TG01 vaccine / IOVaxis, Circio Holding - LARVOL DELTA

TG01 mutant RAS cancer vaccine data showing clinical benefit in multiple myeloma presented at EHA 2025 (Circio Press Release) - P1/2 | N=20 | NCT05841550 | "Circio Holding ASA...announces that interim data from the TG01 phase 1/2 clinical trial in multiple myeloma at Oslo University Hospital (OUS) has been presented at the European Hematology Association 2025 annual meeting....Available data demonstrate excellent tolerability and safety of TG01/QS-21 vaccination. 50% (6/12) of vaccinated patients show vaccine-induced specific T-cell responses against mutant K/N-RAS-peptides. 50% (6/12) of patients remain on study with stable disease (SD), no objective responses have so far been observed. 67% (4/6) of patients with SD had a K/N-RAS-peptide specific immune response by ELISPOT (1/2 negative patients fell very narrowly below positivity threshold). Enrollment and analysis of the TG01 vaccine-specific responses are ongoing."

P1/2 data • Multiple Myeloma

TESLA: Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer (clinicaltrials.gov) - P2 | N=24 | Active, not recruiting | Sponsor: University of Kansas Medical Center | Recruiting ➔ Active, not recruiting

Enrollment closed • Gastrointestinal Cancer • Hepatology • Neutropenia • Oncology • Pancreatic Cancer • Solid Tumor

TESLA: TG01/QS-21 ± PD-1 inhibitor for MRD in RAS mutated pancreatic cancer (YouTube) - "Anup Kasi...presents a Phase II randomized TESLA trial (NCT05638698) focusing on patients with surgically resected Stage 1-3 RAS mutant pancreatic ductal adenocarcinoma (PDAC) who are minimal residual disease positive (MRD+) after completing standard adjuvant chemotherapy."

Interview • Video

The first patient has been dosed in Circio’s TG01 triple combination study (Circio Press Release) - "Circio Holding ASA...today announces that the first patient has been dosed in the collaborative phase 2 trial sponsored by Georgetown University. In this study, mutant RAS cancer vaccine TG01 is being tested in combination with daratumumab (anti-CD38, Janssen) and nivolumab (anti-PD1, BMS) in patients with RAS-mutated pancreatic cancer (PDAC) and patients with non-small cell lung cancer (NSCLC)."

Trial status • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor

Circio joins collaboration to test the combination of TG01 vaccination with daratumumab and nivolumab in immunotherapy resistant patients with mutant RAS cancers (Circio Press Release) - "Circio Holding ASA...today announces that it has entered into a collaboration with Georgetown University as part of a collaborative research support agreement with Janssen Scientific Affairs, LLC (Janssen) and a drug supply agreement with Bristol Myers Squibb (BMS) to test its drug candidate TG01 in combination with daratumumab (anti-CD38) and nivolumab (anti-PD1) in patients with RAS-mutated pancreatic cancer and patients with non-small cell lung cancer (NSCLC)."

Licensing / partnership • Gastrointestinal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pancreatic Cancer • Solid Tumor

The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Oslo University Hospital | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Malignancies • Multiple Myeloma • Oncology • IFNG • KRAS • NRAS • RAS • TNFA

Circio: First patient in multiple myeloma trial dosed with TG01 at Oslo University Hospital (Market Screener) - "Circio Holding ASA...today announces that the first multiple myeloma (MM) patient has been dosed with mutant RAS cancer vaccine TG01 at Oslo University Hospital (OUS). The study is led by multiple myeloma expert Dr. Fredrik Schjesvold in a clinical collaboration between OUS and Circio. OUS is the study sponsor, with Dr. Schjesvold as the principal investigator, in collaboration with project lead Dr Hanne Norseth and Research medical student Hedda Monsen. Circio will provide TG01 drug supply, scientific support and a financial contribution."

Trial status • Hematological Malignancies • Multiple Myeloma • Oncology

Targeting minimal residual disease (MRD) in resected RAS mutated pancreatic cancer with vaccine TG01/QS-21 +/- PD-1 inhibitor, balstilimab: A randomized phase II study (TESLA). (ASCO 2023) - P2 | "Br J Cancer 2020 122:971-77. Clinical trial information: NCT05638698."

Clinical • IO biomarker • Minimal residual disease • P2 data • Residual disease • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Adenocarcinoma • Pancreatic Cancer • Solid Tumor • CD4 • CD8

The TG01 Study With TG01/QS-21 Vaccine in Patients With High-risk Smouldering Multiple Myeloma and Multiple Myeloma (clinicaltrials.gov) - P1/2 | N=20 | Not yet recruiting | Sponsor: Oslo University Hospital

New P1/2 trial • Hematological Malignancies • Multiple Myeloma • Oncology • KRAS • NRAS • RAS

Targovax: First patient dosed with TG01 in the USA (Market Screener) - "Targovax ASA...announces that the first patient has been dosed with cancer vaccine TG01 in the combination study with PD-1 checkpoint inhibitor (CPI) balstilimab in mutant RAS pancreatic cancer in the USA....In this study, 24 pancreatic cancer patients who have detectable tumor DNA in the blood following surgery and follow-up treatment will be randomly allocated to either TG/QS-21 vaccination alone or vaccination combined with PD-1 CPI balstilimab."

Trial status • Gastrointestinal Cancer • Oncology • Pancreatic Cancer

Targovax announces financing of up to NOK 300m over three years to advance its clinical cancer programs & pre-clinical circular RNA platform (Targovax Press Release) - "The financing will enable Targovax to drive long-term shareholder value by supporting progress for its three R&D pillars, including: Dosing the first patients in the ONCOS-102 phase 2 trial in PD-1 resistant melanoma at prestigious cancer centers in the USA and Europe; Generation of in vivo proof-of-concept data in multiple settings for Targovax´s unique circRNA program, an area of rapidly growing interest among big pharma and biotech; Supporting two clinical trials with the enhanced mutant RAS vaccine TG01 led by major academic centers in Norway and the USA."

