ABL105 / ABL Bio, Yuhan Corp - LARVOL DELTA

A phase 1/2, open-label, multicenter, first-in-human study to evaluate the safety, pharmacokinetics, and anti-tumor activity of YH32367 in patients (pts) with HER2+ locally advanced/metastatic (a/m) solid tumors (AACR 2025) - "Primary endpoint was treatment emergent adverse events (TEAEs) up to Day 21; secondary endpoints included pharmacokinetics (PK), objective response rate (ORR), disease control rate (DCR), and duration of response (DoR). At data cutoff (May 24, 2024), 32 pts enrolled across 8 dose levels (63% male; median age, 60 yrs; most common tumors, biliary tract [BTC; n=14 {44%}] and gastric [n=9 {28%}]; median [range] prior treatment lines, 2 [0-7]; prior trastuzumab-based regimen, 1 [0-3]).No dose-limiting toxicities were observed; maximum-tolerated dose was not reached. YH32367, at doses ≤30 mg/kg, showed favorable safety, promising clinical benefit, and non-linear PK in previously treated pts with HER2+ a/m solid tumors, supporting further development in the dose optimization phase.Table. Safety and efficacy outcomesDose, mg/kg0.30.751.536122030TotalSafety set, n1136666332TEAE, n (%)01 (100)2 (66.7)4 (66.7)5 (83.3)6 (100)4 (66.7)3 (100)25 (78.1)Grade ≥301 (100)001 (16.7)1..."

Clinical • Metastases • P1/2 data • PK/PD data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor • HER-2

Yuhan Corporation presents phase 1 results of immunotherapy YH32367…at AACR [Google translation] (BioTimes) - P1/2 | N=137 | NCT05523947 | Sponsor: Yuhan Corporation | "The results announced this time are from the dose-escalation part conducted in Korea and Australia, and a total of 32 patients (14 biliary tract cancer, 9 gastric cancer, and 9 other solid tumors) were enrolled from October 2022....In the clinical trial results, there were no dose-limiting toxicities (DLTs) at any dose, and the maximum tolerated dose (MTD) was not reached. Treatment-related adverse reactions (TRAEs) were reported in 10 patients (31%), and were mainly mild (grade 1 to 2) such as fever and chills. Of the 31 patients with measurable lesions, 7 were evaluated as partial response (PR) and 10 as stable disease (SD), resulting in an objective response rate (ORR) of 23% and a disease control rate (DCR) of 55%."

P1 data • Biliary Tract Cancer • Cholangiocarcinoma • Gastric Cancer • Solid Tumor

ABL Bio, '4-1BB Single Antibody' Patent Decision in the US and Australia [Google translation] (HIT News) - "ABL Bio...announced on the 30th that its patent for the 4-1BB monoclonal antibody and its uses has been granted in the United States and Australia. The patent was applied for internationally in December 2019, and ABL Bio can protect its rights to the 4-1BB monoclonal antibody until 2039...The 4-1BB monoclonal antibody has a mechanism that activates T cells, one of the immune cells, and causes the T cells to attack cancer cells....Representative pipelines to which Grabody-T is applied include ABL503 (Ragistomig), ABL111 (Givastomig), ABL103, and ABL105."

Patent • Oncology • Solid Tumor

[Hankyung Eureka Featured Stock] ABL Bio, Expected New Drug Development Momentum Until Next Year [Google translation] (Hankyung) - "In addition, 'ABL105 (breast cancer/stomach cancer)' and 'ABL103 (breast cancer/solid cancer)' are scheduled to announce phase 1 clinical data in 2025, and it was announced that many R&D momentums are valid next year as well."

P1 data • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

ABL Bio Completes Third-Party Allocation Paid-in Capital Increase for Development of Next-Generation Dual Antibody ADC [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 11th that it has completed payment for a third-party allocation paid-in capital increase worth 140 billion won....Meanwhile, the existing 4-1BB-based dual antibody immunotherapy and blood-brain barrier (BBB) ​​shuttle platform 'Grabody-B' are planned to be developed with the technology fee (milestone) that ABL Bio is scheduled to receive in the future and the contract fee for additional technology transfer. The representative 4-1BB-based dual antibodies ABL503 and ABL111 are currently undergoing clinical phase 1 tumor expansion part and triple combination therapy (ABL111 + nivolumab (Opdivo) + chemotherapy) evaluation clinical trials, respectively. Another 4-1BB dual antibody ABL103's domestic phase 1 clinical trial and ABL105's Korean and Australian phase 1 clinical trials, which were transferred to Yuhan-Yanghaeng and are currently under development, are also progressing smoothly."

Commercial • Oncology • Solid Tumor

Yuhan Corporation applies for patent examination of dual antibody anticancer drug… Commercialization begins [Google translation] (News1 Korea) - "Reporter Tae-Hwan Kim = Yuhan-Yanghaeng...has set out to secure a patent related to the dual antibody anticancer drug substance 'YH32367' (ABL105) that it is jointly developing with ABL Bio...According to the patent search service Kiprice on the 18th, Yuhan Corporation applied for a patent priority examination to the Korean Intellectual Property Office (KIPO) early this month for a patent...It is about a dual antibody that simultaneously targets 'HER2' and '4-1BB' expressed on the surface of solid tumors and an anticancer drug....It will complete the recruitment of patients for the phase 1 dose-escalation trial in the first half of this year and conduct a trial to find the optimal dose in the second half."

Enrollment status • Patent • Trial status • Oncology • Solid Tumor • HER-2

Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=137 | Recruiting | Sponsor: Yuhan Corporation | Trial primary completion date: Jan 2024 ➔ Oct 2026

Metastases • Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Yuhan Corporation, sales in the first quarter of KRW 444.6 billion… maintained first place in the industry [Google translation] (Health Korea News) - "According to Yuhan Corporation's first quarter performance disclosure (consolidated financial statements) released on the 16th, sales were KRW 444.6 billion, an increase of 0.35% compared to the same period last year (KRW 443 billion)...'R&D expenses increased compared to the previous year due to the progress of the clinical stage pipeline YH32324 (allergy treatment, clinical trial phase 1b) and YH32367 (HER2x4-1BB bispecific antibody, clinical trial phase 1/2)....'Leclaza', a new drug for non-small cell lung cancer, is expected to contribute to improving profitability starting in the second quarter due to the expansion of nursing care benefits to patients receiving first-line treatment for EGFR non-small cell lung cancer and the final drug price being determined."

Commercial • Allergy • Breast Cancer • Gastric Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

ABL Bio participates in ‘Bio Korea 2024’ exhibition [Google translation] - "ABL Bio...announced on the 2nd that it plans to participate in the exhibition program of the 'BIO Korea 2024 International Convention' and showcase its bispecific antibody technology...Through this booth exhibition, ABL Bio introduces...ROR1 targeting ADC ABL202, which is currently in development in the non-clinical stage. Information on the concept of bispecific antibody ADC will also be introduced....'This year, including Bio Korea, clinical trials for ABL503, ABL202, and ABL001 will be conducted. Various events are scheduled, including the announcement of results.'"

Clinical • Clinical data • New trial • Hematological Malignancies • Oncology • Solid Tumor

ABL Bio participates in ‘Bio Korea 2024’ exhibition [Google translation] (ABL Bio Press Release) - "ABL Bio...announced on the 2nd that it plans to participate in the exhibition program of the 'BIO Korea 2024 International Convention' and showcase its bispecific antibody technology....Through this booth exhibition, ABL Bio introduces its dual antibody-based immuno-anticancer drug and blood-brain barrier (BBB) ​​shuttle 'Grabody-B' through posters. The immunotherapy pipeline being introduced this time includes ABL503, ABL111, ABL103, and ABL105 using the 4-1BB-based dual antibody platform 'Grabody-T..."

Clinical • Oncology • Solid Tumor

The HER2/4-1BB bispecific antibody, YH32367 (ABL105) demonstrates optimal efficacy and safety for HER2-expressing tumors and exhibits synergistic efficacy when combined with anti-PD-L1 (AACR 2024) - P1/2 | "Currently, new HER2-targeted therapy like trastuzumab deruxtecan have improved outcomes not only for HER2-positive tumors but also for HER2-low tumors. Furthermore, its combination with anti-PD-1 Ab has shown synergistic efficacy, indicating that YH32367 may offer treatment options not only as a monotherapy but also in combination therapy for HER2 expressing tumors. The phase 1 dose escalation study is currently underway (NCT05523947), and a dose optimization study to determine the recommended phase 2 dose (RP2D) is scheduled for the second half of 2024."

