Alphamab Oncology Announces Promising Results for JSKN016 at 2026 ASCO Annual Meeting

Key Highlights

• Alphamab Oncology (HKEX: 9966) presented updated results for its novel bispecific ADC, JSKN016, at the 2026 ASCO Annual Meeting.
• JSKN016 targets both TROP2 and HER3 and is being developed for HER2-negative (HER2-) locally advanced or metastatic breast cancer (BC).
• Phase I data from China showed robust efficacy and a promising safety profile in heavily pretreated patients, including those with triple-negative breast cancer (TNBC) and hormone receptor-positive/HER2- breast cancer (HR+/HER2- BC).
• Multiple phase II and phase III clinical trials are ongoing or planned, including for lung cancer and as first-line and perioperative therapy in breast cancer.
• The company is leveraging its proprietary glycan-specific conjugation technology for this and other drug candidates.

Detailed Clinical Trial Results

Study Design

• The phase I study (JSKN016-101, NCT06592417) is an open-label, multi-center trial in patients with advanced solid tumors in China.
• It included a dose escalation and dose expansion stage, assessing safety, tolerability, pharmacokinetics/pharmacodynamics, and anti-tumor activity to determine the maximum tolerated dose (MTD) and recommended phase II dose (RP2D).
• Six dose levels (0.5, 1, 2, 4, 6, 8 mg/kg, Q3W) were explored. The MTD was not reached; RP2D for BC was established at 6mg/kg Q3W.

Patient Characteristics

• As of December 22, 2025, 82 patients with HER2- BC were enrolled: 50 with TNBC, 32 with HR+/HER2- BC.
• Most patients (98.8%) had stage IV disease; 7.3% had brain metastases.
• All TNBC patients had prior taxane chemotherapy, with 28% having received three or more prior systemic therapies.
• All HR+/HER2- BC patients had disease progression after at least one line of endocrine therapy with a CDK4/6 inhibitor and at least one line of chemotherapy.

Efficacy Results

• At RP2D (6 mg/kg Q3W), as of December 22, 2025:
  • For TNBC (31 evaluable patients):
    • Investigator-assessed ORR: 64.5%; Median PFS: 7.6 months
    • IRC-assessed ORR: 61.3%; Median PFS: 7.9 months
  • For HR+/HER2- BC (29 evaluable patients):
    • Investigator-assessed ORR: 51.7%; median PFS not mature
    • IRC-assessed ORR: 55.2%; median PFS: 11.1 months; 6-month PFS rate: 84.5%
• With extended data cut-off to March 17, 2026:
  • TNBC: Investigator-assessed ORR remained 64.5%, Disease Control Rate (DCR) 83.9%, mPFS 8.5 months (95% CI: 4.11, 10.02)
  • HR+/HER2- BC: Investigator-assessed ORR 51.7%, DCR 100%, mPFS not mature, 12-month PFS rate 61.7%

Safety Results

• Median follow-up: 7.8 months (as of March 17, 2026)
• At RP2D:
  • Grade 3 or higher treatment-related adverse events (TRAEs) in 24.6% of patients; no grade 4 or 5 TRAEs
  • Serious adverse events (SAEs) in 15.4%, with 12.3% being treatment-related
  • Dose reduction due to TRAEs in 46.2% of patients
  • Only 1 patient (1.5%) discontinued due to grade 3 conjunctivitis
  • No TRAEs led to death; No interstitial lung disease (ILD) observed
  • Most common grade 3 TRAEs: neutrophil count decreased (7.7%), white blood cell count decreased (6.2%), amylase increased (4.6%), stomatitis (4.6%), asthenia (1.5%), lymphocyte count decreased (1.5%), weight decreased (1.5%), abdominal pain (1.5%), anemia (1.5%), conjunctivitis (1.5%)

Significance for Investors & Price-sensitive Information

• JSKN016 demonstrated robust anti-tumor activity and a favorable safety profile in a heavily pretreated population, indicating strong potential as a future treatment option for HER2- breast cancer, especially TNBC—a population with high unmet medical need.
• Phase II and Phase III clinical trials are ongoing, expanding the scope of JSKN016 to include first-line, perioperative, and combination treatments in breast and lung cancer, potentially driving future growth and licensing opportunities.
• The results strengthen Alphamab’s leadership in ADC and bispecific antibody development, leveraging its proprietary technology that may differentiate its pipeline from competitors.
• Potential catalysts: Positive results in future trials, regulatory approvals, or licensing deals could have a significant impact on share price.
• Risks and caution: There is no guarantee of ultimate successful development or commercialization—investors should be aware of clinical and regulatory risks.

About JSKN016 & Alphamab Oncology

• JSKN016 is a bispecific ADC developed in-house, targeting TROP2 and HER3, using Alphamab’s proprietary glycan-specific conjugation platform.
• Upon binding to target antigens, JSKN016 is internalized and releases a cytotoxic topoisomerase I inhibitor, causing tumor cell death and exerting a bystander effect even on antigen-negative tumor cells.
• Alphamab is a PRC-based, leading biopharmaceutical company with a comprehensive pipeline in ADCs, monoclonal antibodies, and bispecific antibodies, and multiple products in late-stage development.

Disclaimer

Disclaimer: This article is for informational purposes only and does not constitute investment advice. The development and commercialization of pharmaceutical products carry significant risks, and there is no guarantee that Alphamab Oncology will successfully develop or market JSKN016 or any other product. Investors should exercise due diligence and consult a financial advisor before making any investment decisions.

【廣東話版本】Alphamab Oncology於2026 ASCO年會公佈JSKN016突破性臨床數據

重點摘要

• Alphamab Oncology（康諾亞生物，9966.HK）於2026年ASCO年會發佈其自主研發雙靶點ADC JSKN016的臨床最新結果。
• JSKN016同時針對TROP2及HER3，主攻HER2陰性（HER2-）晚期或轉移性乳癌。
• 中國I期臨床數據顯示，JSKN016在多線治療失敗患者（包括三陰性乳癌TNBC及激素受體陽性/HER2-乳癌HR+/HER2- BC）中展現出顯著療效及有利安全性。
• 多個II期及III期臨床試驗正進行中，涵蓋肺癌及乳癌一線和術前/術後聯合治療。
• 公司憑藉其獨家糖基特異性偶聯平台技術持續推進管線發展。

詳細臨床試驗數據

試驗設計

• I期試驗（JSKN016-101, NCT06592417）為多中心、開放性研究，入組晚期實體腫瘤中國患者。
• 研究包括劑量爬坡及擴展階段，評估安全性、耐受性、藥代/藥效及抗腫瘤活性，確定最大耐受劑量（MTD）及II期推薦劑量（RP2D）。
• 共探索六個劑量級（0.5, 1, 2, 4, 6, 8mg/kg, 每三週一次），未達最大耐受劑量，乳癌RP2D為6mg/kg Q3W。

患者特徵

• 截至2025年12月22日，共82名HER2-乳癌患者入組：50名TNBC，32名HR+/HER2- BC。
• 98.8%為IV期，7.3%有腦轉移。
• 所有TNBC患者曾接受紫杉醇化療，28%接受過三線或以上系統治療。
• 所有HR+/HER2- BC患者在CDK4/6抑制劑聯合內分泌治療及至少一線化療後出現疾病進展。

療效數據

• RP2D（6mg/kg Q3W）劑量下，截至2025年12月22日：
  • TNBC（31例可評估）：ORR 64.5%，中位無進展生存期（mPFS）7.6個月；IRC評估ORR 61.3%，mPFS 7.9個月
  • HR+/HER2- BC（29例可評估）：ORR 51.7%，mPFS未成熟；IRC評估ORR 55.2%，mPFS 11.1個月，6個月PFS率84.5%
• 數據截止延長至2026年3月17日：
  • TNBC：ORR 維持64.5%，DCR 83.9%，mPFS 8.5個月（95% CI: 4.11, 10.02）
  • HR+/HER2- BC：ORR 51.7%，DCR 100%，mPFS未成熟，12個月PFS率 61.7%

安全性數據

• 隨訪中位期：7.8個月（截至2026年3月17日）
• RP2D下：
  • 3級或以上治療相關不良事件（TRAEs）發生率24.6%，無4級或5級TRAEs
  • 嚴重不良事件（SAEs）發生率15.4%，其中12.3%與治療相關
  • 因TRAEs減量治療比例達46.2%
  • 僅1人（1.5%）因3級結膜炎永久停藥
  • 無治療相關死亡，未觀察到間質性肺疾病（ILD）
  • 常見3級TRAEs包括：中性粒細胞減少（7.7%）、白細胞減少（6.2%）、澱粉酶升高（4.6%）、口腔炎（4.6%）、乏力（1.5%）、淋巴細胞減少（1.5%）、體重下降（1.5%）、腹痛（1.5%）、貧血（1.5%）、結膜炎（1.5%）

對股東的意義及潛在股價敏感信息

• JSKN016在多線治療失敗HER2-乳癌（特別是TNBC）中展現出強勁療效及良好安全性，市場潛力巨大。
• 多項II期及III期臨床試驗正進行，涵蓋一線、圍手術期及聯合治療，有望推動未來增長及授權變現。
• 進一步鞏固公司在ADC及雙抗領域技術領導地位，憑藉自主技術建立差異化競爭優勢。
• 潛在催化劑：未來臨床數據、監管批准或授權合作均可能對公司股價產生重大影響。
• 風險提示：藥物開發具高風險，最終能否成功上市仍有不確定性，投資者需審慎評估。

關於JSKN016及康諾亞

• JSKN016為自主研發雙靶點ADC，靶向TROP2及HER3，基於公司獨家糖基偶聯技術平台。
• 藥物結合靶點後內吞至溶酶體，釋放拓撲異構酶I抑制劑，殺死腫瘤細胞，並可對抗原陰性細胞產生旁觀者效應。
• 康諾亞為中國領先生物製藥企業，擁有多元創新管線及多項進入III期或關鍵臨床階段產品。

免責聲明

免責聲明：本文僅供資訊參考，並不構成任何投資建議。藥物研發及商業化存在高風險，康諾亞最終能否成功開發及上市JSKN016或其他產品仍有不確定性。投資者應審慎評估風險並諮詢專業顧問後再作投資決策。

View ALPHAMAB-B Historical chart here