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Active Biotech Shares Climb on Ipsen Milestone

By Cormac Sheridan
Staff Writer

Shares in Active Biotech AB climbed more than 12 percent Monday on news that the company earned a €10 million (US$12.7 million) milestone payment from its partner, Ipsen SA, after reaching the halfway point in recruitment into a 1,200-patient, Phase III registration trial of tasquinimod in metastatic castrate-resistant prostate cancer.

Lund, Sweden-based Active Biotech said it expects top-line data from the study by the end of 2014 and a regulatory filing, based on a progression-free-survival primary endpoint, could follow in 2015.

The study is randomly assigning recruits into either a drug treatment arm (n = 800) or a placebo arm (n = 400). Patients in the treatment arm receive one of three doses: 0.25 mg, 0.5 mg or 1 mg per day.

"The overall survival part of the study will continue into 2015," Hans Kolam, chief financial officer at Active Biotech, told BioWorld International. "We still believe we can file based on progression-free survival."

Prostate cancer is becoming an increasingly crowded space. Several therapies in late-stage development are being lined up to join recently approved therapies such as Dendreon Corp.'s autologous cell therapy Provenge (sipuleucel-T), Sanofi Aventis SA's taxane Jevtana (cabazitaxel) and Johnson & Johnson's androgen biosynthesis inhibitor Zytiga (abiraterone acetate).

Bavarian Nordic A/S's off-the-shelf therapeutic vaccine Prostvac began a 1,200-patient Phase III registration trial late last year. (See BioWorld International, Nov. 23, 2011.)

Medivation Inc. will report further data from its Phase III Affirm trial of its enzalutamide (MDV3100), an oral androgen-receptor-signaling inhibitor, in post-chemotherapy prostate cancer patients at the upcoming American Society of Clinical Oncology (ASCO) meeting in Chicago. Several other companies will report data from several earlier stage trials at the same meeting. (See BioWorld Today, May 18, 2012.)

Active Biotech and Ipsen are presenting Phase II survival data at ASCO, based on 97 events. Median time to death for patients on tasquinimod was 34.2 months vs. 30.2 months for those on placebo.

According to a subgroup analysis in bone-metastatic patients, median time to death was 34.2 months for the drug group vs. 25.6 months for the placebo group.

Active Biotech and Ipsen aim to differentiate tasquinimod on the basis of its pleotropic mechanism of action. It has apparent immunomodulatory, anti-angiogenic and anti-metastatic effects.

"Tasquinimod is not a hormonal therapy. Most of the competition is [targeting] the hormonal pathway," Active Biotech CEO Tomas Leanderson told BioWorld International. "As long as you have your own mode of action . . . you usually find your niche in the market."

"We are currently running the Phase III trial in castrate-resistant patients. Our hope is definitely to get into patients earlier than that," Kolam said. A Phase I combination study with Jevtana and prednisone is under way in the U.S., which is also in castrate-resistant patients.

How precisely tasquinimod works is not fully understood, although studies in mice and on human tumor biopsies are beginning to yield clues.

"We know that at least one target for this molecule is S100A9, which is very important for a subset of myeloid cells called myeloid-derived suppressor cells," Leanderson said.

Those cells can suppress T-cell responses and are thought to play a role in down-regulating the immune response to cancer.

"We modulate the performance of these white blood cells in the tumor," Leanderson said. "It could be as simple as inhibiting myeloid cells in the tumor [means] we could hit the tumor growth at multiple levels."

The €10 million is part of a series of staggered payments through which Paris-based Ipsen will effectively pay for the Phase III development of tasquinimod.

The program, which commenced prior to last year's $285 million licensing agreement between the two companies, will cost €90 million to €100 million in total, Kolam said. (See BioWorld International, April 20, 2011.)

Active Biotech's stock (STOCKHOLM:ACTI) closed Monday at SEK45.80 (US$6.43), up SEK5.