CASI Pharmaceuticals Announces FDA Clearance of IND Application for CID-103 in Renal Allograft Antibody-Mediated Rejection (AMR)
CASI Pharmaceuticals (NASDAQ:CASI) has received FDA clearance for its Investigational New Drug (IND) application for CID-103, a potential best-in-class anti-CD38 monoclonal antibody targeting renal allograft antibody-mediated rejection (AMR). The company plans to initiate a Phase 1 clinical trial to evaluate the safety, tolerability, and efficacy of CID-103 in adults with active and chronic active renal allograft AMR.
AMR is identified as a leading cause of kidney transplant failure, often resulting in dialysis or repeat transplantation. The Phase 1 study will focus on dose-ranging and safety assessments, addressing an urgent medical need in transplant medicine where current treatment options are limited.
CASI Pharmaceuticals (NASDAQ:CASI) ha ottenuto l'autorizzazione dalla FDA per la sua domanda di Nuovo Farmaco Sperimentale (IND) per CID-103, un potenziale anticorpo monoclonale anti-CD38 di prima classe, destinato a contrastare il rigetto anticorpale del trapianto renale (AMR). L'azienda prevede di avviare una fase 1 di sperimentazione clinica per valutare la sicurezza, la tollerabilit脿 e l'efficacia di CID-103 in adulti con AMR renale attiva e cronica attiva.
L'AMR 猫 riconosciuto come una delle principali cause di insuccesso del trapianto renale, spesso portando alla necessit脿 di dialisi o di un nuovo trapianto. Lo studio di fase 1 si concentrer脿 sulla valutazione delle dosi e sulla sicurezza, rispondendo a un urgente bisogno medico nel campo dei trapianti, dove le opzioni terapeutiche attuali sono limitate.
CASI Pharmaceuticals (NASDAQ:CASI) ha recibido la aprobaci贸n de la FDA para su solicitud de Nuevo F谩rmaco en Investigaci贸n (IND) para CID-103, un potencial anticuerpo monoclonal anti-CD38 de primera clase dirigido al rechazo mediado por anticuerpos en el trasplante renal (AMR). La compa帽铆a planea iniciar un ensayo cl铆nico de fase 1 para evaluar la seguridad, tolerabilidad y eficacia de CID-103 en adultos con AMR renal activo y cr贸nico activo.
El AMR se identifica como una causa principal del fracaso del trasplante de ri帽贸n, que a menudo conduce a di谩lisis o a un nuevo trasplante. El estudio de fase 1 se centrar谩 en la dosificaci贸n y evaluaci贸n de seguridad, abordando una necesidad m茅dica urgente en la medicina de trasplantes, donde las opciones de tratamiento actuales son limitadas.
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CASI Pharmaceuticals (NASDAQ:CASI) a obtenu l'autorisation de la FDA pour sa demande de nouveau m茅dicament exp茅rimental (IND) concernant CID-103, un anticorps monoclonal anti-CD38 potentiellement de premier ordre ciblant le rejet m茅di茅 par les anticorps du greffon r茅nal (AMR). La soci茅t茅 pr茅voit de lancer un essai clinique de phase 1 afin d'茅valuer la s茅curit茅, la tol茅rance et l'efficacit茅 de CID-103 chez les adultes atteints d'AMR r茅nale active et chronique active.
L'AMR est reconnue comme une cause majeure d'茅chec de la transplantation r茅nale, conduisant souvent 脿 la dialyse ou 脿 une retransplantation. L'茅tude de phase 1 se concentrera sur la d茅termination des doses et l'茅valuation de la s茅curit茅, r茅pondant 脿 un besoin m茅dical urgent en m茅decine de la transplantation o霉 les options th茅rapeutiques actuelles sont limit茅es.
CASI Pharmaceuticals (NASDAQ:CASI) hat die FDA-Zulassung f眉r seinen Antrag auf ein Investigational New Drug (IND) f眉r CID-103 erhalten, einen potenziellen erstklassigen anti-CD38 monoklonalen Antik枚rper, der auf die antik枚rpervermittelte Absto脽ung (AMR) von Nierentransplantaten abzielt. Das Unternehmen plant die Einleitung einer Phase-1-Studie, um die Sicherheit, Vertr盲glichkeit und Wirksamkeit von CID-103 bei Erwachsenen mit aktiver und chronisch aktiver Nieren-Transplantat-AMR zu bewerten.
AMR gilt als Hauptursache f眉r das Versagen von Nierentransplantaten, was h盲ufig zu Dialyse oder erneuter Transplantation f眉hrt. Die Phase-1-Studie wird sich auf Dosierungsbereiche und Sicherheitsbewertungen konzentrieren und damit einen dringenden medizinischen Bedarf in der Transplantationsmedizin adressieren, in der die derzeitigen Behandlungsm枚glichkeiten begrenzt sind.
- FDA clearance received for CID-103 IND application
- CID-103 shows potential as best-in-class anti-CD38 monoclonal antibody
- Addresses significant unmet medical need in kidney transplant rejection
- Early-stage development (Phase 1) indicates long path to potential commercialization
- No efficacy data available yet
- Faces competition in the transplant rejection treatment market
CID-103 is a potential best-in-class, anti-CD38 monoclonal antibody; binds to unique CD38 epitope
Phase 1 study in adults with active and chronic active renal allograft AMR planned to initiate
AMR is a leading cause of kidney transplant loss, leading to dialysis and/or repeat renal transplant
SAN FRANCISCO, CA / / August 4, 2025 / CASI Pharmaceuticals, Inc. (NASDAQ:CASI), a clinical-stage biopharmaceutical company focused on developing innovative therapies for patients with organ transplant rejection and autoimmune diseases, today announced FDA clearance of an IND application for CID-103, an anti-CD38 monoclonal antibody in adults with active and chronic active renal allograft antibody mediated rejection (AMR). The Phase 1 clinical trial is a dose-ranging and safety study evaluating the tolerability and efficacy of CID-103 in patients with AMR.
"Antibody-mediated rejection remains a significant challenge in kidney transplantation, with limited safe and effective treatment options currently available for those patients whose disease that has progressed," said Alex Zukiwski, M.D., Chief Medical Officer of CASI. "New therapeutic treatment options are urgently needed for patients with resistant AMR."
"This IND for CID-103 is a significant milestone in our mission at CASI to develop innovative therapies for patients with organ transplant rejection and autoimmune diseases," said David Cory, CEO of CASI. "We look forward to providing guidance in the future regarding the CID-103 development program."
About CID-103
CID-103 is a fully human IgG1, potentially best-in-class, anti-CD38 monoclonal antibody recognizing a unique epitope that has demonstrated an encouraging pre-clinical efficacy and safety profile compared to other anti-CD38 monoclonal antibodies, and for which CASI owns exclusive global rights. A body of evidence demonstrates the therapeutic promise of targeting CD38 in autoimmune diseases and organ transplant rejection. The CID-103 IND/CTA for immune thrombocytopenic purpura (ITP) has been approved by FDA and Chinese Health Authority and is actively recruiting and dosing patients. FDA has approved the IND application for renal allograft antibody-mediated rejection (AMR). The Company plans to initiate a Phase 1 study in adults with active and chronic active renal allograft AMR.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the U.S., and throughout the world. The Company is focused on acquiring, developing, and commercializing products that augment its focus on hematology oncology therapeutics and therapeutics for organ transplant rejection and autoimmune disease, as well as other areas of unmet medical need. The Company intends to execute its plan to become an industry leader by launching medicines in the Greater China market, leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., located in Beijing, China. More information on CASI is available at .
Forward Looking Statements
This announcement contains forward-looking statements. These statements are made under the "safe harbor" provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Among other things, the business outlook and quotations from management in this announcement, as well as the Company's strategic and operational plans, contain forward-looking statements. The Company may also make written or oral forward-looking statements in its periodic reports to the U.S. Securities and Exchange Commission (the "SEC"), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about the Company's beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: uncertainties related to the possibility that the transaction for the divestiture of certain assets in China (the "Transaction") will not occur as planned if events arise that result in the termination of the Equity and Assets Transfer Agreement, or if one or more of the various closing conditions to the Transaction are not satisfied or waived; the possibility that our plan with respect to our business operations after the consummation of the Transaction can be implemented successfully; our recurring operating losses have raised substantial doubt regarding our ability to continue as a going concern; the possibility that we may be delisted from trading on The Nasdaq Capital Market if we fail to satisfy applicable continued listing standards; the volatility in the market price of our ordinary shares; the risk of substantial dilution of existing shareholders in future share issuances; the difficulty of executing our business strategy on a global basis including China; our inability to enter into strategic partnerships for the development, commercialization, manufacturing and distribution of our proposed product candidates or future candidates; legal or regulatory developments in China that adversely affect our ability to operate in China; our lack of experience in manufacturing products and uncertainty about our resources and capabilities to do so on a clinical or commercial scale; risks relating to the commercialization, if any, of our products and proposed products (such as marketing, safety, regulatory, patent, product liability, supply, competition and other risks); our inability to predict when or if our product candidates will be approved for marketing by the U.S. Food and Drug Administration, European Medicines Agency, PRC National Medical Products Administration, or other regulatory authorities; our inability to receive approval for renewal of license of our existing products; the risks relating to the need for additional capital and the uncertainty of securing additional funding on favorable terms; the risks associated with our product candidates, and the risks associated with our other early-stage products under development; the risk that result in preclinical and clinical models are not necessarily indicative of clinical results; uncertainties relating to preclinical and clinical trials, including delays to the commencement of such trials; our ability to protect our intellectual property rights; the lack of success in the clinical development of any of our products; and our dependence on third parties; the risks related to our dependence on Juventas to conduct the clinical development of CNCT19 and to partner with us to co-market CNCT19; risks related to our dependence on Juventas to ensure the patent protection and prosecution for CNCT19; the risk related to the Company's ongoing development of and regulatory application for CID-103 with respect to the treatment of antibody-mediated rejection for organ transplant and the license arrangements of CID-103; risks relating to interests of our largest shareholder and our Chairman and CEO that differ from our other shareholders; risks related to the development of a new manufacturing facility by CASI Pharmaceuticals (Wuxi) Co., Ltd. and risks related to our disagreement with Acrotech with respect to the termination of agreements regarding EVOMELA庐. Further information regarding these and other risks is included in the Company's filings with the SEC. All information provided herein is as of the date of this announcement, and the Company undertakes no obligation to update any forward-looking statement, except as required under applicable law. We caution readers not to place undue reliance on any forward-looking statements contained herein.
EVOMELA庐 is proprietary to Acrotech Biopharma Inc. and its affiliates. FOLOTYN庐 is proprietary to Acrotech Biopharma Inc and its affiliates. The Company is currently involved in disputes and legal proceedings related to certain pipeline products, including EVOMELA庐 and CNCT-19.Please refer to the Company's earlier SEC filing for further information.
COMPANY CONTACT:
Ingrid Choong, PhD
650-619-6115
[email protected]
SOURCE: CASI Pharmaceuticals
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FAQ
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