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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

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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.

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Positive

  • 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

Negative

  • 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

News Market Reaction – TIL

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+2.22% News Effect

On the day this news was published, TIL gained 2.22%, reflecting a moderate positive market reaction.

Data tracked by StockTitan Argus on the day of publication.

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 $50 million as well as potential additional development, regulatory, and commercial milestones exceeding $2 billion plus single digit to low double-digit percentage royalties on global ex-China sales.

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

What antibodies are included in the license agreement between Instil Bio (TIL) and ImmuneOnco?

The license agreement between Instil Bio (TIL) and ImmuneOnco includes two antibodies: IMM2510, a PD-L1xVEGF bispecific antibody, and IMM27M, a next-generation anti-CTLA-4 antibody.

What are the potential benefits of IMM2510 developed by ImmuneOnco for Instil Bio (TIL)?

IMM2510 is potentially a best-in-class bispecific antibody that has shown multiple responses in advanced solid tumors, including in patients who previously failed PD-1 inhibitors. It has a smaller molecular weight for better tumor penetration and enhanced antibody-dependent cellular cytotoxicity.

What are the financial terms of the agreement between Instil Bio (TIL) and ImmuneOnco?

Instil Bio (TIL) will make an upfront payment and potential near-term payments of up to $50 million. Additional development, regulatory, and commercial milestones exceed $2 billion, plus single-digit to low double-digit percentage royalties on global ex-China sales.

What rights does Instil Bio (TIL) receive for IMM2510 and IMM27M under the agreement?

Instil Bio (TIL) receives global development and commercialization rights for IMM2510 and IMM27M outside of Greater China, while ImmuneOnco retains rights in Greater China (including Taiwan, Macau, and Hong Kong).
Instil Bio, Inc.

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Biotechnology
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