IMMUNABS
3.8.2022 16:02:08 CEST | Business Wire | Press release
ImmunAbs Inc. (www.immunabs.com ) announced that it has received US FDA approval for a Phase 1 clinical trial and that it is now ready to initiate a phase 1 clinical trial in the United States.
ImmunAbs is developing IM-101, a monoclonal antibody targeting complements that play essential roles in the immune system but, when out of regulation, cause various autoimmune diseases, including but not limited to paroxysmal nocturnal hemoglobinuria (PNH). The complement inhibitors drug market showed its growth potential by achieving an average annual growth rate of 20.7% and a market size of USD $ 5.1 billion in 2020 and is expected to grow to USD $19 billion by 2027.
Paroxysmal nocturnal hemoglobinuria is one example of complement-mediated autoimmune diseases where the membrane proteins protecting the red blood cells from complement activation are lost due to mutations, which results in red blood cells being destructed by the complements. Due to insufficient inhibition of complements shown by currently approved complement inhibitors, SolirisⓇ and UltomirisⓇ , patients who receive these drugs still suffer from the residual symptoms of PNH, which include anaemia, fatigue, and decreased productivity at work.
ImmunAbs’ new complement therapeutic IM-101 targets the safest and most potent component of the complement system, complement C5. IM-101 has been shown to completely inhibit complement activation, and thus is expected to alleviate the symptoms that persist with the standard of care. ImmunAbs will initiate a phase 2a clinical trial in the United States in 2024.
“This is a historical milestone for ImmunAbs.” said Dr. DongJo Kim, the company’s CEO. “We are delighted to see IM-101’s efficacy in humans which has been proven in our ex vivo study. We hope that our IM-101 will reach patients who may suffer from symptoms that persist due to insufficient complement inhibition by the current treatments.”
About ImmunAbs Inc.
ImmunAbs Inc. was established in 2017 by experts of global standard antibody therapeutics development. The vision is "Hope for Patients, Dreams for All." Currently, ImmunAbs has several antibody therapeutics in global standard development for autoimmune diseases, diabetic retinopathy, and metabolic syndrome. ImmunAbs successfully raised KRW 18.1 billion from Seed to series A funding in 2021 and got a non-clinical study national grant for developing IM-101 from Korea Drug Development Fund in November last year.
View source version on businesswire.com: https://www.businesswire.com/news/home/20220803005380/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Incyte Announces Positive CHMP Opinion for Opzelura® (ruxolitinib) Cream for the Treatment of Adults with Moderate Atopic Dermatitis26.6.2026 13:30:00 CEST | Press release
If approved, Opzelura® (ruxolitinib) cream will be the first steroid-free, topical JAK treatment option in the European Union (EU) for adults with moderate atopic dermatitis (AD) for whom standard topical therapies have failedAD, the most common type of eczema which affects 230 million people globally,1 is a chronic, recurring, inflammatory and highly pruritic (itchy) skin condition that can have a significant impact on daily life2Phase 3 TRuE‑AD4 data supporting the positive CHMP opinion demonstrated that ruxolitinib cream met both co‑primary endpoints at Week 8, maintained disease control with as-needed treatment through Week 24 and was well tolerated3,4,5 Incyte (Nasdaq: INCY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of Opzelura® (ruxolitinib) cream for the treatment of moderate atopic dermatitis (AD) in adult patients for whom topical corticosteroids
Datroway® Recommended for Approval in the EU by CHMP as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who Are Not Candidates for Immunotherapy26.6.2026 13:00:00 CEST | Press release
Recommendation based on TROPION-Breast02 phase 3 trial where Daiichi Sankyo and AstraZeneca’s Datroway showed a statistically significant and clinically meaningful improvement for the dual primary endpoints of overall survival and progression-free survival If approved, Datroway has potential to be the first TROP2 directed antibody drug conjugate for patients in EU with a demonstrated overall survival benefit as first-line treatment Datroway® (datopotamab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the first-line treatment of adult patients with unresectable or metastatic triple negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy. Datroway is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (LSE/STO/NYSE: AZN). The Committee for Medicinal Products for Human Use
DAYBU®(trofinetide) Recommended for Approval in the European Union by CHMP26.6.2026 12:49:00 CEST | Press release
-- European Commission decision expected in the coming months-- If approved, DAYBU®would become the first treatment for neurobehavioral symptoms of Rett syndrome in the European Union Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion following a re-examination procedure, recommending the granting of a marketing authorization for DAYBU® (trofinetide) for the treatment of neurobehavioral symptoms of Rett syndrome in adults and pediatric patients aged five years and older. If granted marketing authorization by the European Commission, DAYBU® would be the first therapy approved for this indication in the European Union (EU). “The CHMP’s positive opinion for DAYBU® is an important milestone in our mission to bring this innovative therapy to the EU, where there are no therapies specifically approved for the neurobehavioral symptoms of this devastating
HTEC Showcases Lakebase Branching at Databricks’ Data & AI Summit26.6.2026 11:18:00 CEST | Press release
HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. The Solution was developed in collaboration with a leading risk and compliance technology provider who serves financial institutions. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260626875859/en/ HTEC, the global technology and AI engineering firm headquartered in Silicon Valley, last week showcased how it used Lakebase data branching to enable faster development, safer operations, and new possibilities for data-driven organizations operating in highly regulated environments. Solving Critical Development Bottlenecks in Regulated Environments At the core of the collaboration was a shared challenge: how to enable modern data workflows in an envi
Stallergenes Greer Named One of Switzerland’s Best Managed Companies for 202626.6.2026 10:28:00 CEST | Press release
Stallergenes Greer, a global leader in allergy care, has been recognised for its overall business performance, company culture, and sustained growth by receiving the prestigious 2026 Switzerland’s Best Managed Companies award. The 2026 Best Managed Companies programme award winners are among Switzerland’s best private companies. The awards are derived from Deloitte’s global Best Managed Companies awards programme, an internationally recognised programme that evaluates businesses based on their leadership in the areas of strategy, culture and commitment, capabilities, innovation, governance and financial performance. Applicants are evaluated by an independent jury of experts. The evaluation of the Switzerland awards is based on more than 30 years of observed practice from the global awards programme that has been rolled out in 50+ countries worldwide. This recognition reflects Stallergenes Greer's consistent ability to deliver on its strategic vision while maintaining the operational di
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom