liraltagene autoleucel (lira-cel) / Anixa Biosci, Moffitt Cancer Center - LARVOL DELTA

MCC-21113: Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jul 2026 ➔ Oct 2026

First-in-human • Trial primary completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA • FOLR1 • PD-L1

EVEREST-2: Phase 1/2 Study of Logic-Gated Tmod CAR T A2B694 in Lung Cancer and Other Tumors Expressing MSLN With HLA-A*02 LOH (IASLC-WCLC 2025) - P, P1/2 | "Patient 5 has KRAS G12V / STK11 co-mutated NSCLC adenocarcinoma that progressed on carboplatin, pemetrexed, and pembrolizumab. A2B694 has manageable safety and tolerability in patients with advanced solid MSLN-expressing tumors with tumor-associated HLA-A*02 LOH. The dose-escalation phase continues to enroll patients. All patients exhibited CAR T expansion, and there is an ongoing partial response in a patient with NSCLC."

P1/2 data • Colorectal Cancer • Fatigue • Lung Adenocarcinoma • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • KRAS • MSLN • STK11

Anixa Biosciences to Present at the 2026 Cantor Fitzgerald Global Healthcare Conference Highlighting its…Ovarian Cancer CAR-T Therapy (PRNewswire) - "Mr. Catelani will also discuss Anixa's ovarian cancer CAR-T therapy, liraltagene-autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center. Participants in this trial are highly pre-treated, recurrent and resistant ovarian cancer patients, who have failed conventional therapies and are progressing. In the lira-cel trial, dosing has advanced to the fifth and highest cohort evaluated to date, which incorporates lymphodepletion for the first time. No dose-limiting toxicities have been observed in the study to date, and four patients have surpassed one year of survival following treatment, with the longest at approximately 28 months."

P1 data • Platinum resistant • Ovarian Cancer

Anixa Biosciences…announced that management will participate in the H.C. Wainwright 28th Annual Global Investment Conference being held September 14 - 16, 2026 (PRNewswire) - "Dr. Kumar will also discuss Anixa's ovarian cancer CAR-T therapy, liraltagene-autoleucel, or lira-cel, which is being evaluated in an ongoing Phase 1 clinical trial in collaboration with Moffitt Cancer Center. Participants in this trial are highly pre-treated, recurrent and resistant ovarian cancer patients, who have failed conventional therapies and are progressing. In the lira-cel trial, dosing has advanced to the fifth and highest cohort evaluated to date, which incorporates lymphodepletion for the first time. No dose-limiting toxicities have been observed in the study to date, and four patients have surpassed one year of survival following treatment, with the longest at approximately 28 months."

P1 data • Platinum resistant • Ovarian Cancer

Anixa Biosciences…announced that the first patient has been treated in the fifth cohort of its ongoing Phase 1, dose-escalating, clinical trial (ClinicalTrials.gov NCT05316129) evaluating its novel FSHR-targeted CAR-T/CER-T therapy for recurrent ovarian cancer (PRNewswire) - "The patient received a dose of 1×10⁷/kg CAR-positive cells following lymphodepletion, representing the highest dose level evaluated to date in the study. To date, no dose-limiting toxicities have been observed across any cohort up to and including the dose level of 3x106/kg CAR-T cells, the prior dose tested. As of the date of this release, five patients in the study have surpassed one year of survival following treatment, with individual patients surviving approximately 28, 20, 17, 17, and 13 months post-treatment, respectively."

P1 data • Platinum resistant • Trial status • Ovarian Cancer

Anixa Biosciences Reports Positive Data from Completed Breast Cancer Vaccine Phase 1 Trial and Positive Survival Observations from Ongoing CAR-T Phase 1 Trial at New York Academy of Sciences' Frontiers in Cancer Immunotherapy Symposium (PRNewswire) - "The Company's breast cancer vaccine presentation...reported final Phase 1 findings for the investigational vaccine, including that all major primary endpoints were met, the vaccine was safe and well tolerated at the maximum tolerated dose based on safety and tolerability, and protocol-defined immune responses were elicited in 74% of trial participants. The Company's lira-cel presentation...reported the clinical trial design and objectives, as well as the current status of Anixa's ongoing Phase 1 clinical trial of lira-cel, including survival observations of multiple patients living over one year past treatment."

P1 data • Trial status • Ovarian Cancer • Triple Negative Breast Cancer

A logic-gated chimeric antigen receptor T-cell (CAR T) therapy with an armored, membrane-tethered IL-12 booster in patients with advanced solid tumors with HLA-A*02 loss of heterozygosity (LOH): EVEREST-2, a phase 1/2 study. (ASCO 2026) - P, P1/2 | "Early efficacy results include the first ever reported complete response in a patient with non-small cell lung cancer following treatment with a CAR T-cell therapy (A2B694). The phase 1 primary objective is to evaluate the safety and tolerability of A2B543 and identify a recommended phase 2 dose (RP2D). The phase 2 primary objective is to assess overall response rate."

CAR T-Cell Therapy • Clinical • Metastases • P1/2 data • Idiopathic Arthritis • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor • HLA-A • IL12A • MSLN

Anixa Biosciences Reports Updated Positive Survival Observations from Ongoing Phase 1 Trial of Lira-cel Ovarian Cancer CAR-T Therapy (PRNewswire) - "Updated data were presented on May 7, 2026, at the International Society for Cell & Gene Therapy ('ISCT') 2026 Annual Meeting....Several trial participants have lived significantly beyond their median expected survival of three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment, at 18, 17 and 17 months, respectively, and four additional patients have survived 11, 11, 8 and 7 months, respectively. Three of the patients who reached 18, 17 and 11 months, respectively, remain alive, and one additional patient who was treated more recently is also currently alive."

P1 data • Platinum resistant • Ovarian Cancer

Anixa Biosciences Announces Presentation of its Ovarian Cancer CAR-T Therapy at the International Society for Cell & Gene Therapy 2026 Annual Meeting (PRNewswire) - "Ms. Cox's presentation, titled 'Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer', will discuss the clinical trial design and objectives, as well as the current status of Anixa's ongoing Phase 1 clinical trial of lira-cel."

Clinical protocol • Platinum resistant • Trial status • Ovarian Cancer

EVEREST-2: A seamless phase 1/2 study of A2B694, a logic-gated Tmod CAR T-cell therapy, in patients with mesothelin-expressing solid tumors with human leukocyte antigen-A*02 loss of heterozygosity (AACR 2025) - P, P1/2 | "The first patient was enrolled on EVEREST-2 in April 2024. Dose escalation is ongoing."

CAR T-Cell Therapy • Clinical • First-in-human • IO biomarker • P1/2 data • Colorectal Cancer • Hematological Malignancies • Lung Cancer • Mesothelioma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

Anixa Biosciences to Participate in RedChip's Biotech Resurgence: Platforms and Pipelines of Today's Innovators Conference on April 16, 2026 (Anixa Biosciences Press Release) - "The presentation will cover several topics, including an overview of the Company and its business model, the Company's breast cancer vaccine meeting primary endpoints and generating protocol-defined immune responses in 74% of participants in its Phase 1 clinical trial, and the Company's ovarian cancer CAR-T therapy, lira-cel, exhibiting positive survival data in its ongoing Phase 1 clinical trial."

P1 data • Ovarian Cancer • Triple Negative Breast Cancer

Developing uPAR CAR T Cells for High-Grade Serous Ovarian Cancer (AACR 2024) - "Ongoing efforts encompass the assessment of the long-term safety and toxicity profiles of uPAR CAR T cells utilizing a humanized mouse model platform. Our results provide a strong rationale for developing uPAR CAR T cells as an anticancer strategy relevant to a broad range of tumor types, and provide an avenue for safety profiling of uPAR CAR T cells prior to clinical testing in non-cancer patients harboring senescence-related pathologies."

CAR T-Cell Therapy • IO biomarker • Bladder Cancer • High Grade Serous Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor

Anixa Biosciences…announced that Dr. Robert Wenham, Chair of the Gynecologic Oncology Department at Moffitt Cancer Center and principal investigator for the Company's ongoing ovarian cancer CAR-T therapy Phase 1 trial, will be presenting at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer… (PRNewswire) - "Dr. Wenham's presentation, titled 'Phase 1 clinical trial of autologous T cells genetically engineered with a chimeric receptor to target the follicle-stimulating hormone receptor (FSHR) in recurrent ovarian cancer,' will discuss the clinical trial design and objectives, as well as the current status of Anixa's ongoing Phase 1 clinical trial of lira-cel."

Clinical protocol • Trial status • Ovarian Cancer

Anixa Biosciences…announced that it will host its 2026 Annual Meeting of Stockholders (the 'Meeting') on Tuesday, March 10, 2026… (Yahoo Finance) - "The presentation will include a review of recent clinical milestones across the Company's oncology pipeline, including: (i) Encouraging survival observations and regulatory approval for substantial dose escalation in the Company's ongoing Phase 1 ovarian cancer CAR-T trial; and (ii) Final Phase 1 data from the breast cancer vaccine program, which met primary endpoints and demonstrated favorable tolerability and protocol-defined immune responses in the majority of participants."

P1 data • Platinum resistant • Breast Cancer • Ovarian Cancer

Anixa Biosciences Announces Dr. Jose Conejo-Garcia will Keynote the South Carolina Clinical & Translational Research Institute 2026 Retreat (PRNewswire) - "Dr. Conejo-Garcia's keynote presentation will include a discussion of Anixa's ongoing Phase 1 clinical trial of liraltagene autoleucel, or lira-cel, which utilizes the FSHR-mediated CAR-T therapy first discovered by Dr. Conejo-Garcia and his team at The Wistar Institute."

P1 data • Platinum resistant • Ovarian Cancer

Anixa Biosciences Reports Encouraging Patient Survival Observations in Ovarian Cancer CAR-T Trial; Achieves Regulatory Approval Enabling Major Dose Escalation (PRNewswire) - "To date, twelve patients have been treated in the trial at four dosage levels. Of these patients, seven have lived beyond their expected median survival of approximately three to four months, based on disease stage and prior therapy history. One patient survived 28 months following treatment, three patients have survived greater than one year following treatment (17, 15 and 14 months, respectively) and three patients have survived 11, 8 and 8 months, respectively. Three patients that have reached 15, 14 and 8 months remain alive, and one additional patient who was treated more recently, is also currently alive."

P1 data • Platinum resistant • Ovarian Cancer

Anixa Biosciences...announced that the United States Adopted Names (USAN) Council approved 'liraltagene autoleucel' for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer (PRNewswire) - "This U.S. approval follows the earlier approval for international use of the name by the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO)."

Commercial • Ovarian Cancer

Anixa Biosciences…announced that the International Nonproprietary Names (INN) Expert Committee of the World Health Organization (WHO) approved 'liraltagene autoleucel' for the non-proprietary name of the Company's novel FSHR-targeted CAR-T therapy for recurrent ovarian cancer (PRNewswire) - "'We remain focused on the successful execution of our ongoing Phase 1 trial of liraltagene autoleucel for the treatment of ovarian cancer, and look forward to commencing the 5th dose cohort in the coming weeks. The Phase 1 study is being conducted in partnership with Moffitt Cancer Center'."

Commercial • Platinum resistant • Trial status • Ovarian Cancer

Super-resolution high-speed video microscopy reveals rapid cytotoxicity and cooperative dynamics of folate receptor alpha CAR T cells against ovarian cancer (SITC 2025) - "Bystander CAR T cells would occasionally become activated during attacks and thereby amplify cytotoxicity.Conclusions This study captured a wide array of cell dynamics, revealing rapid target elimination, cooperative swarm-like behaviors, and on-site proliferation. These findings underscore the potential of high-resolution imaging to optimize CAR T-cell design for functionality and performance."

CAR T-Cell Therapy • Video • Oncology • Ovarian Cancer • Solid Tumor • FOLR1 • IL2

Targeting Dysregulated Wound Healing Programs in Cancer and Fibrosis with Immune Engineering (SITC 2025) - "Therapeutic efficacy was tracked via noninvasive biomarkers, including circulating soluble uPAR and uPAR-targeted PET imaging. Despite detectable expression in subsets of myeloid cells, treatment with uPAR CAR T cells did not induce sustained myelodepletion in mice with a humanized immune system.Conclusions These findings establish uPAR-targeted CAR T cells as a promising therapeutic strategy across cancer, fibrosis, and degenerative diseases by eliminating shared pathological cell states that sustain chronic inflammation and tissue dysfunction (figure 1).Abstract 299 Figure 1Request permissionsAbstract images (poster)"

Oncology • Ovarian Cancer • Solid Tumor

MCC-21113: Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer (clinicaltrials.gov) - P1 | N=10 | Recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Jul 2025 ➔ Jul 2026

Platinum resistant • Trial primary completion date • Germ Cell Tumors • Oncology • Ovarian Cancer • Solid Tumor • BRCA • PD-L1

Anixa Biosciences Announces Treatment of Second Patient in Fourth Cohort of Ovarian Cancer CAR-T Clinical Trial (PRNewswire) - "Patients in the fourth cohort are receiving a dose of three million CAR-positive cells per kilogram of body weight-representing a 30-fold increase over the initial dose level. To date, no dose-limiting toxicities (DLTs) have been observed in the fourth cohort."

Platinum resistant • Trial status • Ovarian Cancer

Anixa Biosciences Announces Issuance of Additional U.S. Patent for CAR-T Technology (PRNewswire) - "Anixa Biosciences...announced that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent Number 12,384,826 covering its chimeric antigen receptor-T cell (CAR-T) technology. This new patent extends protection of Anixa's CAR-T technology to 2045....Anixa's CAR-T technology is currently in a clinical trial at Moffitt Cancer Center, treating recurrent ovarian cancer patients."

Patent • Ovarian Cancer

Anixa Biosciences and Moffitt Cancer Center Complete Dosing of Fourth Cohort in Ovarian Cancer CAR-T Clinical Trial; Multiple Patients Surpassing Median Expected Survival (PRNewswire) - "The fifth cohort is expected to commence following a routine 30-day safety verification that no adverse effects have been observed in the fourth cohort....Notably, one patient from the 1st cohort remains alive 28 months post-treatment."

Trial status • Ovarian Cancer

Anixa Biosciences Initiates Dosing in Fourth Cohort in its Ovarian Cancer CAR-T Clinical Trial (PRNewswire) - "Anixa Biosciences...announced that it has dosed its first patient in the fourth dosage cohort in the ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer. The study is being conducted through a research partnership with Moffitt Cancer Center....The fourth cohort in the trial will receive a dose of three million CAR-positive cells per kilogram of body weight, representing a thirty fold increase from the first cohort. No dose-limiting toxicities were observed in the third cohort, enabling advancing to the fourth dosage cohort."

Platinum resistant • Trial status • Ovarian Cancer