Immunomedics Announces Key Oral Presentations at ESMO 2020

Sept. 9, 2020
Morris Plains, N.J.,
NASDAQ: IMMU

press release

Breadth of presentations include i) Full results from ASCENT; ii) Final results from TROPHY U-01 cohort 1; iii) First results with Trodelvy in brain tumors  

Conference call and webcast with key opinion leaders on September 19, 2020 

Morris Plains, N.J., Sept. 9, 2020 — Immunomedics, Inc. (NASDAQ: IMMU) (“Immunomedics” or the “Company”), a leading biopharmaceutical company in the area of antibody-drug conjugates, today announced the presentation of five abstracts at ESMO Virtual Congress 2020, highlighted by oral presentations of the ASCENT study in metastatic triple-negative breast cancer and the TROPHY U-01 study in metastatic urothelial cancer, as well as an investigator-sponsored study of Trodelvy in brain tumors. The Company will host a conference call and webcast with key opinion leaders on Saturday, September 19, 2020 at 2:00 p.m. Eastern Time to discuss these results. Members of Immunomedics leadership team will also be present to provide a corporate update.

Key opinion leaders participating in the call will include Hope S. Rugo, M.D., FACP, Professor of Medicine; and Director, Breast Oncology and Clinical Trials Education, University of California San Francisco Helen Diller Family Comprehensive Cancer Center, Petros Grivas, M.D., Ph.D., Associate Professor, Division of Oncology, Department of Medicine; Clinical Director, Genitourinary Cancers Program, University of Washington; Associate Member, Clinical Research Division, Fred Hutchinson Cancer Research Center, and Andrew J. Brenner, M.D. Ph.D., Clinical Investigator, Institute for Drug Development; Co-Leader, Experimental and Developmental Therapeutics Program; S & B Kolitz/CTRC-Zachry Endowed Chair in Neuro-Oncology Research, Mays Cancer Center at UT Health San Antonio.

To access the conference call supported with slides, please dial (877) 303-2523 or (253) 237-1755 using the Conference ID 1871157. The conference call with supporting slides will be webcast via the Investors page on the Company’s website at https://immunomedics.com/investors/. Approximately two hours following the live event, a webcast replay of the conference call will be available on the Company’s website for approximately 30 days.

Details of Trodelvy presentations at ESMO Virtual Congress 2020 are as follows:

Thursday, September 17, 2020

9:00 Central European Summer Time (CEST) (3:00 a.m. Eastern Time)

  1. Phase 1b/2 study of antibody-drug conjugate, sacituzumab govitecan, in combination with the PARP inhibitor, talazoparib, in metastatic triple-negative breast cancer (Bardia, et al.)

Session Title: Poster Display – Breast Cancer, Metastatic
Poster #: 358TiP

  1. TROPHY-U-01 cohort 3: sacituzumab govitecan (SG) and pembrolizumab (pembro) in patients (pts) with progression or recurrence of metastatic urothelial cancer (mUC) after platinum (PLT)-based therapy (Grivas, et al.)

Session Title: Poster Display – Genitourinary Tumours, Non-Prostate
Poster #: 796TiP

Friday, September 18, 2020

12:01-12:06 CEST (6:01-6:06 a.m. Eastern Time)

  1. Delivery and activity of SN-38 by sacituzumab govitecan in CNS Tumors (Brenner, et al.)

Session Title: Mini Oral – CNS
Presentation #: 373MO

Saturday, September 19, 2020

  1. ASCENT: A randomized phase 3 study of sacituzumab govitecan (SG) vs treatment of physician’s choice (TPC) in patients (pts) with previously treated metastatic triple-negative breast cancer (mTNBC) (Bardia, et al.)

Session Title: Proffered Paper 1 – Breast cancer, metastatic
Session Time: 16:20-18:00 CEST
Presentation #: LBA17
Presentation Time: 17:04-17:16 CEST (11:04-11:16 a.m. Eastern Time)
Channel 1

  1. TROPHY-U-01 cohort 1 final results: A Phase 2 study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI) (Loriot, et al.)

Session Title: Proffered Paper 1 – GU, non prostate
Session Time: 16:20-18:00 CEST
Presentation #: LBA24
Presentation Time: 17:04-17:16 CEST (11:04-11:16 a.m. Eastern Time)
Channel 3

About Immunomedics

Immunomedics is a leader in next-generation antibody-drug conjugate (ADC) technology, committed to help transform the lives of people with hard-to-treat cancers. Our proprietary ADC platform centers on using a novel linker that does not require an enzyme to release the payload to deliver an active drug inside the tumor cell and the tumor microenvironment, thereby producing a bystander effect. Trodelvy, our lead ADC, is the first ADC the FDA has approved for the treatment of people with metastatic triple-negative breast cancer and is also the first FDA-approved anti-Trop-2 ADC. For additional information on the Company, please visit its website at https://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 expectations for achieving full FDA approval based on our confirmatory data for TRODELVY and the Company’s development of TRODELVY for additional indications, 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 reliance on third-party relationships and outsourcing arrangements (for example in connection with manufacturing, logistics and distribution, and sales and marketing) over which it may not always have full control, including the failure of third parties on which the Company is dependent to meet the Company’s business and operational needs for investigational or commercial products and, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business; the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain requirements, and promotional and marketing compliance); imposition of significant post-approval regulatory requirements on our products, including a requirement for a post-approval confirmatory clinical study, or failure to maintain or obtain full regulatory approval for the Company’s products, if received, due to a failure to satisfy post-approval regulatory requirements, such as the submission of sufficient data from a confirmatory clinical study; the uncertainties inherent in research and development; safety and efficacy concerns related to the Company’s products and product candidates; uncertainties in the rate and degree of market acceptance of products and product candidates, if approved; inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of the Company’s products and product candidates, if approved; inaccuracies in the Company’s estimates of the size of the potential markets for the Company’s products and product candidates or limitations by regulators on the proposed treatment population for the Company’s products and product candidates; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of the Company’s products and product candidates; 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 relating to the COVID-19 pandemic in the U.S. and around the world; risks associated with litigation to which the Company is or may become a party, including the cost and potential reputational damage resulting from such litigation; loss of key personnel; 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

For More Information:
Dr. Chau Cheng
(862) 260-3727
ccheng@immunomedics.com

For Media Inquiries:
Darren Opland, Ph.D.
(646) 627-8387
Darren@lifescipublicrelations.com