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AbelZeta Announces Remaining China Rights to GPC3 Armored CAR-T Therapy to be Acquired by AstraZeneca

ROCKVILLE, MD and SHANGHAI, CHINA January 18, 2026 – AbelZeta Pharma, Inc. (“AbelZeta”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, announced that AstraZeneca has agreed to acquire AbelZeta’s 50% share of the China development and commercialization rights to C-CAR031, such that AstraZeneca acquires the sole right to develop, manufacture and commercialize C-CAR031 globally. Under the terms of the agreement, AbelZeta will be entitled to receive up to $630 million from AstraZeneca including an upfront payment, and development, regulatory and sales milestone payments for the GPC3 program in China.

Under the terms of a prior agreement with AbelZeta, AstraZeneca owns the development, manufacturing and commercialization rights to C-CAR031 in rest of world, outside of China. AbelZeta is also eligible to receive additional milestone payments and royalties for rest of world development.

“This transaction reflects our commitment to leverage our platform technology to develop novel cell therapies in solid tumors of high unmet medical need, including Hepatocellular carcinoma (HCC), and provides the opportunity to maximize C-CAR031’s global reach” said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta.

C-CAR031 is an autologous, Glypican 3 (GPC3)-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, designed using AstraZeneca’s dominant negative transforming growth factor-beta receptor II armoring platform, and is currently being investigated for the treatment of HCC and other solid tumors.

About HCC
Liver cancer is the third-leading cause of cancer death and the sixth most commonly diagnosed cancer worldwide. Several types of primary liver cancer occur in adults, HCC being the most common form. About 75% of all primary liver cancers in adults are HCC. Liver cancers are categorized based on the originating cell type. HCC begins in the liver as either a single tumor or several small nodules and at this local stage, it can be treated by locally targeted or surgical methods. However, most patients are diagnosed at advanced-stage, or their disease progresses to advanced-stage HCC when the prognosis is poor, with a 5-year survival rate of only 7% and a median survival of approximately 20 months. According to Frost & Sullivan, the incidence of HCC in China has been growing steadily to approximately 344,500 cases in 2024.

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies, inflammatory and immunological diseases and solid tumors. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward looking statements are based on the current beliefs and management’s expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.’s (“AbelZeta” or the “Company”) control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta to Attend 44th Annual J.P. Morgan Healthcare Conference and Join Panel Discussion

ROCKVILLE, MD, January 6, 2026 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, will attend  the 44th Annual J.P. Morgan Healthcare Conference on January 12-15, 2026 in San Francisco, CA, and host meetings showcasing the Company’s recent accomplishments and sharing strategic plans moving forward. The Company’s Chairman and CEO, Tony (Bizuo) Liu, has also been invited as a panel speaker at the Conference.

Session:            Emerging Biotechs from China
Time & Date:    January 14, 2026, 16:30 – 17:15 PST
Location:          Pacific Hall, Convene, 40 O’Farrell St, San Francisco
Description:     China is emerging as a hub of global biotech innovation. Leveraging on strong capability in early discovery and clinical resources, China’s biotech companies are joining the global innovation in the next wave of oncology and autoimmune assets. In this panel, J.P. Morgan invited CEOs with lead assets in cell therapy and other modalities and will discuss differentiation of their assets and strategy for business developments.

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies, inflammatory and immunological diseases and solid tumors. AbelZeta advances research and development in its own GMP facilities at its centers of excellence, with a pipeline comprised of multiple CAR-T therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward looking statements are based on the current beliefs and management’s expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.’s (“AbelZeta” or the “Company”) control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta Announces Late-Breaking Poster Presentation at ACR Convergence 2025 of First-in-Human Phase I Trial of anti-CD20/BCMA Bispecific CAR-T Therapy in Patients with Refractory Autoimmune Diseases

ROCKVILLE, MD, October 20, 2025 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that clinical data from the first-in-human Phase I trial (NCT06249438) of C-CAR168 in patients with refractory autoimmune diseases will be presented as a late-breaking poster presentation at American College of Rheumatology (ACR) Convergence 2025, being held October 24-29, 2025, at McCormick Place in Chicago, Illinois. C-CAR168 is an autologous anti-CD20/BCMA bispecific Chimeric Antigen Receptor T-cell (CAR-T) therapy designed to simultaneously target autoantibody-producing plasma cells and their B-cell precursors, aiming to achieve “immune reset”. 

