IN8bio Reports Continued Durable Remissions in Phase 1 Trial of INB-200 in Plenary Oral Presentation at the Society for Neuro-Oncology (SNO) Annual Meeting
IN8bio presented results from their fully enrolled Phase 1 trial of INB-200 at the Society for Neuro-Oncology Annual Meeting. 50% of patients receiving repeated doses (n=10) remained alive and in remission beyond expected median overall survival, while single-dose patients (n=3) did not achieve this outcome. The trial demonstrated that 92% of evaluable patients surpassed median standard-of-care progression-free survival (PFS) of 6.9 months. Notably, multi-dose cohorts showed improved peripheral T cell recovery, with one patient remaining progression-free at 40.5 months. Biopsy results confirmed gamma-delta T cell presence in the brain tumor microenvironment. The treatment showed no serious adverse events, with most common side effects being Grade 1-2 toxicities.
IN8bio ha presentato i risultati del loro studio di Fase 1 completamente arruolato su INB-200 durante l'Annual Meeting della Society for Neuro-Oncology. Il 50% dei pazienti che hanno ricevuto dosi ripetute (n=10) sono rimasti vivi e in remissione oltre il tempo atteso di sopravvivenza complessiva mediana, mentre i pazienti che hanno ricevuto una singola dose (n=3) non hanno raggiunto questo risultato. Lo studio ha dimostrato che il 92% dei pazienti valutabili ha superato la mediana della sopravvivenza libera da progressione (PFS) standard di 6,9 mesi. È importante notare che i gruppi di pazienti con dosi multiple hanno mostrato un miglioramento nel recupero delle cellule T periferiche, con un paziente rimasto senza progressione per 40,5 mesi. I risultati delle biopsie hanno confermato la presenza di cellule T gamma-delta nell'ambiente tumorale cerebrale. Il trattamento non ha mostrato eventi avversi gravi, con gli effetti collaterali più comuni che sono stati tossicità di Grado 1-2.
IN8bio presentó los resultados de su ensayo de Fase 1 completamente inscrito sobre INB-200 en la Reunión Anual de la Sociedad de Neuro-Oncología. El 50% de los pacientes que recibieron dosis repetidas (n=10) permanecieron vivos y en remisión más allá de la supervivencia media general esperada, mientras que los pacientes que recibieron una sola dosis (n=3) no lograron este resultado. El ensayo demostró que el 92% de los pacientes evaluables superaron la mediana de la supervivencia libre de progresión (PFS) estándar de 6.9 meses. Notablemente, los grupos de múltiples dosis mostraron una mejor recuperación de células T periféricas, con un paciente sin progresión a los 40.5 meses. Los resultados de la biopsia confirmaron la presencia de células T gamma-delta en el microambiente tumoral cerebral. El tratamiento no mostró eventos adversos graves, siendo los efectos secundarios más comunes toxicidades de Grado 1-2.
IN8bio는 신경종양학회 연례 회의에서 INB-200의 완전 등록된 1상 시험 결과를 발표했습니다. 반복 투여를 받은 환자(모집단 n=10)의 50%가 예상된 중간 전체 생존 기간을 초과하여 생존 및 관해 상태를 유지했습니다. 단일 투여 환자(n=3)는 이 결과를 달성하지 못했습니다. 시험 결과 평가 가능한 환자 중 92%가 6.9개월의 기준 치료 자유 생존(PFS) 중간값을 초과했습니다. 특히, 다중 투여 그룹은 말초 T 세포 회복이 개선되었으며, 한 환자는 40.5개월 동안 진행 없이 생존했습니다. 생검 결과는 뇌 종양 미세환경에서 감마-델타 T 세포의 존재를 확인했습니다. 치료는 심각한 부작용을 보이지 않았고, 가장 흔한 부작용은 1-2도 독성이었습니다.
IN8bio a présenté les résultats de son essai de phase 1 entièrement recruté sur l'INB-200 lors de la réunion annuelle de la Société d'oncologie neuro-oncologique. 50 % des patients ayant reçu des doses répétées (n=10) sont restés en vie et en rémission au-delà de la durée médiane de survie globale attendue, tandis que les patients ayant reçu une dose unique (n=3) n'ont pas atteint ce résultat. L'essai a démontré que 92 % des patients évaluables ont dépassé la médiane de la survie sans progression (PFS) standard de 6,9 mois. Il est à noter que les cohortes à doses multiples ont montré une récupération améliorée des cellules T perphériques, un patient restant sans progression pendant 40,5 mois. Les résultats des biopsies ont confirmé la présence de cellules T gamma-delta dans le microenvironnement tumoral cérébral. Le traitement n'a montré aucun événement indésirable grave, les effets secondaires les plus courants étant des toxicités de grade 1-2.
IN8bio stellte die Ergebnisse ihrer vollständig rekrutierten Phase-1-Studie zu INB-200 auf dem Jahrestreffen der Society for Neuro-Oncology vor. 50 % der Patienten, die wiederholt Dosen erhielten (n=10), blieben am Leben und in Remission über die erwartete mediane Gesamtüberlebenszeit hinaus, während Patienten mit einer Einzeldosis (n=3) dieses Ergebnis nicht erreichten. Die Studie zeigte, dass 92 % der evaluierbaren Patienten die mediane Progressionsfreie Überlebenszeit (PFS) von 6,9 Monaten der Standardbehandlung übertrafen. Bemerkenswerterweise zeigten die Gruppen mit Mehrfachdosen eine verbesserte Erholung der peripheren T-Zellen, wobei ein Patient 40,5 Monate ohne Progression blieb. Die Biopsieresultate bestätigten das Vorhandensein von Gamma-Delta-T-Zellen in der Mikroumgebung des Gehirntumors. Die Behandlung zeigte keine schwerwiegenden Nebenwirkungen, wobei die häufigsten Nebenwirkungen Grad 1-2-Toxizitäten waren.
- 92% of evaluable patients exceeded standard-of-care PFS of 6.9 months
- 50% of patients receiving repeated doses remained alive and in remission
- One patient remains progression-free at 40.5 months post-treatment
- No treatment-related serious adverse events or dose-limiting toxicities reported
- Confirmed presence of gamma-delta T cells in tumor biopsies
- Single-dose patients (n=3) failed to achieve expected survival outcomes
- Grade 1-2 toxicities observed in white blood cell and platelet counts
Insights
The Phase 1 trial results for INB-200 show promising outcomes in glioblastoma (GBM) treatment. The 50% survival rate in repeated dose patients versus 0% in single-dose patients demonstrates clear dose-dependent efficacy. Key findings include:
- 92% of evaluable patients exceeded the standard-of-care progression-free survival of 6.9 months
- Repeated dosing showed a 79% increase in median PFS compared to standard treatment
- Confirmed presence of gamma-delta T cells in tumor biopsies validates the mechanism of action
- Strong safety profile with no serious treatment-related adverse events
The data suggests INB-200 could represent a significant advancement in GBM treatment, particularly given the historically poor outcomes in this indication. The immune cell infiltration in traditionally "cold" tumors and sustained remission in some patients are particularly noteworthy.
For IN8bio, with a micro-cap market value of
- First-in-class potential in GBM, an indication with treatment options
- Strong safety profile reducing development risk
- Demonstrated durability with one patient reaching 40.5 months progression-free
- Platform validation for gamma-delta T cell therapy in solid tumors
The results support advancement to later-stage trials and could attract partnership interest from larger pharmaceutical companies. The market opportunity in GBM is substantial, with current treatments showing efficacy.
50% of patients who received repeated doses (n=10) remained alive and in remission beyond the expected median overall survival (OS) from standard-of-care Stupp regimen while none of the patients who received a single dose (n=3) achieved this outcome.
- Biopsy results confirmed the presence and persistence of gamma-delta T cells along with CD3+ and CD8+ T cells within the brain tumor microenvironment in two patients following treatment with INB-200.
- Patients in the multi-dose cohorts demonstrated a trend toward improved peripheral T cell recovery, suggesting potential immune system benefits.
- The majority of patients exceeded their expected progression free survival (PFS) based on age and tumor status; five patients remain alive and three patients have returned to their occupations, with one patient remaining progression free at 40.5 months post treatment.
NEW YORK, Nov. 25, 2024 (GLOBE NEWSWIRE) -- IN8bio, Inc. (Nasdaq: INAB), a clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, presented results from the fully enrolled Phase 1 trial of INB-200 in a plenary oral presentation at the 29th Annual Meeting of the Society for Neuro-Oncology in Houston, TX. The survival data along with histopathology and radiographic data 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 solid tumor cancers such as glioblastoma (GBM).
“As the clinical trial data continues to mature, this novel immuno-cell therapy leveraging gamma-delta T cells is highly feasible with a well-tolerated safety profile and biological evidence of improved immune surveillance in glioblastoma patients,” said Burt Nabors, M.D., Division Director, Neuro-Oncology at the Heersink School of Medicine at the University of Alabama at Birmingham.
“This novel treatment leverages the DNA damage induced by chemotherapy combined with genetically engineered gamma-delta T cells and we believe it represents a significant advancement in the treatment of solid tumor cancers such as GBM,” said William Ho, co-founder and CEO of IN8bio. “Glioblastomas are often classified as cold, immune desert tumors due to their limited immune cell infiltration. For the first time, we have confirmed the infiltration of gamma-delta T cells into these tumors through paired tissue biopsies following treatment with INB-200. We are encouraged by the patient follow-up with repeat dose patients demonstrating a
The Phase 1 trial assessed the safety and preliminary efficacy of the addition of DeltEx DRI gamma-delta T cells to maintenance therapy with TMZ. The trial assessed the administration of 1x107 cells per dose across three different dosing regimens increasing from a single dose in Cohort 1, three doses in Cohort 2, and six doses in Cohort 3. A total of 13 patients have been enrolled and treated with INB-200, including three patients in Cohort 1, four patients in Cohort 2 and six patients in Cohort 3.
