Wells Fargo analyst Larry Biegelsen raised his price target for Baxter to $89 from $80 as he believes the company has a “robust near-term pipeline” that will produce a number of important launches in late 2019 through 2020 to help accelerate sales growth from 2020 to 2023. The analyst reiterates an Outperform rating on the shares.
Wednesday, April 3, 2019
IMV Inc. presents preclinical research for immunotherapy program at AACR
IMV (IMV) announced that preclinical research presented at the American Association for Cancer Research Annual Meeting 2019 demonstrated how the mechanism of action of IMV’s proprietary DPX technology can enhance a broad spectrum of immune cell infiltration into tumors, which included T cells, Natural Killer cells, and macrophages. Analyses also revealed the differentiated characteristics of the immune cell responses and the potential implications for enhanced anti-tumor efficacy. In the poster titled, T-distributed stochastic neighbor embedding analysis of tumor infiltrating lymphocytes after treatment with a T cell activating therapy identifies a unique population of recruited CD8+ T cells and novel options for combination immunotherapy, IMV researchers used specialized data analytics to examine how DPX-based agents, when combined with cyclophosphamide, induced T cells to infiltrate tumors and attack cancerous cells. The study closely examined the types of immune cell responses and how and why they were able to affect disease. The data indicated that this approach stimulated the infiltration of a broad base of immune cells into tumors, including T cells, NK cells, and macrophages. The specific T cell population that moved into tumors could be grouped based on the co-expression of different checkpoint molecules such as PD-1 and Tim-3. However, those stimulated to infiltrate tumors generally did not express CTLA-4. Researchers also found that combining DPX/CPA treatments with a CTLA-4-blocking antibody increased efficacy in controlling tumor growth in the animal models. The data suggested that this result was due to the antibodies acting on T cells present in the tumors, rather than those induced by treatment. This finding contrasts previously published studies with anti-PD-1 combinations in which treatment directly enhanced DPX-induced T cell responses. IMV’s current clinical program includes multiple phase 2 studies assessing the safety and efficacy of its lead candidate, DPX-Survivac, in combination with mCPA and Merck’s (MRK) checkpoint inhibitor, Keytruda.
Arena Pharmaceuticals price target raised to $77 from $63 at Credit Suisse
Credit Suisse analyst Martin Auster raised his price target for Arena Pharmaceuticals to $77 from $63 as he believes etrasimod has an opportunity to emerge as the oral agent of choice in the treatment of moderate-to-severe IBD. While several effective biologic approaches exist to manage IBD, the analyst received feedback that a safe and effective oral agent will likely play a major long-term role in managing patients’ refractory to SoC, TNF-alpha antagonists. Etrasimod may be the 3rd or 4th oral agent to the market, but Auster sees its clinical profile supporting it as the best agent. The analyst reiterates an Outperform rating on the shares.
Bio-Path Holdings presents BP1003 data at AACR
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.
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.
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