Drugs / BN301
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | China (NMPA) | — | hematopoietic and lymphoid cell neoplasm | — | “submitted its IND for BN301 (STRO-001) to the National Medical Products Administration for the treatment of hematologic malignancies.” sutrobio.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05611853 | Nov 2022 → Dec 2023 | diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma | BioNova Pharmaceuticals (Shanghai) LTD. | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2021-12-13 | Sutro Biopharma, Inc. | Results Fred Hutchinson Cancer Research Center, in Partnership with Sutro Biopharma, to Present at ASH 2021 sutrobio.com ↗
We further demonstrated that STR0-002 effectively targets a high-risk AML subtype and STRO-001 effectively targets AML and ALL cells that express CD74, providing promising nonclinical data for possible treatment options. |
| 2021-01-12 | Sutro Biopharma, Inc. | Results BioSpace – Sutro Biopharma Maximizes Synergy to Treat Cancer and Preserve Quality of Life sutrobio.com ↗
Sutro presented interim data from the study at the 62 nd American Society of Hematology Annual Meeting (ASH), which showed one CR two 2 PRs, as well as a strong safety profile with 90% of treatment-emergent adverse events (TEAEs) being at either grade one or two. |
| 2020-12-09 | Sutro Biopharma, Inc. | Results Onco’Zine – ASH 2020: Preclinical Models Identify CD74 as Potential Target for the Treatment of AML sutrobio.com ↗
Importantly, the investigators did not observe ocular or neuropathy toxicity. |
| 2020-12-07 | Sutro Biopharma, Inc. | Results 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 sutrobio.com ↗
STRO-001 was generally well-tolerated in patients with late-line NHL with no ocular or neuropathy toxicity signals; MTD has not been reached |
| 2020-11-04 | Sutro Biopharma, Inc. | Results American Society of Hematology Conference 2020 – STRO-001 – Abstract sutrobio.com ↗
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 |
| 2019-11-06 | Sutro Biopharma, Inc. | Results American Society of Hematology Conference 2019 – STRO-001 – Abstract sutrobio.com ↗
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. |
| 2019-07-15 | Sutro Biopharma, Inc. | Results International Conference in Malignant Lymphoma (ICML) 2019 – STRO-001 Poster sutrobio.com ↗
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. |
| 2019-06-15 | Sutro Biopharma, Inc. | Results Sutro Biopharma Announces Encouraging Interim Phase 1 Safety Data on a Potential First-in-Class Antibody-Drug Conjugate STRO-001 for the Treatment of B-cell Malignancies at the European Hematology Association Congress sutrobio.com ↗
The data also showed encouraging preliminary anti-tumor activity for the ADC, including one complete response (CR) and one partial response (PR) among a cohort of heavily pre-treated patients with DLBCL. |
| 2019-06-15 | Sutro Biopharma, Inc. | Results European Hematology Association Congress (EHA) 2019 – STRO-001 Poster sutrobio.com ↗
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. |
| 2019-05-16 | Sutro Biopharma, Inc. | Results Sutro Biopharma Announces Presentation at the 2019 European Hematology Association Congress sutrobio.com ↗
The abstract summarizes preliminary results from the first 14 patients enrolled in the company’s ongoing Phase 1 study of STRO-001, the first antibody-drug conjugate generated with Sutro’s novel cell-free protein synthesis technology, in patients with advanced B-cell malignancies. |
| 2019-05-16 | Sutro Biopharma, Inc. | Results European Hematology Association (EHA) 2019 – STRO-001 Abstract sutrobio.com ↗
14 patients (7 MM and 7 NHL), have been treated at 7 dose levels: .05, .075, .15, .27, .43, .65 and .91 mg/kg. |
| 2018-10-12 | Sutro Biopharma, Inc. | Regulatory Sutro’s STRO-001 Receives U.S. FDA Orphan Drug Designation for Treatment of Multiple Myeloma sutrobio.com ↗
Sutro Biopharma , Inc. (NASDAQ: STRO),has been granted Orphan Drug Designation by the United States Food and Drug Administration (FDA) for STRO-001 for the treatment of multiple myeloma. |
| 2018-01-01 | Sutro Biopharma, Inc. | Results STRO-001 – Publication Highlights sutrobio.com ↗
Anti-CD74 antibody SP7219 binds to both human and cyno CD74 ECD with high affinity (K D =0.85nM for human, K D =2.4nM for cyno). |
| 2017-12-12 | Sutro Biopharma, Inc. | Results Sutro Antibody Effectively Targets CD74 in Lymphoma & Multiple Myeloma Preclinical Studies sutrobio.com ↗
Additionally, STRO-001 demonstrated potent in vitro cytotoxicity and in vivo antitumor activity in multiple B-cell tumor cell lines and xenograft models. |
| 2017-12-06 | Sutro Biopharma, Inc. | Results American Society of Hematology (ASH) 2017 – Oral Presentation sutrobio.com ↗
High Frequency of CD74 Expression in B-cell Non-Hodgkin’s Lymphoma (NHL) and Targeting with STRO-001, a Novel Anti-CD74 Antibody Drug Conjugate (ADC) with Potent In Vitro Cytotoxicity and In Vivo Anti-Tumor Activity |
| 2017-04-03 | Sutro Biopharma, Inc. | Results Sutro ADC Targeting CD74 Eradicates B-Cell Hematologic Malignancy, Prolongs Survival in Tumor Models sutrobio.com ↗
STRO-001, an antibody drug conjugate developed by Sutro Biopharma Inc., demonstrated potent anti-tumor activity in multiple myeloma, diffuse large B-cell lymphoma and mantle cell lymphoma tumor models while reducing the potential for toxic secondary effects on adjacent healthy cells, according to findings presented this past Sunday at the American Association for Cancer Research’s annual meeting in Washington, DC. |
| 2016-12-06 | Sutro Biopharma, Inc. | Results Sutro ADC Targeting CD74 Exhibits Potent Anti-tumor Activity in Multiple Malignant Cell Lines and Animal Models of Non-Hodgkin Lymphoma and Multiple Myeloma sutrobio.com ↗
STRO-001 demonstrated efficient cell killing in multiple malignant B-cell lines and exhibited potent anti-tumor activity in six mouse tumor models of non-Hodgkin lymphoma and multiple myeloma, according to studies recently completed by Sutro. |
All press releases naming this drug 18 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | BN301 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05611853 ↗ |
| Route | Intravenous | “administered intravenously” NCT05611853 ↗ |
| Target | CD74 | “Anti-CD74 Antibody Drug Conjugate” NCT05611853 ↗ |