3Sbio Inc., of Shenyang, China, and Verseau Therapeutics Inc., of Bedford, Mass., said they selected VTX-0811, a PSGL-1-targeting monoclonal antibody, as the first licensed program under their partnership agreement focused on developing monoclonal antibodies in the field of immuno-oncology. By targeting PSGL-1, an adhesion molecule that is highly expressed on tumor-associated macrophages across most tumor types, VTX-0811 reprograms macrophages to a pro-inflammatory state, activates T cells and attracts other immune cells to generate a coordinated and powerful antitumor response. Under the terms of the agreement, 3Sbio received an exclusive license to develop and commercialize a selected number of macrophage checkpoint modulator (MCM) antibodies for all human oncology indications in greater China, including mainland China, Taiwan, Hong Kong and Macau, while Verseau retains global rights to all MCM programs outside of greater China. (See BioWorld, Feb. 15, 2019.)
Acasti Pharma Inc., of Laval, Quebec, reported preclinical data on Capre (omega-3 phospholipid) to explain the mechanism of action that resulted in a reduction of hemoglobin A1c in the company's phase II Colt study. In the diet-induced obese C57BL6 mouse model, Capre produced higher levels of 18RS-HEPE in the blood compared to Vascepa (icosapent ethyl, Amarin Corp.). Capre increased plasma levels of 17S-HDHA and PDX, while Vascepa showed virtually no response.
Aerie Pharmaceuticals Inc., of Durham, N.C., signed an agreement to acquire Avizorex Pharma SL (AVX Pharma), of Barcelona, Spain, for $10 million plus undisclosed additional clinical and regulatory milestone payments. AVX's shareholders are also eligible for royalties on net sales of approved products from AVX's development pipeline. Aerie gains access to AVX-012, an agonist of the TRPM8 ion channel that has completed a phase IIa study in patients with dry eye, and plans to start a phase IIb study in late 2020.
Artelo Biosciences Inc., of La Jolla, Calif., published preclinical data on its fatty acid binding protein 5 (FABP5) inhibitor program, SBFI-102 and SBFI-103, in The Prostate. The drugs produced cytotoxicity in prostate cancer cells and the addition of docetaxel or cabazitaxel had a synergistic effect on cytotoxicity in vitro. In a mouse tumor model, FABP5 inhibitors reduced tumor growth and FABP5 inhibitors plus a submaximal dose of docetaxel reduced tumor growth more than each drug alone.
Bristol-Myers Squibb Co., of New York, said the U.S. Federal Trade Commission accepted the proposed consent order in connection with its pending merger with Celgene Corp., of Summit, N.J. The deal is expected to close on Nov. 20. Separately, BMS said its offers to exchange Celgene's notes for new notes issued by BMS and cash is expected to expire on Nov. 20 and to be settled on Nov. 22. (See BioWorld, Jan. 4, 2019.)
Centogene AG, of Rostock, Germany, and PTC Therapeutics Inc., of South Plainfield, N.J., signed an agreement to offer a no-cost diagnostic for aromatic L-amino acid decarboxylase (AADC) deficiency. The diagnostic product will use Centogene's Centocard dried blood spot collection kit to measure 3-O-methyldopa levels, followed by next-generation sequencing of the dopa decarboxylase (DDC) gene and deletion/duplication analysis if necessary. Centogene is in the process of validating a test for DDC enzyme activity, which could be combined with the other tests on a single Centocard. PTC is developing PTC-AADC, a gene therapy for AADC, with the BLA scheduled to be submitted to the FDA before the end of the year.
Mimivax LLC, of Buffalo, N.Y., licensed the Chinese rights to Survaxm, an immunotherapy targeting survivin for the treatment of glioblastoma brain cancers, to Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd., of Shanghai. Mimivax will receive $10 million up front and is eligible for development and sales milestone payments of up to $28 million and $110 million, respectively.
Preclinical data from Madrid, Spain-based Pharmamar SA's antitumor compound, Yondelis (trabectedin), found the Geistra score system was a useful tool for selecting the clinical profile of patients who may be the best candidates to be treated with trabectedin, a synthetically produced antitumor agent originally isolated from Ecteinascidia turbinata, a type of sea squirt. It is designed to inhibit active transcription, a type of gene expression on which proliferating cancer cells are particularly dependent. Also, preclinical data on Pharmamar's plocabulin demonstrated its antitumor activity surpassed that of doxorubicin, according to the company, justifying the possibility of exploring the compound's activity in the clinic.
The POP1 research and drug discovery program at Propanc Biopharma Inc., of Melbourne, Australia, has advanced toward producing synthetic versions of two proenzymes, trypsinogen and chymotrypsinogen. Propanc wants to produce both for commercial use exhibiting minimal variation between lots and without sourcing the proenzymes from animals. The company is researching the project with the universities of Jaén and Granada in Spain. The universities' researchers are attempting to synthesize by an in vivo system both proenzymes to produce crystalized proteins that could be maintained for long periods without degradation, even in absence of refrigeration, in order to create a longer shelf-life.
Strongbridge Biopharma plc, of Dublin, is eliminating about 38 positions, which is 34% of its workforce. The restructuring includes all commercial costs related to the Macrilen (macimorelin) sales force effective Dec. 1. Strongbridge sold its rights to Macrilen to Novo Nordisk A/S, of Bagsvaerd, Denmark, this past December. The estimated annualized cost savings of approximately $4.2 million beginning in 2020 is based upon eliminating 15 of the 38 positions. The company estimates it will incur approximately $1.4 million for severance and other costs.
Vertex Pharmaceuticals Inc., of Boston, and Austin, Texas-based Molecular Templates Inc. will collaborate to discover and develop targeted conditioning regimens that may enhance the hematopoietic stem cell transplant process, including transplants conducted as part of treatment with ex vivo CRISPR/Cas9 gene editing therapies such as CTX-001. CTX-001 is in two ongoing phase I/II studies in patients with transfusion-dependent beta-thalassemia and severe sickle cell disease, where a hematopoietic stem cell transplant is required as part of treatment with CTX-001. Vertex will make an up-front payment of $38 million to Molecular Templates, including an equity investment. Molecular Templates is eligible to receive future development, regulatory and sales milestones and option payments of up to $522 million across two targets and tiered royalty payments on future sales.