Amgen Inc., of Thousand Oaks, Calif., said the European Commission granted marketing authorization of a pediatric formulation (granules in capsule for opening) of Mimpara (cinacalcet) for the treatment of secondary hyperparathyroidism (HPT) in children, 3 and older, with end-stage renal disease on maintenance dialysis therapy in whom secondary HPT is not adequately controlled with standard-of-care therapy.
Beigene Ltd., of Beijing, said it closed its oncology collaboration deal with Celgene Corp., of Summit, N.J., which was announced in July. As part of the deal, Beigene is acquiring Celgene’s commercial operations in China, including the right to sell Abraxane (nab-paclitaxel), Revlimid (lenalidomide), Vidaza (azacitidine) and pipeline candidate CC-122. Celgene also gets exclusive right to Beigene’s investigational anti-PD1 antibody, BGB-A317, for solid tumors worldwide outside of Asia. Beigene will receive an aggregate of $413 million from Celgene in up-front licensing fees and equity investment, and is eligible for up to an additional $980 million in development, regulatory and sales milestones, as well as royalties on future sales of BGB-A317. (See BioWorld, July 12, 2017.)
Heptares Therapeutics, of London, the wholly owned subsidiary of Sosei Group Corp., said a new research collaboration has been launched under its ORBIT initiative with Juntendo University in Tokyo. The new collaboration, its fourth under the ORBIT program, is with the research group of Takehiko Yokomizo, in the Department of Molecular and Cellular Biochemistry. Program activities will focus on the design and profiling of leukotriene receptor modulators with potential therapeutic utility in intractable skin/intestinal ulcers. ORBIT (Opportunities in Receptor Biology for Industrial Translation) was launched in February last year and is designed to promote and broaden the application of the company’s structure-based drug design expertise directed at GPCRs to create transformative medicines.
Iovance Biotherapeutics Inc., of San Carlos, Calif., said the FDA granted fast track designation for LN-144, its adoptive cell therapy using its tumor-infiltrating lymphocyte technology, for the treatment of advanced melanoma. C-144-01 is a phase II study evaluating LN-144 and will enroll up to 60 patients.
Macrogenics Inc., of Rockville, Md., said its partner Janssen Biotech Inc., one of the Janssen Pharmaceutical companies of New Brunswick, N.J.-based Johnson & Johnson, terminated their collaboration and licensing agreement for duvortuxizumab, a CD19 x CD3 DART molecule. In a phase I dose-escalation trial, patients experienced treatment-related neurotoxicity, which has been seen with other CD19-targeted T-cell therapies, leading enrollment in the trial to be discontinued. Janssen will continue development of MGD-015, also known as JNJ-9383, a second DART molecule licensed from Macrogenics, which Janssen plans to begin a clinical trial for in 2018. (See BioWorld Today, May 19, 2016.)
Oncurious NV, of Leuven, Belgium, said it is acquiring exclusive licenses to a portfolio of five next-generation immuno-oncology assets from VIB. The deal will involve VIB Discovery Sciences taking the lead in the preclinical development of those new projects and VIB will increase its stake in the company, with Thrombogenics NV, also of Leuven, remaining the majority shareholder. VIB will also receive a royalty on future sales of any of those assets. Thrombogenics has also invested an additional €2.1 million (US$2.49 million) in Oncurious, which is conducting a phase I/IIa trial of TB-403 in the treatment of medulloblastoma, in collaboration with Bioinvent International AB, of Lund, Sweden. TB-403 is a humanized monoclonal antibody against placental growth factor, which is expressed in several types of cancer.
Pepvax Inc., of Bethesda, Md., said it initiated its in vivo efficacy study for lead candidate PVX-009, which targets a specific protein, MAGE A, in an effort to find a treatment for triple-negative breast cancer (TNBC). The study will determine which combination provides the best immune response to stop the growth of the TNBC tumor in mice. The company said it plans to file an IND with the FDA for approval to conduct phase I trials late next year or early 2019. The company recently raised a bridge round of funding in order to continue R&D efforts and expects to undertake a series A investment round in the fourth quarter.
Sangamo Therapeutics Inc., of Richmond, Calif., said it presented preclinical data demonstrating its engineering capabilities in T-cell genome editing using zinc finger nucleases (ZFNs) at the Immuno-Oncology Summit in Boston. The research data illustrate the development of allogeneic T-cell immunotherapies utilizing ZFN editing techniques including: elimination of endogenous T-cell receptor (TCR) expression by knockout of the TCR alpha constant locus (TRAC); elimination of human leukocyte antigen (HLA) class I proteins by knockout of b2-microglobulin (B2M); and co-delivery double knockout of TRAC and B2M, all with greater than 90 percent efficiency.
Sanofi SA, of Paris, said the FDA granted tentative approval of Admelog (insulin lispro injection) 100 units/mL, a rapid-acting human insulin analogue, for improving glycemic control in adults and children with diabetes mellitus. With the tentative approval, the FDA concluded that Admelog met all necessary regulatory requirements for approval in the U.S., pending any patent issues that are yet to be resolved.