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Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Ada

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By Business Wirevia The Motley Fool

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Emergent BioSolutions Announces Positive Preclinical Efficacy and PK Data for Its New Bispecific Adaptir Protein Therapeutic ES414 at AACR

ROCKVILLE, Md.–(BUSINESS WIRE)– Emergent BioSolutions Inc. (NYS: EBS) today announced that two posters on the development of its lead bispecific ADAPTIRTM (Modular Protein Technology) molecule, ES414, were presented earlier this week at the American Association for Cancer Research annual meeting in Washington, D.C.

The ES414 molecule was constructed using Emergent’s ADAPTIR technology platform and selectively binds to the T cell receptor on cytotoxic T cells and Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on prostate cancer cells. In preclinical studies, ES414 has been shown to redirect T-cell cytotoxicity (RTCC) towards prostate cancer cells expressing PSMA. ES414 is being developed as a potential therapeutic for castrate-resistant prostate cancer.

In the first poster, Emergent scientists described the efficacy of ES414 to prevent growth of human prostate cancer cells in vivo that express the PSMA protein on their surface:

  • “Anti-PSMA x anti-CD3 ADAPTIR molecule inhibits tumor growth in vivo”

    • Treatment with ES414 showed statistically significant inhibition of subcutaneous tumor outgrowth in the presence of human T cells in two independent mouse xenograft models of prostate cancer (C4-2B, MDA-PCa-2b). In both models, all treatment groups also showed a statistically significant decrease in serum PSA compared to negative controls.

The second poster described initial PK and tolerability:

  • “Pharmacokinetic evaluation and tolerability assessment of anti-PSMA x anti-CD3 ADAPTIR molecule”

    • These non-clinical studies showed that ES414 is pharmacologically active, has an extended serum half-life compared to antibody fragments, is well tolerated at levels well above the expected human dose, and possesses suitable characteristics for further in vivo toxicology studies.

“We were excited to present the results of these studies and were very pleased with the interest these data received at the meeting,” said Jane Gross, Ph. D., vice president of applied research at Emergent BioSolutions. “ES414 is a promising molecule. Non-clinical efficacy studies have shown that it is well tolerated. It can also be manufactured using standard methodologies. These findings certainly support further development of this molecule and have generated significant partnering interest in our product candidate.”

From: http://www.dailyfinance.com/2013/04/11/emergent-biosolutions-announces-positive-preclinic/

Business, Finance, Occupation & Industry

GenSpera's G-202 Granted U.S. Orphan Drug Designation for Treatment of Hepatocellular Carcinoma

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By Business Wirevia The Motley Fool

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GenSpera’s G-202 Granted U.S. Orphan Drug Designation for Treatment of Hepatocellular Carcinoma

SAN ANTONIO–(BUSINESS WIRE)– GenSpera, Inc. (OTCBB:GNSZ) announced that the U.S. Food and Drug Administration’s Office of Orphan Products Development has granted Orphan Drug Designation to its lead candidate, G-202, for the treatment of hepatocellular carcinoma (HCC), the most common form of primary liver cancer. G-202 is currently in a Phase II clinical trial for patients with hepatocellular carcinoma whose disease has worsened on standard therapy for this indication.

Primary hepatocellular carcinoma is cancer that forms in the tissues of the liver. Although relatively rare in the U.S., its incidence is growing rapidly and it is the most common cancer in other parts of the world, with more than 1 million new cases diagnosed each year. Contributing to the growing incidence of the cancer are diseases or conditions such as hepatitis, alcoholism and fatty liver disease resulting from obesity. Even with current optimal treatments the five-year relative survival rate for patients with metastatic liver cancer is only three percent.

Orphan drug designation aims to encourage the development of drugs involved in the diagnosis, prevention or treatment of a medical condition affecting fewer than 200,000 people in the country. The designation grants U.S. market exclusivity to a drug for a particular indication for a seven-year period if the sponsor complies with certain FDA specifications. Additional incentives for the sponsor include tax credits related to clinical trial expenses, access to funding to support the clinical studies necessary to gain marketing approval for the drug, and a possible exemption from FDA user fees.

“We are excited to receive orphan drug status for G-202, which we feel further enhances the value of the Company’s proprietary property once regulatory approval is achieved,” said Craig Dionne, PhD, GenSpera CEO and President. “We are optimistic that our Phase II clinical trial with G-202 will soon indicate significant potential benefits for HCC patients.”

About GenSpera

GenSpera’s technology platform combines a powerful, plant-derived cytotoxin (thapsigargin) with a prodrug delivery system that targets release of the drug within the tumor. Unlike typical chemotherapeutic agents, thapsigargin kills cells irrespective of the rate of cell division, which may provide an effective approach to kill both fast- and slow-growing cancers as well as cancer stem cells. GenSpera’s lead drug candidate, G-202, is activated by the enzyme PSMA which is found at high levels in prostate cancer and in the vasculature of almost all solid tumors and is therefore expected to …read more
Source: FULL ARTICLE at DailyFinance