Yingshi Biotech announced the IN10018 clinical research data at the 2022 International Melanoma Society (SMR) Annual Meeting

Yingshi Biologics, a global innovative drug R&D company focused on breaking through drug resistance in solid tumors, announced that at the 19th Annual Meeting of the International Melanoma Society (SMR), it announced the preliminary results of a Phase Ib malignant melanoma clinical study conducted in the United States and Australia under research pipeline IN10018, which will be presented
in the form of a poster (Abstract #:P-141) during the conference 。 The data show that IN10018 shows great potential anti-tumor efficacy and good controllable safety
in the treatment of patients with uveal melanoma (UM) and NRAS mutant melanoma.

IN10018 is a highly effective and selective Focal Adhesion Kinase (FAK) inhibitor, which is being developed for platinum-resistant recurrent ovarian cancer, melanoma, triple-negative breast cancer, head and neck tumors, KRAS G12C mutant tumors, pancreatic adenocarcinoma and other solid tumor indications that lack effective treatment.
Among them, IN10018 combined with PLD for the treatment of platinum-resistant recurrent ovarian cancer has obtained fast-track certification from the US Food and Drug Administration (FDA) in August 2021, and was recognized
as a breakthrough therapy drug by the China National Medical Products Administration (NMPA) in April this year.

The Phase Ib study, presented at this meeting, aims to evaluate the safety and anti-tumor efficacy
of IN10018 monotherapy or in combination with the MEK inhibitor Cobimetinib (Cobi) in patients with UM or NRAS-mutated melanoma.
The study is being conducted
at a total of eight centres in the United States and Australia.
As of June 30, 2022, a total of 45 patients with UM or NRAS mutant melanoma were enrolled, 93% of whom had previously received immune checkpoint inhibitor therapy
.
IN10018 100 mg QD alone or in combination with Cobi 60 mg was determined to be the recommended dose
.
Cobi is developed and listed by Roche, after reaching a global clinical development collaboration
with Roche for IN10018 and Cobi combination therapy.

IN10018 in combination with Cobi has shown promising antitumor activity
in patients with UM or NRAS mutant melanoma.
Among UM patients, IN10018 monotherapy had a median progression-free survival (mPFS) of 2.
73 months in 10 patients with evaluable efficacy; IN10018 plus Cobi had an mPFS of 6.
52 months
in 8 evaluable patients.
In patients with NRAS mutant melanoma, IN10018 monotherapy had an mPFS of 2.
79 months in seven physiothetically assessable patients, of whom 1 had PR.

More encouraging results came from IN10018 in combination with Cobi for patients with NRAS-mutated melanoma, with 5 PRs and 5 SDs reported in 13 evaluable patients, with an ORR of 38.
5% (5/13), a DCR of 76.
9% (10/13), and a median PFS of 5.
45 months
.

In terms of safety, IN10018 and Cobi combination therapy is comparable to IN10018 monotherapy, and no toxic superposition is observed
.

Yingshi Biotech has the exclusive global development and commercial operation rights of
IN10018.
The company's Nanjing Translational Medicine Center has conducted original mechanism exploratory research on IN10018 and FAK targets, and has made breakthroughs, which have been published
in high-level international academic journals.
Relevant data show that IN10018 is expected to overcome the tumor stromal fibrosis barrier and improve local immune function, so as to synergize with targeted therapy, chemotherapy and immunotherapy, and become a new choice
for combination drugs.
The clinical data of IN10018 further confirmed its good safety profile and efficacy
of multiple cancers.
Yingshi plans to carry out clinical proof-of-concept and collaborative development
globally in multiple solid tumor indications and in combination with different drugs.

In addition to advancing the global clinical development of IN10018, the company expects that several innovative drug projects with new targets and mechanisms will be approved for IND and clinical trials
in China and the United States this year.
These drug candidates are all centered on the synergistic layout of multiple drug resistance mechanisms and fibrotic microenvironments of various types of solid tumors, and are currently actively communicating and preparing with the corresponding regulatory agencies
.