library TCR-T-cell therapy / Alaunos Therap - LARVOL DELTA

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors (clinicaltrials.gov) - P=N/A | N=19 | Terminated | Sponsor: Alaunos Therapeutics | N=2000 ➔ 19 | Suspended ➔ Terminated; TCR001-002 protocol was combined with TCR001-201 protocol, which was terminated due to business decisions.

Enrollment change • IO biomarker • Trial termination • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Non-Viral TCR Gene Therapy (clinicaltrials.gov) - P2 | N=0 | Withdrawn | Sponsor: National Cancer Institute (NCI) | N=210 ➔ 0 | Trial completion date: Dec 2029 ➔ Mar 2024 | Not yet recruiting ➔ Withdrawn | Trial primary completion date: Dec 2028 ➔ Mar 2024

Enrollment change • Gene therapy • IO biomarker • Metastases • Trial completion date • Trial primary completion date • Trial withdrawal • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gene Therapies • Genito-urinary Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Alaunos Therapeutics (TCRT) Reports Q3, Phase 1 Clinical Data and Continued Exploration of Strategic Alternatives (Streetinsider.com) - P1/2 | N=180 | NCT05194735 | Sponsor: Alaunos Therapeutics | "Clinical Data from TCR-T Library Phase 1/2 Trial:...Overall, the trial showed the Company’s T cells were well-tolerated in all evaluable participants with no dose-limiting toxicities (DLTs) and no immune effector cell-associated neurotoxicity syndrome (ICANS) were observed....One patient with non-small cell lung cancer (NSCLC) achieved an objective partial response with six months progression-free survival. Six other patients achieved best overall response of stable disease. The total overall response rate was 13% and disease control rate was 87% in evaluable patients with advanced, metastatic, refractory solid tumors..."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

HLA Typing & Tumor Neoantigen Identification for Phase I/II Study of Autologous TCR-T Cells in Subjects With Solid Tumors (clinicaltrials.gov) - P1/2 | N=2000 | Suspended | Sponsor: Alaunos Therapeutics | Recruiting ➔ Suspended

IO biomarker • Trial suspension • Biliary Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Hepatology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer

Alaunos Therapeutics Announces Second Quarter 2023 Financial Results, Interim Clinical Data and Exploration of Strategic Alternatives (GlobeNewswire) - P1/2 | N=180 | NCT05194735 | Sponsor: Alaunos Therapeutics | "Interim Clinical Data from TCR-T Library Phase 1/2 Trial: Eight patients have been treated in the Company’s TCR-T Library Phase 1/2 trial to date, six of which are evaluable as of today. The trial showed that the Company’s T-cells were generally well-tolerated in all evaluable participants and achieved an 83% disease control rate in evaluable patients with metastatic, refractory solid tumors. Disease control is measured by objective responses and stable disease. Persistence of TCR-T cells in peripheral blood was detected in all evaluable patients at last follow-up....Alaunos has decided to wind down its TCR-T Library Phase 1/2 trial and prioritize the hunTR® platform to explore potential partnering opportunities."

P1/2 data • Trial status • Oncology • Solid Tumor

Alaunos Therapeutics Announces Presentation at the 2nd Hawaii Global Summit on Thoracic Malignancies (GlobeNewswire) - "Alaunos Therapeutics, Inc...today announced that the Company will present at the 2nd Hawaii Global Summit on Thoracic Malignancies taking place June 27 – July 1, 2023. Alaunos Director of Translational Sciences Matthew Collinson-Pautz, Ph.D., will discuss the Company’s TCR-T therapy in solid tumors targeting specific, cancer-driving mutations..."

Clinical • Oncology • Solid Tumor • Thoracic Cancer

Alaunos Therapeutics to Present Early Data from TCR-T Library Phase 1/2 Trial at 2023 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - P1/2 | N=180 | NCT05194735 | Sponsor: Alaunos Therapeutics | "Alaunos Therapeutics, Inc...announced that the Company will present early translational data from the first three patients treated in its ongoing TCR-T Library Phase 1/2 trial at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2-6, 2023, at the McCormick Place Convention Center in Chicago....Anti-tumor activity was seen in two patients, as previously reported, including one patient with non-small cell lung cancer (NSCLC) who achieved partial response with six-month progression-free survival, and one colorectal cancer patient who achieved a best overall response of stable disease at six weeks with three-month progression-free survival....Alaunos expects to provide an interim data update on multiple new patients in the third quarter of 2023 and anticipates establishing a recommended Phase 2 dose by year-end 2023."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Alaunos Therapeutics Reports First Quarter 2023 Financial Results (GlobeNewswire) - "Recent Developments and Upcoming Milestones: TCR-T Library Phase 1/2 trial actively enrolling patients:...Alaunos currently expects to provide an interim data update on multiple new patients in the third quarter of this year as the Company advances the program towards Phase 2 readiness with a recommended Phase 2 dose anticipated by year end 2023."

