Microtest has signed an agreement with UK-based biopharmaceutical company Antisoma to begin the aseptic manufacturing of AS1411, a new drug being developed for the treatment of various cancers. Under the terms of the agreement, Microtest will be responsible for the formulation and aseptic fill/finish of AS1411 material for upcoming Phase II trials. Microtest will also be responsible for stability testing of the AS1411 product.

“AS1411 is the first aptamer to be tested in cancer clinical trials. After successfully completing Phase I trials, we are now advancing to Phase II trials in renal cancer and AML. We are pleased to be supported in this work by expert specialist collaborators such as Microtest.” said Glyn Edwards, Antisoma’s chief executive officer.

“This agreement provides a strategic opportunity for us at Microtest to form a strong working partnership with an important category leader like Antisoma,” said Steve Richter, Microtest’s president. “Our flexibility, skills, and manufacturing expertise seamlessly compliment Antisoma’s scientific strength and clinical trial plans.”

Barrier Therapeutics achieved positive results from its Phase IIb dose ranging study for its antifungal candidate pramiconazole (previously known as Azoline). Pramiconazole met the primary endpoint of effectively treating tinea (pityriasis) versicolor, a common skin fungal infection characterized by a discolored, scaly, itchy rash primarily on the back, chest and upper arms. Also, the secondary endpoints of complete cure, mycological cure and investigators' global assessment achieved statistical significance.

The randomized, double-blind, placebo-controlled study enrolled 147 patients in six treatment groups. Results showed a positive linear dose response for the primary endpoint "effectively treated" at day 28, which was defined as significant reduction in disease signs and symptoms, including redness, scaling and itching, and complete mycological cure. Response rates for the primary endpoint ranged from 35% for the lowest dose to 85% for the highest dose as compared to 16% for placebo. The drug was well tolerated across all treatment arms and no serious adverse events were reported.

AppTec and Boehringer Ingelheim's first year of partnering is providing enhanced capabilities and a smooth transition to large-scale manufacturing for clients, according to the companies. Last spring, AppTec announced that Boehringer Ingelheim had become a preferred partner for its commercial cell culture production, including supply of Phase III material and CMC submission to meet specific customer needs. Through this collaboration, AppTec has non-exclusive access to Boehringer’s comprehensive manufacturing technology platform for cell culture products, including its state-of-the-art mammalian high expression system (BI HEX).

For AppTec, the collaboration has resulted in the ability to provide customers with a seamless path to large-scale manufacturing capabilities, according to the company.

“AppTec has been very pleased to be able to include this high-value option in our service offerings for mammalian-cell-based biologics," said Bonnie Baskin, Ph.D., chief executive officer of AppTec. “It further strengthens our ability to provide customers with one-stop solutions that can minimize the time required to move from preclinical to commercial supply of their products.”

“As shown over the past year, AppTec has proved to be an excellent partner for Boehringer Ingelheim, broadening our presence in the U.S. and providing our IP to even more new customers for their time-to-market product development,” commented Prof. Dr. h.c. Rolf G. Werner, senior vice president of the corporate division biopharmaceuticals at Boehringer Ingelheim GmbH.

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