Fate Therapeutics’ clinical operations group is seeking a motivated and talented individual to perform in-house monitoring tasks, including coordinating GCP activities both internally and at clinical sites to ensure compliance for the conduct of clinical trials and to follow up with the monitoring staff, other departments, and clinical sites to assure due diligence. The ideal candidate will have relevant industry experience monitoring oncology trials. Candidates must thrive in a fast-paced team environment. Excellent communication, organizational abilities, and problem-solving skills are a must.

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43LW – Clinical Research Assistant / Clinical Research Associate I

Fate Therapeutics’ clinical operations group is seeking a motivated and talented individual to monitor clinical trials at investigative clinical sites and assure adherence to the protocol(s) and GCP/ICH guidelines and applicable regulations. The successful candidate will oversee the progress of early phase protocols and ensure that studies are on track for meeting various timelines. The ideal candidate will have relevant industry experience monitoring early development oncology trials. Candidates must thrive in a fast-paced team environment. Excellent communication, organizational abilities, and problem-solving skills are a must.

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42LW – Clinical Research Associate II (In-House)

Fate’s Stem Cell Biology Group is currently seeking a talented auditory physiologist to lead a preclinical evaluation of compounds in rodent models of hearing loss. The successful candidate will have expertise in functional measurements of hearing, including ABR and EOAE, and experience with methods of intratympanic drug delivery. The candidate will also work with a team of scientists to collect cochlear samples for analytic and histologic analysis. This is a full time position that requires hands-on research and development, and reports to the Sr. Director, Stem Cell Biology.

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41ST – Scientist, Auditory Physiology

Fate’s Technology Group is currently seeking a talented cell biologist to provide assay development to support internal discovery programs. The candidate must have extensive flow cytometry based rare cell sorting and standard molecular biology techniques (nucleic acid purification, qPCR, RT-qPCR) experience. This is a full-time position that requires hands-on research and development for multiple programs and potentially management of research associates. This position reports to the Chief Technology Officer.

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40DS – Scientist, Assay Development

Fate Therapeutics’ development group is seeking a motivated and talented individual to serve as a Technical Specialist for Fate’s clinical stage ex vivo cell therapy program. The successful candidate will demonstrate technical expertise in development and manufacturing of cell therapy products, producing tangible and timely results as products progress from early development towards registration and subsequent commercialization.

The ideal candidate will have expertise in development and clinical manufacturing of cell therapy products in a GTP/GMP environment. Candidates must thrive in a fast-paced team environment. Excellent communication, organizational abilities, and problem-solving skills are a must.

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39PM – Technical Specialist, Product Development

Fate Therapeutics’ development group is seeking a motivated and talented individual to lead the development of novel cellular therapies, comprising Fate’s clinical stage ex vivo cell therapy program. The successful candidate will demonstrate technical expertise and leadership in development and manufacturing of cell therapy products, producing tangible and timely results as products progress from early development towards registration and subsequent commercialization.

The ideal candidate will have extensive expertise in development and clinical manufacturing of cell therapy products in a GTP/GMP environment, as well as relevant industry experience in the conduct of clinical trials for investigational products. Candidates must thrive in a fast-paced team environment. Excellent communication, organizational abilities, and problem-solving skills are a must.

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38PM – Sr. Technical Field Specialist, Product Development

“Fate’s lead therapeutic, ProHema, has already demonstrated potential benefit to patients that are stricken with life‐threatening hematologic malignancies and are in need of hematopoietic reconstitution. I am excited to shepherd ProHema’s further clinical development and its access to patients,” said Dr. Rastetter. “I am also impressed with Fate’s approach to identifying therapeutic intervention points in adult stem cell biology, which have translated into a promising pipeline of product candidates. I look forward to collaborating with the Fate team and board of directors to continue to drive forward in the development of innovative regenerative medicines.”
Fate Therapeutics announced yesterday promising clinical results from a Phase 1b trial of ProHema as part of double‐umbilical cord blood (UCB) transplants in adult patients with hematologic malignancies who have undergone reduced‐intensity conditioning therapy. The data were presented at the 53rd annual American Society of Hematology (ASH) meeting. Of the twelve subjects that received ProHema, the median time to neutrophil recovery (> 500 cells/μL) was 17.5 days, which compares favorably to historical norms for patients undergoing double‐UCB. In addition, ProHema provided the dominant source of hematopoiesis in ten of the twelve subjects, suggesting that treatment with ProHema may confer preferential engraftment.

“Given Dr. Rastetter’s industry experience in developing and commercializing highly innovative products, such as Rituxan®, we feel privileged that he will join our efforts in creating a world‐leading therapeutics enterprise from our foundational science in adult stem cell biology,” said John Mendlein, Ph.D., founder and Vice Chairman of Fate Therapeutics. “Dr. Rastetter joins us at a transformational time as our innovative ProHema product advances closer to patient and commercialization reality. His proven leadership in translating new therapeutic modalities into successful products enhances our team and our vision to deliver life‐changing therapeutics to patients.”
Dr. Rastetter also serves as the Chairman of Illumina, Inc., of Neurocrine Biosciences, Inc., and of Receptos, Inc., and is a partner in the venture capital firm Venrock. Dr. Mendlein, in addition to his role as founder and Vice Chairman of Fate Therapeutics, is currently the Executive Chairman and CEO of aTyr Pharma.

