TuHURA Biosciences and Kineta Present Updated Results from Kineta's Phase I-II Study of KVA12123 and 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
TuHURA Biosciences (NASDAQ:HURA) and Kineta presented updated results from two clinical studies at the AACR Annual Meeting. The first study, VISTA-101, evaluated KVA12123 (anti-VISTA antibody) alone and with pembrolizumab in advanced solid tumors. At 1,000mg dose every two weeks, KVA12123 achieved >90% VISTA receptor occupancy with no dose-limiting toxicities across 41 total patients.
The second study focused on TuHURA's IFx-Hu2.0 in advanced melanoma patients who previously failed checkpoint inhibitor (CPI) therapy. Three out of four heavily pre-treated patients achieved durable anti-tumor responses when rechallenged with CPI after IFx-Hu2.0 treatment. The therapy demonstrated increased T cell and B cell production with only mild Grade 1 and 2 adverse events.
TuHURA plans to initiate a Phase 3 trial in Merkel cell carcinoma and expects to close its merger with Kineta in Q2 2025, which includes acquiring rights to KVA12123.
TuHURA Biosciences (NASDAQ:HURA) e Kineta hanno presentato i risultati aggiornati di due studi clinici al Congresso Annuale AACR. Il primo studio, VISTA-101, ha valutato KVA12123 (anticorpo anti-VISTA) da solo e in combinazione con pembrolizumab in tumori solidi avanzati. Alla dose di 1.000 mg ogni due settimane, KVA12123 ha raggiunto oltre il 90% di occupazione del recettore VISTA senza tossicità dose-limitanti in 41 pazienti complessivi.
Il secondo studio si è concentrato su IFx-Hu2.0 di TuHURA in pazienti con melanoma avanzato che avevano precedentemente fallito la terapia con inibitori del checkpoint (CPI). Tre pazienti su quattro, fortemente pretrattati, hanno ottenuto risposte antitumorali durature quando sono stati nuovamente trattati con CPI dopo la terapia con IFx-Hu2.0. Il trattamento ha mostrato un aumento della produzione di cellule T e B con solo lievi eventi avversi di grado 1 e 2.
TuHURA prevede di avviare uno studio di Fase 3 nel carcinoma a cellule di Merkel e si aspetta di concludere la fusione con Kineta nel secondo trimestre 2025, che include l’acquisizione dei diritti su KVA12123.
TuHURA Biosciences (NASDAQ:HURA) y Kineta presentaron resultados actualizados de dos estudios clínicos en la Reunión Anual de AACR. El primer estudio, VISTA-101, evaluó KVA12123 (anticuerpo anti-VISTA) solo y en combinación con pembrolizumab en tumores sólidos avanzados. Con una dosis de 1,000 mg cada dos semanas, KVA12123 alcanzó más del 90% de ocupación del receptor VISTA sin toxicidades limitantes de dosis en un total de 41 pacientes.
El segundo estudio se centró en IFx-Hu2.0 de TuHURA en pacientes con melanoma avanzado que previamente no respondieron a la terapia con inhibidores del punto de control (CPI). Tres de cuatro pacientes con tratamientos previos intensivos lograron respuestas antitumorales duraderas al ser tratados nuevamente con CPI después del tratamiento con IFx-Hu2.0. La terapia demostró un aumento en la producción de células T y B con solo eventos adversos leves de grado 1 y 2.
TuHURA planea iniciar un ensayo de fase 3 en carcinoma de células de Merkel y espera cerrar su fusión con Kineta en el segundo trimestre de 2025, lo que incluye la adquisición de los derechos sobre KVA12123.
TuHURA Biosciences (NASDAQ:HURA)와 Kineta는 AACR 연례 회의에서 두 건의 임상 연구 최신 결과를 발표했습니다. 첫 번째 연구인 VISTA-101은 진행성 고형 종양에서 KVA12123(항-VISTA 항체)을 단독 및 펨브롤리주맙과 함께 평가했습니다. 2주마다 1,000mg 용량 투여 시 KVA12123은 총 41명의 환자에서 90% 이상의 VISTA 수용체 점유율을 달성했으며 용량 제한 독성은 없었습니다.
두 번째 연구는 이전에 면역관문억제제(CPI) 치료에 실패한 진행성 흑색종 환자에서 TuHURA의 IFx-Hu2.0에 초점을 맞추었습니다. 집중 치료를 받은 4명 중 3명이 IFx-Hu2.0 치료 후 CPI 재투여 시 지속적인 항종양 반응을 보였습니다. 이 치료법은 경증 1~2등급 부작용만 나타내면서 T 세포와 B 세포 생산이 증가함을 입증했습니다.
TuHURA는 머클 세포암 3상 시험을 시작할 계획이며, 2025년 2분기에 Kineta와의 합병을 완료할 것으로 예상하며, 여기에는 KVA12123 권리 취득도 포함됩니다.
TuHURA Biosciences (NASDAQ:HURA) et Kineta ont présenté des résultats actualisés de deux études cliniques lors de la réunion annuelle de l’AACR. La première étude, VISTA-101, a évalué KVA12123 (anticorps anti-VISTA) seul et en association avec le pembrolizumab dans des tumeurs solides avancées. À la dose de 1 000 mg toutes les deux semaines, KVA12123 a atteint plus de 90 % d’occupation des récepteurs VISTA sans toxicités limitantes de dose chez 41 patients au total.
La deuxième étude s’est concentrée sur IFx-Hu2.0 de TuHURA chez des patients atteints de mélanome avancé ayant précédemment échoué à un traitement par inhibiteurs de points de contrôle (CPI). Trois des quatre patients lourdement prétraités ont obtenu des réponses antitumorales durables lors d’une nouvelle administration de CPI après le traitement par IFx-Hu2.0. Le traitement a démontré une augmentation de la production de cellules T et B avec seulement des effets indésirables légers de grades 1 et 2.
TuHURA prévoit de lancer un essai de phase 3 dans le carcinome à cellules de Merkel et s’attend à finaliser sa fusion avec Kineta au deuxième trimestre 2025, ce qui inclut l’acquisition des droits sur KVA12123.
TuHURA Biosciences (NASDAQ:HURA) und Kineta präsentierten aktualisierte Ergebnisse von zwei klinischen Studien auf dem AACR-Jahrestreffen. Die erste Studie, VISTA-101, untersuchte KVA12123 (Anti-VISTA-Antikörper) allein und in Kombination mit Pembrolizumab bei fortgeschrittenen soliden Tumoren. Bei einer Dosis von 1.000 mg alle zwei Wochen erreichte KVA12123 eine VISTA-Rezeptorbesetzung von über 90 % ohne dosislimitierende Toxizitäten bei insgesamt 41 Patienten.
Die zweite Studie konzentrierte sich auf TuHURAs IFx-Hu2.0 bei Patienten mit fortgeschrittenem Melanom, die zuvor eine Checkpoint-Inhibitor (CPI)-Therapie nicht erfolgreich hatten. Drei von vier stark vorbehandelten Patienten erzielten anhaltende antitumorale Reaktionen, als sie nach der IFx-Hu2.0-Behandlung erneut mit CPI behandelt wurden. Die Therapie zeigte eine erhöhte Produktion von T- und B-Zellen mit nur milden Nebenwirkungen der Grade 1 und 2.
TuHURA plant, eine Phase-3-Studie beim Merkelzellkarzinom zu starten und erwartet den Abschluss der Fusion mit Kineta im zweiten Quartal 2025, was auch den Erwerb der Rechte an KVA12123 umfasst.
- Strong efficacy: 3 out of 4 melanoma patients responded to treatment after IFx-Hu2.0 therapy
- KVA12123 achieved >90% VISTA receptor occupancy at 1,000mg dose
- Excellent safety profile with no dose-limiting toxicities in both studies
- Strategic acquisition of Kineta's KVA12123 antibody pending merger completion
- Advancement to Phase 3 trial in Merkel cell carcinoma
- Merger completion with Kineta still subject to closing conditions
- Small patient sample size in melanoma study (only 4 patients)
- Phase 3 trial initiation dependent on merger closing
Insights
TuHURA reports positive clinical data for two cancer immunotherapy candidates with favorable safety profiles and plans for near-term Phase 3 and Phase 2 trials.
The latest data from TuHURA and Kineta's clinical programs reveal promising developments in cancer immunotherapy. KVA12123, Kineta's anti-VISTA antibody, achieved >90% VISTA receptor occupancy at the 1,000mg dose level throughout the two-week dosing interval - a crucial pharmacodynamic marker indicating target engagement. Notably, the drug demonstrated a clean safety profile with no dose-limiting toxicities across all 41 patients in both monotherapy and combination arms.
VISTA represents a particularly compelling target in acute myeloid leukemia (AML), where 30-35% of patients harbor NPM1 mutations causing high VISTA expression on leukemic blasts. This appears to be a key immune evasion mechanism driving treatment failures in AML - presenting a clear development opportunity for KVA12123.
TuHURA's own IFx-Hu2.0 technology showed equally interesting results. In patients with advanced melanoma who had progressed on checkpoint inhibitor therapy - typically a difficult-to-treat population - 3 of 4 patients achieved clinically meaningful, durable responses when rechallenged with checkpoint inhibitors following IFx-Hu2.0 treatment. Mechanistically, IFx-Hu2.0 stimulates both T and B cell immune responses against tumors, potentially explaining its ability to overcome resistance mechanisms.
The company's clinical development timeline appears well-structured, with a Phase 3 accelerated approval trial in Merkel cell carcinoma planned for later this quarter, and a Phase 2 randomized study in relapsed AML targeting Q4 2025 following the Kineta merger. While the sample sizes remain small, these early signals suggest TuHURA is developing treatments addressing significant unmet needs in immunotherapy-resistant cancers.
TuHURA's pending acquisition of Kineta strengthens pipeline with complementary cancer immunotherapy assets targeting Q2 2025 close with clear strategic rationale.
TuHURA's pending acquisition of Kineta represents a strategically coherent transaction that substantially enhances the company's oncology portfolio. The merger, targeted to close by the end of Q2 2025, will bring Kineta's novel anti-VISTA antibody KVA12123 under TuHURA's control - complementing their existing IFx-Hu2.0 platform with a different mechanism of action in cancer immunotherapy.
This transaction demonstrates thoughtful capital allocation. TuHURA previously made an exclusivity payment to Kineta that enabled completion of the Phase I study for KVA12123, securing critical pharmacokinetic and receptor occupancy data at the 1,000mg dose level. This approach allowed TuHURA to de-risk the acquisition by validating key clinical parameters before full commitment.
The deal structure - comprising both cash and TuHURA common stock - preserves capital while giving Kineta shareholders potential upside in the combined entity. While specific financial terms aren't disclosed, the transaction appears to provide TuHURA with a clear development pathway for two complementary oncology assets targeting different molecular mechanisms.
From an operational perspective, TuHURA has outlined specific development timelines for both assets: a Phase 3 trial for IFx-Hu2.0 in Merkel cell carcinoma this quarter, and a Phase 2 study for KVA12123 in relapsed AML in Q4 2025. This indicates disciplined clinical development planning with potential for value creation across multiple indications. The complementary nature of these assets—one targeting innate and adaptive immunity broadly and the other targeting the specific VISTA immune checkpoint—provides pipeline diversification while maintaining focus in oncology immunotherapy.
Kineta presents updated clinical data from VISTA-101 trial of KVA12123, demonstrating >
TuHURA's Phase 3-ready IFx2.0 produced clinically meaningful anti-tumor responses and abscopal effect, after checkpoint inhibitor (CPI) therapy failure in patients with advanced melanoma when rechallenged with CPI
TAMPA, Fla., April 28, 2025 /PRNewswire/ -- TuHURA Biosciences, Inc. (NASDAQ:HURA) ("TuHURA"), a Phase 3 immune-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today reported on poster presentations of Kineta Inc.'s ("Kineta") KVA12123 novel anti-VISTA antibody and TuHURA's IFx-Hu2.0 in advanced melanoma and at the American Association for Cancer Research (AACR) Annual Meeting in
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 (NCT05708950). The poster, was presented by Thierry Guillaudeux, Ph.D., Chief Scientific Officer of Kineta. KVA12123 was found to be generally safe and well tolerated in all monotherapy and combination arms, with no dose-limiting toxicities observed. Additionally, KVA12123 demonstrated a favorable pharmacokinetic (PK) and pharmacodynamic (PD) profile at all dose levels, including:
- 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 are pleased to have Thierry present the latest data from the KVA12123 program, a valuable drug candidate that TuHURA will acquire following the closure of the proposed merger with Kineta which is currently targeted for the end of Q2 2025. TuHURA's exclusivity payment last July allowed Kineta the ability to restart and complete the Phase I study providing important data regarding receptor occupancy and other PK, PD and translational biomarker data at the previously unstudied 1,000mg dose level. The study demonstrated in excess of
Dr. Bianco continued, "Our primary interest in VISTA is its potential in immunologic tolerance in a variety of blood related cancers. Recent scientific data demonstrates that NPM1 mutation, present in
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.
"Demonstration of the development of antibody specific response to the Emm55 bacterial protein expressed on the surface of the tumor cell following IFx-Hu2.0 in the phase 1 study and an abscopal effect in murine model of melanoma is consistent with the data generated in patients with advanced cutaneous malignancies like melanoma or Merkel cell carcinoma," noted Dr. Bianco. "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."
In the second poster presentation relating to IFx-Hu2.0 entitled: "Mechanistic Insights into IFx- Hu2.0 Responses in the First Human Trial After Prior Anti-PD-1 Therapy Failure," (3428/23) IFx-Hu2.0's first-in-human study demonstrated stimulation of an innate immune response, with increased T cell and B cell production in peripheral blood compared to tumor tissue. This innate immune activation underscores the potential of IFx-Hu2.0 to generate tumor specific activate T and B cells for patients who are resistant to anti-PD-1 CPIs. Additionally, IFx-Hu2.0 was generally safe and well tolerated, with only mild Grade 1 and Grade 2 adverse events, largely injection site reactions.
As previously announced, on December 11, 2024, TuHURA entered into a definitive agreement with Kineta, Inc. (OTC Pink: KANT) ("Kineta"), in which TuHURA agreed to 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 upon the terms and conditions and subject to the conditions set forth in TuHURA's Form 8-K filed on December 12, 2024. The merger is currently targeted to close in Q2 2025 pending the satisfaction of certain closing conditions.
About TuHURA Biosciences, Inc.
TuHURA Biosciences, Inc. (Nasdaq: HURA) is a Phase 3 immuno-oncology company developing novel technologies to overcome primary and acquired resistance to cancer immunotherapy, two of the most common reasons cancer immunotherapies fail to work or stop working in the majority of patients with cancer.
TuHURA's lead innate immune agonist, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) compared to Keytruda® plus placebo in first line treatment for advanced or metastatic Merkel Cell Carcinoma.
In addition to its innate immune agonist product candidates, TuHURA is leveraging its Delta Opioid Receptor technology to develop first-in-class, bi-specific antibody drug conjugates and antibody peptide conjugates targeting Myeloid Derived Suppressor Cells to inhibit their immune- suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.
For more information, please visit www.tuhurabio.com and connect with TuHURA on Facebook, X, and LinkedIn.
IMPORTANT ADDITIONAL INFORMATION
In connection with the proposed acquisition by merger (the "Merger") of Kineta, Inc. ("Kineta") by TuHURA Sciences, Inc. ("TuHURA"), TuHURA filed with the
A definitive copy of the Joint Proxy Statement/Prospectus will be mailed to Kineta and TuHURA stockholders when that document is final. Investors and stockholders will be able to obtain free copies of the documents filed or that will be filed with the SEC by TuHURA, when they become available, through the website maintained by the SEC at www.sec.gov. The documents filed by TuHURA with the SEC may also be obtained free of charge at TuHURA's website at www.tuhurabio.com or upon written request to: TuHURA, 10500 University Drive, Suite 110,
NO OFFER OR SOLICITATION
This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the Merger and is not intended to and does not constitute an offer to sell or the solicitation of an offer to buy the securities of TuHURA or Kineta, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act.
PARTICIPANTS IN THE SOLICITATION
TuHURA and Kineta and their respective directors and officers and other members of management may, under SEC rules, be deemed to be participants in the solicitation of proxies from stockholders in connection with the Merger and other matters that may be set forth in the Joint Proxy Statement/Prospectus. Information about TuHURA's directors and executive officers is set forth in TuHURA's filings with the SEC, including TuHURA's Form 10-K filed on March 31, 2025. Additional information regarding the direct and indirect interests, by security holdings or otherwise, of those persons and other persons who may be deemed participants in the solicitation of proxies in the Merger may be obtained by reading the Joint Proxy Statement/Prospectus when it becomes available. You may obtain free copies of these documents as described above under "IMPORTANT ADDITIONAL INFORMATION".
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This press release contains certain "forward-looking statements" within the meaning of, and subject to the safe harbor created by, Section 27A of the Securities Act, Section 21E of the Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These Forward-looking statements are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, projections, anticipated events and other future conditions. In some cases you can identify these statements by forward-looking words such as "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "could," "should," "would," "project," "plan," "expect," "goal," "seek," "future," "likely" or the negative or plural of these words or similar expressions. Examples of such forward-looking statements include but are not limited to express or implied statements regarding TuHURA's expectations, hopes, beliefs, intentions or strategies regarding the future and include, without limitation, statements regarding TuHURA's IFx-Hu2.0 product candidate and anticipated Phase 3 trial, its tumor microenvironment modulators development program, its potential acquisition by merger of Kineta Inc. and the statements about Kineta's VISTA-101 development program and statements regarding the closing conditions for the transaction, TuHURA's needs and expectations regarding its existing capital resources and its need for additional capital, and any developments or results in connection therewith and the anticipated regulatory pathway and timing of the foregoing development programs, studies and trials. In addition, any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking statements. You are cautioned that such statements are not guarantees of future performance and that actual results or developments may differ materially from those set forth in these forward-looking statements. Factors that could cause actual results to differ materially from these forward-looking statements are described in detail in our registration statements, reports and other filings with the SEC, which are available on the combined company's website, and at www.sec.gov.
The forward-looking statements and other information contained in this press release are made as of the date hereof, and TuHURA does not undertake any obligation to update publicly or revise any forward-looking statements or information, whether as a result of new information, future events or otherwise, unless so required by applicable securities laws. Nothing herein shall constitute an offer to sell or the solicitation of an offer to buy any securities.
Investor Contact:
Gilmartin Group
Monique Kosse
Monique@GilmartinIR.com
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FAQ
What were the key results of KVA12123 in the VISTA-101 trial for HURA?
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What safety profile did IFx-Hu2.0 demonstrate in clinical trials?
