bezetabart debotansine (STRO-001) / Sutro Biopharma - LARVOL DELTA

Preclinical in vitro and in vivo evidence for CD74-targeting as effective treatment strategy for cutaneous T cell lymphomas. (PubMed, Br J Dermatol) - "CD74 is expressed across common CTCL subtypes, and CD74-targeting efficiently kills CTCL cells in vitro and in vivo. Our data thus identify CD74-targeting as highly promising treatment strategy for CTCL."

Journal • Preclinical • Cutaneous T-cell Lymphoma • Dermatology • Hematological Malignancies • Lymphoma • Mycosis Fungoides • Non-Hodgkin’s Lymphoma • Oncology • Sezary Syndrome • T Cell Non-Hodgkin Lymphoma • Transplantation • CD74

Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1 | N=70 | Completed | Sponsor: Sutro Biopharma, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Nov 2023 ➔ Mar 2024 | Trial primary completion date: Jan 2023 ➔ Feb 2024

Metastases • Trial completion • Trial completion date • Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1/2 | N=9 | Terminated | Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. | N=50 ➔ 9 | Trial completion date: Dec 2024 ➔ Dec 2023 | Recruiting ➔ Terminated; Due to company decision

Enrollment change • Metastases • Trial completion date • Trial termination • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: BioNova Pharmaceuticals (Shanghai) LTD. | Not yet recruiting ➔ Recruiting

Enrollment open • Metastases • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD74

PRELIMINARY RESULTS OF A PHASE 1 DOSE ESCALATION STUDY OF THE FIRST-IN-CLASS ANTI-CD74 ANTIBODY DRUG CONJUGATE (ADC), STRO-001, IN PATIENTS WITH ADVANCED B-CELL MALIGNANCIES. (EHA 2019) - P1; "The study continues to enroll patients in dose escalation with single patient MM cohorts and 3+3 NHL cohorts. This study is registered with clinicaltrials.gov identifier NCT03424603."

Clinical • P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Ophthalmology

Sutro Biopharma : BioNova Announces First Patient Dosed in a Phase 1/2 Study of BN301 for the Treatment of Hematologic Malignancies in China (Market Screener) - "BioNova Pharmaceuticals Limited (BioNova)...announced that the first patient has been dosed in the phase 1 clinical study of BN301 (STRO-001) for the treatment of advanced B-cell Non-Hodgkin's Lymphoma (NHL). BN301 is a novel target, site-specific antibody drug conjugate (ADC) comprised of a human aglycosylated anti-CD74 IgG1 antibody and 2 non-cleavable maytansinoid drug-linkers....The multi-center Phase 1/2 clinical trial of BN301 is to evaluate BN301 in patients with B-cell NHL who have previously failed standard therapy or who are intolerant to standard therapy."

Trial status • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Targeting CD74 in B-cell non-Hodgkin lymphoma with the antibody-drug conjugate STRO-001. (PubMed, Oncotarget) - "In MCL Mino and Jeko-1 xenografts, STRO-001 starting at 3 mg/kg significantly prolonged survival or induced tumor regression, respectively, leading to tumor eradication in both models. In summary, high CD74 expression levels in tumors, nanomolar cellular potency, and significant anti-tumor in DLBCL and MCL xenograft models support the ongoing clinical study of STRO-001 in patients with B-cell NHL."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • CD74

Preclinical studies targeting CD74 with STRO-001 antibody-drug conjugate in acute leukemia. (PubMed, Blood Adv) - No abstract available

Journal • Preclinical • Hematological Malignancies • Leukemia • Oncology • CD74

Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1 | N=70 | Active, not recruiting | Sponsor: Sutro Biopharma, Inc. | Recruiting ➔ Active, not recruiting | N=220 ➔ 70

Enrollment change • Enrollment closed • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Pediatric Acute Myeloid Leukemia with Co-Occurring BCR::ABL and CBFA2T3::GLIS2 Dual Fusion with Deep Response to FOLR1-Targeting Antibody Drug Conjugate Stro-002 and Tyrosine Kinase Inhibitor (ASH 2022) - "Review of diagnostic genomic profile mid induction showed a BCR::ABL minor breakpoint fusion as well as CBF::GLIS fusion.The child began AML induction on COG AAML1831 trial randomized to the experimental arm with CPX-351 and gemtuzumab ozogamicin (GO). Due to lack of response to AML therapy at end of Induction (EOI) I, she was taken off protocol and started on modified ALL regimen for Induction II consisting of cytarabine, low dose weekly methotrexate and bimonthly peg-asparaginase with addition of an oral TKI, dasatinib...Given availability of FOLR1 directed ADC on single-patient compassionate use basis, patient received single agent STRO-001 on a bi-monthly basis...Long-term follow-up is required to assess durability of remission. Additional testing of this approach in a larger patient population is needed to determine the role of STRO-002 in this high-risk pediatric AML population."

Clinical • IO biomarker • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics • Transplantation • CBFA2T3 • FOLR1 • GLIS2 • NCAM1 • PTPRC

Study of BN301, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1/2 | N=50 | Not yet recruiting | Sponsor: BioNova Pharmaceuticals (Shanghai) LTD.

New P1/2 trial • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD74

Sutro Biopharma Reports Second Quarter 2022 Financial Results, Business Highlights and Anticipated Milestones (GlobeNewswire) - "BioNova announced in July 2022 that it had submitted its IND for BN301 (STRO-001) to the National Medical Products Administration for the treatment of hematologic malignancies. Sutro is providing clinical drug supply to BioNova for clinical studies in Greater China."

New trial • Hematological Malignancies • Oncology

Study of STRO-001, an Anti-CD74 Antibody Drug Conjugate, in Patients With Advanced B-Cell Malignancies (clinicaltrials.gov) - P1 | N=220 | Recruiting | Sponsor: Sutro Biopharma, Inc. | Trial primary completion date: Nov 2021 ➔ Nov 2022

Trial primary completion date • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Mantle Cell Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Therapeutic Targeting of CD74 with STRO-001 Antibody-Drug Conjugate in AML and ALL (ASH 2021) - "Through transcriptomics profiling and validation of the cell surface expression by flow cytometry, we have identified CD74 as a viable therapeutic target for AML and ALL in children and adults. We further demonstrate that targeting CD74 with STRO-001 effectively eliminates leukemia cells both in vitro and in vivo , providing the preclinical data to compel evaluation of STRO-001 in clinical trials for childhood and adult leukemia."

Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Oncology • Pediatrics • Transplantation • CD123 • CD19 • CD22 • CD33 • CD7 • CD74

Fred Hutchinson Cancer Research Center, in Partnership with Sutro Biopharma, to Present at ASH 2021 (PRNewswire) - "Sutro Biopharma, Inc...announced that its research collaborators at the Fred Hutchinson Cancer Research Center presented nonclinical data of STRO-002 and STRO-001 in two oral presentations at the 63rd American Society of Hematology Annual Meeting (ASH 2021) in Atlanta, Georgia...Data from AML and ALL cell lines, as well as from nonclinical xenograft models, demonstrated robust in vitro and in vivo cytotoxicity of STRO-001 on cells expressing high- to -moderate levels of CD74, with no cytotoxicity observed in cells without CD74 expression. Potent anti-leukemia activity was also demonstrated in three primary AML patient samples with varied CD74 expression levels."

Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Oncology

Sutro Biopharma Reports Third Quarter 2021 Financial Results, Business Highlights, and Anticipated 2021 Milestones (PRNewswire) - "Patient enrollment has been completed for the STRO-002 Phase 1 ovarian cancer dose-expansion cohort, and an interim data update is expected in the second half of 2021; STRO-001 Phase 1 dose escalation for non-Hodgkin's lymphoma and multiple myeloma is ongoing to achieve a recommended Phase 2 dose."

P1 data • Trial status • Gynecologic Cancers • Hematological Malignancies • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer

Aberrant Expression of and Cell Death Induction by Engagement of the MHC-II Chaperone CD74 in Anaplastic Large Cell Lymphoma (ALCL). (PubMed, Cancers (Basel)) - "Furthermore, CD74 engagement enhances the cytotoxic effects of conventional chemotherapeutics in ALCL cell lines, as well as the action of the ALK-inhibitor crizotinib in ALK ALCL or of CD95 death-receptor signaling in ALK ALCL. Finally, we demonstrate that the CD74-targeting antibody-drug conjugate STRO-001 efficiently and specifically kills CD74-positive ALCL cell lines in vitro. Taken together, these findings enabled us to demonstrate aberrant CD74-expression in ALCL cells, which might serve as tool for the development of new treatment strategies for this lymphoma entity."

Journal • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • T Cell Non-Hodgkin Lymphoma • ALK • CD74 • FAS

Sutro Biopharma and BioNova Pharmaceuticals Enter into Collaboration for STRO-001 in Greater China (PRNewswire) - "Sutro Biopharma, Inc...and BioNova Pharmaceuticals Limited...jointly announced an option agreement for BioNova to develop and commercialize STRO-001, a CD74-targeting Antibody-Drug Conjugate (ADC), for patients with hematologic cancers, in Greater China, including mainland China, Hong Kong, Macau and Taiwan....BioNova will pay to Sutro an initial licensing option payment of $4 million, with potential payments totaling up to $200 million related to option exercise, development, regulatory, and commercial milestones. Sutro will provide STRO-001 to BioNova under appropriate clinical and commercial supply service agreements. Upon commercialization, Sutro will receive tiered, double-digit royalties based on annual net sales of STRO-001 in Greater China."

