Biotech company Geron (GERN) recently presented encouraging interim data on its pipeline candidate, GRNVAC1, at the annual meeting of the American Society of Hematology (ASH). GRNVAC1 is a vaccine, which is being developed to help extend the remission of acute myelogenous leukemia (AML). Data from the multi-center, open-label phase II study showed that the candidate achieved its endpoints of safety and tolerability.

The trial has been designed to study the safety and tolerability of the vaccination regimen in patients with AML who are in complete clinical remission. Additional objectives include the evaluation of immune responses to GRNVAC1 and to explore the effects of vaccination on minimal residual disease and relapse rates in this patient population.

Interim data showed that 14 out of 20 patients in the study remain in complete clinical remission (CR) and the median duration of CR Incorporatedluding patients who have relapsed, is 12 months. The vaccine was found to be safe and generally well tolerated.

Geron announced that several high risk patients (n=6), who have been in remission for periods ranging from 4 months to almost 2 years, have entered the extended boost phase of the vaccination regimen.

GRNVAC1 works by targeting telomerase, an enzyme which is found in many malignant tumors. The vaccine is designed to induce an immune response to tumor cells, which express telomerase on their surface. While we were encouraged to see the positive data on GRNVAC1, we note that the company will have to conduct additional studies to determine the efficacy of the vaccine compared to other therapies.

AML is the most common form of acute leukemia in adults and remains an unmet clinical need, especially in patients over 60 or who are at a high risk of relapse. If successfully developed, GRNVAC1 could represent significant commercial opportunity for Geron given the need for additional therapies for patients at high risk of relapse.

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