GI Innovation Announces New Clinical Trial Collaboration and Supply Agreement to Evaluate GI-102 in Combination with KEYTRUDA® (pembrolizumab) in Patients with Immunotherapy-Resistant Liver Cancer, Melanoma, and Renal Cell Carcinoma
August 26 2024 - 1:56AM
Business Wire
- Phase 2 Clinical Trial of GI-102 in Combination with
KEYTRUDA for Immunotherapy Resistant Liver Cancer, Melanoma, and
Renal Cell Carcinoma Set to Begin
The South Korean biotech company GI Innovation announced today
that it has signed a clinical trial collaboration and supply
agreement with MSD (a tradename of Merck& Co., Inc., Rahway,
NJ, USA) to evaluate the combination of GI-102 and MSD’s anti-PD-1
therapy, KEYTRUDA® (pembrolizumab) in patients with
immunotherapy-resistant liver cancer, melanoma, and renal cell
carcinoma.
This agreement marks GI Innovation’s second clinical trial
collaboration with MSD, following a previous collaboration for
GI-101A.
The Phase 2 clinical trial including GI-102 in combination with
KEYTRUDA will enroll patients with resistance or non-response to
immuno-oncology treatments, leaving them with no further treatment
options. GI Innovation is focused on three indications with
significant market potential and potential likelihood of success:
metastatic liver cancer, melanoma, and renal cell carcinoma. The
company has already demonstrated strong anti-cancer efficacy with a
42.9% overall response rate (ORR) in a monotherapy trial of GI-102
in melanoma patients who failed to respond to standard-of-care
treatment (3 partial responses out of 7 patients). Complete tumor
regression was previously observed in 60% of mice treated with
GI-102 monotherapy in a preclinical liver cancer model.
Fourteen hospitals in South Korea and world-renowned sites in
the U.S. have agreed to join the trial, including the Mayo Clinic
(campuses in Rochester, Florida, and Arizona), Cleveland Clinic and
Memorial Sloan Kettering Cancer Center. In South Korea, the trial
will take place at leading hospitals including Samsung Medical
Center, Asan Medical Center, Seoul National University Hospital,
Severance Hospital of Yonsei University, and St. Vincent’s
Hospital.
"We are pleased to enter into another clinical trial
collaboration and supply agreement with MSD, a world leader in
immuno-oncology. We aim to maximize the therapeutic value of GI-102
by combining it with KEYTRUDA, MSD’s anti-PD-1 therapy”, said Dr
Myung-Ho Jang, GI Innovation’s Chief Scientific Officer.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
LLC, a subsidiary of Merck & Co., Inc., Rahway NJ, USA.
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GI Innovation Eun-Hee Rho selly215@gi-innovation.com