Daiichi Sankyo and LYSA-LYSARC-CALYM Enter Research Collaboration for Valemetostat in Patients with Relapsed/Refractory B-Cell Lymphoma
Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and LYSA-LYSARC-CALYM today announced that they have entered a strategic research collaboration to study valemetostat (DS-3201), Daiichi Sankyo’s potential first-in-class EZH1/2 dual inhibitor, in B-cell malignancies starting with a phase 2 study in patients with five subtypes of relapsed/refractory B-cell lymphoma.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210223006211/en/
The collaboration brings together Daiichi Sankyo’s innovative science and the multidisciplinary expertise of the Lymphoma Study Association (LYSA), the Lymphoma Academic Research Organization (LYSARC) and the CALYM research consortium to conduct clinical and translational research that will build upon the ongoing phase 1 study of valemetostat in patients with relapsed/refractory non-Hodgkin lymphoma.1
Lymphoma is a heterogenous disease with more than 90 different subtypes and while new treatment advances have improved outcomes for some patients, management of relapsed/refractory B-cell lymphoma remains a major challenge.2 There are currently no dual EZH1/2 directed therapies approved for cancer treatment.
“We are pleased to join forces with Europe’s largest lymphoma research organization to advance and strengthen the development of valemetostat as a potential novel precision medicine for patients with relapsed/refractory B-cell lymphoma,” said Arnaud Lesegretain, Vice President, Global Oncology Development, Alpha Portfolio, Daiichi Sankyo. “LYSA-LYSARC-CALYM together with Daiichi Sankyo have designed a phase 2 study that will enroll patients based on disease subtype and biomarkers in order to further evaluate safety and efficacy, and we are planning a comprehensive translational research program to answer important scientific questions relating to clinical utility, optimal patient selection and mechanisms of resistance.”
“We are very happy to engage our cooperative group in a collaboration with Daiichi Sankyo for this promising development program with valemetostat targeting relevant epigenetic factors EZH2 and EZH1 in B-cell lymphomas,” said Franck Morschhauser, Professor of Hematology in Lille, France and President of LYSA-LYSARC. “We believe that our extensive multidisciplinary and international expertise will help advance the science behind the novel mechanism of action and we look forward to playing a role in bringing this potential new medicine to patients with lymphoma.”
About the Collaboration
Under the agreement, LYSA-LYSARC will execute a multi-center, non-randomized, open-label phase 2 study to evaluate the safety and efficacy of valemetostat in six cohorts of patients with relapsed/refractory B-cell lymphoma.
The study will enroll patients with diffuse large B-cell lymphoma (with and without an EZH2 mutation) that has progressed on at least one prior treatment; follicular lymphoma (EZH2 mutant and EZH2 wild-type), mantle cell lymphoma, and marginal zone lymphoma/other indolent lymphomas that have progressed on two or more prior treatments; and Hodgkin lymphoma that has progressed on three or more prior treatments including checkpoint inhibitors.
The primary endpoint of the study is best overall response rate determined by investigator assessment. Secondary endpoints include complete response rate, progression-free survival, duration of response, time to response and safety measures including adverse events. Exploratory endpoints include overall survival and measures of biomarker expression and treatment response. Pharmacokinetic endpoints will also be assessed.
The study will include approximately 140 patients at 22 sites in France and Belgium and is anticipated to initiate in 2021.
About EZH1 and EZH2
EZH1 (enhancer of zeste homolog 1) and EZH2 (enhancer of zeste homolog 2) enzymes are part of polycomb protein complexes that act through histone methylation to regulate gene expression.3 EZH1 and EZH2 are recurrently highly expressed or mutated in many hematologic malignancies.4 Epigenetic dysregulation of the methylation process is associated with suppression of genes that regulate cancer cell growth and proliferation.4 Research shows that both EZH1 and EZH2 have a role in hematologic cancer progression and that simultaneous inhibition would be effective in targeting the cancers.5 There are no dual EZH1/2 directed therapies approved for treatment of cancer.
