Regression of Breast Cancer Metastases Following Treatment with Irradiated SV-BR-1-GM, a GM-CSF Overexpressing Breast Cancer Cell Line: Intellectual Property and Immune Markers of Response

Author: Lacher, Markus D. ; Macúchová, Eva ; Sunkari, Vivekananda G. ; Dozio, Vito ; Kharazi, Alexander ; Galeas, Jacqueline L. ; Wiseman, Charles L. ; Williams, William V. ; Hashwah, Hind

Background:SV-BR-1-GM, derived from a patient with grade 2 (moderately differentiated) breast cancer, is a GM-CSF-secreting breast cancer cell line with properties of antigen-presenting cells. SV-BR-1-GM and next-generation versions are covered by several pending and granted patents.Methods:We report findings from an open-label phase I, single-arm pilot study with irradiated SV-BR-1-GM cells in 3 breast and 1 ovarian cancer subjects. Inoculations were preceded by low-dose intravenous cyclophosphamide and followed by interferon-alpha2b injections into the SV-BR-1-GM inoculation sites. We assessed both cellular and humoral immune responses, and measured expression levels of SV-BR-1-GM HLA alleles.Results:Treatment was generally safe and well tolerated. Immune responses were elicited universally. Overall survival was more than 33 months for three of the four patients. As previously reported, one patient had prompt regression of metastases in lung, breast, and soft tissue. Following cessation of treatment, the patient relapsed widely, including in the brain. Upon retreatment, rapid tumor response was again seen, including complete regression of brain metastases. Consistent with a role of Class II HLA in contributing to SV-BR-1-GM’s mechanism of action, this patient allele-matched SV-BR-1-GM at the HLA-DRB1 and HLA-DRB3 loci. We are in the process of developing next-generation SV-BR-1-GM, expressing patient-specific HLAs. Patent applications were filed in various jurisdictions. Thus far, one is granted, in Japan.Conclusion:A whole-cell immunotherapy regimen with SV-BR-1-GM cells induced regression of met-astatic breast cancer. We develop intellectual property based on SV-BR-1-GM’s predicted mechanism of action to develop additional whole-cell immunotherapies for cancer patients.Clinical Trail Registration:This clinical trial was registered under ClinicalTrials.gov Identifier NCT00095862.

01 Jun 2022·VirusDisease

Refractory atypical trigeminal neuralgia associated with reactivated herpesvirus infection: pathogenetic link and efficacy of combination antiviral therapy

Article

Author: Maltsev, Dmitry ; Fedirko, Volodymyr

The purpose of this study is to diagnose herpesvirus infections in refractory atypical trigeminal neuralgia, to assess pathogenetic links, and to explore the efficacy of antiviral treatment. In a prospective controlled study, 95 patients with trigeminal neuralgia received antiviral therapy (valacyclovir + alpha2b-interferon) (experimental group, EG). Other patients refused to receive treatment (control group 1 (CG1), n = 31). Control group 2 (CG2) included 32 healthy individuals of the same age and sex. Herpesvirus infection was diagnosed in blood leukocytes by PCR (Biocom, Russian Federation). Serum concentrations of IgM, IgA and IgG to HSV-1/2, VZV (ELISA, Vector-Best, Russian Federation) were determined. Reactivation of herpesvirus infections was observed in the EG in 87% of cases. The heterogeneity of herpesvirus-associated damage of trigeminal nerves and anatomically related areas of the central nervous system (CNS) has been demonstrated. The treatment applied was effective for herpesvirus infection (77%) and pain (61%) and ineffective for immunity correction (26% of cases). Atypical refractory trigeminal neuralgia is associated with herpesvirus infections that reactivate due to minor immunodeficiencies. Antiviral treatment suppresses herpesviruses and reduces the intensity of pain.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13337-022-00769-9.

01 May 2017·Urologic Oncology: Seminars and Original InvestigationsQ3 · MEDICINE

Bacillus Calmette-Guerin strain may not effect recurrence-free survival when used intravesically with interferon-alpha2b for non–muscle-invasive bladder cancer

Q3 · MEDICINE

Article

Author: Mott, Sarah L ; Thomas, Lewis J ; Brooks, Nathan A ; O'Donnell, Michael A ; Steinberg, Ryan L

OBJECTIVESAdjuvant intravesical Bacillus Calmette-Guerin (BCG) remains the standard-of-care for high-grade non-muscle-invasive bladder cancer (NMIBC). Conflicting reports exist regarding disparate outcomes among BCG strains. We sought to determine whether a difference in recurrence-free survival (RFS) existed between TICE BCG and Connaught BCG strains used with interferon (IFN) for the treatment of NMBIC.MATERIALS AND METHODSA post hoc analysis of the phase 2 BCG/IFN study, conducted from May 1999 to February 2001. A total of 901 patients had sufficient records for analysis. Enrollment criteria were liberal and included primary and recurrent NMIBC, patients with and without carcinoma in situ, and patients with prior BCG failure. At the beginning, 3 to 8 weeks after transurethral resection or biopsy, patients received induction with 6 weekly intravesical treatments of BCG (TICE or Connaught) with 50 million units of IFN. Surveillance for recurrence began 4 to 6 weeks after induction and quarterly thereafter for 2 years. If no recurrence was identified, patients received maintenance therapy. Separate models were created for BCG naïve and failure patients. Multivariable analysis was performed using Cox proportional hazards regression.RESULTSOverall, 609 patients received TICE BCG and 292 received Connaught BCG with similar baseline characteristics. BCG strain was not associated with worse RFS in both the multivariable BCG naïve model (P = 0.28) and BCG failure model (P = 0.53). Duration of disease, tumor focality, tumor size, and BCG failure interval (in the BCG failure model) were associated with worse RFS.CONCLUSIONNo significant difference in RFS was observed among patients treated with TICE BCG or Connaught BCG in combination with IFN.

100 Deals associated with Albumin-interferon alpha2b fusion protein (Tianjin SinoBiotech)

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Indication	Highest Phase	Country/Location	Organization	Date
Hepatitis B	Discovery	CN	Tianjin PuYing Biotechnology Co., Ltd.	27 Mar 2021
Hepatitis C	Discovery	CN	Tianjin PuYing Biotechnology Co., Ltd.	-

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