Cellular Biomedicine Group to Present CAR-T Phase I Clinical Trial Data for Tumors; Idera Pharma Reports Presentation of New Intratumoral IMO-2125 Preclinical Data Print E-mail
By Marilyn Mullen   
Wednesday, 16 September 2015 18:51
Below is a look at some of the headlines for companies that made news in the healthcare sector on September 16, 2015.  
   
Cellular Biomedicine Group Inc. (NASDAQ: CBMG), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced that it would give an oral presentation to discuss Phase I clinical trial data for EGFR (HER-1)-targeted Chimeric Antigen Receptor-Modified T-Cells (CAR-T) Immunotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) and other solid tumors at the 5th World Congress on Cancer Therapy on September 28, 2015.
   
Conference: 5th World Congress on Cancer Therapy, September 28-30, 2015 Atlanta, Georgia, USA
Title: EGFR (HER-1)-targeted Chimeric Antigen Receptor-Modified T-Cells Immunotherapy for Patients with Advanced or Relapsed/Refractory Solid Tumors
Oral Presentation: Scientific Program, September 28, 2015 18:05-18:25
Location: Hilton Atlanta Airport
Presenter: Wei Dong Han, MD, PhD, Chinese PLA General Hospital
  
The presentation expands on the data that will be presented at the European Cancer Congress poster presentation in Vienna on September 26, and will detail PLAGH/CBMG's Phase I clinical trial data using Chimeric Antigen Receptor-Modified T-Cells (CAR-T) targeting EGFR (HER-1) for the treatment of patients with EGFR (HER-1) expressing advanced relapsed/refractory Non-Small Cell Lung Cancer (NSCLC) as well as other EGFR (HER-1) expressing solid tumors. The CAR-T trial was designed and conducted by Chinese PLA General Hospital ("PLAGH", Beijing, also known as "301 Hospital"), led by Principal Investigator Wei Dong Han, MD, PhD, head of PLAGH's cancer immunotherapy department. Dr. Han and his research team have authored several CAR-T publications, including "Tolerance and Efficacy of Autologous or Donor-derived T-Cells Expressing CD19 Chimeric Antigen Receptors in Adult B-ALL with Extramedullary Leukemia" and "Effective Response and Delayed Toxicities of Refractory Advanced Diffused Large B-cell Lymphoma Treated by CD20-directed Chimeric Antigen Receptor-modified T-cells". (OncoImmunology (Impact Factor: 6.28). 03/2015; DOI: 10.1080/2162402X.2015.1027469 and Clin Immunol. 2014 Dec;155(2):160-75. doi: 10.1016/j.clim.2014.10.002) The Company previously announced positive clinical data from its Phase I clinical trials using CAR-T constructs against CD19, CD20 and CD30 for late-stage blood cancers.
   
Company management will attend the conference and be available for discussions. Full detail of the presented data will be available on the Company website following the presentation.
   
   
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Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, today announced new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2125 alone and in combination with ipilimumab demonstrated potent and systemic anti-tumor activity in preclinical cancer models. IMO-2125 is a synthetic oligonucleotide-based agonist of Toll-like receptor 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Additionally, Idera presented preclinical data which demonstrated that IMO-2125 induces a systemic antitumor immune response with the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors. These data are being presented at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference in New York City, beginning today.
   
"The body of preclinical data that we have assembled further illustrates the potential of intratumoral IMO-2125 to play an important role in the emerging field of cancer immunotherapy," stated Sudhir Agrawal, D.Phil., President of Research at Idera Pharmaceuticals. "We are looking forward to advancing this approach into clinical development with our first study and exploring additional clinical studies with intratumoral IMO-2125 in other tumor types and with other checkpoint inhibitor combination regimens."
   
In the presentation, entitled "Intratumoral administration of IMO-2125, a novel TLR9 agonist, modulates the tumor microenvironment and exerts systemic antitumor activity alone and in combination with an anti-CTLA4 monoclonal antibody (mAb)," Idera scientists presented data suggesting that intratumoral IMO-2125 monotherapy led to dose-dependent decreases in treated and distant tumor volume, an increase in infiltrating CD8+ T cells and specific cytotoxic T cell responses against tumor antigens. Combination of intratumoral IMO-2125 and an anti-CTLA4 mAb showed improved inhibition of tumor growth, regression of systemic lung metastases and infiltration of TILs versus monotherapy with either agent. Collectively, these data demonstrate the potent antitumor activity of IMO-2125, a novel immunostimulatory TLR9 agonist, alone and in combination with a checkpoint inhibitor.
   
