Immune globulin (GC Pharma)

YOGIN, South Korea, Dec. 17, 2023 /PRNewswire/ -- GC Biopharma Corp (006280.KS) today announces that the US Food and Drug Administration (FDA) has approved ALYGLO (immune globulin intravenous, human-stwk) 10% Liquid, formerly referred to as "GC5107," for the treatment of adult patients aged 17 years and older with primary humoral immunodeficiency (PI). The ALYGLO pivotal phase 3 clinical study followed FDA guidance for the treatment of patients with PI. The clinical trial (NCT02783482) GC5107B was a prospective, open-label, single-arm, historically controlled, multicenter phase 3 study to assess the efficacy and safety of GC5107B in patients with a confirmed diagnosis of PI. The studies were conducted in the United States and Canada. Key findings from the phase 3 clinical trial for patients aged 17 years and older include the following: A primary efficacy end point of 0.03 acute serious bacterial infections (aSBIs) per patient-year, which met the FDA efficacy requirement of less than one aSBI per patient-year. The proportion of infusions with temporally associated adverse events occurring during or within 72 hours after infusion was 0.22 (95% one-sided upper confidence bound: 30%), which met the FDA-required prespecified end point of less than 0.40. Secondary analyses were annual rate or days of other infections, antibiotic use, days out of work/school/day care or unable to perform normal activities due to infection, and days of hospitalization due to infection. ­­The results of the phase 3 trial by GC Biopharma are published in Frontiers in Immunology (2021). Dr. Elena Perez, MD., Allergy Immunologist from Allergy Associates of the Palm Beaches, and lead study investigator, said, "Alyglo will significantly impact clinical practice in the U.S. due to its strong safety and efficacy profile. It is an important treatment option for primary immune-deficient patients. This product provides additional confidence in treatment options for this important patient population." In addition, ALYGLO uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing coagulation factor XIa (FXIa) to undetectable levels. The presence of residual activated FXIa in some commercial IGIV products has been identified as the root cause of a small number of thromboembolic events in patients receiving immunoglobulin infusions. A recent study published in Frontiers in Cardiovascular Medicine details the extensive testing of ALYGLO and its results of the GC Biopharma manufacturing process. GC Biopharma is committed to evaluating how this new manufacturing process serves to further improve product safety. Dr. Eun-chul Huh, President and CEO of GC Biopharma, said, "The approval of ALYGLO by the US FDA is a significant milestone for GC Biopharma and patients with primary immunodeficiency disease. It reinforces GC Biopharma's commitment to patients and health care professionals by expanding our product portfolio globally to serve individuals with rare diseases. We are pleased to offer patients another important treatment option in the coming months that is both safe and effective." For any medical or scientific questions regarding ALYGLO, call the GC Biopharma USA medical department at 1-833-426-6426, or email [email protected]. About ALYGLO ALYGLO is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent treatment, and nanofiltration. ALYGLO also uses its novel Cation Exchange Chromatography (CEX) in the manufacturing process for removing FXIa to undetectable levels. About PI Primary Humoral Immunodeficiency (PI) refers to a group of disorders where the body's ability to produce antibodies is impaired, affecting the immune system's ability to fight infections. In PI, there's a deficiency or absence of B cells or plasma cells, which are key in producing antibodies, particularly immunoglobulin G. This leads to increased susceptibility to infection, especially bacterial infections affecting the respiratory and gastrointestinal tracts. People with PI might experience frequent infections, some of which can be severe or chronic. Treatment often involves immunoglobulin replacement therapy to boost the immune system. Vaccinations and antibiotics may also be used to prevent and treat infections. The exact type and severity of PI can vary widely among individuals. The PI indication for ALYGLO includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. About GC Biopharma Corp. GC Biopharma Corp. (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer and has been dedicated to quality health care solutions for over half a century. About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company, GC Biopharma's, expertise—a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma further extends its footprint, bringing its expertise and legacy to the United States. This press release may contain forward-looking statements that express the current beliefs