First Patient Dosed in IB-T101 ccRCC Trial

renal cell carcinoma: © dr microbe - stock.adobe.com

The first patient with clear cell renal cell carcinoma (ccRCC) has been dosed in a clinical trial evaluating IB-T101.¹

IB-T101 is an autologous chimeric antigen receptor (CAR) T-cell therapy that works to target CD70. The agent is powered by OUTLAST, a novel platform from Inceptor Bio. This program enhances T-cell persistence by metabolically reprogramming and conditioning them to withstand the hostile tumor microenvironment.

With over 300,000 new cases of ccRCC diagnosed globally each year and limited treatment options for patients who progress on VEGF-targeted therapies and immune checkpoint inhibitors, there remains a critical need for novel therapeutic approaches.

"This is a major milestone for Inceptor Bio as we advance IB-T101 into the clinic," said Matthias Schroff, PhD, chief executive officer of Inceptor Bio, in a press release. "Similar to elite athletes training at high elevation, T cells conditioned in challenging environments develop the attributes needed to outperform in solid tumors.”

Preclinically, superior efficacy was demonstrated with IB-T101 in an aggressive RCC tumor model.² At low dose levels of CAR T, the agent significantly outperformed conventionally manufactured CAR T cells, and the same was true when given after re-challenge. Further, OUTLAST CAR T cells led to higher levels of activation and less exhaustion in the model.

“With the support and confidence of our investors, we are focused on advancing our lead program with the goal of delivering a best-in-class therapy that has the potential to change the treatment paradigm for patients facing these challenging cancers," added Schroff.¹

This investigator-initiated, open-label, single-center trial plans to evaluate the safety, tolerability, and preliminary efficacy of IB-T101 when given to adult patients with relapsed ccRCC. The study follows a dose-escalation design to establish the optimal dosing regimen.

Patients must have relapsed on prior VEGF-targeting therapies alone or when given in combination with an immune checkpoint inhibitor. The primary end points being evaluated include safety and tolerability. Secondary end points consist of antitumor activity and pharmacokinetics.

"Dosing the first patient in a clinical trial is a significant milestone for any biotech company, and we are proud to support Inceptor Bio as they advance IB-T101 into the clinic," said Shailesh Maingi, managing partner of Kineticos Life Sciences, in the press release. "The OUTLAST™ platform represents a compelling approach to addressing key challenges in CAR T therapy, and we believe this program has the potential to make a real difference for patients with solid tumors."

REFERENCES:

1. Inceptor Bio announces first patient dosed in clinical trial of IB-T101 for clear cell renal cell carcinoma (ccRCC) and $21M series A2 financing. News release. Inceptor Bio. February 25, 2025. Accessed February 25, 2025. https://tinyurl.com/5dvkrjy6

2. Our science. Inceptor Bio. Accessed February 25, 2025. https://inceptor.bio/our-science/car-t/