Bio-Path Holdings announced that data from pre-clinical studies supporting the potential of BP1003, a liposome-incorporated STAT3 oligodeoxynucleotide inhibitor, for the treatment of pancreatic cancer, non-small cell lung cancer, or NSCLC, and acute myelogenous leukemia, or AML, were presented in a poster at the American Association for Cancer Research, or AACR. The poster highlights four antisense oligo sequences directed against STAT3 mRNA identified by Bio-Path and manufactured using DNAbilize antisense RNAi nanoparticle technology. Cell viability tests and western blots were conducted to determine the inhibitory effects of liposome-incorporated STAT3 antisense oligo on NSCLC and AML cells. An ex vivo live tissue sensitivity assay was performed with a panel of 20 pancreatic ductal adenocarcinoma patient-derived xenografts to study the overall activity of BP1003 alone, and in combination with gemcitabine. Using previously defined criteria, tissue slice viability inhibition greater than 30% and with a less than 0.05 value was considered to be a response. For validation of ex vivo results, tumor bearing mice were administered BP1003 and gemcitabine twice a week for 28 days. Tumor volumes were monitored for up to 49 days. The most potent liposome-incorporated STAT3 antisense sequence in decreasing NSCLC cell viability was selected as the drug candidate BP1003. Further validation in AML cells demonstrated that BP1003 inhibited cell viability and STAT3 protein expression. In the ex vivo LTSA assay, BP1003 at a dose of 10 microM significantly inhibited the tissue slice viability in 9 out of 18 PDAC PDXs by more than 30%. The combination of BP1003 and gemcitabine further enhanced ex vivo efficacy of BP1003 in a subset of PDXs. In the in vivo study, a combination of BP1003 and gemcitabine caused tumor regression during the 28-day drug treatment period. This anti-cancer activity was maintained for another 21 days, even when drug treatment had ceased. Preclinical pancreatic cancer models demonstrated that BP1003 successfully penetrated the stroma into pancreatic tumors. Finally, the results in pancreatic cancer showed that BP1003 inhibited tumor slice viability in nine of 18.
Wednesday, April 3, 2019
Varian Medical reports first preclinical results of Flash therapy at AACR
Varian presented publicly, at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, the first pre-clinical results of its research on ultra-high dose rate cancer treatments with protons. Known as Flash therapy, it is a non-invasive therapy for cancer delivering high doses of radiation in ultra-high-speeds and according to the company, represents the potential for a major breakthrough in the treatment of cancer. The preclinical Flash therapy results presented at AACR showed reduced toxicity in healthy tissues and organs. Conducted on a clinical device capable of translation to humans, the Flash therapy preclinical tests, compared to conventional proton treatments, displayed 25%-30% less damage to lung tissue, resulting in less fibrosis of the lung, and an average of 35% reduction in skin dermatitis during treatment.
Scynexis’ ibrexafungerp featured in six presentations at 29th ECCMID congress
Scynexis announced data demonstrating the potential use of ibrexafungerp as an agent to address multiple serious fungal infections. The collection of data will be presented at the 29th European Congress of Clinical Microbiology and Infectious Diseases, April 13-16, in Amsterdam. Ibrexafungerp, the first representative of a novel family of compounds referred to as “fungerps”, is being developed for oral and intravenous administration and is in clinical development for the treatment of several serious fungal infections. Six presentations will provide additional evidence of antifungal activity of oral ibrexafungerp, including new clinical case studies from the CARES and FURI trials as well as preclinical data. Case studies from the CARES trial, the first study of an investigational agent to treat patients with Candida auris infections, show “favorable” outcomes following treatment with oral ibrexafungerp. Ibrexafungerp shows “strong” clinical activity in difficult-to-treat patients with resistant Candida pathogens in a variety of infections.
Omeros announces EBMT case report of resolution of gastrointestinal HSCT-TMA
Omeros Corporation announced the recent presentation of a case report describing resolution of gastrointestinal hematopoietic stem cell transplant-associated thrombotic microangiopathy following narsoplimab treatment under a compassionate-use protocol. The case was presented at the 2019 Annual Meeting of the European Society for Blood and Marrow Transplantation. Omeros is reporting the case to ensure broad availability of the information presented. Narsoplimab, Omeros’ antibody to inhibit the lectin pathway of complement, has received breakthrough therapy designation from FDA and is in Phase 3 development for the treatment of HSCT-TMA. The case was presented by Rafael Duarte M.D., Ph.D., F.R.C.P., Associate Professor, Head of Hematopoietic Transplantation and Hemato-oncology Section, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain, and Secretary of the EBMT. Dr. Duarte described an 18-year-old patient with biopsy-proven HSCT-TMA of the gastrointestinal tract causing severe gastrointestinal bleeding requiring transfusions. The patient received narsoplimab, her TMA resolved, and all transfusions have been discontinued. The patient continues to do well after cessation of narsoplimab treatment. Hematopoietic stem cell transplant-associated TMA was a focus of the EBMT meeting program. In addition to the educational course on early transplant complications that included Dr. Duarte’s presentation, the program included a review session on renal complications of HSCT-TMA and an Omeros-sponsored symposium entitled “How Do I Diagnose HSCT-TMA.” The meeting program also contained several other podium and poster presentations directed to complications related to endothelial injury, which include HSCT-TMA, graft-versus-host disease and diffuse alveolar hemorrhage. Omeros is preparing both a U.S. biologics license application and a European marketing authorization application for narsoplimab in the treatment of HSCT-TMA. The FDA has agreed that a rolling BLA submission is appropriate and discussions with European regulators are ongoing.
Meridian Bioscience price target cut to $14 from $17 at Baird
Baird analyst Catherine Ramsey Schulte lowered her price target on Meridian Bioscience to $14 from $17 and maintained a Neutral rating after the company reported preliminary Q2 revenue well below the Street, with the miss mostly driven by Diagnostics, with particular weakness in molecular and respiratory issues. The analyst says she remains on the sidelines, as she believes ongoing headwinds are likely to persist near-term and management’s new strategy will likely take time to drive better results.
Orgenesis announces independent study published
Orgenesis announced the publication of an independent study which was published in the February issue of Journal of Stem Cell Research and Therapy. Insulin dependent diabetes is a multifactorial disorder that could be theoretically cured by functional pancreatic islets and autologous insulin producing cells, or AIP cells, implantation. Regenerative medicine approaches include the potential for growing tissues and organs in the laboratory and transplanting them when the body cannot heal itself. There are several obstacles that remain to be overcome in order to bring regenerative medicine approaches for diabetes closer to clinical implementation; the cells generated in-vitro are typically of heterogenic and immature nature and the site of implantation should be readily vascularized for the implanted cells to survive in vivo. The study was able to address these two limitations by analyzing the effect of co-implanting AIP cells with vasculature promoting cells in an accessible site such as subcutaneous. It further analyzed the effects of reconstituting the in-vivo environment in-vitro on the maturation and function of insulin producing cells. The study results show that co-implantation of mesenchymal stem cells, or MSCs, and endothelial colony forming cells, or ECFCs, with AIP cells led to doubling the survival rates and a three-fold increase in insulin production, in-vivo. ECFCs and MSCs co-culture, as well as conditioned media of co-cultures resulted in significant increased expression of pancreatic specific genes and an increase in glucose-regulated insulin secretion, compared with AIP cells alone. Mechanistically, the study demonstrated that ECFCs and MSCs co-culture increases the expression of CTGF and ACTIVINssa, that play a key role in pancreatic differentiation.
Guardant Health price target raised to $70 from $40 at Cowen
Cowen analyst Doug Schenkel raised his 2019 revenue forecast for Guardant Health by about $14M to $133.8M, which he noted is consistent with management guidance and consensus. While he sees some instances where he believes some expectations for Guardant “have got a bit ahead of themselves,” Schenkel keeps an Outperform rating on the shares and raised his price target to $70 from $40, citing his view that the company has established itself as “the leader in comprehensive liquid biopsy testing for metastatic cancer patients.”
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