Clinical • IO biomarker • Oncology • HER-2 • IFNG • TNFRSF9

K-anticancer drug is ready for global application as a ‘bio-innovative new drug’ at the US AACR [Google translation] (BioTimes) - "Yuhan Corporation plans to announce preclinical test results of its dual antibody pipelines ‘YH32367’ and ‘YH41723’...Yuhan Corporation is conducting phase 1 clinical trials in Korea and Australia targeting patients who show resistance to existing anticancer treatments in a number of HER2-expressing solid cancers, such as breast cancer, stomach cancer, and biliary tract cancer. We are developing YH32367 with the goal of completing the recruitment of patients for the phase 1 clinical dose escalation trial by the first half of the year and starting a trial to set the optimal dose in the second half of the year."

Enrollment status • Preclinical • Trial status • Oncology • Solid Tumor • HER-2

Yuhan Corporation announces non-clinical results of two types of immunotherapy at the American Cancer Society [Google translation] (Medifonews) - "Yuhan Corporation...will present the results of non-clinical research on YH32367 (ABL105) and YH41723 (IMC202), immunotherapy drugs under development, at the American Association for Cancer Research (AACR 2024)...YH32367 not only showed significantly superior anticancer efficacy and safety compared to control antibodies in various non-clinical experiments on HER2-expressing tumors, but also showed superior efficacy compared to competing drugs even in tumors with low HER2 expression...YH41723 specifically binds to tumor cells expressing PD-L15, a representative target of anti-cancer immunotherapy, and activates T immune cells by interfering with PD-1, which inhibits the activity of T immune cells....Yuhan Corporation aims to start clinical trials for YH41723 in 2025."

New trial • Preclinical • Oncology • Solid Tumor • HER-2

"K-Bio shows off new cancer-conquering technology"… American Cancer Society's 'AACR' scramble [Google translation] (Nate) - "Yuhan Corporation announces the results of pre-clinical studies on YH32367 (ABL105) and 'YH29407', which are being developed as immuno-oncology drugs. YH32367, a drug under joint research with ABL Bio, is an anticancer drug that binds to HER2-expressing tumor cells and increases the anticancer activity of immune cells through stimulation of 4-1BB, a T immune cell activation receptor."

Preclinical • Oncology

Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=110 | Recruiting | Sponsor: Yuhan Corporation | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

Clinical Trial of YH32367 in Patients With HER2 Positive Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1/2 | N=110 | Not yet recruiting | Sponsor: Yuhan Corporation

New P1/2 trial • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • HER-2

A novel HER2/4-1BB bispecific antibody, YH32367 (ABL105) exhibits the optimal efficacy and superior safety profile through tumor-directed 4-1BB agonism (AACR 2022) - "Although HER2-targeted therapies such as Herceptin® (trastuzumab) have dramatically improved outcomes for solid cancer patients with HER2 overexpression, it remains a challenge to cure the HER2 positive cancer patients with resistance to current HER2-targeted therapies. These results suggest that YH32367 could be a promising therapeutic for HER2-positive cancer patients, especially with HER2 drug resistance as an effective HER2-targeted therapy. Phase I clinical study is expected to begin in 2022."

Clinical • IO biomarker • Oncology • Solid Tumor • HER-2 • IFNG • TNFRSF9

[VIRTUAL] A novel HER2/4-1BB bispecific antibody, YH32367 (ABL105) exerts significant anti-tumor effects through tumor-directed T cell activation (ESMO 2021) - "YH32367 also showed superior efficacies on immune cells activation as well as tumor growth inhibition in both HER2-expressing tumor-bearing hPBMC humanized mice and h4-1BB knock-in mice models compared to the equimolar dosing of trastuzumab and benchmark 4-1BB agonistic antibodies. In conclusion, YH32367 exhibited potent in vitro and vivo effect through tumor-directed T cell activation. It suggests that YH32367 could be promising to develop for the patients with HER2 positive cancer as an effective HER2-directed therapy."

IO biomarker • Oncology • Solid Tumor • HER-2 • IFNG • TNFA • TNFRSF9

Korean drugmakers unveil pipeline developments at annual ESMO meeting (Korea Biomedical Review) - "Yuhan Corp. presented the preclinical efficacy and toxicity test results of YH32367, an immuno-oncology dual antibody candidate under development as a new treatment for solid cancers, such as breast, stomach, and lung cancer, during a poster session. Yuhan and ABL Bio are conducting joint research on YH32367, which has a mechanism to increase the anticancer activity of immune cells by stimulating T-immune cell activation receptors that kill viruses or cancer cells. Yuhan believes that the treatment is effective in resistant patients to existing anticancer drugs and plans on starting clinical trials in 2022."

New trial • Preclinical • Breast Cancer • Gastric Cancer • Gastrointestinal Cancer • Lung Cancer • Oncology