Presentation Type: Poster
Session: Late-Breaking Posters
Display Dates: October 26-28, 2025
Presentation Date & Time: Tuesday, October 28 , 10:30 AM – 12:30 PM CT
Location: Hall F1, McCormick Place
Abstract ID: 2211304
Abstract Title: Anti-CD20/BCMA Bispecific CAR-T Cell Therapy Promotes Immune Reset and Sustained Drug Free Remission in Refractory Autoimmune Diseases

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to numerous factors. Forward looking statements are based on the current beliefs and management’s expectations and are subject to significant risks and uncertainties outside of AbelZeta Pharma, Inc.’s (“AbelZeta” or the “Company”) control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, AbelZeta does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta Announces Promising Long-Term Outcomes for C-CAR039, a Novel CD19/CD20 Bi-Specific CAR-T Therapy, in Patients with R/R B NHL at EHA 2025

MILAN, June 16, 2025 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, presented promising four-year clinical outcomes from 48 relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients treated with C-CAR039 (also known as Prizloncabtagene Autoleucel) in greater China, at the European Hematology Association (EHA) 2025 Congress.

The study evaluated the safety and efficacy of C-CAR039, a novel anti-CD19/CD20 bi-specific CAR-T therapy. The dual-targeting approach to both CD20 and CD19 antigens aims to enhance therapeutic efficacy and reduce the likelihood of antigen escape, a common mechanism of resistance in B-cell malignancies.

Key Findings:

  • The overall response rate (ORR) and complete response (CR) rate were 91.5% and 85.1%, respectively for all patients
  • Among the 43 LBCL pts, ORR and CR were 90.7% and 86.0%, respectively
  • With a median follow-up of 45.5 months (range, 3.1–62.8), the median duration of response (DOR), progression-free survival (PFS), and overall survival (OS) were not reached
  • KM estimates of 48-m PFS rate are 52.5% for all patients and 53.4% for LBCL patients, respectively
  • KM estimates of 48-m OS rate are 65.4% for all patients and 66.7% for LBCL patients, respectively

Safety Highlights:

  • CRS of any grade:8% | Grade ≥3: 2.1%
  • ICANS of any grade:3% | No severe cases (Grade ≥3) reported
  • No new safety signals were observed with longer follow-up

C-CAR039 has continued to show an excellent safety profile and deep and durable responses in R/R B-NHL patients, especially in those with R/R LBCL. These results continue to provide strong support for the curative potential of C-CAR039 as a next-generation therapy for R/R B-NHL. Late-stage clinical development is ongoing.

“The long-term clinical outcomes data for C-CAR039 are highly encouraging, demonstrating sustained responses in patients with relapsed or refractory B-cell non-Hodgkin lymphoma,” said Tony (Bizuo) Liu, Chairman and Chief Executive Officer of AbelZeta. “These results underscore our commitment and corporate goal to develop transformative therapies that address significant unmet medical needs in cancer.”

Dr. Yihong Yao, Chief Scientific Officer of AbelZeta, commented, “The strong clinical results of C-CAR039 demonstrate the added value of targeting CD20 in addition to CD19 in aggressive B-NHL. By addressing the limitations of single-antigen therapies – such as CD19 antigen escape – C-CAR039 enables deeper tissue penetration and more complete B-cell depletion. The durable responses observed support the continued advancement of C-CAR039 as a promising new treatment for patients with aggressive B-cell malignancies.”

For more information on the study and access to the poster presentation, please visit the EHA Library poster here.

AbelZeta previously presented 30-month Phase 1 clinical trial results at the 65th American Society of Hematology (ASH) Annual Meeting in December 2023, through oral presentation #1025, as well as at EHA 2024, through poster presentation #P1475. The data with 30 months follow up was published in Blood 2025 Apr 3;145(14):1526-1535.

AbelZeta Inc. (formerly known as Cellular Biomedicine Group, Inc.), entered into a worldwide collaboration and licensing agreement with Johnson & Johnson* in 2023 to develop and commercialize next-generation CAR-T cell therapies (excluding Greater China). The Phase 1 study for C-CAR039 was conducted by AbelZeta in China for the treatment of patients with B-cell non-Hodgkin lymphoma. Johnson & Johnson is evaluating the safety and efficacy of this asset (known as JNJ-90014496 outside of Greater China) through a separate study involving a global patient population. Phase 1b data for JNJ-90014496 were presented at EHA 2025 on Friday, June 13, informing the recommended Phase 2 dose and an initial assessment of safety, efficacy and pharmacokinetics in R/R LBCL patients. For more information, please visit Johnson and Johnson website: https://www.jnj.com/media-center/press-releases/johnson-johnsons-dual-targeting-car-t-cell-therapy-shows-encouraging-first-results-in-large-b-cell-lymphoma.

*The legal entity to the worldwide collaboration and license agreement is Janssen Biotech, Inc., a Johnson & Johnson company.

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta Receives RMAT Designation for C-CAR168 for the Treatment of Refractory SLE, Including LN

ROCKVILLE, MD, May 27, 2025 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigens (BCMA) in the treatment of patients with autoimmune diseases including autoimmune neurological diseases. The RMAT designation, granted under Investigational New Drug (IND) 30283, is based on promising early clinical data demonstrating the potential of C-CAR168 to address serious unmet medical needs in patients with treatment-resistant forms of autoimmune disease. Early clinical results from the Phase 1, first-in-human investigator-initiated trial (IIT) of C-CAR168 in patients with refractory autoimmune disease (NCT06249438) were shared as a podium presentation at the 16th International Congress on Systemic Lupus Erythematosus (LUPUS 2025), in Toronto, Canada on May 22, 2025. The presentation can be viewed on the Company website page “Publications & Presentations”.

“We are pleased to receive the RMAT designation from the FDA for C-CAR168, a recognition made possible by the unwavering efforts of our dedicated team,” said Tony (Bizuo) Liu, AbelZeta’s Chairman and CEO. “This designation represents a significant milestone highlighting the promise that C-CAR168 holds for patients suffering from severe, treatment-resistant lupus and lupus nephritis. It also enables us to work more closely with the FDA, allowing us to accelerate development of this innovative therapy and bring hope and the potential for drug free disease remission to patients around the world who currently face limited treatment options.”

The RMAT designation enables sponsors to have early and frequent interactions with the FDA, including obtaining guidance on the development plan and the potential eligibility for priority review and accelerated approval. AbelZeta plans to request a multidisciplinary type B meeting with the FDA to discuss the next steps in the clinical and manufacturing development of C-CAR168.

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta Presents New Data on C-CAR168 for the Treatment of Autoimmune Diseases at LUPUS 2025

  • Novel Anti-CD20/BCMA Bispecific Autologous CAR-T Therapy Targeting Lupus Nephritis , Systemic Lupus Erythematosus and Multiple Sclerosis
  • Phase 1, First-in-Human Investigator-Initiated Trial (IIT)

ROCKVILLE, MD, May 22, 2025 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that data from its Phase 1 first-in-human investigator-initiated trial (IIT) of C-CAR168 study (NCT06249438, the “Study”) has been published in an abstract shared in a podium presentation at the 16th International Congress on Systemic Lupus Erythematosus (“LUPUS 2025”) in Toronto, Canada. The Principal Investigator (PI) of the Study, Professor Nan Shen from Department of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine, presented the early clinical results in patients with refractory autoimmune disease.

Key Highlights:

  • Overall, 10 patients have been treated with C-CAR168 including 7 LN patients, 1 Secondary Progressive Multiple Sclerosis (SPMS), 1 Neuromyelitis Optica Spectrum Disorder (NMOSD) and 1 Immune-Mediated Necrotizing Myopathy (IMNM) patient as of February 28, 2025;
  • Early clinical data showed that C-CAR168 was well tolerated. Four LN patients and one SPMS patient experienced low-grade 1-2 CRS with median time to onset of 2 days post C-CAR168 treatment. Neither ICANS nor severe infection was observed.

Mechanism of Action and Efficacy in LN Patients and a SPMS Patient:

  • Robust C-CAR168 expansion and rapid, complete depletion of B cells, CD20dim T cells, and plasma cells in peripheral blood was observed. Complete elimination of B cells, CD19+– and CD19– long-lived plasma cells in bone marrow was also demonstrated in the only patient in whom bone marrow was examined;
  • Four LN patients treated with C-CAR168 reached the 6-month evaluation timepoint. All 4 achieved and remained in SRI (4), 2 patients achieved CR, and 1 PR based on Kidney Disease: Improving Global Outcomes (KDIGO) 2024 LN Response Criteria;
  • All patients discontinued IS/biologics after lymphodepletion, and most patients steroid-free after C-CAR168 infusion;
  • One LN patient flared before 6-month post treatment;
  • Evidence of C-CAR168-induced immune reset was demonstrated through peripheral blood flow cytometry and RNA sequencing analysis in LN patients;
  • The SPMS patient treated showed very promising early efficacy signal, including improvement in gait and orbital movement, significant reduction of brain inflammation and lesion size, improvement in EDSS, 9-HPT, T25-FW, and biomarker level.

“The early clinical results for C-CAR168 mark a significant step forward in the treatment of patients suffering from LN and SPMS with severe manifestations and few effective treatment options,” said Tony (Bizuo) Liu, the Company’s Chairman and CEO. “These findings support the extension of our bi-specific CAR-T platform, including anti CD20/19 bispecific CAR-T for NHL and now adding C-CAR168, anti-CD20/BCMA, for autoimmune diseases. Success in treatment with C-CAR168 would enable patients to discontinue immunosuppressive therapy and substantially reduce disease activity. We will work closely with the FDA and the scientific community to move forward with Phase 1b and Phase 2 studies.”

About the Study (NCT06249438)

This is an investigator-initiated, multicenter, open-label study of C-CAR168 for the treatment of adult patients with autoimmune diseases and neurological diseases, such as refractory LN, SLE and progressive Multiple Sclerosis (MS), resistant and refractory to standard therapy. As of February 28, 2025, 7 patients with refractory LN received C-CAR168 therapy, with 4 dosed at 0.75×106 cells/kg and 3 at 1.5×106 cells/kg. The treated population had long-standing refractory disease (median SLE duration 9 years, LN 5 years) with exposure to a median of 4 IS or biologic agents.

About C-CAR168

C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigens (BCMA). The Food and Drug Administration (FDA) has granted clearance of the Investigational New Drug (IND) application of C-CAR168 and preclinical data was presented at the American College of Rheumatology (ACR) Convergence 2024 held in Washington, DC, in November 2024.

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta Announces Upcoming Oral Presentations at LUPUS 2025

ROCKVILLE, MD, May 16, 2025 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the abstract presenting early clinical results from the Phase 1, first-in-human investigator-initiated trial (IIT) of C-CAR168 in Chinese patients with refractory autoimmune disease (NCT06249438) has been selected for a podium presentation at the 16th International Congress on Systemic Lupus Erythematosus (“LUPUS 2025”), to be held in Toronto, Canada on May 21-24, 2025.

C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigens (BCMA) in the treatment of patients with autoimmune diseases and neurological diseases, such as resistant and refractory Lupus Nephritis (LN), Systemic Lupus Erythematosus (SLE), and progressive Multiple Sclerosis (MS). The Food and Drug Administration (FDA) has granted clearance of the Investigational New Drug (IND) application of C-CAR168 and the preclinical data was presented at the American College of Rheumatology (ACR) Convergence 2024 held in Washington, DC, in November 2024.

Details of the oral presentation are as follows:

  • Abstract: https://cslide.ctimeetingtech.com/lupus25/attendee/confcal/show/session/23
  • Abstract Title: Clinical Impact of C-CAR168, A Novel Anti-CD20/BCMA Composite Autologous CAR-T Therapy, in Refractory Lupus Nephritis
  • Session Title: Abstract Concurrent Session 04: Advancing Lupus Therapies and Insights
  • Presentation Time and Date:  May 22, 2025 / 14:10 – 14:20
  • Presenter: Nan Shen, M.D., PhD, Principal Investigator (PI), Department of Rheumatology, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine
  • Location: Westin Harbour Castle, Toronto, Canada
  • Room: Queens Quay

In addition, the Company’s Vice President of Clinical Development, Barbara Mittleman, M.D, is an invited speaker at the congress in the following Scientific Session:

  • Session Name: Cell Therapy in Lupus
  • Session Time and Date: May 23, 2025 / 11:35 – 12:20
  • Room: Pier 2&3
  • The session will cover the following topics:
  1. Cell Therapy in SLE: Where We Are and how We Got Here
  2. Considerations, Challenges and Opportunities

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

Download PDF

AbelZeta to Attend 43rd Annual J.P. Morgan Healthcare Conference and Join Panel at 8th Annual BFC Healthcare Conference

ROCKVILLE, MD, December 23, 2024 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, will attend  the 43rd Annual J.P. Morgan Healthcare Conference on January 13-16, 2025, in San Francisco, CA, and host meetings showcasing the Company’s recent accomplishments and sharing strategic plans moving forward. The Company’s Chairman and CEO, Tony (Bizuo) Liu, has also been invited as a panel speaker  at the 8th Annual BFC Global Healthcare BD and Investment Conference on Sunday, January 12, 2025.

Session:              Faith to Incubate: Global Biotech Investment Trends and Focus
Time & Date:    January 12, 2025, 09:15 – 10:15 PST
Location:            The St. Regis San Francisco
Registration:    http://2025sf.bfcconference.com/

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

Download PDF

AbelZeta Presents Preclinical Data from Study of C-CAR168 for the Treatment of Autoimmune Diseases at ACR Convergence 2024

  • Novel Anti-CD20/BCMA Bispecific Autologous CAR-T Therapy targeting LN and SLE

ROCKVILLE, MD, November 16, 2024 – AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced that preclinical data from its C-CAR168 study has been presented as a podium presentation at the American College of Rheumatology (ACR) Convergence 2024 held in Washington, DC, November 14-19, 2024. C-CAR168 is a novel autologous bi-specific CAR-T therapy targeting both CD20 and B-cell maturation antigen (BCMA) for the treatment of resistant and refractory Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) patients. The Food and Drug Administration (FDA) granted clearance of the Investigational New Drug (IND) application to proceed with the Phase 1 clinical development of C-CAR168 in May 2024.

Abstract Title: C-CAR168 as a Novel Anti-CD20/BCMA Bispecific Autologous CAR-T Therapy for the Treatment of Autoimmune Diseases

Abstract Number: 0876
Session Title: Abstracts: T Cell Biology & Targets in Autoimmune & Inflammatory Disease
Session Type: Abstract Session
Session Time: 3:00PM-4:30PM EST
Presentation location: The Walter E. Washington Convention Center, Room143ABC
Presentation time: Saturday, November 16, 2024, 4:00PM-4:15PM EST
The presentation may be viewed on the Company website page “Publications & Presentations”

Key Highlights:

  • Scientific Rationale in Targeting B Cells and Plasma Cells: C-CAR168 is engineered to selectively target CD20 and BCMA, markers associated with pathogenic B cells and long-lived plasma cells (LLPCs) involved in autoimmune responses. Studies showed that C-CAR168 effectively induced cell death in CD20 and/or BCMA-positive cells, including the age-associated B cell (ABC) subset that is highly expanded in autoimmune conditions.
  • Potent In Vivo Cytotoxicity: In immunodeficient mouse models, a single dose of C-CAR168 demonstrated significant activity across multiple dosage levels, effectively inhibiting the growth of CD20 and BCMA single-positive or double-positive in various xenograft models.
  • Minimal Off-Target Toxicity: Comprehensive assays, including membrane proteome array, confirmed that C-CAR168 specifically targets CD20 and BCMA proteins, with no significant binding to non-target cells.
  • Safety Profile: In vitro assays showed minimal risk of carcinogenicity or unintended cell transformation, supporting the potential safety of C-CAR168 as a therapeutic option.

“We are encouraged by the progress we have made of C-CAR168 thus far. We believe we potentially have an excellent drug for patients suffering a variety of autoimmune diseases with severe manifestations and poor prognoses,” said Tony (Bizuo) Liu, Chairman and CEO. “This progress marks a major stride forward for us to deliver potentially best-in-class and/or best-in-disease  innovative cellular therapies for cancer and inflammatory & immunological diseases.”

Yihong Yao, PhD, Chief Scientific Officer of AbelZeta, commented, “We are excited about the potential of C-CAR168. CD20 has been shown to be a highly effective target for eliminating B cells and treating r/r NHL. It has also shown good promise in autoimmune diseases as evidenced by other approved therapies. Our dual target CD20 and BCMA CAR-Ts have proven to be safe and effective in NHL and multiple myeloma. C-CAR168 was designed to recognize and kill B cells, plasmablasts and LLPCs to eliminate the source of autoantibodies and to provide a definitive treatment in a variety of severe autoimmune diseases resistant to current treatment, including LN and SLE.”

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

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AbelZeta announces clinical data showing preliminary anti-tumor activity for C-CAR031, an armored autologous GPC3 CAR-T, in patients with advanced hepatocellular carcinoma, at ASCO Annual Meeting 2024

CAR031 study at 9.03-mo median follow up achieves disease control rate (DCR) of 91.3% and objective response rate (ORR) of 56.5% for patients across all dose levels (DLs) and ORR of 75.0% at DL4

 

ROCKVILLE, Md., June 4, 2024 /PRNewswire/ — AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on the discovery and development of innovative and proprietary cell-based therapeutic products, today announced preliminary safety and efficacy results from its first time in human investigator-initiated trial (IIT) of C-CAR031 in connection with the Company’s oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The presentation shared data indicating a manageable safety profile and encouraging anti-tumor activity of C-CAR031 in patients with heavily pretreated advanced hepatocellular carcinoma (HCC) (1-6 lines of prior therapy). C-CAR031 is based on a novel GPC3-targeting CAR-T designed by AstraZeneca (LSE/STO/Nasdaq: AZN) and is manufactured by AbelZeta. C-CAR031 is being co-developed in China by AbelZeta and AstraZeneca.

“We are encouraged by the first clinical results of C-CAR031 in advanced hepatocellular carcinoma (HCC) patients,” said Tony (Bizuo) Liu, Chairman and CEO of AbelZeta. “The early data presented today provide compelling proof-of-concept to potentially redefine therapeutic paradigms in HCC and other GPC3-expressing solid tumors.”

Principal Investigator (PI) of the study, Professor Tingbo Liang from the First Affiliated Hospital of Zhejiang University, stated “C-CAR031 showed a good safety profile and promising efficacy in late-stage hepatocellular carcinoma patients, who typically have a limited number of treatment options available. The observed tumor shrinkage in the large/vast majority (91.3%) of the patients suggests that C-CAR031 has the potential to bring clinical value and offer hope to these patients.”

As of March 14, 2024, 23 of 24 patients on the study were eligible for efficacy assessment. Tumor reductions were observed in 91.3% patients, in both intrahepatic and extrahepatic lesions, with a median reduction of 42.2% (range, -28.1% 94.4%). The disease control rate was 91.3% and the ORR was 56.5% for patients across all DLs. In DL4, the ORR was 75.0%. With 9.03-month median follow-up, Kaplan-Meier estimation of median overall survival (mOS) is 11.14 months (95% CI, 7.56-NE).

No dose-limiting toxicity or immune effector cell associated neurotoxicity syndrome (ICANS) was observed. Cytokine release syndrome (CRS) was observed in 22 (91.7%) patients with the majority (87.5%) grade 1/2 CRS  and only 1 (4.2%) grade 3 CRS.

About C-CAR031
C-CAR031 is an autologous, armored GPC3-targeting chimeric antigen receptor T-Cell (CAR-T) therapy, being studied for the treatment of HCC. It is based on a novel GPC3-targeting CAR-T designed by AstraZeneca using their dominant negative transforming growth factor-beta receptor II dominant negative (dnTGFβRII) armoring discovery platform and is manufactured by AbelZeta in China. C-CAR031 is being developed in China under a co-development agreement between AbelZeta and AstraZeneca.1

About the Study
A Phase I clinical study (NCT05155189) aiming to assess the safety and anti-tumor activity of C-CAR031 injection in advanced/unresectable HCC patients is being conducted in China. As of March 14, 2024, a total of 24 patients received C-CAR031 infusion at 4 dose levels (DLs). 83.3% (20/24) had extrahepatic metastasis. The median number of prior lines of systemic therapy was 3.5 (range 1-6).

Abstract Title: “Phase I study of C-CAR031, a GPC3-specific TGFβRIIDN armored autologous CAR-T, in patients with advanced hepatocellular carcinoma (HCC).”
Abstract Number: 4019
Session Type and Title: Rapid Oral Abstract – Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary
Session Date and Time: 6/3/2024; 9:45 AM-11:15 AM CDT

References
1. AbelZeta Pharma Announces Agreement with AstraZeneca to Co-Develop a novel Glypican 3 (GPC3) Armored CAR-T Therapy in China. December 2023. https://www.abelzeta.com/abelzeta-pharma-announces-agreement-with-astrazeneca-to-co-develop-a-novel-glypican-3-gpc3-armored-car-t-therapy-in-china/

About AbelZeta Pharma, Inc.

AbelZeta is a global clinical-stage biopharmaceutical company with centers of excellence in Rockville, Maryland and Shanghai, China. AbelZeta is focusing on developing innovative and proprietary cell-based therapeutic products and is committed to ushering in bespoke treatments that harness the body’s own immune system to fight against hematological malignancies and solid tumors, as well as inflammatory and immunological diseases. AbelZeta advances research and development in its own GMP facilities at its centers of excellence for early-stage clinical studies, with a pipeline comprised of CAR-T and TIL therapies.

Forward-Looking Statements

Statements in this communication relating to plans, strategies, specific activities, and other statements that are not descriptions of historical facts are forward-looking statements. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors, which include any risks detailed from time to time in the Company’s reports. Such statements are based on the management’s current beliefs and expectations and are subject to significant risks and uncertainties outside of management and the Company’s control. Given these uncertainties, you should not place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as otherwise required by law, the Company does not undertake any obligation, and expressly disclaims any obligation, to update, alter or otherwise revise any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future events or otherwise.

Company Contact:

Sarah Kelly
Director of Communications
AbelZeta Pharma Inc.
Phone: +1 (240) 552 5870
Email: [email protected]

Download PDF

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