Taiho Pharmaceutical Exercises Option for an Exclusive License to Quemliclustat in Japan and Certain Territories in Asia
Arcus Biosciences and Taiho Pharmaceutical announced that Taiho has exercised its option for an exclusive license to quemliclustat in Japan and certain other Asian territories, excluding mainland China. This action is part of a 2017 agreement, marking the fourth option Taiho has exercised in Arcus's projects. Taiho will make a payment for this option and additional payments upon reaching certain milestones. Quemliclustat is an investigational CD73 inhibitor, and Arcus plans to begin a Phase 3 trial (PRISM-1) in 2024 for treating metastatic pancreatic ductal adenocarcinoma. This decision follows promising survival data from a Phase 1b study presented at the ASCO GI Cancers Symposium. Taiho will also support and manage the PRISM-1 study in Japan.
- Taiho Pharmaceutical exercised its option for an exclusive license to quemliclustat in Japan and certain Asian territories.
- Arcus Biosciences will receive an option exercise payment and additional milestone payments from Taiho.
- Quemliclustat has shown promising survival results in a Phase 1b study, leading to a planned Phase 3 trial in 2024.
- Taiho will support the development and commercialization of quemliclustat, enhancing its market potential.
- None.
Insights
The decision by Taiho Pharmaceutical to exercise its option for quemliclustat represents a significant development for Arcus Biosciences, both from a financial and strategic standpoint.
From a financial perspective, this agreement includes an option exercise payment along with potential milestone payments tied to clinical, regulatory and commercialization successes. These payments can influence Arcus' revenue streams positively in the short term, contributing to cash flow and reducing the reliance on equity financing.
Moreover, royalties on net sales offer a long-term financial upside, contingent on successful product approval. It's important to note that such deals can mitigate financial risks by leveraging Taiho's resources and capabilities in Asian markets.
Strategically, this partnership allows Arcus to remain capital-efficient while expanding its geographic footprint. Taiho's established presence in Japan and certain Asian territories facilitates market entry and expedites the clinical trial process, potentially accelerating time-to-market for quemliclustat. However, reliance on Taiho's execution capabilities introduces a degree of operational risk.
Furthermore, the upcoming Phase 3 study PRISM-1, supported by overall survival data from the Phase 1b ARC-8 study, underscores the potential of quemliclustat in addressing metastatic pancreatic ductal adenocarcinoma—a high-need area.
The involvement of quemliclustat, a small molecule CD73 inhibitor, in the upcoming PRISM-1 Phase 3 study signifies a promising advancement in the treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The CD73 enzyme plays a role in creating an immunosuppressive tumor environment and inhibiting it may enhance anti-tumor immune responses.
Quemliclustat's progress to a Phase 3 trial is underpinned by encouraging overall survival results from the Phase 1b ARC-8 study, which were highlighted at the ASCO GI Cancers Symposium. If these results hold in larger, more definitive trials, quemliclustat could represent a meaningful advancement in a cancer type notoriously resistant to treatment.
For patients, this potential new treatment option could offer improved survival and quality of life. The involvement of Taiho in operationalizing the trial in Japan is crucial, given their local expertise and resources. However, investors should be aware of the inherent uncertainties and risks associated with clinical trials, including potential adverse effects and regulatory hurdles.
In exchange for the exclusive license of quemliclustat, Taiho will make an option exercise payment, as well as additional payments upon achievement of clinical, regulatory and commercialization milestones, and, if any products from the program are approved, will pay royalties on net sales of such products.
Quemliclustat is an investigational small molecule CD73 inhibitor. In 2024, Arcus plans to initiate the global, registrational Phase 3 study PRISM-1, comparing quemliclustat plus chemotherapy to chemotherapy alone as a treatment for patients with previously untreated metastatic pancreatic ductal adenocarcinoma (mPDAC). Advancement to a Phase 3 study is based on overall survival results observed in the Phase 1b ARC-8 study that were presented earlier this year at the American Society of Clinical Oncology Gastrointestinal (ASCO GI) Cancers Symposium.
Through this collaboration, Taiho will further support the development and potential commercialization of quemliclustat and will operationalize the PRISM-1 study in
About Quemliclustat
Quemliclustat is an investigational small molecule CD73 inhibitor. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types. Quemliclustat has been shown to block the production of adenosine. Once the immunosuppressive effects of adenosine are removed, activation of antitumor immune cells may be restored, resulting in cancer cell death.
In addition to the planned registrational Phase 3 study PRISM-1 by Arcus, quemliclustat is being co-developed by Arcus and Gilead Sciences in combination with other molecules within the companies’ portfolios with chemotherapy, including Phase 2 studies in lung and upper gastrointestinal cancers. Quemliclustat is an investigational medicine and is not approved for use globally.
About Taiho and Arcus Agreement
Based on the option and license agreement that Taiho and Arcus entered into in 2017, Taiho has obtained exclusive development and commercialization rights to a total of four programs in
For other territories in the world, Gilead obtained the rights to commercialize in the
About Arcus Biosciences
Arcus Biosciences is a clinical-stage, global biopharmaceutical company developing differentiated molecules and combination medicines for people with cancer. In partnership with industry collaborators, patients and physicians around the world, Arcus is expediting the development of first- and best-in-class medicines against well-characterized biological targets and pathways and studying novel, biology-driven combinations that have the potential to help people with cancer live longer. Founded in 2015, the company has expedited the development of multiple investigational medicines into clinical studies, including new combination approaches that target TIGIT, PD-1, the adenosine axis (CD73 and dual A2a/A2b receptor), HIF-2a, CD39 and AXL. For more information about Arcus Biosciences’ clinical and pre-clinical programs, please visit www.arcusbio.com.
About Taiho Pharmaceutical Co., Ltd. (
Taiho Pharmaceutical, a subsidiary of Otsuka Holdings Co., Ltd. (https://www.otsuka.com/en/), is an R&D-driven specialty pharma focusing on the fields of oncology and immune-related diseases. Its corporate philosophy takes the form of a pledge: “We strive to improve human health and contribute to a society enriched by smiles.” In the field of oncology, in particular, Taiho Pharmaceutical is known as a leading company in
Forward-Looking Statements
This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: statements regarding events or results to occur in the future contained herein, including, but not limited to, Arcus’s receipt of milestones or royalties; the planning and initiation of additional clinical development activities, including activities related to PRISM-1; and realization of any potential benefits from this transaction. All forward-looking statements involve known and unknown risks and uncertainties and other important factors that may cause Arcus’ actual results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: difficulties associated with the management of the collaboration activities or expanded clinical programs; data from ARC-8 may not be replicated in future studies evaluating the same investigational molecules or regimen, including PRISM-1; the unexpected emergence of adverse events or other undesirable side effects the inherent uncertainty associated with pharmaceutical product development and clinical trials; delays in Arcus’s clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; and changes in the competitive landscape for Arcus’s programs. Risks and uncertainties facing Arcus are described more fully in the “Risk Factors” section of Arcus’s most recent periodic report filed with the
The Arcus name and logo are trademarks of Arcus Biosciences, Inc. All other trademarks belong to their respective owners.
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Arcus Investor Inquiries:
Pia Eaves
Head of Investor Relations & Strategy
(617) 459-2006
peaves@arcusbio.com
Arcus Media Inquiries:
Holli Kolkey
VP of Corporate Communications
(650) 922-1269
hkolkey@arcusbio.com
Taiho Pharmaceutical Co., Ltd. Inquiries:
Yuji Kawahara
Strategic Communications
+81-3-3293-2878
th-koho@taiho.co.jp
Source: Arcus Biosciences
FAQ
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