National Institute of Diabetes & Digestive & Kidney Diseases

—Award from Highly Competitive Initiative Will Enable Ancilia to Advance Its Lead Program through IND Filing for Its First Clinical Trial— —Ancilia Also Awarded $274,000 NIH STTR Grant to Expand Its Platform to Diseases of the Gastrointestinal Tract— NEW YORK, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Ancilia Biosciences, Inc., (Ancilia Bio), a biotechnology company harnessing the natural power of CRISPR to create bacterial therapies and products with immunity against destructive viruses, today announced that it has been selected to receive a $3 million award over two years from the Sprint for Women’s Health of the Advanced Research Projects Agency for Health (ARPA-H), an agency within the U.S. Department of Health and Human Services (HHS). This effort was designed to address critical unmet challenges in women’s health, champion transformative innovations and tackle health conditions that primarily affect women, generated an unprecedented worldwide response. Ancilia’s winning Sprint for Women’s Health proposal, Enabling a New Class of Bacterial Therapies for Vaginal Health, applies the company’s unique technologies to develop a safer and more effective treatment for bacterial vaginosis (BV), a common but undertreated health condition that affects 3.5 million women in the U.S. each year. BV is associated with impaired fertility, pelvic inflammatory disease, preterm labor and sexually transmitted diseases. Ancilia’s solution, a novel bacterial therapy that is immune to predatory viruses and restores the vaginal microbiome to its naturally healthy state, has demonstrated proof of concept in preclinical studies. The award will enable the company to complete preclinical testing and advance its lead therapeutic candidate through Investigational New Drug (IND) submission for a first-in-human clinical trial. Co-founder and chief executive officer Alexandra Sakatos, PhD, noted, “Our conviction that Ancilia’s unique approach has great potential to improve the treatment of challenging diseases is further confirmed by this prestigious award, which followed a highly competitive review process that selected just 23 winners from the more than 1,700 proposals received from 45 states, the District of Columbia, and 34 countries. We are honored to be among the recipients and thrilled that this non-dilutive funding will prepare us to begin clinical trials. We also were recently awarded a grant by the NIH that will help fund expansion of our platform technologies into gastrointestinal diseases, a prime target for bacteria-based therapeutics. These recent successes position us well to advance our programs and prepare for our next financing round.” Despite evidence that therapeutics based on beneficial bacteria can potentially transform the treatment of many diseases, efforts to develop them have often failed. Ancilia believes a key reason is that the therapeutic bacteria are being targeted by predatory viruses, known as bacteriophages, that are present in the microbiome of patients. Ancilia is harnessing nature’s first immune system, known as CRISPR, to immunize beneficial bacteria against these viruses and increase their chances of therapeutic success. While best known for its role in human genome editing, CRISPR actually evolved in bacteria to protect them from destructive viruses. Ancilia is the first company harnessing this natural function of CRISPR to develop improved bacteria-based therapies for diseases with high unmet need. Its platform uses novel computational tools to identify and characterize destructive viruses and then leverages CRISPR to “immunize” beneficial bacteria against these viruses. The ARPA-H Sprint for Women’s Health is conducted in collaboration with the Investor Catalyst Hub of ARPANET-H, the agency’s nationwide health innovation network that connects people, innovators and institutions to accelerate better health outcomes for everyone. Ancilia will work with an ARPA-H Program Manager and the Investor Catalyst Hub over two years to develop their proposed solution, receiving milestone-based payments aligned to research activities and performance objectives. Ancilia Advisor Caroline Mitchell, MD, MPH, a clinician who is Director of the Vulvovaginal Disorders Program at Massachusetts General Hospital and an Associate Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School, noted, “Clinically, when I see people with recurrent symptoms due to a disrupted vaginal microbiome, my options for treatment are the same as we were using 40 years ago, and they don’t work well. The need for novel, breakthrough therapies in this area is widely acknowledged and long overdue. Ancilia’s innovative approach intersects with my lab’s focus on how vaginal microbes influence reproductive health and disease, as well as the design of new treatments to address these disorders. We are encouraged that the ARPA-H Sprint for Women’s Health initiative is supporting Ancilia’s important work.” Ancilia also announced that Jacques Ravel, PhD, has been named a Scientific Advisor to the company. Dr. Ravel is the Acting Director at the Institute for Genome Sciences and a Professor of