Singota Solutions, a pharmaceutical contract development and manufacturing organization, will manufacture Noveome’s lead candidate for Phase I / II clinical trials
Bloomington, IN (May 12, 2020)- Singota Solutions has been selected to collaborate with Noveome Biotherapeutics, Inc. to manufacture the ST266 investigational drug product, a biologic being evaluated in clinical studies for its potential treatment of the severe inflammatory reaction known as Cytokine Release Syndrome (CRS), also known as the Cytokine Storm, observed in COVID-19 patients.
Singota specializes in small batch aseptic filling of high-value injectable products into vial, syringe, and cartridge formats using the robotic Vanrx SA25 Aseptic Filling Workcell. Singota will manufacture Noveome’s ST266 to be used for IV infusion in Phase I and II clinical trials. In preclinical and clinical studies, ST266 has demonstrated significant anti-inflammatory activity, which could potentially be lifesaving for patients experiencing the often-fatal CRS, a severe and systemic complication of COVID-19 that causes multi-organ damage, especially to the lungs.
“We commit to working quickly, yet carefully to get our clients’ products out to patients,” said Laura Englander, Sr. Business Development and Marketing Manager. “Noveome has been a great partner for Singota. They have moved swiftly on the front-end, entrusting us to excel at our promise of adhering to their tight timeline to get this critical product ready for their patients.”
Singota will manufacture 30 mL vial fills of ST266 in June. This timeline helps Noveome in its accelerated efforts to treat patients in the clinic, which they are prepared to initiate immediately should the FDA approve its requested authorization to proceed with dosing.
In response to the collaboration, Alisa Kilgas, CEO at Singota stated, “We’re all in this together. Singota is proud to work with Noveome in the fight against the Coronavirus, especially to help the patients around the world, but also those close to home.”
“Noveome is aggressively pursuing our investigational drug ST266 as an important therapeutic in the treatment of patients experiencing one of the most serious and life-threatening conditions brought about by COVID19 infection. Singota’s application of isolators paired with single-use technologies uniquely positions them to establish GMP manufacturing in weeks as opposed to what would typically take several months. In addition to this enabling technology, the response and flexibility of the team at Singota has been exceptional in the rapid establishment of this collaboration,” said Kevin McCracken, Chief Operating Officer, Noveome Biotherapeutics, Inc.
For more information about our services, please contact: Laura Englander, Sr. Business Development and Marketing Manager – firstname.lastname@example.org or 812.961.1752.
About Singota Solutions
Singota Solutions is a contract development and manufacturing organization focused on moving products through the development pipeline faster—with agility, accountability, and transparency. Founded in 2006, the company is a woman-owned business operating in Bloomington, Indiana. Singota’s gloveless, robotic aseptic filling service is ideally suited for the production of clinical and niche commercial injectable products in vial, syringe, and cartridges formats. Singota also provides customized solutions for formulation development, supply chain & materials management, analytical testing, and labeling & kitting services. For more information, please visit www.singota.com.
About Noveome® Biotherapeutics
Based in Pittsburgh, Noveome Biotherapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing next-generation biologics for the promotion and restoration of cellular integrity of inflamed or damaged tissues. Noveome has launched a program to test its novel platform biologic, ST266, as a treatment for the severe inflammatory response seen in COVID-19 infection. ST266 is currently being evaluated in multiple indications including a Phase 1 open label clinical trial to establish the safety of ST266 in intranasal transcribriform delivery from nose to brain and eye and a Phase 2 open-label clinical trial evaluating the efficacy of ST266 in healing persistent corneal epithelial defects (PEDs). For more information, visit www.noveome.com.