Shanghai, China, July 12, 2022--Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics, announced today that it has entered into a strategic partnership with Orient EuroPharma (OEP). Under the partnership, OEP is granted the exclusive right to distribute and commercialize in Taiwan and Singapore ZYNLONTA®, the world’s first and only CD19-targeted ADC approved by the U.S. Food and Drug Administration. Through this partnership, Overland ADCT BioPharma will join forces with OEP to drive the commercialization of ZYNLONTA and address the unmet needs of appropriate diffuse large B-cell (DLBCL) lymphoma patients in Taiwan and Singapore.
Signing Ceremony
Overland ADCT BioPharma CEO Eric Koo said, “ZYNLONTA has demonstrated significant efficacy with a good safety profile in clinical trials in a broad range of heavily pre-treated patients. We believe OEP is our ideal partner because of its leadership role and exceptional performance in drug commercialization across Taiwan and Singapore. The strategic partnership with OEP marks another milestone for us in delivering first-in-class innovative ADC therapies with proven clinical outcomes in greater China and Singapore.”
Calvin Tsai, CEO of the OEP Group, said, “We are very excited to partner with Overland ADCT BioPharma in the fight against cancer. OEP has been developing and marketing anticancer drugs for 20 years. We not only have solid sales and marketing teams in Taiwan, Hong Kong, Singapore, and The Philippines, but also have established strong relationships with physicians specializing in blood cancer, thoracic cancer, and cancer surgery. OEP has been striving to expand its anticancer portfolio to cover more types of cancer and bring new hope to cancer patients in Taiwan and other regions of Asia. We believe ZYNLONTA will become a welcome option for patients with relapsed / refractory DLBCL in Taiwan.”
DLBCL is the most common type of non-Hodgkin's lymphoma (NHL), accounting for about 30-40% of newly diagnosed lymphomas worldwide[1]. In East and Southeast Asia, DLBCL accounts for 42% of all NHL cases[2]. Although about 60% of the patients can be cured with standard immunotherapy, about 40% of patients do not respond to first-line treatments or will suffer from a relapse after attaining a remission[3]. The prognosis for the patients with r/r DLBCL after first-line treatment failure is poor, especially for those not suitable for hematopoietic stem cell transplantation. With limited treatment options available there are significant unmet clinical needs[4].
About ZYNLONTA® (loncastuximab tesirine)
ZYNLONTA® is a CD19-directed antibody drug conjugate (ADC). Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload. The potent payload binds to DNA minor groove with little distortion, remaining less visible to DNA repair mechanisms. This ultimately results in cell cycle arrest and tumor cell death.
The U.S. Food and Drug Administration (FDA) has approved ZYNLONTA (loncastuximab tesirine-lpyl) for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), DLBCL arising from low-grade lymphoma and also high-grade B-cell lymphoma. The trial included a broad spectrum of heavily pre-treated patients (median three prior lines of therapy) with difficult-to-treat disease, including patients who did not respond to first-line therapy, patients refractory to all prior lines of therapy, patients with double/triple hit genetics and patients who had stem cell transplant and CAR-T therapy prior to their treatment with ZYNLONTA. This indication is approved by the FDA under accelerated approval based on overall response rate and continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
ZYNLONTA is also being evaluated as a therapeutic option in combination studies in other B-cell malignancies and earlier lines of therapy.
ZYNLONTA® is a registered trademark of ADC Therapeutics SA.
About Overland ADCT BioPharma
Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics, is developing and commercializing four of ADC Therapeutics’ antibody drug conjugate (ADC) product candidates for difficult-to-treat hematologic and solid tumors – ZYNLONTA®, ADCT-601, ADCT-602 and ADCT-901 – in greater China and Singapore. www.oladct.com
About Orient EuroPharma
Founded in 1982, Orient EuroPharma (OEP) became officially listed in the Taiwan Exchange (4120) in 2003, focusing on prescription medicines, nutricare and anti-aging, respectively. The company has R&D centers in Taiwan and the United States. It has two pharmaceutical plants producing oral preparations and highly allergenic injections approved by the FDA in Taiwan. The company has sales teams in Southeast Asia, Hong Kong, Chinese Mainland, and the United States. It is a multinational pharmaceutical company with R&D, manufacturing and marketing capabilities.
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2 Wong Y, Meehan MT, Burrows SR, Doolan DL, Miles JJ. Estimating the global burden of Epstein-Barr virus-related cancers. J Cancer Res Clin Oncol. 2022;148(1):31-46.
3 Coiffier B, Sarkozy C. Diffuse large B-cell lymphoma: R-CHOP failure-what to do?. Hematology Am Soc Hematol Educ Program. 2016;2016(1):366-378.
4 Sawalha, Y. Relapsed/Refractory Diffuse Large B-Cell Lymphoma: A Look at the Approved and Emerging Therapies. J. Pers. Med. 2021, 11, 1345.