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Instil Bio, Inc. (Nasdaq: TIL) is a clinical-stage biopharmaceutical company dedicated to the development and commercialization of autologous tumor infiltrating lymphocyte (TIL) therapies to treat patients with cancer. The company's core technology leverages a patient’s own T cells, harvested from their tumor, expanded in number, and then reinfused to target and kill cancer cells. This innovative approach is designed to harness and enhance the body’s natural defense mechanisms to fight solid tumor cancers.
Headquartered in the greater Los Angeles area, Instil Bio also has a significant presence in Manchester, UK, where it houses additional manufacturing and research facilities. This strategic international footprint enables the company to execute clinical trials globally, advancing its pipeline of novel TIL therapies.
Instil Bio is currently focused on its lead candidate, ITIL-306, a next-generation, genetically-engineered TIL therapy using its proprietary Co-Stimulatory Antigen Receptor (CoStAR™) platform. ITIL-306 is designed to target a tumor-associated antigen FRα, prevalent in various solid tumors including ovarian, uterine, non-small cell lung cancer (NSCLC), and renal cancers. The company is actively progressing this candidate through clinical trials, with promising preclinical data supporting its potential efficacy.
Recent Achievements:
- June 26, 2023: Instil Bio presented data at the British Society for Gene and Cell Therapy Annual Conference, showcasing the enhanced activity of TILs using the CoStAR platform against autologous tumors.
- August 14, 2023: Reported successful manufacturing improvements at its Manchester facility, which could significantly impact the therapeutic profile of ITIL-306 in patients with advanced cancers.
Financial Condition:
As of the latest reports, Instil Bio has a solid financial foundation with cash, cash equivalents, marketable securities, and long-term investments enabling the company to fund its operations beyond 2026. Despite typical R&D and administrative expenses associated with a clinical-stage company, Instil has managed to maintain a stable financial position to propel further developments.
Partnerships and Collaborations:
Instil Bio is supported by premier global institutional investors and is led by a team of world-class cell therapy experts. These partnerships bolster the company’s capability to innovate and bring transformative therapies to market.
Instil Bio’s strategic focus on cutting-edge TIL therapies, robust financial health, and innovative research make it a significant player in the biopharmaceutical landscape, with great potential to bring effective cancer treatments to patients worldwide.
Instil Bio (NASDAQ: TIL) provided a corporate update and financial results for Q3 2021. Key highlights include the initiation of a Phase 2 trial (DELTA-1) for ITIL-168 in metastatic melanoma after receiving FDA IND clearance and Fast Track Designation. The company reported $20.4 million in cash and cash equivalents with $495 million in marketable securities as of September 30, 2021, enabling operations through 2023. Research and development expenses surged to $29.1 million for Q3 2021, compared to $4.9 million in 2020, reflecting ramped-up clinical efforts.
Instil Bio, Inc. (Nasdaq: TIL) announced the presentation of pre-clinical data for its CoStimulatory Antigen Receptor (CoStAR) platform at the SITC 2021. Key findings indicate that CoStAR significantly enhances the effector function of T cells when combined with tumor-reactive signals. Notably, the anti-FOLR1 CoStAR construct demonstrated over 40% transduction efficiency in primary ovarian cancer TILs. The company looks forward to initiating a Phase 1 study of ITIL-306 in early 2022, with the potential to reduce toxicity associated with high-dose IL-2.
Instil Bio, Inc. (Nasdaq: TIL) announced its participation in two investor conferences in November 2021. The Cowen 5th Annual IO Next Summit is scheduled for November 15, 2021, from 4:45 PM to 5:05 PM ET, with a live session link available. The Jefferies Global Healthcare Conference will be held on November 18, 2021, at 3:00 AM ET, also offering a live session link. An archived replay of both events will be accessible on the company's website for 90 days post-presentation. Instil is dedicated to developing TIL therapies targeting various cancers.
Instil Bio, Inc. (NASDAQ: TIL) presented a subset analysis of treatment outcomes for its TIL therapy at the ESMO Congress 2021. The analysis focused on 12 patients with checkpoint inhibitor-refractory advanced cutaneous melanoma. Among them, 58% achieved an objective response, with a median overall survival of 21.3 months, indicating the potential effectiveness of TIL therapy in difficult cases. The therapy demonstrated manageable side effects, primarily from the pre-treatment regimen. Instil aims to further explore TIL therapy in its upcoming Phase 2 DELTA-1 clinical trial.
Instil Bio (Nasdaq: TIL) has received FDA clearance for its DELTA-1 Phase 2 clinical trial of ITIL-168, aimed at treating patients with advanced melanoma. The trial will focus on patients who have relapsed after PD-1 inhibitors and will include expanded cohorts for those who faced toxicity or had unsatisfactory responses. Topline results are expected in 2023, with potential regulatory submissions for a biologics license application in the U.S. and a marketing authorization in Europe in 2024.
Instil Bio, Inc. (NASDAQ: TIL) announced its participation in two investor conferences this September. The first is the Morgan Stanley 19th Annual Global Healthcare Conference on September 9 at 2:00 p.m. ET, featuring a fireside chat. Following that, Instil will present at Baird’s 2021 Virtual Global Healthcare Conference on September 14 at 5:30 p.m. ET. Live webcasts of these events will be available on the company’s website, with archived recordings accessible after the events.
Instil Bio (NASDAQ: TIL) reported significant clinical advancements in its second quarter 2021 update. In a compassionate use study for advanced melanoma, 67% of patients showed an objective response, with 19% achieving a complete response. The lead asset, ITIL-168, received orphan drug designation from the FDA. Instil is on track to initiate a Phase 2 trial for ITIL-168 in H2 2021 and a Phase 1 trial for ITIL-306 in H1 2022. Financially, cash reserves increased to $566.7 million, supporting operations through 2023.
Instil Bio (Nasdaq: TIL) announced its management will present an overview at the Jefferies Virtual Healthcare Conference on June 4, 2021, at 9:30 a.m. ET. Interested parties can access a live webcast at here. Instil is focused on developing TIL therapies, advancing products like ITIL-168 and ITIL-306 for cancer treatment, particularly advanced melanoma and solid tumors.
Instil Bio (NASDAQ: TIL) reported its Q1 2021 financial results, highlighting a strong IPO with $368 million gross proceeds completed in March 2021. The company is advancing its lead product, ITIL-168, which received orphan drug designation from the U.S. FDA for melanoma. As of March 31, 2021, cash and equivalents reached $609.6 million, allowing operations to be funded into 2023. R&D expenses significantly increased to $14.4 million from $2 million in Q1 2020. The company plans to initiate a Phase 2 trial for ITIL-168 in advanced melanoma in H2 2021.
Instil Bio (Nasdaq: TIL) has received orphan drug designation from the FDA for its ITIL-168 therapy, targeting melanoma stages IIB to IV. This designation provides incentives such as tax credits and market exclusivity for up to seven years upon approval. ITIL-168, an autologous cell therapy utilizing tumor infiltrating lymphocytes, aims to enhance treatment efficacy with a flexible manufacturing process. Instil plans to initiate a global phase 2 trial for advanced melanoma in 2021, with further trials for other solid tumors to follow in 2022.
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