Handok closer to commercialize new innovative drugs for BTC

Limited treatment options for biliary tract cancer…a significant unmet medical need for new drugs

Handok shows notable achievements in biliary tract cancer area with its new drug HDB001A

'HDB001A' received fast track designation from the FDA, Phase 2/3 top-line results expected to be announced later in March

Biliary tract cancer (BTC) is known for being difficult to treat.

 

The five-year survival rate is 29.4%, which is the second lowest of all cancer types.

 

Early diagnosis of BTC is difficult, and treatment for BTC is extremely limiting despite of the high risk.

 

Fortunately, the situation is changing.

 

New treatments are being approved in South Korea and new drugs are being developed actively.

 

For instance, Handok's pharmaceuticals are showing potential for treating BTC.

 

Currently, standardized second-line treatments are not available for BTC when the first-line treatment fails.

 

Due to difficulties in early diagnosis, only 25% of the patients are operable at the diagnosis, and patients show a high recurrence rate of about 60%.

 

The second-line treatment for BTC has been limited to chemotherapy in combination with a first-line treatment, used regardless of the patient's condition.

 

Even if patients undergo second-line treatment, patients have poor prognosis due to low response rates and life expectancy.

 

In 2023, Handok obtained the domestic approval of Pemazyre, which can be used as a second-line treatment for BTC.

 

Pemazyre is indicated for patients with 'locally advanced or metastatic BTC who have FGFR2 gene fusions.' Pemazyre is the first BTC-targeted treatment approved in South Korea.

 

Pemazyre demonstrated significant data based on the Phase 2 FIGHT-202 clinical trial.

 

The primary endpoint, the combination therapy's Overall Response Rate (ORR), was 37%.

 

Although the study involved patients with advanced disease after first-line treatment or above, the drug showed favorable effects.

 

Pemazyre has been used in the U.S., Europe, and Japan.

 

It is expected to be reimbursed this year.

 

Handok has been putting efforts into introducing its new BTC treatment, HDB001A.

 

In 2019, Handok entered into a strategic partnership with ABL Bio, the original developer of HDB001A, and secured domestic commercialization rights for the product.

 

Subsequently, Handok made a US$ 5 million equity investment in the American biotech venture TRIGR Therapeutics, which had obtained global commercialization rights (excluding Korea and China) from ABL Bio in 2018.

 

In 2021, TRIGR Therapeutics was merged into Compass Therapeutics.

 

Handok and Compass Therapeutics are collaborating to develop HDB001A for BTC indication.

 

Handok conducted a Phase 2 clinical trial in South Korea in 2021 involving BTC patients and secured significant data.

 

The efficacy evaluation of this Phase 2 study showed that the ORR for patients receiving a combination of HDB001A and paclitaxel was 37.5% in second- and third-line treatments and a 63.6% ORR in second-line treatment.

 

These results were presented at the 2023 ASCO GI Symposium.

 

A view of Handok Future Complex, an integrated R&D center located in Magok district in Seoul.

Building on the significant Phase 2 results of HDB001A (Compass Therapeutics project name: CTX-009) led by Handok, Compass Therapeutics has been conducting the U.S.-based Phase 2/3 trial COMPANION-002 to evaluate HDB001A (CTX-009) as a second-line treatment for BTC.

 

COMPANION-002 is designed to compare the combination therapy of HDB001A (CTX-009) with paclitaxel against paclitaxel monotherapy in 150 patients with metastatic or recurrent BTC, with top-line results expected to be announced later this month.

 

HDB001A (CTX-009) development is progressing rapidly.

 

Handok has swiftly advanced its Phase 2 clinical trial in South Korea through close collaboration with researchers, providing the clinical protocol and data that enabled Compass Therapeutics to secure global Phase 2/3 approval from the FDA quickly.

 

In addition, HDB001A (CTX-009) received Fast Track designation from the FDA in 2024, further accelerating its development.

 

Handok plans to use the results from the COMPANION-002 study as clinical data for domestic approval of HDB001A (CTX-009) and launch it as Handok's proprietary anticancer therapy within two years.

 

Handok also collaborates with global companies such as Jazz Pharmaceuticals and Incyte to introduce anticancer treatments in areas with unmet needs.

 

Currently, it exclusively supplies the domestic market with its therapies for hepatic vein occlusion 'Defitellio,' high-risk acute myeloid leukemia 'Vyxeos,' intrahepatic cholangiocarcinoma 'Pemazyre,' and diffuse large B-cell lymphoma 'Minjuvi.' In addition, Handok is strengthening its internal research capabilities and developing new anticancer agents using its dual-targeting platform and targeted protein degradation platform.

 

In April 2024, the company presented poster data on its new lung cancer therapeutic, 'HDBNJ-2812,' at the American Association for Cancer Research (AACR 2024).

 

In April, another poster presentation on its in-house new drug development is scheduled for AACR 2025.

 

Moreover, in March 2024, Handok launched collaborative research on next-generation innovative new drugs with partners Genexine and ToolGen.