About ProHema
ProHema is a first‐in‐class therapeutic consisting of pharmacologically‐enhanced hematopoietic stem cells (HSC), where pharmacologic modulation imparts a greater than 20‐fold up‐regulation of key biological factors for enhanced HSC homing and proliferation. Fate Therapeutics has completed a Phase 1b clinical study for ProHema in hematologic malignancy patients undergoing double‐umbilical cord HSC transplant, and is exploring the therapeutic benefits of ProHema in other settings of HSC transplantation. The Company has submitted to the FDA a clinical protocol to evaluate ProHema in a single‐cord blood allogeneic transplant setting, and intends to begin enrolling patients into that study within the next three months.

San Diego, CA – Fate Therapeutics, Inc. announced today promising clinical results from a Phase 1b trial of ProHema (FT1050‐enhanced umbilical cord blood) as part of double‐umbilical cord blood (UCB) transplants in adult patients with hematologic malignancies who have undergone reduced‐intensity conditioning therapy. The data are being presented at the 53rd annual American Society of Hematology (ASH) meeting, being held December 10‐13, in San Diego, California (Abstract Number: 653; entitled, “FT1050 (16,16‐dimethyl Prostaglandin E2)‐Enhanced Umbilical Cord Blood Accelerates Hematopoietic Engraftment After Reduced Intensity Conditioning and Double Umbilical Cord Blood Transplantation”). ProHema is a first‐in‐class therapeutic candidate, consisting of pharmacologically‐enhanced hematopoietic stem cells (HSC), designed to improve HSC support during the normal course of a stem cell transplant for the treatment of patients with hematologic malignancies.

The Phase 1b double‐UCB study conducted at the Dana‐Farber Cancer Institute and the Massachusetts General Hospital achieved its primary objective of demonstrating safety and tolerability of ProHema based upon patient engraftment by Day 42 with greater than 5% chimerism of the ProHema unit. In addition, of the twelve subjects presented in the abstract that received a ProHema unit and an untreated unit, the median time to neutrophil recovery (> 500 cells/μL) was 17.5 days, which compares favorably to a median of 21 days for a historic control group of similarly treated subjects at the Dana‐Farber Cancer Institute (n=53). In addition, the ProHema unit was the dominant source of hematopoiesis in ten of the twelve subjects, suggesting that treatment with ProHema may confer preferential engraftment. “These clinical trial data support Fate’s novel therapeutic approach for the development of stem cell biology‐based medicines,” said Pratik Multani, M.D., Senior Vice President, Clinical Development at Fate Therapeutics. “We believe these clinical observations represent the first evidence that the ex vivo pharmacologic modulation of hematopoietic stem cells has the potential to improve patient outcomes, and we look forward to rapidly advancing ProHema into broader clinical investigation.”

There were no instances of primary or secondary graft failure in the twelve subjects. The adverse events associated with the infusion of the ProHema unit appeared to be no greater than the background expected rate associated with cord blood infusion. The events consisted of five Grade 1/2 infusion‐related events of chills, flushing, abdominal pain, or cough in 4 subjects. In addition, one subject experienced transient Grade 4 ST‐ elevation following infusion and evidence of myocardial ischemia by cardiac troponin assay. To date, two cases of Grade 2 acute graft‐versus‐host disease (GvHD) have been observed in the first 100 days, and one subject developed NIH mild chronic GvHD. Currently, treatment related mortality is 8% (one subject). One subject has relapsed, while the remaining ten subjects are alive without relapse with a median follow‐up of approximately 8.5 months.

“ProHema appears to offer the potential to improve clinical outcomes for patients undergoing double‐UCB transplantation,” said Corey Cutler M.D., M.P.H., F.R.C.P.C., associate professor of medicine at the Dana‐Farber Cancer Institute and Harvard Medical School and principal investigator of the Phase 1b clinical study. “Given the competitive engraftment dynamic of double‐UCB transplantation, the clinical data suggest that the ProHema unit was able to preferentially engraft over the untreated cord blood unit. While further investigation is needed to confirm this finding, these data open the possibility for clinicians to treat the best‐matched unit to encourage more favorable patient outcomes.”

Fate Therapeutics is exploring the benefits of ProHema in other settings of HSC transplantation. The Company has submitted to the FDA a clinical protocol to evaluate ProHema in a single‐cord blood allogeneic transplant setting, and intends to begin enrolling patients into that study within the next three months.

About Hematopoietic Stem Cell Support Intensive chemotherapy, radiation and/or immunotherapy are often used to treat patients with hematologic malignancies, such as leukemia and lymphoma, who have not been cured with conventional treatment. These high‐dose regimens, designed to kill the cancer cells, will also often destroy the patient’s normal blood and immune systems in the process. Therefore, hematopoietic reconstitution through the administration of HSCs is necessary to restore normal bone marrow function. In addition, the immune cells generated by the HSCs, in some cases, play a role in eradicating cancer cells. Possible sources of HSCs include bone marrow, peripheral blood or umbilical cord blood. The entire procedure is often referred to as hematopoietic stem cell support.

