IV-Administered SB 11285 Phase 1 Trial Planned to Initiate in Coming Weeks
HOPKINTON, MA, USA I July 29, 2019 I Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, announced that its Investigational New Drug (IND) application for a Phase 1 trial of SB 11285, the company’s intravenously (IV)-administered STING (STimulator of INterferon Gene) agonist development candidate, is now effective following clearance by the FDA. The Phase 1 trial aims to evaluate safety, tolerability and initial anti-tumor activity of IV SB 11285 in patients with advanced solid tumors.
“The FDA’s acceptance of our IV SB 11285 IND will allow us to soon begin the clinical development program for our novel second-generation intravenously-administered STING agonist product candidate,” said Atif Abbas, M.D., Vice President & Head of Oncology/Immunology Development at Spring Bank. “An intravenously-administered STING agonist may have the ability to treat a broad range of cancers. We look forward to working with our Phase 1 trial investigators to explore the effects of a new novel intravenously-administered immunotherapeutic treatment regimen in patients.”
SB 11285 is a second-generation STING agonist immunotherapeutic agent being investigated for the treatment of selected cancers such as certain breast cancers, certain lung cancers, colo-rectal cancers and melanoma. In vitro and in vivo preclinical findings indicate that SB 11285, if approved, may be used to target a variety of tumors at various anatomic sites and has the potential to enhance the activity of other therapeutic modalities such as immune checkpoint inhibitors. Preclinical studies also indicated that SB 11285 could be administered clinically either intratumorally or intravenously.
Part 1 of the IV SB 11285 Phase 1 trial is a dose-escalation study with monotherapy followed by combination with a checkpoint inhibitor and is designed to determine a recommended Phase 2 dose. Part 2 of the trial will explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in selected tumor types. The trial will be conducted at multiple sites in the United States. The company intends to enroll patients in this trial expeditiously with a plan to report top-line results in mid-2020.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleotide platform. The company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The company’s lead product candidate, inarigivir, is being developed for the treatment of chronic hepatitis B virus (HBV). Inarigivir is designed to activate within hepatic cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense. The company is also developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers. For more information, please visit www.springbankpharm.com.
SOURCE: Spring Bank Pharmaceuticals
Post Views: 178
IV-Administered SB 11285 Phase 1 Trial Planned to Initiate in Coming Weeks
HOPKINTON, MA, USA I July 29, 2019 I Spring Bank Pharmaceuticals, Inc. (Nasdaq: SBPH), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of viral infections, inflammatory diseases and certain cancers, announced that its Investigational New Drug (IND) application for a Phase 1 trial of SB 11285, the company’s intravenously (IV)-administered STING (STimulator of INterferon Gene) agonist development candidate, is now effective following clearance by the FDA. The Phase 1 trial aims to evaluate safety, tolerability and initial anti-tumor activity of IV SB 11285 in patients with advanced solid tumors.
“The FDA’s acceptance of our IV SB 11285 IND will allow us to soon begin the clinical development program for our novel second-generation intravenously-administered STING agonist product candidate,” said Atif Abbas, M.D., Vice President & Head of Oncology/Immunology Development at Spring Bank. “An intravenously-administered STING agonist may have the ability to treat a broad range of cancers. We look forward to working with our Phase 1 trial investigators to explore the effects of a new novel intravenously-administered immunotherapeutic treatment regimen in patients.”
SB 11285 is a second-generation STING agonist immunotherapeutic agent being investigated for the treatment of selected cancers such as certain breast cancers, certain lung cancers, colo-rectal cancers and melanoma. In vitro and in vivo preclinical findings indicate that SB 11285, if approved, may be used to target a variety of tumors at various anatomic sites and has the potential to enhance the activity of other therapeutic modalities such as immune checkpoint inhibitors. Preclinical studies also indicated that SB 11285 could be administered clinically either intratumorally or intravenously.
Part 1 of the IV SB 11285 Phase 1 trial is a dose-escalation study with monotherapy followed by combination with a checkpoint inhibitor and is designed to determine a recommended Phase 2 dose. Part 2 of the trial will explore IV SB 11285 antitumor activity in combination with a checkpoint inhibitor in selected tumor types. The trial will be conducted at multiple sites in the United States. The company intends to enroll patients in this trial expeditiously with a plan to report top-line results in mid-2020.
About Spring Bank Pharmaceuticals
Spring Bank Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company engaged in the discovery and development of a novel class of therapeutics using its proprietary small molecule nucleotide platform. The company designs its compounds to selectively target and modulate the activity of specific proteins implicated in various disease states. The company’s lead product candidate, inarigivir, is being developed for the treatment of chronic hepatitis B virus (HBV). Inarigivir is designed to activate within hepatic cells retinoic acid-inducible gene 1 (RIG-I), which has been shown to inhibit HBV viral replication and induce the intracellular interferon signaling pathways for antiviral defense. The company is also developing its lead STING agonist product candidate, SB 11285, an immunotherapeutic agent for the treatment of selected cancers. For more information, please visit www.springbankpharm.com.
SOURCE: Spring Bank Pharmaceuticals
Post Views: 178
