TBS-2025 / TuHURA Bio - LARVOL DELTA

VISTA a Potential New Immuno-Oncology Target in Acute Myeloid Leukemia (ASH 2023) - "Kineta has developed a fully human monoclonal antibody targeting VISTA, KVA12123, currently evaluated in a Phase 1/2 clinical trial alone and in combination with pembrolizumab in cancer patients with advanced solid tumors...Therefore, we have tested in vivo, in a Kasumi-3 AML disseminated tumor model, the efficacy of our antibody alone or in combination with standard of care therapy, cytarabine and doxorubicin...5mg/kg Dox by IV injections) was initiated in indicated groups for 5 cycles, before starting treatment with KVA12 for the rest of the study...Our data showed that KVA12123 and KVA12402 as single agents and in combination with chemotherapy reduced Kasumi-3 tumor load in the blood, spleen and bone marrow within the groups and significantly improved survival when compared to IgG1 control groups. These data all together indicate that anti-VISTA targeted therapy should be evaluated in myeloproliferative disorders like AML alone or in combination with standard of care."

Immuno-oncology • IO biomarker • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myeloproliferative Neoplasm • Oncology • Solid Tumor • CD33 • CD34 • PTPRC • VSIR

Upcoming Targeted Milestones by Program:…TBS-2025 (VISTA inhibiting antibody) (PRNewswire) - "(i) Q4 2025: Submission of the Phase 2 protocol and plan to the FDA for TBS-2025 in hematologic malignancies; (ii) Q1 2026: Initiation of a Phase 2 trial of VISTA inhibiting mAb in relapsed or refractory NPM1-mutated AML in combination with a menin inhibitor."

FDA event • New P2 trial • Acute Myelogenous Leukemia

Upcoming Targeted Milestones by Program:…TBS-2025 (GlobeNewswire) - "2H 2025: Planned initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of relapsed or refractory NPM1-mutated AML."

New P2 trial • Acute Myelogenous Leukemia

TuHURA Biosciences Completes Acquisition of Kineta (PRNewswire) - "TuHURA Biosciences...announced the successful completion of the acquisition of Kineta, Inc. (OTCPK:KANT) ('Kineta'), the maker of the novel VISTA inhibiting mAb formerly known as KVA12123, now renamed as TBS-2025....Acquisition adds Phase 2 ready novel VISTA inhibiting monoclonal antibody (mAb) to TuHURA's late-stage immuno-oncology pipeline. TuHURA planning to initiate a Phase 2 randomized trial involving VISTA inhibiting antibody in 2nd Half 2025. Completion of the acquisition unlocks the fourth tranche of funds from $12.5 million aggregate PIPE financing announced June 3, 2025....'We believe, in a relatively inexpensive, small Phase 2 study, we can determine if TBS-2025, our VISTA inhibiting antibody, can augment the response rates seen with menin inhibitors and decrease the rate of relapse in patients with NMP1 mutated relapsed or refractory AML'."

M&A • New P2 trial • Acute Myelogenous Leukemia

TuHURA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides a Corporate Update (PRNewswire) - "Upcoming Anticipated Milestones by Program:...VISTA Inhibiting Monoclonal Antibody: (i) Q2 2025: TuHURA expects to close its acquisition of Kineta, Inc. and Kineta's VISTA inhibiting mAb; (ii) Q3 2025: Initiation of Phase 2 trial of VISTA inhibiting mAb in combination with a menin inhibitor for the treatment of NPM1-mutated AML."

M&A • New P2 trial • Acute Myelogenous Leukemia

Initial results from a first in human phase 1 study of KVA12123, an anti-VISTA antibody, alone and in combination with pembrolizumab in patients with advanced solid tumors (AACR 2025) - P1/2 | "In January 9th 2025, 36 patients were dosed including 24 patients in Part A and 12 in Part B. Enrollment in all monotherapy cohorts (3 to 1000mg) has been completed as well as 3 of the 4 combination cohorts (30 to 300mg KVA + Pembro 400mg). Treatments have been well tolerated and no dose limiting toxicities observed. The most common adverse events are grade 1 and 2 chills, fatigue and infusion related reactions with no evidence of CRS."

Clinical • Combination therapy • IO biomarker • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma

TuHURA Biosciences and Kineta Present Updated Results from Kineta's Phase I-II Study of KVA12123…at the American Association for Cancer Research Annual Meeting (PRNewswire) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor: Kineta Inc. | "In the first poster presentation, (CT041/20) TuHURA and Kineta provided updated results from VISTA-101, a Phase I-II first-in-human study of KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors....At 1,000mg every two weeks, KVA12123 demonstrated greater than dose proportional PK profile exceeding 90% VISTA receptor occupancy, providing important PK data for determining recommended Phase 2 dose. No dose limiting toxicities were observed in the study, including at the 1,000mg dose level, among the 24 patients treated in the monotherapy or in the 17 patients in the combination with pembrolizumab arms....'We look forward to evaluating the VISTA inhibiting antibody in a Phase 2 randomized study in relapsed AML, which we expect to initiate in the fourth quarter of 2025 based on the anticipated closing of the proposed merger with Kineta'."

New P2 trial • P1/2 data • Acute Myelogenous Leukemia • Solid Tumor

TuHURA Biosciences, Inc. Announces Abstracts Accepted for Poster Presentation at the 2025 AACR Annual Meeting (PRNewswire) - "TuHURA Biosciences, Inc...today announced that an abstract highlighting Kineta Inc.'s novel KVA12123 antibody and an abstract from Moffitt Cancer Center scientists examining the mechanisms of Company's IFx-Hu2.0 therapy in advanced melanoma have been selected for poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2025, taking place April 25-30, 2025, at the McCormick Place Convention Center in Chicago, IL."

Clinical data • Solid Tumor

TuHURA Biosciences, Inc. Enters into Definitive Merger Agreement to Acquire Kineta, Inc. (Kineta Press Release) - "TuHURA Biosciences, Inc...and Kineta, Inc...announced that they have entered into a definitive merger agreement in which TuHURA would acquire Kineta, including the rights to Kineta’s novel KVA12123 antibody, for a combination of cash and shares of TuHURA common stock via a merger transaction (the 'Proposed Transaction')....In connection with the merger agreement, TuHURA and Kineta entered into a Clinical Trial Funding Agreement under which TuHURA agreed to continue to fund clinical trial expenses for KVA12123 in an amount of up to $900,000, which may be increased upon mutual agreement....Targeting Phase 2a/b trial with KVA12123 in mutated NPM1 AML in 2025."

M&A • New P2 trial • Acute Myelogenous Leukemia

A phase 1/2 clinical trial of antiVISTA – KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors (SITC 2024) - P1/2 | "20230297 8. Advarra Study level: Pro00067861 All participants gave informed consent before taking part in this trial."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma

Kineta Updates KVA12123 Clinical Results from Ongoing Phase 1/2 VISTA101 Study at Society for Immunotherapy of Cancer (2024) (GlobeNewswire) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor: Kineta Inc. | "Monotherapy Dose Escalation...Of the 24 patients enrolled in the six monotherapy dose cohorts, 19 patients had at least one follow-up scan and 13 of these patients experienced stable disease (iRECIST); Durable clinical outcomes have been observed in a number of monotherapy patients with one patient with non-small cell lung cancer that failed six prior lines of therapy, including checkpoint inhibitor (CPI) therapy, experiencing stable disease lasting 60 weeks...Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W)...iCR and iPR responses have been observed and the combination has been well tolerated; Confirmed Partial Response in one mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a confirmed complete response (CR) in non-target lesions....Two remaining combination cohorts are expected to be fully enrolled by year-end."

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

Kineta Announces Completion of Enrollment in the Monotherapy Arm of the VISTA-101 Phase 1 Clinical Study in Advanced Solid Tumors (GlobeNewswire) - "Kineta...announced today that it has completed the enrollment of new patients into the monotherapy arm of the VISTA-101 phase 1 clinical trial evaluating KVA12123, Kineta’s novel VISTA blocking immunotherapy, in patients with advanced solid tumors. The monotherapy portion of the trial enrolled patients in 6-dose cohorts ranging from 3mg to 1000mg every two weeks and no dose limiting toxicities or cytokine related adverse events have been observed in the study. The Company is continuing to enroll patients into cohorts evaluating KVA12123 in combination with Merck’s...KEYTRUDA (pembrolizumab)....The company will present additional scientific data in 2024 at an upcoming scientific meeting."

Enrollment status • P1 data • Solid Tumor

Kineta Announces KVA12123 Abstract Accepted for Poster Presentation at Society for Immunotherapy of Cancer (SITC) 2024 (GlobeNewswire) - "Kineta...announced today that its abstract on the KVA12123 clinical program has been accepted for poster presentation at the Society for Immunotherapy of Cancer (SITC) 40th Annual Meeting....On November 8, 2024 Jason Henry M.D., Associate Director...will be presenting the poster with new clinical data from an ongoing Phase 1/2 clinical trial on KVA12123, Kineta’s VISTA blocking immunotherapy, alone and in combination with Merck’s (known as MSD outside of the US and Canada) anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with advanced solid tumors."

P1/2 data • Solid Tumor

Kineta Announces the Extension of the TuHURA Biosciences Exclusivity and Right of First Offer Agreement for KVA12123, Kineta’s VISTA blocking antibody Currently in Phase 1 (GlobeNewswire) - "Kineta...announced today that TuHURA Biosciences Inc (TuHURA) is exercising its right to extend their exclusivity and right of first offer agreement (the 'Agreement') for Kineta’s VISTA blocking antibody KVA12123. Under the terms of the Agreement entered in July 2024 between Kineta and TuHURA, TuHURA has the right to extend their rights for up to two 10-day periods. Kineta is entitled to receive $150,000 for each 10-day extension....Kineta and TuHURA are collaborating on the ongoing Phase 1/Phase 2 clinical trial in patients with advance solid tumor cancer."

Licensing / partnership • Solid Tumor

TuHURA Biosciences and Kintara Therapeutics Announce Kineta Inc. Reopens Enrollment for VISTA-101 Clinical Trial Evaluating KVA12123 in Patients with Advanced Solid Tumor Cancer (PRNewswire) - "TuHURA Biosciences...and Kintara Therapeutics...announced that Kineta...has reopened enrollment in its ongoing VISTA-101 Phase 1/2 clinical trial....To date, KVA12123 has cleared the fifth of six monotherapy dose levels and two of the four cohorts in combination with Merck's anti-PD1 therapy, KEYTRUDA (pembrolizumab)....30 of a projected 39 patients have been enrolled in the clinical trial to date, including a monotherapy arm with KVA12123 and a combination arm utilizing KVA12123 together with Merck's anti-PD1 therapy, KEYTRUDA (pembrolizumab). Kineta anticipates the trial to be fully enrolled by the end of 2024."

Enrollment status • Solid Tumor

TuHURA Biosciences Enters into Exclusivity and Right of First Offer Agreement for Kineta, Inc.'s KVA12123 Novel anti-VISTA Checkpoint Inhibitor (PRNewswire) - "TuHURA Biosciences...and Kintara Therapeutic...announced TuHURA has entered into an Exclusivity and Right of First Offer Agreement (the 'Agreement') with Kineta...for the potential acquisition of Kineta's KVA12123 anti-VISTA antibody and related rights and assets associated with and derived from the asset....Under the terms of the Agreement, TuHURA will pay Kineta $5.0 million, with $2.5 million paid at signing and, subject to certain provisions, an additional $2.5 million to be paid by July 15, 2024. In conjunction with the Agreement, TuHURA sold $5.0 million of shares of its common stock in a private offering to an existing shareholder. The exclusivity period under the Agreement lasts for 90 days (until October 1, 2024), subject to extension for an additional 20 days."

Licensing / partnership • Solid Tumor

Interim results of the ongoing phase 1-2 clinical trial of KVA12123, an engineered IgG1 targeting VISTA, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors (AACR 2024) - P1/2 | "Forty-two patients have been enrolled in the dose escalation monotherapy arm of the study. KVA12123 was administered at doses ranging from 3 to 1000 mg every 2 weeks over a 6-week cycle. KVA12123 was well tolerated at all dose levels and no DLTs were observed."

Clinical • Combination therapy • IO biomarker • Metastases • Monotherapy • P1/2 data • Oncology • Solid Tumor • CCL2 • CCL3 • CD4 • CD8 • CXCL10

Kineta Reports Initial Clinical Response Data at AACR 2024 of its Ongoing Phase 1/2 VISTA-101 Clinical Trial (GlobeNewswire) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor: Kineta Inc. | "Kineta...announced today at the...AACR in San Diego, CA an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123....Monotherapy Dose Escalation (3–300 mg KVA12123 Q2W):...Best overall response (BOR) in 9 of 12 patients with at least one follow-up scan is stable disease with a mean duration of 15 weeks; One patient with non-small cell lung cancer that failed 6 prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced stable disease lasting 28 weeks....Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W):...BOR in 2 of 3 patients with at least one follow up scan is: Partial Response in 1 mucoepidermoid carcinoma patient with a 54% reduction in target lesions and a complete response in non-target lesions. Stable disease in 1 renal cell carcinoma patient that had progressed on prior CPI therapy with a 24% reduction in target lesions."

P1/2 data • Non Small Cell Lung Cancer • Renal Cell Carcinoma

Kineta Reports Full Year 2023 Financial Results and Provides Corporate Update (GlobeNewswire) - "ANTICIPATED FUTURE MILESTONES: (i) Additional KVA12123 monotherapy safety and efficacy data in Q2 2024; (ii) Initial KVA12123 and pembrolizumab combination therapy data in Q2 2024."

P1/2 data • Solid Tumor

KVA12123 Clears Additional Cohorts in Monotherapy and in Combination Therapy Arms in the Phase 1/2 VISTA-101 Clinical Trial; Initial Clinical Response Data Reported (GlobeNewswire) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor: Kineta Inc | "Monotherapy Dose Escalation (3 – 300 mg KVA12123 Q2W): Best overall response (BOR) in 9 of 12 patients with at least one follow-up scan is stable disease with a mean duration of 15 weeks....One patient with non-small cell lung cancer that failed 6 prior lines of therapy, including checkpoint inhibitor (CPI) therapy, has experienced stable disease lasting 28 weeks; Combination Therapy Dose Escalation (30-100 mg KVA12123 Q2W, 400 mg pembrolizumab Q6W): BOR in 2 of 3 patients with at least one follow up scan is: Stable disease in 1 CPI-failure renal cell carcinoma patient with a 24% reduction in target lesions....Partial Response in 1 patient with a PD-L1 negative mucoepidermoid carcinoma and a 54% reduction in target lesions and a complete response in non-target lesions."

P1/2 data • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Kineta to Present New Preclinical Data on its Anti-VISTA Antibody KVA12123 in Acute Myeloid Leukemia at the AACR Blood Cancer Discovery Symposium (GlobeNewswire) - "Kineta...announced today that it will present new preclinical data on KVA12123, the Company’s anti-VISTA antibody, in acute myeloid leukemia (AML) at the American Association for Cancer Research (AACR) Blood Cancer Discovery Symposium, to be held on March 4-6 in Boston, Massachusetts....The abstract will be published as a freely available supplement in an AACR journal on the first day of the symposium."

Preclinical • Acute Myelogenous Leukemia

Kineta Provides Update on its Ongoing Phase 1/2 VISTA-101 Clinical Trial of KVA12123 in Patients with Advanced Solid Tumors (GlobeNewswire) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor: Kineta Inc. | "Kineta, Inc...announced today an update on its ongoing VISTA-101 Phase 1/2 clinical trial evaluating KVA12123 in patients with advanced solid tumors. KVA12123...cleared the first four monotherapy dose levels and the first cohort in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab). KVA12123 was well tolerated with no dose limiting toxicities (DLT) or cytokine related adverse events at any dose level. Additionally, KVA12123 demonstrates robust and dose proportional induction of pro-inflammatory biomarkers required for strong anti-tumor activity, demonstrating on target effects of blocking VISTA."

P1 data • Trial status • Oncology • Solid Tumor

A highly potent anti-VISTA antibody KVA12123 - a new immune checkpoint inhibitor and a promising therapy against poorly immunogenic tumors. (PubMed, Front Immunol) - "These results establish that KVA12123 is a promising drug candidate with a distinct but complementary mechanism of action of the first generation of immune checkpoint inhibitors. This antibody is currently evaluated alone and in combination with pembrolizumab in a Phase 1/2 open-label clinical trial in patients with advanced solid tumors."

Checkpoint inhibition • Journal • Hematological Disorders • Oncology • Solid Tumor

Kineta Publishes Preclinical Data Demonstrating the Potential of Anti-VISTA Antibody KVA12123 as an Immunomodulatory Therapy for Cancer (GlobeNewswire) - "Key results from the publication include: High affinity binding to VISTA through a unique epitope that is distinct from other clinical-stage anti-VISTA mAbs; High specificity against VISTA with no cross-reactivity against other members of the B7 family; Strong single-agent antitumor activity in several syngeneic tumor models and enhanced efficacy in combination with anti-PD-1; Well tolerated in preclinical toxicology studies without antibody-dependent cellular cytotoxicity or induction of CRS-related cytokines....Additional clinical efficacy data in the monotherapy arm and initial combination data with pembrolizumab are anticipated in Q2 2024."

P1/2 data • Preclinical • Oncology • Solid Tumor

KVA12123 Appears Well-Tolerated in Advanced Solid Tumors Across 3 Doses (Targeted Oncology) - P1/2 | N=314 | VISTA-101 (NCT05708950) | Sponsor : Kineta Inc. | "KVA12123 has demonstrated safety and is well tolerated at doses of 3, 10, and 30 mg in patients with advanced solid tumors, according to new data from the phase 1/2 VISTA-101 trial (NCT05708950). Across the first 3 cleared monotherapy cohorts, KVA12123 was well-tolerated with no dose-limiting toxicities observed. There was also no evidence of cytokine release syndrome (CRS)-associated toxicities detected. At the 30 mg dose level, administration of KVA12123 achieved >90% VISTA receptor occupancy (RO), and there was a greater than dose-proportional increase in drug exposure across all the doses evaluated in the trial."

P1/2 data • Colorectal Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Gynecologic Cancers • Head and Neck Cancer • Kidney Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor