Business Wire

IMMUNABS

3.8.2022 16:02:08 CEST | Business Wire | Press release

Share
ImmunAbs Inc. Announces US FDA Approval for a Phase 1 Clinical Trial

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.

Link:

ClickThru

About Business Wire

Business Wire
Business Wire
101 California Street, 20th Floor
CA 94111 San Francisco

http://businesswire.com

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

Together AI and HUMAIN Form Strategic Partnership to Accelerate AI Infrastructure and Cloud Services in Saudi Arabia31.8.2026 14:00:00 CEST | Press release

The partnership, which was announced on stage at LEAP, Combines HUMAIN’s AI Infrastructure Foundation with Together’s AI Native Cloud Platform and Global Reach Together AI, a leading San Francisco-based AI Native Cloud platform, and HUMAIN, a PIF company delivering full-stack artificial intelligence capabilities globally, today at LEAP announced a strategic partnership to connect HUMAIN’s rapidly expanding AI compute capacity in Saudi Arabia with global AI-native and enterprise demand. The partnership will include the construction of a new 250 megawatt data center, located in Saudi Arabia. The partnership brings together HUMAIN’s large-scale, multi-chip AI infrastructure footprint, expanding cloud and inference capabilities with Together AI’s global customer ecosystem and AI-native inference platform. Together, the companies will offer an additional option for developers, enterprises, and AI-native organizations worldwide to access high-performance AI infrastructure for inference and t

SLB to Acquire Kelvion, Expanding its Role Across Data Center Infrastructure31.8.2026 12:50:00 CEST | Press release

Scalable, energy-efficient and reliable thermal management technologies will optimize operating performance in increasingly complex data centers and industrial systems SLB (NYSE: SLB) today announced it has signed an agreement to acquire Kelvion, a global provider of thermal management and heat exchange technologies. The acquisition strengthens SLB's Data Center Solutions business with critical thermal management technologies and expands the company's role in data center infrastructure, which is one of the world’s fastest-growing industrial and technology markets. “AI is driving the most significant infrastructure investment cycle in our lifetime,” said Olivier Le Peuch, chief executive officer of SLB. “This transaction accelerates our ambition to become an industrial technology partner to the data center industry and help customers address the growing infrastructure complexity required to scale AI. Kelvion advances our path toward more integrated data center infrastructure solutions,

BeOne Medicines Announces New Phase 3 Survival Data Reinforcing Benefit of ZIIHERA-Containing Regimens in First-Line HER2+ Gastroesophageal Cancer31.8.2026 12:00:00 CEST | Press release

Findings provide further evidence of overall survival benefit of TEVIMBRA plus ZIIHERA and chemotherapy regimen in HER2+ GEAZIIHERA plus chemotherapy demonstrated statistically significant overall survival benefit at second interim analysis of HERIZON-GEA-01 trial BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced positive topline results from the second interim analysis (IA2) of the Phase 3 HERIZON-GEA-01 trial evaluating ZIIHERA® (zanidatamab), in combination with chemotherapy, with and without TEVIMBRA® (tislelizumab), as first-line treatment for HER2+ locally advanced or metastatic gastroesophageal adenocarcinoma (GEA). At IA2, ZIIHERA plus chemotherapy demonstrated a statistically significant and clinically meaningful improvement in overall survival (OS) compared with trastuzumab plus chemotherapy, meeting the remaining primary endpoint analysis of the study. IA2 also provided longer follow-up data for the TEVIMBRA plus ZIIHERA

GigaDevice Strengthens EMEA and Southeast Asia Market Reach Through Strategic Partnership with Rutronik31.8.2026 09:00:00 CEST | Press release

GigaDevice, a leading semiconductor company specializing in Flash memory, 32-bit microcontrollers (MCUs), sensors, and analog products, today announced a new strategic franchise partnership with Rutronik Elektronische Bauelemente GmbH, one of Europe’s leading broadline distributors of electronic components. The agreement covers EMEA and Southeast Asia, including India, and provides customers with broader access to GigaDevice’s comprehensive portfolio of microcontrollers, sensors, and power management solutions. The partnership further strengthens GigaDevice’s distribution network and local market presence across key regions. With its strong presence across Europe and growing coverage in Southeast Asia, Rutronik provides GigaDevice with an established channel supported by extensive market reach, technical expertise, and customer relationships. The collaboration will help expand access to GigaDevice’s embedded solutions across a broad range of applications and industries, including indus

Alnylam Presents New Data at ESC Congress 2026 Reinforcing Strength in RNAi-Powered TTR Silencing Across ATTR-CM Patient Populations and Treatment Settings30.8.2026 14:23:00 CEST | Press release

–Late-Breaking Prespecified Subgroup Analysis of HELIOS-B Demonstrates that Vutrisiran Provided Consistent Clinical Benefit Across All-Cause Mortality and Recurrent Cardiovascular Events in Patients With or Without Tafamidis Use at Baseline ––Additional Post Hoc Analyses Highlight Positive Impact of Vutrisiran in Addressing the Multisystemic Manifestations of ATTR-CM ––Pooled Analysis Across Four Positive Phase 3 Studies of Vutrisiran and Patisiran Shows Consistent Treatment Effect Across Sexes ––New Subgroup Analysis from KARDIA-3 Phase 2 Study of Zilebesiran Highlights Potential to Provide Enhanced Blood Pressure Control – Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced new data at the European Society of Cardiology (ESC) Congress 2026 demonstrating the strength of RNAi-powered silencing for cardiovascular disease. The findings further reinforce the clinical profile of AMVUTTRA® (vutrisiran) across transthyretin amyloidosis (ATTR)

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
World GlobeA line styled icon from Orion Icon Library.HiddenA line styled icon from Orion Icon Library.Eye