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Hybridon, Inc.'s (HBY) Toll-Like Receptor 9 Agonist Enhances Antitumor Activity Of Cetuximab In Preclinical Studies


10/19/2005 5:12:55 PM

CAMBRIDGE, Mass., March 3 /PRNewswire-FirstCall/ -- Hybridon, Inc. today announced a presentation of preclinical data that show a proprietary immune modulatory oligonucleotide (IMO(TM)) agonist of Toll-like receptor 9 (TLR9) enhanced the antitumor activity of a monoclonal antibody against the EGF receptor (cetuximab) and the cytotoxic agent irinotecan in mouse models. The presentation entitled "A Novel Modified CpG Agonist of TLR- 9 Inhibits EGF Receptor Signalling and Synergistically Enhances Antitumor Activity of Cetuximab and Irinotecan Eradicating Colon Cancer Xenografts" will be presented tomorrow at the 3rd International Symposium on Targeted Anticancer Therapies in Amsterdam (poster number P.509) by Giampaolo Tortora, M.D., Associate Professor of Medical Oncology, University Federico II, Naples, Italy.

"This study is consistent with previous preclinical data on the potential applications of our IMO compounds in combination with monoclonal antibodies and chemotherapy for oncology," said Tim Sullivan, Vice President of Development Programs at Hybridon. "Our lead IMO candidate for oncology is IMOxine(TM), which is currently in a monotherapy Phase II trial in patients with renal cell carcinoma. We expect to expand into new clinical trials to evaluate IMOxine in combination with chemotherapy in additional cancer indications later this year."

About IMOxine

IMOxine is a 2nd-generation immune modulatory oligonucleotide (IMO(TM)) that functions as an agonist of Toll-like Receptor 9 (TLR9), a specific protein receptor in certain cells of the immune system. Other receptors also may play a role in the immune system response to IMOxine. TLR9 has been shown to recognize bacterial DNA and induce a defensive immune response, producing a Th1-type cytokine profile that allows modulation of host innate and adaptive immune responses. TLR9 is expressed on human plasmacytoid dendritic cells and B lymphocytes. IMOxine and its murine analogue have been studied in a variety of preclinical tumor models, as monotherapy and in combinations with selected chemotherapeutic agents and monoclonal antibodies, and with radiation. IMOxine (also known as HYB2055 for Injection) is currently in a Phase 2, multi-center, open label monotherapy study in patients with metastatic or recurrent clear cell renal carcinoma.

About Hybridon

Hybridon, Inc. is developing novel therapeutics based on synthetic nucleic acid chemistry for the treatment of cancer, asthma/allergies, and infectious diseases. Hybridon's proprietary IMO drug candidates are designed to modulate immune responses through Toll-like receptors, the body's first line of defense against disease. The Company's nucleic acid chemistry expertise has also generated a portfolio of partnered products and intellectual property, creating the potential for long-term value for Hybridon. For more information please visit our website at http://www.hybridon.com/.

This press release contains forward-looking statements concerning Hybridon that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Hybridon's actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in preclinical studies or early clinical trials, such as the preclinical results referred to above, will be indicative of results obtained in future preclinical studies or clinical trials, or warrant clinical trials and product development; whether products based on Hybridon's technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether, if such products receive approval, they will be successfully distributed and marketed; whether the patents and patent applications owned or licensed by Hybridon will protect the Company's technology and prevent others from infringing it; whether Hybridon's cash resources will be sufficient to fund product development; and such other important factors as are set forth under the caption "Risk Factors" in Hybridon's Quarterly Report on Form 10-Q filed on November 12, 2004, which important factors are incorporated herein by reference. Hybridon disclaims any intention or obligation to update any forward-looking statements.

Hybridon, Inc.

CONTACT: Tim Sullivan, Ph.D. of Hybridon, Inc., +1-617-679-5500, ext.5526, tsullivan@hybridon.com; or Christopher Erdman of MacDougallBioCommunications, +1-508-647-0209, chris@macbiocom.com


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