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Vital Therapies, Inc. is a biotherapeutic company focused on developing a cell-based system for the treatment of acute liver failure. Our product candidate, the ELAD® System, is a human cell-based, bio-artificial liver support system that operates outside the body, or extracorporeally, and is designed with the proposed intent to allow the patient’s own liver to regenerate to a healthy state, or to stabilize the patient until liver transplant. The ELAD System incorporates our human liver-derived cells, or VTL C3A cells, contained in four hollow fiber cartridges, that are combined with single use customized disposable sets and an ancillary delivery system. Data from ELAD clinical studies has shown trends that may indicate a potential to increase survival rates in patients with acute liver failure. ELAD has received orphan designation in the United States and Europe for the treatment of acute liver failure. Prior to the initiation of our ongoing Phase III clinical trial program, over 145 subjects have received therapy with the ELAD System in seven clinical trials and through a compassionate use program, which we believe collectively suggests a promising therapeutic profile. In March 2013, we initiated VTI-208, a Phase III randomized, controlled clinical trial in 200 subjects with alcohol-induced liver decompensation. We reached the midpoint in enrollment of this trial in April 2014, and anticipate the release of preliminary data in the first half of 2015. In addition, we are conducting a second Phase III randomized, controlled clinical trial, VTI-210, in 150 subjects with severe acute alcoholic hepatitis, or AAH, which is a subset of AILD, and expect to initiate enrollment of subjects later in 2014. In the second quarter of 2014, we began enrollment of a Phase II clinical trial of the ELAD System in subjects with either fulminant hepatic failure, or FHF, or surgery-induced acute liver failure, or SILF. We anticipate the release of data from VTI-210 in 2016 and the Phase II component of VTI-212 in 2015 or 2016.
Advaxis, Inc., a clinical development stage biotechnology company, focuses on developing immunotherapies for cancer and infectious diseases. Its Lm -LLO immunotherapy platform technology stimulates the immune system to induce antigen-specific anti-tumor immune responses involving innate and adaptive arms of the immune system by inhibiting the T-cells, Tregs, myeloid-derived suppressor cells, and MDSC to promote immunologic tolerance of cancer cells in the tumor. The company’s platform technology also facilitates the immune response by altering the tumor microenvironment to reduce immunologic tolerance in the tumors that makes the tumor more susceptible to immune attack. It has approximately 15 distinct immunotherapies in various stages of development, directly developed by the company and through strategic collaborations. The company’s products in clinical development stage comprise ADXS-HPV that is being evaluated in various clinical trials for cervical cancer, head and neck cancer, and anal cancer; ADXS-PSA for the treatment of prostate cancer; and ADXS-cHER2 for the treatment of overexpressing cancers, such as breast, gastric, and other cancers in humans, as well as for osteosarcoma in canines. Advaxis, Inc. was founded in 2002 and is based in Princeton, New Jersey.
CinCor is a clinical-stage biopharmaceutical company targeting cardiovascular, metabolic and kidney diseases.
Rubius Therapeutics is a biopharmaceutical company pioneering a new era of cellular medicines. Our proprietary RED PLATFORM™ was designed to genetically engineer and culture Red Cell Therapeutics™ that are selective, potent and ready to-use cellular therapies for the potential treatment of several diseases across multiple therapeutic areas. Our initial focus is to advance RCT™ product candidates for the treatment cancer and autoimmune diseases by leveraging two distinct therapeutic modalities — potent cell-cell interaction and tolerance induction. We are currently enrolling patients in a Phase 1/2 clinical trial of RTX-240; the trial has two Phase 1 arms enrolling adult patients with advanced solid tumors: an ongoing monotherapy dose escalation arm in adults with relapsed/refractory or locally advanced solid tumors and a combination therapy dose escalation arm with pembrolizumab in adults with relapsed/refractory or locally advanced solid tumors. In April 2022, the combination arm with pembrolizumab was expanded to focus on non-small cell lung cancer and renal cell carcinoma patients. We are also enrolling patients in a Phase 1/2 clinical trial of RTX-224 for the treatment of patients with certain advanced solid tumors, including non-small cell lung cancer, cutaneous melanoma, head and neck squamous cell carcinoma, urothelial (bladder) carcinoma and triple-negative breast cancer.
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