Immunomedics announces clinical collaboration with AstraZeneca in first-line triple-negative breast and urothelial cancers
Phase 1/2 Studies will Evaluate the Combination of Imfinzi® (Durvalumab) and Sacituzumab Govitecan in Previously-Untreated Patients with Triple-negative Breast Cancer and Urothelial Cancer
Morris Plains, N.J., July 23, 2018 — Immunomedics, Inc., (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced a clinical collaboration with AstraZeneca (NYSE: AZN) and its global biologics research and development arm, MedImmune, to evaluate the safety and efficacy of the combination of Imfinzi® (durvalumab), a human monoclonal antibody directed against PD-L1, and Immunomedics’ lead antibody-drug conjugate (ADC) product candidate, sacituzumab govitecan, as a frontline treatment of patients with triple-negative breast cancer (TNBC) and urothelial cancer (UC).
“We are pleased to be partnering with AstraZeneca, a global leader in oncology drug development, to advance sacituzumab govitecan into potential first line of use, which could benefit a significantly larger patient population,” said Usama Malik, Chief Business Officer of Immunomedics.
David Berman, Senior Vice President, Head of IO Franchise, AstraZeneca said, “Our collaboration with Immunomedics will focus on the combination of sacituzumab govitecan with Imfinzi® (durvalumab), expanding our efforts in triple-negative breast cancer and bladder cancer where unmet medical needs still exist. We believe combining Immunomedics’ antibody-drug conjugate, a late-stage agent that has demonstrated encouraging clinical activity, with Imfinzi will complement our existing clinical trial efforts in this area and maximize benefit to patients.”
Part one of the two-part Phase 1/2 studies will be co-funded by the two companies. Immunomedics will supply the study drug and AstraZeneca will utilize its existing clinical trial infrastructure to accelerate the enrollment of the sacituzumab govitecan and durvalumab combination. The trial design allows for rapid transition into randomized Phase 2 studies should the first part of these studies show promising data and the companies agree to proceed based on efficacy and safety results obtained.
“The collaboration with AstraZeneca is an important milestone in our strategy to establish sacituzumab govitecan as a foundational therapy in TNBC and UC,” commented Dr. Robert Iannone, Head of Research & Development and Chief Medical Officer of Immunomedics. “The two agents have different modes of action, a largely non-overlapping safety profile and are expected to complement each other in their anticancer activities. We look forward to working with AstraZeneca to bring sacituzumab govitecan to cancer patients in earlier lines of therapy.”
About Sacituzumab Govitecan
Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class antibody-drug conjugate (ADC). It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with metastatic triple-negative breast cancer who previously received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of metastatic triple-negative breast cancer.
Durvalumab, a human monoclonal antibody directed against PD-L1, blocks PD-L1 interaction with PD-1 and CD80 on T cells, countering the tumor’s immune-evading tactics and inducing an immune response.
As part of a broad development program, durvalumab is being investigated as monotherapy and in combination with IO, small molecules, and chemotherapies across a range of tumors and stages of disease.
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer and other serious diseases. Immunomedics’ corporate objective is to become a fully-integrated biopharmaceutical company and a leader in the field of antibody-drug conjugates. For additional information on the Company, please visit its website at https://www.immunomedics.com/. The information on its website does not, however, form a part of this press release.
Cautionary note regarding forward-looking statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, including the filing and approval timelines for BLAs and BLA supplements, out-licensing arrangements, forecasts of future operating results, potential collaborations, capital raising activities, and the timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
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