BioPhase Solutions specializes in recruiting top talented professionals for San Diego’s Scientific community. We are currently looking for a Production Technician to work for a leading San Diego biotechnology company.
We are a clinical-stage biotechnology company focused on developing and commercializing novel cancer therapies that target the tumor microenvironment. Our lead proprietary program, investigational drug PEGPH20, applies a unique approach to targeting solid
Mirati Therapeutics’ Mocetinostat Included In Stand Up To Cancer’s Cutting-Edge Clinical Trial Initiative For NSCLC Patients
· Clinical trial combining mocetinostat with pembrolizumab and guadecitabine in NSCLC now open and enrolling patients· Enrollment continues in Mirati-sponsored clinical trial of mocetinostat combined with durvalumab in checkpoint refractory NSCLC; first cohort expands to stage 2.
SAN DIEGO, Oct. 12, 2017 /PRNewswire/ — Mirati Therapeutics, Inc. (NASDAQ: MRTX), a clinical stage oncology biotechnology company, announced today that the Company has been included in the SU2C CatalystTM program, a cutting-edge research initiative led by Stand Up To Cancer (SU2C) designed to bring innovative cancer treatments to patients quickly through novel collaborations between industry and academia.
A clinical trial research grant has been awarded to the Van Andel Research Institute (Grand Rapids, Michigan) to evaluate the potential of epigenetic agents to improve patient responses to immunotherapy in non-small cell lung cancer (NSCLC). The $2.5 million research grant will support a Phase 1/1b study combining Mirati’s mocetinostat, an orally-bioavailable, spectrum-selective Class 1 & IV HDAC inhibitor, guadecitabine, a DNA methyltransferase (DNMT) inhibitor from Astex, and pembrolizumab, a PD-1 checkpoint inhibitor from Merck (known as MSD outside the U.S. and Canada). The grant is provided by Merck, a SU2C Catalyst Founding Supporter.
“We are honored to participate in this ground-breaking trial with pembrolizumab and guadecitabine. The combination of immunotherapy with epigenetic agents such as mocetinostat has great potential to positively impact outcomes for patients with NSCLC,” said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer. “The SU2C Catalyst program is an exceptional example of a collaboration designed to benefit cancer patients in an unprecedented way.”
The team is led by Stephen Baylin, M.D., and Matthew Hellmann, M.D. Dr. Baylin is the co-director of the Cancer Biology Division and associate director for research programs for Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins as well as the co-leader of the VARI-SU2C Epigenetics Dream Team while Dr. Hellmann is an oncologist at Memorial Sloan Kettering Cancer Center in New York. Memorial Sloan Kettering will coordinate the trial with Dr. Hellmann as principal investigator.
“Despite the current and exciting advances with immune checkpoint therapy, many patients with NSCLC still do not receive benefit and this continues to be an extremely challenging disease. However, we remain optimistic that with continued research on the immune modulatory effects of epigenetic agents, the ability to test the hypothesis in trials like this, that these drugs combined with immune checkpoint therapy will contribute to improved ways to treat patients with NSCLC,” said Dr. Baylin.
The trial is now open and enrolled its first patient in August 2017. Additional information on the trial can be found at https://clinicaltrials.gov/show/NCT03220477. For information on SU2C Catalyst and this project, visit SU2C.org.
Mirati is also conducting a Phase 2 study of mocetinostat in combination with durvalumab in NSCLC patients who have experienced progression of disease after treatment with checkpoint inhibitor therapy. Patients are stratified into two cohorts based upon their best response to prior checkpoint therapy. Stage 1 of the study is currently enrolling nine patients in each cohort; one cohort has already met the prespecified criteria for expansion into stage 2 with at least one confirmed partial response. Mirati will provide an update on this study by the end of the year.
About Mirati Therapeutics
Mirati Therapeutics is a clinical-stage oncology company developing targeted drugs to address the genetic, epigenetic and immunological promoters of cancer. Our precision oncology clinical programs utilize next-generation genomic testing to identify and select cancer patients who are most likely to benefit from targeted drug treatment. In immuno-oncology, we are advancing clinical programs where the ability of our drugs to improve the immune environment of tumor cells may enhance and expand the efficacy of existing immunotherapy medicines when given in combination. Our pre-clinical programs include potentially first-in-class and best-in-class drugs specifically designed to address mutations and tumors where few treatment options exist. We approach each of our discovery and development programs with a singular focus: to translate our deep understanding of the molecular drivers of cancer into better drugs and better outcomes for patients. For more information, visit www.mirati.com.
