autotaxin

SEONGNAM, South Korea and BOSTON, Dec. 30, 2024 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis and cancer, today announced that James Jungkue Lee, Founder and CEO of Bridge Biotherapeutics, will present at the 43rd Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2025. Location: Georgian Room (Mezzanine Level) at The Westin St. Francis Date: Thursday, January 16, 2025 Time: 9:45-10:25 a.m. PST During the conference, Bridge Biotherapeutics will also meet with potential partners and investors as the Company is looking for Business Development opportunities for further development of BBT-877, a novel drug candidate for idiopathic pulmonary fibrosis (IPF). Top-line results from the Phase 2 study of BBT-877 are expected in April 2025. To arrange a meeting with the Bridge Biotherapeutics team, send a meeting request here. About Bridge Biotherapeutics, Inc. Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S., is a publicly traded, clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs, including fibrotic diseases and cancers. The company is developing BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-207, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at . SOURCE Bridge Biotherapeutics, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Completed Phase I DIONE-01 study demonstrates clinical activity and long-term safety of roginolisib, a unique allosteric modulator of PI3Kδ Patients with uveal melanoma showed a doubling of overall survival compared to historical controls Site activation ongoing for randomized Phase II OCULE-01 study in uveal melanoma GENEVA and AMSTERDAM, Dec. 11, 2024 /PRNewswire/ -- iOnctura, a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers, today provides a clinical update on its lead asset, roginolisib. Results from the completed Phase I DIONE-01 study are due to be presented at the European Society for Medical Oncology Immuno-Oncology (ESMO-IO) annual congress tomorrow, 12 December at 12:30 CET (presentation 164P). Allosteric modulator of PI3Kδ, roginolisib, has a unique chemical structure and binding mechanism which makes it highly specific for PI3Kδ, giving it an advantageous pharmacology profile and an unprecedented safety profile compared to previous generations of PI3Kδ inhibitors. Roginolisib is being investigated in solid and hematological malignancies including uveal melanoma (UM), a rare cancer of the eye. Eye melanoma is a rapidly growing market which is projected to be worth USD 9.56B by 2032[1]. The two-part Phase I study DIONE-01, firstly evaluated continuous daily dosing of roginolisib [at 10, 20, 40 and 80 mg] in 24 patients with pretreated solid tumors and follicular lymphoma (FL), and secondly evaluated a dose confirmation cohort in 20 UM patients. Results from DIONE-01 show: Study met its primary objective to determine the safety of the anticipated optimal biologically effective dose (BED): Roginolisib was well tolerated at the recommended Phase II dose (RP2D) of 80mg, with <7% Grade 3/4 treatment-emergent adverse events (TEAEs) considered to be related to roginolisib. TEAEs did not result in immune-related toxicity, or dose-limiting toxicity, in either solid tumor or hematological patients. In contrast to prior PI3Kδ inhibitors, roginolisib dosing did not require dose modifications. Roginolisib is well tolerated over long periods of treatment, up to 4.5 years. Median overall survival (OS) was 16 months for the 29 patients with UM treated with roginolisib, who had previously received a median of two prior therapies. This exceeds the median OS of 7 months observed in historical controls in patients receiving immunotherapies as second line treatment[2]. Median progression free survival (PFS) was 5 months for patients treated with roginolisib versus less than 3 months for historical controls2. Clinical findings validate the mechanism of action of roginolisib: roginolisib reduces immune-suppressive immune cells and chemokines, UM-related tumor clones (ctDNA) and PI3K-related signaling indicating a rebalancing of the immune system. Catherine Pickering, Chief Executive Officer of iOnctura, said: "The Phase I DIONE-01 data highlight the benefits of roginolisib for patients with uveal melanoma and advanced cancers. Roginolisib's unique allosteric binding mechanism has translated into a differentiated beneficial clinical profile, including a doubling of overall survival compared to historical controls in uveal melanoma. We are delighted to announce these data support progression of roginolisib into a randomized Phase II study." Professor Michele Maio, University of Siena and Principal Investigator of the roginolisib studies, added: "Being able to continue to investigate roginolisib in a randomized Phase II study is a positive step to understand more about this already well tolerated molecule. Roginolisib has given prolonged disease stabilization to patients with uveal melanoma who have exhausted all other therapeutic options. So far, these patients have maintained a good quality of life without major limitations. I'm looking forward to seeing what the Phase II trial delivers over the coming months." Activation of trial sites for the Phase II OCULE-01 study (NCT06717126) investigating roginolisib versus investigator's choice in the second-line+ treatment of uveal melanoma is ongoing. About iOnctura iOnctura is a clinical-stage biopharmaceutical company combating neglected and hard-to-treat cancers with precision oral small molecules that target cancers in novel ways. The bold new treatments extend lives and improve healthspans, changing the outlook for patients and their families. Two therapeutic candidates have progressed into mid-stage clinical development: roginolisib is the first allosteric modulator of PI3Kδ; and cambritaxestat is the only autotaxin inhibitor in clinical development to treat cancer. iOnctura BV is headquartered in Amsterdam, The Netherlands with its wholly owned Swiss subsidiary, iOnctura SA, located in Geneva, Switzerland. iOnctura is backed by specialist institutional investors including Syncona, EIC Fund, M Ventures, Inkef Capital, VI Partners and Schroders Capital. About roginolisib Roginolisib is an allosteric modulator of PI3Kδ with a unique chemical structure and binding mode. The PI3K signaling pathway is one of the most commonly dysregulated pathways in cancer and the precise targeting of the PI3Kδ isoform delivers substantial anti-tumor effects with a low-toxicity profile. Clinical data have demonstrated roginolisib's excellent safety profile and sustained clinical activity in uveal melanoma (UM), a rare eye cancer with few available treatments. Site activation for the randomized Phase II OCULE-01 study in uveal melanoma is ongoing, and Phase II studies in other cancers, including non-small cell lung cancer and myelofibrosis, are in planning. [1] Emergen Research, Jan 2024 [2] Rantala et al., Melanoma Res., 2019 Dec 29(6):561-568 SOURCE iOnctura WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

SEONGNAM, South Korea, July 29, 2024 /PRNewswire/ -- Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company based in South Korea developing novel drugs for fibrosis and cancer, today announced that patient participant enrollment has been completed in the Phase 2 clinical study of BBT-877, a novel autotoxin (ATX) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF). The Phase 2, multi-center, randomized, double-blind, placebo-controlled study (NCT05483907) aims to evaluate the efficacy, safety, and tolerability of BBT-877 in patients with IPF, with or without anti-fibrotic (AF) approved background therapies (pirfenidone or nintedanib). The primary objective is the evaluation of the efficacy of BBT-877 in IPF patients by measuring the reduction in forced vital capacity (FVC) in patients treated with BBT-877 compared to those treated with a placebo at week 24 of treatment. Secondary objectives of the study include the evaluation of drug safety, pharmacokinetics (PK), diffusing capacity of lung for carbon monoxide (DLCO), and functional exercise capacity in all patients. A total of 120 patient participants were enrolled from approximately 50 clinical trial sites located in the U.S., South Korea, Australia, Poland, and Israel, representing diversity of ethnicity and race. Patients were randomized to either the experimental drug arm or the placebo arm, following a 200mg, twice daily (BID) regimen of BBT-877 or a placebo. James Lee, founder and CEO of Bridge Biotherapeutics, said: "The completion of enrollment in the phase 2a clinical study of BBT-877 marks an important milestone in our efforts to develop innovative treatments for patients suffering from IPF. Closely looking for business alliance opportunities in the global pharmaceutical industry, we will remain dedicated to advancing this novel drug candidate, which we believe has the potential to make clinically meaningful outcomes in IPF patients." The Company expects topline data from this study to be announced in the first half of 2025. In parallel with advancing the study, the company pursues a global partnership to prepare for the next phase of the study to further validate the efficacy and safety of BBT-877 in a larger number of patients around the world. BBT-877, an experimental Autotaxin (ATX) inhibitor, demonstrated its ability to inhibit lysophosphatidic acid (LPA) production by up to 90 percent in the first-in-human study. LPA is known to bind to cell receptors and induce various physiological activities, such as neovascularization, sclerosis, tumorigenesis, and tumor metastasis, leading to the development of various fibrotic diseases, including IPF. The National Institutes of Health (NIH) in the U.S. estimates that more than 30,000 new cases of IPF are diagnosed in the U.S. alone each year, and as many as 3 million patients are affected worldwide. About Bridge Biotherapeutics, Inc. Bridge Biotherapeutics Inc., based in the Republic of Korea and the U.S., is a publicly traded, clinical-stage biotech company founded in 2015. Bridge Biotherapeutics is engaged in the discovery and development of novel therapeutics, focusing on therapeutic areas with high unmet needs, including fibrotic diseases and cancers. The company is developing BBT-877, a novel autotaxin inhibitor for the treatment of fibrotic diseases including idiopathic pulmonary fibrosis (IPF), and BBT-207, a potent targeted cancer therapy for non-small cell lung cancer (NSCLC) with EGFR C797S mutations. Learn more at . About BBT-877 BBT-877 is an orally administered autotaxin enzyme inhibitor which is under development as a treatment for idiopathic pulmonary fibrosis (IPF). During the Phase 1 Clinical Study, the experimental autotaxin inhibitor demonstrated lysophosphatidic acid (LPA) inhibition of up to 90 percent in multiple-ascending dose cohorts. The topline data of the Phase 2a Clinical Study are expected to be announced in the first half of 2025. About Autotaxin Autotaxin (ATX), a protein of approximately 900 amino acids discovered in the early 1990s, is an important enzyme for generating the lipid-signaling molecule, lysophosphatidic acid (LPA). Autotaxin's lysophospholipase D activity converts lysophosphatidylcholine (LPC) into LPA, which engages in signaling via LPA receptors. LPA signaling results in cell proliferation, migration, secretion of cytokines and chemokines, and reduction of cell apoptosis. Ultimately, autotaxin has a pathogenic role in processes of inflammation and fibrosis, making it an attractive drug target. About idiopathic pulmonary fibrosis (IPF) IPF is a rare, debilitating, and fatal lung disease that affects approximately 3 million people worldwide. The progression of IPF is variable and unpredictable. Over time, the lung function of an IPF patient gradually and irreversibly declines. SOURCE Bridge Biotherapeutics, Inc.