Idera expects to initiate the first clinical study of intratumoral IMO-2125 in combination with ipilimumab in patients with metastatic melanoma in the fourth quarter of this year as part of the previously announced clinical research alliance with MD Anderson Cancer Center.
   
In the presentation, entitled "Modulation of checkpoint expression in tumor microenvironment by intratumoral administration of a novel TLR9 agonist: Rationale for combination therapy," Idera scientists presented data suggesting that intratumoral IMO-2125 treatment led to antitumor activity in preclinical tumor models of lymphoma, colon carcinoma and melanoma. Specifically, intratumoral IMO-2125 treatment resulted in changes in the tumor microenvironment in both treated and distant tumors, as demonstrated by modulation of immune checkpoint gene expression. These data showed that intratumoral IMO-2125 has the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors.
   
These presentations are both currently available on Idera's website at http://www.iderapharma.com/our-science/key-presentations-and-publications.
   
Additionally, Idera announced that pre-clinical data relating to the combination of intratumoral IMO-2125 and an anti-PD-1 mAb in a murine colon carcinoma model will be presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston from November 5-9th.
   
   
   
Also Wednesday:
   
   
   
Advanced Accelerator Applications (AAA), an international specialist in molecular nuclear medicine, today announced that the pivotal Phase 3 NETTER-1 clinical study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut Neuro Endocrine Tumors (midgut NETs) has met its primary endpoint, demonstrating a statistically significant and clinically meaningful increase in progression-free survival for Lutathera versus a double dose of Sandostatin LAR.
   
BioBlast Pharma Ltd., (Nasdaq:ORPN), a clinical-stage biotechnology company committed to developing meaningful therapies for patients with rare and ultra-rare genetic diseases, announced today that Tom Dubin has joined its Board of Directors, effective immediately.   "Given Tom's significant operating, reimbursement, and legal experience, especially in the orphan drug arena, and as a member of the Executive Committee of Alexion, there is no doubt he will be a tremendous asset to us, as we seek to develop and commercialize our product platforms. We are very pleased to welcome Tom to our Board of Directors," said Fredric Price, Executive Chairman of BioBlast.
   
Cellular Biomedicine Group Inc. (NASDAQ:CBMG), a biomedicine firm engaged in the development of effective stem cell therapies for degenerative diseases and immunotherapies for cancer, today announced that it would give an oral presentation to discuss Phase I clinical trial data for EGFR (HER-1)-targeted Chimeric Antigen Receptor-Modified T-Cells (CAR-T) Immunotherapy for patients with Non-Small Cell Lung Cancer (NSCLC) and other solid tumors at the 5th World Congress on Cancer Therapy on September 28, 2015.
   
Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that it has entered into a collaboration agreement with Center for Immune Cell Therapies (CICT) at Memorial Sloan Kettering Cancer Center focused on the CellWerksTM portfolio of devices for intra-laboratory stem cell purification applications. Under the terms of the agreement, CICT will utilize Cesca's newest evolution of the AutoXpress® platform under the Company's "Early Technology Access Program". Specifically, this latest innovation of specialized cell processing algorithms will be applied to a CICT initiated study within the Adoptive Immune Cell Therapy Facility. The study's completion is anticipated by the end of calendar year 2015.
   
Galectin Therapeutics Inc. (NASDAQ:GALT), the leading developer of therapeutics that target galectin proteins to treat fibrosis and cancer, announces the commencement of its Phase 2 clinical trial with GR-MD-02 in patients with non-alcoholic steatohepatitis (NASH) with advanced fibrosis (the NASH-FX trial). This 30-patient study is being conducted by Stephen A. Harrison, M.D., FACP, FAASLD, Colonel, Medical Corps U.S.A., Director, Medical Education, Associate Dean, San Antonio Uniformed Services Health Education Consortium, Professor of Medicine, Uniformed Services University of the Health Sciences and Consultant to The Army Surgeon General for Gastroenterological Diseases, San Antonio Military Medical Center. The NASH-FX trial, which focuses on advanced fibrosis, is part of Galectin's overall Phase 2 clinical program with GR-MD-02 in NASH that addresses both advanced fibrosis and cirrhosis.
   
Geron Corporation (Nasdaq:GERN) today announced the dosing of the first patient in a Phase 2 clinical trial to evaluate imetelstat in patients with myelofibrosis (MF). This clinical trial, also referred to as the IMbarkTM study, is being conducted by Janssen Biotech, Inc. (Janssen), under the terms of the exclusive worldwide imetelstat license and collaboration agreement between the companies.
   
Heat Biologics, Inc., (Nasdaq:HTBX), a clinical stage cancer immunotherapy company, announced that it will present a poster titled "Locally Secreted Fc-OX40L is Superior to Systemic, Antibody Mediated, OX40 Co-Stimulation for Combination Immunotherapy" at the International Cancer Immunotherapy Conference. Heat's poster highlights further findings from the preclinical research conducted with ComPACT, the company's next-generation combination immunotherapy platform. The poster (#B006) will be presented in the Empire Ballroom at the Sheraton Times Square Hotel in New York City from 4:45 p.m. to 6:45 p.m. on Friday, September 18, 2015.  
    
Histogenics Corporation (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space and Collagen Solutions plc (AIM:COS), the developer and manufacturer of medical grade collagen components for use in regenerative medicine, medical devices and in-vitro diagnostics, today announced the execution of a supply agreement between Histogenics and Collagen Solutions (UK) Ltd.     The supply agreement will encompass additional collagen material sources for use in Histogenics' investigational product candidate, NeoCart®, a regenerative medicine product currently in Phase 3 clinical trials using autologous cell therapy, biomaterials and engineering to develop a tissue implant to repair knee cartilage damage. The supply agreement may also encompass additional future products in the Histogenics pipeline for use in markets outside of the United States.
   
Idera Pharmaceuticals, Inc. (NASDAQ:IDRA), a clinical-stage biopharmaceutical company developing Toll-like receptor (TLR) and RNA therapeutics for patients with cancer and rare diseases, today announced new preclinical data that showed cancer immunotherapy with intratumoral injections of IMO-2125 alone and in combination with ipilimumab demonstrated potent and systemic anti-tumor activity in preclinical cancer models. IMO-2125 is a synthetic oligonucleotide-based agonist of Toll-like receptor 9 discovered and developed by Idera. Ipilimumab is a checkpoint inhibitor targeting cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). Additionally, Idera presented preclinical data which demonstrated that IMO-2125 induces a systemic antitumor immune response with the potential to sensitize the tumor microenvironment for combination with various checkpoint inhibitors. These data are being presented at the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference in New York City, beginning today.
   
Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development of therapeutics for central nervous system (CNS) disorders, today announced positive results from the first Phase 3 clinical trial of ITI-007 for the treatment of patients with schizophrenia. In this trial, once-daily ITI-007 60 mg met the primary endpoint and demonstrated antipsychotic efficacy with statistically significant superiority over placebo at Week 4 (study endpoint) as measured by the change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score (p=0.022). Moreover, ITI-007 60 mg showed significant antipsychotic efficacy as early as week 1, which was maintained at every time point throughout the entire study. ITI-007 60 mg also met the key secondary endpoint of statistically significant improvement on the Clinical Global Impression Scale for Severity of Illness (CGI-S; p=0.003). These findings confirm the positive results demonstrated by ITI-007 60 mg in the Company's Phase 2 study. Consistent with previous studies, ITI-007 had a favorable safety and tolerability profile as evidenced by motoric, metabolic, and cardiovascular characteristics similar to placebo, and no clinically significant changes in akathisia, extrapyramidal symptoms, prolactin, body weight, glucose, insulin, or lipids.
   
Kraig Biocraft Laboratories, Inc. (OTCQB:KBLB), the leading developer of advanced spider silk based fibers, announces an advance conference call advisory for all shareholders and other interested parties.  The Company plans to host a conference call for the purpose of updating shareholders on production, scientific milestones, commercialization strategy and other corporate developments.  The call will be hosted by Kraig’s founder and CEO, Kim Thompson and is planned for late October, pending the travel schedule of Thompson and members of the Kraig Labs team.
  
Kura Oncology, Inc. (OTCQB:KURO), a clinical stage biopharmaceutical company advancing a pipeline of precision medicines for the treatment of solid tumors and blood cancers, announced today that its common stock has been approved for quotation on the OTCQB® marketplace in the United States under the symbol "KURO".
  
