TPIV200 / Mayo Clinic, Marker Therap - LARVOL DELTA

Vaccination with folate receptor-alpha peptides in patients with ovarian cancer following response to platinum-based therapy: A randomized, multicenter clinical trial. (PubMed, Gynecol Oncol) - P2 | "TPIV200 was well tolerated but was not associated with improved PFS. Additional studies are required to uncover potential synergies using multiepitope vaccines targeting FRα. Trial Registration NLM/NCBI Registry, NCT02978222, https://clinicaltrials.gov/search?term=NCT02978222."

Clinical • Journal • Oncology • Ovarian Cancer • Solid Tumor • CSF2 • FOLR1

[VIRTUAL] A randomized multicenter phase II trial to evaluate the safety and efficacy of vaccination with folate receptor alpha (FRα) peptides admixed with GM-CSF as an adjuvant versus GM-CSF alone in patients with platinum-sensitive ovarian cancer (EOC). (ASCO 2020) - P2 | "Although TPIV200 had a manageable safety profile, the study was terminated for futility after the planned interim analysis. Future development of FRα-targeted therapy will likely focus on the careful selection of patients whose cancers show high FRα expression. Research Funding: Marker Therapeutics, Inc."

Clinical • P2 data • Fatigue • Gynecologic Cancers • Oncology • Ovarian Cancer • Pain • Peritoneal Cancer • Sarcoma • Solid Tumor • CSF2 • FOLR1

A phase II trial of TPIV200 (a polypeptide vaccine against folate receptor alpha) plus durvalumab (anti-PD-L1 antibody) in patients with platinum-resistant ovarian cancer (SGO 2018) - "TPIV200/huFR-1 and durvalumab can be safely combined in heavily pretreated patients with platinum-resistant refractory OC. Analysis for the primary EP is ongoing and will be presented."

Clinical • IO biomarker • P2 data • PD(L)-1 Biomarker • Ovarian Cancer

Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer (clinicaltrials.gov) - P2; N=80; Completed; Sponsor: Marker Therapeutics, Inc.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

Folate Receptor Alpha Peptide Vaccine With GM-CSF in Patients With Triple Negative Breast Cancer (clinicaltrials.gov) - P2; N=80; Active, not recruiting; Sponsor: Marker Therapeutics, Inc.; Trial completion date: Dec 2021 ➔ Aug 2021; Trial primary completion date: Dec 2021 ➔ Aug 2021

Clinical • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • FOLR1 • HER-2

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P2; N=120; Terminated; Sponsor: Marker Therapeutics, Inc.; Trial completion date: Dec 2020 ➔ Jan 2020; Active, not recruiting ➔ Terminated; Trial primary completion date: Dec 2020 ➔ Jan 2020; Futility analysis did not support continuation of the trial

Clinical • Trial completion date • Trial primary completion date • Trial termination • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P2; N=80; Not yet recruiting; Sponsor: Tapimmune Inc.

Clinical • New P2 trial • Endometrial Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P2; N=120; Active, not recruiting; Sponsor: Marker Therapeutics, Inc.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P2; N=80; Recruiting; Sponsor: Tapimmune Inc.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Endometrial Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

Folate Receptor Alpha Peptide Vaccine With GM-CSF Versus GM-CSF Alone in Patients With Platinum Sensitive Ovarian Cancer (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Tapimmune Inc.; N=80 ➔ 120

Clinical • Enrollment change • Endometrial Cancer • Gynecologic Cancers • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Solid Tumor

TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P2; N=29; Completed; Sponsor: Memorial Sloan Kettering Cancer Center; Active, not recruiting ➔ Completed; Trial completion date: May 2021 ➔ Jan 2021; Trial primary completion date: May 2021 ➔ Jan 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Endometrial Cancer • Oncology • Ovarian Cancer • Solid Tumor

Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy (clinicaltrials.gov) - P1; N=19; Active, not recruiting; Sponsor: Mayo Clinic; Trial completion date: Dec 2020 ➔ Dec 2021

Clinical • Trial completion date • Endometrial Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Ovarian Serous Adenocarcinoma • Peritoneal Cancer • Solid Tumor

Safety, immunogenicity, and clinical efficacy of durvalumab in combination with folate receptor alpha vaccine TPIV200 in patients with advanced ovarian cancer: a phase II trial. (PubMed, J Immunother Cancer) - "Combination of TPIV200 and durvalumab was safe and elicited robust FRα-specific T cell responses in all patients. Unexpectedly durable survival in this heavily pretreated population highlights the need to investigate the impact of FRα vaccination on the OC biology post-treatment."

