Ono Pharma USA, Inc.

- Double the investment scale to accelerate open innovation and make strategic investments in bio-venture companies - OSAKA, Japan, Dec. 1, 2023 /PRNewswire/ -- Ono Pharmaceutical Co., Ltd. (Osaka, Japan; President and CEO: Gyo Sagara; "Ono") today announced that in order to accelerate the open innovation, it has increased its investment pool from US$100 million to US$200 million to continue strategic investment in Ono Venture Investment Fund I, L.P. ("OVI FI"), which was established as a corporate venture capital fund in CA, USA in May 2020. With the aim of accessing and partnering on drug discovery targets and cutting-edge technologies for the generation of innovative medicines, Ono established Ono Venture Investment, Inc. (South San Francisco, CA, USA: "OVI"), as well as OVI FI as local subsidiaries in the U.S. in May 2020. OVI manages the investment fund and invests in bio-ventures and startup companies. Since the establishment in 2020, OVI and OVI FI have been supporting the drug discovery activities through strategic investments in 11 bio-venture companies to date, including the most recent investment in Photys Therapeutics (Waltham, MA, USA). With this increase in investment, Ono will create and accelerate further open innovation through OVI and OVI FI activities, and make more strategic investments in bio-venture companies and startup companies. In this way, Ono will continue to promote innovation and work to achieve the sustainable growth through the creation of innovative new drugs. SOURCE ONO PHARMA USA, INC.

CAMBRIDGE, Mass., April 18, 2023 /PRNewswire/ -- ONO PHARMA USA today announced partnerships with LabCentral in Cambridge, Mass., and MBC BioLabs in San Francisco, to award each organization one Golden Ticket for an innovative life sciences startup company. The competition is sponsored by ONO PHARMA USA's parent company, Ono Pharmaceutical Co., Ltd. (ONO), and applications will be received through May 2023. The Golden Ticket awards provide promising early-stage R&D companies lab space and mentorship, two components vital to the success of nascent life science businesses. The Golden Tickets ONO is sponsoring this year will provide one outstanding applicant lab space and related services at each of the partner locations, as well as mentorship from ONO's renowned researchers and business leaders across its global network. Interested applicants may submit their non-confidential company presentations: LabCentral, by May 26, to: labcentral-goldenticket2023_ml@ono-pharma.com. Winners will receive a $50,000 credit towards space and services available at LabCentral 700 for use within a 13-month period, beginning upon receipt. MBC BioLabs, by May 12, to: . Winners will receive one-year free lab space at MBC BioLabs and access to its shared amenities and services. Initial submissions will be accepted for each location, Cambridge and San Francisco, and reviewed by ONO's internal committee. Finalists for each location will be notified and invited to present to ONO in person or virtually at the end of June. Winners will be presented with the Golden Tickets shortly thereafter. In 2021, ONO entered sponsorship agreements with LabCentral and MBC BioLabs, two non-profit organizations that support the development of biotech startups and entrepreneurs by providing access to comprehensive laboratory facilities and technologies. ONO has long been a proponent of collaboration in R&D and credits its own open innovation model for supporting key scientific breakthroughs over the years. "As longtime believers in open innovation and the power of partnerships, we are excited once again to offer this Golden Ticket competition in collaboration with LabCentral and MBC BioLabs," said Kunihiko Ito, President and CEO of ONO PHARMA USA. "We look forward to reviewing applicants' presentations and encourage companies who are doing outstanding work in ONO's four focus areas – oncology, immunology, neurology and specialty medicine – to apply." About ONO PHARMA USA ONO PHARMA USA, established in 1998 as the U.S. subsidiary of Ono Pharmaceutical Co., Ltd., is pursuing the clinical development of new drug candidates and aiming to establish operations in the U.S., from clinical development to regulatory approval and commercialization. In addition, ONO PHARMA USA is engaged in promotion of the discovery alliances and licensing activities to expand Ono's development pipeline and pursue the commercialization opportunities in the U.S. For more information, please visit . About Ono Pharmaceutical Co., Ltd. Ono Pharmaceutical Co., Ltd., headquartered in Osaka, is an R&D-oriented pharmaceutical company committed to creating innovative medicines in specific areas. ONO focuses its research on oncology, immunology, neurology, and specialty area with high medical needs as priority areas for discovery and development of innovative medicines. For further information, please visit the company's website at . About LabCentral LabCentral is a network of laboratory spaces and scientific communities, purposed designed to jumpstart the launch of promising early-stage life-sciences companies and accelerate scientific innovation in service of human health. Operating over 225,000 square-feet in Cambridge and on the Harvard University Campus, LabCentral is a convener of biotech stakeholders, connecting early and mid-stage companies with established institutions and organizations in the industry. LabCentral provides first-class operational support, curated events and programming, and access to a diverse network of sponsors to as many as 125 startups comprising approximately 1000 scientists and entrepreneurs. More information is available at . About MBC BioLabs MBC BioLabs is dedicated to helping life-science startups succeed. By renting space as small as a single lab bench and providing these entrepreneurial scientists with access to millions of dollars of equipment, MBC BioLabs allows companies to be fast, focused, and frugal. It has three sites: one in the Dogpatch neighborhood in San Francisco and two campuses in San Carlos, California. Each site has a complete molecular biology core facility that allows companies to do experiments on day one. MBC BioLabs has partnerships with leading pharmaceutical and life-science companies as well as a built-in venture capital firm, Mission BioCapital. These partnerships provide entrepreneurs with valuable insights about where to focus their efforts and accelerates the innovation pipeline. Since opening in 2013, MBC BioLabs has helped launch and grow 290 companies. These companies have brought 153 programs to the clinic, produced 13 approved diagnostics, and raised over $13 billion. For more information, visit . Contact: ONO PHARMA USA info@ono-usa.com View original content to download multimedia: SOURCE ONO PHARMA USA, INC.

CAMBRIDGE, Mass., March 23, 2023 /PRNewswire/ -- ONO PHARMA USA, INC., announced that its candidate, tirabrutinib (ONO-4059), a Bruton's tyrosine kinase inhibitor, was granted Orphan Drug Designation on March 21, 2023 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with primary central nervous system lymphoma (PCNSL). The FDA's Orphan Drug Designation program supports the development and evaluation of investigational drugs and biologics that show promise for the diagnosis, treatment, or prevention of rare diseases or disorders, affecting fewer than 200,000 people in the United States (U.S.). PCNSL is a rare and aggressive extra nodal non-Hodgkin lymphoma affecting the brain, its protective membranes, the spinal cord, and/or eye, without systemic involvement at the time of diagnosis. In the U.S., the incidence of PCNSL is approximately five out of 1,000,000 people per year, with higher rates in people over 65 years old.1 Symptoms can vary depending on the location of the tumor and may include headache, nausea, vomiting, visual symptoms, and seizures, among others. ONO is currently recruiting newly diagnosed and relapsed or refractory adult PCNSL patients in the U.S. for the PROSPECT clinical study (; NCT04947319). "We are extremely pleased that tirabrutinib has been granted orphan drug status for the treatment of PCNSL," said Kunihiko Ito, President and CEO of ONO PHARMA USA. "The designation represents a milestone for ONO. Currently, ONO is carrying out a Phase 2 trial of tirabrutinib in people with newly diagnosed or relapsed/refractory PCNSL, and we look forward to advancing clinical trials so that patients may have therapeutic options as soon as possible." About PCNSL PCNSL is a rare and aggressive extra nodal non-Hodgkin lymphoma (NHL) that is confined to the brain parenchyma, spinal cord, eye, or leptomeninges, without systemic involvement. The annual incidence rate of PCNSL is approximately five cases per 1,000,000 people in the U.S. The rate can further increase among immunocompetent people aged 65 years and older. The signs and symptoms presented in patients with PCNSL vary depending on the neuroanatomical site of the lesion, and include cranial neuropathy, neuropsychiatric symptoms, symptoms associated with increased intracranial pressure, seizures, ocular symptoms, headache, dysmotility, cranial neuropathy, and radiculopathy. There are no therapeutic products specifically approved for the treatment of PCNSL in the U.S., and data guiding therapeutic approaches are very limited. Despite recent progress resulting in the improvement of clinical outcomes in newly diagnosed patients with PCNSL after an induction treatment, approximately 20 to 30 percent of patients are refractory to the initial treatment, and up to 60 percent of patients will eventually relapse. About Tirabrutinib Tirabrutinib, discovered and developed by Ono Pharmaceutical Co., Ltd., is a highly potent selective BTK inhibitor. Signaling through the B-cell receptor (BCR) regulates cellular proliferation and activation, and promotes survival, differentiation, and clonal expansion of B-cells. The BCR signaling pathway plays an important role in a number of B-cell malignancies. Gene expression profiling data revealed BCR signaling as the most prominent pathway activated in chronic lymphocytic leukemia (CLL) cells isolated from lymphatic tissues. In Japan, tirabrutinib was approved in March 2020 for the treatment of relapsed or refractory PCNSL and launched under the tradename of Velexbru® in May 2020. In addition, tirabrutinib was approved for the treatment of relapsed or refractory PCNSL in South Korea in November 2021 and in Taiwan in February 2022. Moreover, Velexbru® was approved for the treatment of Waldenstrom macroglobulinemia and lymphoplasmacytic lymphoma in Japan in August 2020. About the PROSPECT Study The PROSPECT Study is the Phase 2 trial (NCT04947319) evaluating the safety and effectiveness of an investigational oral medicine called tirabrutinib for potential treatment of newly diagnosed or relapsed/refractory primary central nervous system lymphoma, which is a type of cancer that either does not improve from treatment (refractory) or improves only for a limited time (relapsed). Current treatment options for relapsed or refractory PCNSL are limited, and there are no medications approved in the U.S. for the treatment of PCNSL. Learn more about the PROSPECT Study here: . About ONO PHARMA USA ONO PHARMA USA is the U.S. subsidiary of Ono Pharmaceutical Co., Ltd. ("ONO"), a Japanese pharmaceutical company. For more than 300 years, ONO has been focused on developing safe, high-quality, and effective therapies that help people lead healthier lives. ONO is dedicated to pursuing the clinical development of new therapeutic candidates for the U.S. market. ONO is also engaged in strategic alliances, partnerships, and licensing activities to expand its development and commercialization pipeline. For more information, please visit . Contact: ONO PHARMA USA [email protected] Reference Ostrom QT, Price M, Neff C, et al. CBTRUS Statistical Report: Primary Brain and Other Central Nervous System Tumors Diagnosed in the United States in 2015-2019. Neuro Oncol. 2022;24(Suppl 5): v1-v95. SOURCE ONO PHARMA USA, INC.