Data Supports Continued Dose Escalation and Further Investigation in
Metastatic Renal Cell Carcinoma (mRCC)
MAINZ, Germany–(BUSINESS WIRE)–EXUMA Biotechnology and affiliate Shanghai PerHum Therapeutics announced
today interim results of two first-in-human solid tumor CAR-T products
in subjects with recurrent or refractory stage IV metastatic renal cell
carcinoma (mRCC). The data, presented at the Association for Cancer
Immunotherapy (CIMT) 2019 Annual Meeting, continues to support the
feasibility, comparative safety and pharmacokinetics of dose escalation
of two CAR-T products, CCT301-38 (AXL) and CCT301-59 (ROR2), 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 (TME) – 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 (CAB)-CAR-T technology to
increase the safety profile of CAR-T therapeutics in mRCC and
potentially other target-positive solid tumors.
“The cell processing feasibility, cell exposure and preliminary
comparative safety of the two novel products support the potential of
CAB-CAR-T technology for solid tumors,” said Wendy Li, M.D., Chief
Medical Officer of EXUMA Biotechnology. “We look forward to the complete
data set from these ongoing clinical studies with collaborators and to
bringing these programs forward into multicenter studies in the future.”
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.
About EXUMA Biotechnology
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 capitalization 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. Learn more at exumabio.com.
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.
Contacts
Frannie Marmorstein
+1 305-567-0821
frannie.marmorstein@rbbcommunications.com