P1/2 data • Trial status • Oncology • Solid Tumor

Alaunos Therapeutics Announces Poster Presentation at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting (GlobeNewswire) - "Alaunos Therapeutics...announced a poster presentation for its lead non-viral Sleeping Beauty TCR-T cell therapy program in solid tumors at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting....The TCR-T Library Phase 1/2 trial is an open-label, dose-escalation trial being conducted at The University of Texas MD Anderson Cancer Center. The trial is enrolling patients with non-small cell lung, colorectal, endometrial, pancreatic, ovarian and bile duct cancers that have a matching human leukocyte antigen (HLA) whose tumors contain at least one of the targeted driver mutations in KRAS, TP53 and EGFR."

P1 data • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • Thoracic Cancer • Uterine Cancer

Alaunos Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results (GlobeNewswire) - "Actively enrolling patients in TCR-T Library Phase 1/2 trial; expect to report interim data on multiple patients in mid-2023: The Company continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53 and EGFR hotspot mutations across six solid tumor indications....With these enhancements, the Company expects to enroll multiple patients in the months ahead....Expanding application of the hunTR^® TCR discovery platform to add additional TCRs to the TCR Library in 2023....Alaunos expects to expand its TCR library to 15 TCRs by the end of 2023."

P1/2 data • Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Adenocarcinoma • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Alaunos Therapeutics Highlights Strategic Priorities and Anticipated Portfolio Milestones for 2023 (GlobeNewswire) - "Expand TCR library using hunTR^® TCR discovery platform to increases addressable market...In 2023, the Company expects to further expand its library with exclusively owned TCRs targeting recurrent hotspot mutations​ in KRAS, TP53 and EGFR. Advance TCR-T library program to Phase 2 readiness: The Company continues to actively enroll patients in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR hotspot mutations across six solid tumor indications....The Company successfully dosed its third patient in the trial in December 2022 and expects to enroll multiple patients in the first half of 2023. Alaunos anticipates providing an interim data update by mid-2023 as it works towards advancing the program into Phase 2."

P1/2 data • Pipeline update • Trial status • Biliary Tract Cancer • Cholangiocarcinoma • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

First-in-human phase 1/2 study of autologous T cells engineered using the Sleeping Beauty System transposon/transposase to express T-cell receptors (TCRs) reactive against cancer-specific mutations in patients with advanced solid tumors. (ASCO 2022) - P1/2 | "Given the number and complexity of different neoantigen/HLA combinations on solid tumors, a TCR library approach is warranted...During the Treatment Period, patients will undergo lymphodepletion with cyclophosphamide and fludarabine...In Arm B, if initiated by protocol, subjects will also receive aldesleukin (interleukin-2) infusion starting on Day 0 (within 24 hours of TCR-T cell product infusion) at 720K IU/kg, every eight hours for up to 4 days...Clinical and radiologic response will be assessed at 6 and 12 weeks after TCR-T cell drug product infusion and every 12 weeks thereafter until up to 2 years or study discontinuation (e.g., disease progression, initiation of new anti-cancer therapy, consent withdrawn), whichever occurs first. All subjects will continue to be followed in the Long-Term Follow-up Protocol for up to 15 years post-TCR-T cell drug product infusion."

Clinical • IO biomarker • P1/2 data • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor • EGFR • IL2 • KRAS • TP53

Alaunos Therapeutics Reports Third Quarter 2022 Financial Results (GlobeNewswire) - "Expect to file IND amendment in 4Q22 to expand its TCR Library and move from a fresh to cryopreserved manufacturing process....Presented data highlighting potential of the Company’s hunTR platform to expand its TCR Library at the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting: In November 2022, the Company presented a poster at the SITC annual meeting, highlighting its proprietary hunTR (human neoantigen T-cell Receptor) platform....In the study, Alaunos evaluated hundreds of thousands of TCR+HLA+neoantigen permutations in nine patients across colorectal, endometrial and breast cancers. All patients screened had at least one detectable neoantigen-reactive TCR, including one shared KRAS mutation. Further screening of additional patients only for KRAS mutations resulted in discovery of KRAS-G12V reactive TCRs."

Clinical data • IND • Breast Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Gynecologic Cancers • Oncology

hunTR™: a hyperplex platform for the discovery of neoantigen-reactive T-cell receptors (SITC 2022) - "hunTR allows for the expansion of our hotspot mutation-targeted TCR library, increasing the addressable population of solid tumor patients (with matching hotspot mutation and HLA allele) eligible for TCR-T cell treatment. In addition, hunTR is applicable for personalized TCR-T therapy such that most solid tumor patients could be eligible for mutation-targeted cell therapy. Ethics Approval Human-derived specimens were obtained through a commercial source that adheres to all applicable regulations and guidelines of the relevant countries including the US."

IO biomarker • Tumor-specific neoantigens • Biliary Cancer • Cholangiocarcinoma • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor • KRAS

Alaunos Therapeutics Highlights Data from TCR-T Library Phase 1/2 Trial at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (GlobeNewswire) - P1/2 | N=180 | NCT05194735 | Sponsor: Alaunos Therapeutics | "Alaunos Therapeutics, Inc...announced early clinical data from the first patient in its ongoing TCR-T Library Phase 1/2 trial....Key highlights to be presented: First patient dosed was diagnosed with non-small cell lung cancer and had previously progressed on three prior lines of treatment. The patient was germline for HLA-A*11:01 with a KRAS G12D mutation, matching one of the ten TCRs within Alaunos’ TCR library....The patient was confirmed to have achieved a partial response with a regression of 46.3% in target lesions at six weeks, which subsequently deepened to 51.2% at week 12. T-cell persistence was ongoing as of week 12; The TCR-T cell therapy was well-tolerated and a manageable safety profile was observed in the first patient."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Alaunos Therapeutics Announces Early Clinical Data Showing Objective Clinical Response Using its TCR-T Cell Therapy (GlobeNewswire) - P1/2 | N=180 | NCT05194735 | Sponsor: Alaunos Therapeutics | "Alaunos Therapeutics, Inc...announced early clinical findings from its ongoing TCR-T Library Phase 1/2 trial....The TCR-T Library Phase 1/2 trial is an open label, dose escalation study being conducted at The University of Texas MD Anderson Cancer Center....The first patient dosed was diagnosed with non-small cell lung cancer with a KRAS G12D mutation, matching one of the ten TCRs within the Company’s TCR library....The patient had a confirmed objective partial response. The Company has dosed a second patient in the study, diagnosed with colon cancer, who has been treated at the second dose level and has cleared the 28-day safety window....Data is scheduled to be presented during a proffered talk at CICON, which is being held in New York, NY from September 28 – October 1, 2022."

P1/2 data • Trial status • Colon Cancer • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Alaunos Therapeutics to Present at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (GlobeNewswire) - "Alaunos Therapeutics...announced that it has been accepted to present a proffered talk at the CRI-ENCI-AACR Sixth International Cancer Immunotherapy Conference (CICON) being held in New York, NY from September 28 - October 1, 2022."

Clinical data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Thoracic Cancer

Alaunos Therapeutics to Present Trials in Progress Poster for its TCR-T Library Phase 1/2 trial at the 2022 American Society of Clinical Oncology Annual Meeting (GlobeNewswire) - "Alaunos Therapeutics...today announced a Trials in Progress poster presentation at the 2022 American Society of Clinical Oncology Annual Meeting being held in Chicago, IL June 3-7, 2022. The Trials in Progress poster presentation will summarize the adaptive trial design, dosing regimen, and follow up strategy for Alaunos’ ongoing TCR-T Library Phase 1/2 trial....'With the first patient successfully dosed we look forward to sharing an initial look at data later this year as we continue to enroll additional patients into our study.'"

Clinical protocol • Biliary Cancer • Biliary Tract Cancer • Colorectal Cancer • Endometrial Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Solid Tumor

Alaunos Therapeutics Doses First Patient in TCR-T Library Phase 1/2 trial for the Treatment of Patients with Solid Tumors (GlobeNewswire) - "Alaunos Therapeutics...announced that the first patient has been dosed in its TCR-T Library Phase 1/2 trial targeting KRAS, TP53, and EGFR mutations across six solid tumor indications using the Company’s Sleeping Beauty transposon/transposase technology....'We look forward to an initial data readout in the second half of this year'."

P1/2 data • Trial status • Oncology • Solid Tumor

Non-Viral TCR Gene Therapy (clinicaltrials.gov) - P2 | N=210 | Recruiting | Sponsor: National Cancer Institute (NCI) | Suspended ➔ Recruiting

Enrollment open • IO biomarker • Brain Cancer • Breast Cancer • Colorectal Cancer • Gastrointestinal Cancer • Gastrointestinal Disorder • Gene Therapies • Genito-urinary Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Solid Tumor

Ziopharm Oncology to Present Poster at American Association for Cancer Research Virtual 2021 Annual Meeting (GlobeNewswire) - "Ziopharm Oncology, Inc...announced today it will be presenting a poster at the upcoming American Association for Cancer Research (AACR) Virtual 2021 Annual Meeting...The poster is entitled 'Hotspot mutations in KRAS and TP53 targeted by TCR-T cells genetically modified with the Sleeping Beauty transposon/transposase system.'"

Clinical data • Oncology

Ziopharm Oncology Reports Third Quarter 2020 Financial Results and Provides Corporate Update (GlobeNewswire) - "The ongoing pandemic led to the depletion of patients available to be treated on TCR-T trials at the NCI due to disease progression while the facility was largely shut down and has added time needed to accrue new patients. As previously mentioned, the NCI has been proactively screening patients for neoantigens and TCRs to render them eligible for the trial (NCT0402436)."

Trial status • Breast Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Glioblastoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer