On March 17, 2022 IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company focused on the discovery and development of innovative gamma-delta T cell therapies utilizing its DeltEx platform, reported financial results and operational highlights for the fourth quarter and full-year ending December 31, 2021 (Press release, In8bio, MAR 17, 2022, View Source [SID1234610260]). In addition, the Company provided an overview of recent corporate developments.
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"Our leading clinical programs, INB-100 in leukemia and INB-200 in newly diagnosed GBM, are advancing and generating promising early clinical results," said William Ho, Chief Executive Officer and co-founder of IN8bio. "We are encouraged by these data and hopeful that these trends will translate to real long-term benefits for cancer patients in terms of durable remissions and increased time with respect to survival. We look forward to providing clinical updates and announcing exciting new preclinical programs throughout this year."
Business Highlights & Updates
In October 2021, IN8bio announced the peer-reviewed publication of preclinical results that provide the foundational support for the Phase 1 trial of its DeltEx Drug Resistant Immunotherapy (DRI) in newly diagnosed GBM. This work, published in Scientific Reports, a Nature Portfolio journal, focused on the use of gamma-delta T cells genetically engineered to be chemotherapy resistant through the addition of a gene encoding the O6-Methylguanine-DNA Methyltransferase (MGMT) protein. Concurrent dosing of DRI cells with temozolomide (TMZ) chemotherapy resulted in 80% long-term survivors and complete eradication of tumor in a patient-derived xenograft model of classical primary high-grade gliomas.
In November 2021, IN8bio presented preclinical data on the potential for their DeltEx DRI in combination with poly (ADP-ribose) polymerase (PARP) inhibitors in solid tumors at the 36th Annual Meeting of the Society for Immunotherapy Conference (SITC; Poster 158). The research, conducted in collaboration with the laboratory of Dr. Anita Hjelmeland, at the University of Alabama at Birmingham (UAB), demonstrated that gamma-delta T cell therapy could be enhanced through therapeutic combinations that drive increased mRNA expression of immune markers (NKG2DL) by as much as 2,800%.
In November 2021, IN8bio appointed Trishna Goswami, M.D., as Chief Medical Officer. Dr. Goswami has extensive experience managing the clinical development and regulatory approval of oncology product candidates, including those for both solid and hematologic tumors.
In December 2021, IN8bio promoted Kate Rochlin, Ph.D., to Chief Operating Officer. Dr. Rochlin had previously served as the Company’s Vice President, Operations and Innovation.
In December 2021, IN8io provided an update from the ongoing Phase 1 clinical trial of its allogeneic gamma-delta T cell therapy, INB-100, in leukemia patients undergoing HSCT. Of the three patients treated, all remain in morphologic remission with durable responses of greater than 1.5 years observed in two patients. The third patient remains in remission for six months as of December 2021.
In January 2022, IN8bio provided a clinical update from the Phase 1 clinical trial of its genetically modified gamma-delta T cell therapy candidate in newly diagnosed GBM. In the single ascending dose cohort 1 (n=3), all three patients showed no dose limiting toxicities (DLTs), cytokine release syndrome, or neurotoxicity and showed a manageable safety profile. Cohort 2, which received three repeat doses of DeltEx DRI gamma-delta T cells, includes one patient who has received all three doses without any DLTs or significant drug related adverse events. Of the four patients treated as of the last clinical update on January 6, 2022, all have exceeded their expected progression-free survival interval based on age and MGMT status and with encouraging trends in overall survival.
Upcoming Milestones and Events
Second half of 2022: Plan to file an investigational new drug (IND) application for a Phase 1b/2 clinical trial of INB-400 in GBM.
May 2022: plan to hold an investor event during the American Society of Gene + Cell Therapy (ASGCT) (Free ASGCT Whitepaper) 25th Annual Meeting.
2022: Plan to announce new preclinical programs and indications.
Recent and Expected Upcoming Scientific Presentations
European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2022 (virtual), March 2022: presenting preclinical data on novel gamma-delta CAR-T approaches for systemic delivery in solid tumors (Poster 23P).
48th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) (hybrid), Prague, Czech Republic, March 2022: presenting on INB-100 clinical status and correlative biology.
American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, New Orleans, April 2022: two presentations; (1) "Dual chlorotoxin and methylguanine-DNA methyltransferase (MGMT) gamma-delta T cells for drug resistant immunotherapy" (INB-300) and (2) "maintenance-phase temozolomide as a lymphodepletion platform for intracranial-adoptive gamma-delta T cell-based therapy in primary high-grade gliomas" (INB-200).
International Society for Cell & Gene Therapy (ISCT) 2022, San Francisco, May 2022.
ASGCT 25th Annual Meeting, Washington, D.C., May 2022: Presenting new programs along with an oral presentation by Lawrence Lamb, Ph.D., Off the Shelf Cell Therapies – Beyond T Cells (Education Session); The Next Generation of γδ T Cell-based Therapies.
Fourth Quarter and Full Year 2021 Financial Highlights
Cash position: As of December 31, 2021, the Company had cash of $37.0 million, compared to $18.0 million as of December 31, 2020. The increase in cash was primarily due to the initial public offering proceeds, net of cash used by the Company in operations to advance its programs and research and development.
Research & Development (R&D) expenses: R&D expenses were $2.7 million for the three months ended December 31, 2021, compared to $1.5 million for the comparable prior year period. R&D expenses were $7.3 million for the year ended December 31, 2021, compared to $5.4 million in the prior year. The increase in R&D expenses were primarily due to increased personnel-related costs, including salaries, benefits and stock-based compensation. In addition, for the year, the increase in R&D expenses were related to increased third-party clinical trial-related activities and contract manufacturing costs for the ongoing clinical trials.
General and administrative expenses: General and administrative expenses were $3.2 million for the three months ended December 31, 2021, compared to $0.8 million for the comparable prior year period. General and administrative expenses were $7.3 million for the year ended December 31, 2021, compared to $3.2 million in the prior year. The increase was primarily due to increased personnel costs, including salaries, benefits and stock-based compensation, increased legal expenses, facilities and costs associated with operating as public company.
Net loss: The Company reported a net loss of $5.9 million, or $0.44 per basic and diluted common share, for the three months ended December 31, 2021, compared to a net loss of $2.3 million and a net loss attributable to common stockholders of $3.0 million, or $0.82 per basic and diluted common share, for the comparable prior year period. For the full year, net loss was $14.7 million, or $1.47 per basic and diluted common share compared to a net loss of $8.6 million and a net loss attributable to common stockholders of $10.3 million, or $3.02 per basic and diluted common share, for the comparable prior year.