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Instil Bio, Inc. reports developments as a Nasdaq-listed biopharmaceutical company focused on identifying and advancing innovative therapeutic opportunities. Company updates have covered financial results, capital resources, restructuring and impairment charges, strategic development efforts, licensing activity, and subsidiary actions through Axion Bio.
Recent announcements also document the completed discontinuation of clinical development of AXN-2510 and the termination of related license and collaboration rights, after earlier updates on the PD-L1xVEGF bispecific antibody program, FDA IND clearance, non-small cell lung cancer data presented by ImmuneOnco, and solid-tumor development activity.
Instil Bio (Nasdaq: TIL) and ImmuneOnco Biopharmaceuticals (HKEX: 1541.HK) announced they will co-host an investor and analyst breakfast event in Chicago on May 31, 2025. The event, scheduled from 8:00 to 9:30 am CT near McCormick Convention Center, will feature company management and a key opinion leader in immuno-oncology. They will discuss the PD-(L)1xVEGF bispecific antibody landscape and provide clinical trial updates. Interested investors and analysts can register by emailing investorrelations@instilbio.com.
Instil Bio (TIL) has reported its Q4 and full year 2024 financial results. The company ended 2024 with $115.1 million in total cash and equivalents, down from $175.0 million in 2023. Their cash runway is expected to extend beyond 2026.
Key clinical developments include anticipated data for AXN-2510/IMM2510 monotherapy in relapsed/refractory NSCLC in China during 1H 2025, with additional safety data expected from approximately 100 patients across multiple solid tumors. ImmuneOnco plans to begin enrolling first-line NSCLC patients in Q2 2025 for a combination therapy trial with chemotherapy, with initial data expected in 2H 2025.
Financial highlights show reduced losses, with full-year 2024 net loss per share at $11.39, improved from $24.00 in 2023. R&D expenses decreased to $11.8 million in 2024 from $39.6 million in 2023, while G&A expenses slightly decreased to $44.2 million from $47.6 million.
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.
Instil Bio reported Q3 2024 financial results and corporate updates. The company licensed SYN-2510, a PD-L1xVEGF bispecific antibody, for global ex-China development. Cash position was $122.9M as of September 30, 2024, expected to fund operations beyond 2026. Q3 net loss per share was $3.54. Clinical updates include anticipated data from ImmuneOnco for SYN-2510 in 1H 2025, planned Phase 1b/2 studies in NSCLC and TNBC, and targeted U.S. clinical study initiation in 2H 2025.
Instil Bio (Nasdaq: TIL) and ImmuneOnco Biopharmaceuticals have announced their global registrational strategy for the PD-L1xVEGF bispecific antibody SYN-2510/IMM2510 in non-small cell lung cancer (NSCLC) and triple-negative breast cancer (TNBC). Key points include:
1. Phase 1b/2 trials of IMM2510/SYN-2510 + chemotherapy in first-line NSCLC to start in China by late 2024
2. Phase 1b/2 trials in first-line TNBC to begin in China by early 2025
3. US IND submission for SYN-2510 planned for late 2024, starting with Phase 2 monotherapy trial in second-line NSCLC
4. Potential global Phase 3 trials in first-line NSCLC and TNBC based on positive proof-of-concept data
This strategy aims to address significant unmet medical needs in NSCLC and TNBC patients, potentially improving the current standard of care.
Instil Bio (Nasdaq: TIL) reported Q2 2024 financial results and provided a corporate update. Key highlights include:
1. In-licensed SYN-2510 and SYN-27M, potentially best-in-class therapeutics, from ImmuneOnco.
2. Executed a 15-year lease of cell therapy manufacturing facility to AstraZeneca, with initial base rent exceeding $7.5 million annually.
3. Cash, cash equivalents, marketable securities, and long-term investments totaled $152.6 million as of June 30, 2024.
4. Q2 2024 R&D expenses were $2.9 million, down from $8.5 million in Q2 2023.
5. Net loss per share for Q2 2024 was $2.29, improved from $2.87 in Q2 2023.
6. Cash runway expected to extend beyond 2026.
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.