Cell Genesys Inc.

San Francisco, CA, United States

Cell Genesys Inc.

San Francisco, CA, United States
SEARCH FILTERS
Time filter
Source Type

PALO ALTO, Calif.--(BUSINESS WIRE)--twoXAR, Inc., a company dedicated to improving health through computation, today announced the appointment of Brian Moriarty as Chief Financial Officer and Jill Jene, PhD as Senior Vice President, Business Development. In addition, co-founder and former Chief Business Officer, Andrew M. Radin has been named to the newly created position of Chief Marketing Officer. “We are pleased to welcome Jill and Brian to the twoXAR management team,” said Andrew A. Radin, co-founder and Chief Executive Officer of twoXAR. “Their leadership and expertise in finance, operations, and business development will support our growing pipeline of partnerships and drug candidates, positioning twoXAR for success over the years to come.” Prior to joining twoXAR, Mr. Moriarty advised small and mid-size companies on strategic matters, led M&A activity as a corporate development executive, and advised clients as an investment banker. His 20+ year career includes: CFO of ChartOne, Vice President at Hewlett-Packard where he supported HP’s separation into two publicly-traded companies and led the HR group responsible for M&A and outsourcing; Vice President of M&A at Sun Microsystems where he led 17 acquisitions and helped the company sell itself to Oracle Corporation; and ten years as an investment banker advising clients. Mr. Moriarty holds a Master of Management from Northwestern University and a BA in English and economics from the University of California, Davis. Dr. Jene brings nearly 20 years of business development expertise in the life science and biopharmaceutical industries and a deal sheet totaling over $3 Billion to her new role at twoXAR. She joins twoXAR from Depomed, Inc. where she was the Vice President Business Development, closing over 20 transactions resulting in raising over $750 Million in non-dilutive financing and acquiring four commercial franchises. With almost 20 years of experience in the healthcare and biotech industry, Dr. Jene has an established track record for closing transactions, both acquisitions and divestitures. Prior to joining Depomed, Dr. Jene held business and corporate development roles with increasing responsibilities at Baxter, Cell Genesys (acquired by Biosante), and 3M Pharmaceutical Division (now Valeant). Dr. Jene earned a BS in chemistry from Bradley University graduating, with honors, and holds both a PhD and MS in chemistry from Northwestern University and an MBA in strategic management from DePaul University. twoXAR is an artificial intelligence-driven biopharmaceutical company. The company leverages its computational platform to identify promising drug candidates, de-risks the opportunities through preclinical studies, and progresses drug candidates to the clinic through industry partnerships. Based in Palo Alto, California, the twoXAR team includes experts in drug discovery and development, biomedical informatics, computational biology, data science, and software development. For more information, please visit www.twoXAR.com.


Liang S.C.,Cell Genesys Inc. | Liang S.C.,Nodality | Moskalenko M.,Cell Genesys Inc. | Moskalenko M.,Genentech | And 3 more authors.
Clinical Immunology | Year: 2013

In this report, a Treg-depleting anti-FR4 antibody is combined with a GM-CSF-secreting tumor cell immunotherapy (GVAX) for treatment of melanoma-bearing animals. Median survival time (MST) of animals treated with GVAX was 41. days, compared to a MST of 32. days in untreated animals. Anti-FR4 monotherapy had no effect on MST. Combination of anti-FR4 and GVAX significantly prolonged MST to 55. days, suggesting that these two agents can function cooperatively. Combination therapy increased expression of IFN-γ and granzyme B by CD8 T cells. In contrast to anti-CD25-mediated Treg depletion, administration of anti-FR4 after GVAX did not reduce efficacy, suggesting that anti-FR4 does not deplete effector cells induced by GVAX. Triple combination of a blocking CTLA4 antibody with GVAX and anti-FR4 further enhanced overall survival and reduced growth of well-established melanomas. Considered together, anti-FR4 antibody and GVAX may be a promising approach for the treatment of patients with cancer. © 2013 Elsevier Inc.


