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.

开始日期2024-12-04

申办/合作机构

Sutro Biopharma, Inc.

[+1]

NCT06555263

/ Recruiting临床2期

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

开始日期2024-08-21

申办/合作机构

Sutro Biopharma, Inc.

NCT06238687

/ Recruiting临床1/2期

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.

开始日期2023-11-08

申办/合作机构

天士力医药集团股份有限公司

[+1]

100 项与 Luveltamab Tazevibulin 相关的临床结果

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100 项与 Luveltamab Tazevibulin 相关的转化医学

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100 项与 Luveltamab Tazevibulin 相关的专利（医药）

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项与 Luveltamab Tazevibulin 相关的文献（医药）

2024-11-01·Cancer Medicine

The Efficacy and Safety of Folate Receptor α‐Targeted Antibody‐Drug Conjugate Therapy in Patients With High‐Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers: A Systematic Review and Meta‐Analysis

Review

作者: Lim, Myong Cheol ; Kim, Eun Taeg ; Kim, Ji Hyun ; Park, Eun Young ; Park, Han Song ; Park, Sang‐Yoon ; Song, In Hye

ABSTRACT:

Background:

Antibody‐drug conjugates (ADC) have emerged as a highly promising systemic option in the treatment of recurrent ovarian cancer. The present study aimed to evaluate the treatment efficacy of folate receptor α (FRα)‐targeting ADCs, associated treatment‐related adverse events (TRAEs), and their impact on treatment safety.

Methods:

We conducted an electronic search to identify prospective trials of single‐agent ADCs targeting FRα and those combined with chemotherapy in recurrent ovarian cancer. Information regarding the objective response rate (ORR) and TRAEs was collectively analyzed, and differences in subgroups based on FRα receptor expression levels were investigated. The protocol was registered with PROSPERO (CRD42023491151).

Results:

Ten studies with a total of 940 patients (859 treated with Mirvetuximab soravtansine‐gynx (MIRV)), 45 with Farletuzumab Ecteribulin (MORAb‐202), and 36 with Luveltamab Tazevibulin (STRO‐002) were included in this meta‐analysis. Based on the pooled data, the ORR of the entire cohort was 37% (95% CI: 0.30–0.43), while that of the high‐FRα expression group was 34% (95% CI: 0.26–0.42). The incidence of grade ≥ 3 adverse events was 27% (95% CI: 0.19–0.36).

Conclusion:

FRα‐targeting ADCs, including MIRV, demonstrated definite efficacy and good safety as novel choices for second‐line and beyond treatment of advanced or recurrent ovarian cancer. Patients with high FRα expression showed ORR and PFS benefits similar to those in the overall cohort.

2023-05-01·American Society of Clinical Oncology educational book. American Society of Clinical Oncology. Annual Meeting

Antibody-Drug Conjugates in Gynecologic Cancer.

Review

作者: 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.

2022-11-22·Blood advances

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

Article

作者: Brodersen, Lisa Eidenshinck ; Abrahams, Cristina ; Bedard, Kristin ; Kirkey, Danielle ; Le, Quy ; Tang, Thao ; Loken, Michael R. ; 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.

126

项与 Luveltamab Tazevibulin 相关的新闻（医药）

2024-12-10

·GlobeNewswire-Health Care

Sutro Biopharma Announces Selected Dose for Luvelta and Topline Results from Dose-Optimization Portion of REFRαME-O1 Trial in Platinum Resistant Ovarian Cancer

