Last update 07 Nov 2024

Luveltamab Tazevibulin

Last update 07 Nov 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Antibody drug conjugate (ADC)

Synonyms

anti-FolRa ADC STRO-002, DBCO-Alexa647-conjugated SP7219, luvelta

+ [5]

Target

FOLR1

Mechanism

FOLR1 antagonists(Folate receptor alpha antagonists)

Therapeutic Areas

NeoplasmsEndocrinology and Metabolic DiseaseUrogenital Diseases+ [3]

Active Indication

Fallopian Tube CarcinomaOvarian Epithelial CarcinomaPlatinum-Resistant Ovarian Carcinoma+ [8]

Inactive Indication-

Originator Organization

Sutro Biopharma, Inc.

Active Organization

Sutro Biopharma, Inc.

Piramal Pharma Solutions, Inc.

Tasly Pharmaceutical Group Co., Ltd.

Inactive Organization

Shanghai Tasly Pharmaceutical Co. Ltd.

Drug Highest PhasePhase 2/3

First Approval Date-

RegulationOrphan Drug (US), Rare Pediatric Disease (US), Fast Track (US)

Structure

Molecular FormulaC27H44N4O4

InChIKeyILRXQTICSGMLFH-ZYRIPLEJSA-N

CAS Registry1977557-86-0

View All Structures (2)

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Gene Sequence

Sequence Code 13410342L

Source: *****

Sequence Code 669201441H

Source: *****

Clinical Trials associated with Luveltamab Tazevibulin

NCT06679582 / Not yet recruitingPhase 1/2

A Phase 1/2, Open-label Study Evaluating the Efficacy, Safety, and Pharmacokinetics (PK) of Luveltamab Tazevibulin (STRO-002) in Infants and Children < 12 Years of Age with CBFA2T3::GLIS2 Acute Myeloid Leukemia (AML)

This trial will evaluate whether luveltamab tazevibulin is well tolerated and active against a rare form of AML carrying a particular genetic abnormality called CBFA2T3::GLIS2 that arises in infants and children. To be treated in this trial children must have a leukemia which did not respond or recurred after prior treatment. Luveltamab tazevibulin is an antibody-drug conjugate, which brings tazevibulin, an anticancer drug, to a molecule called FOLR1, present on the surface of CBFA2T3::GLIS2 AML cells.

Start Date01 Nov 2024

Sponsor / Collaborator

Sutro Biopharma, Inc.

[+1]

NCT06555263 / RecruitingPhase 2

A Phase 2, Open-label Study Evaluating STRO-002, an Anti-folate Receptor Alpha (FOLR1) Antibody-Drug Conjugate, in Subjects with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer Expressing FOLR1

A Phase 2 study evaluating STRO-002 in subjects with previously treated advanced or metastatic non-small cell lung cancer expressing FOLR1

Start Date21 Aug 2024

Sponsor / Collaborator

Sutro Biopharma, Inc.

NCT06238687 / RecruitingPhase 1/2

A Phase I/IIa Study to Evaluate the Safety, Tolerability , Pharmacokinetics and Preliminary Efficacy of STRO-002 in Chinese Adults With Advanced Epithelial Ovarian Cancer, Endometrial Cancer, and Other Advanced Malignant Solid Tumors.

This is a multi-center, open-label, monotherapy dose escalation, PK bridging, and dose expansion Phase I/IIa study in Chinese adult subjects to evaluate the safety, tolerability, Pharmacokinetics (PK) profiles, immunogenicity, and preliminary efficacy of STRO-002 in patients with advanced malignant solid tumors.

Start Date08 Nov 2023

Sponsor / Collaborator

Tasly Pharmaceutical Group Co., Ltd.

[+1]