Van den Eertwegh A.J.M.,VU University Amsterdam | Versluis J.,VU University Amsterdam | Van den Berg H.P.,VU University Amsterdam | Santegoets S.J.A.M.,VU University Amsterdam | And 14 more authors.
The Lancet Oncology | Year: 2012

Background: The granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells vaccine (GVAX) has antitumour activity against prostate cancer; preclinical studies have shown potent synergy when combined with ipilimumab, an antibody that blocks cytotoxic T-lymphocyte antigen 4. We aimed to assess the safety of combined treatment with GVAX and ipilimumab in patients with metastatic castration-resistant prostate cancer (mCRPC). Methods: We did an open-labelled, single-centre, dose-escalation study of ipilimumab concurrent with a fixed dose of GVAX, with a subsequent expansion phase, both at the VU University Medical Centre (Amsterdam, Netherlands). Eligible patients had documented mCRPC and had not been previously treated with chemotherapy. All patients received a 5×10 8 cell priming dose of GVAX intradermally on day 1 with subsequent intradermal injections of 3×10 8 cells every 2 weeks for 24 weeks. The vaccinations were combined with intravenous ipilimumab every 4 weeks. We enrolled patients in cohorts of three; each cohort received an escalating dose of ipilimumab at 0·3, 1·0, 3·0, or 5·0 mg/kg. Our primary endpoint was safety. This study is registered with ClinicalTrials.gov, number NCT01510288. Findings: We enrolled 12 patients into our dose-escalation cohort. We did not record any severe immune-related adverse events at the first two dose levels. At the 3·0 mg/kg dose level, one patient had grade 2 and two patients grade 3 hypophysitis; at the 5·0 mg/kg dose level, two patients had grade 3 hypophysitis and one patient developed grade 4 sarcoid alveolitis (a dose-limiting toxic effect). Due to observed clinical activity and toxic events, we decided to expand the 3·0 mg/kg dose level, rather than enrol a further three patients at the 5·0 mg/kg level. 16 patients were enrolled in the expansion cohort, two of whom developed grade 2 hypophysitis, three colitis (one grade 1 and two grade 2), and one grade 3 hepatitis-all immune-related adverse events. The most common adverse events noted in all 28 patients were injection-site reactions (grade 1-2 events seen in all patients), fatigue (grade 1-2 in 20 patients, grade 3 in two), and pyrexia (grade 1-2 in 15 patients, grade 3 in one). 50% or greater declines in prostate-specific antigen from baseline was recorded in seven patients (25%); all had received 3·0 mg/kg or 5·0 mg/kg ipilimumab. Interpretation: GVAX combined with 3·0 mg/kg ipilimumab is tolerable and safe for patients with mCRPC. Further research on the combined treatment of patients with mCRPC with vaccination and ipilimumab is warranted. Funding: Cell Genesys Inc, Prostate Cancer Foundation, Dutch Cancer Society (KWF-VU 2006-3697), and Foundation Stichting VUmc Cancer Center Amsterdam. © 2012 Elsevier Ltd.


Jostock T.,Novartis | Dragic Z.,Novartis | Fang J.,Cell Genesys Inc. | Jooss K.,Cell Genesys Inc. | And 2 more authors.
Applied Microbiology and Biotechnology | Year: 2010

The recently described 2A/furin technology combines both chains of the antibody in a single open reading frame. Upon translation and secretion, the peptide is processed by the cell to generate native fully functional IgG antibodies. Here, we describe the results of an evaluation study of this technology for an industrial CHO cell line development process. The 2A/furin expression cassette setup was combined with a Novartis vector system. A transfection, selection, and cloning procedure in chemically defined media was established at Novartis and applied for a monoclonal test antibody. The productivity of 2A/furin-vector-derived clones in non-optimized generic shake flask fed-batch models was in a comparable range with clones derived from the reference control vector. Higher clonal production stability was seen for the majority of clones generated with the 2A/furin technology compared to the clones generated with the reference control vector. Product quality was analyzed by SDS-PAGE and no significant difference was detected between the two systems. Thus, it was shown that the 2A/furin technology can be successfully combined with a Novartis CHO expression system and platform. Due to the single ORF setup, the 2A/furin technology may therefore offer a suitable approach to reduce vector size and complexity. © 2010 Springer-Verlag.