- 32% objective response rate (ORR) in evaluable patients at the 5.2 mg/kg starting dose – the selected dose for randomized portion (Part 2) of ongoing registrational REFRαME-O1 trial - - These data confirm luvelta’s robust response rate in patients with late-stage ovarian cancer expressing a broad range of folate receptor alpha (FRα) - - Neutropenia well-managed; no new safety findings - - Luvelta is positioned for an Accelerated Approval application in mid-2027 - SOUTH SAN FRANCISCO, Calif., Dec. 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), today announced the selected dose from the dose-optimization portion (Part 1) of REFRαME-O1, the registration-directed trial of luveltamab tazevibulin (luvelta) in platinum-resistant ovarian cancer (PROC), following a meeting with the U.S. Food and Drug Administration (FDA). "The topline results confirm luvelta’s favorable safety and efficacy profile at the starting dose of 5.2 mg/kg, further supporting our confidence that it can improve clinical outcomes compared to chemotherapy in our ongoing registrational trial," said Anne Borgman, M.D., Sutro’s Chief Medical Officer. “Consistent response rates were observed in patients across all levels of FRα expression of 25% or greater, reconfirming luvelta's potential to expand the benefit of a targeted treatment to 8 out of 10 PROC patients." REFRαME-O1 (Part 1) REFRαME-O1 (Part 1) evaluated luvelta in patients with PROC with low, medium, and high FRα expression levels. This includes patients with ≥25% Tumor Proportion Score (TPS), defined as at least 25% of tumor cells expressing FRα, at any staining intensity. In the dose-optimization (Part 1), patients were randomized 1:1 to a 5.2 mg/kg with prophylactic pegfilgrastim (G-CSF) for 2 cycles followed by 4.3 mg/kg for subsequent cycles (5.2 mg/kg group), or a 4.3 mg/kg dose of luvelta for all cycles (4.3 mg/kg group). We plan to present additional data at future medical meetings. Topline Results from Evaluable Patients (5.2 mg/kg group; N = 25): Achieved an objective response rate (ORR) of 32%, which includes one partial response that confirmed post data extraction1Disease control rate of 96%Approximately half of the patients treated were ineligible for an approved FRα-targeting ADC88% of patients received prior bevacizumabGrade 3 or higher neutropenia occurred in 32% of patients, no febrile neutropenia “The clinical results from Part 1 of REFRαME-O1 provide compelling evidence that luvelta has the potential to be both first in class and best in class for patients who have low to medium expression of FRα. FRα is a validated target, and luvelta has the opportunity to reach more patients in need,” commented Bradley Monk, M.D., Florida Cancer Specialists and Research Institute; Director GOG Partners. “The topline safety profile of luvelta from Part 1 is encouraging. Neutropenia rates were low, highlighting successful management guidelines. Furthermore, the lack of serious ocular damage, pancytopenia, or Interstitial Lung Disease provide further confidence in our ability to treat a broad group of women with PROC with a focus on their overall wellbeing,” stated Wendel Naumann, M.D., Professor, Levine Cancer, Atrium Health/Wake Forest University, Charlotte, NC. REFRαME-O1 (Part 2) Registrational Trial REFRαME-O1 (Part 2) is an ongoing global registrational trial for patients with PROC, evaluating a 5.2 mg/kg dose with prophylactic pegfilgrastim (G-CSF) for the first two cycles followed by a 4.3 mg/kg dose for subsequent cycles. Part 2 will enroll approximately 500 patients, randomized 1:1 to luvelta or investigators’ choice of chemotherapy. Luvelta is positioned for an Accelerated Approval application in mid-2027. *1: Data as of Aug 16, 2024. About Luveltamab TazevibulinLuveltamab 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. Forward-Looking StatementsThis 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; outcome of discussions with regulatory authorities; potential benefits of luvelta and the Company’s other product candidates and platform; potential business development and partnering transactions; and potential market opportunities for luvelta and the Company’s other product candidates. 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, 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.

快速通道加速审批临床结果孤儿药

2024-11-13

·GlobeNewswire-Health Care

Sutro Biopharma Reports Third Quarter 2024 Financial Results and Business Highlights