Valemetostat (DS-3201) is a potential first-in-class small molecule oral EZH1/2 dual inhibitor currently in clinical development in the Alpha portfolio of Daiichi Sankyo for several hematologic cancers. Valemetostat targets epigenetic regulation by inhibiting both the EZH1 and EZH2 enzymes. Valemetostat has displayed antitumor activity in various hematological malignancies in preclinical models.5,6
The development program of valemetostat includes a pivotal phase 2 trial in patients with relapsed or refractory adult T-cell leukemia/lymphoma (ATL) in Japan; a phase 1 study in patients with several types of non-Hodgkin lymphomas (NHL) including B-cell lymphoma, adult T-cell leukemia-lymphoma (ATL) and peripheral T-cell lymphoma (PTCL) in the U.S. and Japan; and a phase 1 study in patients with acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) in the U.S.
In April 2019, valemetostat received SAKIGAKE Designation for the treatment of adult patients with relapsed or refractory PTCL by the Japan Ministry of Health, Labour and Welfare (MHLW).
Valemetostat is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.
About B-Cell Lymphoma
Lymphoma is the most common type of blood cancer.7 There were more than 627,000 new cases of lymphoma diagnosed globally and more than 283,000 deaths from the disease in 2020.8
There are more than 90 different lymphoma subtypes, which occur in varying frequencies in different geographic regions around the world.7 Most lymphomas originate in B-cell lymphocytes, with the most common types being diffuse large B-cell lymphoma (about 33 percent), follicular lymphoma (about 20 percent), mantle cell lymphoma (about 5 percent) and marginal zone lymphoma (5 to 10 percent).9 Treatment recommendations and prognosis vary for different subtypes of B-cell lymphoma.10 New treatment advances have improved outcomes for some patients with certain types of B-cell lymphoma, but management of relapsed or refractory lymphoma remains a major challenge and new and novel treatments are needed.2
About LYSA-LYSARC-CALYM, A Multidisciplinary Research Ecosystem
LYSA-LYSARC-CALYM form a multidisciplinary community of more than 800 professionals committed to lymphoma research in France and Belgium. Their shared missions are the following: fighting against lymphomas, researching better treatments and improving the patients’ quality of life. The origin of LYSA-LYSARC dates back to the 1980s and 90s. European lymphoma research experts have coordinated their efforts and competences over the years to create a premiere multidisciplinary ecosystem at the international level.
LYSA - A Network of Clinical Research Professionals
The Lymphoma Study Association, or LYSA, is the internationally leading cooperative group for lymphoma research in Europe, conducting clinical studies ranging from the first tests of new medicines in humans to the establishment of reference therapeutic strategies. LYSA includes in its network more than 120 care centers distributed throughout four countries (France, Belgium, Portugal, Israel), and collaborates with many scientific teams at the international level.
LYSARC - An Academic Research Organization Linked to the LYSA
The Lymphoma Academic Research Organization, or LYSARC, is the LYSA operational structure that conducts clinical research projects on lymphomas at the international level. LYSARC has all the integrated functions and dedicated platforms for pathology, biology and imagery to conduct as sponsor many phase 1 to 4 clinical studies or registries every year in lymphoma.
CALYM CARNOT INSTITUTE - A Consortium of Experts Dedicated to Partnership-Based Research
The purpose of the Carnot Institute CALYM, a consortium for the acceleration of innovation and its transfer to the field of lymphoma research, is to promote the development of diagnostic and care solutions for lymphomas, in partnership with the public and private socio-economic sector. It consists of 20 complementary research organizations: 18 public research laboratories, and LYSA and LYSARC. For more information about LYSA-LYSARC-CALYM visit lymphoma-research-experts.org.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.
1 Morishima S et al. 2019 ASH Annual Meeting Poster Presentation. Abstract #4025.
2 Ayyappan and Maddocks. J Hematol Oncol. 12, 82 (2019).
3 Honma D et al. 2017 ASH Annual Meeting Poster Presentation. Abstract #2073.
4 Nakagawa M and Kitabayashi I. Cancer Sci. 2018;109:2342–2348.
5 Honma D et al. Cancer Sci. 2017 Oct; 108(10): 2069–2078
6 Fujita S et al. Blood. 2015 126:457.
7 Suzumiya J International Journal of Hematology. (2018). 107:392–394.
8 Global Cancer Observatory. Population Fact Sheet. Updated November 2020.
9 American Cancer Society. Types of B-cell Lymphoma. Updated 2019.
10 American Cancer Society. Treating B-cell Non-Hodgkin Lymphoma. Updated 2020
Daiichi Sankyo, Inc.
+1 908 992 6631 (office)
+1 908 900 3183 (mobile)
Daiichi Sankyo Europe GmbH
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)
Daiichi Sankyo Co., Ltd.
+81 3 6225 1126 (office)
Investor Relations Contact:
LYSA - LYSARC - CALYM
Head of Communication
LYSA – LYSARC – CALYM
Direct : +33 (0)4 27 01 27 31
Mobile : +33 (0)6 76 93 86 61
About Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 202123.4.2021 16:05:00 CEST | Press release
LEO Pharma A/S, a global leader in medical dermatology, today announced results on the long-term safety and efficacy profile of tralokinumab in adult patients with moderate-to-severe atopic dermatitis. Results were shared as an oral presentation during the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021. Tralokinumab is a high affinity, human monoclonal antibody that specifically binds to and inhibits the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.2,3 It is an investigational therapy in clinical development, and its safety and efficacy are currently being evaluated by regulatory authorities. The interim analysis at 56 weeks in the ECZTEND trial (NCT03587805) showed tralokinumab 300 mg every other week plus optional topical corticosteroids (TCS) demonstrated long-term improvements in itch, sleep, and in atopic dermatitis signs and symptoms.1 Patients who had enrolled in pivotal Phase 3 trials ECZTRA 1 and 2 who continued into ECZTEND w
Merck Announces New Data Strengthening Evidence for Continued Safe and Effective MAVENCLAD ® Use During the COVID-19 Pandemic23.4.2021 15:11:00 CEST | Press release
Not intended for UK and U.S. based media Merck, a leading science and technology company, today announced a new analysis from the MAGNIFY-MS sub-study showing a specific immune repopulation pattern in patients with relapsing multiple sclerosis (RMS) treated with MAVENCLAD® (cladribine tablets), which may contribute to their ability to fight infections and develop protective antibodies from vaccines. The data were presented at the 2021 American Academy of Neurology (AAN) Annual Meeting that was held virtually 17-22 April 2021. In the MAGNIFY-MS study, reduction of memory B cells occurred as early as one month after MAVENCLAD initiation with lowest levels sustained for up to 12 months, while naïve B cells, which are typically required for the generation of antibody responses following vaccination, began recovering immediately. Previously shared data from MAGNIFY-MS indicated that patients receiving MAVENCLAD are able to mount responses to influenza and varicella zoster vaccines, irrespec
Xsolla Offers Exit Strategies to Game Studios for Exit Advising and Planning23.4.2021 15:00:00 CEST | Press release
Xsolla, the video game commerce company powered by its Transaction Engine and Business Engine to help developers and publishers market, sell, connect and optimize their games globally, has announced Xsolla Exit Strategies. The new service will connect development studios with financial and transaction advisors, guiding them through the process of selling their game property or studio, from due diligence preparation to exiting. The unveil of Xsolla Exit Strategies comes full circle from Xsolla Funding Club, launched March 2019, which provides matchmaking between vetted game projects and qualified investors. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210423005013/en/ Let Xsolla Exit Strategies match you with a financial and transaction advisor to help meet your exit goals. (Graphic: Business Wire) The gaming industry continues to flourish as demand is high for strategic partnerships and acquisitions for both game companies
Wipro Achieves Google Cloud Partner Specialization in Application Development23.4.2021 14:33:00 CEST | Press release
Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today announced that it has achieved the Google Cloud Partner Specialization in application development. This marks the fourth Partner Specialization badge that Wipro has received from Google Cloud, following recognition for outstanding cloud security, migration, and work transformation. This specialization demonstrates Wipro’s capabilities across multiple areas as a Google Cloud SI partner. As a trusted Google Cloud partner, Wipro can help customers leverage the best of Google Cloud platform as they develop and manage cloud-native business applications, enabling faster time to market, increasing scalability of applications and integrating them with external and internal systems in the IT landscape. This specialization will allow Wipro’s team of certified professionals to accelerate the customer modernization journey, increase agility and adapta
LEO Pharma Receives Positive CHMP Opinion of Adtralza ® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis23.4.2021 13:59:00 CEST | Press release
LEO Pharma A/S, a global leader in medical dermatology, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion and recommended granting a marketing authorization of Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The CHMP positive opinion is one of the final steps before the European Commission makes its decision on the Marketing Authorization Application for use of Adtralza, an investigational therapy in clinical development, throughout the European Union. This final decision is expected in the coming months and if authorized, Adtralza will be the first fully human, monoclonal antibody available to specifically target the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms. Adtralza specifically targets IL-13 with high affinity and is developed to improve the symptoms of atopic derma
Schlumberger Announces First-Quarter 2021 Results23.4.2021 12:50:00 CEST | Press release
Schlumberger Limited (NYSE: SLB) today reported results for the first-quarter 2021. First-Quarter Results(Stated in millions, except per share amounts)Three Months EndedChange Mar. 31, 2021 Dec. 31, 2020 Mar. 31, 2020 SequentialYear-on-yearRevenue* $5,223 $5,532 $7,455 -6% -30% Income (loss) before taxes - GAAP basis $386 $471 $(8,089) -18% n/m Net income (loss) - GAAP basis $299 $374 $(7,376) -20% n/m Diluted EPS (loss per share) - GAAP basis $0.21 $0.27 $(5.32) -22% n/m Adjusted EBITDA** $1,049 $1,112 $1,347 -6% -22% Adjusted EBITDA margin** 20.1% 20.1% 18.1% 0 bps 203 bps Pretax segment operating income** $664 $654 $776 1% -14% Pretax segment operating margin** 12.7% 11.8% 10.4% 88 bps 230 bps Net income, excluding charges & credits** $299 $309 $351 -3% -15% Diluted EPS, excluding charges & credits** $0.21 $0.22 $0.25 -5% -16% Revenue by Geography International $4,211 $4,343 $5,225 -3% -19% North America* 972 1,167 2,180 -17% -55% Other 40 22 50 n/m n/m $5,223 $5,532 $7,455 -6% -30%
ANAORI kakugama: The New Cooking Tool Shaking Up the Culinary World23.4.2021 12:30:00 CEST | Press release
Japanese brand ANAORI, a leader in manufacturing carbon graphite products, has developed a groundbreaking cooking tool that combines new technologies and natural materials in a unique design. In the coming weeks, renowned chefs from around the world will apply their expertise to showcase the potential of ANAORI kakugama. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210423005016/en/ ANAORI kakugama Watch the ANAORI kakugama video here ANAORI kakugama: The Culinary Tool Combining Tradition and Innovation The philosophy of ANAORI was born out of respect for Japanese culture, rooted in a tradition of living in harmony with nature. Naturality according to ANAORI means understanding the principles of nature without confronting it, multiplying its powers by means of minimal intervention, in order to best utilise it. The Japanese company unveils two ANAORI kakugama models in two different sizes, to cook with the rhythm of the seas