23 May 2019 - - German biotechnology company Exuma biotechnology and affiliate Shanghai PerHum Therapeutics have presented interim results of two first-in-human solid tumor CAR-T products in subjects with recurrent or refractory stage IV metastatic renal cell carcinoma, the companies said.

The data, presented at the Association for Cancer Immunotherapy 2019 annual meeting, continues to support the feasibility, comparative safety and pharmacokinetics of dose escalation of two CAR-T products, CCT301-38 and CCT301-59, in a single patient population.

The umbrella clinical trial design being run at SPHCC (Shanghai Public Health Clinical Center) under the direction of lead investigator Tongyu Zhu, M.D., examines the first two CAR-T products in human clinical trial to use AND logic gate control technology.

The logic gate design leverages the tumor microenvironment turning the growth inhibitory acidic TME into an activating signal thereby minimizing the potential of on-target, off-tumor activity.

One trigger of the logic gate is the TME, and the other is the target antigen (AXL or ROR2, depending on the product).

Some of the key highlights presented include:

No dose-limiting toxicities have been observed to date with no indications of on-target, off-tumor toxicity attributed to either product.

CAR-T product blood exposure up to 80,000 copies/ μg observed at the 1 x 106/kg dose level.

Early radiologic evidence of antitumor activity, with stable disease as best response.

In this heavily pre-treated patient population, 6 out of 7 subjects are alive with a median follow-up of 140 days.

These interim results continue to support the potential of the company's conditionally active biologics -CAR-T technology to increase the safety profile of CAR-T therapeutics in mRCC and potentially other target-positive solid tumors.

The full abstract is now available on the annual CIMT meeting website (Abstract #123) and the poster will be presented on May 21, 9:00-11:30 am EST.
Exuma biotechnology, a clinical-stage biotechnology company developing CAR-T solutions for the solid tumor markets in Asia, was formed in April 2016 as a Cayman Special Economic Zone company with capitalisation and exclusive technology licenses from F1 Oncology, Inc.

Its wholly owned subsidiaries, Exuma biotechnology Hong Kong Ltd. and Shanghai Exuma biotechnology Ltd., oversee the development, manufacturing, quality, clinical, regulatory, and commercial operating units located in Shanghai and Shenzhen, PRC.

Exuma biotechnology was formed to maximize the development and commercialization of enabling products and technology from F1 Oncology in the Greater China markets.

Exuma biotechnology and F1 Oncology were founded and co-funded by Gregory Frost, Ph.D., co-founder and former CEO of Halozyme Therapeutics Inc., and current managing director of F1 BioVentures, LLC, a biotechnology-focused investment vehicle.