nespecabtagene autoleucel (AT101) / AbClon - LARVOL DELTA

PROMISING EFFICACY OF AT101, A NOVEL ANTI-CD19 CAR-T THERAPY, IN RELAPSED OR REFRACTORY LARGE B-CELL LYMPHOMA: INTERIM ANALYSIS OF A MULTICENTER PHASE 2 TRIAL (EHA 2025) - "Patients received 5×10⁶ CAR-T cells/kg following conditioning with fludarabine (30 mg/m²) and cyclophosphamide (400 mg/m²) for 3 days. AT101, employing a novel anti-CD19 scFv, demonstrates a remarkable response rate with a manageable safety profile in patients with relapsed or refractory B-cell non-Hodgkin lymphoma."

Clinical • IO biomarker • P2 data • Anemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Mediastinal B Cell Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Thrombocytopenia • CXCL10 • GZMB • IFNG • IL10 • IL2 • IL6 • TNFA

AbClon, CAR-T Treatment 'Nespecel' Approved by WHO International Nonproprietary Name [Google translation] (HIT News) - "AbClon announced on the 2nd that it had received approval from the World Health Organization (WHO) for the International Nonproprietary Name (INN) of 'nespe-cel (nespecabtagene autoleucel)' for its CAR-T treatment AT101. The International Nonproprietary Name is a unique name given by the WHO to prevent drug misuse and ensure international consistency of information, and is used as an official identifier in the approval process and commercialization process of each country. 'Nespecel' means CAR-T treatment derived from Abclon's own antibody platform 'NEST' technology."

Commercial • Hematological Malignancies

AbClon's CAR-T candidate 'AT101' targets expanded indications for blood cancers FL and MZL [Google translation] (The Bio) - "AbClon announced on April 10 its plans to expand the indications for its CAR-T treatment candidate, 'AT101,' to include follicular lymphoma (FL) and marginal zone lymphoma (MZL). The company aims to secure domestic investigational new drug (IND) clinical trial plan approval within the year."

IND • Follicular Lymphoma • Marginal Zone Lymphoma

AbClon signs CAR-T cell therapy tech transfer deal with Turkey’s TCT Health (Korea Biomedical Review) - "AbClon announced on Tuesday that it has signed an exclusive technology transfer agreement with TCT Health Technology, a Turkish company, for its homegrown CAR-T cell therapy, AT101. The agreement, signed on Feb. 28, will remain valid for 20 years from its effective date. Under the deal, AbClon will transfer CD19 CAR sequences, CD19 CAR-T-specific manufacturing processes and analytical methods, as well as CMC-related technologies. In return, TCT Health Technology will gain exclusive rights to develop and commercialize AT101 in the Turkish market....AT101 is an anti-CD19 CAR-T cell therapy designed for patients with relapsed or refractory B-cell non-Hodgkin lymphoma."

Licensing / partnership • Non-Hodgkin’s Lymphoma

App Clone succeeds in paying 19 billion won worth of CB and third-party allocation paid-in capital increase [Google translation] (AbClon Press Release) - "Antibody drug development specialist AbClon announced on the 13th that it has completed the payment of a total of KRW 19 billion in CB and third- party allocation paid-in capital increase issuance proceeds...The company explained that with this funding, it will be able to focus on its ongoing clinical trials and R&D while improving its financial soundness. In particular, it will focus on completing Phase 2 clinical trials for the successful commercialization of its core pipeline , CAR-T treatment AT101. It also aims to successfully develop follow-up pipelines, such as switchable CAR-T treatment AT-501 and dual antibody treatment AM105, to meet market and investor expectations ."

Financing • Hematological Malignancies • Solid Tumor

AbClon, CB·CPS issuance of 31 billion decided.. Daily Partners Lead [Google translation] (Biospectator) - "AbClon held a board meeting on the 28th and announced that it decided to raise 31 billion won through a paid-in capital increase by issuing convertible bonds (CB) and third-party allocated convertible preferred shares (CPS)...AppClon explained that this funding acquisition will allow it to focus on clinical trials and R&D while improving its financial soundness. In particular, it emphasized that it will focus on completing Phase 2 clinical trials for the successful commercialization of its core AT101 and meeting market and investor expectations through the successful development of its core pipeline....AppClon plans to use this fund to focus on completing and commercializing phase 2 clinical trials of its CD19 CAR-T 'AT101' for blood cancer and developing the next-generation solid cancer HER2 switchable CAR-T 'AT501'. It also plans to strategically use it to develop T cell engager EGFRx4-1BB dual antibodies 'AM105 (colon cancer)' and 'AT109 (prostate cancer)'."

