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First Patient Receives Novel OUTLAST-Enhanced CAR-T Therapy for Advanced Kidney Cancer

  • Inceptor Bio has initiated clinical trials of IB-T101, an innovative CAR-T cell therapy targeting CD70, with the first clear cell renal cell carcinoma patient receiving treatment.

  • The therapy utilizes Inceptor Bio's OUTLAST platform, which uniquely conditions T-cells to maintain effectiveness within hostile tumor environments, similar to high-altitude training for athletes.

  • This trial addresses a critical need in ccRCC treatment, where over 300,000 new cases are diagnosed globally each year with limited options for patients who progress beyond standard therapies.

Inceptor Bio has reached a significant milestone in advanced kidney cancer treatment with the dosing of its first patient in a clinical trial evaluating IB-T101, an innovative CAR-T cell therapy. The treatment, specifically designed for clear cell renal cell carcinoma (ccRCC), represents a novel approach in solid tumor immunotherapy.
IB-T101 employs a unique mechanism targeting CD70 through autologous chimeric antigen receptor (CAR) T-cells. What sets this therapy apart is its foundation in the OUTLAST platform, a proprietary technology that metabolically reprograms T-cells to maintain their effectiveness within the challenging tumor microenvironment.
"Similar to elite athletes training at high elevation, T cells conditioned in challenging environments develop the attributes needed to outperform in solid tumors," explains Matthias Schroff, PhD, Chief Executive Officer of Inceptor Bio.

Strong Preclinical Evidence

The therapy has demonstrated compelling results in preclinical studies, particularly in aggressive RCC tumor models. Even at low doses, IB-T101 significantly outperformed conventional CAR-T cells, maintaining its effectiveness even after re-challenge. The OUTLAST-enhanced cells showed higher activation levels and reduced exhaustion compared to standard approaches.

Trial Design and Patient Population

The investigator-initiated study is structured as an open-label, single-center trial focusing on adult patients with relapsed ccRCC. Following a dose-escalation design, the trial aims to:
  • Evaluate safety and tolerability as primary endpoints
  • Assess antitumor activity and pharmacokinetics as secondary endpoints
  • Include patients who have progressed on VEGF-targeting therapies alone or in combination with immune checkpoint inhibitors

Addressing an Urgent Medical Need

The trial's launch comes at a crucial time, as ccRCC treatment options remain limited for patients who progress beyond current standard therapies. With over 300,000 new cases diagnosed globally each year, the need for innovative treatment approaches is pressing.
"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," states Schroff.
Shailesh Maingi, managing partner of Kineticos Life Sciences, emphasizes the significance of this milestone: "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."
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