Oxaliplatin

COVINGTON, Ky., Oct. 31, 2024 /PRNewswire/ -- Bexion Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing a novel class of biologic therapy to treat advanced solid tumors and chemotherapy-induced peripheral neuropathy (CIPN), today announced the publication of first-in-human data from a Phase 1 study of BXQ-350 in Clinical Cancer Research, an American Association of Clinical Research (AACR) journal. The study showed that BXQ-350 was well-tolerated with no dose-limiting toxicities. BXQ-350 is currently being studied for the first line treatment of metastatic colorectal cancer (mCRC). "These data provide a large body of work on the use of BXQ-350 in patients," said Robert Wesolowski, MD, Clinical Professor of Internal Medicine at the James Cancer hospital and the Ohio State University Comprehensive Cancer Center. "In a population with such advanced disease, the fact that two patients are alive without disease progression seven years after initiating BXQ-350 treatment is remarkable." The publication highlights adverse event and efficacy data, including multiple patients who survived more than six months without disease progression. The study enrolled 86 patients across over 20 different tumor types, including advanced metastatic disease and high-grade glioma. Preliminary PK data showed that BXQ-350 exhibited linear exposure, crossing the blood–brain barrier and accumulating in relevant tissues. "We are excited to have our Phase 1 monotherapy data published in Clinical Cancer Research," said Jim Beach, CEO and President of Bexion Pharmaceuticals. "These data demonstrate the safety and tolerability of BXQ-350 in a large population with advanced solid tumor disease and high-grade glioma. We are now generating data on the use of BXQ-350 in metastatic colorectal cancer." The Phase 1b/2 trial (ASIST study; NCT05322590) is currently underway evaluating BXQ-350 in combination with the standard of care in newly diagnosed patients with mCRC. About BXQ-350 Bexion's lead drug candidate is BXQ-350, a first-in-class biologic containing the multifunctional, sphingolipid activator protein, Saposin C, and a phospholipid. Clinically, two Phase 1 clinical trials, one in adults and one in pediatric DIPG patients, have demonstrated a robust safety profile for BXQ-350 with evidence of single agent activity across multiple solid tumor types. Additionally, other clinical and non-clinical data suggest BXQ-350 has activity in chemotherapy-induced peripheral neuropathy, an area of high unmet medical need in solid tumor patients treated with oxaliplatin and other chemo-toxic agents, as well as other neurological diseases. About Bexion Pharmaceuticals Bexion Pharmaceuticals, a clinical-stage biopharmaceutical company, is developing a new generation of biologic therapy to treat solid tumor cancers and chemotherapy-induced peripheral neuropathy (CIPN) with potential portfolio expansion opportunities in other cancers and broader neuropathic pain indications. Bexion has generated data in multiple classes of solid tumors, including high-grade gliomas, pediatric brain tumors, and colorectal cancer. The Company has also competed enrollment in a proof-of-concept trial for the treatment of CIPN. The Phase 1b/2 study in mCRC is enrolling patients in the open label portion of the study. Investor Contact: William Windham Solebury Strategic Communications 646-378-2946 [email protected] Media Contact: Joyce LaViscount Bexion Pharmaceuticals 859-446-7386 [email protected] SOURCE Bexion Pharmaceuticals, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Astellas Pharma’s Vyloy (zolbetuximab-clzb) has been approved by the US Food and Drug Administration (FDA) as part of a first-line combination treatment for a subset of gastric cancer patients. The claudin 18.2-directed cytolytic antibody has been authorised for use alongside fluoropyrimidine- and platinum-containing chemotherapy to treat adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2-negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma whose tumours are claudin 18.2 positive. About 26,890 new cases of gastric cancer are expected to be diagnosed in the US this year and adenocarcinomas, which develop from cells in the innermost lining of the stomach, account for the majority of cases. The disease usually develops slowly over many years and early-stage symptoms frequently overlap with more common stomach-related conditions, causing most cases to go undetected until an advanced or metastatic stage. Vyloy now is the first and only claudin 18.2-targeted therapy to be approved in the US and was recently approved by the European Commission and UK Medicines and Healthcare products Regulatory Agency for the same patient population. Among the data supporting the FDA’s decision was results from the late-stage SPOTLIGHT trial, which assessed Vyloy plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6. Median progression-free survival was 10.61 months with the Vyloy regimen compared to 8.67 months for placebo plus mFOLFOX6, while median overall survival was 18.23 months versus 15.54 months in the respective treatment groups. The approval was also informed by positive results from the phase 3 GLOW study, which evaluated Vyloy alongside CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin). Moitreyee Chatterjee-Kishore, senior vice president and head of immuno-oncology development at Astellas, said: “The approval of Vyloy as the first and only targeted therapy for CLDN18.2-positive patients in the US further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage.” Vyloy has also been approved in Japan and South Korea, and Astellas has submitted applications for the drug to regulatory agencies around the world.