Nguyen M.C.,Cell Genesys Inc. | Tu G.H.,Cell Genesys Inc. | Koprivnikar K.E.,Cell Genesys Inc. | Gonzalez-Edick M.,Cell Genesys Inc. | And 3 more authors.
Cancer Immunology, Immunotherapy | Year: 2010

A critical factor in clinical development of cancer immunotherapies is the identification of tumor-associated antigens that may be related to immunotherapy potency. In this study, protein microarrays containing >8,000 human proteins were screened with serum from prostate cancer patients (N = 13) before and after treatment with a granulocyte-macrophage colony-stimulating factor (GM-CSF)-secreting whole cell immunotherapy. Thirty-three proteins were identified that displayed significantly elevated (P ≥ 0.05) signals in post-treatment samples, including three proteins that have previously been associated with prostate carcinogenesis, galectin-8, T-cell alternative reading frame protein (TARP) and TNF-receptor-associated protein 1 (TRAP1). Expanded analysis of antibody induction in metastatic, castration-resistant prostate cancer (mCRPC) patients (N = 92) from two phase 1/2 trials of prostate cancer immunotherapy, G-9803 and G-0010, indicated a significant (P = 0.03) association of TARP antibody induction and median survival time (MST). Antibody induction to TARP was also significantly correlated (P = 0.036) with an increase in prostate-specific antigen doubling time (PSADT) in patients with a biochemical (PSA) recurrence following prostatectomy or radiation therapy (N = 19) from in a previous phase 1/2 trial of prostate cancer immunotherapy, G-9802. RNA and protein encoding TARP and TRAP1 was up-regulated in prostate cancer tissue compared to matched normal controls. These preliminary findings suggest that antibody induction to TARP may represent a possible biomarker for treatment response to GM-CSF secreting cellular immunotherapy in prostate cancer patients and demonstrates the utility of using protein microarrays for the high-throughput screening of patient-derived antibody responses. © 2010 Springer-Verlag.


Xu H.,New York University | Scott G.M.,New York University | Jiang F.,Cell Genesys Inc. | Kelly C.,Oregon State University
Holzforschung | Year: 2010

Manganese peroxidase (MnP) is the main enzyme implicated in the biobleaching of kraft pulps by white-rot fungi. However, potential commercial applications of this enzyme have been limited by its availability in large quantities. Advances have been made to produce high-yield concentrated recombinant MnP (rMnP). The objective of this study was to evaluate the ability of rMnP to delignify and brighten kraft pulps. The rMnP, produced from the yeast Pichia pastoris - in high-cell density and in fed-batch fermentations - was found to be effective in lignin removal in both hardwood and softwood unbleached kraft pulps. The rMnP applied at 30?U g -1 pulp for 24?h followed by alkali extraction caused significant kappa number reductions for all the pulps tested with different initial lignin contents and structures. Softwood and hardwood pulps showed similar delignification rates during rMnP treatments. Highly delignified pulps with kappa number less than 10 are less susceptible to delignification by rMnP compared with the pulps with higher lignin content. The rMnP-treated pulp was also shown to be more susceptible to subsequent peroxide bleaching compared with the control pulp. More than 60% of the kappa number reduction was achieved by sequential rMnP treatments combined with alkaline extraction. Sequential treatment with xylanase and rMnP also resulted in more extensive delignification than in each enzyme treatment alone or in the case of simultaneous application of the enzymes. © 2010 by Walter de Gruyter Berlin New York.


Xu H.,New York University | Scott G.M.,New York University | Jiang F.,Cell Genesys Inc. | Kelly C.,Oregon State University
Holzforschung | Year: 2010

The recombinant manganese peroxidase (rMnP) produced from the yeast Pichia pastoris has been investigated in totally chlorine free (TCF) and elemental chlorine free (ECF) bleaching sequences for improving the bleachability of kraft pulps. In TCF bleaching, oxygen delignified hardwood kraft pulp was treated with rMnP, followed by a sequence combining a chelating and alkaline peroxide bleaching stage. The inclusion of the enzymatic treatment significantly improved the pulp brightness to a level that is difficult to obtain by chemical bleaching alone. Furthermore, the treatment with rMnP resulted in energy savings during pulp refining with PFI mill with a slight improvement in pulp strength properties such as tensile index and burst index. In ECF bleaching, a significant reduction in chlorine dioxide consumption was obtained. A three-stage rMnP treatment combined with alkaline extraction, followed by DED bleaching sequence for hardwood kraft pulp (HWKP) or DEDED bleaching sequence for softwood kraft pulp (SWKP), reduced the total effective chlorine by 41% and 32% for HWKP and SWKP, respectively, compared with the conventional bleaching sequences without enzymatic treatment. The strength properties of the enzyme-treated pulp were also slightly better than that of the control pulp. Further reductions in the consumption of total effective chlorine were obtained when a xylanase pretreatment was incorporated into the bleaching sequence before the repeated rMnP treatment. © 2010 by Walter de Gruyter Berlin New York.