Financing • Colon Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Prostate Cancer • Solid Tumor

AbClon, Kati Treatment AT101 US Split Patent Registration... Strengthening Competitiveness by Expanding Rights Scope [Google translation] (AbClon Press Release) - "AbClon announced on the 5th that it has completed registration of a US divisional patent for its catheter treatment 'AT101'...The US divisional patent acquired this time has additional content covering the AT101 components, including the antibody....The company explained that with this patent registration, it has secured the rights to a wider range of catheter treatments."

Patent • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AppClon “AT101, Rapid Test Method Approved… From Patient-tailored Manufacturing to Administration Possible within 3 Weeks” [Google translation] (AbClon Press Release) - "AppClon announced...that it has received approval from the Ministry of Food and Drug Safety to change the rapid testing method for the sterility test and replication competent virus negative test for 'AT101', a CD19 targeting cell therapy currently in phase 2 clinical trials...The sterility test in the existing clinical sample manufacturing process took 14 to 18 days, and the replication competent virus negative test took 33 to 42 days. With the new rapid method, these periods can now be completed in 7 and 1 day, respectively. With this approval, it will take less than 3 weeks to manufacture AT101 KATI treatment from the blood cells of a clinical patient, complete quality inspection, and finally administer it to the patient....AT101's clinical indication, diffuse large B -cell lymphoma, is a rapidly growing malignant lymphoma. The longer the period of manufacturing the KATI treatment, the higher the possibility that the patient's condition..."

Commercial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AppClon Increases Technology Export Potential with Differentiated CAR-T Treatment [Google translation] (Pharm News) - "On the 11th, Daishin Securities analyzed that AppClon has a high possibility of global technology export due to its differentiation from existing chimeric antigen receptor T cell (CAR-T) treatments...Daishin Securities explained that AT101 can be launched in the domestic market in 2026 and that annual sales of 25 to 30 billion won can be expected. It plans to announce interim results in the second half of this year, and said that the recent researcher clinical trial approval from the Ministry of Food and Drug Safety in Korea will increase the possibility of global technology exports if meaningful results are announced....'We have secured the ability to produce up to 150 doses of treatment per year by building our own GMP facility.'"

Commercial • Launch non-US • P2 data • Sales projection • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClone, AT101 phase 2 clinical trial agreement with National New Drug Development Agency [Google translation] (AbClon Press Release) - "On the 17th, AbClon announced that it had signed a business agreement with the National New Drug Development Project...for the phase 2 clinical trial of 'AT101'. Based on the results of this phase 2 clinical trial, we plan to speed up product approval by the Ministry of Food and Drug Safety (MFDS )...As the first task of this year's national new drug development project, phase 2 clinical trials will be conducted over the next two years...The primary goal of the project is objective response rate evaluation, and the secondary goals include evaluation of tolerability , efficacy, and pharmacokinetic characteristics....The company explained that expectations for phase 2 are also increasing due to the high efficacy confirmed in phase 1 clinical trials."

Licensing / partnership • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

FOLLOW-UP ON PHASE 1 STUDY OF AT101, A NOVEL ANTI-CD19 CHIMERIC ANTIGEN RECEPTOR CELL THERAPY (CAR-T) IN RELAPSED OR REFRACTORY (R/R) B-CELL NON-HODGKIN LYMPHOMA PATIENTS (EHA 2024) - P1/2 | "In this first-in-human phase 1 trial, AT101 was tolerable with limited and manageable toxicities. In comparisonto current FMC63 scFv-based CD19 CAR-T therapies, AT101 exhibited potent and more enduring efficacy with aremarkable suppression of relapse after CR. A phase 2 clinical trial is currently underway for patients withDLBCL."

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock

Follow-up on phase 1 study of AT101, a novel anti-CD19 chimeric antigen receptor cell therapy (CAR-T) in patients with relapsed or refractory (r/r) b-cell non-Hodgkin lymphoma. (ASCO 2024) - P1/2 | "In this first-in-human phase 1 trial, AT101 was tolerable with limited and manageable toxicities. In comparison to current FMC63 scFv-based CD19 CAR-T therapies, AT101 exhibited potent and more enduring efficacy with a remarkable suppression of relapse after CR. A phase 2 clinical trial is currently under-going for DLBCL patients."

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock

AbClone “AT101 Global maintains overwhelming cure effect compared to CAR-T” [Google translation] (Hankyung) - P1/2 | N=82 | NCT05338931 | Sponsor: AbClon | "AbClone announced on the 4th that it announced follow-up data from the phase 1 clinical trial for blood cancer for its chimeric antigen receptor T cell (CAR-T) treatment drug 'AT101' at the American Society of Clinical Oncology (ASCO)...At a median follow-up period of 16.4 months, AT101 demonstrated superior treatment effectiveness compared to existing CAR-T treatments. Of the 9 subjects who showed complete response in the phase 1 clinical trial evaluation, 7 maintained complete response for more than 12 months, and the long-term complete response rate reached 77.8%...Despite including patients administered a very small dose, equivalent to 4% of the phase 2 clinical trial, the overall survival (OS) rate was 82.5% and the progression-free survival (PFS) rate was 66.7%....'Based on the effectiveness and safety of AT101 obtained in phase 1 clinical trial, we are currently conducting phase 2 clinical trial.'"