About Ex Vivo HSC Modulation UCB transplantation relies on a small number of HSCs to restore hematopoiesis. Even with double‐UCB transplantation, engraftment times are prolonged and immune reconstitution delayed. Preclinical studies conducted by Leonard Zon, M.D., Grousbeck Professor in Hematology/Oncology at the Children’s Hospital Boston and a Scientific Founder of Fate Therapeutics, have suggested that the ex vivo treatment of HSCs with certain prostaglandins can enhance the effective cell dose of HSCs – without stem cell expansion or differentiation of HSCs to committed progenitors – and improve the time to, and durability of, engraftment (North TE, Nature, 2007, 447:1007‐1011). Using both murine and human‐xenograft model systems, the mechanisms of action have been demonstrated to involve improved homing via CXCR4‐SDF‐1, increased proliferation and entry into the cell cycle, and decreased rates of apoptosis (Goessling 2009; Hoggatt 2009; Goessling 2011).

San Diego, CA  – Fate Therapeutics, Inc. announced today that the United States Patent and Trademark Office has granted a patent covering compositions that are broadly utilized throughout the field of induced pluripotent stem cell (iPSC) technology. U.S. Patent No. 8,071,369, entitled “Compositions for Reprogramming Somatic Cells,” claims a composition comprising a somatic cell having an exogenous nucleic acid that encodes an Oct4 protein introduced into the cell. The invention by Rudolf Jaenisch, M.D., founding member of the Whitehead Institute for Biomedical Research and scientific founder of Fate Therapeutics, represents the second patent granted under U.S. Patent Application Number 10/997,146, which has a priority date of November 26, 2003. Fate Therapeutics holds an exclusive license to the patent for pharmaceutical applications, including for drug discovery and validation, disease modeling, and therapeutic purposes.
“This issuance further validates the groundbreaking contributions of Dr. Jaenisch to the field of cellular reprogramming,” said Dr. John Mendlein, a founder of Fate Therapeutics. “His pioneering discoveries created a revolution in stem cell research, and major academic, research and commercial laboratories throughout the world are now aggressively working to unlock the therapeutic potential of iPSC technology for the benefit of patients.”

In his 2003 U.S. patent application, Dr. Jaenisch first described the generation of human pluripotent cells from somatic cells, and how reprogrammed human cells might enable autologous cell therapy including for the treatment of neurological diseases such as Alzheimer’s, Parkinson’s or ALS. The application is the first to describe key compositions, broad methods and key agents to reprogram human somatic cells to a pluripotent state. Because reprogrammed human cells have been shown to behave similarly to embryonic stem cells with respect to their ability to differentiate into various cell types, reprogrammed human cells hold significant promise for the creation of human disease‐specific models for drug screening and for the development of stem cell based therapeutics.

San Diego, California, November 16, 2011 – Fate Therapeutics, Inc. announced today that the United States Patent and Trademark Office has granted a patent covering the novel stem cell modulator commonly known as Thiazovivin. U.S. Patent No. 8,044,201 entitled “Stem Cell Cultures” claims Thiazovivin, a small molecule Rho- associated kinase (ROCK) inhibitor, as well as compositions and cell culture media comprising
Thiazovivin. Thiazovivin is crucial to the efficient generation of human induced pluripotent stem cells (iPSCs), and the survival of human embryonic stem cells (hESCs), in culture. Fate Therapeutics holds an exclusive license from The Scripps Research Institute (TSRI) to the patent in all commercial fields.
“The generation, survival and expansion of pluripotent stem cells – without compromise to their self-renewal capacity and ultimate differentiation potential – remains critical to realizing the potential of stem cell biology-based therapeutics,” said Dr. John Mendlein, Executive Chairman of Fate Therapeutics. “We believe that our industrialized iPSC product engine, including our high throughput methods of reprogramming, cell selection, characterization and single-cell passaging, offers a powerful opportunity for stem cell research and drug discovery, and for the potential development of iPSC-derived cell therapies.”
The importance of Thiazovivin in enabling an industrialized iPSC product platform was first elucidated by Sheng Ding, Ph.D., a scientific founder of Fate Therapeutics, while at TSRI. Under a research collaboration between TSRI and Fate Therapeutics, Dr. Ding and his team of TSRI scientists first demonstrated that Thiazovivin, in combination with other small molecules, dramatically improves the reprogramming of human fibroblasts by 200-fold as compared to non-chemically enhanced methods of iPSC generation (Lin, T., et al, Nature Methods 6, 805 – 808 (2009)), and that Thiazovivin promotes the survival of hESCs after single-cell dissociation (Xu, Y., et al, PNAS 107(18): 8129-8134). Thiazovivin is believed to be a critical factor in maintaining the stem cell niche during conditions that might otherwise be detrimental to cell viability.