NeoImmuneTech's Promising Results in Combining NT-I7 with CAR-T Therapy for LBCL Patients
NeoImmuneTech has disclosed encouraging interim findings from its Phase Ib clinical trial, which involved a unique combination of a CAR-T therapy with NT-I7 (efineptakin alfa) to address large B-cell lymphoma (LBCL). The trial, dubbed NIT-112, aimed to evaluate the safety and effectiveness of this innovative blend, emphasizing the augmentation, continuity, and essential nature of CAR-T cells in LBCL patients. The research enrolled individuals who had previously undergone established CAR-T treatments like Kymriah, Yescarta, or Breyanzi, followed by an NT-I7 dose 21 days post-infusion.
The preliminary results exhibited that mid-level NT-I7 doses upheld a consistent safety record, devoid of cases related to cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS), high-risk side effects often linked to CAR-T therapies. Mild effects such as erythema and swelling at the injection site were observed in six out of 11 participants but were easily managed.
Significantly, the inclusion of NT-I7 substantially amplified the proliferation of CAR-T cells, extended their presence in the body, and fortified T cell essentialness. The trial reported a remarkable overall response rate (ORR) of 81.1%, with seven patients achieving complete response (CR) and two showing partial response (PR). This ORR surpasses the 52% reported for Kymriah alone in LBCL patients.
Dr. Luke Oh, NeoImmuneTech's president and CEO, expressed enthusiasm about the initial results, spotlighting NT-I7's potential to elevate patient outcomes. The company intends to pursue technology transfer related to integrating NT-I7 with CAR-T therapies and is eager to engage with organizations already conducting preclinical studies on this combination.
Key Takeaways
- NT-I7 enhances CAR-T cell amplification, persistence, and stemness in LBCL patients.
- No severe side effects like CRS or ICANS observed with NT-I7 doses.
- Overall response rate of 81.1% achieved, higher than Kymriah alone.
- Manageable mild side effects reported.
- NeoImmuneTech plans to pursue technology transfer for NT-I7 with CAR-T therapies.
Analysis
NeoImmuneTech's interim findings propose that NT-I7 could bring about a transformation in CAR-T therapy for LBCL, mitigating side effects and enhancing efficacy. In the short term, this could offer safer and more effective treatments for patients. In the long term, it could potentially alter market dynamics, impacting companies such as Novartis (Kymriah), Gilead (Yescarta), and Bristol-Myers Squibb (Breyanzi). NeoImmuneTech's success could attract investments, driving research and development as well as potential partnerships. The absence of severe side effects positions NT-I7 as a safer alternative, potentially increasing patient access and market share.
Did You Know?
- CAR-T Therapy:
- Explanation: Chimeric Antigen Receptor T-cell (CAR-T) therapy is a form of immunotherapy that involves modifying a patient's T-cells to express a chimeric antigen receptor (CAR). These modified T-cells are then reintroduced into the patient to target and eliminate cancer cells expressing specific antigens. In the context of the article, CAR-T therapy is utilized for treating large B-cell lymphoma (LBCL).
- NT-I7 (efineptakin alfa):
- Explanation: NT-I7, also known as efineptakin alfa, is a human granulocyte-macrophage colony-stimulating factor (GM-CSF) analog. It is designed to bolster the immune response by promoting the expansion and continuity of immune cells, particularly T-cells. In the study, NT-I7 was utilized in combination with CAR-T therapy to enhance the proliferation, persistence, and essential nature of CAR-T cells in LBCL patients.
- Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS):
- Explanation: CRS and ICANS are severe side effects linked with CAR-T therapy. CRS is a systemic inflammatory response that can lead to fever, hypotension, and organ dysfunction. ICANS is a neurological toxicity that can cause confusion, seizures, and other neurological symptoms. Both conditions are high-risk complications that can be life-threatening. In the study, the combination of CAR-T therapy with NT-I7 did not result in any cases of CRS or ICANS, indicating a favorable safety profile.