AKTX-101 / Akari Therap - LARVOL DELTA

Akari Therapeutics Builds Momentum for AKTX-101 with Compelling Urothelial Cancer Data Supporting Differentiated ADC Strategy (GlobeNewswire) - "Demonstrated statistically significant anti-tumor activity in the UM-UC-14 advanced urothelial carcinoma model, which represents metastatic urothelial cancer, a setting where Padcev® (enfortumab vedotin) is currently approved as first-line therapy. While Padcev had limited responsiveness on the tumor in this model, AKTX-101 achieved statistically significant tumor growth inhibition compared with vehicle, supporting the potential of its differentiated payload mechanism in settings where current ADC payloads may have reduced effectiveness....Tumors initially treated with Trodelvy subsequently developed resistance and resumed growth. When these resistant tumors were switched from Trodelvy to AKTX-101....Akari continues to advance IND-enabling activities for AKTX-101 with the goal of initiating a Phase 1 clinical trial in mid-2027."

New P1 trial • Preclinical • Urothelial Cancer

AKTX-101 advancing through IND-enabling development activities toward planned initiation of Phase 1 clinical trial in mid-2027 (Akari Therapeutics Press Release)

New P1 trial • Oncology

Combination synergy of spliceosome modulator ADC with a K-Ras inhibitor in K-Ras –mutated pancreatic cancers. (ASCO 2026) - "Funded by Akari Therapeutics, Plc Background: AKTX-101 is a TROP2 ADC containing the spliceosome modulator payload, PH1(1). The TROP2 ADC, AKTX-101 exhibited synergistic efficacy with adagrasib in K-Ras G12C and G12D mutated pancreatic cancer cell lines. This synergy may be linked to PH1-specific effects on K-Ras splicing and may have contributed to improved adagrasib efficacy in G12D-mutated pancreatic cancer, where currently adagrasib is not approved. References Mitra SK, Monteith W, Do M, Tuffy G, Savage S, Kang J, Abuhay M, Losic T, Ghone S, Haskins WE, Jammalamadaka V, Satyal S. Cancer Res."

ADC • Genito-urinary Cancer • Lung Cancer • Oncology • Pancreatic Cancer • Prostate Cancer • Solid Tumor • AR • KRAS • TOP1

Akari Therapeutics Reports Breakthrough Preclinical Data Demonstrating Synergistic Activity of AKTX-101 with KRAS Inhibition in KRAS-Mutated Pancreatic Cancer Models (GlobeNewswire) - "The ASCO abstract evaluated the activity of AKTX-101 in combination with adagrasib...across pancreatic cancer cell lines harboring KRAS G12D and KRAS G12C. In these studies, the combination of AKTX-101 and adagrasib demonstrated synergistic cell killing in KRAS mutant cell lines driven by G12C and G12D. This synergistic inhibition was not observed with the comparator first-in-class topoisomerase I-targeting TROP2 ADCs. Instead, these ADCs exhibited antagonism when paired with adagrasib....Akari has initiated IND-enabling studies for AKTX-101 and is targeting initiation of a Phase 1 first-in-human clinical trial by mid-2027."

New P1 trial • Preclinical • Pancreatic Cancer

Rationale for the development of a differentiated Trop2 ADC in solid tumors of the bladder, lung, and breast (AACR 2026) - "Our results support the clinical development of AKTX-101 in bladder cancer and in other solid tumor niches. These niches will be explored further in planned translational studies."

ADC • IO biomarker • Bladder Cancer • Breast Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • EGFR • HER-2 • TACSTD2

Akari Therapeutics Reports Positive Preclinical Data for AKTX-101 Demonstrating Differentiated Cytotoxicity for First-in-Class TROP2 ADC Payload Targeting RNA Splicing (GlobeNewswire) - "AKTX-101 demonstrated strong, single-agent anti-tumor activity across multiple models across bladder, lung, and breast cancers. AKTX-101 demonstrated greater potency and cell killing compared to current TROP2 ADCs, including Topoisomerase I inhibitor-resistant tumor models, as well as standard-of-care chemotherapies and targeted therapies. Combination of AKTX-101 with anti-PD-1 therapy resulted in synergistic anti-tumor efficacy and tumor regressions within in vivo models, supporting future combinations with checkpoint inhibition to maximize tumor remissions rates."

Preclinical • Bladder Cancer • Breast Cancer • Non Small Cell Lung Cancer

Akari Therapeutics Announces Abstract Accepted for Poster Presentation at the American Association for Cancer Research Annual Meeting 2026 (GlobeNewswire) - "The Company has initiated IND enabling studies for AKTX-101 with a goal of starting its First-In-Human trial by late 2026/early 2027."

