Immunomedics Develops Potential New Treatment Regimen for Non-Hodgkin Lymphoma
Phase I Study Combines Radioimmunotherapy and Immunotherapy
Results Presented at 2012 Annual Meeting of the Society of Nuclear Medicine
MIAMI BEACH, Fla., June 13, 2012 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today reported initial clinical experience with a combination of epratuzumab, the Company's humanized anti-CD22 antibody, labeled with the radioisotope, yttrium-90 (90Y), and veltuzumab, the Company's humanized anti-CD20 antibody, in patients with relapsed aggressive non-Hodgkin lymphoma (NHL).
Unlike indolent NHL, aggressive NHLs have proven to be more resistant to currently approved antibody therapies unless they are combined with chemotherapy, such as rituximab + CHOP (R-CHOP) for diffuse large B-cell lymphoma (DLCBL) and rituximab + hyper-fractionated CVAD for mantle cell lymphoma (MCL). A significant percentage of these patients who relapsed or become refractory are ineligible for high-dose salvage therapy or stem cell transplant due to advanced age, chemo-resistant disease, and/or concurrent co-morbid medical conditions. Indeed, elderly DLBCL patients who failed R-CHOP have a poor prognosis after disease progression. Thus, there is a considerable need for developing better treatment alternatives for these patients.
A novel approach for NHL therapy that the Company is pursuing
involves radioimmunotherapy (RAIT) with 90Y-epratuzumab combined
with immunotherapy using unlabeled veltuzumab. This is a new
therapy concept due to the fact that CD22 and CD20 are distinct
anti-CD20 antibodies would not cross-block anti-CD22 RAIT, which, at least in the case of DLBCL, could allow for more effective consolidation with anti-CD22 RAIT after R-CHOP therapy. (For more information on the potential use of 90Y-epratuzumab as a consolidation therapy in DLBCL following R-CHOP treatment, please refer to the Company's press release at www.immunomedics.com/pdfs/news/2011/PR06072011a.pdf).
Thirteen patients with various types of aggressive NHL who had failed 1 or more prior standard therapies have been enrolled into this Phase I/II study to receive four weekly treatment of veltuzumab at 200 mg/m2, with indium-111-epratuzumab for imaging and pharmacokinetics on week 2 and 90Y-epratuzumab at planned dose levels on weeks 3 and 4. At the time of reporting, results from 10 patients were available. Five patients received 6 or 9 mCi/m2 of 90Y-epratuzumab while the other 5 patients were dosed at 12 or 15 mCi/m2.
Half of the patients showed an overall objective response rate,
with 1 DLBCL patient having a complete response which is ongoing at
Three patients with transformed follicular NHL and 1 DLBCL patient were partial responders. Three of these partial responders relapsed after 3 to 6 months with 1 ongoing for 4 weeks. For MCL, all three patients had disease stabilization as their best response, with 2 patients relapsing after 3 to 6 months and 1 ongoing at 4 weeks.
Commenting on these preliminary results, Cynthia L. Sullivan,
President and Chief Executive Officer remarked, "We are pleased
with this initial evidence of therapeutic activity in these
difficult to treat patients.
The trial is continuing to determine an acceptable 90Y dose for this population and define the safety and efficacy profile of this combination approach."
The combination treatment was well tolerated, with the
pharmacokinetic behavior of the two agents substantially unchanged
when given together.
Hematologic toxicity necessitated lowering the 90Y dose, most likely due to the prior aggressive chemotherapies or depletion of the normal B-cell pool by veltuzumab that preceded 90Y-epratzumab.
This study was supported in part by Award Number R44CA139668 from the National Cancer Institute. The content is solely the responsibility of the Company and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 199 patents issued in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
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, out-licensing arrangements
(including the timing and amount of contingent payments), forecasts
of future operating results, potential collaborations, and capital
raising activities, involve significant risks and uncertainties and
actual results could differ materially from those expressed or
Factors that could cause such differences include, but are not limited to, risks associated with any cash payment that the Company might receive in connection with a sublicense involving a third party and UCB, which is not within the Company's control, new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, 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.
CONTACT: Dr. Chau Cheng
Director, Investor Relations & Grant Management
(973) 605-8200, extension 123
Posted: June 2012