Overland ADCT BioPharma Announces NMPA Accepts Biologics License Application and Grants Priority Review for ZYNLONTA® for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

By: ADC Therapeutics SA via GlobeNewswire

July 24, 2023 at 07:21 AM EDT

BOSTON and SHANGHAI, China and LAUSANNE, Switzerland, July 24, 2023 (GLOBE NEWSWIRE) -- Overland ADCT BioPharma, a joint venture of Overland Pharmaceuticals (CY) Inc. and ADC Therapeutics SA (NYSE: ADCT), today announced that the China National Medical Products Administration (NMPA) has accepted the Biologics License Application (BLA) for ZYNLONTA^® (loncastuximab tesirine-lpyl), which is seeking an indication for the treatment of adult patients with relapsed or refractory (r/r) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy in China. The BLA has been granted priority review by the NMPA.

The application was made based on the positive results from OL-ADCT-402-001, a Phase 2 bridging clinical trial for ZYNLONTA. The study was designed to evaluate the efficacy and safety of ZYNLONTA as a single-agent treatment for Chinese patients with r/r DLBCL.

Professor Zhu Jun, principal investigator of the OL-ADCT-402-001 study and Party Secretary of Beijing Cancer Hospital and Director of Internal Medicine, said: “Safer and more effective treatments are still urgently needed to address significant unmet medical needs among r/r DLBCL patients after two or more lines of systemic therapy in China. I hope ZYNLONTA will be accessible to Chinese r/r DLBCL patients soon.”

“We are pleased with the swift progress of the development program for ZYNLONTA in China as evidenced by the NMPA’s recent acceptance of the BLA and priority review designation,” said Ameet Mallik, Chief Executive Officer of ADC Therapeutics. “This is a significant step forward in our commitment to making ZYNLONTA available to benefit patients worldwide.”

Ed Zhang, Co-founder and CEO of Overland Pharmaceuticals, said: "This is a meaningful milestone. Our partnership with ADC Therapeutics began in December 2020, and it took us only two and a half years to complete the clinical study and submit the first BLA. We would like to extend our sincere gratitude to participating patients, clinical investigators, the health authority and our partner ADC Therapeutics for their strong support in making this achievement possible. We look forward to our continued collaboration with all stakeholders to maximize the potential benefits of ZYNLONTA for patients in China."

Overland ADCT BioPharma holds the exclusive rights to develop and commercialize ZYNLONTA in Greater China and Singapore. The BLAs for ZYNLONTA have already been submitted in Singapore, Hong Kong and Taiwan. It is expected to address the unmet needs of patients with r/r DLBCL across these regions.

About ZYNLONTA^® (loncastuximab tesirine-lpyl)

The U.S. Food and Drug Administration (FDA) and the European Medicines Agency have 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 DLBCL not otherwise specified, 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 and in the European Union under conditional 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. Please see full prescribing information including important safety information about ZYNLONTA at www.ZYNLONTA.com.

About ADC Therapeutics

ADC Therapeutics (NYSE: ADCT) is a commercial-stage global leader and pioneer in the field of antibody drug conjugates (ADCs). The Company is advancing its proprietary ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.

ADC Therapeutics’ CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) received accelerated approval by the FDA and conditional approval from the European Commission for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy. ZYNLONTA is also in development in combination with other agents and in earlier lines of therapy. In addition to ZYNLONTA, ADC Therapeutics has multiple ADCs in ongoing clinical and preclinical development.

ADC Therapeutics is based in Lausanne (Biopôle), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey. For more information, please visit https://adctherapeutics.com/ and follow the Company on Twitter and LinkedIn.

ZYNLONTA^® is a registered trademark of ADC Therapeutics SA.

About Overland Pharmaceuticals

Overland Pharmaceuticals is building a fully integrated biopharma company with a mission to bring innovative medicines to underserved patients in Asia and around the world. By leveraging our resources, global network, and local expertise across the biopharma ecosystem in Asia, Overland is establishing a portfolio of differentiated therapeutic candidates in a few carefully selected therapeutic areas. Through formative partnerships, Overland will move forward the development and commercialization of the most promising advances in medicine. www.overlandpharma.com

ADC Therapeutics Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to certain risks and uncertainties that can cause actual results to differ materially from those described. Factors that may cause such differences include, but are not limited to: Overland ADCT BioPharma’s ability to obtain marketing authorization approval for ZYNLONTA in China, actions by the NMPA related to the pending BLA in China for ZYNLONTA, the timing of any BLA approval in China and any revenue from the same, the Company’s ability to achieve the 2023 net product sales guidance for ZYNLONTA^® and the decrease in total operating expenses for 2023 and 2024, the expected cash runway into the middle of 2025, the Company’s ability to continue to commercialize ZYNLONTA^® in the United States and future revenue from the same; Swedish Orphan Biovitrum AB (Sobi^®) ability to successfully commercialize ZYNLONTA^® in the European Economic Area and market acceptance, adequate reimbursement coverage, and future revenue from the same; our strategic partners’, including Mitsubishi Tanabe Pharma Corporation and Overland Pharmaceuticals, ability to obtain regulatory approval for ZYNLONTA^® in foreign jurisdictions, and the timing and amount of future revenue and payments to us from such partnerships; the Company’s ability to market its products in compliance with applicable laws and regulations; the Company’s expectations regarding the impact of the Infrastructure Investment and Jobs Act; the timing and results of the Company’s or its partners’ research projects or clinical trials including LOTIS 2, 5 and 9, ADCT 901, 601 and 212, the timing and outcome of regulatory submissions and actions by the FDA or other regulatory agencies with respect to the Company’s products or product candidates; projected revenue and expenses; the Company’s indebtedness, including Healthcare Royalty Management and Blue Owl and Oaktree facilities, and the restrictions imposed on the Company’s activities by such indebtedness, the ability to repay such indebtedness and the significant cash required to service such indebtedness; the Company’s ability to obtain financial and other resources for its research, development, clinical, and commercial activities and other statements regarding matters that are not historical facts, and involve predictions. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. In some cases you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “would,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “seem,” “seek,” “future,” “continue,” or “appear” or the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Additional information concerning these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the “Risk Factors” section of the Company's Annual Report on Form 20-F and in the Company's other periodic reports and filings with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. The Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Overland Pharmaceuticals
Investors and Media
Michael Chen
Overland Pharmaceuticals
ylchen@overlandpharma.com
+86 152-2175-2295

ADC Therapeutics
Investors
Eugenia Litz
ADC Therapeutics
Eugenia.Litz@adctherapeutics.com
+44 7879 627205
+1 908-723-2350

Media
Nicole Riley
ADC Therapeutics
Nicole.Riley@adctherapeutics.com
+1 862-926-9040

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Overland ADCT BioPharma Announces NMPA Accepts Biologics License Application and Grants Priority Review for ZYNLONTA® for Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

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