First-in-human • New trial • Preclinical • Bladder Cancer • Breast Cancer • Non Small Cell Lung Cancer

Akari Therapeutics Initiates GMP Manufacturing of AKTX-101 ADC Program to Support Phase 1 First-in-Human Clinical Trial (GlobeNewswire) - "Akari and WuXi XDC are building a strategic partnership around AKTX-101, combining Akari’s innovative ADC design and payload technology with WuXi’s global leadership in ADC development and manufacturing. The resulting GMP-grade drug product is intended to support Akari’s planned Phase 1 first-in-human clinical trial, which the Company expects to initiate in late 2026 or early 2027, subject to regulatory clearance."

Commercial • First-in-human • New P1 trial • Solid Tumor

Akari Therapeutics Highlights Preclinical Data Demonstrating Therapeutic Potential of Lead Candidate, AKTX-101, for Hard-to-Treat K-Ras Mutant Pancreatic Cancer (GlobeNewswire) - "Data highlights the ability of Akari’s Trop2 ADC, AKTX-101, to kill K-Ras G12V mutated cancer cell lines in preclinical models, potentially addressing one of the most lethal cancers with the lowest survival rates....AKTX-101 exhibited single digit nanomolar cytotoxic potency in all K-Ras G12V PDAC cell lines tested. Of significance, AKTX-101 also outperformed daraxonrasib in multiple PDAC cell lines....The Company plans to present this preclinical data at an upcoming scientific conference and is currently advancing AKTX-101 towards a first-in-human trial, expected to initiate in late 2026, and preliminary safety and efficacy data in 2027."

First-in-human • New trial • Preclinical • Pancreatic Ductal Adenocarcinoma

Akari Therapeutics Announces Abstract Accepted for Oral Presentation at the 40th Annual Society for Immunotherapy of Cancer (SITC) Meeting (GlobeNewswire)

Preclinical • Solid Tumor

Akari Therapeutics Reports Full Year 2024 Financial Results and Provides Corporate Update (GlobeNewswire) - "Upcoming Expected Value-Driving Milestones: Next-Generation Precision Bi-Functional ADC Platform - Present anticipated PH1 Payload preclinical data at scientific conference; Complete additional preclinical studies for AKTX-101; Continue to advance pipeline by generating additional validating data on PH1 payload while advancing discovery work on additional novel payloads PH5 and PH6....Seek licensing/strategic partner for AKTX-101 (TROP2 PH1 ADC)."

Licensing / partnership • Preclinical • Oncology • Solid Tumor

Akari Therapeutics and Peak Bio Announce Definitive Agreement to Merge as Equals Creating an Expanded Pipeline That Features a Novel Antibody Drug Conjugate (ADC) Toolkit (GlobeNewswire) - "Akari Therapeutics...and Peak Bio...announce a definitive agreement to merge as equals in an all-stock transaction. The combined entity will operate as Akari Therapeutics, Plc, which is expected to continue to be listed and trade on the Nasdaq Capital Market as AKTX....The merged pipeline features a robust ADC toolkit with novel payload and linker technologies. By combining chemotherapy with immunotherapy strategies, the merged company aims to develop cutting-edge solutions for cancer patients. In addition, the program includes a novel pre-clinical ADC candidate targeting TROP-2."

M&A • Oncology

Peak Bio, Inc. Presents Preclinical Data Highlighting Potential of Differentiated Trop2 PH1 (Novel Payload) ADC in Poster at 2023 AACR Annual Meeting (GlobeNewswire) - "These data highlight the rationale for the clinical development of Trop2 PH1 ADC as an investigational therapeutic for the treatment of solid cancers. Trop2 ADCs, conjugated with PH1 toxin at a drug-to-antibody (DAR) ratio of 4, demonstrated single digit nanomolar potency in eight different solid tumor indications....The unique design of the Trop2 PH1 ADC resulted in minimal off-target effects and demonstrated a differentiated safety profile versus first-in-class ADCs Furthermore, Trop2 PH1 ADCs exhibited more potent TGI at a lower DAR and dose, than FIC, in gastric cancer model."

Preclinical • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Rationale for the development of a differentiated Trop2 ADC (AACR 2023) - "The Trop2 ADC Trodelvy® (also known as Sacituzumab govitecan/ IMMU-132) is approved for therapy of TNBC and urothelial cancer, and Datopotamab DXd (DS-1062) is currently being tested in NSCLC.Peak Bio’s Thailanstatin suite of immunomodulatory linker-toxins (L-Ts) is a set of 7 related molecules with distinct ADC features that have been extensively characterized in vitro and in vivo as Her2 ADCs and is being used as a platform to generate a pipeline of potentially differentiated ADCs (AACR; Cancer Res 2021;81(13_Suppl):Abstract nr 1832). M2.8 is a fully humanized Peak Bio antibody (Ab) that targets human Trop2 (hTrop2) with high binding affinity [Kd (M)= 8.97-09]. The target validation studies suggest that Trop2 PH1 ADCs were sufficiently differentiated in areas of preclinical efficacy and well tolerated in a toxicologically relevant host."

Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • Urothelial Cancer • HER-2 • TACSTD2