Microbiology and Immunology at the University of Maryland School of Medicine. Dr. Ravel is an expert in microbial genetics and is well-known for his pioneering work in mapping and exploring the critical role of the vaginal microbiome in women’s health. Separately, Ancilia announced that it has been awarded a $274,000 grant under the Small Business Technology Transfer (STTR) program of the NIH that will enable the company to expand its technology platforms to address diseases of the gastrointestinal tract, facilitating Ancilia’s goal of developing novel live bacterial products for a range of diseases and applications. The company has now raised approximately $8 million in total dilutive and non-dilutive funding. Ancilia’s newly awarded STTR grant is supported by the National Institute Of Diabetes And Digestive And Kidney Diseases of the NIH under Award Number R41DK141344. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH. See today’s White House statement on the Sprint for Women’s Health awards at: https://www.whitehouse.gov/briefing-room/statements-releases/2024/10/23/fact-sheet-biden-harris-administration-announces-110-million-in-awards-from-arpa-hs-sprint-for-womens-health-to-accelerate-new-discoveries-and-innovation/. A video on the awards can be viewed at https://arpa-h.gov/engage-and-transition/sprint. About AnciliaAncilia Biosciences is developing live bacterial products for human health and other applications. The company aims to overcome a major obstacle to the success of these products—the failure to address the role of predatory bacterial viruses in limiting their effectiveness. The company’s proprietary enabling technologies identify and characterize these viruses and leverage the natural function of CRISPR to produce a new class of live biotherapeutics and other microbial products with immunity to key viral pathogens. Ancilia’s founders and advisors include scientific leaders across CRISPR and the virome. The company’s core technologies are based on the pioneering work of co-founder Dr. Rodolphe Barrangou, who established this natural function of CRISPR in bacteria and filed the first-ever CRISPR patent in 2004, and co-founder and chief technology officer David Paez-Espino, PhD, who has published more than 20 high impact papers in virology and bioinformatics and holds multiple patents in the field. Ancilia has obtained both issued and pending patents for its technologies. The company is headquartered in New York City. For more information, visit anciliabio.com. Contacts: Ancilia Corporate:Alexandra Sakatos, PhDChief Executive Officerinfo@anciliabio.com Ancilia Media:Barbara LindheimBLL Partners for Anciliablindheim@bllbiopartners.com(917) 355-9234

ROCKVILLE, Md., Oct. 23, 2024 /PRNewswire/ -- Rise Therapeutics announced today that it has received funding from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institute of Health (NIH) to enable infrastructure improvement that will scale GMP production and accelerate quality assurance (QA) and quality control (QC), significantly enhancing its biologics drug manufacturing capabilities. This Commercial Readiness Pilot (CRP) Program SBIR award will also support Phase 2 clinical GMP manufacturing to advance Rise Therapeutics' R-3750 program currently completing a Phase 1 proof-of-concept clinical trial in patients suffering from ulcerative colitis. "This funding package from NIH will help drive our transition to large scale GMP manufacturing," stated Dr. Gary Fanger, President and CEO of Rise Therapeutics. "With four different products progressing through Phase 1 proof-of-concept clinical studies, our ability to seamlessly transition those programs into pivotal Phase 2/3 studies is critical for Rise Therapeutics' evolution to a late-stage clinical company. This funding is an important component to that transition, and we appreciate the support by NIDDK for helping enable us to develop R-3750 as an innovative new drug candidate." About R-3750 Being an oral immunotherapy, R-3750 represents a novel breakthrough in the way we treat Inflammatory Bowel Disease (IBD). Rise Therapeutics has utilized its proprietary synthetic biology approach to develop R-3750, an immunologically-directed microbiome medication, orally administered as a capsule for the treatment of IBD. Affecting greater than 3 million adults in the US each year, IBD is composed of two chronic inflammatory diseases of the gastrointestinal tract: Crohn's disease (CD) and ulcerative colitis (UC). IBD is a lifelong disease that currently has few treatments available, and of those treatments, many have debilitating side effects and risks. Rise Therapeutics' R-3750 therapy represents a novel immune regulatory approach for mediating anti-inflammatory control in the gut and a promising solution for mitigating colitis. About Rise Therapeutics Rise Therapeutics is an emerging, privately held biotechnology company located in Rockville, Maryland, which leverages its expertise in synthetic biology and immunological drug development to create novel cellular-based immune therapies. With a strong emphasis on product development and its internal clinical GMP manufacturing infrastructure, Rise is focused on developing immunological-based