ImmuneOnco Announced Preliminary Safety & Efficacy Data from the Clinical Trial Studying IMM2510/AXN-2510, a PD-L1xVEGF Bispecific Antibody, in Combination with Chemotherapy in Front-line NSCLC in China
Instil Bio (NASDAQ:TIL) and ImmuneOnco reported promising preliminary data from a Phase 2 trial of IMM2510/AXN-2510, their PD-L1xVEGF bispecific antibody, combined with chemotherapy for front-line non-small cell lung cancer (NSCLC) patients in China.
The trial showed significant efficacy with partial responses in 62% of evaluable patients, including 80% response rate in squamous NSCLC and 46% in non-squamous NSCLC patients. Among 33 patients treated at 10 mg/kg, the drug demonstrated a favorable safety profile with no dose-limiting toxicities and minimal serious adverse events.
The company plans to advance the drug to Phase 3 studies and initiate a US Phase 1 trial by the end of 2025.
Instil Bio (NASDAQ:TIL) e ImmuneOnco hanno riportato dati preliminari promettenti da uno studio di Fase 2 su IMM2510/AXN-2510, il loro anticorpo bispecifico PD-L1xVEGF, in combinazione con chemioterapia per pazienti cinesi con carcinoma polmonare non a piccole cellule (NSCLC) in prima linea.
Lo studio ha mostrato un'efficacia significativa con risposte parziali nel 62% dei pazienti valutabili, inclusa una percentuale di risposta dell'80% nei pazienti con NSCLC squamoso e del 46% nei pazienti con NSCLC non squamoso. Tra i 33 pazienti trattati con 10 mg/kg, il farmaco ha dimostrato un profilo di sicurezza favorevole senza tossicit脿 dose-limitante e con eventi avversi gravi minimi.
L'azienda prevede di avanzare il farmaco agli studi di Fase 3 e di avviare una sperimentazione di Fase 1 negli Stati Uniti entro la fine del 2025.
Instil Bio (NASDAQ:TIL) e ImmuneOnco informaron datos preliminares prometedores de un ensayo de Fase 2 con IMM2510/AXN-2510, su anticuerpo bispec铆fico PD-L1xVEGF, combinado con quimioterapia para pacientes chinos con c谩ncer de pulm贸n no microc铆tico (NSCLC) en primera l铆nea.
El ensayo mostr贸 una eficacia significativa con respuestas parciales en el 62% de los pacientes evaluables, incluyendo una tasa de respuesta del 80% en NSCLC escamoso y del 46% en NSCLC no escamoso. Entre 33 pacientes tratados con 10 mg/kg, el medicamento demostr贸 un perfil de seguridad favorable sin toxicidades limitantes de dosis y con eventos adversos graves m铆nimos.
La compa帽铆a planea avanzar el medicamento a estudios de Fase 3 e iniciar un ensayo de Fase 1 en EE.UU. para finales de 2025.
Instil Bio (NASDAQ:TIL)鞕� ImmuneOnco電� IMM2510/AXN-2510, PD-L1xVEGF 鞚挫韸轨澊頃泊毳� 頇旐暀鞖旊矔瓿� 氤戩毄頃橃棳 欷戧淡鞐愳劀 1彀� 牍勳唽靹疙彫韽愳晹(NSCLC) 頇橃瀽毳� 雽�靸侅溂搿� 頃� 2靸� 鞛勳儊鞁滍棙鞐愳劀 鞙犽頃� 齑堦赴 雿办澊韯半ゼ 氤搓碃頄堨姷雼堧嫟.
鞛勳儊鞁滍棙 瓴瓣臣 韽夑皜 臧�電ロ暅 頇橃瀽鞚� 62%鞐愳劀 攵�攵� 氚橃潙鞚� 氤挫榾鞙茧┌, 韼疙弶靸來敿 牍勳唽靹疙彫韽愳晹 頇橃瀽鞐愳劀電� 80%鞚� 氚橃潙毳�, 牍勴幐韽夓儊頂� 牍勳唽靹疙彫韽愳晹 頇橃瀽鞐愳劀電� 46%鞚� 氚橃潙毳�鞚� 雮橅儉雰堨姷雼堧嫟. 10 mg/kg 鞖╇焿鞙茧 旃橂氚涭潃 33氇呾潣 頇橃瀽 欷� 鞎诫鞚� 鞖╇焿 鞝滍暅 霃呾劚 鞐嗢澊 鞎堨爠靹� 頂勲韺岇澕鞚� 鞖办垬頃橂┌ 鞁皝頃� 鞚挫儊 氚橃潙霃� 瓯办潣 鞐嗢棃鞀惦媹雼�.
須岇偓電� 2025雲� 毵愱箤歆� 鞚� 鞎诫鞚� 3靸� 鞁滍棙鞙茧 歆勴枆頃橁碃 氙戈淡鞐愳劀 1靸� 鞁滍棙鞚� 鞁滌瀾頃� 瓿勴殟鞛呺媹雼�.