P1 data • Trial status • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

AbClone, expected to have higher efficacy compared to existing CAR-T treatments [Google translation] (Pharm News) - "The Korea IR Council said on the 3rd that it has confirmed that AbClone has high therapeutic potential compared to existing chimeric antigen receptor T cell (CAR-T) treatments, and that expectations about the platform and technology pipeline will be reflected in the stock price...AbClone is a company that develops new drugs for various cancer types based on platform technologies such as monoclonal antibodies, double antibodies, and CAR-T treatments. The main pipeline, CAR-T treatment 'AT101', is undergoing phase 2 clinical trials for non-Hodgkin B-cell lymphoma....and it is expected that conditional approval will be available when positive intermediate phase 2 clinical results are announced in the second half of this year. "

Clinical • P2 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClone "CAR-T treatment AT101, certified as a new technology by the Korea Industrial Technology Promotion Association" [Google translation] (Nate) - "AbClone announced on the 31st that its chimeric antigen receptor T cell (CAR-T) treatment product 'AT101' received new technology (NET) certification from the Korea Industrial Technology Association. The company emphasized that this is the first case of receiving new technology certification for CAR-T treatment technology....This treatment targets diffuse large B-cell lymphoma."

Commercial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Seoul Asan Medical Center approves AT101 clinical trial for researchers [Google translation] (AbClon Press Release) - "This project aims to develop AT101...in patients with relapsed or refractory diffuse large B- cell lymphoma (DLBCL) exposed to anti-CD19 Chimeric antigen receptor T cell (CAR-T) treatment at Asan Medical Center in Seoul. This is an ‘exploratory clinical study on T cells’ and is a high-risk clinical study in the field of gene therapy...This study uses 'domestically produced humanized CAR-T ', which can reduce the possibility of 'antibody formation against CAR-T', which is one of the causes of CAR-T treatment failure, and addresses unmet needs due to failure of treatment with existing CAR-T....Since the principal investigator is participating in a clinical trial of another CAR-T treatment , the committee requested that the study subjects be limited to patients who failed commercialized CAR-T treatment to prevent overlap between the study and the study subjects. The researcher accepted and deliberated. It was approved by the committee...."

New trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClone, AT101 phase 1 clinical follow-up data, abstract received from overseas clinical conferences, 'long-term follow-up data positive' [Google translation] (AbClon Press Release) - P1 | N=82 | NCT05338931 | Sponsor: AbClon | "AbClon announced on the 22nd that it has received a research abstract to present AT101 phase 1 clinical follow-up data at an overseas clinical conference in June...AbClone conducted a phase 1 clinical trial of AT101 on a total of 12 patients. Of these, all six patients who received medium and high doses achieved complete response (CR). Among the 6 patients in the low-dose treatment group, 3 had a complete response and 1 had a partial response (PR), and the objective response rate (ORR) reached 92%. Commercialized CAR-T treatments, Kymriah and Yescarta, have complete response rates of only 29% and 51%, respectively....AT101 is currently undergoing phase 2 clinical trials at 7 domestic institutions targeting 82 people."

P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClon, ‘The second HLB?’ Early stage similar…'First-line treatment for stomach cancer, expected to increase royalty sales [Google translation] (AbClon Press Release) - "HLB rose from a market capitalization of hundreds of billions of won to 10 trillion won, ranking third in KOSDAQ market capitalization . Some are evaluating AbClon as the 'second HLB ' and that it is very similar to the progress of new drugs in the early days of the stock price surge...Henlius plans to secure competitiveness in the market by increasing treatment effectiveness through combination therapy with HLX02 and AC101....The pipeline of most interest is AT101. AbClon announced follow-up data for patients in the AT101 phase 1 clinical trial at ASCO in June and aims to secure interim data for the phase 2 clinical trial in the second half of the year."

Commercial • P1 data • P2 data • Gastric Cancer • Gastrointestinal Cancer • Hematological Malignancies • Oncology • Solid Tumor

AbClone, 3 billion 3-way allocation request..'CD19 CAR-T Phase 2 Input' [Google translation] (Biospectator) - "AbClon announced that it held a board of directors meeting on the 13th and resolved to conduct a rights increase (issuance of convertible preferred shares allotment to a third party) worth a total of KRW 3 billion to raise funds for the phase 2 clinical trial of its CD19 CAR-T therapy candidate 'AT101'...The terms of issuance are a total of 276,492 shares, with an issue price of 10,850 won. Five institutional investors participated in the one-year custody....'We are also doing our best to apply for expedited approval of AT101 in the second half of 2024 in Korea.'"