Clinical • Combination therapy • IO Biomarker • Journal • P2 data • Gynecologic Cancers • Immune Modulation • Inflammation • Oncology • Ovarian Cancer • Solid Tumor • CSF2 • FOLR1

Tapimmune, Inc. (TPIV) reports 50% patient enrollment in phase 2 study of Novel T-Cell vaccine targeting TNBC (Streetinsider.com) - P2, N=40; NCT02593227; Sponsor: Tapimmune;  “TapImmune…announced that it has enrolled 50% (40/80) of the patients in its randomized Phase 2 clinical study of its novel T-cell vaccine candidate TPIV 200 for treating triple-negative breast cancer (TNBC). The four-arm study is designed to determine the optimal vaccine dose and regimen to maximize the immune response generated against the vaccine's molecular target, folate receptor-alpha (FRa)… look forward with confidence to completing patient enrollment by the end of the year.”

Enrollment change • Enrollment closed • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy (clinicaltrials.gov) - P=N/A; N=19; Active, not recruiting; Sponsor: Mayo Clinic; Trial primary completion date: Sep 2017 ➔ Sep 2018

Trial primary completion date • Biosimilar • Bladder Cancer • Endometrial Cancer • Genito-urinary Cancer • Gynecologic Cancers • Immunology • Oncology • Ovarian Cancer • Solid Tumor • Urothelial Cancer

TapImmune's HER2/neu-targeted breast cancer vaccine to be studied in a large phase 2 immunotherapy combination study funded by an $11 million U.S. Department of Defense grant (PRNewswire) - "This grant [of $11 million from the U.S. Department of Defense (DoD)] will cover the costs of a large Phase 2 study [N=380] of TapImmune's HER2/neu-targeted breast cancer vaccine, TPIV110, in combination with another immunotherapeutic, trastuzumab (Herceptin®), for treating women with HER2/neu-positive breast cancer...TapImmune is also currently enrolling women into a 280-patient Phase 2 randomized, multi-center, double-blinded, placebo-controlled clinical trial of its novel therapeutic vaccine candidate TPIV200 [for TNBC/NCT03012100]..."

Enrollment open • Grant • New P2 trial • Biosimilar • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy (clinicaltrials.gov) - P1; N=19; Active, not recruiting; Sponsor: Mayo Clinic; Trial completion date: Dec 2019 ➔ Dec 2020

Trial completion date

Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy (clinicaltrials.gov) - P1; N=19; Active, not recruiting; Sponsor: Mayo Clinic; Phase classification: P=N/A ➔ P1

Clinical • Phase classification

Marker Therapeutics provides business and clinical update (PRNewswire) - P2, N=120; NCT02978222; P2, N=80; NCT02978222; Sponsor: Marker Therapeutics; "...the Company...has completed enrollment in its Phase 2 study in ovarian cancer using TPIV200 as a maintenance therapy for patients in their first remission after surgery and platinum-based chemotherapy...[and] expects to reach its planned interim analysis trigger of 55 patients who have progressed before the end of 2019; Triple negative breast cancer data: Of 27 patients evaluated to date for immunogenicity, 26 showed significant immune response to the vaccine treatment. Of 80 patients treated at 11 clinical sites, 11 have shown disease progression to date following treatment with TPIV200."

Enrollment status • P2 data

TPIV200/huFR-1 (A Multi-Epitope Anti-Folate Receptor Vaccine) Plus Anti-PD-L1 MEDI4736 (Durvalumab) in Patients With Platinum Resistant Ovarian Cancer (clinicaltrials.gov) - P2; N=29; Active, not recruiting; Sponsor: Memorial Sloan Kettering Cancer Center; Trial completion date: May 2019 ➔ May 2020; Trial primary completion date: May 2019 ➔ May 2020

Clinical • Trial completion date • Trial primary completion date

Vaccine Therapy in Treating Patients With Stage IIIC-IV Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cavity Cancer Following Surgery and Chemotherapy (clinicaltrials.gov) - P=N/A; N=19; Active, not recruiting; Sponsor: Mayo Clinic; Trial completion date: Dec 2018 ➔ Dec 2019

Clinical • Trial completion date