100 Clinical Results associated with Luveltamab Tazevibulin

100 Translational Medicine associated with Luveltamab Tazevibulin

100 Patents (Medical) associated with Luveltamab Tazevibulin

Literatures (Medical) associated with Luveltamab Tazevibulin

01 May 2023·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Antibody-Drug Conjugates in Gynecologic Cancer.

Review

Author: Powell, Sachia Stonefeld ; Pothuri, Bhavana ; Karpel, Hannah C

The present article reviews the current evidence for antibody-drug conjugates (ADCs) in gynecologic cancer. ADCs consist of a highly selective monoclonal antibody for a tumor-associated antigen and a potent cytotoxic payload conjugated through a linker. Overall, the toxicity profiles of ADCs are manageable. Ocular toxicity is a known class effect of some ADCs and is managed with prophylactic corticosteroid and vasoconstrictor eye drops as well as dose interruptions/holds and dose modifications. In ovarian cancer, mirvetuximab soravtansine, an ADC targeting alpha-folate receptor (FRα), received US Food and Drug Administration (FDA) accelerated approval in November 2022 after data from the single-arm phase III SORAYA trial. A second ADC targeting FRα, STRO-002, received FDA fast track designation in August 2021. Multiple studies with upifitamab rilsodotin, an ADC comprising a NaPi2B-binding antibody, are underway. In cervical cancer, tisotumab vedotin, an ADC-targeting tissue factor, received FDA accelerated approval in September 2021 after the phase II innovaTV 204 trial. Tisotumab vedotin in combination with chemotherapy and other targeted agents is currently being evaluated. Although there are no currently approved ADCs for endometrial cancer, there are many under active evaluation, including mirvetuximab soravtansine. Trastuzumab-deruxtecan (T-DXd), an ADC targeting human epidermal growth factor receptor 2 (HER2), is currently approved for HER2-positive and HER2-low breast cancer and shows promise in endometrial cancer. Like all anticancer treatments, the decision for a patient to undergo therapy with an ADC is a personal choice that balances the potential benefits with the side effects and requires thorough and compassionate support of their physician and care team and shared decision making.

01 Feb 2023·Molecular cancer therapeutics

Discovery of STRO-002, a Novel Homogeneous ADC Targeting Folate Receptor Alpha, for the Treatment of Ovarian and Endometrial Cancers

Article

Author: Stephenson, Heather T. ; Abrahams, Cristina L. ; Bedard, Kristin ; Hallam, Trevor J. ; Bajjuri, Krishna ; Hanson, Jeffrey ; Henningsen, Robert ; Tran, Cuong ; Zhou, Sihong ; Stafford, Ryan L. ; Calarese, Daniel ; Li, Xiaofan ; Yin, Gang ; Sato, Aaron K. ; Krimm, Stellanie ; Smith, Jennifer ; Yam, Alice Y. ; Heibeck, Tyler H. ; Lupher, Mark Jr. ; Kline, Toni ; De Almeida, Venita I.

Abstract:

STRO-002 is a novel homogeneous folate receptor alpha (FolRα) targeting antibody–drug conjugate (ADC) currently being investigated in the clinic as a treatment for ovarian and endometrial cancers. Here, we describe the discovery, optimization, and antitumor properties of STRO-002. STRO-002 was generated by conjugation of a novel cleavable 3-aminophenyl hemiasterlin linker-warhead (SC239) to the nonnatural amino acid para-azidomethyl-L-phenylalanine incorporated at specific positions within a high affinity anti-FolRα antibody using Sutro's XpressCF+, which resulted in a homogeneous ADC with a drug–antibody ratio (DAR) of 4. STRO-002 binds to FolRα with high affinity, internalizes rapidly into target positive cells, and releases the tubulin-targeting cytotoxin 3-aminophenyl hemiasterlin (SC209). SC209 has reduced potential for drug efflux via P-glycoprotein 1 drug pump compared with other tubulin-targeting payloads. While STRO-002 lacks nonspecific cytotoxicity toward FolRα-negative cell lines, bystander killing of target negative cells was observed when cocultured with target positive cells. STRO-002 is stable in circulation with no change in DAR for up to 21 days and has a half-life of 6.4 days in mice. A single dose of STRO-002 induced significant tumor growth inhibition in FolRα-expressing xenograft models and patient-derived xenograft models. In addition, combination treatment with carboplatin or Avastin further increased STRO-002 efficacy in xenograft models. The potent and specific preclinical efficacy of STRO-002 supports clinical development of STRO-002 for treating patients with FolRα-expressing cancers, including ovarian, endometrial, and non–small cell lung cancer. Phase I dose escalation for STRO-002 is in progress in ovarian cancer and endometrial cancer patients (NCT03748186 and NCT05200364).

