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Instil Bio (TIL) filed an 8-K (Item 8.01) reporting partner ImmuneOnco’s interim data from a Phase 2 open-label study of bispecific antibody IMM2510/AXN-2510 plus chemotherapy in first-line advanced non-small-cell lung cancer (NSCLC) patients in China.

By 1 Jul 2025, 33 patients had received 10 mg/kg; 21 were efficacy-evaluable. The overall partial response rate (PRR) was 62 %, with a pronounced signal in squamous NSCLC (80 %, 8/10) versus non-squamous (46 %, 5/11). Most patients had undergone only a single tumor assessment at the data cut-off, limiting durability insight.

Safety appeared acceptable: no dose-limiting toxicities, no treatment-related deaths or dose reductions, and just one discontinuation. Grade ≥3 treatment-related adverse events were mainly hematologic and infrequent; VEGF-linked and immune events were uncommon and generally low-grade.

The dataset will be presented at a future medical meeting. Though preliminary and based on a small cohort, the efficacy signal and tolerability profile are encouraging for ‘2510’s continued development and could strengthen Instil’s oncology pipeline prospects.

Instil Bio (TIL) ha presentato un modulo 8-K (Voce 8.01) riportando i dati intermedi del partner ImmuneOnco provenienti da uno studio di Fase 2 in aperto con l'anticorpo bispecifico IMM2510/AXN-2510 in combinazione con chemioterapia in pazienti cinesi con carcinoma polmonare non a piccole cellule (NSCLC) avanzato in prima linea.

Al 1° luglio 2025, 33 pazienti avevano ricevuto 10 mg/kg; 21 erano valutabili per efficacia. Il tasso complessivo di risposta parziale (PRR) è stato del 62%, con un segnale marcato nel NSCLC squamoso (80%, 8/10) rispetto al non squamoso (46%, 5/11). La maggior parte dei pazienti aveva effettuato una sola valutazione tumorale al momento del cut-off dati, limitando la comprensione della durata della risposta.

La sicurezza è risultata accettabile: nessuna tossicità dose-limitante, nessun decesso correlato al trattamento o riduzione di dose, e solo una sospensione. Gli eventi avversi correlati al trattamento di grado ≥3 erano principalmente ematologici e rari; gli eventi legati a VEGF e immunitari erano poco frequenti e generalmente di basso grado.

Il dataset sarà presentato in un prossimo congresso medico. Sebbene preliminari e basati su una piccola coorte, il segnale di efficacia e il profilo di tollerabilità sono promettenti per lo sviluppo continuativo del ‘2510 e potrebbero rafforzare le prospettive della pipeline oncologica di Instil.

Instil Bio (TIL) presentó un formulario 8-K (Ítem 8.01) reportando datos intermedios de su socio ImmuneOnco de un estudio abierto de fase 2 con el anticuerpo bispecífico IMM2510/AXN-2510 más quimioterapia en pacientes chinos con cáncer de pulmón no microcítico (NSCLC) avanzado en primera línea.

Al 1 de julio de 2025, 33 pacientes habían recibido 10 mg/kg; 21 fueron evaluables para eficacia. La tasa global de respuesta parcial (PRR) fue del 62%, con una señal pronunciada en NSCLC escamoso (80%, 8/10) frente a no escamoso (46%, 5/11). La mayoría de los pacientes solo habían tenido una evaluación tumoral al momento del corte de datos, limitando la información sobre la durabilidad.

La seguridad fue aceptable: sin toxicidades limitantes de dosis, sin muertes relacionadas con el tratamiento ni reducciones de dosis, y solo una discontinuación. Los eventos adversos relacionados con el tratamiento de grado ≥3 fueron principalmente hematológicos e infrecuentes; los eventos vinculados a VEGF e inmunitarios fueron poco comunes y generalmente de bajo grado.

El conjunto de datos se presentará en una próxima reunión médica. Aunque preliminares y basados en una cohorte pequeña, la señal de eficacia y el perfil de tolerabilidad son alentadores para el desarrollo continuo del ‘2510 y podrían fortalecer las perspectivas de la cartera oncológica de Instil.

Instil Bio (TIL)는 파트너사 ImmuneOnco의 2상 공개 라벨 연구 중간 데이터를 8-K 보고서(Item 8.01)를 통해 발표했습니다. 연구는 중국의 1차 치료를 받는 진행성 비소세포폐암(NSCLC) 환자 대상 bispecific 항체 IMM2510/AXN-2510과 화학요법 병용 치료에 관한 것입니다.

2025년 7월 1일까지 33명의 환자가 10 mg/kg 용량을 투여받았고; 21명은 효능 평가 대상이었습니다. 전체 부분 반응률(PRR)은 62%로, 편평세포 NSCLC에서 80%(8/10), 비편평세포에서는 46%(5/11)의 뚜렷한 차이를 보였습니다. 대부분 환자는 데이터 컷오프 시점에 단 한 번의 종양 평가만 받아 반응 지속성에 대한 정보는 제한적입니다.

안전성은 양호한 편으로 나타났습니다: 용량 제한 독성 없음, 치료 관련 사망이나 용량 감량 없음, 중단은 단 1건뿐이었습니다. 3등급 이상 치료 관련 이상반응은 주로 혈액학적이며 드물었고, VEGF 관련 및 면역 관련 이상반응은 드물고 대체로 경증이었습니다.

이 데이터는 향후 의료 학회에서 발표될 예정입니다. 비록 예비 단계이고 소규모 코호트에 기반하지만, 효능 신호와 내약성 프로필은 ‘2510’의 지속 개발에 긍정적이며 Instil의 종양학 파이프라인 전망을 강화할 수 있습니다.

Instil Bio (TIL) a déposé un rapport 8-K (Article 8.01) présentant les données intermédiaires de son partenaire ImmuneOnco issues d'une étude de phase 2 en ouvert portant sur l'anticorps bispécifique IMM2510/AXN-2510 associé à une chimiothérapie chez des patients chinois atteints d'un cancer du poumon non à petites cellules (NSCLC) avancé en première ligne.

Au 1er juillet 2025, 33 patients avaient reçu 10 mg/kg ; 21 étaient évaluables pour l'efficacité. Le taux global de réponse partielle (PRR) était de 62 %, avec un signal marqué dans le NSCLC épidermoïde (80 %, 8/10) contre non épidermoïde (46 %, 5/11). La plupart des patients n'avaient subi qu'une seule évaluation tumorale au moment de la coupure des données, limitant ainsi la compréhension de la durabilité.

La sécurité semblait acceptable : aucune toxicité limitante, aucun décès lié au traitement ni réduction de dose, et seulement une interruption. Les événements indésirables liés au traitement de grade ≥3 étaient principalement hématologiques et peu fréquents ; les événements liés au VEGF et immunitaires étaient rares et généralement de faible intensité.

Le jeu de données sera présenté lors d'une prochaine réunion médicale. Bien que préliminaires et basés sur une petite cohorte, le signal d'efficacité et le profil de tolérance sont encourageants pour le développement continu du ‘2510’ et pourraient renforcer les perspectives du pipeline oncologique d’Instil.

Instil Bio (TIL) reichte einen 8-K-Bericht (Punkt 8.01) ein, der Zwischenberichte des Partners ImmuneOnco aus einer Phase-2-Studie mit offenem Label zum bispezifischen Antikörper IMM2510/AXN-2510 plus Chemotherapie bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkarzinom (NSCLC) in China enthält.

Bis zum 1. Juli 2025 hatten 33 Patienten 10 mg/kg erhalten; 21 waren hinsichtlich Wirksamkeit auswertbar. Die Gesamt-Teilansprechrate (PRR) betrug 62%, mit einem ausgeprägten Signal bei squamösem NSCLC (80 %, 8/10) gegenüber nicht-squamösem (46 %, 5/11). Die meisten Patienten hatten zum Zeitpunkt des Datenstichtags nur eine Tumorbewertung, was die Aussage zur Dauer der Wirksamkeit einschränkt.

Die Sicherheit schien akzeptabel: keine dosislimitierenden Toxizitäten, keine behandlungsbedingten Todesfälle oder Dosisreduktionen und nur eine Therapieabbrüche. Grad ≥3 behandlungsbedingte Nebenwirkungen waren hauptsächlich hämatologisch und selten; VEGF-assoziierte und immunologische Ereignisse waren ungewöhnlich und meist niedriggradig.

Der Datensatz wird auf einer zukünftigen medizinischen Tagung präsentiert. Obwohl vorläufig und auf einer kleinen Kohorte basierend, sind das Wirksamkeitssignal und das Verträglichkeitsprofil ermutigend für die weitere Entwicklung von ‚2510‘ und könnten die Perspektiven der Onkologie-Pipeline von Instil stärken.

Positive
  • 62 % overall partial response rate in interim analysis, outperforming historical chemo benchmarks.
  • 80 % PRR in squamous NSCLC, a subtype with high unmet need.
  • No dose-limiting toxicities or treatment-related deaths; safety profile appears manageable.
Negative
  • Small efficacy-evaluable cohort (n = 21) limits statistical confidence.
  • Most patients had only one tumor assessment, providing little durability data.
  • Results are from a single-arm study in China; lack of control arm or global data may hinder comparability.

Insights

TL;DR — Early Phase 2 data show strong PRR and clean safety; still small but directionally positive.

The 62 % PRR, especially the 80 % in squamous disease, materially exceeds typical first-line chemo benchmarks (~25-35 %). Absence of DLTs and minimal high-grade VEGF/immune toxicities suggest an attractive risk-benefit profile. However, only one scan for most subjects and lack of complete or durability data temper enthusiasm. If confirmed in larger cohorts or randomized settings, ‘2510 could challenge PD-1/VEGF combos and expand Instil’s value beyond its TIL cell-therapy focus.

TL;DR — Encouraging signal but limited sample; modest positive equity impact today.

For a development-stage company, any positive mid-phase oncology read-out can catalyze sentiment. The filing highlights differentiated efficacy in a high-incidence indication and a benign safety profile, reducing clinical risk. Yet, the data are uncontrolled, geographically limited, and lack progression-free or overall survival metrics, so valuation uplift may be constrained until more mature results or a strategic update (e.g., licensing economics) emerges.

Instil Bio (TIL) ha presentato un modulo 8-K (Voce 8.01) riportando i dati intermedi del partner ImmuneOnco provenienti da uno studio di Fase 2 in aperto con l'anticorpo bispecifico IMM2510/AXN-2510 in combinazione con chemioterapia in pazienti cinesi con carcinoma polmonare non a piccole cellule (NSCLC) avanzato in prima linea.

Al 1° luglio 2025, 33 pazienti avevano ricevuto 10 mg/kg; 21 erano valutabili per efficacia. Il tasso complessivo di risposta parziale (PRR) è stato del 62%, con un segnale marcato nel NSCLC squamoso (80%, 8/10) rispetto al non squamoso (46%, 5/11). La maggior parte dei pazienti aveva effettuato una sola valutazione tumorale al momento del cut-off dati, limitando la comprensione della durata della risposta.

La sicurezza è risultata accettabile: nessuna tossicità dose-limitante, nessun decesso correlato al trattamento o riduzione di dose, e solo una sospensione. Gli eventi avversi correlati al trattamento di grado ≥3 erano principalmente ematologici e rari; gli eventi legati a VEGF e immunitari erano poco frequenti e generalmente di basso grado.

Il dataset sarà presentato in un prossimo congresso medico. Sebbene preliminari e basati su una piccola coorte, il segnale di efficacia e il profilo di tollerabilità sono promettenti per lo sviluppo continuativo del ‘2510 e potrebbero rafforzare le prospettive della pipeline oncologica di Instil.

Instil Bio (TIL) presentó un formulario 8-K (Ítem 8.01) reportando datos intermedios de su socio ImmuneOnco de un estudio abierto de fase 2 con el anticuerpo bispecífico IMM2510/AXN-2510 más quimioterapia en pacientes chinos con cáncer de pulmón no microcítico (NSCLC) avanzado en primera línea.

Al 1 de julio de 2025, 33 pacientes habían recibido 10 mg/kg; 21 fueron evaluables para eficacia. La tasa global de respuesta parcial (PRR) fue del 62%, con una señal pronunciada en NSCLC escamoso (80%, 8/10) frente a no escamoso (46%, 5/11). La mayoría de los pacientes solo habían tenido una evaluación tumoral al momento del corte de datos, limitando la información sobre la durabilidad.

La seguridad fue aceptable: sin toxicidades limitantes de dosis, sin muertes relacionadas con el tratamiento ni reducciones de dosis, y solo una discontinuación. Los eventos adversos relacionados con el tratamiento de grado ≥3 fueron principalmente hematológicos e infrecuentes; los eventos vinculados a VEGF e inmunitarios fueron poco comunes y generalmente de bajo grado.

El conjunto de datos se presentará en una próxima reunión médica. Aunque preliminares y basados en una cohorte pequeña, la señal de eficacia y el perfil de tolerabilidad son alentadores para el desarrollo continuo del ‘2510 y podrían fortalecer las perspectivas de la cartera oncológica de Instil.

Instil Bio (TIL)는 파트너사 ImmuneOnco의 2상 공개 라벨 연구 중간 데이터를 8-K 보고서(Item 8.01)를 통해 발표했습니다. 연구는 중국의 1차 치료를 받는 진행성 비소세포폐암(NSCLC) 환자 대상 bispecific 항체 IMM2510/AXN-2510과 화학요법 병용 치료에 관한 것입니다.

2025년 7월 1일까지 33명의 환자가 10 mg/kg 용량을 투여받았고; 21명은 효능 평가 대상이었습니다. 전체 부분 반응률(PRR)은 62%로, 편평세포 NSCLC에서 80%(8/10), 비편평세포에서는 46%(5/11)의 뚜렷한 차이를 보였습니다. 대부분 환자는 데이터 컷오프 시점에 단 한 번의 종양 평가만 받아 반응 지속성에 대한 정보는 제한적입니다.

안전성은 양호한 편으로 나타났습니다: 용량 제한 독성 없음, 치료 관련 사망이나 용량 감량 없음, 중단은 단 1건뿐이었습니다. 3등급 이상 치료 관련 이상반응은 주로 혈액학적이며 드물었고, VEGF 관련 및 면역 관련 이상반응은 드물고 대체로 경증이었습니다.

이 데이터는 향후 의료 학회에서 발표될 예정입니다. 비록 예비 단계이고 소규모 코호트에 기반하지만, 효능 신호와 내약성 프로필은 ‘2510’의 지속 개발에 긍정적이며 Instil의 종양학 파이프라인 전망을 강화할 수 있습니다.

Instil Bio (TIL) a déposé un rapport 8-K (Article 8.01) présentant les données intermédiaires de son partenaire ImmuneOnco issues d'une étude de phase 2 en ouvert portant sur l'anticorps bispécifique IMM2510/AXN-2510 associé à une chimiothérapie chez des patients chinois atteints d'un cancer du poumon non à petites cellules (NSCLC) avancé en première ligne.

Au 1er juillet 2025, 33 patients avaient reçu 10 mg/kg ; 21 étaient évaluables pour l'efficacité. Le taux global de réponse partielle (PRR) était de 62 %, avec un signal marqué dans le NSCLC épidermoïde (80 %, 8/10) contre non épidermoïde (46 %, 5/11). La plupart des patients n'avaient subi qu'une seule évaluation tumorale au moment de la coupure des données, limitant ainsi la compréhension de la durabilité.

La sécurité semblait acceptable : aucune toxicité limitante, aucun décès lié au traitement ni réduction de dose, et seulement une interruption. Les événements indésirables liés au traitement de grade ≥3 étaient principalement hématologiques et peu fréquents ; les événements liés au VEGF et immunitaires étaient rares et généralement de faible intensité.

Le jeu de données sera présenté lors d'une prochaine réunion médicale. Bien que préliminaires et basés sur une petite cohorte, le signal d'efficacité et le profil de tolérance sont encourageants pour le développement continu du ‘2510’ et pourraient renforcer les perspectives du pipeline oncologique d’Instil.

Instil Bio (TIL) reichte einen 8-K-Bericht (Punkt 8.01) ein, der Zwischenberichte des Partners ImmuneOnco aus einer Phase-2-Studie mit offenem Label zum bispezifischen Antikörper IMM2510/AXN-2510 plus Chemotherapie bei Patienten mit fortgeschrittenem nicht-kleinzelligem Lungenkarzinom (NSCLC) in China enthält.

Bis zum 1. Juli 2025 hatten 33 Patienten 10 mg/kg erhalten; 21 waren hinsichtlich Wirksamkeit auswertbar. Die Gesamt-Teilansprechrate (PRR) betrug 62%, mit einem ausgeprägten Signal bei squamösem NSCLC (80 %, 8/10) gegenüber nicht-squamösem (46 %, 5/11). Die meisten Patienten hatten zum Zeitpunkt des Datenstichtags nur eine Tumorbewertung, was die Aussage zur Dauer der Wirksamkeit einschränkt.

Die Sicherheit schien akzeptabel: keine dosislimitierenden Toxizitäten, keine behandlungsbedingten Todesfälle oder Dosisreduktionen und nur eine Therapieabbrüche. Grad ≥3 behandlungsbedingte Nebenwirkungen waren hauptsächlich hämatologisch und selten; VEGF-assoziierte und immunologische Ereignisse waren ungewöhnlich und meist niedriggradig.

Der Datensatz wird auf einer zukünftigen medizinischen Tagung präsentiert. Obwohl vorläufig und auf einer kleinen Kohorte basierend, sind das Wirksamkeitssignal und das Verträglichkeitsprofil ermutigend für die weitere Entwicklung von ‚2510‘ und könnten die Perspektiven der Onkologie-Pipeline von Instil stärken.

SEC Form 4
FORM 4 UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP

Filed pursuant to Section 16(a) of the Securities Exchange Act of 1934
or Section 30(h) of the Investment Company Act of 1940
OMB APPROVAL
OMB Number: 3235-0287
Estimated average burden
hours per response: 0.5
Check this box if no longer subject to Section 16. Form 4 or Form 5 obligations may continue. See Instruction 1(b).
Check this box to indicate that a transaction was made pursuant to a contract, instruction or written plan for the purchase or sale of equity securities of the issuer that is intended to satisfy the affirmative defense conditions of Rule 10b5-1(c). See Instruction 10.
1. Name and Address of Reporting Person*
TUCHMAN MARTIN