biological medicines using a unique and proprietary oral biologics delivery platform. For more information, go to . CONTACT: [email protected] SOURCE Rise Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Grant will lead to the creation of USDHub, a novel research tool bringing together research and clinical data from hundreds of thousands of kidney stone patients of all ages PHILADELPHIA, Oct. 15, 2024 /PRNewswire/ -- Researchers from Children's Hospital of Philadelphia (CHOP) and Vanderbilt University Medical Center were awarded a $7.37 million RC2 grant from the National Institutes of Health (NIH) to lead a five-year multisite project across the U.S. focused on kidney stone disease research. Continue Reading Dr. Gregory Tasian Led by CHOP pediatric urologist, Gregory Tasian, MD, MSc, MSCE and Vanderbilt University Medical Center urologist, Ryan Hsi, MD, the goal of this initiative is to establish a new research tool called the Urinary Stone Disease Hub (USDHub), which will aggregate data from across healthcare systems and research networks into one comprehensive platform drawing data from a cohort of more than 230,000 patients suffering from kidney stone disease. Urinary stone disease is a painful condition that can cause a substantial amount of suffering for affected patients. The prevalence of kidney stones is about 11% in Americans, and kidney stones send more than half a million patients to the emergency room each year, according to the National Kidney Foundation. Although urinary and kidney stones are traditionally thought of as an adult diagnosis, kidney stones in children are becoming more common, and CHOP clinicians encounter them daily. To address the unique needs of children with kidney stones, CHOP created the Pediatric Kidney Stone Center, a multidisciplinary program within its Divisions of Urology and Nephrology that is solely dedicated to the dietary, medical, and surgical management of kidney stones. There have been few advancements in the diagnosis and management of urinary stone disease, partly due to a lack of datasets that contain clinically important information about individuals with urinary stone disease across the lifespan. To help address these challenges, USDHub will draw from medical expertise across adult and pediatric urology and nephrology and combine informatics and AI to establish a novel data resource that includes clinically important information from CT images, clinical notes, stone composition, and 24-hour urine labs, which are not available in existing research databases. "We see this painful condition more frequently now, but strong evidence to support decisions about treating children is lacking because urinary stone disease was once rare," said Tasian, who holds the Cheers for CHOP Chair in Clinical Epidemiology of Pediatric Urological Disease. "Opportunities exist both for expanding the evidence base around the management of kidney and urinary stones and for improving the research process itself." In addition to the work being led by Drs. Tasian at CHOP and Hsi at Vanderbilt, USDHub will involve seven other sites involved are part of the STAR and PEDSnet, which are two PCORnet clinical research networks that have standardized electronic health record data. In addition to CHOP and Vanderbilt University Medical Center, USDHub sites include University of North Carolina, Medical University of South Carolina, Duke University, Texas Children's Hospital, Nationwide Children's Hospital, Lurie Children's Hospital of Chicago and Cincinnati Children's Hospital. "USDHub will be a collaborative effort to synergize efforts and expertise across adult and pediatric stone disease, and to engage patients and caregivers in the design process to ensure that our sustainable data access model meets their needs," Tasian said. "This program will finally provide us with longitudinal data and eliminate our reliance on single-center data sources that segregate pediatric and adult patients. We see the potential to significantly accelerate and improve urinary stone disease research." This research is funded by the National Institute of Diabetes and Digestive and Kidney Diseases (grant 1RC2DK140865-01). About Children's Hospital of Philadelphia: A non-profit, charitable organization, Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, the hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. The institution has a well-established history of providing advanced pediatric care close to home through its CHOP Care Network, which includes more than 50 primary care practices, specialty care and surgical centers, urgent care centers, and community hospital alliances throughout Pennsylvania and New Jersey, as well as the Middleman Family Pavilion and its dedicated pediatric emergency department in King of Prussia. In addition, its unique family-centered care and public service programs have brought Children's Hospital of Philadelphia recognition as a leading advocate for children and adolescents. For more information, visit . Contact: Kaila Revello Children's Hospital of Philadelphia (610) 457-5916 [email protected] SOURCE Children's Hospital of Philadelphia WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED