North American Pipeline

A legacy of exploratory research continues

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Continuous advancements for patients

For more than 30 years, we have pursued scientific discoveries that address unmet clinical needs. The process of developing biologics and small-molecule drugs draws on the expertise of many, inside and outside the organization. Together, we work to investigate new molecules that have the potential to change medicine and change lives.

3 FDA drug approvals

between 2018 and 2019

Notably, our work in pharmaceutical research and development has led to 3 FDA drug approvals between 2018 and 2019; two of these were recognized with breakthrough medicine status. Data on these medicines earned recognition as Best of ASBMR (2013), Best of ASCO (2016), and Best of ASH (2018).

North American Pharmaceutical Pipeline

Our development work in North America is coordinated with global colleagues to bring new medicines to patients around the world in 4 therapeutic areas: neurology, immunology & allergy, oncology, and nephrology. Many of our programs target rare diseases for which patients lack sufficient treatment options.

Our North American teams are currently working on these assets. To view the most current global Kyowa Kirin pipeline, click here.

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Phase
Phase
Candidate
Proposed Indication

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Proposed Indication Proposed Indication

Candidate Cand.

Phase

Mycosis fungoides and Sézary syndrome

Mogamulizumab KW-0761

Filed (CA)

Fd (CA)

Investigational use:

Mogamulizumab (KW-0761) is a CCR4-targeted monoclonal antibody that leverages POTELLIGENT® technology.

Formulation:

Injection

Collaborators:

In-house with Stanford University

Market:

Canada

Follicular lymphoma (FL),
marginal zone lymphoma (MZL)

Zandelisib combined
with Rituximab
ME-401

Phase 3 (US)

P3 (US)

Investigational use:

Zandelisib (ME-401) is an inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ)

Study name:

COASTAL

Formulation:

Oral

Sponsor:

MEI Pharma

Clinicial trial information:

NCT04745832

Atopic dermatitis

KHK4083

Phase 2 (US)

P2 (US)

Investigational use:

KHK4083 is an anti-OX40 fully human monoclonal antibody that leverages POTELLIGENT® technology.

Formulation:

Injection

Collaborators:

Amgen(US, International Markets)

Clinicial trial information:

NCT03703102

Follicular lymphoma (FL),
marginal zone lymphoma (MZL)

Zandelisib ME-401

Phase 2 (US)

P2 (US)

Investigational use:

Zandelisib (ME-401) is an inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).

Study name:

TIDAL

Formulation:

Oral

Sponsor:

MEI Pharma

Clinicial trial information:

NCT03768505

Parkinson's Disease

KW-6356

Phase 2 (US)

P2 (US)

Investigational use:

KW-6356 is an adenosine A2A receptor antagonist/inverse agonist.

Formulation:

Oral

Collaborators:

In-house

Clinicial trial information:

NCT02939391,NCT03703570

Urothelial carcinoma

KHK2455

Phase 1 (US)

P1 (US)

Investigational use:

KHK2455 is an IDO1 inhibitor.

Formulation:

Oral

Collaborators:

In-house

Clinicial trial information:

NCT03915405

Solid tumor

KHK2455

Phase 1 (US)

P1 (US)

Investigational use:

KHK2455 is an IDO1 inhibitor in clinical development for use in combination with KW-0761.

Formulation:

Oral

Collaborators:

In-house

Clinicial trial information:

NCT02867007,NCT04321694

B-cell malignancies

Zandelisib ME-401

Phase 1 (US)

P1 (US)

Investigational use:

Zandelisib (ME-401) is an inhibitor of phosphatidylinositol 3-kinase delta (PI3Kδ).

Study name:

B-cell malignancies

Formulation:

Oral

Sponsor:

MEI Pharma

Clinicial trial information:

NCT02914938

ONCOLOGY

IMMUNOLOGY/ALLERGY

CENTRAL NERVOUS SYSTEM

Information accurate as of September 2021. Clinical testing of novel compound drugs is a complex process with no guaranteed results. Our hope in pursuing these proposed indications is to deliver to patients the advances that may have a profound impact on their disease. However, the safety and efficacy of these agents remain under investigation and have not been established or reviewed by regulatory agencies or health authorities.

Innovative clinical trial design

With our clinical research, Kyowa Kirin North America aspires to contribute to the enhancement of medical care, the advancement of medical and pharmaceutical sciences, and the overall improvement of patients' health and well-being. We have accomplished the swift completion of registrational programs with innovative trial design by applying innovative methods for data capture and analysis.

Clinical trials enable our researchers to responsibly evaluate the safety and efficacy of potential treatments. These trials investigate new treatments in terms of efficacy and the presence of side effects. We are committed to publishing the results of our trials in peer-reviewed publications and in presentations at medical conferences around the world.

When engaging in clinical research, we give maximum consideration to the protection of the human rights and safety of patients who participate in the research. Furthermore, we strive to comply with relevant laws and regulations and to secure transparency in clinical research, scientific validity, independence, and reliability.

Kyowa Kirin Group Clinical Research Policy

We have established and are implementing the Kyowa Kirin Group Clinical Research Policy, which summarizes our approach to clinical research and code of conduct. Visit clinicaltrials.gov to learn about clinical research sponsored by Kyowa Kirin.

To learn about clinical trials sponsored by Kyowa Kirin, visit clinicaltrials.gov and enter “Kyowa Kirin” into the search field labeled, “Other Terms.”

Our expertise

Cross-functional teams help create and deliver innovative new medicines.

 

Transcript

Rachel Soloff: So other companies, or other labs maybe, you have your Molecular Biologists and your Immunologists who never talk to each other. Whereas here we're constantly communicating, and we'll get ideas from individuals that aren't necessarily trained Immunologist, so they're not hampered by the paradigms of Immunology. It can cause us to see things in a different light and develop novel approaches to discover new antibodies, [00:00:30] new drugs.

Expanded access

Expanded access programs provide a process to make investigational treatments available to physicians with patients who face life-threatening diseases for which no approved therapy is available and who cannot participate in a clinical study. Kyowa Kirin North America welcomes inquiries about access to treatments that are currently in clinical studies.

Please review our policy for expanded access to unapproved drugs.

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