Instil Bio (NASDAQ:TIL) et ImmuneOnco ont rapport茅 des donn茅es pr茅liminaires prometteuses d'un essai de phase 2 sur IMM2510/AXN-2510, leur anticorps bisp茅cifique PD-L1xVEGF, en combinaison avec une chimioth茅rapie chez des patients chinois atteints de cancer du poumon non 脿 petites cellules (NSCLC) en premi猫re ligne.
L'essai a montr茅 une efficacit茅 significative avec des r茅ponses partielles chez 62 % des patients 茅valuables, incluant un taux de r茅ponse de 80 % chez les NSCLC 茅pidermo茂des et de 46 % chez les NSCLC non 茅pidermo茂des. Parmi les 33 patients trait茅s 脿 10 mg/kg, le m茅dicament a d茅montr茅 un profil de s茅curit茅 favorable sans toxicit茅s limitant la dose et avec peu d'茅v茅nements ind茅sirables graves.
La soci茅t茅 pr茅voit de faire progresser le m茅dicament vers des 茅tudes de phase 3 et de lancer un essai de phase 1 aux 脡tats-Unis d'ici la fin 2025.
Instil Bio (NASDAQ:TIL) und ImmuneOnco berichteten 眉ber vielversprechende vorl盲ufige Daten aus einer Phase-2-Studie mit IMM2510/AXN-2510, ihrem bispezifischen PD-L1xVEGF-Antik枚rper, kombiniert mit Chemotherapie bei Erstlinien-Patienten mit nicht-kleinzelligem Lungenkrebs (NSCLC) in China.
Die Studie zeigte eine signifikante Wirksamkeit mit partiellen Ansprechen bei 62 % der auswertbaren Patienten, darunter eine 80 % Ansprechrate bei Plattenepithel-NSCLC und 46 % bei nicht-plattenepithelialem NSCLC. Bei 33 Patienten, die mit 10 mg/kg behandelt wurden, zeigte das Medikament ein g眉nstiges Sicherheitsprofil ohne dosislimitierende Toxizit盲ten und mit minimalen schwerwiegenden Nebenwirkungen.
Das Unternehmen plant, das Medikament in Phase-3-Studien weiterzuf眉hren und bis Ende 2025 eine Phase-1-Studie in den USA zu starten.
- None.
- Majority of patients had only one tumor assessment at data cut-off
- Most common Grade 3+ treatment-related adverse events were hematologic
Insights
ImmuneOnco's bispecific antibody shows promising 62% response rate in NSCLC with favorable safety profile, potentially positioning it as best-in-class.
The preliminary Phase 2 data for IMM2510/AXN-2510 demonstrates encouraging efficacy signals in front-line non-small cell lung cancer (NSCLC) patients. The observed
What makes these results clinically significant is the differentiated response rates between histological subtypes. Squamous NSCLC has historically been more challenging to treat with targeted therapies compared to non-squamous variants. The pronounced activity in squamous NSCLC suggests IMM2510's dual-targeting mechanism may overcome resistance pathways in this difficult-to-treat population.
The safety profile appears manageable and consistent with expectations for both mechanism classes. The absence of dose-limiting toxicities across 33 patients is reassuring, as is the low discontinuation rate (only one patient). Most importantly, the common adverse events follow predictable patterns: primarily hematologic toxicities (likely chemotherapy-related) with notably low incidence of VEGF-inhibition side effects (hypertension, proteinuria) and immune-related adverse events.
While promising, several limitations warrant caution: this represents early data with most patients having only one tumor assessment, and the trial is open-label without a control arm. The small sample size (21 efficacy-evaluable patients) means response rates could fluctuate significantly with additional patient data. Furthermore, durability of response, progression-free survival, and overall survival data鈥攃ritical endpoints for clinical significance鈥攁re not yet reported.
The preliminary Phase 2 data for ImmuneOnco's IMM2510/AXN-2510 bispecific antibody represents a significant positive development for Instil Bio's pipeline. The
The bifurcated efficacy profile between squamous (
From a development perspective, the clean safety profile significantly de-risks the pathway to regulatory approval. The absence of dose-limiting toxicities and the low rate of VEGF-related and immune-related adverse events suggests a potentially differentiated safety profile that could enable more flexible dosing and combination strategies.
The planned US Phase 1 trial initiation later this year indicates confidence in the asset's potential and suggests an accelerating clinical development timeline. The partnership structure between Instil Bio and ImmuneOnco provides geographical diversification with ImmuneOnco leading development in China while Instil advances US development.
Key uncertainties remain around durability of response, progression-free survival data, and the competitive landscape with other PD-(L)1xVEGF bispecifics in development. Additionally, the small sample size and limited follow-up necessitate caution in extrapolating these early results to larger populations.
Partial responses observed in
Safety profile supports further clinical development, with no dose-limiting toxicities observed in patients with front-line NSCLC
ImmuneOnco expects to present updated safety and efficacy data at a future medical conference
DALLAS and SHANGHAI, July 31, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Nasdaq: TIL, 鈥淚nstil鈥�) noted that ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK) (鈥淚mmuneOnco鈥�), today announced preliminary safety and efficacy data from the Phase 2 open-label, multicenter study of IMM2510/AXN-2510 (鈥�2510) in combination with chemotherapy for front-line patients with advanced non-small cell lung cancer (NSCLC) conducted in China by ImmuneOnco.
As of July 1, 2025, 33 patients were dosed at 10 mg/kg, with 21 patients having at least one tumor assessment (efficacy evaluable). Partial responses were observed in
The 鈥�2510 safety profile supports further clinical development, with no dose-limiting toxicities observed in the 33 safety evaluable patients. In these patients, there were no treatment-related adverse events (TRAE) leading to dose reduction or death, and only one TRAE leading to drug discontinuation. The most common Grade 3+ TRAEs were hematologic, with uncommon clinical sequelae. Adverse events typically associated with VEGF inhibition (e.g., hypertension, proteinuria, hemoptysis) and immune-related adverse events were uncommon and generally low-grade, and infusion-related reactions were nearly all low-grade.
鈥溾��2510 has demonstrated early but compelling activity in front-line NSCLC patients,鈥� said Professor Caicun Zhou, M.D., Ph.D., director of the Department of Oncology at Shanghai East Hospital, Tongji University, and lead investigator on the study of 鈥�2510 in 1L NSCLC. 鈥淭he PD-(L)1xVEGF bispecific class has the potential to become the new standard of care for front-line NSCLC, and I look forward to the generation of additional data with 鈥�2510 in this setting.鈥�
Dr. Tian Wenzhi, CEO of ImmuneOnco, said 鈥淲e are delighted to witness the progress of 鈥�2510 in front-line non-small cell lung cancer (NSCLC). This data paves the way for its advancement into Phase 3 clinical studies and provides valuable insights to support further research across multiple indications.鈥�
鈥淲e are pleased with the preliminary clinical results of the combination of 鈥�2510 with chemotherapy in patients with front-line NSCLC, which suggest the potential for best-in-class efficacy in the promising PD-(L)1xVEGF bispecific antibody class,鈥� said Bronson Crouch, CEO of Instil. 鈥淲e look forward to further public updates from ImmuneOnco on these data, as well as the initiation of our previously announced US phase 1 clinical trial before the end of this year.鈥�
About IMM2510/AXN-2510
IMM2510/AXN-2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. IMM2510/AXN-2510 is differentiated from other PD-(L)1xVEGF bispecific antibodies by its VEGF trap, which binds multiple VEGF receptor ligands beyond VEGF-A, a bispecific structure which leverages PD-L1 as an anchor in the tumor microenvironment (TME), and enhanced antibody-dependent cellular cytotoxicity (ADCC) to direct killing of PD-L1-positive tumor cells.
About ImmuneOnco
ImmuneOnco is a clinical-stage biotech company focused on discovery and development of biologics to treat cancers, autoimmune diseases and metabolic diseases. With 10+ assets all originated in-house and the most advanced asset in phase III right now, ImmuneOnco is pursuing innovative therapies to improve patients鈥� health. For more information visit .
About Instil Bio
Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil's lead asset, AXN-2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumors. For more information, visit聽.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as 鈥渁nticipates,鈥� 鈥渂elieves,鈥� 鈥渆xpects,鈥� 鈥渇uture,鈥� 鈥渋ntends,鈥� 鈥渕ay,鈥� 鈥減lans,鈥� 鈥減otential,鈥� 鈥渢argets鈥� and 鈥渨ill鈥� or similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding our expectations with respect to the therapeutic potential, safety and efficacy profile, and clinical development of IMM2510/AXN-2510, including timing of initiation of a clinical trial in the United States, additional clinical trials and expansion into additional indications, the generation and presentation of clinical data from clinical trials, and other statements that are not historical fact. Forward-looking statements are based on management's current expectations and are subject to various risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements, including risks and uncertainties associated with the costly and time-consuming drug product development process and the uncertainty of clinical success; the risks inherent in relying on collaborators and other third parties, including for generating clinical data, and the ability to rely on any such data from clinical trials in China in regulatory filings submitted to regulatory authorities outside of China; the risks and uncertainties related to successfully making regulatory submissions and initiating, enrolling, completing and reporting data from clinical trials, as well as the risks that results obtained in any clinical trials to date, including preliminary clinical data, may not be indicative of final results in such clinical trials or results obtained in ongoing or future trials and that product candidates may otherwise not be effective treatments in their planned indications; risks related to macroeconomic conditions, including as a result of international conflicts and U.S.-China trade and political tensions, as well as interest rates, inflation, tariffs and other factors, which could materially and adversely affect our business and operations and those of our collaborators; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process; and other risks and uncertainties affecting Instil's plans and development programs, including those discussed in the section titled 鈥淩isk Factors鈥� in Instil's Quarterly Report on Form 10-Q, for the quarter ended March 31, 2025 filed with the SEC, as well as Instil鈥檚 other filings with the SEC. Additional information will be made available in other filings that Instil makes from time to time with the SEC. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. These forward-looking statements speak only as the date hereof, and Instil disclaims any obligation to update these statements except as may be required by law.
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