The National Cancer Institute awarded a $1,542,555 Project Grant to Sloan-Kettering Institute For Cancer Research under the Cancer Treatment Research program (CFDA 93.395). The grant will fund research from December 2022 through November 2027 to develop more effective treatments for localized bladder cancer. Specifically, the grantee will conduct genomic analyses of bladder cancer patient cohorts to validate DNA damage response mutations as predictors of sensitivity to bacillus Calmette-Guérin...
This federal Project Grant award from the National Cancer Institute's Cancer Biology Research Program (CFDA 93.396) provides funding to the Icahn School of Medicine at Mount Sinai (ISMMS) to conduct a multi-scale analysis of the Bacillus Calmette-Guerin (BCG) resistant tumor microenvironment in non-muscle invasive bladder cancer (NMIBC). The $684,877 award, which begins on April 17, 2025 and runs through March 31, 2030, will utilize single-cell and spatial sequencing techniques across 36 patient...
This Project Grant award from the National Cancer Institute (NCI), under the Cancer Detection and Diagnosis Research program (CFDA 93.394), provides $821,797 to Early IS Good, Inc. to execute a clinical validation study for their bladder cancer diagnostic assay, BCDX. BCDX is a multi-omic, multiplex diagnostic test that uses advanced nanotechnology to detect twelve different biomarkers directly from a urine sample. Feasibility studies have demonstrated the test's high sensitivity and ability...
The National Cancer Institute (NCI) awarded a $2,084,026 Project Grant under the Cancer Treatment Research program (CFDA 93.395) to Privo Technologies, Inc. to support a Phase 3 clinical trial for its topical nanotechnology-based treatment, PRV111, for carcinoma in situ of the oral cavity (stage 0 oral cancer). The goal of this trial is to demonstrate the chemoablative efficacy of PRV111 as an alternative to invasive surgical resection, which can lead to significant functional and cosmetic...
This $275,000 Small Business Technology Transfer (STTR) Phase I grant from the National Science Foundation (CFDA 47.084 - NSF Technology, Innovation, and Partnerships program) was awarded to Oncoblaze LLC to develop a novel device for targeted delivery of chemotherapy agents to tissue surrounding surgically removed tumors. The project aims to address the issue of tumor recurrence after cancer surgery, which affects 30-40% of patients for certain cancers. The device uses an infrared laser to heat...
The National Cancer Institute (NCI) awarded a $984,000 Project Grant (CFDA 93.395 - Cancer Treatment Research) to The University of Texas Southwestern Medical Center in Dallas, Texas. The grant, titled "Precision Engineering of STING-DC Immunity to Overcome Tumor Immune Evasion," will fund research to develop a novel STING agonist nanoparticle therapy that selectively activates the STING pathway within the tumor microenvironment to enhance antitumor immune responses. The research...
The University of Washington (UW) was awarded a $1,039,794 Project Grant from the National Cancer Institute (NCI) under the Cancer Cause and Prevention Research (CFDA 93.393) federal grant program. The 5-year grant, effective July 1, 2024, will support research to compare long-term clinical and patient-reported outcomes between bladder-sparing therapy and radical cystectomy for patients with recurrent high-grade non-muscle invasive bladder cancer (NMIBC). The project will also evaluate the...
This Project Grant award from the National Institute of Allergy and Infectious Diseases (NIAID), under the Allergy and Infectious Diseases Research program (CFDA 93.855), provides $270,176 in funding to Oncosting, LLC to develop an improved tuberculosis (TB) vaccine candidate designated OS-151. The award supports two phases of work: In Phase I, the project will conduct mouse immunogenicity and efficacy studies to support using data generated with the OS-101 strain in regulatory filings for the...
This $295,881 Project Grant awarded by the National Cancer Institute (CFDA 93.395 - Cancer Treatment Research) supports the development of a novel antimicrobial agent called GASK7B to selectively inhibit the pathogenic Lactobacillus iners bacteria. The objective is to establish GASK7B as a drug candidate that can reverse the resistance of cervical cancer cells to chemoradiation treatment induced by L. iners. The project involves synthesizing GASK7B, characterizing its in vitro potency,...
The National Cancer Institute (NCI) awarded a $499,238 Project Grant under the Cancer Treatment Research federal grant program (CFDA 93.395) to Yale University to conduct research on enhancing the effects of DNA-damaging cancer therapies through modulation of the tumor stimulator of interferon genes (STING) pathway. The project aims to develop a novel tumor-targeted STING agonist (PHLIP-STINGA) to overcome the limitations of current STING agonists and synergize with reactive oxygen...
STING AGONIST-EXPRESSING BCG FOR BLADDER CANCER - ABSTRACT MORE THAN 80,000 AMERICANS ARE DIAGNOSED WITH BLADDER CANCER EACH YEAR, AND MORE THAN 17,000 DIE FROM THE DISEASE. APPROXIMATELY 75% OF NEW BLADDER CANCER PATIENTS PRESENT WITH NON-MUSCLE INVASIVE BLADDER CANCER (NMIBC). NOT ONLY IS NMIBC ASSOCIATED WITH HIGH RECURRENCE RATES (>50%) AND RISK OF PROGRESSION, BUT 30% OF PATIENTS ARE UNRESPONSIVE TO THE STANDARD OF CARE TREATMENT: TRANSURETHRAL RESECTION WITH INTRAVESICAL BACILLUS CALMETTE-GUERIN (BCG) INSTILLATION, THE ONLY APPROVED MICROBIAL THERAPEUTIC FOR CANCER. THESE INDIVIDUALS ARE LEFT WITH LIMITED THERAPEUTIC OPTIONS. WHILE THERE HAVE BEEN EFFORTS TO GENERATE IMPROVED RECOMBINANT BCG (RBCG) STRAINS, SUCH EFFORTS HAVE NOT YET YIELDED DEMONSTRABLE IMPROVEMENT OVER TRADITIONAL BCG. WITH VERY FEW ADVANCES IN TREATMENT OVER THE PAST TWO DECADES FOR EARLY STAGE DISEASE AND A LIMITED PIPELINE OF THERAPEUTICS IN DEVELOPMENT, THERE IS A MAJOR UNMET NEED FOR IMPROVED TREATMENTS FOR NMIBC. TO ADDRESS THIS NEED, ONCOSTING IS DEVELOPING OS-101, A BREAKTHROUGH RBCG IMMUNOTHERAPY THAT OVEREXPRESSES A POTENT STIMULATOR OF IFN GENES (STING) AGONIST. STING AGONISTS POTENTIATE ANTI-TUMOR RESPONSES THROUGH THE INNATE IMMUNE STING-IRF3-NF-B PATHWAY. WHILE OTHER COMPANIES ARE DEVELOPING SMALL MOLECULE STING AGONISTS AS NOVEL ANTI-CANCER IMMUNOTHERAPIES, ONCOSTING IS THE ONLY COMPANY DEVELOPING STING AGONIST DELIVERY BY A LIVE BACTERIAL VACCINE-BCG-THAT ITSELF IS A WELL-KNOWN IMMUNOTHERAPY ALREADY IN USE FOR THE TREATMENT OF BLADDER CANCER, THUS OFFERING THE BENEFITS OF BOTH. BECAUSE IT IS A LIVE BACTERIA, OS-101 ALLOWS FOR CONTINUOUS AND PROLONGED DELIVERY OF THE STING AGONIST TO THE TUMOR MICROENVIRONMENT. COMPARED WITH WILD TYPE BCG, OS-101 DEMONSTRATES SUPERIOR ANTITUMOR EFFICACY IN MODELS OF NMIBC; MORE POTENT PRO-INFLAMMATORY CYTOKINE RESPONSES; GREATER MYELOID CELL REPROGRAMMING, PRODUCING AN M1 SHIFT WITH ENHANCED PHAGOCYTOSIS/AUTOPHAGY; MORE PRONOUNCED EPIGENETIC CHANGES IN KEY CYTOKINE PROMOTER REGIONS; AND METABOLOMIC CHANGES FAVORING ANTITUMOR IMMUNITY. IN PHASE I OF THIS FAST TRACK PROJECT, ONCOSTING WILL CREATE A NEXT-GENERATION, ANTIBIOTIC RESISTANCE-FREE VERSION OF 0S-101 USING A NOVEL, PATENT-PENDING METHOD. THE CURRENT RBCG PROTOTYPE, OS-101, RELIES ON A BACTERIAL PLASMID THAT IS MAINTAINED USING AN ANTIBIOTIC RESISTANCE CASSETTE. HOWEVER, PHASE 3 STUDIES WILL REQUIRE THE REMOVAL OF ANTIBIOTIC RESISTANCE GENES. THE EFFICACY OF THE NEW CONSTRUCT, CALLED OS-151, WILL THEN BE CONFIRMED IN FOUR RELEVANT BIOASSAYS. IN PHASE II, OS-151 WILL BE COMPARED TO ADU-S100 (ADURO'S SMALL MOLECULE STING AGONIST WHICH IS IN CURRENT CLINICAL TRIALS) AND WILD TYPE BCG IN RELEVANT MODELS OF BLADDER CANCER. PRE-IND, PHARMACOKINETIC AND SAFETY STUDIES OF OS-151 WILL ALSO BE CONDUCTED, AND OPTIMIZATION WORK WILL ENSURE PRODUCTION OF OS-151 AT SCALE. FINALLY, TUMOR REPETITIVE DOSING STUDIES AND RECHALLENGE STUDIES WILL BE CARRIED OUT IN MOUSE SYNGENEIC MODELS. ONCE APPROVED, OS-151 WILL FIRST BE USED TO TREAT PATIENTS WITH BCG-UNRESPONSIVE NMIBC, WITH POTENTIAL TO EXPAND TO OTHER CANCER INDICATIONS.