22 Nov 2022·Blood advances

Targeting FOLR1 in high-risk CBF2AT3-GLIS2 pediatric AML with STRO-002 FOLR1–antibody-drug conjugate

Article

Author: Brodersen, Lisa Eidenshinck ; Abrahams, Cristina ; Bedard, Kristin ; Kirkey, Danielle ; Le, Quy ; Loken, Michael R. ; Tang, Thao ; Pardo, Laura ; Meshinchi, Soheil ; Tarlock, Katherine ; Perkins, LaKeisha ; Castro, Sommer ; Molina, Arturo ; Smith, Jenny ; Loeb, Keith R. ; McKay, Cyd Nourigat

We identified the FOLR1 transcript to be uniquely expressed in CBF/GLIS AML but silent in most other types of AML, normal CD34+ cells, and bone marrow samples.Here, we present preclin. studies on the efficacy of STRO-002, a FOLR1-directed antibody-drug conjugate (ADC), developed by Sutro Biopharma for solid malignancies against CBF/GLIS AML.To evaluate the specificity of STRO-002 against FOLR1-pos. AML, MV4;11 AML cells were transduced with a FOLR1- expressing construct (MV4;11 FOLR1+).The viability of MV4;11 FOLR1+ cells and parental MV4;11 cells lacking FOLR1 expression was determined after incubation with increasing concentrations of STRO-002.To assess the activity of STRO-002 in xenograft mouse models, we first transplanted MV4;11 FOLR1+ cells transduced with green fluorescent protein/firefly luciferase into NOD/SCID/IL2rγnull NOD scid gamma(NSG) mice.The mice that underwent transplantation received 3 weekly doses of STRO-002 at 2.5 mg/kg and 5 mg/kg 1 wk after transplantation.In addition, STRO-002 therapy resulted in stable complete remission, with treated mice surviving up to the end of the study (112 days) compared with untreated MV4;11 FOLR1+ xenograft mice, which developed progressive disease and had a median survival of 52 days after receiving injection for leukemia (P = .002).In this study, we show that FOLR1 is uniquely expressed in CBF/ GLIS AML but silent in normal cells, providing a strategy to target leukemia cells without affecting normal hematopoiesis. FOLR1 is targeted by STRO-002, an ADC that is currently in a phase 1 clin. trial for the treatment of solid tumors.We demonstrate that STRO-002 exhibits target-dependent cytotoxicity against FOLR1-expressing AML cells.STRO-002 therapy is highly effective against MV4;11 FOLR1+ and CBF/GLIS-CB but has only modest activity against the CBF/GLIS-pos. WSU-AML cell line expressing lower levels of FOLR1.In conclusion, we have shown that preclin. studies with STRO-002, a FOLR1-directed ADC, can effectively eliminate CBF/GLISpos. AML, providing a promising approach to treating this aggressive pediatric leukemia.

News (Medical) associated with Luveltamab Tazevibulin

03 Nov 2024

·pipelinereview.com

Sutro Biopharma Announces Initiation of the Registration-enabling REFRαME-P1 Trial with Luvelta for Pediatric Patients with CBF/GLIS AML

SOUTH SAN FRANCISCO, CA, USA I November 01, 2024 I Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), today announced that REFRαME-P1, the registration-directed study of luveltamab tazevibulin (luvelta) for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) acute myeloid leukemia (AML), has been initiated and is open for enrollment. “We are excited to announce the initiation of our second pivotal trial, the registration-enabling clinical trial of luvelta in infants and toddlers with a rare and aggressive form of leukemia,” said Anne Borgman, M.D., Sutro’s Chief Medical Officer. “We look forward to bringing this promising targeted therapy to a pediatric patient group with limited effective treatment options.” “Beginning this trial is an important next step in the clinical development pathway for luvelta, as it has the opportunity to address the unmet in many types of cancer that express Folate Receptor-α (FRα) beyond ovarian,” said Soheil Meshinchi, M.D., Ph.D. “With my focus on the biology of AML, I am honored to have been a part of making this medicine available to patients in dire need via a compassionate use mechanism sponsored by Sutro, through which we have seen encouraging results in this devastating disease.” In December 2023, Dr. Meshinchi presented data on anti-leukemic activity from the compassionate use of luvelta in 25 pediatric patients with relapsed/refractory CBFA2T3-GLIS2 (CBF/GLIS) acute myeloid leukemia (AML) at the American Society of Hematology Annual Meeting and Exposition. Data demonstrated that treatment with luvelta produced meaningful clinical responses, including complete remission in 42% of patients with ≥5% blasts, and prolonged overall survival, enabling some patients to receive hematopoietic stem cell transplant, a potentially curative therapy. CBF/GLIS subtype AML is a rare and highly lethal form of leukemia found exclusively in infants and young children, with the average age of onset at 18 months 1 . There are no therapies specifically approved to target this form of leukemia and it is resistant to conventional chemotherapy, with an induction failure rate of over 80% 2 . Due to a lack of effective treatment, children diagnosed with the disease have a dismal two-year survival rate 3 . Recent studies have shown that FOLR1, which encodes for FRα, is silent in normal hematopoiesis, but is uniquely induced by the CBF/GLIS gene fusion 4 . REFRaME-P1 is a registration-enabling study evaluating the efficacy and safety of luvelta in infants and children under 12 years of age with CBF/GLIS AML. This will be a global study, with the majority of sites planned to be open by the end of the year. *1: National Institutes of Health [NIH], 2022; Quessada et al 2021; Masseti et al 2019 *2: Smith JL, et al. Comprehensive Transcriptome Profiling of Cryptic CBFA2T3-GLIS2 Fusion-Positive AML Defines Novel Therapeutic Options: A COG and TARGET Pediatric AML Study. Clin Cancer Res. 2020 Feb 1;26(3):726-737. doi: 10.1158/1078-0432.CCR-19-1800. Epub 2019 Nov 12. PMID: 31719049; PMCID: PMC7002196. *3: Tang T, et al. Targeting FOLR1 in high-risk CBF2AT3-GLIS2 pediatric AML with STRO-002 FOLR1-antibody-drug conjugate, Blood Adv. 2022 Nov 22;6(22):5933-5937. doi: 10.1182/bloodadvances.2022008503. PMID: 36149945; PMCID: PMC9701621. *4: Le Q, et al. Targeting FOLR1 in High-Risk CBFA2T3-GLIS2 AML with Stro-002 FOLR1-Directed Antibody-Drug Conjugate, Blood, Volume 138, Supplement 1, 2021, Page 209, ISSN 0006-4971, https://doi.org/10.1182/blood-2021-153076 . About Luveltamab Tazevibulin Luveltamab tazevibulin, abbreviated as “luvelta” and formerly known as STRO-002, is a FRα-targeting antibody-drug conjugate (ADC) designed to treat a broad range of patients with ovarian cancer, including those with lower FRα-expression who are not eligible for approved treatment options targeting FRα. Developed and manufactured with Sutro’s cell-free XpressCF ® platform, luvelta is a homogeneous ADC with four hemiasterlin cytotoxins per antibody, precisely positioned to efficiently deliver to the tumor while ensuring systemic stability after dosing. REFRαME-O1, a Phase 2/3 registration-directed study for patients with platinum-resistant ovarian cancer is ongoing. The Company has another ongoing registration-directed trial, REFRαME-P1, for patients with CBF/GLIS acute myeloid leukemia, a rare subtype of pediatric cancer, as well as additional ongoing trials in patients with endometrial cancer, non-small cell lung cancer, and in combination with bevacizumab in patients with ovarian cancer. The U.S. Food and Drug Administration (FDA) has granted luvelta a Fast Track designation for Ovarian Cancer, as well as Orphan and Rare Pediatric Disease designations for CBF/GLIS Pediatric AML. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF ® , provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com . SOURCE: Sutro Biopharma

Fast TrackASHClinical Study

11 Oct 2024

·pipelinereview.com

Sutro Biopharma Highlights Next-Generation ADC Innovation and Near-term Pipeline at Research Forum