and expectations of GC Biopharma Corp. management. Such statements do not represent any guarantee by GC Biopharma Corp. or its management of future performance and involve known and unknown risks, uncertainties, and other factors. GC Biopharma Corp. undertakes no obligation to update or revise any forward-looking statement contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. INDICATION ALYGLO™ is indicated for the treatment of primary humoral immunodeficiency (PI) in adults aged 17 years and older. This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), Wiskott-Aldrich syndrome, and severe combined immunodeficiencies. IMPORTANT SAFETY INFORMATION WARNING: THROMBOSIS, RENAL DYSFUNCTION and ACUTE RENAL FAILURE Thrombosis may occur with immune globulin intravenous (IGIV) products, including ALYGLO. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. ALYGLO does not contain sucrose. For patients at risk of thrombosis, renal dysfunction or renal failure, administer ALYGLO at the minimum dose and infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Contraindications: ALYGLO is contraindicated in patients who have a history of anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and a history of hypersensitivity. Hypersensitivity: In case of hypersensitivity, discontinue infusion immediately and institute appropriate treatment. Epinephrine should be available for immediate treatment of severe acute hypersensitivity reactions. Hyperproteinemia, Increased Serum Viscosity, and Hyponatremia: Hyperproteinemia, increased serum viscosity, and hyponatremia may occur. Aseptic Meningitis Syndrome (AMS): Aseptic meningitis syndrome (AMS) may occur, especially with high doses or rapid infusion. AMS usually begins within several hours to 2 days following ALYGLO treatment. Discontinuation of treatment has resulted in remission of AMS within several days without sequelae. Hemolysis: Delayed hemolytic anemia due to enhanced red blood cell (RBC) sequestration and acute hemolysis consistent with intravascular hemolysis have been reported. Cases of severe hemolysis-related renal dysfunction/failure or disseminated intravascular coagulation have occurred following infusion of IGIV. Closely monitor patients for clinical signs and symptoms of hemolysis, particularly patients with risk factors. Transfusion-Related Acute Lung Injury: Noncardiogenic pulmonary edema (transfusion-related acute lung injury [TRALI]) may occur. TRALI is characterized by severe respiratory distress, pulmonary edema, hypoxemia, normal left ventricular function, and fever. Patients with TRALI may be managed using oxygen therapy with adequate ventilator support. Monitor patients for pulmonary adverse reactions. Transmissible Infectious Agents: Because ALYGLO is made from human blood, it may carry a risk of transmitting infectious agents (eg, viruses, the variant Creutzfeldt-Jakob disease [vCJD] agent and, theoretically, the Creutzfeldt-Jakob disease [CJD] agent). Interference with Laboratory Tests: After infusion of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may yield positive serological testing results, with the potential for a misleading interpretation. Adverse reactions (observed in ≥ 5% of study subjects) were headache, nausea/vomiting, fatigue, nasal/sinus congestion, rash, arthralgia, diarrhea, muscle pain/aches, infusion site pain/swelling, abdominal pain/discomfort, cough, and dizziness. It is recommended that ALYGLO be administered separately from other drugs or medications. For more information about ALYGLO, please see full Prescribing Information. GC Biopharma Contact Seunghyun Baek [email protected] Sohee Kim [email protected] Yelin Jun [email protected] GC Biopharma USA Contact (Media) Robin Zvonek [email protected] (312) 636-5744 ©2023 GC Biopharma USA, Inc. All rights reserved. ALYGLO is a trademark of Green Cross Corporation. SOURCE GC Biopharma

TEANECK, N.J., Dec. 5, 2023 /PRNewswire/ -- GC Biopharma USA announced that a manuscript describing its landmark CEX technology, which removes FXIa from its 10% intravenous immunoglobulin (IVIG) preparation (GC5107), was published in Frontiers in Cardiovascular Medicine. The presence of residual activated coagulation factor XI (FXIa) in IVIG products was identified as the root cause of a small number of thromboembolic events (TEEs) in patients who received IVIG therapy1 Immunoglobulin (IG) therapy is a mainstay of treatment for patients with primary immunodeficiencies and autoimmune disorders. Numerous licensed IG products formulated for intravenous (IV) or subcutaneous administration are available. While all human IG is manufactured from pooled plasma using variations on the Cohn-Oncley cold ethanol fractionation process, differences in starting material, downstream purification steps, and added stabilizers result in final products that differ in composition in ways that may be very important to individual patients. Published reports of a small number of TEEs occurring in patients who received high doses of IVIG in the 1990s were attributed to an increase in blood viscosity following infusion or to patient-related factors such as heart disease, renal insufficiency, or prolonged immobilization. Subsequent investigations identified FXIa as a contaminant in some commercial IG preparations. In 2010, an unexpected increase in TEEs associated with using an IVIG product resulted in its temporary removal from the market; residual FXIa was subsequently confirmed to be the root cause2. GC Biopharma USA's rigorous studies have confirmed that a novel 10% IVIG manufacturing process, including CEX chromatography, is a reliable means of removing FXIa from the final preparation. After extensive rounds of testing, including a spiking study to evaluate the capacity of the process to remove high levels of the FXIa protein, the authors have demonstrated that CEX chromatography removes more than 99% of FXIa protein and reduces FXIa activity to below detection limits, even in samples containing 158x greater FXIa levels than that of normal samples. Dr. Jae UK Jeong, Head of R&D, stated, "We are proud to have a world-class team at GC Biopharma focused on developing robust proprietary manufacturing processes for IVIG focused on safety and improved patient outcomes." It is hoped that this novel proprietary manufacturing process will further support the product's safety—especially for high-risk patients who require IVIG. Link to Report–Cation Exchange Chromatography Removes FXIa from a 10% Intravenous Immunoglobulin Preparation About GC5107 GC5107 is a liquid solution containing 10% immunoglobulin G (100 mg/mL) for intravenous infusion, manufactured from pooled human plasma from US donors. The manufacturing process includes three steps to reduce the risk of virus transmission. These include fractionation, solvent/detergent (S/D) treatment, and nanofiltration. About Thrombotic Embolic Events (TEE's) Thrombotic events (TEs) are rare, but often, serious adverse events may occur after administering immune globulin (IG) products.2 FXIa was identified as the major biochemical root cause for the increased procoagulant potential and excluded numerous other factors. This underlines the principal importance of FXIa as an inducing factor of thromboembolic events. The clear-cut correlation of enhanced FXIa levels with an overall elevated procoagulant potential can obviously lead to thrombosis, probably dependent on the individual risk factors, which deserve further investigation.1 As early as 2000, Wolberg and colleagues suggested FXIa in different IVIG brands as a potential reason for an enhanced thrombotic risk during or after IVIG administration.3 About GC Biopharma GC Biopharma (formerly known as Green Cross Corporation) is a biopharmaceutical company that delivers lifesaving and life-sustaining protein therapeutics and vaccines. Headquartered in Yongin, South Korea, GC Biopharma is a leading global plasma protein and vaccine product manufacturer dedicated to quality healthcare solutions for over half a century. About GC Biopharma USA, Inc. GC Biopharma USA, Inc., headquartered in Teaneck, NJ, established its sales, marketing, and business operations in 2018 to serve customers and patients throughout the US. Our foundation is built on the expertise of our parent company, GC Biopharma, a leading biopharmaceutical company delivering plasma therapies and vaccines worldwide. With GC Biopharma USA, Inc., GC Biopharma will further extend its footprint, bringing its expertise and legacy to the United States. This press release may contain forward-looking statements that express GC Biopharma USA management's current beliefs and expectations. Such statements do not represent any guarantee of future performance by GC Biopharma USA or its management and involve known and unknown risks, uncertainties, and other factors. GC Biopharma USA undertakes no obligation to update or revise any forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rules. Roemisch JR, Kaar W, Zoechling A, Kannicht C, Putz M, Kohla G, et al. Identification of activated FXI as the major biochemical root cause in IVIG batches associated with thromboembolic events. Analytical and experimental approaches resulting in corrective and preventive measures implemented into the Octagam manufacturing process. WebmedCentral Immunother. (2011) 2(6):WMC002002. doi: 10.9754/journal.wmc.2011.002002 Daniel GW, Menis M, Sridhar G, Scott D, Wallace AE, Ovanesov MV, et al. Immune globulins and thrombotic adverse events as recorded in a large administrative database in 2008 through 2010. Transfusion (2012) 52(10):2113–21. doi:10.1111/j.1537-2995.2012. 03589.x Wolberg AS, Kon RH, Monroe DM, Hoffman M: Coagulation Factor XI is a contaminant in intravenous immunoglobulin preparations. American Journal of Hematology 2000; 65: 30 34.