofibrosis Patients Independent of Baseline Platelet or Transfusion Status
Presenter: Jean-Jacques Kiladjian, MD, PhD
Session Name: Myeloproliferative Neoplasms – Clinical
Virtual Presentation Available: Friday, June 11, 2021 beginning at 9:00 am CEST

On May 12, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that Bassil Dahiyat, Ph.D., president and chief executive officer, will participate in a virtual fireside chat at the 2021 RBC Capital Markets Global Healthcare Virtual Conference on Wednesday, May 19, 2021 at 1:20 p.m. ET / 10:20 a.m. PT (Press release, Xencor, MAY 12, 2021, View Source [SID1234579823]).

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A live webcast will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Following the webcast, a replay will be archived on the website for at least 30 days.