About Mocetinostat (MGCD103)
Mocetinostat (MGCD103) is an orally-bioavailable, spectrum-selective Class I & IV HDAC inhibitor. Class I HDAC inhibition of histone acetylation is predicted to enhance the recognition of tumor cells by anti-tumor T cells and reverse immunosuppressive factors in the tumor microenvironment. Epigenetic immunomodulation may enhance immune response to tumors, and ultimately improve patient response to immunotherapies. Mocetinostat is being studied in a Phase 2 trial as a combination therapy with durvalumab, targeting the programmed death ligand 1 (PD-L1) pathway, which has been implicated in advanced lung cancers.
Mirati retains worldwide rights to mocetinostat except for certain Asian territories where the program is partnered with Taiho.
About Stand Up To Cancer (SU2C)
Stand Up To Cancer (SU2C) raises funds to accelerate the pace of research to get new therapies to patients quickly and save lives now. SU2C, a division of the Entertainment Industry Foundation (EIF), a 501(c)(3) charitable organization, was established in 2008 by film and media leaders who utilize the industry’s resources to engage the public in supporting a new, collaborative model of cancer research, and to increase awareness about cancer prevention as well as progress being made in the fight against the disease. As SU2C’s scientific partner, the American Association for Cancer Research (AACR) and a Scientific Advisory Committee led by Nobel Laureate Phillip A. Sharp, PhD, conduct rigorous, competitive review processes to identify the best research proposals to recommend for funding, oversee grants administration, and provide expert review of research progress. Current members of the SU2C Council of Founders and Advisors (CFA) include Katie Couric, Sherry Lansing, Lisa Paulsen, Rusty Robertson, Sue Schwartz, Pamela Oas Williams, Ellen Ziffren, and Kathleen Lobb. The late Laura Ziskin and the late Noreen Fraser are also co-founders. Sung Poblete, Ph.D., R.N., has served as SU2C’s president since 2011.
For more information on Stand Up To Cancer, visit www.StandUpToCancer.org.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release regarding the business of the Company that are not historical facts may be considered “forward-looking statements,” including, but not limited to, statements regarding Mirati’s development plans and timelines, potential regulatory actions, expected use of cash resources, the timing and results of clinical trials, and the potential benefits of and markets for Mirati’s product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as “may,” “would,” “believe,” “intend,” “plan,” “anticipate,” “estimate,” “expect,” and other similar terminology. Forward-looking statements are based on current expectations of management and upon what management believes to be reasonable assumptions based on information currently available to it, and are subject to risks and uncertainties. Such risks and uncertainties may cause actual results to differ materially from the expectations set forth in the forward-looking statements. Such risks and uncertainties include, but are not limited to, potential delays in development timelines or negative clinical trial results, reliance on third parties for development efforts, changes in the competitive landscape, changes in the standard of care, as well as other risks detailed in Mirati’s recent filings on Forms 10-K and 10-Q with the United States Securities and Exchange Commission. Mirati undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
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SOURCE Mirati Therapeutics, Inc.
5 years computer validation experience (FDA- biotech/pharma). Participate in a multi-phase project for the preparation and execution of Computer System…From Indeed – Thu, 12 Oct 2017 20:24:55 GMT – View all San Diego, CA jobs
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If you’ve ever checked a surf report to know how big the waves will be for a surfing session, you have Walter Munk to thank. And those calendars that predict high and low tides? They wouldn’t be possible without the research from a UC San Diego legendary oceanographer.
Spruce Biosciences Provides Corporate Update on Series A Venture Financing, Leadership Team and Lead Clinical Program
Clinical-stage, rare endocrine disease Company expands leadership team and advances lead candidate for congenital adrenal hyperplasia
SAN FRANCISCO, Oct. 12, 2017 /PRNewswire/ — Spruce Biosciences, a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders, today provided a corporate update, building upon a previously closed Series A financing of $20 million to expand its leadership team and advance its lead product candidate, SPR001, into advanced clinical trials.
The Spruce team, co-founded by Chief Executive Officer Alexis Howerton, Ph.D., is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. The Company’s lead indication, congenital adrenal hyperplasia (CAH), is caused by genetic mutations that result in the inability to produce the critical ‘stress’ hormone cortisol. Although CAH is part of the newborn screening program, there are currently no FDA-approved therapies for CAH. CAH is typically treated with chronic, high-dose steroids which often result in significant side effects and long-term health consequences.
Spruce closed a $20 million Series A financing in 2016, led by Novo Holdings A/S with additional investment from RiverVest Venture Partners. That financial runway has since enabled the company to complete the licensing of SPR001, together with a substantial body of nonclinical and clinical data, and initiate a Phase 2 clinical trial to study the safety and efficacy of SPR001 in adults with classic CAH. This study is currently enrolling at centers across the United States, with initial data expected in 2018.
Concurrent with the financing, Tiba Aynechi, Ph.D. from Novo Ventures (US) Inc. and Niall O’Donnell, Ph.D. from RiverVest joined the Board of Directors. Earlier this year, Mike Grey was named Executive Chairman. Mr. Grey has founded and held leadership positions in a number of biopharmaceutical companies, including Lumena Pharmaceuticals, Inc., and brings more than 40 years of experience in the pharmaceutical and biotechnology industries.
“Our investors were attracted to our novel small molecule drug candidate because it has a clinically-verified mechanism of action with the potential to improve hormone levels, reduce steroid use and greatly enhance quality of life for patients that have been traditionally underserved. We are pleased that in under 18 months we’ve been successful in using the initial financing to build out our clinical and operational expertise and advance SPR001 into Phase 2,” said CEO Dr. Howerton.
Spruce also recently expanded its leadership team to appoint Michael Huang, MD, as its Chief Medical Officer. Dr. Huang has more than 10 years of clinical research experience in all phases of drug development and has provided leadership resulting in several successful drug approvals prior to joining Spruce. Most recently, Dr. Huang served as Vice President of Clinical Development at Regulus Therapeutics. Prior to Regulus, Dr. Huang held positions of increasing responsibility at Spectrum Pharmaceuticals, Santarus and Auspex Pharmaceuticals.
“I am thrilled to join Spruce and help advance a promising new therapeutic with the potential to treat a serious disease left virtually untouched by the biotech industry. I look forward to working with Spruce’s talented and motivated team to unlock our capacity for developing new medicines for patients suffering from rare endocrine diseases with limited treatment alternatives,” stated Dr. Huang.
For more information on Spruce Biosciences, please visit sprucebiosciences.com.
About Spruce Biosciences
Spruce Biosciences is a clinical-stage biotechnology company developing novel therapies for rare endocrine disorders. The Spruce team is leveraging their extensive expertise in endocrinology and orphan drug development to meet the significant unmet need of patients suffering from rare endocrine diseases. Spruce’s lead product candidate, SPR001, has a novel and clinically verified mechanism of action (MOA) and is currently in Phase 2 clinical trials for congenital adrenal hyperplasia, a rare disease that is screened in newborns and for which there is not yet an FDA-approved therapy. The Company is headquartered in San Francisco and closed a Series A Financing of $20 million in 2016. For more information on Spruce, please visit sprucebiosciences.com.
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SOURCE Spruce Biosciences
OncoSec to Present Updated Clinical and Immune Biomarker Data from its Monotherapy and Combination Therapy Studies with ImmunoPulse® IL-12 at the 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research
OncoSec presented at the 2nd Annual Biomarkers & Precision Medicine USA Congress
SAN DIEGO, Oct. 12, 2017 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ:ONCS), a company developing DNA-based intratumoral cancer immunotherapies, will present new clinical data on ImmunoPulse® IL-12 (intratumoral pIL-12 [tavokinogene telseplasmid or “tavo”] with electroporation), its lead program focused on oncology, at the upcoming 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR). In addition, Chris Twitty, Ph.D., Executive Director of Clinical Science, gave an oral presentation at the 2nd Annual Biomarkers & Precision Medicine USA Congress earlier this week.
“We are excited to share updated data from our phase 2 clinical monotherapy trial with ImmunoPulse IL-12 in patients with stage III/IV melanoma,” said Punit Dhillon, CEO and President at OncoSec. “These data, along with the emerging clinical data from the phase 2 combination study, further support the rationale for our global, open-label, registration directed phase 2b clinical trial, PISCES/KEYNOTE-695, which we anticipate reporting initial data in mid-2018.”
9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research
Dr. Alain Algazi, Associate Professor, Department of Medicine (Hematology/Oncology), at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center, will give an oral presentation contrasting monotherapy ImmunoPulse IL-12 to its combination with pembrolizumab. The presentation includes an assessment of clinical and immune biomarker data from the company’s recently completed monotherapy phase 2 trial. The 9th World Congress of Melanoma – A Joint Meeting with the Society for Melanoma Research (SMR) is to be held on October 18-22, 2017, in Brisbane, Australia.
Details of the presentation are as follows:
Abstract Title: Clinical Immune Monitoring and Biomarker Data of pIL-12 Monotherapy Compared to pIL-12 with Pembrolizumab in Metastatic Melanoma Supports the Rationale for Combination Therapy (Abstract # FC05-3)
Session Title: Biology and Biomarkers
Date and Time: October 19, 2017 at 3:30 PM – 3:40 PM
Location: Brisbane Convention & Exhibition Centre
Dr. Algazi will present new clinical and immune monitoring data from patients treated with ImmunoPulse IL-12, as a monotherapy (n=51 patients) versus the combination of ImmunoPulse IL-12 and the approved anti-PD-1 therapy pembrolizumab (n=22 patients) to better understand the mechanisms associated with each immunotherapy protocol. In the 51 patients treated with ImmunoPulse IL-12 as monotherapy, an average of 33.5% best overall response rate (BORR) at 180 days by a modified “skin” RECIST was demonstrated, in addition to a favorable safety profile (no life threatening or grade 4 AE). In the combination trial of 22 patients treated to date, a 48% BORR was observed at 24 weeks. Biomarker analyses suggest ImmunoPulse IL-12 drives a cellular response leading to an inflamed tumor with an increased TIL frequency whether as a monotherapy or combined with pembrolizumab, converting “cold” tumors to “hot”.
Further details on this presentation will be provided in upcoming Company communications. For more information about this conference, please visit: https://worldmelanoma2017.com
2nd Annual Biomarkers & Precision Medicine USA Congress
Chris Twitty, Ph.D., Executive Director of Clinical Science at OncoSec, gave an oral presentation entitled: “Interrogation of the tumor microenvironment and associated immunity in patients with melanoma” in addition to leading a panel discussion at the 2nd Annual Biomarkers & Precision Medicine USA Congress on October 10, 2017 at the Hilton San Diego Mission Valley Hotel in San Diego, CA. For more information, please visit: https://www.biomarkersusa-congress.com/.
About OncoSec Medical Incorporated:
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse®, for the treatment of cancer. ImmunoPulse is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as plasmid encoded IL-12 (tavokinogene telseplasmid or “tavo”). In Phase 1 and 2 clinical trials, ImmunoPulse® IL-12 has demonstrated a favorable safety profile, evidence of anti-tumor activity in the treatment of various solid tumors, and the potential to reach beyond the site of local treatment to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse IL-12, is currently in clinical development for metastatic melanoma and triple-negative breast cancer. The program’s current focus is on the significant unmet medical need in patients with melanoma who are refractory or have relapsed on anti-PD-1 therapies. In addition to tavo, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse platform. For more information, please visit www.oncosec.com.
OncoSec Medical Incorporated
OncoSec Medical Incorporated
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SOURCE OncoSec Medical Incorporated
Is a multinational biotechnology company specializing in the research and development of novel pharmaceuticals to treat cancer. Polaris Pharmaceuticals, Inc….From Polaris Pharmaceuticals – Thu, 12 Oct 2017 08:58:57 GMT – View all San Diego, CA jobs