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

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

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

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

Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the ESMO Gynaecological Cancers Congress 2025 (PRNewswire) - "Anixa Biosciences, Inc...today announced that Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa's ovarian cancer CAR-T immunotherapy, will present an e-poster at the European Society for Medical Oncology ('ESMO') Gynaecological Cancers Congress 2025, to be held on June 19-21, 2025 in Vienna, Austria."

P1 data • Ovarian Cancer

EVEREST-2: Initial data of the logic-gated Tmod chimeric antigen receptor T-cell (CAR T) therapy A2B694 for patients with solid tumors associated with mesothelin (MSLN) expression and with human leukocyte antigen (HLA) loss of heterozygosity (LOH). (ASCO 2025) - P, P1/2 | " As of January 15, 2025, 5 participants (median age: 60 years; range, 50-84) have enrolled on EVEREST-2 and received A2B694 at DLs 1-2; participants had ovarian cancer (n = 3), pancreatic cancer (n = 1), and non-small cell lung cancer (n = 1) and had received a median of 4 prior lines of therapy (range, 1-7). The logic-gated approach was successful at reducing toxicity seen with prior MSLN-targeted CAR T therapies, and A2B694 showed successful CAR T expansion and tumor infiltration. The maximum tolerated dose has not been reached, and results from the dose-escalation phase continue to determine the RP2D."

CAR T-Cell Therapy • Clinical • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • HLA-A • MSLN

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 | Active, not recruiting ➔ Recruiting

Enrollment open • Platinum resistant • Germ Cell Tumors • Oncology • Ovarian Cancer • Solid Tumor • BRCA • PD-L1

Anixa Biosciences Announces Poster Presentation on Ovarian Cancer CAR-T Clinical Trial at the American Society of Clinical Oncology (ASCO) Annual Meeting (PRNewswire) - "Anixa Biosciences, Inc...today announced that Dr. Pamela D. Garzone, Chief Development Officer of Anixa, will present a poster at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place on May 30 – June 3, 2025, in Chicago, Illinois. Lead author on the poster is Dr. Robert Wenham, Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, and the principal investigator of the Phase 1 clinical trial of Anixa's ovarian cancer CAR-T immunotherapy."

P1 data • 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 • 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 Announces Chief Development Officer Dr. Pam Garzone to Speak at the Alliance for Cancer Gene Therapy Summit 2025 on March 19th (PRNewswire) - "Biosciences, Inc...announced Dr. Pam Garzone, Chief Development Officer of Anixa, will be attending the Alliance for Cancer Gene Therapy (ACGT) Summit 2025 and participating as a panelist on the Gynecologic and Breast Cancers panel. The Alliance for Cancer Gene Therapy Summit 2025 is being held on Wednesday and Thursday, March 19 - 20, 2025, at the Alexandria Center for Life Science in New York City....Dr. Garzone will join leading experts in the field to discuss advancements in cell and gene therapy, including Anixa's CAR-T therapy for ovarian cancer, and its potential impact on gynecologic and breast cancers. The panel is scheduled for Wednesday, March 19, 2025, from 11:15 AM – 12:15 PM ET."

Pipeline update • Ovarian Cancer

MCC-21113: Infusion of Autologous T Cells Engineered to Target FSH Receptor in Recurrent Ovarian Cancer (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: H. Lee Moffitt Cancer Center and Research Institute | N=48 ➔ 10 | Recruiting ➔ Active, not recruiting

Enrollment change • Enrollment closed • Germ Cell Tumors • Oncology • Ovarian Cancer • Solid Tumor • BRCA • PD-L1

Anixa Biosciences and Moffitt Cancer Center Complete Dosing in Third Cohort in Ovarian Cancer CAR-T Clinical Trial (PRNewswire) - "Anixa Biosciences, Inc...today announced has it has dosed its final patient in the third cohort of its ongoing Phase 1 clinical trial evaluating its novel chimeric antigen receptor-T cell (CAR-T) therapy for recurrent ovarian cancer....The fourth cohort is expected to commence after a 30-day verification that there continue to be no adverse effects experienced by the third cohort." "

Trial status • Ovarian Cancer

Anixa Biosciences Featured in Breaking Cancer News Article on Novel CAR-T Therapy for Ovarian Cancer (PRNewswire) - "Anixa Biosciences, Inc...is pleased to announce that its pioneering CAR-T therapy for ovarian cancer, developed in collaboration with Moffitt Cancer Center ('Moffitt'), was prominently featured in Breaking Cancer News in an article...The article highlights the groundbreaking clinical trial led by Dr. Robert Wenham...The trial explores the use of chimeric antigen receptor-T cell (CAR-T) therapy to treat ovarian cancer, a disease with historically limited treatment options for advanced-stage patients....The article also highlights the potential expansion of the study to evaluate repeat dosing, given Gallagher's response, and explores the broader implications of CAR-T therapy for solid tumors—an area of intense research and high unmet medical need."

Trial status • Ovarian Cancer

Anixa Biosciences Announces Approval of Protocol Amendment for Ovarian Cancer CAR-T Clinical Trial (PRNewswire) - "Anixa Biosciences, Inc...today announced that it, along with its partner Moffitt Cancer Center ('Moffitt'), has received approval for an amendment to the protocol governing its ongoing clinical trial using CAR-T therapy for the treatment of ovarian cancer...The key changes in the protocol allows patients who may benefit from a second dose of the CAR-T therapy to receive it and expands enrollment eligibility to include patients with sex cord-stromal tumors (SCSTs) and Sertoli Leydig cell tumors (SLCTs)."

Clinical protocol • Ovarian Cancer

Anixa Biosciences Chairman and CEO Discusses Pioneering CAR-T Cell Therapy and Breast Cancer Vaccine in Alpha Wolf Trading Interview (PRNewswire) - "In the discussion, Dr. Kumar provided insights into Anixa's groundbreaking CAR-T cell therapy for ovarian cancer and its breast cancer vaccine program, highlighting the Company's innovative approach to immunotherapy and cancer prevention. During the interview, Dr. Kumar provided key insights into Anixa's CAR-T cell therapy, which is designed to harness the power of the immune system to target ovarian cancer cells....Dr. Kumar also discussed Anixa's breast cancer vaccine program, which is designed to prevent triple-negative breast cancer (TNBC)—the most aggressive and hardest-to-treat form of breast cancer."

Clinical • Ovarian Cancer • Triple Negative Breast Cancer

Anixa Biosciences to Present at the 18th Annual European Life Sciences CEO Forum (PRNewswire) - "The conference brings together leading executives, investors, and industry experts from the global life sciences sector to discuss the latest innovations, investment trends, and partnership opportunities. Mr. Catelani will provide an update on Anixa's pipeline, highlighting its groundbreaking CAR-T therapy for ovarian cancer in collaboration with Moffitt Cancer Center, its breast cancer vaccine developed in partnership with Cleveland Clinic, and its expanding portfolio of cancer vaccine programs aimed at addressing multiple hard-to-treat cancers....The presentation will highlight recent clinical advancements and strategic initiatives aimed at accelerating the development of Anixa's innovative therapies. Additionally, Mr. Catelani will engage in one-on-one meetings with potential partners and investors."

Pipeline update • Ovarian Cancer • Triple Negative Breast Cancer

Senolytic CAR T Cells with Cancer-Agnostic Potential (LCC 2025) - "Our findings substantiate the potential of uPAR-targeting senolytic CAR T cell as a cancer-agnostic therapy applicable to a wide range of tumor types with minimum toxicity. Furthermore, senolytic CAR T cells synergize with senescence-inducing agents, showing promise in eradicating the minimum residual disease following chemotherapy or targeted therapy."

CAR T-Cell Therapy • Hematological Disorders • Hematological Malignancies • Hepatology • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

EVEREST-2: A seamless phase 1/2 study of A2B694, a logic-gated Tmod chimeric antigen receptor T-cell (CAR T) therapy, in patients with pancreatic cancer (PANC) or other mesothelin (MSLN)-expressing solid tumors and human leukocyte antigen (HLA)–A*02 loss of heterozygosity (LOH). (ASCO-GI 2025) - P, P1/2 | "Two autologous CAR T therapies are currently under investigation: A2B530, targeting carcinoembryonic antigen, in the EVEREST-1 trial, and A2B694, targeting MSLN, in the EVEREST-2 trial, described herein. J Clin Oncol. 2022."

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor • CEACAM5 • HLA-A • MSLN

Anixa Biosciences CEO Provides Letter to Shareholders (PRNewswire) - "Concurrently, our CAR-T program targeting ovarian cancer advanced significantly...2025 holds significant promise as we aim to build on the momentum of 2024...CAR-T Clinical Trial: Complete treatment of the third, fourth, and fifth dose cohorts and share data updates. Additionally, we plan to initiate pre-clinical studies of our CAR-T's effectiveness on other solid tumors; Vaccine Development: Continue development of vaccines for ovarian, lung, prostate, and colon cancers, with progress updates expected throughout the year."

P1 data • Pipeline update • Preclinical • Trial status • Colon Cancer • Lung Cancer • Ovarian Cancer • Prostate Cancer

Anixa Biosciences Initiates Dosing in Third Cohort in its Ovarian Cancer CAR-T Clinical Trial (PRNewswire) - "Anixa Biosciences...announced that it has dosed its first patient in the third cohort in the ongoing Phase 1 clinical trial of 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...No dose limiting toxicity was observed in the initial three-patient cohort or in the second three-patient cohort, in which patients received a CAR-T cell dose triple that of the first cohort. After the required one-month waiting period to assess the occurrence of dose limiting toxicity and review of all safety data, the trial has now dosed its first patient in the third cohort at a tenfold increase over the initial dose."

Trial status • Gynecologic Cancers • Oncology • Ovarian Cancer • Solid Tumor