On August 8, 2024 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies for solid and hematologic cancers, reported financial results for the second quarter ended June 30, 2024 and recent corporate highlights (Press release, In8bio, AUG 8, 2024, View Source [SID1234645605]).

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"Gamma-delta T cell therapies have the potential to revolutionize cancer treatment," said William Ho, CEO and co-founder of IN8bio. "In the second quarter of 2024, our team presented industry-leading data demonstrating that our gamma-delta T cell therapeutic approach in INB-100 and INB-200 can drive durable complete remissions compared to the current standard-of-care in certain aggressive cancers like GBM and AML, where patients have typically faced poor outcomes. This novel approach that leverages gamma-delta T cells seeks to target residual tumors, including chemo-resistant and cancerous stem cells that often result in relapse. We look forward to providing additional updates on our gamma-delta T cell programs as we generate longer patient follow-up and advance our pipeline."

Corporate Highlights and Recent Developments

Presented data at EHA (Free EHA Whitepaper) 2024, showing 100% of treated patients with leukemia (n=10/10) in the Phase 1 trial of INB-100 remained progression-free for at least one year, including high-risk and relapsed AML and one with acute lymphocytic leukemia (ALL) who had previously failed multiple lines of therapy, including CAR-T.
Data continue to show long-term in vivo expansion and persistence of haplo-matched allogeneic gamma-delta T cells 365 days following a single administration post-transplant, demonstrating the first-ever durable persistence and in vivo expansion of an allogeneic cellular therapy.
As of May 31, 2024, two of the patients treated with INB-100 remain alive and relapse free for over three and a half years, and a third patient is nearing three years.
Poster presentation at ASCO (Free ASCO Whitepaper) 2024 demonstrated that 92% of evaluable patients treated with INB-200 exceeded a median PFS of seven months with concomitant temozolomide (TMZ), as of a data cutoff date of May 30, 2024.
The survival data along with radiographic improvements are indicative of positive treatment effects, which highlight the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with newly diagnosed GBM to extend PFS.
The safety profile of gamma-delta T cells continues to be strong across all three dose cohorts with no cell therapy-related toxicities such as immune effector cell-associated neurotoxicity syndrome or cytokine release syndrome reported in any patients across both Phase 1 trials to date (up to the maximum dose of six infusions of therapy).
Multiple presentations at the International Society for Cell & Gene Therapy (ISCT) 2024 demonstrated how IN8bio’s manufacturing process influences product characteristics and the ability to generate a robust, activated and reproducible final product.
DeltEx gamma-delta T cell manufacturing platform has enabled the development of multiple investigational candidates which are now moving into multi-center Phase 2 clinical trials and are designed to target and potentially eradicate cancer cells to help improve patient outcomes.
The cellular characteristics of products from the company’s proprietary clinical-scale gamma-delta T cell manufacturing platform were shown across different donor populations at the ASGCT (Free ASGCT Whitepaper) 2024 Annual Meeting.
Data demonstrated that the manufacturing process results in investigational products with upregulated markers of potency, effector functions and trafficking capabilities, which IN8bio believes represents a significant advancement in the characterization of gamma-delta T cell-based therapies.
Second Quarter 2024 Financial Highlights

Research and Development (R&D) expenses: R&D expenses were $5.2 million, compared to $4.1 million for the comparable prior year period. The increase was primarily due to a $0.5 million increase in personnel-related costs, including salaries and non-cash stock-based compensation due to increased headcount. Direct clinical costs increased by $0.5 million due to increased enrollment costs for our clinical programs, partially offset by a decrease of $0.1 million in facilities costs.
General and administrative expenses: General and administrative expenses remained flat at $3.5 million, compared to $3.6 million for the comparable prior year period.
Net loss: Net loss was $8.6 million, or $0.19 per basic and diluted common share, compared to a net loss of $7.7 million, or $0.27 per basic and diluted common share, for the comparable prior year period.
Cash position: As of June 30, 2024, the Company had cash of $10.2 million, compared to $21.3 million, as of December 31, 2023.