JW Pharmaceutical’s new drugs enter clinical trials

Its STAT3-inhibiting targeted therapy enters Phase I trial… to target solid cancers

Owns a proprietary R&D development platform…makes bid into the fields of hair loss and atopic dermatitis

JW Pharmaceutical is accelerating the development of innovative first-in-class drugs.

 

Recently, the company's STAT3-targeted anticancer drug candidate entered Phase I clinical trials.

 

In addition to targeted anticancer drugs, the company also owns first-in-class drug candidates in the fields of atopic dermatitis, hair loss, and blood cancer.

 

JW Pharmaceutical's competitive edge in drug development is its R&D platform.

 

JW Pharmaceutical is developing innovative new drugs by utilizing its own platforms JWELRY (JW Excellent LibraRY) and CLOVER (C&C researchLaboratoriesOmics serVER) and 3D cancer organoids secured through open innovation, and artificial intelligence (AI).

 

3 3 candidates enter clinical trials through the CLOVER platform...secures many first-in-class new drug candidates According to industry sources on the 21st, JW Pharmaceuticals received approval for its IND (investigational new drug application) to initiate a Phase I trial for its targeted anticancer drug candidate JW2286.

 

The Phase I clinical trial will evaluate the safety and tolerability of JW2286 in 70 healthy Korean and Caucasian adults at Seoul National University Hospital.

 

In the preclinical trial, JW2286 demonstrated efficacy and safety compared to standard of care in STAT3-overexpressing solid tumors.

 

In particular, JW2286 showed an effect in hard-to-target triple-negative breast cancer.

 

JW2286 is a first-in-class drug candidate that selectively inhibits STAT3.

 

STAT3 is known to be one of the causes of various inflammatory diseases, autoimmune diseases, and cancer, and is highly expressed in various solid tumors, including gastric, colorectal, and triple-negative breast cancers.

 

In the past, Japanese companies such as Sumitomo Dainippon Pharma and Otsuka Pharmaceutical have been developing STA3-targeted antitumor drugs, but have failed Phase I clinical trials due to lack of efficacy and toxicity issues.

 

JW Pharmaceutical has secured a clear mechanism of action for targeting STAT3 through its drug discovery platform ‘CLOVER’.

 

CLOVER can derive small molecules that inhibit or activate the STAT signaling pathway and is regarded as a platform that can perform holistic research on mechanisms and biomarkers.

 

Through the platform, JW Pharmaceutical has been developing various new drugs through the efficacy of combining candidates with immuno-oncology drugs that utilize the characteristics of tumor immune microenvironment regulation and its biomarker development strategies.

 

Currently, the company's new drug candidates that have entered clinical trials include JW2286, JW1601 for atopic dermatitis, and URC102 for gout.

 

JW Pharmaceutical

JW1601 has a dual mechanism of action that selectively acts on the histamine H4 receptor to block the activity and migration of immune cells that cause atopic dermatitis while inhibiting histamine signaling.

 

Histamine is a neurotransmitter involved in allergic reactions.

 

However, JW1601 reportedly failed to meet its primary endpoint in a global Phase II trial.

 

As there are no atopic dermatitis drugs with this mechanism, it would have been the first new drug in its class if developed but was unable to reach the commercialization stage.

 

JW Pharmaceutical plans to review the future development direction for JW1601 with the possibility of securing new indications in mind.

 

URC102 is a best-in-class gout drug being developed by JW Pharmaceutical.

 

The new drug candidate has a mechanism of action that inhibits urate transporter 1 (URAT-1), which allows uric acid to be absorbed back into the body and discharged well.

 

It was approved for a Phase III clinical trial in Korea in 2022 and has entered clinical trials in China and Taiwan to confirm its commercialization potential.

 

In addition to STAT3 anticancer drugs, JW Pharmaceutical is also exploring the possibility of developing a STAT3-targeted atopic dermatitis drug, STAT5/3 dual-targeted anticancer drug, and an antibody-drug conjugate (ADC) using the CLOVER platform.

 

Makes bid into the development of first-in-class new drugs in the field of hair loss and blood cancer JW Pharmaceutical has secured the first-in-class new drug candidates 'CWP291' and 'JW0061' in the fields of hair loss and blood cancer.

 

The two drug candidates, which target the Wnt signaling pathway, were derived from JW Pharmaceutical's ‘JWELRY’ platform.

 

JW Pharmaceuticals has been studying the Wnt signaling pathway since the early 2000s and has accumulated data to develop the JWELRY platform.

 

Wnt plays an essential role in cell proliferation or differentiation, and organ development and morphogenesis in animals.

 

Wnt pathway inhibition inhibits the formation, proliferation, and metastasis of cancer cells in various tissues, inhibits cancer stem cell activity, and has an anti-fibrotic effect.

 

On the contrary, activating the Wnt pathway is known to be involved in tissue regeneration by inducing stem cell and cell proliferation.

 

JW Pharmaceutical is developing JW0061, a new drug candidate for hair loss, through the activation of the Wnt signaling pathway.

 

The preclinical trial results that have been recently released show that JW0061 has demonstrated superiority in hair follicle production and hair growth compared to existing standard treatments.

 

JW0061, a Wnt-targeted hair loss treatment, was selected as a ‘2023 1st National new drug development project

In animal models with androgenetic alopecia, JW0061 was administered in four groups: low dose JW0061, high dose JW0061, standard of care (dutasteride or finasteride), and placebo.

 

Results showed that both low and high doses of JW0061 accelerated hair growth compared to standard of care.

 

JW Pharmaceuticals is also developing CWP291, which targets blood cancers by inhibiting the Wnt signaling pathway.

 

CWP291 is a targeted anticancer drug that inhibits Wnt/β-catenin signaling.

 

The potential of the drug candidate is being studied for multiple cancers, including acute myeloid leukemia, multiple myeloma, and gastric cancer.

 

According to the Phase Ia trial results to date, one complete response (CR) and one partial response (PR) were confirmed among 54 patients with acute myeloid leukemia with CWP291.