IFx-2.0 / TuHURA Bio - LARVOL DELTA

Upcoming Targeted Milestones by Program: IFx-2.0 (Innate immune agonist) (PRNewswire) - "(i) Q2 2026: Anticipate preliminary results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP); (ii) Q4 2026: Anticipate completion of enrollment in the randomized, placebo-controlled Phase 3 accelerated approval trial in first line treatment as adjunctive therapy to Keytruda in advanced or metastatic MCC; (iii) Q1 2027: Anticipate topline results from the Phase 3 accelerated approval trial."

Clinical data • Enrollment status • Merkel Cell Carcinoma

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma (clinicaltrials.gov) - P2/3 | N=118 | Recruiting | Sponsor: TuHURA Biosciences, Inc. | Initiation date: Jun 2025 ➔ Oct 2025 | Not yet recruiting ➔ Recruiting

Checkpoint inhibition • Enrollment open • Trial initiation date • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC) (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: TuHURA Biosciences, Inc. | Not yet recruiting ➔ Recruiting | Initiation date: Apr 2025 ➔ Oct 2025

Checkpoint inhibition • Enrollment open • Trial initiation date • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Upcoming Targeted Milestones by Program: IFx-2.0 (GlobeNewswire) - "(i) Year-End 2025: TuHURA anticipates providing an update on enrollment progress in its Phase 3 accelerated approval trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line MCC; (ii) Q1 2026: Anticipated topline results from Phase 1b/2a clinical trial of IFx-2.0 as an adjunctive therapy to pembrolizumab in first line treatment for MCC of unknown primary origin (MCCUP); (iii) 2H 2026: Anticipated topline results from Phase 3 accelerated approval trial."

Clinical data • Enrollment status • Merkel Cell Carcinoma

TuHURA Biosciences Initiates Its Phase 3 Accelerated Approval Trial of IFx-2.0 as an Adjunctive Therapy to Keytruda (pembrolizumab) in First Line Treatment for Advanced or Metastatic Merkel Cell Carcinoma (PRNewswire) - "TuHURA Biosciences...announced the initiation of its Phase 3 accelerated approval trial of IFx-2.0, TuHURA's lead innate immune agonist, in patients with advanced or metastatic Merkel cell carcinoma (MCC)....The Company's Phase 3 accelerated approval trial of IFx-2.0, conducted under an SPA Agreement with the U.S. FDA, will evaluate IFx-2.0 as an adjunctive therapy administered weekly for three weeks concurrent with the approved dose and schedule for Keytruda compared to Keytruda plus placebo in the first line treatment for patients with advanced or metastatic MCC....The pivotal trial for IFx-2.0 is expected to enroll 118 participants across approximately 22 to 25 U.S. sites....The initiation of the Phase 3 trial represents the achievement of a milestone for the third tranche of funding under the Company's recently announced private placement, thereby trigging the purchase from the Company of an additional $2.23 million under the private placement financing."

Financing • Trial status • Merkel Cell Carcinoma

FDA Removes Partial Clinical Hold on TuHURA Biosciences' Phase 3 Accelerated Approval Trial for IFx-2.0 in Advanced or Metastatic Merkel Cell Carcinoma (Yahoo Finance) - "TuHURA Biosciences...announced that the FDA has removed the manufacturing-related partial clinical hold on the Company's Phase 3 accelerated approval trial for IFx-2.0, thereby allowing the trial to proceed as agreed to under the previously announced SPA Agreement with the FDA....'The removal of the partial clinical hold allows TuHURA to begin the trial's initiation and activation of clinical sites for the Phase 3 accelerated approval trial of IFx-2.0'..."

FDA event • Trial status • Merkel Cell Carcinoma

Multicenter, randomized, double-blinded, placebo-controlled trial of IFx-Hu2.0 (IFx) as adjunctive therapy with pembrolizumab (pembro) in checkpoint inhibitor (CPI)-naïve patients with advanced or metastatic Merkel cell carcinoma (MCC). (ASCO 2025) - "Primary and key secondary endpoints include objective response rate and progression-free survival respectively. Other secondary endpoints are safety, duration of response, and overall survival."

Checkpoint inhibition • Clinical • IO biomarker • Metastases • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer • CD14

TuHURA Biosciences Presents IFx-Hu2.0 Trial-in-Progress Poster at the 2025 American Society of Clinical Oncology Annual Meeting (PRNewswire) - "TuHURA Biosciences...announced that Moffitt Cancer Center presented a Trial in Progress poster of the Company's planned Phase 3 accelerated approval trial at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, 2025....The Company's Phase 3 accelerated approval trial of adjunctive IFx-Hu2.0, to be conducted under a SPA agreement with the U.S. FDA, will evaluate IFx-Hu2.0 (0.1 mg) as an adjunctive therapy administered weekly for three weeks concurrent to pembrolizumab (200 mg) Q3W, compared to the same pembrolizumab regimen plus placebo. The pivotal trial is expected to enroll 118 CPI-naïve patients with advanced or metastatic MCC across approximately 22 to 25 U.S. sites."

Trial status • Merkel Cell Carcinoma

TuHURA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides a Corporate Update (PRNewswire) - "Upcoming Anticipated Milestones by Program: IFx-Hu2.0: (i) Q2 2025: TuHURA anticipates the FDA's complete response letter lifting the partial clinical hold relating to completion of certain CMC requirements; (ii) Q2 2025: Initiation of Phase 3 accelerated approval trial in first line Merkel cell carcinoma."

FDA event • New P3 trial • Merkel Cell Carcinoma

TuHURA Biosciences, Inc. to Present at the 3rd Annual H.C. Wainwright BioConnect Conference (PRNewswire) - "TuHURA Biosciences, Inc...today announced that James A. Bianco, M.D., President and Chief Executive Officer of TuHURA, will present a company overview, including highlights of its IFx-Hu2.0 Phase 3 program, and its first-in-class bi-specific immune modulating Antibody drug, or peptide conjugates (ADCs, APCs) targeting Myeloid Derived Suppressor Cells (MDSCs), along with Kineta Inc's. VISTA inhibiting monoclonal antibody program, at the 3rd Annual H.C. Wainwright BioConnect Investor Conference at NASDAQ on Tuesday, May 20, 2025, at 2:30 PM ET."

Trial status • Merkel Cell Carcinoma

TuHURA Biosciences, Inc. Initiates Phase 1b/2a Study of IFx-Hu2.0 as an Adjunctive Therapy to Keytruda (pembrolizumab) in First Line Treatment for Metastatic Merkel Cell Carcinoma of Unknown Primary Origin (MCCUP) (PRNewswire) - "TuHURA...announced the initiation of its Phase 1b/2a trial of IFx-Hu2.0...in patients with MCCUP who would not be eligible for the Company's planned Phase 3 accelerated approval trial, which is targeted to begin enrollment later in Q2 2025...The Phase 1b/2a trial of IFx-Hu2.0 is...designed to assess the safety and feasibility of IFx-Hu2.0 as adjunctive therapy to pembrolizumab in adult patients with non-cutaneous MCC. The trial is designed to enroll a total of nine non-cutaneous MCC patients with either hepatic, pulmonary, or retroperitoneal lesions, enrolling three patients per lesion type (NCT06940440)...Data from the trial is anticipated by the end of Q4 2025 or early Q1 2026...TuHURA is also preparing to initiate...Phase 3 accelerated approval trial of IFx-2.0....The Company has reached agreement with U.S. Food and Drug Administration (FDA) on requirements for lifting a partial clinical hold on this trial and believes it will meet the requirements in Q2 2025."

P1/2 data • Trial status • Merkel Cell Carcinoma

IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC) (clinicaltrials.gov) - P1 | N=9 | Not yet recruiting | Sponsor: TuHURA Biosciences, Inc.

Checkpoint inhibition • New P1 trial • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Patients With Advanced Or Metastatic Merkel Cell Carcinoma (clinicaltrials.gov) - P2/3 | N=118 | Not yet recruiting | Sponsor: TuHURA Biosciences, Inc.

Checkpoint inhibition • New P2/3 trial • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor

Mechanistic insights into IFx-Hu2.0 responses in the first human trial after prior anti-PD-1 therapy failure (AACR 2025) - "The expression of Emm55 in a B16 murine melanoma model induces a direct anti-tumor and abscopal effect, with antibodies to Emm55 detected in murine sera. Further research is needed to assess the role of these antibodies in anti-tumor immunity. Unique clones from TCRSeq and BCRSeq suggest that IFx-Hu2.0 may be a personalized vaccine."

IO biomarker • Melanoma • Oncology • Solid Tumor

TuHURA Biosciences and Kineta Present Updated Results from…TuHURA's Mechanism of IFx-Hu2.0 Responses After Anti-PD-1 Therapy Failure in Advanced Melanoma at the American Association for Cancer Research Annual Meeting (PRNewswire) - "TuHURA also announced that the Markowitz Lab at Moffitt Cancer Center also presented a poster of TuHURA's IFx-Hu2.0 in patients with advanced treatment refractory Melanoma who, like patients in TuHURA's Phase 1b Merkel cell carcinoma trial, progressed while on CPI therapy. The data demonstrated that, among heavily pre-treated patients with advanced Melanoma who were resistant to anti-PD-1-based therapy, following IFx-Hu2.0, three of four patients achieved clinically meaningful, durable anti-tumor responses following re-administration of a CPI....'We look forward to that anticipated initiation of our Phase 3 accelerated approval trial in first line treatment of patients with advanced or metastatic Merkel cell carcinoma targeted for later this quarter'."

New P3 trial • P1 data • Melanoma • Merkel Cell Carcinoma

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov) - P1 | N=23 | Completed | Sponsor: TuHURA Biosciences, Inc. | Active, not recruiting ➔ Completed

Trial completion • Genetic Disorders • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: TuHURA Biosciences, Inc. | Trial completion date: Mar 2024 ➔ Aug 2024

Metastases • Trial completion date • Genetic Disorders • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Kintara Therapeutics and TuHURA Biosciences Provide Update on Recent Corporate and Clinical Advancements and Outline Near Term Milestones (PRNewswire) - "Recent Clinical Advancements...Advanced enrollment, dosing and clinical site expansion in Kintara's open label 15-patient REM-001 study in cutaneous metastatic breast cancer (CMBC); As of June 26, 2024, four patients have been dosed in the open label 15-patient REM-001 study in CMBC; In addition to Memorial Sloan Kettering Cancer Center, Montefiore Medical Center, the University Hospital for Albert Einstein College of Medicine, will soon begin screening patients...Expected Near-term Milestones....Q4 2024: Complete enrollment and 8 week follow-up of 10 patients in the REM-001 study; 2H 2024: Commence TuHURA's Phase 3 trial for IFx-2.0 personalized cancer vaccine for advanced Merkel cell carcinoma under FDA's accelerated approval pathway."

Enrollment status • New P3 trial • Trial status • Breast Cancer • Merkel Cell Carcinoma • Oncology • Skin Cancer • Solid Tumor

Phase 1b trial of IFx-Hu2.0, a novel in situ cancer vaccine, in checkpoint inhibitor-resistant Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (cSCC). (ASCO 2024) - P1 | "IT IFx-Hu2.0 is safe and feasible to administer at weekly dosing repeated up to 3 weeks. An unplanned exploratory analysis revealed frequent (56%) and durable responses in advanced MCC to ICI re-challenge despite prior resistance to this class of drug, suggesting that IFx induced an immune priming effect. Preliminary biomarker analyses to investigate this phenomenon are ongoing and will be presented."

Checkpoint inhibition • IO biomarker • P1 data • Hepatology • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

TuHURA Biosciences and Kintara Therapeutics Announce Positive Results from Phase 1b Trial of IFx-2.0, a Novel Personalized Cancer Vaccine, in Checkpoint Inhibitor Resistant Advanced Merkel Cell Carcinoma (MCC) and Cutaneous Squamous Cell Carcinoma (cSCC) (PRNewswire) - P1b | N=23 | NCT04160065 | Sponsor: TuHURA Biosciences, Inc. | "TuHURA Biosciences...today announced positive results from the primary analysis of TuHURA's completed Phase 1b trial evaluating IFx-2.0 among patients with advanced or metastatic MCC or cSCC who exhibited primary resistance to immune checkpoint inhibitor (ICIs) therapy...Five (5) of these 7 patients progressed within 3.8 months while receiving single agent anti-PD(L)-1 therapy. IFx-2.0 was administered as the immediate post ICI therapy. Following IFx-2.0 treatment, patients were rechallenged with an anti-PD(L)-1 agent. Four (4) of the 5 patients (80%) achieved a durable objective response (CR, pCR, 2 PRs) lasting, on average, 25 months, with 2 responses ongoing at 19 and 23 months."

P1 data • Cutaneous Melanoma • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma

TuHURA Biosciences to Present Its IFx-2.0 Personalized Cancer Vaccine Clinical Trial Results at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (ACCESSWIRE) - "TuHURA Biosciences...announced that its IFx-2.0 Phase 1b clinical trial results have been accepted for poster presentation at the 2024 ASCO Annual Meeting taking place May 31-June 4, 2024 in Chicago, IL."

P1 data • Non-melanoma Skin Cancer • Squamous Cell Skin Cancer

First-in-human stage III/IV melanoma​ clinical trial of immune priming agent IFx-Hu2.0. (PubMed, Mol Cancer Ther) - "IgG and IgM responses were seen in the peripheral blood to Emm55 peptides and known melanoma antigens, suggesting that IFx-Hu2.0 acts as an individualized "in-situ vaccine." Three of four patients previously refractory to anti-PD1 experienced clinical benefit upon subsequent anti-PD1-based treatment. Therefore, this approach is feasible, and clinical/correlative outcomes warrant further investigation for treating metastatic melanoma patients as an immune priming agent."

Journal • P1 data • Melanoma • Oncology • Solid Tumor

Kintara Therapeutics and TuHURA Biosciences Enter into Definitive Merger Agreement (PRNewswire) - "Kintara Therapeutics, Inc...and TuHURA Biosciences, Inc...announced that they have entered into a definitive agreement for an all-stock transaction forming a company with expertise and resources to advance a risk diversified late-stage oncology pipeline....The transaction is expected to close in the third quarter of 2024....IFx-2.0 expects to be entering a Phase 3 trial as adjunctive therapy with the checkpoint inhibitor Keytruda, to improve tumor response rate when compared to Keytruda alone in the first line treatment of patients with advanced or metastatic Merkel cell carcinoma. This single, placebo-controlled registration directed trial is expected to be conducted under the FDA's Accelerated Approval Pathway and is expected to begin enrollment in 2H-2024."

M&A • New P3 trial • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Solid Tumor

Immunotherapy With IFx-Hu2.0 Vaccine for Advanced Non-melanoma Skin Cancers (clinicaltrials.gov) - P1 | N=23 | Active, not recruiting | Sponsor: TuHURA Biosciences, Inc. | Trial completion date: Dec 2023 ➔ Mar 2024 | Recruiting ➔ Active, not recruiting

Enrollment closed • Metastases • Trial completion date • Genetic Disorders • Melanoma • Merkel Cell Carcinoma • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Morphogenesis, Inc. Biomarker Analysis Data from IFx-Hu2.0 in Melanoma Refractory to Anti-PD1-Based Therapies Demonstrates Ability to Overcome Primary Resistance to Checkpoint Inhibitors and Trigger an Innate Immune Response (Yahoo Finance) - P1 | N=20 | NCT04160065 | Sponsor: Morphogenesis, Inc. | "Morphogenesis, Inc...announced positive biomarker analysis data from its first-in-human study evaluating IFx-Hu2.0 for patients with melanoma refractory to anti-PD1-based therapies....The updated clinical information/data presented for the three patients includes: stable disease that was resected after two years without recurrence at > 3.7 years, partial response (PR) lasting 1.1 years, and PR that was resected but then recurred at 1.5 years."

P1 data • Melanoma • Oncology • Skin Cancer • Solid Tumor