Licensing / partnership • Hematological Malignancies • Oncology

A Phase I open-label, safety, pharmacokinetic, and preliminary efficacy study of STRO-001, an anti-CD74 antibody drug conjugate, in patients with advanced B-cell malignancies (AACR 2019) - P1; "No formal statistical hypothesis testing will be conducted in this study. This study is currently open for enrollment in the US at the following sites: Medical College of Wisconsin, City of Hope, UCSF, Rocky Mountain Cancer Centers, Texas Oncology, Virginia Cancer Specialists, Winship Cancer Institute of Emory University, and the Willamette Valley Cancer Institute and Research Center."

Clinical • P1 data • PK/PD data

A phase 1 open-label, safety, pharmacokinetic, and preliminary efficacy study of STRO-001, an anti-CD74 antibody drug conjugate, in patients with advanced B-cell malignancies. (ASCO 2018) - P1; "No formal statistical hypothesis testing will be conducted in this study. This study is currently open for enrollment in the US."

Clinical • P1 data • PK/PD data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Indolent Lymphoma • Multiple Myeloma

[VIRTUAL] Preliminary Results of an Ongoing Phase 1 Dose Escalation Study of the Novel Anti-CD74 Antibody Drug Conjugate (ADC), STRO-001, in Patients with B-Cell Non-Hodgkin Lymphoma (ASH 2020) - P1 | "STRO-001 is the first ADC generated with novel cell-free protein synthesis technology and site-specific conjugation to be tested in the clinic. STRO-001 has been well-tolerated. No ocular or neuropathy toxicity signals have been observed and the MTD has not been reached."

Clinical • P1 data • Burkitt Lymphoma • Cardiovascular • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Fatigue • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology • Optic Neuritis • Pain • CD74

Sutro Biopharma Reports Full Year 2020 Financial Results and Provides Business Highlights and 2021 Anticipated Milestones (PRNewswire) - “STRO-002: Continued progress in Phase 1 trial of STRO-002, folate receptor-alpha (FolRα)-targeted antibody-drug conjugate (ADC) for patients with recurrent platinum resistant or refractory ovarian cancer…Additional data from dose-escalation, with extended follow-up on patients remaining on study, is expected in the first half of 2021. Dose-expansion portion of the Phase 1 trial began enrolling patients in January 2021 and initial dose-expansion data is expected to be reported in the second half of 2021; STRO-001: Phase 1 dose-escalation continues for STRO-001, a CD74-targeted ADC for development in B-cell malignancies…The dose-expansion portion of the Phase 1 trial is expected to begin enrolling patients in the second half of 2021.”

Enrollment status • P1 data • Trial status • Diffuse Large B Cell Lymphoma • Gynecologic Cancers • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology • Ovarian Cancer

Sutro Biopharma Announces Closing of Upsized $144.9 Million Public Offering, including Full Exercise of the Underwriters' Option to Purchase Additional Shares (PRNewswire) - "Sutro Biopharma...announced the closing of its upsized public offering of 6,900,000 shares of its common stock at a public offering price of $21.00 per share, which includes the exercise in full of the underwriters' option to purchase 900,000 shares of common stock...Sutro intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and marketable securities, to fund the continued clinical development of STRO-001 and STRO-002..."

Commercial • Oncology

Sutro Biopharma Presents Data from Ongoing Phase 1 Dose-Escalation Study for STRO-001 for the Treatment of B-cell Non-Hodgkin Lymphoma at the 62nd American Society of Hematology Annual Meeting (PRNewswire) - P1, N=220; NCT03424603; Sponsor: Sutro Biopharma, Inc.; "Sutro Biopharma, Inc...today announced a poster presentation at the virtual 62nd American Society of Hematology (ASH) Annual Meeting for the ongoing Phase 1 dose-escalation clinical trial for its CD74-targeted antibody drug conjugate (ADC) STRO-001 for patients with late-line Non-Hodgkin Lymphoma (NHL)...Most (90%) treatment-emergent adverse events (TEAEs) were grade 1 or 2 and no ocular or neuropathy toxicity signals have been observed...Out of other NHL types, 2 patients with follicular lymphoma had stable disease (SDs), of which one is still on treatment at 9 weeks. One patient with marginal zone lymphoma had SD and is still on treatment at 39 weeks."

P1 data • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Marginal Zone Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Sutro Biopharma Presents Data from Ongoing Phase 1 Dose-Escalation Study for STRO-001 for the Treatment of B-cell Non-Hodgkin Lymphoma at the 62nd American Society of Hematology Annual Meeting (PRNewswire) - "Additionally, data were presented from preclinical studies conducted in collaboration with researchers from the Fred Hutchinson Cancer Research Center...This in vitro data, which identifies CD74 as a viable target in AML, coupled with the 27% incidence of CD74 in nearly 1,000 pediatric AML patients from our clinical trial with bortezomib, strengthens the notion that targeting CD74 with STRO-001 represents a viable targeted therapy in this patient population. In addition to AML, CD74 is highly expressed in high risk acute lymphoblastic leukemia (ALL), including Ph-positive and Ph-like ALL, thus providing rationale for exploring the efficacy of STRO-001 in all leukemias."

Preclinical • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology