VUJ-100 is an innovative therapy designed to prevent the recurrence and spread of cancer by targeting the unique vulnerability of micrometastatic tumors
NATICK, Mass., and HOBOKEN, N.J., Sept. 24, 2024 /PRNewswire-PRWeb/ -- Vuja De Sciences, Inc. ("Vuja De"), a biotechnology company dedicated to improving cancer patient outcomes by developing innovative therapies that target the unique vulnerabilities of micrometastatic tumors before they can cause deadly metastatic cancer recurrence, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for VUJ-100 for the treatment of relapsed, refractory sarcoma and osteosarcoma on Sep 11, 2024.
Vuja De is collaborating with the Sunshine Project™/National Pediatric Cancer Foundation's research program/consortium ("Sunshine/NPCF") on the intended development of VUJ-100 for the treatment and prevention of recurrence in pediatric cancer, with an initial focus on osteosarcoma. VUJ-100 was prioritized for development after demonstrating its ability to target the unique vulnerability of micrometastatic tumors in Vuja De's innovative anti-metastatic platform. VUJ-100 is positioned as a novel combination therapy to prevent the recurrence and spread of cancer, the most urgent needs of most cancer patients. Vuja De's novel approach to preventing and treating recurrence has the potential for game-changing outcomes for patients versus the conventional approach of targeting tumor regression. VUJ-100, which includes the proprietary Phase 2 drug domatinostat, and the FDA-approved drug sirolimus, will be tested in a planned study titled: "Open-label, cohort-sequential dose-escalation and dose-confirmation Phase 1/2 clinical trial to evaluate the safety and efficacy of domatinostat in combination with sirolimus in adolescents and adults with advanced sarcoma and osteosarcoma." The Phase 1/2 trial will be conducted by Sunshine/NPCF with the support of Vuja De.
"We are thrilled to achieve this important milestone for our first product candidate, VUJ-100. We look forward to initiating our Phase 1/2 trial and further determining the potential therapeutic impact of VUJ-100 as a novel anti-metastatic progression and recurrence therapy", said David Warshawsky, Ph.D., Chief Executive Officer of Vuja De. "We are grateful to Sunshine/NPCF for their support in assessing VUJ-100 with a focus on pediatric metastatic osteosarcoma, which has a dismal 5-year survival rate of less than 30%. VUJ-100 was designed as a novel therapeutic strategy to address disease recurrence and progression, addressing the largest unmet needs of osteosarcoma patients" he added.
"We are very excited about the potential of VUJ-100 in treating pediatric cancer," stated David Frazer, the CEO of the National Pediatric Cancer Foundation. "We are impressed by the innovative anti-metastatic progression platform and excellent research performed by Vuja De, which has identified VUJ-100 as an exciting clinical stage candidate for effectively controlling metastatic progression in osteosarcoma."
About VUJ-100
VUJ-100 is uniquely positioned as a therapy to prevent the recurrence and the spread of cancer (versus the conventional approach of targeting tumor regression). VUJ-100 targets the unique vulnerability of micrometastatic tumors, which stems from the dependence of these microscopic tumors on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined "Metastatic Endurance" (ME). ME offers a novel and previously untargeted vulnerability. VUJ-100 is a proprietary combination of a patented, oral clinical stage (Phase 2) epigenetic regulator (Class I selective HDAC inhibitor), domatinostat, plus low-dose FDA-approved oral mTOR inhibitor, sirolimus. VUJ-100 was prioritized as Vuja De's 1st product for clinical trials based on preclinical results from our proprietary anti-metastatic progression and recurrence platform, which prioritizes drugs that target ME, combined with robust pharmacokinetic, pharmacodynamic and safety and tolerability data for each drug in the novel combination. Vuja De's platform was used to screen approximately 3,000 clinical stage drugs in metastatic osteosarcoma models, revealing several drug classes that selectively target ME, and the selected drugs were tested in combination, resulting in the prioritization of VUJ-100 for development. VUJ-100 provides a combination effect targeting networks that regulate a broad range of critical cancer cell functions essential for ME. Domatinostat was developed by 4SC AG, a German biopharmaceutical company and Vuja De has exclusive access to worldwide rights to this promising drug. Through this strategic partnership, Vuja De has also obtained access to drug tablets and API, a robust patent portfolio, and regulatory, CMC and clinical documentation, in support of its upcoming Phase 1/2 trial.
About Osteosarcoma
Osteosarcoma is an aggressive cancer of the bone and is the most common type of bone cancer in children and teens. Since metastatic recurrence has shared biological mechanisms in many other cancer types, therapies that show promise in osteosarcoma can be developed in parallel for many other cancer types, such as breast, kidney and melanoma. Despite successful control of primary osteosarcoma tumors and follow-up chemotherapy, metastasis continues to be the most common cause of mortality. The last 40 years have brought little improvement in survival outcomes for children with osteosarcoma, despite intensification of therapy. Metastatic osteosarcoma has dismal 5-year survival rates of less than 30%. Due to the lack of improved outcomes, new approaches to therapy are desperately needed. Furthermore, if targeted therapeutics are found to prevent metastasis in this cancer, a strong biological rationale would exist for the evaluation of such a therapy in other human cancers.
About Vuja De Sciences
Vuja De is a biotechnology company dedicated to discovering and developing therapies that target the unique vulnerability of undetected micrometastases before they can cause deadly metastatic cancer recurrence. This vulnerability stems from the dependence of these microscopic tumors on a unique phenotype that includes stress adaptation, survival & dormancy, which we have coined "Metastatic Endurance" (ME). ME enables these microscopic tumors to persist undetected at secondary sites like "ticking time-bombs" and eventually start to rapidly divide and form overt deadly tumors. Vuja De has successfully created the first-ever industrialized cell-based and ex vivo drug screening platform that identifies drugs that target ME and metastatic progression. Vuja De is focused initially on the primarily adolescent, orphan disease, osteosarcoma, as the ideal initial indication for developing anti-metastatic progression drugs. We are testing repurposed drugs that have previously been in clinical trials, as well as novel preclinical stage drugs. For more information, please visit http://www.vujade-life.com.
About National Pediatric Cancer Foundation
The National Pediatric Cancer Foundation (founded in 1991) is a national nonprofit organization dedicated to funding research to eliminate childhood cancer. We govern a unique, collaborative research consortium (the Sunshine Project™) consisting of physicians and scientists from over thirty of the top hospitals in the nation. We collaborate to idealize and aggregate the best scientific ideas and fund innovative research. The NPCF has received a perfect 100% score for financial health and transparency and is recognized as the top-rated cancer charity in the U.S. by Charity Navigator. For more information, visit NationalPCF.org.
Media Contact
David Warshawsky, Vuja De Sciences, 1 8572043628, [email protected], https://vujade-life.com/
SOURCE Vuja De Sciences
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