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
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
The Climate Pledge Announces More Than 100 Signatories Committed to Achieving Net-Zero Carbon by 2040 or Sooner21.4.2021 09:01:00 CEST | Press release
Today, Amazon and Global Optimism announced that more than 100 companies have now signed The Climate Pledge. Among the 52 new signatories joining The Climate Pledge today are well-known brands including Alaska Airlines, Colgate-Palmolive, HEINEKEN, PepsiCo, Telefónica, and Visa. Pledge signatories in total generate more than $1.4 trillion in global annual sales and have more than 5 million employees across 25 industries in 16 countries—demonstrating the collective impact The Climate Pledge can have in addressing climate change. Signatories to The Climate Pledge agree to: Measure and report greenhouse gas emissions on a regular basis. Implement decarbonization strategies in line with the Paris Agreement through real business changes and innovations, including efficiency improvements, renewable energy, materials reductions, and other carbon emission elimination strategies. Neutralize any remaining emissions with additional, quantifiable, real, permanent, and socially beneficial offsets t
Shippeo Sustains Stellar Growth, Recognized in 2021 Gartner Magic Quadrant for Real-time Transportation Visibility Platforms21.4.2021 09:00:00 CEST | Press release
Shippeo, the European leader in real-time supply chain transportation visibility, has been recognized in the Gartner Magic Quadrant for Real-time Transportation Visibility Platforms 2021. The complimentary report is available at shippeo.com. Shippeo COO Lucien Besse is pleased to see the company’s market momentum being acknowledged. “We believe our recognition in the Magic Quadrant reflects upon our heavy investment in R&D and rapid deployment support over the past year as the pandemic stimulates unprecedented interest in RTTV solutions.” This interest has led Gartner to predict that, “by 2023, 50% of global product-centric enterprises will have invested in real-time transportation visibility platforms.” “We’re proud to have a market-leading visibility product and to have achieved strong growth with some of the highest customer recommendation rates,” adds Besse. The company has also developed the most accurate and reliable ETA in the industry while offering full GDPR compliance. The CO
Biometrics Experts and New Study Highlight How Behavioral Biometrics Supports Strict Regulation and Offers Better Data Privacy Protections21.4.2021 09:00:00 CEST | Press release
BehavioSec, the industry pioneer and technology leader for behavioral biometrics and continuous authentication, today announced new findings that organizations and consumers can feel more comfortable with wider use of behavioral biometrics to safeguard their online digital experiences and identities. Following a year of digital transformation on a societal level, the demand for better online user experience and a stronger level of digital identity protection has become essential. With a year when the world has seen a combination of personal data theft with new rulings and proposed legislation, like the EU Schrems II in July 2020 and the US National Biometrics Information Privacy Act in August [US Senators Merkley, D-OR and Sanders, I-VT], the need for expert guidance has never been higher. BehavioSec shares this research and a company milestone to highlight how behavioral biometrics can be adopted transparently with clear benefits, and in compliant fashion with comprehensive data prote
GE and Hitachi ABB Power Grids Sign Landmark Agreement to Reduce Environmental Impact in the Electrical Transmission Industry21.4.2021 09:00:00 CEST | Press release
GE Renewable Energy’s Grid Solutions business (NYSE: GE) and Hitachi ABB Power Grids Ltd. announced today a non-exclusive, cross-licensing agreement related to the use of an alternative gas to sulfur hexafluoride (SF6) used in high voltage equipment. This fluoronitrile-based gas mixture has a significantly reduced impact on the environment compared to SF6. Under this landmark agreement announced just before Earth Day 2021 between two global leaders in power technologies – both companies will share complementary intellectual property related to their respective SF6-free solutions. This will help accelerate the use of fluoronitrile-based eco-efficient insulation and switching gas in high-voltage equipment as an alternative to SF6. A recent EU Commission report concluded that fluorinitrile-based gas mixtures may be the only insulating and switching gas alternative to SF6 when space is a constraint. Today’s historic agreement paves the way for a standard SF6-free solution for high-voltage
SES Joins United Nations Global Compact Initiative, Accelerates Purpose-led ESG Programme in 202121.4.2021 08:50:00 CEST | Press release
SES today announced it has joined the United Nations Global Compact, the world’s largest corporate sustainability initiative, underscoring the company's purpose-led Environmental, Social and Governance (ESG) programme. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420006272/en/ SES Joins United Nations Global Compact Initiative, Accelerates Purpose-led ESG Programme in 2021 (Photo: Business Wire) By committing to the UN Global Compact framework, SES is now firmly aligning its long-standing societal and environmental impact efforts to the company’s purpose – doing the extraordinary in space to deliver amazing experiences everywhere on earth – and delivering on its ambitions to provide cloud-enabled, satellite-based intelligent connectivity and to make a difference worldwide. The UN Global Compact is a corporate initiative that encourages both business and non-business organisations to establish and define strategies, poli
Australia Flexes Muscle in Talent War with Newest Immigration Program21.4.2021 07:30:00 CEST | Press release
The global battle for talent supercharged by the Covid-19 pandemic shows no signs of abating, with Australia sending out strong signals that it intends to succeed with its latest immigration offering under the Australia Global Business and Talent Attraction Taskforce. Under the purview of the taskforce, there is a fast-tracked visa program with a streamlined path to permanent residence for talented individuals. The Global Talent visa has been designed to grow Australia’s innovation and tech economies in a bid to boost economic recovery, enhance resilience, and drive competitiveness by attracting dynamic, highly skilled individuals to relocate to its safe shores. With no age limit or investment prerequisite, the only requirements for applicants are to be internationally recognized, prominent in their field, and able to provide evidence of outstanding achievements. The 10 future-focused target sectors are: Agri-food and AgTech, Energy, Health Industries, Defence, Advanced Manufacturing a
A Limited Collection Team-up Between High-end Streetwear Brand LIBERE and Naruto Is Set for Release!21.4.2021 03:00:00 CEST | Press release
A new limited collection teaming up Japanese high-end streetwear brand LIBERE and Naruto is scheduled for release in May. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210420006240/en/ LIBERE characters (Graphic: Business Wire) The theme of the collection is “LIBERE FOR NARUTO” – a series of garments created around the unique points of each character, with the concept of characters of the Naruto world wearing the LIBERE clothing line. Known for its style bringing together diverse elements, in this collection LIBERE suggests a new “street ninja style.” By making liberal use of the clan marks and colorings of 6 major characters: Naruto, Sasuke, Sakura, Kakashi, Shikamaru, and Itachi, the collection achieves a strong affinity with the characters. The collection includes minute details such as straps, pockets, and zippers, featuring high-function reflective surfaces as well as tactical jackets and pants that epitomize ninja fas
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom