Instil Bio and ImmuneOnco Announce License and Collaboration Agreement for Development of IMM2510, a Potentially Best-in-Class PD-L1xVEGF Bispecific Antibody, and IMM27M, a Novel Next-Generation Anti-CTLA-4 Antibody
Instil Bio (Nasdaq: TIL) and ImmuneOnco Biopharmaceuticals have announced a license and collaboration agreement for the development of two promising antibodies: IMM2510 and IMM27M. IMM2510 is a potentially best-in-class PD-L1xVEGF bispecific antibody that has shown multiple responses in advanced solid tumors, including in patients who previously failed PD-1 inhibitors. IMM27M is a novel next-generation anti-CTLA-4 antibody designed to enhance efficacy and reduce toxicity compared to first-generation anti-CTLA-4 antibodies.
Under the agreement, Instil Bio will receive global development and commercialization rights for both antibodies outside of Greater China, while ImmuneOnco retains rights in Greater China. The deal includes an upfront payment and potential near-term payments of up to $50 million, with additional milestones exceeding $2 billion plus royalties on global ex-China sales.
Instil Bio (Nasdaq: TIL) e ImmuneOnco Biopharmaceuticals hanno annunciato un accordo di licenza e collaborazione per lo sviluppo di due promettenti anticorpi: IMM2510 e IMM27M. IMM2510 è un anticorpo bispecifico PD-L1xVEGF potenzialmente di prima classe che ha mostrato molteplici risposte in tumori solidi avanzati, incluso in pazienti che hanno precedentemente fallito i trattamenti con inibitori PD-1. IMM27M è un nuovo anticorpo anti-CTLA-4 di nuova generazione progettato per migliorare l'efficacia e ridurre la tossicità rispetto agli anticorpi anti-CTLA-4 di prima generazione.
Secondo l'accordo, Instil Bio riceverà i diritti globali di sviluppo e commercializzazione per entrambi gli anticorpi al di fuori della Grande Cina, mentre ImmuneOnco mantiene i diritti nella Grande Cina. L'accordo prevede un pagamento iniziale e potenziali pagamenti a breve termine fino a $50 milioni, con ulteriori traguardi superiori a $2 miliardi più royalties sulle vendite globali escludendo la Cina.
Instil Bio (Nasdaq: TIL) e ImmuneOnco Biopharmaceuticals han anunciado un acuerdo de licencia y colaboración para el desarrollo de dos anticuerpos prometedores: IMM2510 e IMM27M. IMM2510 es un anticuerpo bispecífico PD-L1xVEGF potencialmente de primera clase que ha demostrado múltiples respuestas en tumores sólidos avanzados, incluyendo a pacientes que anteriormente fracasaron con inhibidores de PD-1. IMM27M es un nuevo anticuerpo anti-CTLA-4 de nueva generación diseñado para mejorar la eficacia y reducir la toxicidad en comparación con los anticuerpos anti-CTLA-4 de primera generación.
Bajo el acuerdo, Instil Bio recibirá derechos globales de desarrollo y comercialización para ambos anticuerpos fuera de China Continental, mientras que ImmuneOnco retiene los derechos en China Continental. El acuerdo incluye un pago inicial y pagos potenciales a corto plazo de hasta $50 millones, con hitos adicionales que superan los $2 mil millones más regalías sobre las ventas globales fuera de China.
Instil Bio (Nasdaq: TIL)와 ImmuneOnco Biopharmaceuticals는 두 가지 유망한 항체인 IMM2510과 IMM27M의 개발을 위한 라이센스 및 협력 계약을 발표했습니다. IMM2510은 잠재적인 최고급 PD-L1xVEGF 이중특이성 항체로, PD-1 억제제에 실패한 환자들에서도 고형 종양에서 여러 반응을 보여주었습니다. IMM27M은 신세대 항-CTLA-4 항체로 설계되어 1세대 항-CTLA-4 항체에 비해 효능을 높이고 독성을 줄이는 데 중점을 두었습니다.
계약에 따라 Instil Bio는 대중화 중국 외의 두 항체에 대한 글로벌 개발 및 상용화 권리를 받으며, ImmuneOnco는 대중화 중국 내 권리를 유지합니다. 이 거래에는 선불금과 최대 $50 million에 달하는 단기 지불이 포함되며, 추가 이정표는 $2 billion을 초과하고 중국 외 판매에 대한 로열티가 포함됩니다.
Instil Bio (Nasdaq: TIL) et ImmuneOnco Biopharmaceuticals ont annoncé un accord de licence et de collaboration pour le développement de deux anticorps prometteurs : IMM2510 et IMM27M. IMM2510 est un anticorps bispécifique PD-L1xVEGF potentiellement de classe mondiale qui a montré de multiples réponses dans des tumeurs solides avancées, y compris chez des patients qui avaient précédemment échoué avec des inhibiteurs de PD-1. IMM27M est un nouvel anticorps anti-CTLA-4 de nouvelle génération conçu pour améliorer l'efficacité et réduire la toxicité par rapport aux anticorps anti-CTLA-4 de première génération.