Financing • Non-US regulatory • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Novel CAR T-Cell Therapy May Show Early Efficacy in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (THE ASCO POST) - P1 | N=82 | NCT05338931 | Sponsor: AbClon | "In the new phase I trial (ClinicalTrials.gov identifier NCT05338931), the researchers developed and tested AT101 in 12 patients with relapsed or refractory B-cell non-Hodgkin lymphoma...The researchers noted that the new study was designed to increase the dose level of AT101 after safety was confirmed in the first six patients...After a median follow-up of 6.5 months, the researchers found that the patients who received dose level two or higher experienced a 100% complete response rate and no relapsed disease...Additionally, the researchers reported that the novel therapy was found to be safe, with manageable side effects. Cytokine-release syndrome was reported in four patients, and immune cell–related neurotoxicity syndrome occurred in three patients...'the initial results seem very promising, and we look forward to moving into the planned phase II portion of the study.'"

Cytokine release syndrome • P1 data • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

A First-in-Human Phase I Study of AT101, a Novel Anti-CD19 Chimeric Antigen Receptor T Cell Product Targeting a Membrane-Proximal Domain of CD19 in Adults with Relapsed or Refractory B Cell Non-Hodgkin Lymphoma (ASH 2023) - P1/2 | "All pts received lymphodepletion with intravenous fludarabine (250 mg/m2) and cyclophosphamide (25 mg/m2) on days -4, -3, and -2. In this first-in-human phase I trial, AT101 was tolerable with limited and manageable toxicities. Notable preliminary efficacy was observed at the RP2D with no evidence of disease relapse after achieving a CR. These results warrant the pursuit of the planned phase II expansion cohort."

CAR T-Cell Therapy • Clinical • P1 data • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Septic Shock • Transplantation • CD19

Safety and efficacy of a novel anti-CD19 chimeric antigen receptor T cell product targeting a membrane-proximal domain of CD19 with fast on- and off-rates against non-Hodgkin lymphoma: a first-in-human study. (PubMed, Mol Cancer) - P1/2 | "We developed a novel, safe, and potent CART19 product that recognizes a membrane-proximal domain of CD19 with fast on- and off-rates and showed significant efficacy and promising safety in patients with relapsed B-cell NHL."

CAR T-Cell Therapy • Journal • P1 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Announcement of AT101 and new target CD30 CARTI treatment [Google translation] (Medipharms Today) - "AbClon...will participate in the 65th American Society of Hematology (ASH) to be held in San Diego, USA from December 9th to discuss its CAR-T treatment 'AT101' and its new target 'CD30' CARTI treatment. It was announced on the 13th that it would be jointly announced with the University of Pennsylvania School of Medicine in the United States...Additionally, AbClone is participating in ‘Bio Japan 2023’ currently being held in Japan....'We will strive for quick approval along with the successful progress of Phase 2 clinical trials for AT101.'"

New molecule • P1 data • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClone receives IND change approval for Phase 2 clinical trial for CAR-T treatment ‘AT101’ [Google translation] (Money Today Network (MTN)) - "AbClone received approval to change the clinical trial plan (IND) for the chimeric antigen receptor T cell (CAR-T) treatment 'AT101', becoming the second company in Korea to successfully enter Phase 2 clinical trials for a CAR-T treatment...According to the biopharmaceutical industry on the 21st, AbClone announced on the 20th that it received approval from the Ministry of Food and Drug Safety to change the IND for the phase 2 clinical trial of AT101 for patients with B-cell non-Hodgkin lymphoma...Phase 2 clinical trials will be conducted on 82 patients at six hospitals including Asan Medical Center in Seoul. The purpose of phase 2 clinical trials is to evaluate the safety, tolerability, and effectiveness of AT101 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma....'We expect to administer the first patient in October at the latest.'"

Non-US regulatory • Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

AbClon expands phase 2 trial of CAR-T therapy to 7 hospitals (Korea Biomedical Review) - "AbClon said Monday the company would expand its phase 2 clinical trial for its chimeric antigen receptor T-cell (CAR-T) therapy candidate, AT101 to seven sites...In addition to Asan Medical Center, Ajou University Hospital, Ulsan National University Hospital, and Dong-A University Hospital, where the phase 1 trial was conducted, AbClon is adding three new sites -- Samsung Medical Center, Seoul National University Hospital, and the Catholic University of Korea Yeouido St. Mary's Hospital....AbClon is conducting the phase 2 trial of AT101 in patients with hematologic malignancies."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology