Pluristem Therapeutics Inc., of Haifa, Israel, said, due to increased demand, it entered an amended and restated underwriting agreement, with H.C. Wainwright & Co. LLC acting as the sole book-running manager, to increase the size of the previously announced bought deal to $15 million. The underwriter agreed to buy about 12.2 million shares priced at $1.225 each, with warrants to purchase up to about 7.3 million shares. Pluristem also granted the underwriter a 30-day option to purchase up to an additional 1.8 million shares and/or with warrants to purchase 1.1 million shares, for additional aggregate proceeds of up to about $2.25 million. Read More
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said its subsidiary commenced a cash tender offer for all outstanding shares of Ariad Pharmaceuticals Inc., of Cambridge, Mass., for $24 per share. Ariad agreed earlier this month to be acquired by Takeda in a deal valued at about $5.2 billion. Read More
Mateon Therapeutics Inc., of South San Francisco, presented final data from the phase II OX4218 study in patients with neuroendocrine tumors, or NETs, at the Gastrointestinal Cancers Symposium in San Francisco. In OX4218, patients were treated with vascular-disrupting agent combretastatin A4-phosphate (CA4P) 60 mg/m2 on days one, eight and 15 of a 21-day cycle for three cycles. A total of 18 patients were enrolled. Data showed one patient (6 percent) experienced significant symptomatic improvement as measured by ECOG Status and had a partial response per investigator-assessed RECIST, and an additional seven patients (39 percent) had stable disease. Read More
Researchers at Stanford University have developed a way to image chimeric antigen receptor (CAR) T cells in patients by adding a positron emission tomography (PET) reporter gene to glioma-targeting cells. The same team had previously shown that in a single patient, such CAR T cells could be visualized after an autologous transplant, but due to constraints of the study protocol, it was not possible to take a baseline reading. In the current phase I study, the researchers treated seven patients with reporter gene-containing CAR T cells and showed that they could track the infused cells, though the study was not powered to relate cell uptake into tumors to clinical outcome. Read More
Avexxin AS is a testament to perseverance. Over several decades, Berit Johansen, the company's chief scientific officer, conducted basic research into the chronic inflammatory process, both as a visiting scientist at Cambridge, Mass.-based Biogen Inc. and as a researcher at multiple academic institutions. Johansen's understanding of the intracellular mechanisms of chronic inflammatory diseases, beginning with psoriasis, led to the 2005 incorporation of Avexxin, based on Trondheim, Norway. It took another decade for the company to achieve proof of concept for the topical formulation of its lead compound, AVX001. Read More
HONG KONG – Small South Korean biopharma firm Legochem Biosciences Inc. is looking to turbo-charge its operations by partnering with Takeda Pharmaceuticals Co. Ltd., one of just two companies that has successfully commercialized an antibody-drug conjugate (ADC) drug. Read More
HONG KONG – South Korean biopharma Celltrion Inc. is looking forward to seeing its Remsima (infliximab) biosimilar product classified as "interchangeable" after a series of updates to the FDA's guidelines on biosimilars that were released much faster than the company expected. Read More
PERTH, Australia – Proposed recommendations to update Australia's intellectual property (IP) system would be disastrous to the biopharma industry and would put a stranglehold on innovation and investment, industry stakeholders said. Read More
SHANGHAI – The Shanghai-based joint venture Wuxi-Medimmune has received the go-ahead to start clinical trials from Chinese regulators for anti-IL-6 antibody WBP216 (MEDI5117) as a therapeutic for autoimmune and inflammatory diseases, in particular rheumatoid arthritis (RA). Read More
In the wake of U.S. regulators' nod for Synergy Pharmaceuticals Inc.'s Trulance (plecanatide), buyout speculation buzzed while analysts differed on prospects for the drug as a "fast follower" going up against Linzess (linaclotide) from Ironwood Pharmaceuticals Inc. in chronic idiopathic constipation (CIC) and, soon, irritable bowel syndrome with constipation (IBS-C). Read More