En vertu de l'accord, Instil Bio recevra les droits de développement et de commercialisation mondiaux pour les deux anticorps en dehors de la Grande Chine, tandis qu'ImmuneOnco conserve les droits en Grande Chine. L'accord comprend un paiement initial et des paiements potentiels à court terme pouvant atteindre $50 millions, ainsi que des jalons supplémentaires dépassant $2 milliards plus des redevances sur les ventes mondiales hors de Chine.
Instil Bio (Nasdaq: TIL) und ImmuneOnco Biopharmaceuticals haben eine Lizenz- und Kooperationsvereinbarung für die Entwicklung von zwei vielversprechenden Antikörpern, IMM2510 und IMM27M, bekannt gegeben. IMM2510 ist ein potenziell erstklassiger PD-L1xVEGF bispezifischer Antikörper, der in fortgeschrittenen soliden Tumoren, einschließlich bei Patienten, die zuvor an PD-1-Inhibitoren gescheitert sind, mehrere Antworten gezeigt hat. IMM27M ist ein neuartiger Antikörper der nächsten Generation gegen CTLA-4, der entwickelt wurde, um die Wirksamkeit zu steigern und die Toxizität im Vergleich zu Antikörpern der ersten Generation zu reduzieren.
Im Rahmen der Vereinbarung erhält Instil Bio die globalen Entwicklungs- und Vermarktungsrechte für beide Antikörper außerhalb von Greater China, während ImmuneOnco die Rechte in Greater China behält. Der Deal beinhaltet eine Vorauszahlung und potenzielle kurzfristige Zahlungen von bis zu $50 Millionen, sowie zusätzliche Meilensteine von mehr als $2 Milliarden zuzüglich Lizenzgebühren auf den globalen Verkäufen außerhalb Chinas.
- Instil Bio gains rights to two promising antibodies with potential best-in-class status
- IMM2510 has shown multiple responses in advanced solid tumors, including in PD-1 inhibitor-resistant patients
- IMM27M designed to enhance efficacy and reduce toxicity compared to first-generation anti-CTLA-4 antibodies
- Global development and commercialization rights secured for both antibodies outside of Greater China
- Deal structure includes significant milestone payments exceeding $2 billion plus royalties
- Substantial upfront and near-term payments of up to $50 million required from Instil Bio
- Potential for high development and commercialization costs for two pipeline products
This licensing agreement between Instil Bio and ImmuneOnco is a significant development in the immuno-oncology space. The deal centers around two promising antibodies: IMM2510, a PD-L1xVEGF bispecific antibody and IMM27M, a next-generation anti-CTLA-4 antibody.
IMM2510 stands out due to its unique properties:
- Ability to bind multiple VEGF receptor ligands beyond VEGF-A
- Smaller molecular weight, potentially improving tumor penetration
- Enhanced antibody-dependent cellular cytotoxicity (ADCC)
These features could potentially make IMM2510 a best-in-class therapy. The completed dose-escalation trial showing responses in patients with squamous NSCLC who previously failed PD-1 inhibitors is particularly promising, as it addresses a significant unmet need in this patient population.
IMM27M, the anti-CTLA-4 antibody, is designed to enhance efficacy and reduce toxicity compared to first-generation anti-CTLA-4 antibodies. This could be a significant advancement, as toxicity has been a limiting factor for widespread use of CTLA-4 inhibitors like ipilimumab.
The financial terms of the deal, including up to
Investors should monitor the progress of these assets in clinical trials, particularly in combination studies, as positive results could significantly impact both companies' valuations.
The licensing of IMM2510 and IMM27M by Instil Bio represents a potentially significant advancement in cancer immunotherapy. Let's break down the clinical implications:
IMM2510 (PD-L1xVEGF bispecific antibody):
- Targets both PD-L1 and VEGF pathways simultaneously, addressing two critical aspects of tumor biology: immune evasion and angiogenesis
- Demonstrated efficacy in squamous NSCLC patients who failed previous PD-1 inhibitors, suggesting potential in overcoming resistance mechanisms
- Broader VEGF receptor ligand binding could lead to more comprehensive inhibition of tumor angiogenesis
IMM27M (next-generation anti-CTLA-4 antibody):
- Enhanced ADCC activity may lead to more effective depletion of regulatory T cells within the tumor microenvironment
- Potential for improved efficacy and reduced systemic toxicity compared to first-generation CTLA-4 inhibitors like ipilimumab
The combination of IMM2510 and IMM27M, which has already entered clinical trials in China, is particularly intriguing. This approach targets three critical pathways in cancer biology (PD-L1, VEGF and CTLA-4), potentially leading to synergistic anti-tumor effects.
However, it's important to note that while early clinical data is promising, larger randomized trials will be necessary to confirm the efficacy and safety profiles of these agents, particularly in comparison to existing standards of care. The oncology community will be eagerly awaiting results from these studies to determine the true clinical impact of these novel therapies.
This licensing agreement represents a significant strategic move for both Instil Bio and ImmuneOnco, with substantial financial implications:
For Instil Bio:
- Acquisition of global rights (excluding Greater China) to two late-stage assets, potentially accelerating their path to market
- Upfront and near-term payments of up to
$50 million indicate a significant initial investment - Potential milestone payments exceeding
$2 billion suggest high confidence in the assets' future performance - Single to low double-digit royalties on ex-China sales could provide substantial future revenue if the products are successful
For ImmuneOnco:
- Immediate cash infusion from upfront and near-term payments
- Potential for significant future revenue from milestone payments and royalties
- Retention of rights in the lucrative Greater China market
- Validation of their technology platform, potentially increasing investor interest
The structure of the deal, with substantial backend-loaded payments, aligns the interests of both companies and mitigates some risk for Instil Bio. However, it also means that significant value creation is dependent on future clinical and commercial success.
For investors, this deal transforms Instil Bio's risk-reward profile. While it increases their potential upside, it also introduces new clinical and regulatory risks. The market's reaction to this news will likely depend on investors' assessment of the probability of success for IMM2510 and IMM27M.
Looking ahead, key financial metrics to watch will include Instil Bio's cash burn rate, as they take on additional clinical development costs and any updates on the progress of these assets towards potential regulatory approvals and commercialization.
DALLAS and SHANGHAI, Aug. 01, 2024 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Nasdaq: TIL, “Instil”) and ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”), today announced a definitive agreement pursuant to which Instil is in-licensing ex-China development and commercial rights to ImmueOnco’s proprietary PD-L1xVEGF bispecific antibody, IMM2510, as well as its next-generation anti-CTLA-4 antibody, IMM27M.
IMM2510 is a novel, potentially best-in-class bispecific antibody consisting of an anti-PD-L1 antibody fused to a vascular endothelial growth factor (VEGF) receptor “trap” which binds VEGF. IMM2510 is differentiated from other PD(L)1xVEGF antibodies by its ability to bind multiple VEGF receptor ligands beyond VEGF-A, a smaller molecular weight allowing for potentially better tumor penetration, and enhanced antibody-dependent cellular cytotoxicity (ADCC) designed to improve tumor killing. IMM2510 has completed a dose-escalation clinical trial for advanced solid tumors and demonstrated multiple responses including patients with squamous non-small cell lung cancer (NSCLC) who previously failed PD-1 inhibitors.
IMM27M is a next-generation anti-CTLA-4 antibody with enhanced ADCC activity, which has been designed to promote intratumoral regulatory T cell depletion to enhance the efficacy and reduce the toxicity associated with first-generation anti-CTLA-4 antibodies. IMM27M has completed a dose-escalation clinical trial demonstrating anti-tumor activity in patients with advanced solid tumors and has entered combination studies with IMM2510 in China in July 2024.
Terms of License and Collaboration Agreement
Under the terms of the agreement, a wholly owned subsidiary of Instil will receive global development and commercialization rights for IMM2510 and IMM27M outside of Greater China, while ImmuneOnco will retain development and commercialization rights in Greater China including Taiwan, Macau, and Hong Kong. ImmuneOnco will receive an upfront payment and potential near-term payments of up to
About Instil Bio
Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil’s lead asset, IMM2510, is a novel and differentiated PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. For more information visit www.instilbio.com.
About ImmuneOnco
ImmuneOnco is a clinical-stage biotech company focused on discovery and development of biologics to treat cancers and other 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’ health. For more information visit www.immuneonco.com.
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 “anticipates,” “believes,” “expects,” "expected,” “exploring,” “future,” “intends,” “may,” “plans,” “potential,” “projects,” and “will” or similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding Instil’s expectation with respect to the license and collaboration agreement, including clinical development of IMM2510 and IMM27M and the therapeutic potential of IMM2510 and IMM27M, and other statements that are not historical fact. Forward-looking statements are based on Instil 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 in-licensing product candidates and clinical trial collaborations; the costly and time-consuming product development process and the uncertainty of clinical success; the risks inherent in relying on collaborators and other third parties, including for manufacturing; the risks and uncertainties related to successfully initiating, enrolling, completing and reporting data from clinical studies, as well as the risks that results obtained in clinical trials to date may not be indicative of results obtained in ongoing or future trials and that Instil’s product candidates may otherwise not be effective treatments in their planned indications; risks related to macroeconomic conditions, including as a result of international conflicts, U.S.-China trade and political tensions, interest rates, inflation, and other factors, which could materially and adversely affect Instil’s business and operations; the risks and uncertainties associated with the time-consuming and uncertain regulatory approval process and the sufficiency of Instil’s cash resources; and other risks and uncertainties affecting Instil and its plans and development programs, including those discussed in the section titled “Risk Factors” in Instil’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024 filed with the SEC, as well as Instil’s 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.
Contacts:
Investor Relations:
1-972-499-3350
investorrelations@instilbio.com
www.instilbio.com
FAQ
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