On August 12, 2021 Instil Bio, Inc. ("Instil") (NASDAQ: TIL), a clinical-stage biopharmaceutical company focused on developing tumor infiltrating lymphocyte, or TIL, therapies for the treatment of patients with cancer, reported its second quarter 2021 financial results and provided a corporate update (Press release, Instil Bio, AUG 12, 2021, View Source [SID1234586379]).

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"We confirm our commitment to initiating a Phase 2 trial of ITIL-168 in advanced melanoma in the second half of 2021," said Bronson Crouch, Chief Executive Officer of Instil. "With the installation and ongoing qualification of modular clean room pods at our Tarzana, California facility and our progress toward activating additional manufacturing capabilities in Manchester, U.K., we expect increased clinical manufacturing capacity in late 2021 and early 2022 to support our clinical development plans for ITIL-168 and ITIL-306. Our commitment to innovation in manufacturing continues with the development of a shortened 21-day manufacturing process with robust levels of TIL transduction efficiency for ITIL-306, our first genetically engineered CoStAR-TIL. We expect to pursue further enhancements to both ITIL-168 and ITIL-306 manufacturing processes in the future."

Second Quarter 2021 Highlights and Anticipated Milestones:

Clinical Development:

Presented Clinical Data in Advanced Melanoma at AACR (Free AACR Whitepaper): Instil presented clinical data demonstrating a 67% objective response rate and 19% complete response rate from a compassionate use program of TILs for the treatment of metastatic melanoma as a late-breaking e-Poster at the AACR (Free AACR Whitepaper) virtual meeting in April 2021.

Orphan Drug Designation: On April 27, 2021, ITIL-168 received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of melanoma stages IIB to IV.

Phase 2 Clinical Trial Initiation of ITIL-168: Instil expects to start a Phase 2 clinical trial of ITIL-168 for the treatment of advanced melanoma in the second half of 2021. Topline safety and efficacy data would be expected in 2023, followed by submission of a BLA to the FDA and a Marketing Authorization Application to the European Medicines Agency expected in 2023 and 2024, respectively.

Phase 1 Clinical Trial Initiation of ITIL-306: Instil expects to start a Phase 1 clinical trial of ITIL-306 for the treatment of FOLR1-expressing cancer in the first half of 2022.
Manufacturing and Technical Operations:

Facility Readiness for Clinical Trials: Current manufacturing capacity in the U.K. is sufficient to support capacity needs at the start of the expected upcoming Phase 2 clinical trial of ITIL-168. Further expansion of our U.K. manufacturing capacity is expected later this year. Instil has also installed and begun qualification of its modular clean room pods at its Tarzana, California facility. These pods will support U.S. regional manufacturing and are expected to begin producing clinical batches in the first half of 2022.

ITIL-306 Manufacturing Process: Instil’s focus on continued improvements in manufacturing is highlighted by the development of a 21-day manufacturing process for ITIL-306. This process is capable of achieving high TIL transduction efficiencies that are well in excess of published literature.
Second Quarter 2021 Financial and Operating Results:

As of June 30, 2021, cash and cash equivalents totaled $566.7 million, compared to $241.7 million as of December 31, 2020. The Company expects that its cash and cash equivalents as of June 30, 2021 will enable it to fund its operating plan into 2023.

Research and development expenses were $21.2 million and $35.6 million for the three and six months ended June 30, 2021, compared to $2.2 million and $4.2 million for the three and six months ended June 30, 2020.

General and administrative expenses were $14.2 million and $23.2 million for the three and six months ended June 30, 2021, compared to $2.4 million and $4.3 million for the three and six months ended June 30, 2020.