BL-M11D1 / Sichuan Biokin Pharmaceutical, Systimmune - LARVOL DELTA

Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of Bl-M11D1 (clinicaltrials.gov) - P1 | N=52 | Terminated | Sponsor: SystImmune Inc. | N=120 ➔ 52 | Trial completion date: Mar 2027 ➔ Sep 2026 | Recruiting ➔ Terminated | Trial primary completion date: Dec 2026 ➔ Sep 2026; Sponsor prioritization of other development portfolio

Enrollment change • Trial completion date • Trial primary completion date • Trial termination • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • CD33

A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2/3 | N=216 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes (clinicaltrials.gov) - P1/2 | N=92 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Initiation date: May 2026 ➔ Sep 2026

Trial initiation date • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • CD33

Phase II/III clinical trial of BL-M11D1 in combination with cytarabine + daunorubicin or verneclax + azacitidine in patients with acute myeloid leukemia. (clinicaltrials.gov) - P2/3 | N=216 | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=80 ➔ 216

Enrollment change • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • CD33

A Study of BL-M11D1 in Patients With Relapsed/Refractory Myelodysplastic Syndromes (clinicaltrials.gov) - P1/2 | N=92 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1/2 trial • Hematological Malignancies • Myelodysplastic Syndrome • Oncology • CD33

BL-M11D1, a novel CD33-targeting ADC, demonstrates robust anti-tumor efficacy in preclinical evaluation (AACR 2024) - "It is built on gemtuzumab, a specific monoclonal antibody against CD33, having a wt Fc that can mediate ADCC in vitro. In summary, these studies suggest BL-M11D1, a novel CD33-targeting ADC, is potentially efficacious in the treatment of CD33-expressing disease. The clinical phase I trial is being undertaken to evaluate safety, dosing and observations of preliminary signs of efficacy."

ADC • Preclinical • Hematological Malignancies • Oncology • CD33 • CTSB

A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Acute Myeloid Leukemia (clinicaltrials.gov) - P2/3 | N=216 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=80 ➔ 216 | Initiation date: Dec 2025 ➔ Mar 2026

Enrollment change • Trial initiation date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of BL-M11D1 in Combination With Cytarabine + Daunorubicin or Venetoclax + Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia (clinicaltrials.gov) - P2/3 | N=80 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2/3 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

BL-M11D1, a Novel CD33 Antibody-Drug Conjugate (ADC), in Patients with Relapsed/ Refractory Acute Myeloid Leukemia: Initial Results from First-in-Human Phase 1 Study (ASH 2024) - "Conclusion : The preliminary results of this phase I study have demonstrated BL-M11D1 monotherapy with an acceptable safety profile and encouraging anti-cancer activity, including in refractory patients who had not previously achieved remission from prior therapy. The dose escalation of BL-M11D1 is ongoing, to better define the safety profile, anti-cancer activity and the RP2D for future development."

Clinical • First-in-human • P1 data • Acute Myelogenous Leukemia • Anemia • Cardiovascular • Heart Failure • Hepatology • Infectious Disease • Pneumonia • Respiratory Diseases • CD33

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2025 ➔ Dec 2026

Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=130 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=26 ➔ 130 | Trial completion date: Aug 2025 ➔ Dec 2025 | Trial primary completion date: Aug 2025 ➔ Dec 2025

Enrollment change • Trial completion date • Trial primary completion date • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, Efficacy of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=120 | Recruiting | Sponsor: SystImmune Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Multicenter, Open-Label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of BL-M11D1 in Patients with Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=120 | Not yet recruiting | Sponsor: SystImmune Inc.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

SystImmune, Inc. Announces Upcoming Presentation at the 2024 American Society of Hematology (ASH) Annual Meeting (PRNewswire) - "SystImmune, Inc...announced an upcoming poster presentation on BL-M11D1, an antibody drug conjugate (ADC) targeting CD33 at the 66th American Society of Hematology (ASH) Annual Meeting and Exposition, being hosted December 7 – 10th, 2024 in San Diego, CA....At ASH we will present initial safety and efficacy data from the dose escalation portion of the study in relapsed/refractory AML patients."

P1 data • Acute Myelogenous Leukemia

Baili Tianheng: FDA approval for Phase I clinical trial application of BL-M11D1 (CD33-ADC) for the treatment of patients with relapsed or refractory acute myeloid leukemia [Google translation] (163.com) - "According to the financial news on October 13, recently, SystImmune, Inc...received a notice from the U.S. Food and Drug Administration (FDA) that the Phase I clinical trial application of BL-M11D1 (CD33-ADC) for the treatment of patients with relapsed or refractory acute myeloid leukemia has been approved by the FDA. The drug application number is IND171813, the applicant is SystImmune, Inc., and the indication is relapsed or refractory acute myeloid leukemia."

IND • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=26 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology

A Study of BL-M11D1 in Patients With Relapsed/Refractory Acute Myeloid Leukemia (clinicaltrials.gov) - P1 | N=26 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology • Solid Tumor

Sichuan Baili Tianheng Pharmaceutical Co., Ltd. Voluntarily Disclosed Announcement on Obtaining the Phase I Clinical Trial Approval Notice for Injection BL-M11D1 (CD33-ADC) for the Treatment of Acute Myeloid Leukemia [Google translation] (Shanghai Securities News) - "Sichuan Baili Tianheng Pharmaceutical Co., Ltd. voluntarily disclosed announcement on obtaining the Phase I clinical trial approval notice for Injection BL-M11D1 (CD33-ADC) for the treatment of acute myeloid leukemia....The innovative biological drug BL-M11D1 (CD33-ADC) independently developed by Sichuan Baili Tianheng Pharmaceutical Co., Ltd...was officially approved and issued by the National Medical Products Administration (NMPA) on the 18th of this month."

New P1 trial • Acute Myelogenous Leukemia • Hematological Malignancies • Leukemia • Oncology