大鵬薬品 新たながん免疫療法の開発に参入 Arcus Bioscience社のアデノシン受容体阻害剤をアジアで独占的に開
Arcus Biosciences Announces That Taiho Pharmaceutical Has Exercised Its Option to Develop and Commercialize AB928 in Its Territories July 12, 2018 HAYWARD, Calif.--(BUSINESS WIRE)--Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, today announced that Taiho Pharmaceutical Co., Ltd. (Taiho) exercised its option under the Option and License Agreement entered into in September 2017 (Taiho Agreement) to obtain an exclusive development and commercialization license to the Company's adenosine receptor antagonist program, which includes AB928 and back-up compounds, in Japan and certain other territories in Asia (excluding China). In addition to an option exercise payment, Arcus is eligible to receive clinical and regulatory milestones totaling up to $130 million as well as commercialization milestones and royalties on net sales for this program."Our collaboration with Arcus is an important relationship for Taiho, as we expand our oncology franchise in Japan and other important territories in Asia" "We are pleased that Taiho has decided to exercise their option just as we are initiating our Phase 1/1b program for AB928 in the U.S. and Australia," said Terry Rosen, Ph.D., CEO at Arcus. "We believe that Taiho's decision to exercise their option to this program at this early stage reflects their recognition that AB928, the first adenosine 2 receptor antagonist in clinical development to be specifically designed for the oncology setting, has significant potential to treat a broad array of tumor types. We are confident that Taiho's expertise and capabilities in oncology, as well as their experience co-promoting Keytruda® in Japan, make them the ideal partner to bring AB928 to cancer patients as quickly as possible in their territories.""Our collaboration with Arcus is an important relationship for Taiho, as we expand our oncology franchise in Japan and other important territories in Asia," said Masayuki Kobayashi, President and Representative Director at Taiho. "We have been impressed by Arcus's small molecule drug discovery capabilities, the quality of their clinical candidates and the scientific rigor of their candidate selection process. AB928 appears to have the ideal properties to block the immuno-suppressive effects of adenosine in the tumor microenvironment. We look forward to working with Arcus on the development of this important new immuno-oncology mechanism for the treatment of multiple tumor types."
About the Taiho Agreement Arcus and Taiho entered into an option and license agreement in September 2017. Taiho will provide $35.0 million of cash payments to Arcus during the first three years of the agreement in exchange for an exclusive option, over a five-year period, to in-license the development and commercialization rights to clinical stage product candidates from Arcus's portfolio for Japan and certain other territories in Asia (excluding China). Taiho is obligated to pay an option exercise payment for each option exercise of between $3.0 million to $15.0 million, with the amount dependent on the development stage of the applicable Arcus program for which the option is exercised. In addition, Taiho is obligated to pay to Arcus clinical, regulatory and commercialization milestones up to $275.0 million per program as well as royalties ranging from high single digits to mid-teens on net sales in Taiho's territories.
About AB928 AB928 is an orally bioavailable, highly potent antagonist of the adenosine 2a and 2b receptors. The activation of these receptors by adenosine interferes with the activity of key populations of immune cells and inhibits an optimal anti-tumor immune response. By blocking these receptors, AB928 has the potential to reverse adenosine-induced immune suppression within the tumor microenvironment. AB928 was designed specifically for the oncology setting, with a profile that includes potent activity in the presence of high concentrations of adenosine and a minimal shift in potency due to non-specific protein binding, both essential properties for efficacy in the tumor microenvironment. AB928 has other attractive features, including high penetration of tumor tissue and low penetration through the healthy blood-brain barrier. In a Phase 1 trial in healthy volunteers, AB928 has been shown to be safe and well tolerated and to have pharmacokinetic and pharmacodynamic profiles consistent with a once-daily dosing regimen.
About Arcus Biosciences Arcus Biosciences is a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies. Arcus has several programs targeting important immuno-oncology pathways, including a dual adenosine receptor antagonist AB928, which will be evaluated in combination with other agents in multiple tumor types in a Phase 1/1b program, and an anti-PD-1 antibody, which is being evaluated in a Phase 1 trial and will be tested in combination with Arcus's other product candidates. Arcus's other programs include a small molecule inhibitor of CD73 and an anti-TIGIT antibody, both of which are in IND-enabling studies. Arcus has extensive in-house expertise in medicinal chemistry, immunology, biochemistry, pharmacology and structural biology. For more information about Arcus Biosciences, please visit www.arcusbio.com.
( エーブィエ バイオファーム)・販売する権利を取得 大鵬薬品工業株式会社 (本社：東京都千代田区、代表取締役社長：小林将之、以下「大鵬薬品」)は、革新的ながん免疫療法の創薬・開発に注力している米国のArcus Biosciences社 (以下、｢Arcus社｣) が開発中のアデノシン受容体阻害剤AB928とそのバックアップ化合物を、アジア (中国除く) で独占的に開発・販売する権利を取得したことをお知らせいたします。これは、2017年9月に両社が締結したオプション契約に基づき、大鵬薬品がオプション権を行使したものです。AB928は、がん微小環境における免疫抑制メカニズムに関与すると考えられているアデノシン受容体のサブタイプA2aおよびA2bを選択的に阻害する低分子化合物です。アデノシン受容体阻害剤がさまざまな疾患で開発されている中で、AB928はがんをターゲットに設計されたアデノシン受容体阻害剤であり、経口剤としてArcus社が開発を進めています。アデノシン受容体阻害剤は、今後がん免疫療法における新たな治療法になる可能性があるとして期待されています。Arcus社はAB928に関して、健常人における第I相臨床試験を既に実施しており、AB928の安全性、忍容性および薬物動態が確認されています。また、AB928と化学療法やPD-1抗体などさまざまな併用療法を複数のがん種において検討する第I相臨床試験を本年開始しました。Arcus社は本試験を通して、AB928の安全性等をさらに検討する予定です。大鵬薬品は今後Arcus社とともに最適な治療法をできるだけ早期に確立、提供することを目指しています。大鵬薬品は、今後もがん治療において、患者さんや医療関係者により一層貢献できるよう努めてまいります。
Arcus receives FDA approval for Phase l/lb trial of AB928 combination，12 JUNE 2018 Arcus Biosciences has received approval from the US Food and Drug Administration (FDA) validating its two new product candidates, AB928 and AB122. The approval is based on the investigational new drug (IND) applications submitted by Arcus and has enabled the company to conduct its proposed Phase l/lb trial of AB928 in combination with other agents, including AB122 and chemotherapy. The trial aims to examine the safety, tolerability and preliminary efficacy of the AB928 combination for the treatment of patients with breast and gynaecologic malignancies. It will include a dose-escalation phase to determine the optimal dose of AB928 to be combined with fixed doses of AB122 and with each of the three different immunogenic cell death (ICD) inducing chemotherapy regimens. After selecting the recommended dose of AB928 for each combination, the trial will enrol expansion cohorts to investigate AB928 in combination with AB122 or chemotherapy to begin three tumour-specific trials for breast, gynaecologic and gastrointestinal malignancies, as well as lung cancer and renal cell carcinoma (RCC). “If approved, the company will start trials of AB928 combinations in gastrointestinal malignancies, non-small cell lung cancer (NSCLC) and RCC.” Each of the trials will allow Arcus to add new AB928 combination arms in the future. In the dose-escalation portion of the trials, the company will evaluate the evidence of immune engagement to enable a mechanistic understanding of early clinical responses and others. Results from the dose-escalation portion of the Phase l/lb trial are scheduled to be available in the first half of next year. In addition, Arcus plans to submit two additional IND applications this month. If approved, the company will start trials of AB928 combinations in gastrointestinal malignancies, non-small cell lung cancer (NSCLC) and RCC.Arcus has also been completing the regulatory process to investigate the combination of AB928 and AB122 in patients in Australia and expects to dose its first patient with this combination soon.
