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Takeda Expands Oncology Research, Demonstrating Commitment to Patient Community at 15th International Symposium on Myelodysplastic Syndromes

On May 7, 2019 Takeda Pharmaceutical Company Limited [TSE: 4502 / NYSE: TAK] reported that it will present a total of five company-sponsored poster presentations, as well as an oral pipeline symposium, at the 15th International Symposium on Myelodysplastic Syndromes taking place in Copenhagen, Denmark from May 8-11, 2019 (Press release, Takeda, MAY 7, 2019, View Source [SID1234535855]). Takeda’s presentations will highlight the company’s investigations into the epidemiology, prognosis and patient reported outcomes for higher-risk myelodysplastic syndromes (HR-MDS) and the related conditions – chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) – to achieve a deep understanding of these rare cancers and the needs of this patient community.

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"We are excited to join the MDS community at this upcoming meeting where we will share key findings around Takeda’s research in HR-MDS, CMML and AML," said Hui Huang, PhD, Head, Oncology Global Outcomes Research at Takeda. "For over a decade, there has been little advancement in treatment options for people living with HR-MDS and CMML, despite poor patient outcomes. Takeda’s investment in this wide-ranging global outcomes research directly captures patient input to better understand these cancers, as well as AML, and the impact on their lives. These findings are an important aspect of our work as we strive to bring new treatment options to patients."

At this year’s International Symposium on Myelodysplastic Syndromes, Takeda will present results from a variety of innovative research studies. These results are the first global systematic review of HR-MDS and CMML on incidence and prevalence, including the risk of transformation to AML. The results will also quantify the disease burden, discuss the difficulties associated with diagnosis and underscore the significant unmet need of this patient population. Some of this research was conducted in collaboration with the MDS Foundation – an international non-profit advocacy organization whose mission is to support and educate patients and healthcare providers with innovative research into the fields of MDS, AML and related myeloid neoplasms.

Five Takeda Oncology-sponsored abstracts were accepted for poster presentation, as well as an oral pipeline symposium during MDS 2019:

Note: All times listed are in Central European Standard Time

Understanding and Measuring Fatigue In Higher-Risk Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia: Mixed Method Research. Abstract MDS19-0051. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Epidemiology of Chronic Myelomonocytic Leukemia: A Systematic Review. Abstract MDS19-0038. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Is Contemporary Incidence Estimation of Higher-Risk Myelodysplastic Syndrome Possible? Results From a Systematic Literature Review. Abstract MDS19-0037. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Identification of the Most Suitable Patient-Reported Outcomes Measure for Trials in Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia, and Acute Myeloid Leukemia. Abstract MDS19-0052. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
Characteristics of Untreated Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS) Identified in a United States (US) Electronic Medical Record (EMR) Database. Abstract MDS19-0035. Wednesday, May 8, 1:00 p.m. – 9:30 p.m. (Tivoli Conference Center, Room Vandsalen).
A Pragmatic Patient-Reported Outcome Strategy for Rare Disease Clinical Trials: Application of the EORTC Item Library. Oral Symposium Presentation. Thursday, May 9, 11:45 a.m. – 12:45 p.m. (Tivoli Congress Hall).
For more information, the MDS 2019 program is available here: View Source

About Myelodysplastic Syndromes, Chronic Myelomonocytic Leukemia and Acute Myeloid Leukemia

Myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML) and acute myeloid leukemia (AML) are rare forms of blood cancer that are caused by irregular blood cell production within the bone marrow. As a result of this irregular production, a person with MDS, CMML or AML does not have enough normal red blood cells, white blood cells and/or platelets in circulation. Symptoms for MDS, CMML and AML are often vague and related to low blood counts, and may include fatigue, shortness of breath, easy bruising or bleeding, loss of appetite, weakness, pale skin, fever and frequent or severe infections.

There are several classifications of MDS – lower risk to higher-risk – determined by blood counts, blast counts, mutations and cytogenetics. Higher-risk disease is defined as intermediate, high or very high risk on the International Prognostic Scoring System – Revised (IPSS-R), and these patients often have a poorer prognosis. In some cases, MDS and CMML can progress into AML.

Clover Biopharmaceuticals Receives NMPA Approval for SCB-313 (TRAIL-Trimer) to Initiate Clinical Trials in China

On May 7, 2019 Clover Biopharmaceuticals, a biotechnology company focused on developing novel and transformative biologic therapies, reported it has received Clinical Trial Application (CTA) approval from the Chinese National Medical Products Administration (NMPA) to conduct clinical trials in China with SCB-313, an investigational fully-human TRAIL-Trimer fusion protein, for the treatment of cancer patients with intracavitary malignancies (Press release, Clover Biopharmaceuticals, MAY 7, 2019, View Source [SID1234535854]). A phase I clinical trial for malignant ascites is planned to initiate in China this year.

"We are delighted to receive this clearance, as it further validates Clover’s innovative and proprietary Trimer-Tag© technology, in-house R&D capabilities and biomanufacturing expertise," said Dr. Peng Liang, co-founder, Chairman and President of Clover. "We are extremely excited to initiate clinical trials for SCB-313 in China. The treatment of malignant ascites remains a high unmet need globally, with no targeted or biologic antitumor therapies currently approved and available, and we hope that SCB-313 will provide a safe and efficacious option for patients in China and worldwide."

"We believe that SCB-313 has the potential to be a first-in-class and best-in-class TRAIL-based therapy based on our preclinical results to date. TRAIL has long been considered a tantalizing target for cancer therapy because it can induce apoptosis in a tumor-specific manner across many different tumor types. SCB-313, which utilizes our proprietary Trimer-Tag© technology, is able to potently and uniquely target this trimerization-dependent pathway."

New Publication in Cancer Research Highlights Discovery of SY-1365, a First-in-Class Selective CDK7 Inhibitor, and its Promise as a Potentially Transformative Targeted Approach for Difficult-to-Treat Cancers

On May 7, 2019 Syros Pharmaceuticals (NASDAQ: SYRS), a leader in the development of medicines that control the expression of genes, reported the online publication of a new manuscript, Discovery and Characterization of SY-1365, a Selective, Covalent Inhibitor of CDK7, in the American Association for Cancer Research (AACR) (Free AACR Whitepaper)’s (AACR) (Free AACR Whitepaper) journal, Cancer Research (Press release, Syros Pharmaceuticals, MAY 7, 2019, View Source [SID1234535853]). SY-1365, a first-in-class selective cyclin-dependent kinase 7 (CDK7) inhibitor, is currently being investigated in a Phase 1 clinical trial as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations that lack effective treatment options. This publication highlights the discovery, mechanism of action and promise of SY-1365 as a new targeted approach for a range of difficult-to-treat cancers.

"SY-1365 represents a potentially transformative targeted approach for a number of cancers that have eluded treatment with existing approaches," said Eric R. Olson, Ph.D., Syros’ Chief Scientific Officer. "While CDK7 has long been a target of interest, it was historically difficult-to-drug. This new publication profiles our work in discovering SY-1365, which we believe to be the most advanced selective CDK7 inhibitor in clinical development, and the substantial anti-tumor activity seen in preclinical models that supported its advancement into the clinic. We are excited by the promise of CDK7 inhibition and the potential benefit SY-1365 may bring to patients who are in dire need of better therapies."

Syros is currently conducting a Phase 1 clinical trial assessing the safety and efficacy of SY-1365 as a single agent and in combination with standard-of-care therapies in multiple ovarian and breast cancer patient populations. The trial includes cohorts evaluating SY-1365 as a single agent in patients with relapsed ovarian clear cell cancer and in high-grade serous ovarian cancer (HGSOC) patients who have had three or more prior lines of therapy; in combination with carboplatin in HGSOC patients who have had one or more prior lines of therapy; in combination with fulvestrant in metastatic hormone receptor-positive breast cancer patients who are resistant to treatment with a CDK4/6 inhibitor; and as a single agent in patients with solid tumors of any histology accessible for biopsy. Additional details about the trial can be found using the identifier NCT03134638 at www.clinicaltrials.gov.

CDK7 plays a key role in the transcription of genes and in cell cycle regulation, and inhibiting CDK7 disrupts two important processes that cancer cells use to survive: 1) expression of cancer-promoting genes; and 2) uncontrolled cell cycle progression. SY-1365 has shown anti-tumor activity in preclinical models of a range of solid tumors and blood cancers, including cancers that have become resistant to treatment with existing therapies or where existing options have failed to provide meaningful benefit to patients. Further, data suggests that SY-1365 works to inhibit the growth of cell lines representing many different cancer types at nanomolar concentrations, decreases MCL1 protein levels, and demonstrates activity among cancer cells with low BCL-XL expression.

Building on its leadership in CDK7 inhibition, Syros is advancing SY-5609, a highly selective and potent oral CDK7 inhibitor, toward clinical development. In preclinical studies, SY-5609 has demonstrated substantial anti-tumor activity, including inducing complete regressions in cell line-derived xenograft models of breast and ovarian cancers. The company plans to complete investigational new drug application (IND)-enabling studies by the end of 2019 to support the initiation of a Phase 1 oncology trial in early 2020.

Sensei Biotherapeutics Announces Clinical Trial Collaboration Agreement with AstraZeneca for Two Phase 2 Studies of SNS-301

On May 7, 2019 Sensei Biotherapeutics, Inc., a clinical-stage biopharmaceutical company developing precision immuno-oncology therapies, reported a clinical trial collaboration with AstraZeneca to evaluate the safety, tolerability and preliminary activity of AstraZeneca’s IMFINZI (durvalumab), a human monoclonal antibody directed against programmed death-ligand 1 (PD-L1), in combination with SNS-301 (Press release, Sensei Biotherapeutics, MAY 7, 2019, View Source [SID1234535852]). SNS-301, Sensei’s first-in-class immunotherapy candidate, is a therapeutic cancer vaccine utilizing a bacteriophage viral vector targeting aspartate β-hydroxylase (ASPH), a novel embryonic antigen.

Under the terms of the agreement, AstraZeneca and Sensei will collaborate to evaluate the combination of SNS-301 and IMFINZI in patients with locally advanced head and neck cancer in the neoadjuvant setting in conjunction with TPF chemotherapy prior to surgical resection and in ASPH+ patients with various locally advanced unresectable or metastatic/recurrent solid tumors. AstraZeneca will supply IMFINZI for these clinical studies and Sensei will sponsor and fund the Phase 2 studies. AstraZeneca and Sensei will each retain full worldwide rights to their respective molecules.

"We are extremely pleased to collaborate with AstraZeneca, a leader in the cancer immunotherapy field. SNS-301 targets a novel mechanism to activate and direct ASPH-specific T-cells to tumors. We believe that when combined with IMFINZI, SNS-301 has the potential to deepen and broaden the overall immune-mediated response," said John Celebi, President and Chief Executive Officer of Sensei Biotherapeutics. "This clinical collaboration strengthens our position as pioneers of precision oncology therapeutics by focusing on improved clinical outcomes for ASPH-positive patients through novel clinical combinations."

About SNS-301

SNS-301 is a first-in-class immunotherapy candidate utilizing a bacteriophage viral vector that targets human aspartate β-hydroxylase (ASPH), a cell surface enzyme that is normally expressed during fetal development. Following fetal development, the protein is no longer expressed. Expression of ASPH is uniquely upregulated in more than 20 different types of cancer and is related to cancer cell growth, cell motility and invasiveness. ASPH expression levels are inversely correlated with disease prognosis. Though enhanced antigen presentation and other engineered immunotherapeutic features, SNS-301 is designed to overcome self-tolerance and induce robust and durable humoral and cellular immune responses that are specific to ASPH. SNS-301 is delivered through intradermal injection and avoids time consuming and uncomfortable infusions, greatly facilitating ease of use.

About IMFINZI (Durvalumab)

IMFINZI (durvalumab) is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. As part of a broad development program, IMFINZI is being investigated as monotherapy and in combination with immuno-oncology (IO) agents, small molecules, and chemotherapies across a range of tumors and stages of disease.

Kyn Therapeutics Strengthens Leadership Team with Key Appointments

On May 7, 2019 Kyn Therapeutics, a clinical-stage biotechnology company developing highly differentiated cancer immunotherapies, reported the appointment of Jeffrey Ecsedy, Ph.D., as its chief scientific officer and Jason Sager, M.D., as its chief medical officer (Press release, KYN Therapeutics, MAY 7, 2019, View Source [SID1234535851]). Dr. Ecsedy was formerly a member of the Oncology R&D leadership team at Takeda Pharmaceuticals as head of oncology translational medicine following more than a decade at Millennium Pharmaceuticals. Dr. Sager is a highly distinguished clinical oncologist with over 15 years of experience in biotech and pharma. Both executives joined Kyn in 2017, Dr. Sager serving as the company’s interim chief medical officer and Dr. Ecsedy as its senior vice president, R&D. Dr. Ecsedy will head the teams responsible for discovery, non-clinical and translational sciences, while Dr. Sager will provide leadership to Kyn’s clinical operations, clinical development and regulatory teams.

"Jason and Jeff’s guidance and expertise have been invaluable to Kyn through the design and execution of the two ongoing Phase 1b/2 clinical studies of our lead candidate ARY-007, an EP4 receptor antagonist. Their input was also essential to our delivery of important preclinical milestones that validated the novel biology underlying our programs," said Mark Manfredi, Ph.D., Kyn’s president and chief executive officer. "We are now planning entry into the clinic for our AHR and Kynase programs, both partnered with Celgene. Jeff and Jason’s leadership will play a critical role during this significant phase of Kyn’s growth and development."

"At Kyn we have leveraged our discovery, translational and clinical development knowledge to build a differentiated pipeline, which is first and foremost defined by patient need," Dr. Ecsedy said. "By assembling a multi-talented research and development team complemented by a top-tier external scientific and clinical advisory network, we intend to drive our existing programs forward while evaluating compelling opportunities to expand our differentiated portfolio."

"This is an exciting time in cancer therapeutics and the Kyn team is doing outstanding work towards delivering multiple new advances for patients," Dr. Sager said. "I look forward to working together to expand the clinical portfolio and deliver on the two current clinical studies for ARY-007."

Dr. Sager is a pediatric oncologist with extensive experience in biotech, pharma and academic research. Previously, he was a senior medical director in Sanofi’s oncology division, leading development of an early-stage clinical portfolio. Prior to Sanofi, Dr. Sager served as a medical director at Genentech and Novartis, where he brought multiple drugs into the clinic and through to proof of concept. He has also served as advisor for medical technology companies Bionaut Labs and Privo Technologies. In addition to his biotechnology experience, Dr. Sager has worked as a pediatric oncologist at Johns Hopkins University, the National Cancer Institute and the Dana-Farber Cancer Institute. He is currently a Deshpande Center Catalyst at the Massachusetts Institute of Technology, where he mentors grant recipients establishing early stage companies. He is the founder of Sagely Health, a consultancy focused on reducing treatment information asymmetry for cancer patients. Dr. Sager received his B.A. from Johns Hopkins University and his M.D. from Cornell University.

Dr. Ecsedy has over 20 years of experience as a cancer researcher. Prior to joining Kyn, Dr. Ecsedy served as the head of oncology translational medicine at Takeda Pharmaceuticals. He and his team led translational science for a diverse portfolio of molecules spanning all stages of development, including pre-IND activities, FIH studies, regulatory approvals and life-cycle management. As a member of Takeda Oncology R&D leadership, Dr. Ecsedy helped shape a renewed strategic vision for the division. Prior to his roles at Takeda, he led numerous projects from the discovery phase into clinical development through roles of increasing responsibility at Millennium Pharmaceuticals. Dr. Ecsedy received a B.S. from the University of Connecticut, earned his Ph.D. in biological sciences at Boston College and trained as a post-doctoral fellow in genetics at Harvard Medical School.