(Last) (First) (Middle)
405 WEST 13TH STREET, 3RD FLOOR

(Street)
NEW YORK NY 10014

(City) (State) (Zip)
2. Issuer Name and Ticker or Trading Symbol
FTAI Aviation Ltd. [ FTAI ]
5. Relationship of Reporting Person(s) to Issuer
(Check all applicable)
X Director 10% Owner
Officer (give title below) Other (specify below)
3. Date of Earliest Transaction (Month/Day/Year)
07/31/2025
4. If Amendment, Date of Original Filed (Month/Day/Year)
6. Individual or Joint/Group Filing (Check Applicable Line)
X Form filed by One Reporting Person
Form filed by More than One Reporting Person
Table I - Non-Derivative Securities Acquired, Disposed of, or Beneficially Owned
1. Title of Security (Instr. 3) 2. Transaction Date (Month/Day/Year) 2A. Deemed Execution Date, if any (Month/Day/Year) 3. Transaction Code (Instr. 8) 4. Securities Acquired (A) or Disposed Of (D) (Instr. 3, 4 and 5) 5. Amount of Securities Beneficially Owned Following Reported Transaction(s) (Instr. 3 and 4) 6. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 7. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V Amount (A) or (D) Price
Ordinary Shares 07/31/2025 A 143 A $0(1) 379,560 D
Ordinary Shares 277,991 I By Trust
Series C Preferred Shares 800,000 I By Trust
Series D Preferred Shares 40,000 I By Trust
Table II - Derivative Securities Acquired, Disposed of, or Beneficially Owned
(e.g., puts, calls, warrants, options, convertible securities)
1. Title of Derivative Security (Instr. 3) 2. Conversion or Exercise Price of Derivative Security 3. Transaction Date (Month/Day/Year) 3A. Deemed Execution Date, if any (Month/Day/Year) 4. Transaction Code (Instr. 8) 5. Number of Derivative Securities Acquired (A) or Disposed of (D) (Instr. 3, 4 and 5) 6. Date Exercisable and Expiration Date (Month/Day/Year) 7. Title and Amount of Securities Underlying Derivative Security (Instr. 3 and 4) 8. Price of Derivative Security (Instr. 5) 9. Number of derivative Securities Beneficially Owned Following Reported Transaction(s) (Instr. 4) 10. Ownership Form: Direct (D) or Indirect (I) (Instr. 4) 11. Nature of Indirect Beneficial Ownership (Instr. 4)
Code V (A) (D) Date Exercisable Expiration Date Title Amount or Number of Shares
Explanation of Responses:
1. Reflects ordinary shares issued at the election of the reporting person in lieu of cash fees as compensation for services provided to the issuer in accordance with the FTAI Aviation Ltd. 2025 Omnibus Incentive Award Plan and the additional terms established by resolution of the Board of Directors. The applicable closing share price was $144.46 on July 30, 2025.
Remarks:
/s/ BoHee Yoon, as Attorney-in-fact 07/31/2025
** Signature of Reporting Person Date
Reminder: Report on a separate line for each class of securities beneficially owned directly or indirectly.
* If the form is filed by more than one reporting person, see Instruction 4 (b)(v).
** Intentional misstatements or omissions of facts constitute Federal Criminal Violations See 18 U.S.C. 1001 and 15 U.S.C. 78ff(a).
Note: File three copies of this Form, one of which must be manually signed. If space is insufficient, see Instruction 6 for procedure.
Persons who respond to the collection of information contained in this form are not required to respond unless the form displays a currently valid OMB Number.

FAQ

What did Instil Bio (TIL) disclose in its 8-K dated July 31 2025?

The company relayed ImmuneOnco’s interim Phase 2 data showing a 62 % partial response rate and no dose-limiting toxicities in advanced NSCLC.

How many patients were included in the Phase 2 IMM2510 chemo-combo trial?

33 patients received 10 mg/kg; 21 were evaluable for efficacy.

What was the response rate for squamous versus non-squamous NSCLC?

Squamous NSCLC showed an 80 % PRR (8/10); non-squamous had 46 % PRR (5/11).

Were any dose-limiting toxicities or treatment-related deaths reported?

No dose-limiting toxicities or treatment-related deaths occurred; only one discontinuation was linked to treatment.

When will more detailed data be available?

ImmuneOnco plans to present updated safety and efficacy results at a future medical conference.
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