caxmotabart entudotin (IKS014) / Fosun Pharma, LigaChem Biosci, Iksuda Therap - LARVOL DELTA

Early analysis of activity in esophageal cancer during phase 1 dose escalation of IKS014, a HER2-targeting antibody drug conjugate (ADC), in participants with advanced HER2+ and HER2 low solid tumors. (ASCO-GI 2026) - P1 | "Funded by Iksuda Therapeutics Limited Clinical Trial Registration Number: NCT05872295 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Metastases • P1 data • Esophageal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

Riga Chembio announced on the 6th that it won two categories at the 12th World ADC Awards held in San Diego, USA. (Maeil Business Newpaper) - "The company won the top prize for HER2 ADC 'IKS014 (LCB14)' in the 'Most Promising ADC to Watch' category and the second prize in the 'Best ADC Platform Technology' category, respectively."

Commercial • HER2 Positive Breast Cancer

FS-1502 combined with serplulimab in patients with HER2 expression, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJ): An open-label, multicenter, phase II study [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

FS-1502 in patients with HER2 expression, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (GC/GEJ): An open-label, multicenter, phase II study (ESMO 2025) - P2 | "Conclusions FS-1502 demonstrated encouraging efficacy with tolerable and manageable safety profile in HER2-postive, advanced GC/GEJ pts who had received ≥1 prior treatments, regardless of dosing frequency, which warrants further investigations. Table: 2135P ES HER2+ Cohort 1 Cohort 2 Q2W Q3W Q2W Q3W N=14 N=16 N=15 N=19 ORR, (%) 50.0 12.5 13.3 36.8 Median DOR, mos (95% confidence interval[CI]) 7.2 (4.6, -) - (5.4,-) 3.6 (2.8, -) 8.5 (2.2,-) Median PFS, mos (95% CI) 7.4 (1.9, -) 4.3 (1.5, 5.8) 2.7 (1.4, 4.1) 4.4 (3.0, 7.3) Median OS, mos (95% CI) 15.8 (4.5 , -) 10.0 (5.1, 23.6) 7.7 (2.4, 13.4) 15.0 (8.7, 22.2) SS(Safety-analysis-set) N=79 Q2W (N=33) Q3W (N=46) Median FS-1502 treatment duration, days (range) 84.0 (14, 493) 112.0 (21, 800) G≥3 TRAEs, n (%) 14 (42.4) 12 (26.1) Serious TRAEs, n (%) 9 (27.3) 5 (10.9) Dose reduction due to TRAEs, n (%) 6 (18.2) 5 (10.9) Drug suspension due to TRAEs, n (%) 18 (54.5) 9 (19.6) Drug discontinuation due to TRAEs, n (%) 1 (3.0) 0"

Clinical • Metastases • P2 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

A phase I dose escalation trial of IKS014, a HER2-targeting antibody drug conjugate (ADC), in participants with advanced HER2+ solid tumors (ESMO 2025) - P1 | "Partial responses have been observed in various tumor indications such as breast, esophageal, ovarian and gallbladder cancer and in HER2+ and HER2 low tumors. Conclusions Based on the encouraging early signs of activity and the tolerable safety profile observed to date, recruitment to the Part 2 Expansion Cohorts will begin once the RP2D has been selected and will include sites in other countries."

Metastases • P1 data • Gallbladder Cancer • Oncology • Ovarian Cancer • Solid Tumor • HER-2

[ESMO] Targeting ADC Resistance… LigaChem Biosciences' post-Enhertu move with LCB14 (The Bio) - "According to the poster, IKS014 achieved an objective response rate (ORR) of 64% (7/11) overall and 43% (3/7) in patients with HER2-low-expressing breast cancer. Notably, three out of four patients who had previously shown no response to Enhertu exhibited a partial response (PR), highlighting the drug's potential to enter the 'post-Enhertu' therapeutic landscape."

P1 data • HER2 Positive Breast Cancer

Iksuda to Present IKS014 Phase 1 Data at ESMO (Businesswire) - "The Phase 1 study (NCT05872295) is a non-randomised, open-label, multicentre trial evaluating IKS014 in patients with locally advanced or metastatic solid tumours that express HER2. Data will be presented from the dose escalation portion of the trial conducted in Australia..."

P1 data • Gastric Cancer • HER2 Positive Breast Cancer

Ligachem Bio expands global clinical sites for its HER2-ADC 'LCB14'. [Google translation] (HIT News) - "According to information disclosed on clinicaltrials.gov, a US clinical trial registration site, partner company Iksuda Therapeutics has expanded its clinical trial, previously conducted solely in Australia, to six new sites in the US, Singapore, and New Zealand. The company expects this expansion to broaden its clinical network to regions with a high concentration of patients with a history of Enhertu use, accelerating post-Enhertu patient recruitment for its Phase 1b clinical trial, scheduled to begin within the year."

