Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., planned a conference call for this afternoon to discuss the resolution of a lawsuit against the company that represents an important step toward gaining a listing on a national exchange. The settlement agreement with Gary Aronson and John Gorton had to do with claims by the pair that ACT breached an anti-dilution provision contained in warrants held by each of them.
Advaxis Inc., of Princeton, N.J., presented updated data from the ongoing ADXS-cHER2 study in canine osteosarcoma at the 2014 American College of Veterinary Internal Medicine Forum in Nashville. ADXS-cHER2 is an immunotherapy that targets the HER2 receptor, which is overexpressed in certain solid-tumor cancers, including canine and human bone cancer and breast cancer. The preliminary findings of the phase I trial in dogs with osteosarcoma suggest that ADXS-cHER2 is safe and well tolerated at doses up to 3 x 109 CFU with no evidence of cardiac, hematological, or other systemic toxicities.
Antitope Ltd., of London, said it's developing a cell line for the production of a dendritic-cell-targeting vaccine for the treatment of head and neck and cervical cancer that's under development at the Dallas-based Baylor Institute for Immunology Research (BIIR). The transaction extends a relationship the partners formed several years ago when Antitope applied its composite human antibody technology to humanize several BIIR antibodies. Terms of the new deal were undisclosed.
Shareholders of Dendreon Corp., of Seattle, endorsed a shareholder proposal sponsored by the UAW Retiree Medical Benefits Trust, with 84 percent of votes cast favoring the annual election of Dendreon's board members. Investors previously voiced concerns over Dendreon's compensation practices in light of the company's lagging stock price. Dendreon's board indicated in a proxy filing that it would put the measure on its ballot in 2015 if a majority of shareholders voted this year to require the annual election. On Friday, the company's shares (NASDAQ:DNDN) gained 10 cents to close at $2.11.
GW Pharmaceuticals plc, of London, gained FDA fast track status for its investigational cannabidiol orphan drug Epidiolex in the treatment of Dravet syndrome, a rare treatment-resistant form of childhood epilepsy. The company said it's on track to begin a combined phase II/III clinical trial in Dravet syndrome later this year. GW also plans to conduct two additional phase III trials of Epidiolex in another form of epilepsy, Lennox-Gastaut syndrome, next year.
Imstem Biotechnology Inc., of Farmington, Conn., said it successfully treated an animal model of multiple sclerosis (MS) using human embryonic stem cell-(hESC) derived mesenchymal stem cells (MSC), or hES-MSCs. Imstem, a spinoff of the University of Connecticut Stem Cell Institute, collaborated with researchers at the University of Connecticut Health Center and Advanced Cell Technology Inc., of Marlborough, Mass., to develop the therapy, which they said was more effective in an animal model of MS than MSCs from bone marrow of adult human donors. The work was published online in Stem Cell Reports. In addition to MS, the company said its MSCs offer the potential to treat other autoimmune diseases, such as inflammatory bowel disease and rheumatoid arthritis. Imstem is seeking approval to move its hES-MSCs into phase I trials.
Kite Pharma Inc., of Santa Monica, Calif., inked an exclusive, worldwide license with the National Institutes of Health (NIH) for intellectual property related to T cell receptor (TCR)-base candidates targeting the NY-ESO-1 antigen to treat cancers expressing NY-ESO-1. The product candidates are designed to recognize antigens irrespective of their cellular localization and as presented by the major histocompatibility complex on the tumor cell. The NIH's National Cancer Institute is conducting a phase II trial of a murine TCR product candidate targeting the NY-ESO -1 antigen as part of a Cooperative Research and Development Agreement (CRADA) with Kite, which is investigating murine-derived TCR technology platforms developed by the NCI Surgery Branch to treat solid tumors under the CRADA. As part of the license agreement, Kite will make clinical, regulatory and sales milestone payments to the NIH and pay the agency royalties on product sales.
Lundbeck A/S, of Valby, Denmark, moved a step closer to completing its planned acquisition of Chelsea Therapeutics International Ltd. with the expiration of the waiting period mandated by the Hart-Scott-Rodino Act. The Charlotte, N.C., company's board unanimously supports the $530 million bid. (See BioWorld Today, May 9, 2014.)
Xenoport Inc., of Santa Clara, Calif., advised its stockholders to vote for its director nominees and in favor of other items on its ballot at the company's annual meeting, scheduled for June 11. Xenoport said it had the support of the independent proxy advisory firms, Institutional Shareholder Services and Egan-Jones Proxy Services. The company is in a proxy battle with activist shareholder Clinton Group Inc., of New York, which nominated three directors to the board. Xenoport's shares (NASDAQ:XNPT) rose for the second straight day, gaining 20 cents on Friday to close at $4.34.