Lion Biotechnologies, Inc. (Nasdaq:LBIO), a biotechnology company that is developing novel cancer immunotherapies based on tumor-infiltrating lymphocytes (TIL), today announced that Steven A. Rosenberg, MD, PhD, chief of surgery at the National Cancer Institute (NCI), presented updated data from a Phase 2 clinical trial of TIL therapy in metastatic melanoma. The updated results were presented on September 16, 2015 at the American Association for Cancer Research Inaugural International Cancer Immunotherapy Conference in New York.   Consistent with prior findings, updated data from the Phase 2 trial in heavily pre-treated patients with metastatic melanoma confirmed that TIL treatment was associated with high, durable objective response rates (ORR), including in patients who were refractory to checkpoint inhibitors.
   
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel anti-cancer stem cell and immuno-oncology therapeutics, today presented preclinical data for the company's proprietary, wholly owned GITRL-Fc agent during the afternoon poster session of the CRI-CIMT-EATI-AACR Inaugural International Cancer Immunotherapy Conference.   GITRL is a member of the tumor necrosis factor (TNF) family of ligands and functions to activate the co-stimulatory receptor GITR (glucocorticoid-induced tumor necrosis factor receptors) to enhance T-cell modulated immune responses. OncoMed's GITRL-Fc agent is engineered using a novel single-gene linkerless GITRL trimer which enables effective GITR activation and robust anti-tumor immune response.
   
Relypsa Inc. (NASDAQ:RLYP), a biopharmaceutical company, today announced that results of its Phase 1 onset-of-action study of Patiromer for Oral Suspension (Patiromer FOS) were published in Kidney International, the journal of the International Society of Nephrology. Results showed that Patiromer FOS rapidly and significantly reduced blood potassium from baseline levels in patients with moderate-to-severe hyperkalemia (mean blood potassium levels at baseline: 5.93 mEq/L), who had chronic kidney disease (CKD) and were taking at least one renin angiotensin aldosterone system (RAAS) inhibitor. Patiromer FOS started to decrease potassium levels at 4 hours (the first evaluation time point) and the reduction became statistically significant at 7 hours (p=0.004). The reduction in blood potassium levels was significant at all following time points during the 48-hour treatment period (p≤0.004 for hours 7 and 10; p<0.001 for hours 12-48) and was sustained for 24 hours after the last dose. Patiromer FOS was well tolerated with a safety profile consistent with that observed in other clinical trials.
   
ReWalk Robotics Ltd. (Nasdaq:RWLK), the leading global exoskeleton developer and manufacturer, today announced that Deborah DiSanzo has been appointed to its Board of Directors, effective immediately.    "We are very pleased to welcome Deborah DiSanzo to our board and draw upon her expertise as a seasoned medical device executive and leader in our industry as we work to expand our commercialization efforts for the ReWalk exoskeleton and build shareholder value," said Larry Jasinski, Chief Executive Officer.
  
T2 Biosystems, Inc. (Nasdaq:TTOO), a company developing innovative diagnostic products to improve patient health, today announced that results from a data analysis of the company's T2Candida® Panel for the detection and monitoring of Candida infection and sepsis were published in Future Microbiology. The publication compared aggregated results from T2Candida in the detection of invasive candidiasis and candidemia to blood culture, which included samples acquired from more than 1,900 patients. Out of 55 total cases, T2Candida demonstrated a 96.4 percent sensitivity (53 cases) compared to 60 percent (33 cases) with blood culture.
   
Willis North America, a unit of Willis Group Holdings plc (NYSE:WSH), the global risk advisory, re/insurance broking, and human capital and benefits firm, today announced the 10th Annual Managed Care/Pharmacy Benefits Management Roundtable, September 29-30, 2015, in Chicago, IL.   The Willis-sponsored event brings together over 100 risk management, finance, legal and asset preservation professionals for educational and networking opportunities. Participants will include leading specialists from the Willis Managed Care Practice, a sub-specialty of Willis’s National Health Care Practice, along with representatives from dozens of managed care organizations (MCOs) including group health insurers, pharmaceutical benefits managers, local government-sponsored plans, independent provider associations (IPAs) and accountable care organizations (ACOs) of all sizes.



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