Key findings from the INB-200 Phase 1 trial:
92% of evaluable patients treated with INB-200 for GBM surpassed a median standard-of-care (Stupp regimen) PFS of 6.9 months, with a majority exceeding their expected PFS based on their age and the MGMT status of their tumors.- One patient with an IDH-mutant glioma remains alive and progression free at over 40.5 months; IDH-mutant patients in a recently published clinical trial demonstrated a median PFS of 11.1 months in the control arm and 27.7 months in the experimental arm.
- No treatment-related serious adverse events, dose-limiting toxicities, cytokine release syndrome, infusion reactions, or immune effector cell-associated neurotoxicity syndrome have been reported in any cohort.
- The most common treatment emergent adverse events were Grade 1-2 toxicities consisting of white blood cell and platelet count decreases related to standard-of-care TMZ.
- Gamma-delta T cells and other immune subsets such as CD3+ and CD8+ T cells were found in relapsed tumor biopsies in two patients after treatment with INB-200, pointing to persistence of DRI gamma-delta T cells.
- Gamma-delta T cells were within the normal range post-resection and remained stable with repeated doses (Cohorts 2 and 3), whereas the gamma-delta T cells in Cohort 1 continued to drop after the maintenance cycles with TMZ were initiated. This implies that repeat dosing of gamma-delta T cells may globally benefit the peripheral immune environment.
- T cells were low prior to surgery, rose after resection and during the cell collection for the product, were below normal during chemotherapy, and in Cohorts 2 and 3 returned to the normal range following treatment.
- Radiographic evaluation pre- and post-treatment included resolution of midline shift in one patient with evidence of changes in enhancement attributed to treatment effect in multiple patients. One subject was found to have a
36% decrease in a lesion attributed to positive treatment effect.
About IN8bio
IN8bio is a clinical-stage biopharmaceutical company developing gamma-delta T cell-based immunotherapies for cancer patients. Gamma-delta T cells are a specialized population of T cells that possess unique properties, including the ability to differentiate between healthy and diseased tissue. The company’s lead program, INB-100, is focused on AML evaluating haplo-matched allogenic gamma-delta T cells given to patients following a hematopoietic stem cell transplant. The company is also evaluating autologous DeltEx DRI gamma-delta T cells, in combination with standard of care, for glioblastoma. For more information about IN8bio, visit www.IN8bio.com.
Forward Looking Statements
This press release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “aims,” “anticipates,” “believes,” “could,” “estimates,” “expects,” “forecasts,” “goal,” “intends,” “may,” “plans,” “possible,” “potential,” “seeks,” “will” and variations of these words or similar expressions that are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements in this press release include, but are not limited to, statements regarding: the potential of IN8bio’s genetically modified, chemotherapy-resistant gamma-delta T cells as a potential first-in-class therapy for patients with solid tumor cancers such as GBM; the potential of IN8bio’s DeltEx DRI gamma-delta T cells to extend PFS when administered in combination with the current standard of care used to treat newly diagnosed GBM patients; IN8bio’s ability to achieve anticipated milestones, including the advancement of clinical development plans; and other statements that are not historical fact. IN8bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements as a result of various factors, including: risks to site initiation, clinical trial commencement, patient enrollment and follow-up, as well as IN8bio’s ability to meet anticipated deadlines and milestones; uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of IN8bio’s product candidates; the risk that IN8bio may be unable to raise additional capital and could be forced to delay, further reduce or to explore other strategic options for certain of our development programs, or even terminate its operations; IN8bio’s ability to continue to operate as a going concern; the risk that IN8bio may not realize the intended benefits of its DeltEx platform; availability and timing of results from preclinical studies and clinical trials; whether the outcomes of preclinical studies will be predictive of clinical trial results; whether initial or interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; the risk that trials and studies may be delayed and may not have satisfactory outcomes; potential adverse effects arising from the testing or use of IN8bio’s product candidates; the uncertainty of regulatory approvals to conduct trials or to market products; IN8bio’s reliance on third parties, including licensors and clinical research organizations; and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, are described in greater detail in the section entitled “Risk Factors” in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 12, 2024, as well as in other filings IN8bio may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and IN8bio expressly disclaims any obligation to update any forward-looking statements contained herein, whether because of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.
Investor & Company Contacts:
Glenn Schulman, PharmD, MPH
Z3 BioCommunications, llc
203.494.7411
glenn@z3bio.com
Patrick McCall
IN8bio, Inc.
646.933.5603
pfmccall@IN8bio.com
Media Contact:
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KKH Advisors
917.291.5744
kimberly.ha@kkhadvisors.com
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