- Expects to deliver three Investigational New Drug (IND) applications in next three years based on next-generation ADC technology - - Two new clinical trials, REFRαME-P1, a registration-enabling trial of luvelta for pediatric patients with rare leukemia, and REFRαME-L1, a Phase 2 trial of luvelta for patients with non-small cell lung cancer, are underway - - Sutro presented data from the Phase 1b study of luvelta in combination with bevacizumab at ESMO 2024 demonstrating a 56% response rate at the recommended Phase 2 dose of luvelta (4.3 mg/kg) - - As of September 30, 2024, Sutro had $388.3 million in cash, cash equivalents and marketable securities - SOUTH SAN FRANCISCO, Calif., Nov. 13, 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), today reported its financial results for the third quarter of 2024 and its recent business highlights. With its lead program, luveltamab tazevibulin (luvelta), Sutro recently initiated a registrational trial for a rare form of pediatric leukemia, a clinical trial for non-small cell lung cancer (NSCLC), and presented expansion data in combination with bevacizumab. The randomized portion of Sutro’s registrational trial for patients with advanced ovarian cancer is underway. Sutro expects to provide an update following alignment with the U.S. Food & Drug Administration (FDA) on the selected dose for the pivotal portion of this trial around the end of the year. Recognizing the potential patient benefit and commercial opportunity for luvelta, Sutro engaged Lazard to assist in its efforts to identify a partner for luvelta who can provide financial resources and expertise for the multi-indication development and commercialization of luvelta. Additionally, Sutro showcased at a recent Research Forum a portfolio of emerging next-generation ADCs, made possible by our unique cell-free platform, which are expected to drive value creation beyond luvelta. During the event, Sutro announced three planned IND filings over the next three years for wholly owned programs, including STRO-004, a tissue-factor targeting ADC, featuring a DAR8 exatecan payload and site-specific linker design, which is expected to enter the clinic next year. Recent Business Highlights and Select Anticipated Milestones Luveltamab Tazevibulin (luvelta), FRα-Targeting ADC Franchise: Sutro presented updated data from the Phase 1b study of luvelta in combination with bevacizumab for patients with ovarian cancer in a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2024, demonstrating a 56% response rate at the recommended Phase 2 dose of luvelta (4.3 mg/kg) for this study. An expansion study of this combination is ongoing, with data expected in the first half of 2025.Part 2 (randomized portion) of the Phase 3 trial, REFRαME-O1, for treatment of platinum-resistant ovarian cancer (PROC), is ongoing.REFRαME-P1, a registration-enabling trial for pediatric patients with CBFA2T3::GLIS2 (CBF/GLIS; RAM phenotype) AML, is underway.A Phase 2 trial for the treatment of NSCLC is underway, with initial data expected in 2025. Additional Pipeline Development and Collaboration Updates: In October 2024, Sutro hosted a Research Forum highlighting next-generation ADC innovation and near-term pipeline milestones, including: STRO-004, a tissue factor-targeting ADC, which features a drug-antibody-ratio (DAR) of eight exatecan payloads 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 in the second half of 2025.Dual-payload ADCs (ADC2) provide therapeutic benefits compared to standard ADCs, including potential to overcome tumor resistance mechanisms, and show 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. Sutro continues to seek to maximize the value of its proprietary cell-free platform by working with partners on programs in multiple disease spaces and geographies and has generated from collaborators an aggregate of approximately $975 million in payments through September 30, 2024, including equity investments. Upcoming Events: Sutro plans to participate in three upcoming investor conferences. Webcasts of the presentations will be accessible through the News & Events page of the Investor Relations section of the Company’s website at www.sutrobio.com. Archived replays will be available for at least 30 days after the events. Jefferies London Healthcare Conference, November 19-21, 2024, in LondonThe Citizens JMP Hematology and Oncology Summit, December 2, 2024, VirtualPiper Sandler 36th Annual Healthcare Conference, December 3-5, 2024, in New York Third Quarter 2024 Financial Highlights Cash, Cash Equivalents and Marketable Securities As of September 30, 2024, Sutro had $388.3 million in cash, cash equivalents and marketable securities. Realized Gain on Sale of Vaxcyte Common StockIncluded in non-operating interest and other income (expense), net, on the Statement of Operations for the nine months ended September 30, 2024 was a realized gain of $32.1 million from the sale of approximately 0.7 million shares of Vaxcyte common stock, with net proceeds of approximately $74.0 million. As of September 30, 2024, Sutro does not hold any shares of Vaxcyte common stock. RevenueRevenue was $8.5 million for the quarter ended September 30, 2024, as compared to $16.9 million for the same period in 2023, with the 2024 amount related principally to the Astellas collaboration and the Vaxcyte agreement. Future collaboration and license revenue under existing agreements, and from any additional collaboration and license partners, will fluctuate as a result of the amount and timing of revenue recognition of upfront, milestones, and other agreement payments. Operating ExpensesTotal operating expenses for the quarter ended September 30, 2024 were $76.4 million, as compared to $60.9 million for the same period in 2023. The 2024 quarter includes non-cash expenses for stock-based compensation of $6.5 million and depreciation and amortization of $1.8 million, as compared to $6.0 million and $1.7 million, respectively, in the comparable 2023 period. Total operating expenses for the quarter ended September 30, 2024 were comprised of research and development expenses of $62.1 million and general and administrative expenses of $14.3 million. About Sutro BiopharmaSutro 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. 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; outcome of discussions with regulatory authorities; potential benefits of luvelta and the Company’s other product candidates and platform; potential business development and partnering transactions; 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, 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. Sutro Biopharma, Inc.Selected Statements of Operations Financial Data(Unaudited)(In thousands, except share and per share amounts) Three Months EndedNine Months Ended September 30,September 30, 2024 2023 2024 2023 Revenues$8,520 $16,924 $47,234 $40,010 Operating expenses Research and development 62,108 45,669 181,006 126,660 General and administrative 14,331 15,269 39,423 45,780 Total operating expenses 76,439 60,938 220,429 172,440 Loss from operations (67,919) (44,014) (173,195) (132,430)Interest income 4,875 4,550 13,882 9,952 Unrealized gain on equity securities - 694 - 2,023 Non-cash interest expense related to thesale of future royalties (7,910) (5,936) (22,380) (6,378)Interest and other income (expense), net 22,167 (2,739) 26,683 (8,640)Loss before provision for income taxes (48,787) (47,445) (155,010) (135,473)Provision for income taxes - 1,839 8 2,385 Net loss$(48,787) $(49,284) $(155,018) $(137,858)Net loss per share, basic and diluted$(0.59) $(0.81) $(2.07) $(2.30)Weighted-average shares used in computingbasic and diluted loss per share 82,043,671 60,599,025 74,934,737 59,894,181 Sutro Biopharma, Inc.Selected Balance Sheets Financial Data(Unaudited)(In thousands) September 30,2024(1) December 31,2023(2) Assets Cash, cash equivalents and marketable securities$388,254 $333,681 Investment in equity securities - 41,937 Accounts receivable 6,655 36,078 Property and equipment, net 18,997 21,940 Operating lease right-of-use assets 19,027 22,815 Other assets 18,899 14,285 Total Assets$451,832 $470,736 Liabilities and Stockholders’ Equity Accounts payable, accrued expenses and other liabilities$53,222 $64,293 Deferred revenue 90,559 74,045 Operating lease liability 24,864 29,574 Debt - 4,061 Deferred royalty obligation related to the sale of future royalties 171,967 149,114 Total liabilities 340,612 321,087 Total stockholders’ equity 111,220 149,649 Total Liabilities and Stockholders’ Equity$451,832 $470,736 (1) The condensed balance sheet as of September 30, 2024 was derived from the unaudited financial statements included in the Company's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, filed with the Securities and Exchange Commission on November 13, 2024. (2) The condensed balance sheet as of December 31, 2023 was derived from the unaudited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on March 25, 2024.

临床1期临床2期财报抗体药物偶联物引进/卖出

2024-11-03

·PipelineReview

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.libproxy1.nus.edu.sg/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

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100 项与 Luveltamab Tazevibulin 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
输卵管癌	临床3期	美国	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	澳大利亚	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	加拿大	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	以色列	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	新西兰	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	新加坡	Sutro Biopharma, Inc.	2023-07-12
输卵管癌	临床3期	韩国	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	美国	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	澳大利亚	Sutro Biopharma, Inc.	2023-07-12
卵巢上皮癌	临床3期	加拿大	Sutro Biopharma, Inc.	2023-07-12

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05200364 (STRO-002-GM2, ESMO2024) 人工标引	临床1期	复发性卵巢癌	18	Luveltamab tazevibulin	遞廠鹹構範顧製選鑰築(觸衊淵顧廠鏇遞範醖觸) = One pt (5.2 mg/kg) had 2 DLTs (G3 nausea and G4 decreased appetite). 艱壓鬱鹹壓獵範鑰積製 (鏇選齋醖構願鹽淵願遞 ) 更多	积极	2024-09-14
				Luveltamab tazevibulin (Bev naive)
ASH2023 人工标引	N/A	急性髓性白血病	25	Luveltamab Tazevibulin	獵鑰獵簾衊衊鑰鏇廠襯(憲膚觸遞鬱鹽醖夢鑰襯) = 餘齋艱醖觸鹹鹽願糧積襯襯夢範憲淵壓獵顧夢 (構繭鬱願憲齋糧範壓糧 ) 更多	积极	2023-12-11
NCT03748186 (STRO-002-GM1 , ESMO 12023 \| ESMO 22023) 人工标引	临床1期	子宫内膜癌	17	Luveltamab tazevibulin	餘蓋鑰廠獵淵構鏇製獵(夢衊鹹衊獵積膚廠獵鬱) = 構鹽網蓋獵鏇鬱齋選憲繭窪願鬱積鑰顧網築繭 (構願餘觸淵醖夢範遞網 ) 更多	积极	2023-10-22
				Luveltamab tazevibulin (recurrent/progressive epithelial endometrial cancer (EEC) FolRα ≥ 25%)	餘蓋鑰廠獵淵構鏇製獵(夢衊鹹衊獵積膚廠獵鬱) = 鹹襯築襯製鹹夢築糧壓繭窪願鬱積鑰顧網築繭 (構願餘觸淵醖夢範遞網 ) 更多
NEWS 人工标引	临床1期	子宫内膜癌	16	Luveltamab Tazevibulin (TPS ≥1% FolRα expression)	觸齋蓋鑰鏇觸廠製壓糧(蓋襯鏇範網鑰鑰壓淵艱) = 遞醖積衊廠鏇獵餘獵遞築積觸獵鑰餘積糧艱構 (醖築壓願製夢鹽膚衊網 ) 更多	积极	2023-10-22
				Luveltamab Tazevibulin (TPS >25% FolRα expression)	觸齋蓋鑰鏇觸廠製壓糧(蓋襯鏇範網鑰鑰壓淵艱) = 構艱壓觸鬱積簾壓壓遞築積觸獵鑰餘積糧艱構 (醖築壓願製夢鹽膚衊網 ) 更多
NCT03748186 (REFRaME-O1/ENGOT-OV79/GOG-3086, ESMO2023)	临床2/3期	叶酸受体α 阳性铂类耐药的卵巢上皮癌 Folate receptor alpha (FolRα)	-	Luveltamab tazevibulin 4.3 mg/kg	衊繭鏇鑰顧夢衊遞選淵(繭淵糧廠鹽窪簾遞選齋) = 獵襯廠淵窪餘鑰遞淵築製醖夢窪蓋網顧襯糧鹹 (構選夢壓築鬱鏇觸築衊 ) 更多	-	2023-10-22
				Luveltamab tazevibulin 5.2 mg/kg + prophylactic pegfilgrastim	衊繭鏇鑰顧夢衊遞選淵(繭淵糧廠鹽窪簾遞選齋) = 鹽鬱鬱鹽積醖壓構鹽鏇製醖夢窪蓋網顧襯糧鹹 (構選夢壓築鬱鏇觸築衊 )
NCT03748186 (STRO-002-GM1, ASCO2023) 人工标引	临床1期	卵巢上皮癌	44	Luveltamab tazevibulin 4.3 mg/kg	壓網獵獵繭壓遞鑰製夢(夢積襯糧鹹鬱繭積齋鬱) = 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%). 艱憲積鹹構範鹹餘夢顧 (窪遞壓築鹹壓夢願鬱選 )	积极	2023-05-31
				Luveltamab tazevibulin 5.2 mg/kg
NCT03748186 (STRO-002-GM1, PipelineReview) 人工标引	临床1期	卵巢癌 FolRα-selected	-	STRO-002 (FolRα-selected)	餘餘鹽鬱膚醖膚繭糧鑰(鬱鹽構糧製願餘廠製糧) = 網醖網蓋醖鹽製製鹽觸廠艱窪壓鹽願願窪築範 (壓鑰鬱糧壓衊壓鬱築壓 ) 更多	积极	2023-01-09
				STRO-002 (unselected for FolRα)	餘餘鹽鬱膚醖膚繭糧鑰(鬱鹽構糧製願餘廠製糧) = 顧窪膚餘艱選襯壓蓋齋廠艱窪壓鹽願願窪築範 (壓鑰鬱糧壓衊壓鬱築壓 ) 更多
NCT03748186 (STRO-002-GM1, ASCO2021)	临床1期	铂耐药性卵巢癌	39	STRO-002	壓範鹽餘蓋網鬱壓築齋(餘築鹽繭蓋廠壓繭願齋) = 12.8% 憲築淵襯糧醖鬱簾構鹽 (夢窪廠繭願鬱範蓋糧積 ) 更多	积极	2021-05-28
NCT03748186 (138, IGCS2020)	临床1期	铂耐药上皮性卵巢癌 FRÎ±	38	STRO-002	範襯選鹽選醖選壓遞齋(獵範齋觸鏇觸選淵獵網) = 鬱鬱鏇淵餘壓憲繭鬱膚餘獵窪壓鹽鹹淵衊憲構 (夢築蓋廠夢糧鬱顧醖願 ) 更多	积极	2020-11-13