Financing • Melanoma • Oncology • Skin Cancer • Solid Tumor

TESLA: Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer (clinicaltrials.gov) - P2 | N=24 | Recruiting | Sponsor: University of Kansas Medical Center | Not yet recruiting ➔ Recruiting

Enrollment open • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

TESLA: Tg01 Vaccine / Qs-21 Stimulon™ With Or Without Balstilimab As Maintenance Therapy Following Adjuvant Chemotherapy In Patients With Resected Pancreatic Cancer (clinicaltrials.gov) - P2 | N=24 | Not yet recruiting | Sponsor: University of Kansas Medical Center

New P2 trial • Gastrointestinal Cancer • Hepatology • Oncology • Pancreatic Cancer • Solid Tumor

Targovax announces that the TG01 study in multiple myeloma at Oslo University Hospital has received regulatory approvals to proceed (Targovax Press Release) - "It is expected that the study will open, and the first patient will be enrolled at Oslo University Hospital (OUS) in early 2023...Targovax ASA...announces that the planned clinical trial with mutant RAS cancer vaccine TG01 in multiple myeloma has received regulatory approval to proceed from NOMA and REK....The trial is a collaboration between OUS and Targovax and will test TG01 vaccination as a monotherapy in 20 KRAS or NRAS mutated multiple myeloma patients who continue to have measurable disease after completion of standard of care treatment."

New trial • Non-US regulatory • Hematological Malignancies • Multiple Myeloma • Oncology

Targovax announces clinical trial collaboration with Agenus to test TG mutant RAS vaccination in pancreatic cancer (Targovax Press Release) - "Targovax ASA...announces that it has entered into a collaboration agreement with The University of Kansas Cancer Center (KU Cancer Center) and Agenus Inc. to run a clinical trial testing mutant RAS vaccine TG01 in combination with PD-1 CPI balstilimab in pancreatic cancer following surgery and standard-of-care (SoC) chemotherapy....The planned study will be led by gastrointestinal cancer expert Dr. Anup Kasi in a three-way clinical collaboration between KU Cancer Center, Agenus and Targovax testing TG01 vaccination combined with Agenus´ immune-stimulatory adjuvant QS-21 STIMULON™ and PD-1 CPI balstilimab."

Licensing / partnership • Gastrointestinal Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Targovax announces that the FDA has granted authorization to initiate clinical trials with the enhanced TG01 RAS vaccine in the USA (Cision) - "Targovax ASA...announces that the US FDA has approved an IND application for TG01 combined with QS-21 STIMULON, which allows the preparations to initiate clinical trials in the USA to proceed....TG01 will be co-administered with the FDA approved adjuvant QS-21 STIMULON, provided by collaboration partner Agenus. QS-21 STIMULON is expected to enhance TG01 efficacy by driving stronger and broader mutant RAS immune responses."

IND • Oncology • Solid Tumor

Agenus Advances Portfolio with 6 Clinical Collaborations (GlobeNewswire) - "Targovax to conduct a clinical trial combining botensilimab and balstilimab with ONCOS-102...in patients with PD-1 relapsed/refractory melanoma; Oxford BioTherapeutics to conduct a clinical trial combining balstilimab with OBT076...in patients with solid tumors, including lung, gastric, and ovarian cancer; Immunogenesis to conduct a clinical trial combining balstilimab and zalifrelimab with evofosfamide...in patients with advanced solid tumors, including prostate, pancreatic, HPV-negative head and neck cancer; Targovax to conduct a clinical trial combining QS-21 STIMULON with TG01...in up to 3 cancer indications, including multiple myeloma; Rottapharm Biotech is conducting a clinical trial combining balstilimab with CR6086 (EP4 antagonist) in patients with pMMR-MSS colorectal cancer; Nelum is conducting a clinical trial combining zalifrelimab with NLM-001...and chemotherapy in patients with advanced pancreatic cancer."

Licensing / partnership • Colorectal Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Hematological Malignancies • Lung Cancer • Melanoma • Multiple Myeloma • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor

Targovax ASA and Agenus announce collaboration on mutant KRAS cancer vaccine adjuvanted with QS-21 STIMULON (GlobeNewswire) - “Agenus…and Targovax ASA…announce that they have entered into a clinical collaboration and supply agreement to combine Targovax’s TG mutant KRAS cancer vaccines with Agenus´s clinically validated and FDA approved QS-21 STIMULON adjuvant….Under the collaboration with Targovax, Agenus will supply QS-21 STIMULON and scientific support for up to three initial TG01 clinical trials in different cancer indications. If the clinical results meet certain pre-specified performance targets, the collaboration will be extended into an exclusive pivotal development and commercialization agreement where Agenus will be entitled to tiered double-digit royalties on future TG vaccine sales.”

Licensing / partnership • Oncology • Solid Tumor

Targovax grants IOVaxis 3 months extension to the exclusive license option for TG mutant RAS vaccines in Greater China and Singapore (PRNewswire) - "Targovax ASA...today announces that it has granted an extension of 3 months to the exclusive option agreement with IOVaxis Therapeutics of Nantong, China, for clinical development and licensing of the Targovax mutant RAS vaccines TG01 and TG02 in China, Hong Kong, Macau and Singapore...An IND application to initiate clinical development of TG01 has been submitted to the Chinese National Medical Products Administration (NMPA), but the application preparation and regulatory review process has been delayed due to COVID-19 related issues."

Licensing / partnership • Non-US regulatory • Oncology • Pancreatic Cancer