Strategia Therapeutics Initiates a Phase 1/2a Clinical Trial of the Anti-cancer Agent E6201 in Patients with Advanced Hematologic Malignancies

• Download english PDF
• DOWNLOAD JAPANESE PDF

BOSTON–(BUSINESS WIRE) – Strategia Therapeutics, Inc. (Strategia) –  from the company’s former name,  Boston Strategics. Corp. – has begun a Phase 1/2a clinical trial of anti-cancer agent E6201 in patients with advanced hematologic malignancies, including relapsed or refractory acute myeloid leukemia (AML), high-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML).  The trial is being carried out at the University of Texas M.D. Anderson Cancer Center with Gautam Borthakur, M.D., as the Principal Investigator.

There are approximately 19,000 new cases of AML in the U.S. each year, with over 10,000 deaths; the number of patients estimated to be living with AML is 40,000. Patients relapsed or refractory to currently available therapy have limited options. MDS is a type of hematological malignancy, in which the disorder of blood-forming “hematopoietic stem cells” causes inefficient production of blood cells triggering cytopenia. It is also a refractory disease for some patients with poor prognosis, progressing to acute myeloid leukemia. The U.S. incidence of MDS is 14,000 cases per year, most of them in the senior age group.

E6201, discovered by Eisai Co., Ltd., is a dual-inhibitor of FMS-like tyrosine kinase 3 (FLT-3) and mitogen-activated protein (enzyme) kinase (MEK). Activation of FLT3 is observed in patients with AML carrying either internal tandem duplication (ITD) or point (D835) mutations in the FLT3 gene, and E6201 has demonstrated activity against both mutations. The Ras/Raf signaling pathway signals through the downstream signal transducers MEK1 and extracellular signal-related kinases (ERK) and activation of this pathway is seen in AML cells of patients failing FLT3 inhibitor therapy. Preclinical studies conducted by Dr. Borthakur indicate inhibition of both pathways is important to durable responses.

The University of Texas MD Anderson Cancer Center is one of the world’s top general cancer centers with over 10,000 patients enrolled in therapeutic clinical trials each year and approximately 20,000 employees. Strategia is able to utilize the world’s top-level clinical testing functions available at the MD Anderson Cancer Center under a Strategic Alliance Agreement to carry out Phase 1 and early Phase 2 clinical trials to gain safety and preliminary proof of activity in cancer patients at an early stage. “This drug may be important for patients with advanced hematologic malignancies who have failed conventional therapeutics, including single-agent FLT3 inhibitors”, said Gautam Borthakur, M.B.B.S., Associate Professor of Leukemia at M.D. Anderson Cancer Center. By inhibition of both the FLT3 and MEK pathways we hope to provide more durable clinical benefit than through inhibition of one pathway alone. This study will build on our preclinical evidence, and further this important clinical research at our institution.” 

“This is the first proprietary drug under full development by Strategia. Both FLT3 and MEK are important new targets for the treatment of advanced hematologic malignancies. Inhibition of both pathways known to be involved in the progression of FLT3 positive AML is an important next step in new targeted therapeutics for the treatment of this disease“, said Dr. Linda Paradiso, Head of Drug Development for Strategia. “We have in-licensed E6201 from Eisai Co., Ltd. and they have been an excellent collaborative partner. Both companies are fully committed to deliver breakthrough therapies using innovative approaches to achieve industry benchmark-beating timelines, quality, and financial investments for important novel anti-cancer agents”.

About Strategia Therapeutics, Inc. (Strategia)

Strategia is an innovative pharmaceutical R&D company with experience in developing, managing and optimizing global drug development programs. Its mission is to create a new model for collaborative drug development by bringing together small, global expert teams, each of which has expertise specific to a single drug. By focusing its efforts in this way, Strategia rapidly and successfully moves each project forward to completion while keeping internal infrastructure small and streamlined.

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)

Boston Strategic Corporation Announces Name To Strategia Therapeutics, Inc.

• DOWNLOAD English PDF
• DOWNLOAD JAPANESE PDF

BOSTON–(BUSINESS WIRE) – Boston Strategic Corporation, an innovative pharmaceutical R&D company that specializes in streamlining the drug development processes, today announced its new name: Strategia Therapeutics, Inc., effective immediately.

The change, which comes on the Boston-based company’s third anniversary, more accurately reflects its emphasis on serving patients in need, says President and CEO Keizo Koya, Ph.D. “Strategia’s vision is to change the existing drug research and development paradigm,” Koya says. By creating a nimble approach to drug development, he notes, the company can reduce overall costs and time to market, thereby making new, affordable drugs available to patients whose medical needs would otherwise be unmet.

Strategia’s approach is a dramatic break from existing R&D models, which rely mainly on a single company’s in-house research, testing, and production. Instead of using one team to create many different drugs, Strategia pulls together customized global project teams for each new therapeutic agent under development. These teams, which Strategia manages, are made up of partners with specific expertise relevant to a certain drug or medical condition.

“We place drug development strategy first,” says Koya. “This approach streamlines existing research and development extensively, and it lets Strategia create new, effective therapeutics faster and more efficiently than ever before,” he adds. “Our primary goal is positively impacting patient health—so our success is measured by how quickly and effectively we make new drugs accessible to those patients,” he says.

Strategia was founded in April 2012. Since then, the company has collaborated with global partners who have the same vision and passion for improved patient care, and has advanced many new pharmaceutical R&D projects from research to clinical development. Its core team of strategists collectively have more than 200 years of experience in drug development.

The company’s new logo design and tagline (”A New Vision. A Better Future for Patients,”) symbolize its new mission.

Former name：Boston Strategics Corp.
New name：Strategia Therapeutics, Inc.

【Startegia Therapeutics, Inc. Profile】
Company Name:          Strategia Therapeutics, Inc.
President and CEO:     Keizo Koya, Ph.D.
Headquarter Address: 214 Union Wharf, Boston, MA 02109-1204, USA
About Strategia Therapeutics, Inc. (Strategia)

Strategia is an innovative pharmaceutical R&D company with experience in developing, managing and optimizing global drug development programs. Its mission is to create a new model for collaborative drug development by bringing together small, global expert teams, each of which has expertise specific to a single drug. By focusing its efforts in this way, Strategia rapidly and successfully moves each project forward to completion while keeping internal infrastructure small and streamlined.

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)

Boston Strategics Enters into an Innovative Risk-Sharing Agreement with the MD Anderson Cancer Center to Conduct a Phase 1/2a Clinical Trial of E6201 in Patients with Advanced Hematologic Malignancies Including Acute Myeloid Leukemia

• DOWNLOAD english PDF
• DOWNLOAD JAPANESE PDF

BOSTON–(BUSINESS WIRE)–Boston Strategics Corporation (BSC), an integrated clinical-stage drug research and development (R&D) company, Boston, MA, today announced that it has entered into a risk-sharing agreement with the University of Texas MD Anderson Cancer Center (MD Anderson) to conduct a Phase 1/2a clinical trial of E6201 in patients with advanced hematologic malignancies, including acute myeloid leukemia (AML).

Working in collaboration with MD Anderson, BSC will undertake this clinical Proof of Concept (PoC) trial of E6201, a dual-targeted FLT3 and MEK inhibitor for the high unmet need of FLT3 mutated AML. The trial is supported by recent translational data generated by Gautam Borthakur, MD, Michael Andreef, MD, PhD and colleagues in the Leukemia Department at MD Anderson. Dr. Borthakur will serve as Principal Investigator on the clinical trial.

Under this innovative agreement, MD Anderson commits its own resources to conduct the clinical study, while BSC provides the drug supply, study execution, safety monitoring, and data management. Both organizations will share the development challenges and risks for these high unmet need patients with advanced hematologic malignancies who need effective and new treatments.

This collaboration is a further step toward the realization of BSC’s “True” Open Innovation™ platform to develop drug candidates with potential to significantly improve patients’ health care. The BSC approach invites innovative clinical academic centers, such as MD Anderson, to participate more broadly in the clinical development process in an effort to share the risk and trial outcomes. The flexibility and collaborative approach of “True” Open Innovation™ empower centers like MD Anderson to become entrepreneurial partners together with BSC and the other members of its global network.

“We are very excited and pleased to work with MD Anderson, a leading cancer health care institution in which we share our core values of innovative patient-centered and science-based approaches,” says Keizo Koya, Ph.D., CEO of Boston Strategics. “This is a historical milestone for BSC to build on our concept of “True” Open Innovation™ by collaborating with such an institution as MD Anderson to create a new effective treatment for AML patients.”

“Our mission is to bring novel drugs to patients. Unfortunately there are drugs that, despite its promise, struggle to progress through clinical development. To bring those drugs to patients and unlock their full potential, we are firmly committed to working with the oncology community and to devise novel and creative business structures that make those collaborations possible“ says Ferran Prat, Ph.D., VP MD Anderson Cancer Center.

About Boston Strategics Corporation (BSC):

BSC is an integrated drug R&D company with experience in developing, managing and optimizing global drug development programs from late discovery, through translational research, first-in-man or proof-of-concept clinical studies. Its mission is to continuously improve patient health care by changing the drug R&D paradigm using “True” Open Innovation™ platform.

About “True” Open Innovation™ :

“True” Open Innovation™ is a revolutionary business concept that breaks through internal infrastructure limitations by drawing on the Boston Strategics core team of experts and introducing additional external, key expertise in a given area. In a highly specialized industry such as drug development, the limitation of large, internal organizations and the expertise of the internal team members is critical. “True” Open Innovation overcomes such limitations by reducing the need for large infrastructure, and draws on additional critical drug development expertise, based on the unique needs of a particular program. In summary Boston Strategics utilizes its own global core competencies coupled with external Strategic Global Outsourcing as needed.

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)

 

Boston Strategics Corporation Announces Key Agreement In Translational Oncology With Molecular Response

• DOWNLOAD english PDF
• DOWNLOAD JAPANESE PDF

BOSTON, Oct. 14, 2014 /PRNewswire/ – Boston Strategics Corporation (BSC), an integrated clinical-stage drug research and development (R&D) company, Boston, MA, today announced that it has entered into an agreement with Molecular Response (MRL), a privately held molecular diagnostic services company and a leader in the identification of target populations for high value therapeutics. In collaboration with MRL, BSC designs and manages for pharmaceutical drug development programs to improve POS (Probability Of Success) identifying patient sub-populations using patient-derived tumor xenografts (PDX), leveraged by MRL’s proprietary ‘living’ cell bank of primary tumor cells.

This translational program and collaboration is another example of a BSCcollaboration, whereby BSC optimizes and executes the global strategy of key pharmaceutical partners’ drug development programs. Utilizing BSC‘s internal oncology development expertise and its ability to leverage the “True” Open Innovation network to collaborate with the best resources around the world, BSC continues to deliver more efficient and superior outcomes to key partners in treatment of cancer patients worldwide.

“We are excited to work with Boston Strategics to further refine the efficacy package of novel therapeutics for pharmaceutical partners and help the precision of their programs with more targeted approach to patient selection. The collaboration with these partners is proof of our success and continued commitment to enable further evaluation of cancer therapeutics in better characterized models with use of our high content cell-based platforms and exclusive patient-derived xenografts,” said Cyrus K. Mirsaidi, Molecular Response CEO.

“The selection of Molecular Response as a member of Boston Strategics‘ ’True’ Open Innovation platform, and access to their vast bank of characterized near patient models strengthens the ability of our network partners to address translational challenges and assess efficacy of compounds earlier in the life cycle of their programs,” said Dr. Keizo Koya, Boston Strategics, CEO.  ”This approach combined with access to a large and well annotated primary tumor bank will allow foundational work for biomarker development, target population selection, and new indication mining for novel therapeutics.”

About Molecular Response:
Molecular Response is a leader in the utilization of large, clinically relevant tumor banks and predictive patient-derived xenografts (PDX) that help advance high value therapeutics through intelligently designed, biomarker driven in vitro and in vivo models. Our goal is to reduce risk and cost of therapeutic drug development for our partners by use of fully characterized efficacy models to create a clinically predictive knowledge base while fully integrated into existing pharmaceutical development processes and programs; Our results allow for the most informed decisions with best chance of success to advance therapeutic programs.

For additional information please visit www.molecularresponse.com.

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)

Boston Strategics Corporation Initiates a Phase 1 Clinical Trial of the Anti-cancer Agent “FF-10501” for FUJIFILM in Patients with Advanced Hematologic Malignancies

• DOWNLOAD english PDF
• DOWNLOAD JAPANESE PDF

BOSTON–(BUSINESS WIRE)–Boston Strategics Corporation (BSC), a primary global strategic drug development provider for FUJIFILM Pharmaceuticals U.S.A., Inc. (FPHU), has begun a Phase 1 clinical trial of FUJIFILM’s anti-cancer agent FF-10501 in the United States in patients with advanced hematologic malignancies, such as relapsed or refractory high-risk myelodysplastic syndromes (MDS). The trial is carried out at the University of Texas MD Anderson Cancer Center (MD Anderson) with Guillermo Garcia-Manero, M.D., Professor, as the Principal Investigator. Prof. Garcia-Manero is a world-renowned expert in advanced hematologic malignancies, especially MDS.

MDS is a type of hematologic malignancy, in which the disorder of blood-forming “hematopoietic stem cells” causes inefficient production of blood cells triggering cytopenia.  It is also a refractory disease for some patients with poor prognosis, progressing to acute myeloid leukemia. The U.S. incidence of MDS is 60,000 cases per year, most of them in the senior age group.  FF-10501 is expected to inhibit the growth of hematological cancer cells and promote their differentiation to normally functioning cells.

MD Anderson is one of the world’s top general cancer centers with over 10,000 patients enrolled in therapeutic clinical trials each year and approximately 20,000 employees. BSC is able to utilize the world’s top-level clinical testing functions available at the MD Anderson under a Strategic Alliance Agreement to carry out Phase 1 and early Phase 2 clinical trials to gain preliminary safety information and clinical activity in cancer patients. “We are very excited to be collaborating with FPHU and BSC on this important clinical trial in patients with advanced hematologic malignancies,” said Prof. Guillermo Garcia-Manero. “This drug will provide another alternative for patients who have failed conventional chemotherapeutic approaches, and we are pleased to be furthering this research at our institution.” 

This clinical trial is the first example of a BSC and FPHU collaboration, whereby BSC optimizes and executes the global strategy of FPHU Oncology drug development programs. Utilizing Boston Strategics’ internal oncology development expertise and its ability to leverage the “True” Open Innovation™ network to collaborate with the best resources around the world, BSC will be able to deliver to FPHU more efficient and superior outcomes to cancer patients worldwide.

“This is a important milestone in BSC and FPHU partnership to develop a new pharmaceutical R&D platform for FPHU, which looks for an innovative and efficient way for global development of FUJIFILM’s unique oncology pipeline“, says Eita Kitayama, President of Boston Strategics. “Both companies are fully committed to deliver breakthrough therapies using innovative approaches to achieve industry benchmark-beating timelines, quality, and financial investments for important novel anti-cancer agents.”

Contact:
Strategia Therapeutics, Inc.
+1-781-761-0123 (office)
Contact@StrategiaTx.com (email)
http://www.StrategiaTx.com (website)