Instil Bio Announces Clinical Progress in China for IMM2510/SYN-2510, a Clinical-Stage PD-L1xVEGF Bispecific Antibody

Rhea-AI Summary

Instil Bio (NASDAQ: TIL) announced significant progress in the clinical development of IMM2510/SYN-2510, a PD-L1xVEGF bispecific antibody, in China through its collaborator ImmuneOnco. The first patient has been dosed in a Phase 1b/2 clinical trial combining IMM2510/SYN-2510 with chemotherapy for advanced non-small cell lung cancer (NSCLC) patients.

ImmuneOnco plans to present initial clinical data from the trial, including first-line NSCLC patient data, in the second half of 2025. Instil Bio also plans to initiate its own U.S. clinical trial of SYN-2510/IMM2510 combined with chemotherapy for first-line NSCLC patients in the second half of 2025, pending regulatory approvals.

Positive

• First patient dosed in Phase 1b/2 trial in China
• Initial clinical data expected by 2H 2025
• Potential pathway to global registrational study if data is positive

Negative

• U.S. trial initiation dependent on regulatory approvals
• No clinical efficacy data available yet

Insights

Medical Research Analyst

The initiation of Phase 1b/2 trials for IMM2510/SYN-2510 in combination with chemotherapy represents a strategic advancement in NSCLC treatment. This bispecific antibody targeting both PD-L1 and VEGF is particularly noteworthy as it simultaneously addresses two critical pathways in cancer progression: immune checkpoint inhibition and angiogenesis suppression.

The dual-geography approach - with trials in both China and planned U.S. studies - creates a parallel development track that could accelerate the overall clinical development timeline. The targeting of first-line NSCLC patients is especially significant, as success in this setting would position the therapy in the most commercially valuable treatment segment. First-line therapies typically command premium pricing and longer duration of treatment.

For context, the current first-line NSCLC market is dominated by PD-1/PD-L1 inhibitors combined with chemotherapy, with annual revenues exceeding $20 billion. A successful bispecific antibody could potentially capture significant market share by offering improved efficacy through its dual-targeting mechanism.

Financial Analyst

The strategic collaboration between Instil Bio and ImmuneOnco creates a capital-efficient development pathway, leveraging ImmuneOnco's presence in China while preserving Instil's resources for U.S. development. With Instil's market cap of $123.47 million, this approach optimizes R&D spending and risk management.

The potential for accelerated development through parallel trials could significantly impact Instil's valuation metrics. If the initial data readout in 2H 2025 is positive, it could catalyze multiple expansion, particularly given the company's current modest market capitalization relative to the NSCLC market opportunity. The first-line NSCLC setting represents a multi-billion dollar market opportunity and positive data could position Instil for either strategic partnerships or potential M&A interest from larger pharmaceutical companies.

ImmuneOnco announced dosing of first patient in its recently initiated Phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced NSCLC in China

ImmuneOnco announced initial clinical data from the 1L advanced NSCLC trial in China is expected as early as 2H 2025

Instil is targeting initiation of a potential first-line advanced NSCLC clinical trial of IMM2510/SYN-2510 combined with chemotherapy in 2H 2025, assuming necessary regulatory approvals

DALLAS, Jan. 14, 2025 (GLOBE NEWSWIRE) -- Instil Bio, Inc. (Nasdaq: TIL, “Instil”), today announced clinical progress of IMM2510/SYN-2510 in China by its collaborator, ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (HKEX Code: 1541.HK, “ImmuneOnco”).

ImmuneOnco announced that the first patient has been dosed in its phase 1b/2 clinical trial of IMM2510/SYN-2510 in combination with chemotherapy in patients with advanced non-small cell lung cancer (NSCLC) in China. ImmuneOnco announced it plans to enroll first-line patients in this trial and anticipates presenting initial clinical data, including data for first-line NSCLC patients, from this trial as soon as the second half of 2025.

Additionally, Instil announced that for its anticipated initial U.S. clinical trial of SYN-2510/IMM2510 in lung cancer, it plans to target enrollment of first-line patients with NSCLC in combination with chemotherapy with an expected initiation in the second half of 2025, assuming the necessary regulatory approvals are obtained.

“We anticipate that ImmuneOnco’s initial clinical data of IMM2510/SYN-2510 in combination with chemotherapy in patients with front-line NSCLC could be extremely valuable in advancing our development of IMM2510/SYN-2510 in NSCLC,” said Bronson Crouch, CEO of Instil. “The data generated, if positive, could position us to open a potential global registrational study in front-line NSCLC.”

About SYN-2510/IMM2510

SYN-2510/IMM2510 is a PD-L1xVEGF bispecific antibody in development for the treatment of multiple solid tumor cancers. SYN-2510/IMM2510 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 Instil Bio

Instil Bio is a clinical-stage biopharmaceutical company focused on developing a pipeline of novel therapies. Instil's lead asset, SYN-2510, 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.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words (and variations of words) such as “anticipates,” “believes,” “could,” “expects,” “expected,” “exploring,” “future,” “intends,” “may,” “plans,” “potential,” “projects,” “will,” “target,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements include express or implied statements regarding Instil's expectations with respect to the therapeutic potential of SYN-2510/IMM2510, the clinical development of SYN-2510/IMM2510, including IND submissions and clearances, clinical trials and the timing, scope and design thereof, the availability and timing of data from clinical trials, regulatory approvals and interactions 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 and clinical trial operation; 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 for product candidates across multiple indications and multiple regulatory authorities; the impact of product candidates that may compete with those developed by Instil; 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 September 30, 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 is the current status of IMM2510/SYN-2510 clinical trials for TIL in China?

The first patient has been dosed in a Phase 1b/2 clinical trial combining IMM2510/SYN-2510 with chemotherapy for advanced NSCLC patients in China.

When will Instil Bio (TIL) release initial clinical data for IMM2510/SYN-2510 in NSCLC?

ImmuneOnco expects to present initial clinical data, including first-line NSCLC patient data, in the second half of 2025.

When will Instil Bio (TIL) begin U.S. clinical trials for IMM2510/SYN-2510?

Instil Bio plans to initiate U.S. clinical trials for first-line NSCLC patients in the second half of 2025, subject to regulatory approvals.

What is the potential market opportunity for IMM2510/SYN-2510 according to TIL?

According to Instil Bio's CEO, positive data could position the company to open a potential global registrational study in front-line NSCLC.