Proprietary cell-free platform enables the design of next-generation ADCs intended to broaden addressable patient populations STRO-004 (tissue factor ADC) preclinical data has demonstrated greater anti-tumor activity and lower toxicity compared to a benchmark tissue factor ADC Preclinical models highlight potent anti-tumor activity of Sutro dual-payload (ADC 2 ) and immunostimulatory (iADC) ADCs Expects to deliver three Investigational New Drug (IND) applications over the next three years with potential for best in class SOUTH SAN FRANCISCO, CA, USA I October 10, 2024 I Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting an investor webcast today highlighting its proprietary cell-free platform and its use to design and develop next-generation ADC innovation, including a near-term pipeline of differentiated programs with potential across a broad range of tumor types. The presentation will include an overview of Sutro’s strategic approach with the goal of improving the therapeutic index of ADCs. It will also provide details on the Company’s early-stage ADC pipeline, including STRO-004 (tissue factor-targeting ADC), dual-payload ADCs (ADC 2 ) and immunostimulatory ADCs (iADC). “The precise design enabled by Sutro’s cell-free platform has allowed us to develop ADCs with a wide range of features that are not currently possible with other cell-bound approaches,” said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. “This includes the ability to safely increase potency and combine different payloads to overcome specific limitations such as tumor resistance. Today we are highlighting key data supporting our advancements in these areas, along with the long-term potential of our platform to deliver new ADC innovation. This includes plans for three IND filings for wholly owned programs over the next three years and the advancement of additional differentiated preclinical programs for internal development or external partnering.” The event will feature presentations by members of Sutro’s senior management team, functional leaders and Peter Sandor, M.D., EVP and Head of Corporate Strategy at Astellas Pharma (previously SVP, Primary Focus Lead Immuno-Oncology at Astellas, with responsibility for the Sutro-Astellas strategic collaboration to advance iADCs). Sutro management will participate in a Q&A session at the end of the presentation. Next-Generation ADC Innovation: Data Highlights and Near-Term Pipeline Milestones: Webcast Information: To access the live audio webcast beginning at 1:30 p.m. PT / 4:30 p.m. ET, please go to https://ir.sutrobio.com/news-events/ir-calendar . An archived replay of the webcast will be available on the Company’s website following the event. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF ® , provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit www.sutrobio.com . SOURCE: Sutro Biopharma

ADC

10 Oct 2024

·www.biospace.com

Sutro Biopharma Highlights Next-Generation ADC Innovation and Near-term Pipeline at Research Forum

High DAR Dual-Payload ADC Sutro unveils unique cell-free capabilities Proprietary cell-free platform enables the design of next-generation ADCs intended to broaden addressable patient populations STRO-004 (tissue factor ADC) preclinical data has demonstrated greater anti-tumor activity and lower toxicity compared to a benchmark tissue factor ADC Preclinical models highlight potent anti-tumor activity of Sutro dual-payload (ADC 2 ) and immunostimulatory (iADC) ADCs Expects to deliver three Investigational New Drug (IND) applications over the next three years with potential for best in class Investor webcast today at 1:30 p.m. PT / 4:30 p.m. ET; SOUTH SAN FRANCISCO, Calif., Oct. 10, 2024 (GLOBE NEWSWIRE) -- Sutro Biopharma, Inc. (Sutro or the Company) (NASDAQ: STRO), a clinical-stage oncology company pioneering site-specific and novel-format antibody drug conjugates (ADCs), is hosting an investor webcast today highlighting its proprietary cell-free platform and its use to design and develop next-generation ADC innovation, including a near-term pipeline of differentiated programs with potential across a broad range of tumor types. The presentation will include an overview of Sutro’s strategic approach with the goal of improving the therapeutic index of ADCs. It will also provide details on the Company’s early-stage ADC pipeline, including STRO-004 (tissue factor-targeting ADC), dual-payload ADCs (ADC 2 ) and immunostimulatory ADCs (iADC). “The precise design enabled by Sutro’s cell-free platform has allowed us to develop ADCs with a wide range of features that are not currently possible with other cell-bound approaches,” said Hans-Peter Gerber, Ph.D., Sutro’s Chief Scientific Officer. “This includes the ability to safely increase potency and combine different payloads to overcome specific limitations such as tumor resistance. Today we are highlighting key data supporting our advancements in these areas, along with the long-term potential of our platform to deliver new ADC innovation. This includes plans for three IND filings for wholly owned programs over the next three years and the advancement of additional differentiated preclinical programs for internal development or external partnering.” The event will feature presentations by members of Sutro’s senior management team, functional leaders and Peter Sandor, M.D., EVP and Head of Corporate Strategy at Astellas Pharma (previously SVP, Primary Focus Lead Immuno-Oncology at Astellas, with responsibility for the Sutro-Astellas strategic collaboration to advance iADCs). Sutro management will participate in a Q&A session at the end of the presentation. Next-Generation ADC Innovation: Making ADCs better outside the tumor: Sutro’s proprietary cell-free platform enables key elements of ADC design that are intended to reduce platform toxicities associated with current-generation ADCs, including interstitial lung disease; skin, eye, liver and kidney toxicities; and thrombocytopenia. This includes transformational technology across the design of antibodies, payloads, linker and conjugation chemistry that have been demonstrated in preclinical models to reduce toxicities and improve pharmacokinetics. Making ADCs better inside the tumor: Sutro highlights three approaches enabled by its cell-free platform: 1) increasing potency safely with higher drug-antibody ratio (DAR) exatecan ADCs; 2) combining payloads to overcome tumor resistance with dual-payload ADCs (ADC 2 ); and 3) delivering next-generation immuno-oncology therapeutics with immunostimulatory ADCs (iADC) that combine immune activation with cytotoxic payloads. Data Highlights and Near-Term Pipeline Milestones: STRO-004, a tissue factor-targeting ADC, which features a DAR8 exatecan payload and site-specific linker design, demonstrated greater anti-tumor activity and lower toxicities than a tissue factor benchmark ADC in preclinical models. Sutro anticipates filing an IND for STRO-004 with the U.S. Food & Drug Administration in the second half of 2025. Dual-payload ADCs (ADC 2 ) provide therapeutic benefits compared to standard ADCs, including overcoming tumor resistance mechanisms, showing increased anti-tumor activity and desirable properties in preclinical models. iADCs provide a novel mechanism of action, bridging innate and adaptive immunity to enable broad protection in a single molecule, and show increased and durable anti-tumor activity in a preclinical model compared to standalone ADCs or immune-stimulating antibody conjugates. Sutro’s proprietary and partnered preclinical ADC portfolio has potential across a broad range of tumor types and the Company plans to deliver three INDs over the next three years, including for STRO-004 in the second half of 2025. The Company also intends to advance a deep pipeline of preclinical programs, providing further potential for internal development and/or partnering. Webcast Information: To access the live audio webcast beginning at 1:30 p.m. PT / 4:30 p.m. ET, please go to . An archived replay of the webcast will be available on the Company’s website following the event. About Sutro Biopharma Sutro Biopharma, Inc., is a clinical-stage company relentlessly focused on the discovery and development of precisely designed cancer therapeutics, to transform what science can do for patients. Sutro’s fit-for-purpose technology, including cell-free XpressCF ® , provides the opportunity for broader patient benefit and an improved patient experience. Sutro has multiple clinical stage candidates, including luveltamab tazevibulin, or luvelta, a registrational-stage folate receptor alpha (FolRα)-targeting ADC in clinical studies. A robust pipeline, coupled with high-value collaborations and industry partnerships, validates Sutro’s continuous product innovation. Sutro is headquartered in South San Francisco. For more information, follow Sutro on social media @Sutrobio, or visit . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, anticipated preclinical and clinical development activities, including enrollment and site activation; timing of announcements of clinical results, trial initiation, and regulatory filings; potential benefits of luvelta and the Company’s other product candidates and platform; potential market opportunities for luvelta and the Company’s other product candidates; and the Company’s expected cash runway. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, the Company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the Company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the Company’s ability to advance its product candidates, the receipt and timing of potential regulatory designations, approvals and commercialization of product candidates and the Company’s ability to successfully leverage Fast Track designation, the market size for the Company’s product candidates to be smaller than anticipated, clinical trial sites, supply chain and manufacturing facilities, the Company’s ability to maintain and recognize the benefits of certain designations received by product candidates, the timing and results of preclinical and clinical trials, the Company’s ability to fund development activities and achieve development goals, the Company’s ability to protect intellectual property, the value of the Company’s holdings of Vaxcyte common stock, and the Company’s commercial collaborations with third parties and other risks and uncertainties described under the heading “Risk Factors” in documents the Company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. A photo accompanying this announcement is available at CONTACT: Contact Emily White Sutro Biopharma (650) 823-7681 ewhite@sutrobio.com

ADCFast Track

100 Deals associated with Luveltamab Tazevibulin

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Fallopian Tube Carcinoma	Phase 3	US	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	AU	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	CA	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	IL	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	NZ	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	SG	Sutro Biopharma, Inc.	12 Jul 2023
Fallopian Tube Carcinoma	Phase 3	KR	Sutro Biopharma, Inc.	12 Jul 2023
Ovarian Epithelial Carcinoma	Phase 3	US	Sutro Biopharma, Inc.	12 Jul 2023
Ovarian Epithelial Carcinoma	Phase 3	AU	Sutro Biopharma, Inc.	12 Jul 2023
Ovarian Epithelial Carcinoma	Phase 3	CA	Sutro Biopharma, Inc.	12 Jul 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05200364 (STRO-002-GM2, ESMO2024) Manual	Phase 1	Recurrent ovarian cancer	18	Luveltamab tazevibulin	gczklnzelr(fhcatbeocy) = One pt (5.2 mg/kg) had 2 DLTs (G3 nausea and G4 decreased appetite). rcnmssjhix (pfnyslstpw ) View more	Positive	14 Sep 2024
				Luveltamab tazevibulin (Bev naive)
ASH2023 Manual	Not Applicable	Acute Myeloid Leukemia	25	Luveltamab Tazevibulin	guxyocdxqx(pkffqgvtqk) = igiyewqrpc kxbldmsfdk (izouzqrhrj ) View more	Positive	11 Dec 2023
NEWS Manual	Phase 1	Endometrial Carcinoma	16	Luveltamab Tazevibulin (TPS ≥1% FolRα expression)	vwkxynexxr(jlwuyqmynf) = bvusqgzaks lvetinkvxh (gmurgmundr ) View more	Positive	22 Oct 2023
				Luveltamab Tazevibulin (TPS >25% FolRα expression)	vwkxynexxr(jlwuyqmynf) = xudkdbbala lvetinkvxh (gmurgmundr ) View more
NCT03748186 (STRO-002-GM1 , ESMO2023) Manual	Phase 1	Endometrial Carcinoma	17	Luveltamab tazevibulin	xduhvmdvdp(nkvcxrqhdy) = tlkpmpwzeg rajlristru (kfiycjdnly ) View more	Positive	22 Oct 2023
				Luveltamab tazevibulin (recurrent/progressive epithelial endometrial cancer (EEC) FolRα ≥ 25%)	xduhvmdvdp(nkvcxrqhdy) = nsbvehphpe rajlristru (kfiycjdnly ) View more
NCT03748186 (REFRaME-O1/ENGOT-OV79/GOG-3086, ESMO2023)	Phase 2/3	Recurrent ovarian cancer	-	Luveltamab tazevibulin 4.3 mg/kg	ibsjwqxdlj(cmkpastlti) = bjhujebsad ishgczkbkg (zullsicpvz ) View more	-	22 Oct 2023
				Luveltamab tazevibulin 5.2 mg/kg + prophylactic pegfilgrastim	ibsjwqxdlj(cmkpastlti) = gtwjmbudbr ishgczkbkg (zullsicpvz )
NCT03748186 (STRO-002-GM1, ASCO2023) Manual	Phase 1	Ovarian Epithelial Carcinoma	44	Luveltamab tazevibulin 4.3 mg/kg	qpsjottrpn(eovychzdrh) = The most common grade ≥ 3 treatment emergent adverse events (TEAEs) included neutropenia (70.5%), arthralgia (18.2%), and anemia (13.6%). G3/4 neutropenia had a higher incidence at 5.2 mg/kg than 4.3 mg/kg (76% vs 65%); most notable for G4 neutropenia (52% vs 22%). wtpptmhgos (crqwglfhgm )	Positive	31 May 2023
				Luveltamab tazevibulin 5.2 mg/kg
PipelineReview Manual	Phase 1	Ovarian Cancer FolRα-selected	-	STRO-002 (FolRα-selected)	paulveyhxf(glhehafjaa) = lmrgggprcg xszrsslcji (pasacyxdlo ) View more	Positive	09 Jan 2023
				STRO-002 (unselected for FolRα)	paulveyhxf(glhehafjaa) = azjtpoqwpy xszrsslcji (pasacyxdlo ) View more
NCT03748186 (STRO-002-GM1, ASCO2021)	Phase 1	Platinum-Resistant Ovarian Carcinoma	39	STRO-002	sbhrkahshb(yfqiaygftw) = 12.8% xohsezblyk (pduwltavot ) View more	Positive	28 May 2021
NCT03748186 (138, IGCS2020)	Phase 1	Platinum-Resistant Epithelial Ovarian Carcinoma FRÎ±	38	STRO-002	pztkgdtlek(cpgldgrgpi) = rovmmandvb laykmhuphh (wmfxmvikcv ) View more	Positive	13 Nov 2020

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