certain this is old news to many here......
HUMAN GENOME SCIENCES ANNOUNCES JOINT DEVELOPMENT OF
ANTIBODY FOR THE TREATMENT OF CANCER WITH KIRIN
- Kirin acquires exclusive development and commercialization rights in Japan and Asia/Australasia to TRAIL Receptor-2 human monoclonal antibody -
- Human Genome Sciences acquires exclusive rights in North America, Europe and the rest of the world to Kirin's TRAIL Receptor-2 human monoclonal antibodies -
ROCKVILLE, Maryland -- December 3, 2002 -- Human Genome Sciences, Inc. (NASDAQ: HGSI) announced today a license agreement with the Pharmaceutical Division of Kirin Brewery Company, Ltd., under which the two companies will collaborate on the development and commercialization of agonistic human monoclonal antibodies to TRAIL Receptor-2. Under the terms of the agreement, Human Genome Sciences and Kirin will work together to identify and optimize the best candidate to enter into clinical development. Kirin will develop and commercialize any resulting drug in Japan and Asia/Australasia. Human Genome Sciences will develop and commercialize any resulting drug in North America, Europe, and the rest of the world.
According to the terms of the agreement, Kirin will pay milestone payments and royalties to Human Genome Sciences for any TRAIL-R2 mAb product that is developed and marketed in Japan and Asia/Australasia. Human Genome Sciences will pay royalties to Kirin for any product based on the Kirin TRAIL-R2 mAb that is developed and marketed in Europe, North America and the rest of the world.
The TRAIL (tumor necrosis factor apoptosis-inducing ligand) Receptor-1 and TRAIL Receptor-2 proteins were discovered by Human Genome Sciences. TRAIL Receptor-2 human monoclonal antibody (TRAIL-R2 mAb) specifically recognizes the TRAIL Receptor-2 protein, found on the surface of a number of solid tumor and hematopoietic cancer cells. Binding of TRAIL-R2 mAb to TRAIL Receptor-2 triggers cell death.1, 2 TRAIL-R2 mAb mimics the activity of native TRAIL and is therefore considered an agonistic antibody. Unlike native TRAIL, TRAIL-R2 mAb does not bind to the surface proteins DcR1 and DcR2 or the soluble receptor osteoprotegerin. TRAIL binds to these proteins, but such binding does not trigger cell death.3
William A. Haseltine, Ph.D., Chairman and Chief Executive Officer of Human Genome Sciences, said, "We are pleased that we will be working with Kirin to develop and commercialize an agonistic human monoclonal antibody to TRAIL Receptor-2 in Japan and Asia/Australasia. We are also pleased that we will now have the opportunity to study the Kirin antibodies to TRAIL Receptor-2 alongside our own antibody to determine the optimal drug candidate to enter into clinical trials and, hopefully, to develop and commercialize worldwide. The results of preclinical studies suggest that an agonistic antibody to TRAIL Receptor-2 is an attractive candidate for the treatment of cancer.1, 2 We look forward to completing the preclinical development of TRAIL-R2 mAb, and to entering this promising antitumor drug candidate into clinical trials."
For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com.
The Pharmaceutical Division of Kirin Brewery Co., Ltd., is focused on the development of new products in areas including cancer and hematopoietic disease. Kirin is an established leader in the development and sales of pharmaceutical products in Asia.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.
HGS and Human Genome Sciences are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the company's unproven business model, dependence on new technologies, uncertainty and timing of clinical trials, ability to develop and commercialize products, dependence on collaborators for services and revenue, substantial indebtedness, intense competition, uncertainty of patent and intellectual property protection, dependence on key management, uncertainty of regulation of products, dependence on key suppliers, the impact of future alliances or transactions and other risks that may be described in the company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
(ditto for the following).......
HUMAN GENOME SCIENCES REPORTS RESULTS OF PRECLINICAL
STUDIES OF ALBULEUKIN™ AND TRAIL-R1 AND TRAIL-R2
AGONISTIC HUMAN MONOCLONAL ANTIBODIES
AT THE SOCIETY FOR BIOLOGICAL THERAPY
- Preclinical data provide strong support for ongoing Phase 1 clinical trials of Albuleukin and TRAIL-R1 agonistic human monoclonal antibody -
- In vitro and in vivo data support Human Genome Sciences' plan to file
Investigational New Drug application for TRAIL-R2 agonistic
human monoclonal antibody in first half of 2003 -
ROCKVILLE, Maryland, November 11, 2002 – Human Genome Sciences, Inc. (Nasdaq: HGSI) described today data presented at the 17th annual meeting of the Society for Biological Therapy held in San Diego from November 7-10, 2002. Company scientists presented the results of preclinical studies of Albuleukin™, and TRAIL-R1 and TRAIL-R2 agonistic human monoclonal antibodies.
Albuleukin
Albuleukin is Human Genome Sciences' novel, long-acting form of interleukin-2. A Phase 1 clinical trial of Albuleukin is currently under way to evaluate its safety and pharmacology in patients with solid tumors.1
A poster presented on November 8, entitled Induction of Anti-B16 Melanoma Responses in Mice by Albuleukin™, An Interleukin-2 (IL-2)/Human Serum Albumin Fusion Protein (Poster #28), describes the results of a preclinical study designed to assess Albuleukin's ability, compared with recombinant interleukin-2, to control disease progression and improve survival outcomes at the maximum tolerated dose in a mouse model of malignant melanoma that has metastasized to the liver. The maximum tolerated dose for recombinant interleukin-2 was determined to be 1.0 mg/kg/day administered in two doses per day, whereas the maximum tolerated dose for Albuleukin was determined to be 1.75 mg/kg administered in one dose every other day. Results show that, at the maximum tolerated dose, both Albuleukin and recombinant interleukin-2 significantly reduced the mean tumor size in mice. In addition, mice treated with Albuleukin had a significantly decreased frequency of residual hepatic tumor cells compared with mice treated with recombinant interleukin-2. Furthermore, Albuleukin significantly improved the survival of mice relative to interleukin-2.
Summary
These results show that Albuleukin has an improved ability to mediate a potent anti-tumor response, with less frequent dosing and less administered drug on a molar basis, compared with recombinant interleukin-2, in a mouse model of human malignant melanoma that has metastasized to the liver. The data also demonstrated improved survival outcomes for Albuleukin compared with recombinant interleukin-2. In addition, results suggest that sustained drug plasma levels may be key to optimizing the anti-tumor response.
TRAIL-R1 And TRAIL-R2 Agonistic Human Monoclonal Antibodies
Human Genome Sciences is currently enrolling patients in a Phase 1 clinical trial to evaluate the safety and pharmacology of TRAIL-R1 mAb in patients with advanced tumors.2, 3, 4 TRAIL-R2 mAb is in advanced preclinical development.5 Human Genome Sciences hopes to file an Investigational New Drug (IND) application in the first half of 2003, seeking clearance from the U.S. Food and Drug Administration to begin clinical development of TRAIL-R2 mAb for use in the treatment of cancer. The TRAIL (tumor necrosis factor apoptosis-inducing ligand) Receptor-1 and TRAIL Receptor-2 proteins were discovered by Human Genome Sciences. TRAIL Receptor-1 human monoclonal antibody (TRAIL-R1 mAb) specifically recognizes the TRAIL Receptor-1 protein, found on the surface of a number of solid tumor and hematopoietic cancer cells. TRAIL Receptor-2 human monoclonal antibody (TRAIL-R2 mAb) specifically recognizes the TRAIL Receptor-2 protein, similarly found on the surface of a number of solid tumor and hematopoietic cancer cells. Both TRAIL-R1 mAb and TRAIL-R2 mAb mimic the activity of native TRAIL. As such, they are considered agonistic antibodies. Binding of TRAIL-R1 mAb to TRAIL Receptor-1, or of TRAIL-R2 mAb to TRAIL Receptor-2, triggers cell death.
An oral presentation on November 10, entitled TRAIL-R1 and TRAIL-R2 Human Agonistic Monoclonal Antibodies Display In Vitro and In Vivo Activity on Human Tumor Cells, described data from preclinical studies of TRAIL-R1 mAb and TRAIL-R2 mAb. The objective of the studies was the generation and characterization of human agonistic monoclonal antibodies to TRAIL-R1 and TRAIL-R2 that might be useful therapeutics for human cancer. Such monoclonal antibodies were developed and analyzed for their in vitro ability to bind to TRAIL-R1 or TRAIL-R2, respectively, and promote apoptosis.
Results of these preclinical studies show that TRAIL-R1 mAb binds with high affinity and specificity to the human TRAIL Receptor-1 protein. In vitro data demonstrate that TRAIL-R1 mAb induces apoptosis in colon, uterine, and lymphoma cancer cell lines expressing the TRAIL Receptor-1 protein. Furthermore, TRAIL-R1 mAb inhibited tumor growth in a mouse model of human colon carcinoma and reduced the growth of pre-established uterine tumors in athymic mice by up to fifty percent. In vivo data also show that the anti-tumor activity of TRAIL-R1 mAb is enhanced when given in combination with the chemotherapeutic agent, topotecan.
Results of preclinical studies evaluating TRAIL-R2 mAb show that TRAIL-R2 mAb binds with high affinity and specificity to the human TRAIL Receptor-2 protein. In vitro data demonstrate that TRAIL-R2 mAb induces apoptosis in colon and breast cancer cell lines expressing the TRAIL Receptor-2 protein. TRAIL-R2 mAb was shown to inhibit tumor growth or induce tumor regression in mouse models of human colon and breast cancer. A single injection of TRAIL-R2 mAb reproducibly reduced tumor size by eighty percent in one mouse model of human colon cancer, and was active in inducing tumor regression in a mouse model of large human colon tumors. A TUNEL analysis of TRAIL-R2 mAb treated tumors demonstrated that reduction in tumor size was mediated through apoptosis. (TUNEL analyses use immunohistochemistry to identify DNA fragmentation in nuclei of cells undergoing apoptosis.)
Summary
The results of these preclinical studies reinforce other preclinical data suggesting that TRAIL-R1 mAb and TRAIL-R2 mAb are attractive candidates for the treatment of cancer.
For additional information on Human Genome Sciences, please visit our web site at www.hgsi.com. For more information on Albuleukin, see www.hgsi.com/products/Albuleukin.html. For more information on TRAIL-R1 mAb, see www.hgsi.com/products/TRAIL-R1_mAb.html.
Health professionals interested in the Albuleukin or TRAIL-R1 mAb trials or any other study involving HGSI products are encouraged to inquire via the Contact Us section of the Human Genome Sciences web site, www.hgsi.com/products/request.html, or by calling us at (301) 610-5790, extension 3550.
Human Genome Sciences is a company with the mission to treat and cure disease by bringing new gene-based drugs to patients.
HGS, Human Genome Sciences, and Albuleukin are trademarks of Human Genome Sciences, Inc.
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences' current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of the Company's unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials, the Company's ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with planned facilities, intense competition, the uncertainty of patent and intellectual property protection, the Company's dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company's filings with the Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
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Footnotes:
1. (HGSI Press Release) Human Genome Sciences Initiates Trial Of Albuleukin™, A Recombinant Human Protein For Treating Solid Tumor Cancers. January 7, 2002.
2. (HGSI Press Release) Cambridge Antibody Technology And Human Genome Sciences Announce Second Drug Partnership. January 8, 2002
3. (HGSI Press Release) Human Genome Sciences Initiates Clinical Development Of A Novel Anticancer Drug. April 30, 2002.
4. (HGSI Press Release) Takeda Exercises Option To Develop Novel Human Genome Sciences Antibody Drug In Japan. August 14, 2002.
5. (HGSI Press Release) Human Genome Sciences And Cambridge Antibody Technology Commit To Exclusive Development Of Antibody To Trail Receptor-2. May 20, 2002. |