PubMed | Cell Genesys Inc.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

5146 Background: A Phase 1 trial is underway to study GVAX immunotherapy for prostate cancer [GVAX immunotherapy (GVAX IT)] and ipilimumab (Ipi) in chemonave mHRPC patients (pts).Twelve pts were treated in a dose-escalation phase for 24 weeks (wks) with bi-weekly intradermal injections of GVAX IT and monthly Ipi. Pts were enrolled in cohorts of 3; each cohort received an escalating dose of Ipi: 0.3, 1, 3 or 5 mg/kg. Sixteen pts were then enrolled in an expansion cohort to be treated with GVAX IT and 3 mg/kg Ipi.Escalation Cohort: Median follow-up of 12 pts is 21.2 months (m). Five of six pts at the higher Ipi doses (3 and 5 mg/kg) developed Grade 2 or 3 immune-related adverse events (irAEs), including Grade 2 or 3 hypophysitis and Grade 3 alveolitis. Late onset PSA responses (declines > 50%) were seen in these 5 pts with response durations of 6.7, 8.6, 9.5, 13.8 (on-going), and 23.1 m. Four of these pts had stable disease on bone scan for at least 12 m, and up to 21 m. Multiple tumor-reactive antibodies (abs) induced by treatment were identified by serologic analysis (SEREX), including abs to filamin B, PSMA and NY-ESO-1. Biopsies of injection sites showed T cell infiltration and Granzyme B expression; these T cells are being tested for antigen-specific lytic activity. Expansion Cohort: Sixteen pts were enrolled, 6 have completed treatment, 10 are on-going. Three pts have experienced irAEs of Grade 1 diarrhea, Grade 3 adrenal insufficiency, and a Grade 3 hepatitis that resolved with steroids. With median follow-up of 6.5 months in the 6 pts who have completed treatment, 1 pt had a PSA response (> 50% decline) and 3 obtained stable PSA, accompanied in one pt by pain relief and decrease in alkaline phosphatase.The GVAX IT and ipilimumab combination is active in mHRPC in this trial. IrAEs appear manageable and may correlate with anti-tumor activity. The maximum tolerated dose of the combination is not established. Follow-up on the 16 expansion cohort pts will provide data on safety, clinical activity and immunologic correlates. [Table: see text].


PubMed | Cell Genesys Inc.
Type: Journal Article | Journal: Journal of clinical oncology : official journal of the American Society of Clinical Oncology | Year: 2016

14635 Background: GVAX IT has been tested in phase I/ II and is currently being tested in phase III clinical trials of patients (pts) with androgen-independent prostate carcinoma (AIPC). Immunological and PSA responses have been described in men receiving GVAX IT. Preclinical studies have shown that antitumor immune responses induced by GVAX IT could be augmented further by making animals lymphopenic and reconstituting with lymphocytes prior to vaccination. A clinical trial was designed to study the effects of lymphopenic reconstitution in pts with AIPC.All pts had MC collection by leukapheresis pre-treatment. Study groups were as follows: Arm A - GVAX IT given every two weeks for 6 months; Arm B - Cyclophosphamide (350 mg/mSeven pts have been treated thus far and completed at least 2 GVAX IT treatments. Pts had ECOG performance status 1, castrate testosterone levels, 1 prior chemotherapy regimen and measurable or evaluable metastatic AIPC. Lymphopenia was induced in all pts enrolled in Arms B and C, with recovery of total granulocytes and lymphocytes within 4 weeks following treatment. Monitoring of humoral and cellular immunological responses is underway and shall be presented.GVAX IT and lymphopenic reconstitution is feasible in men with AIPC. Analysis of clinical and immune response is ongoing. Supported by DAMD grant PC020094 and generous support of Mr. Tom Denhart, the Chiles Foundation and the Murdock Trust. [Table: see text].


Loading Cell Genesys Inc. collaborators
Loading Cell Genesys Inc. collaborators