Trial status • Breast Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma

FS-CY1502-Ph1-01: Phase 1 Study of FS-1502 in Patients With HER2 Expressed Advanced Solid Tumors and Breast Cancer. (clinicaltrials.gov) - P1 | N=161 | Completed | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | Active, not recruiting ➔ Completed | N=297 ➔ 161

Enrollment change • Trial completion • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

LigaChem Biosciences plans 20 ADC drug candidates by 2027, CEO announces progress (Chosun Biz) - "Kim Yong-joo, CEO of LigaChem Biosciences, announced plans to secure a total of 20 antibody-drug conjugate (ADC) candidates by 2027....LCB84 has completed Phase 1 trials for solid cancer patients, including those with triple-negative breast cancer and non-small cell lung cancer, and is expected to announce results within this year. LCB14...is preparing to enter Phase 2 trials in patients who received the ADC cancer drug 'Enhertu' (ingredient name trastuzumab deruxtecan) but relapsed. LNCB74, which is being co-developed with NextCure, has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA), and CS5001, currently developed with ABL Bio in Korea, is undergoing global Phase 1b trials."

New P2 trial • P1 data • Pipeline update • Trial status • Non Small Cell Lung Cancer • Triple Negative Breast Cancer

Iksuda Therapeutics Receives FDA IND Clearance for IKS014 (Businesswire) - "Iksuda Therapeutics...announces that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for IKS014, a human epidermal growth factor receptor 2 (HER2) ADC targeting patients with advanced HER2+ solid tumours, enabling the expansion of ongoing clinical trials....FDA decision will enable Iksuda to expand its ongoing clinical trial in the US, Australia and Singapore....The first stage of this phase 1 trial, to determine the recommended phase 2 dose for dose expansion, is nearing completion. The expansion phase will assess several patient cohorts including those with HER2-positive breast cancer...The phase 1 trial is expected to complete in 2H 2026."

IND • Trial status • HER2 Positive Breast Cancer

A multicenter, open-label, double-cohort, phase II study: to evaluate the efficacy and safety of FS-1502 in patients with HER2-overexpressing locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (ChiCTR) - P2 | N=79 | Completed | Sponsor: Sir Run Run Shaw Hospital , Zhejiang University School of Medicine; Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd.

New P2 trial • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2

IKS014 in Advanced Solid Tumors That Express HER2 (clinicaltrials.gov) - P1 | N=165 | Recruiting | Sponsor: Iksuda Therapeutics Ltd. | Trial primary completion date: Sep 2025 ➔ Sep 2026

Trial primary completion date • Breast Cancer • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • HER2 Positive Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2

An open, two-cohort, multicenter Phase II study of FS-1502 in combination with Srulizumab and chemotherapy in patients with HER2-expressing advanced gastric cancer (ChiCTR) - P2 | N=58 | Completed | Sponsor: Beijing Cancer Hospital; Shanghai Fosun Pharmaceutical (Group) Limited by Share Ltd

New P2 trial • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • HER-2 • PD-L1 • TMB

Clinical momentum is lined up starting this year [Google translation] (eDaily) - "...China Fosun Pharmaceutical is applying for conditional approval of LCB14 in the first half of 2025 and aims to enter the Chinese market in 2026. Therefore, the results of LCB14's phase 3 breast cancer clinical trial in China are expected to be released within the first half of 2025."

China approval • Launch non-US • P3 data • Breast Cancer

Efficacy and Safety of GQ1005, a Promising HER2-ADC, in Patients with Metastatic HER2-Positive Breast Cancer. (SABCS 2024) - P1 | "All participants had received chemotherapy, 93.3% had received trastuzumab, 86.7% had received HER2 TKIs (nearly all received pyrotinib), and 63.2% had received other HER2 ADCs (including TDM1, FS-1502, A-166, etc.). GQ1005 demonstrates robust anti-tumor activity and a favorable safety profile in patients with heavily pretreated HER2-positive MBC. Notably, GQ1005 exhibits significantly superior safety profiles, attributable to its higher linker stability and minimal payload shedding in circulation. These promising results warrant further investigation in randomized, controlled phase III studies."

Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2

LCB14, a strong candidate... [Google translation] (Nate) - "The possibility of a third-party technology transfer for Ligachem Bio's...HER2 target ADC treatment LCB14 is being raised simultaneously. The analysis is that there is a high need for a new pipeline from global big pharma due to changes in the HER2 ADC market environment, and LCB14 is the pipeline that will satisfy this need....In particular, Iksuda has announced that it will pursue technology transfer for LCB14 after completing phase 1 clinical trials in Australia. Global big pharmas such as Roche and AstraZeneca are emerging as potential candidates."

Licensing / partnership • Gastric Cancer • Gastrointestinal Cancer • HER2 Breast Cancer • Lung Cancer • Oncology • Solid Tumor

Ligachem Bio to Enter Three Clinical Trials This Year… Expectations for ADC Phase 2 Next Year [Google translation] (Medipana) - "The HER2-ADC candidate LCB14 began phase 1a clinical trial patient administration at the end of last year through the company's partner, Iksuda Therapeutics...The results of the phase 1b trial are expected to come out in the second half of next year...Ligachem Bio is also preparing a pipeline that will enter additional phase 1 clinical trials next year. The LCB41 and LCB97 candidates are expected to enter phase 1 next year."

New P1 trial • P1 data • Oncology • Solid Tumor

RigaChem Bio partner Fosun Pharmaceutical discloses ‘LCB14’ breast cancer phase 1a and 1b results [Google translation] (HIT News) - P1a/1b | N=297 | NCT03944499 | Sponsor: Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. | "RigaChem Bioscience...told Nature communications that its partner Fosun Pharma is testing the company's HER2-ADC, 'LCB14(FS-1502)', for patients with HER2-expressing metastatic breast cancer. It was announced on the 18th that the results of a phase 1a/1b clinical trial were published...Among the 150 patients administered medication in phase 1 clinical trials, 2 (3.0%) of 67 patients administered medication at the recommended phase 2 dose (RP2D, 2.3 mg/kg, Q3W) achieved complete response (CR), 34 50.7% of patients achieved partial response (PR). Accordingly, the objective response rate (ORR) was 53.7%...'Based on these clinical results, conditional approval in China will be granted in the first half of 2025.'....'Accordingly, we expect commercialization in China and receipt of royalties from RigaChem Bio as early as 2026.'"

China approval • Launch non-US • Licensing / partnership • P1 data • HER2 Breast Cancer • Oncology • Solid Tumor

RigaChem Bio, platform value rises… First commercialization expected next year [Google translation] (Nate) - "The platform value of RigaChem Bio...is increasing...Attention is also paid to ‘LCB14’, which will be commercialized as early as next year....In particular, LCB14 is noteworthy in that it is a pipeline that has a high possibility of becoming RigaChem Bio's first commercialized new drug."

Launch non-US • Oncology • Solid Tumor • HER-2

‘Big deal and even profit’ RigaChem Bio is on the verge of overcoming the absence of commercialized products [Google translation] (Money Today) - "According to the industry on the 30th, China's Fosun Pharmaceutical, which has received Rigachem Bio's HER2-ADC candidate 'LCB14' and is conducting local clinical trials, is expected to meet the conditions to apply for conditional approval in the second half of the year. If approved, it will be the first commercialization of a substance using RigaChem Bio technology...As phase 1 is expected to be completed and interim results are expected to be produced in the second half of the year..."

China approval • P1 data • Oncology • Solid Tumor • HER-2

HER2-targeting antibody drug conjugate FS-1502 in HER2-expressing metastatic breast cancer: a phase 1a/1b trial. (PubMed, Nat Commun) - P1 | "Of 67 HER2-positive BC patients receiving the RP2D, the best ORR was 53.7% (95% CI, 41.1-66.0%), including PRs confirmed (confirmed ORR, 37.5%) and pending for confirmation. FS-1502 was well tolerated with limited ocular and pulmonary findings and demonstrated promising antitumor activity in HER2-positive BC patients."

Journal • Metastases • P1 data • P1 data • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Pneumonia • Solid Tumor

FS-1502 in patients with HER2 high expression, locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma: An open-label, multicenter, phase II study. (ASCO 2024) - "FS-1502 showed promising activity with tolerable and manageable safety profile, which warrants further development in HER2-postive, advanced gastric or gastroesophageal junction adenocarcinoma who had received ≥1 prior treatment regimens."

Clinical • Metastases • P2 data • Esophageal Cancer • Fatigue • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

RigaChem Bio ‘Fosun Pharmaceutical L/O ‘Gastric cancer ADC new drug candidate’ Phase 2 confirmed possibility of replacing Enhertu’ [Google translation] (LigaChem Biosciences Press Release) - P2 | N=112 | CTR20220633 | Sponsor: Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. | "RigaChem Bioscience...will use 'FS-1502...for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal cancer at ASCO 2024...According to Rigachem, in phase 2 clinical trials, LCB14 was administered to HER2-positive patients at a dose of 2.3 mg/kg once every three weeks...The efficacy results of LCB14 are as follows: Cohort 1 (16 patients) had an objective response rate (ORR) of 37.5%, median progression-free survival (mPFS) of 4.3 months, and overall survival (OS) of 10.0 months....The median progression-free survival time of LCB14 is shorter than that of Enhertu (the longest treatment period of 303 days and 435 days for Enhertu, compared to 171 days for LCB14), making accurate comparison difficult, and the final value will depend on future clinical results."

P2 data • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • HER-2

RigaChem Bio proves ADC technology with 1Q sales… Real growth begins [Google translation] (Medipana) - "According to the disclosure, sales in the first quarter of this year were 31,055.84 million won, a 305.6% increase compared to 7,658.04 million won in the same period last year...The reason why RigaChem Bio was able to increase sales equivalent to the previous year's performance in just one quarter was because of the signing of a technology transfer agreement for LCB84 (Trop2-ADC) with Janssen, a global pharmaceutical company, on December 22 last year....RigaChem Bio, which has multiple ADC pipelines, has confirmed that the safety data confirmed in the LCB14 clinical results has been proven again in the clinical results of other pipelines, including LCB71, and major pipelines, including LCB84, will also confirm clinical results in 2025."

Commercial • P1/2 data • Hematological Malignancies • Oncology • Solid Tumor