The goal of this clinical trial is to test in Chinese Subjects with Metastatic or Recurrent Solid Malignancies. The main questions it aims to answer are:
How is the PK of tisotumab vedotin?
How is the immunogenicity of tisotumab vedotin?
How is the safety and tolerability of tisotumab vedotin?
How is the clinical efficacy of tisotumab vedotin? Participants will receive 2.0 mg/kg tisotumab vedotin (up to a maximum of 200 mg in subjects ≥ 100 kg) as a 30-minute IV infusion 1Q3W with the aim to characterize the PK profiles and to evaluate immunogenicity, safety, and tolerability of tisotumab vedotin in the Chinese population.
Subjects will receive study treatment until disease progression or any other discontinuation criteria are met, whichever occurs first. Subjects will undergo an end of treatment (EOT) visit 30 days (± 5 days) after the last dose of study treatment or within 7 days after treatment discontinuation has been decided, whichever occurs later.

Start Date16 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

CTR20231348

/ CompletedPhase 1

一项在复发或转移性的中国实体瘤受试者中评估Tisotumab Vedotin药代动力学的开放性Ⅰ期试验

[Translation] An open-label phase I trial evaluating the pharmacokinetics of tisotumab vedotin in Chinese subjects with recurrent or metastatic solid tumors

主要：评估tisotumab vedotin的PK。次要：评估tisotumab vedotin的免疫原性。评估tisotumab vedotin的安全性和耐受性。探索性：评估tisotumab vedotin的临床疗效。

[Translation]

Primary: To evaluate the PK of tisotumab vedotin. Secondary: To evaluate the immunogenicity of tisotumab vedotin. To evaluate the safety and tolerability of tisotumab vedotin. Exploratory: To evaluate the clinical efficacy of tisotumab vedotin.

Start Date06 Jun 2023

Sponsor / Collaborator

Zai Lab (Shanghai) Co., Ltd.

[+2]

CTR20223290

/ Active, not recruitingPhase 3

一项在二线或三线复发性或转移性宫颈癌患者中比较 Tisotumab vedotin 与研究者所选化疗方案的随机、开放标签、III 期试验

[Translation] A randomized, open-label, phase III trial comparing tisotumab vedotin with investigator's choice of chemotherapy in patients with second- or third-line recurrent or metastatic cervical cancer

主要目的：在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的临床疗效改善次要目的：1.在 2L-3L 宫颈癌参与者中评估 Tisotumab vedotin 相较于化疗的临床疗效改善 2.在 2L-3L 宫颈癌参与者中证明 Tisotumab vedotin 相较于化疗的抗肿瘤活性改善 3.在 2L-3L 宫颈癌参与者中表征 Tisotumab vedotin 和化疗的抗肿瘤应答 4.评估 Tisotumab vedotin 的安全性和耐受性 5.评估健康相关生活质量 (HRQOL) 6.评估 Tisotumab vedotin 的药代动力学 (PK) 和免疫原性

[Translation]

Primary objective: To demonstrate improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer Secondary objectives: 1. To evaluate the improved clinical efficacy of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 2. To demonstrate improved antitumor activity of Tisotumab vedotin compared to chemotherapy in participants with 2L-3L cervical cancer 3. To characterize the antitumor response of Tisotumab vedotin and chemotherapy in participants with 2L-3L cervical cancer 4. To evaluate the safety and tolerability of Tisotumab vedotin 5. To evaluate health-related quality of life (HRQOL) 6. To evaluate the pharmacokinetics (PK) and immunogenicity of Tisotumab vedotin

Start Date09 Feb 2023

Sponsor / Collaborator

Rps Medical Technology (Beijing) Co Ltd

100 Clinical Results associated with Tisotumab Vedotin-tftv

100 Translational Medicine associated with Tisotumab Vedotin-tftv

100 Patents (Medical) associated with Tisotumab Vedotin-tftv

Literatures (Medical) associated with Tisotumab Vedotin-tftv

01 Dec 2024·Annals of Emergency Medicine

Antibody-Drug Conjugates: The Toxicities and Adverse Effects That Emergency Physicians Must Know

Review

Author: Yeung, Sai-Ching J ; Merlin, Jeffrey ; Markides, Danna Michelle ; Hita, Angel Guido ; Reyes-Gibby, Cielto

Antibody-drug conjugates are novel antineoplastic agents whose use is expanding, both in terms of the number of drugs and the number of patients being treated. This article reviews the known toxicities and complications of antibody-drug conjugates that are currently approved for the treatment of cancer in the United States, with a focus on their emergency presentation and management. Similar to many other cancer therapies, most antibody-drug conjugates can cause diarrhea, nausea/vomiting, rash, peripheral neuropathy, and cytopenia, which are generally treated following standard-of-care. Interstitial lung disease, which may mimic pneumonia and cause respiratory failure and death, has been seen with trastuzumab deruxtecan and mirvetuximab soravtansine; emergency treatment of this condition includes oxygenation, ventilatory support, and corticosteroids. Inotuzumab ozogamicin and gemtuzumab ozogamicin are both associated with sinusoidal obstruction syndrome, a potentially fatal liver dysfunction that presents with weight gain, fluid overload, and jaundice. Abnormal liver function tests in patients who have been recently treated with these agents should be cautiously evaluated. Cardiac adverse events with antibody-drug conjugates are rare, but trastuzumab emtansine and trastuzumab deruxtecan may cause a decrease in cardiac contractility, and heart rate corrected QT interval prolongation is a rare effect of trastuzumab deruxtecan. Ocular adverse events, especially blurred vision, and keratopathy, are common with mirvetuximab soravtansine and tisotumab vedotin. Progressive multifocal leukoencephalopathy has been reported with brentuximab vedotin and polatuzumab vedotin. Tumor lysis syndrome may occur after treatment with gemtuzumab ozogamicin, polatuzumab vedotin, and brentuximab vedotin. Patients receiving enfortumab vedotin or brentuximab vedotin may develop hyperglycemia, sometimes presenting as diabetic ketoacidosis. Tisotumab vedotin and trastuzumab emtansine are associated with bleeding; although it is minor in most cases, severe bleeding and intracranial hemorrhage have occurred. Several antibody-drug conjugates can cause an anaphylactoid infusion-related reaction, which occurs most commonly during or soon after infusion but may be delayed up to 24 hours. Further research is needed to establish the real-world incidence of rare complications and how often patients with these complications present to the emergency department.

01 Dec 2024·Gynecologic Oncology Reports

Tisotumab vedotin extravasation injury in a patient with recurrent cervical cancer

Article

Author: Dwyer, Kaitlin W ; Taylor, Jolyn S ; Cain, Katherine E ; Sims, Travis T. ; Taylor, Jolyn S. ; Marten, Claire A. ; Son, Ji ; Marten, Claire A ; Cain, Katherine E. ; Sims, Travis T

•Infusion site extravasation injury is a rare but serious adverse event of tisotumab vedotin.•Central venous access device should be considered in patients with risk factors receiving antibody drug conjugate therapy.•Topical steroids may be used as part of supportive measures.

01 Dec 2024·Cancer Science

Anti‐tissue factor antibody conjugated with monomethyl auristatin E or deruxtecan in pancreatic cancer models

Article

Author: Yasunaga, Masahiro ; Takashima, Hiroki ; Matsumura, Yasuhiro ; Koga, Yoshikatsu ; Tsumura, Ryo ; Anzai, Takahiro

AbstractAntibody–drug conjugates (ADCs) have been recognized as a promising class of cancer therapeutics. Tissue factor (TF), an initiator of the blood coagulation pathway, has been investigated regarding its relationship with cancer, and several preclinical and clinical studies have presented data on anti‐TF ADCs, including tisotumab vedotin, which was approved in 2021. However, the feasibility of other payloads in the design of anti‐TF ADCs is still unclear because no reports have compared payloads with different cytotoxic mechanisms. For ADCs targeting other antigens, such as Her2, optimizing the payload is also an important issue in order to improve in vivo efficacy. In this study, we prepared humanized anti‐TF Ab (clone.1084) conjugated with monomethyl auristatin E (MMAE) or deruxtecan (DXd), and evaluated the efficacy in several cell line‐ and patient‐derived xenograft models of pancreatic cancer. As a result, optimizing the drug / Ab ratio was necessary for each payload in order to prevent pharmacokinetic deterioration and maximize delivery efficiency. In addition, MMAE‐conjugated anti‐TF ADC showed higher antitumor effects in tumors with strong and homogeneous TF expression, while DXd‐conjugated anti‐TF ADC was more effective in tumors with weak and heterogeneous TF expression. Analysis of a pancreatic cancer tissue array showed weak and heterogeneous TF expression in most TF‐positive specimens, indicating that the response rate to pancreatic cancer might be higher for DXd‐ than MMAE‐conjugated anti‐TF ADC. Nevertheless, our findings indicated that optimizing the ADC payloads individually in each patient could maximize the potential of ADC therapeutics.

107

News (Medical) associated with Tisotumab Vedotin-tftv

15 Jan 2025

·ir.zailaboratory.com

Zai Lab Announces Positive Topline Results for TIVDAK in the China Subpopulation of the Global Phase 3 innovaTV 301 Trial in Patients with Recurrent or Metastatic Cervical Cancer

Improved overall survival (OS), progression-free survival (PFS) and confirmed objective response rate (ORR) were observed in the China subpopulation treated with TIVDAK compared to chemotherapy, consistent with those in the global population The safety profile of TIVDAK among the China subpopulation was manageable and consistent with that observed in the global population Zai Lab intends to submit a New Drug Application (NDA) to China’s National Medical Products Administration (NMPA) in the first quarter of 2025 Zai Lab will leverage its commercial footprint of ZEJULA in women’s cancer to bring the medicine to patients in China if approved SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 15, 2025-- Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. The China subpopulation results were consistent with those in the global population: TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy (HR: 0.55 [95% CI: 0.27-1.15] in the China subpopulation who had received prior standard systemic therapies, with more than half of this Chinese population having received prior anti-PD(L)1 therapy. Median OS for patients treated with TIVDAK was not reached versus chemotherapy 10.7 months [95% CI: 6.0-not reached] with a median follow-up of 11.5 months. Secondary endpoints of PFS and confirmed ORR also favored treatment with TIVDAK compared to chemotherapy. The safety profile of TIVDAK in the China subpopulation was manageable and consistent with the global profile. “Recurrent or metastatic cervical cancer remains a significant challenge for patients, highlighting a critical unmet need for effective treatments that extend survival after relapse,” said Dr. Rafael Amado, M.D., President, Head of Global Research and Development at Zai Lab. “The consistent and positive results in the China subpopulation of the global Phase 3 study reinforce the potential for TIVDAK, the only ADC therapy in this disease setting, to increase options in this therapeutically unmet clinical setting. If approved, we expect TIVDAK to add to ZEJULA and augment our commercial franchise in women’s tumors.” “There are approximately 150,000 new cases of cervical cancer annually in China1, and patients face limited treatment options once their cancer recurs or spreads after initial treatment,” said Dr. Lingying Wu, Professor of the Department of Gynecologic Oncology of National Cancer Center / Cancer Hospital Chinese Academy of Medical Sciences. “While the recent adoption of immunotherapy as a first-line treatment in China represents progress, there is a lack of effective options for patients following relapse. The promising results from TIVDAK, which demonstrated superior survival extension in patients whose disease progressed after initial treatments, including prior anti-PD(L)1 treatment, offer hope for addressing this critical unmet need.” In April 2024, the U.S. Food and Drug Administration (FDA) approved the supplemental Biologics License Application (sBLA) granting full approval for TIVDAK® (tisotumab vedotin-tftv) for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The approval was based on results from the global, randomized, Phase 3 innovaTV 301 clinical trial (NCT04697628), which met its primary endpoint, demonstrating overall survival (OS) benefit in adult patients with previously treated recurrent or metastatic cervical cancer treated with TIVDAK compared to chemotherapy. TIVDAK demonstrated a 30% reduction in the risk of death compared to chemotherapy (hazard ratio [HR]: 0.70 [95% CI: 0.54-0.89], two-sided p=0.0038)2. Median OS for patients treated with TIVDAK was 11.5 months [95% CI: 9.8-14.9] versus chemotherapy 9.5 months [95% CI: 7.9-10.7]. PFS and confirmed ORR were also significantly improved compared to chemotherapy. The safety profile of TIVDAK was consistent with its known safety profile as presented in the U.S. prescribing information, and no new safety signals were observed. Based on these encouraging results, Zai Lab intends to submit an NDA for TIVDAK to China’s National Medical Products Administration (NMPA) in the first quarter of 2025. The full China subpopulation data will be presented at a future medical conference in 2025. About innovaTV 301 Trial Design The innovaTV 301 trial (NCT04697628) is a global, 1:1 randomized, open-label Phase 3 trial evaluating TIVDAK® (tisotumab vedotin) versus investigator’s choice of single agent chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed) with recurrent or metastatic cervical cancer who received chemotherapy. Patients with recurrent or metastatic cervical cancer with squamous cell, adenocarcinoma, or adenosquamous histology, and disease progression during or after treatment with chemotherapy doublet +/- bevacizumab and an anti-PD-(L)1 agent (if eligible) are included. The primary endpoint was overall survival. The main secondary outcomes were progression-free survival and objective response rate. The study was conducted by Seagen, which was acquired by Pfizer in December 2023, in collaboration with Genmab, European Network of Gynaecological Oncological Trial Groups (ENGOT, study number ENGOT cx-12) and the Gynecologic Oncology Group (GOG) Foundation (study number GOG 3057), as well as other global gynecological oncology cooperative groups. For more information about the Phase 3 innovaTV 301 clinical trial and other clinical trials with tisotumab vedotin, please visit www.clinicaltrials.gov. About Cervical Cancer in China Cervical cancer remains one of the leading causes of cancer death in women in China and globally. An estimated 150,000 new cases of cervical cancer occur annually in China1. Current treatment options are limited for patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. TIVDAK is well positioned to provide a new option for previously treated advanced cervical cancer patients who currently have limited treatment options and poor outcomes. About TIVDAK® (tisotumab vedotin) TIVDAK® (tisotumab vedotin) is an antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal antibody directed to tissue factor (TF) and Pfizer’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the microtubule-disrupting agent monomethyl auristatin E (MMAE) to the antibody. Nonclinical data suggest that the anticancer activity of tisotumab vedotin is due to the binding of the ADC to TF-expressing cancer cells, followed by internalization of the ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE disrupts the microtubule network of actively dividing cells, leading to cell cycle arrest and apoptotic cell death. In vitro, tisotumab vedotin also mediates antibody-dependent cellular phagocytosis and antibody-dependent cellular cytotoxicity. TIVDAK received accelerated approval from the FDA in September 2021 and full approval in April 2024 for adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. Please see full prescribing information, including BOXED WARNING for TIVDAK here. Zai Lab has an exclusive license from Seagen Inc., a company later acquired by Pfizer, to develop and commercialize TIVDAK in Greater China (mainland China, Hong Kong, Macau, and Taiwan, collectively). About Zai Lab Zai Lab (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide. For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global. Zai Lab Forward-Looking Statements This press release contains forward-looking statements relating to our future expectations, plans, and prospects, including, without limitation, statements relating to our prospects and plans for developing and commercializing TIVDAK in Greater China, the potential benefits of TIVDAK, and the potential treatment of cervical cancer. These forward-looking statements may contain words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “will,” “would,” and other similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical fact or guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this press release and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to (1) our ability to successfully commercialize and generate revenue from our approved products, (2) our ability to obtain funding for our operations and business decisions, (3) the results of our clinical and pre-clinical development of our product candidates, (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates, (5) risks related to doing business in China, and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Our SEC filings can be found on our website at www.zailaboratory.com and the SEC’s website at www.sec.gov. Notes: 1 Bingfeng Han et al., "Cancer incidence and mortality in China, 2022" Journal of the National Cancer Center, 2024. DOI: 10.1016/j.jncc.2024.01.006. 2 The threshold for statistical significance is 0.0226 (2-sided). View source version on businesswire.com: https://www.businesswire.com/news/home/20250115437262/en/ Investor Relations: Christine Chiou / Lina Zhang +1 (917) 886-6929 / +86 136 8257 6943 christine.chiou1@zailaboratory.com / lina.zhang@zailaboratory.com Media: Shaun Maccoun / Xiaoyu Chen +1 (857) 270-8854 / +86 185 0015 5011 shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com Source: Zai Lab Limited

Phase 3Clinical ResultDrug ApprovalLicense out/inImmunotherapy

10 Jan 2025

·pipelinereview.com

Zai Lab Announces Strategic Partnership with MediLink Therapeutics to Develop a Novel LRRC15 Antibody-Drug Conjugate

SHANGHAI & SUZHOU, China & CAMBRIDGE, MA, USA I January 09, 2025 I Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced a new strategic collaboration and worldwide license agreement with MediLink Therapeutics (Suzhou) Co., Ltd. (“MediLink”) to use MediLink’s TMALIN ® antibody-drug conjugate (ADC) platform for the development of a novel LRRC15 ADC, ZL-6201, consisting of an antibody discovered by Zai Lab. Through this collaboration, Zai Lab further expands its global oncology pipeline with another potential first-in-class ADC targeting multiple solid tumors and addressing significant unmet medical needs. ZL-6201 has demonstrated encouraging preclinical data with an IND expected to be filed in 2025. “MediLink has built a differentiated proprietary ADC technology platform, and we are excited to broaden our global partnership,” said Rafael G. Amado, M.D., President, Head of Global Research and Development at Zai Lab. “Building on the promising findings from our ongoing clinical trials for ZL-1310, this new collaboration demonstrates our continued focus on developing cancer therapies with ADC drugs and enriches our global oncology pipeline to address unmet medical needs. We look forward to working with MediLink to advance this compound into the clinic soon.” “Zai Lab’s strong commitment to innovation and proven track record of global development impressed us through our existing collaboration,” said Tony Xue, PhD, CEO at MediLink. “This new partnership further validates our technology and enhances our strategic partnership. We believe our collaboration with Zai Lab will bring this innovative therapy to patients worldwide.” About LRRC15 Leucine-rich repeat-containing protein 15 (LRRC15) is a type I transmembrane protein involved in cell-cell and cell-extracellular matrix (ECM) interactions. It is overexpressed in various mesenchymal tumors such as sarcoma, glioblastoma and melanoma, where it promotes tumor metastasis. Additionally, LRRC15 is upregulated in cancer-associated fibroblasts (CAFs) across various cancer types, contributing to immune-excluded and immune-suppressive tumor microenvironment (TME). This makes LRRC15 an appealing target for cancer therapy. About Zai Lab in ADC Zai Lab is building a portfolio of potential first- and/or best-in-class ADCs around the world. In addition to this next-generation ADC, the company has one near to commercial stage asset TIVDAK (tisotumab vedotin) and two next-generation ADC programs, ZL-1310 and ZL-6301, with exclusive worldwide rights. ZL-1310, a potential first-in-class ADC, is an investigational DLL3-targeted ADC being developed in a Phase 1 trial. Zai Lab presented encouraging efficacy and safety results for ZL-1310 from the ongoing Phase 1 study in patients with recurrent extensive-stage small cell lung cancer (SCLC) at the 2024 EORTC-NCI-AACR (ENA) Annual Symposium. About Zai Lab Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious diseases, and neuroscience. Our goal is to leverage our competencies and resources to positively impact human health in China and worldwide. For additional information about Zai Lab, including our products, business activities and partnerships, research, and other events or developments, please visit www.zailaboratory.com or follow us at www.twitter.com/ZaiLab_Global . SOURCE: Zai Lab

Phase 1License out/inADCAACR

09 Jan 2025

·www.businesswire.com

Biocom California Appoints New Members to its Board of Directors

SOUTH SAN FRANCISCO, Calif. & LOS ANGELES & SAN DIEGO--( BUSINESS WIRE )--Biocom California, the association representing the California life science industry, today announced that it appointed Aliza Apple, Ph.D., a vice president of Catalyze360 AI/ML at Eli Lilly; Carolyn Ng, Ph.D., business unit partner at TPG Life Sciences Innovations; and Nancy Whiting, Pharm.D., president and CEO at Recludix Pharma, to its board of directors. Additionally, Tim Scott has assumed his role as CEO and president of Biocom California, and Sabrina Martucci Johnson, CEO at Daré Biosciences, has been appointed board chair. “Our new members’ expertise in drug discovery, clinical development and navigating the fundraising environment will complement the diverse perspectives of our current board,” said Tim Scott, president and CEO of Biocom California. “As the life science industry evolves, we continue to rely on the deep industry knowledge and key insights of our board of directors, helping shape our 2025 initiatives and ensure we meet the needs of our member companies and foster innovative progress throughout California.” Aliza Apple, Ph.D. is a vice president of Catalyze360 AI/ML at Eli Lilly. In this capacity, Dr. Apple leads the strategy, build and launch of Lilly’s external-facing AI/ML efforts for drug discovery. In her previous role at Lilly, Dr. Apple served as the COO and head of Lilly Gateway Labs West Coast, where she supported the local biotech ecosystem through early engagement and providing tailored offerings to meet their needs. Prior to Lilly, Dr. Apple served as a co-founder at Santa Ana Bio, a venture-backed precision biologics company focused on autoimmune disease, and as an advisor to the founders of Firefly Biologics. Prior to biotech, Dr. Apple was a partner in McKinsey & Co’s life sciences practice. During her nine years at McKinsey in New York and San Francisco, she collaborated with leaders from over 20 biopharma companies to develop their corporate and portfolio strategies, evaluate business development opportunities and improve their organizational effectiveness. Dr. Apple completed her Ph.D. in bioengineering at UC Berkeley and UCSF, and holds a bachelor of science in physics from Georgetown University. She completed a postdoctoral fellowship at Cornell Medical College supported by the NIH Kirschtein National Research Service Award. Carolyn Ng, Ph.D. is a business unit partner at TPG Life Sciences Innovations, where she is one of the founding senior leaders of the investment fund. She has spent the past decade of her career leading investments into transformative companies of early to mid-stage in different therapeutic areas. She currently serves on the board of directors of Adcendo, Mbrace Therapeutics and Bicara Therapeutics. Prior to joining TPG in 2021, Dr. Ng was a managing director at Vertex Ventures HC, a global healthcare and life sciences venture fund, where she co-headed the investment team. Dr. Ng has previously served on the board of directors for other promising public and private life sciences companies including Bicycle Therapeutics PLC, Boundless Bio, Obsidian Therapeutics, 28-7 Therapeutics, Epirium Bio, Nuvaira and a board observer to Visterra (acquired by Otsuka Pharmaceutical). Dr. Ng is a mentor to the Women in Bio Boardroom Ready Program. She also currently serves on the panel of the Singapore Therapeutics Development Review Panel, a funding scheme aimed at identifying high-value drug discovery and development projects from the public research community in Singapore. Prior to her investing career, Carolyn was a consultant at Deallus Consulting, a specialized life sciences strategy consulting firm where she collaborated with leaders of global biopharmaceutical companies. Dr. Ng holds a Ph.D. in cancer molecular biology from the National University of Singapore, where she was the recipient of the prestigious NGS, Integrative Sciences and Technology, Ph.D. scholarship, and patent holder of a novel small molecule nuclear receptor activator indicated for the treatment of neuroblastoma. Nancy Whiting, Pharm.D. is a president and CEO at Recludix Pharma. Previously, Dr. Whiting was a 15-year veteran of Seagen, formerly Seattle Genetics, and served as the executive vice president of corporate strategy, where she had the broad remit of corporate strategy and planning, strategic alliances and partnerships, investor relations, corporate communications and information technologies. During her tenure, she was also the executive vice president of late-stage development, senior vice president of clinical development and medical affairs, and head of experimental medicine. Dr. Whiting played a central role in the development and regulatory approval of ADCETRIS for lymphoma, PADCEV for bladder cancer, TUKYSA for breast cancer, TIVDAK for cervical cancer and several other pipeline compounds. Prior to transitioning to the pharmaceutical industry, Dr. Whiting practiced as a clinical oncology pharmacist at the Seattle Cancer Care Alliance. She currently serves on the board of directors of Caribou BioSciences and Boundless BioSciences. Dr. Whiting completed her undergraduate training at the University of British Columbia and received her Pharm.D. from the University of Washington. She also completed a residency in clinical pharmacy practice at Vancouver General Hospital. About Biocom California Biocom California is the leader and advocate for California’s life science sector. We work on behalf of more than 1,800 members to drive public policy , build an enviable network of industry leaders , create access to capital , introduce cutting-edge STEM education programs and create robust value-driven purchasing programs . Founded in 1995 in San Diego, Biocom California provides the strongest public voice to research institutions and companies that fuel the local and state-wide economy. Our goal is simple: to help our members produce novel solutions that improve the human condition. In addition to our San Diego headquarters , Biocom California operates core offices in Los Angeles and the San Francisco Bay Area , with satellite offices in Sacramento , Washington, D.C. and Tokyo . Our broad membership benefits apply to biotechnology, pharmaceutical, medical device, genomics and diagnostics companies of all sizes, as well as to research universities and institutes, clinical research organizations, investors and service providers. For more information on Biocom California, please visit our website at www.biocom.org . Connect with us on LinkedIn , Facebook and X .

Executive Change

100 Deals associated with Tisotumab Vedotin-tftv

External Link

KEGG	Wiki	ATC	Drug Bank
-	Tisotumab Vedotin-tftv	-	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	MO	Zai Lab Ltd.	06 Aug 2024
Recurrent Cervical Cancer	MO	Zai Lab Ltd.	06 Aug 2024
Uterine Cervical Cancer	US	Seagen Inc.	20 Sep 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	NDA/BLA	US	Pfizer Inc.	09 Jan 2024
Metastatic Cervical Carcinoma	NDA/BLA	US	Genmab A/S	09 Jan 2024
Recurrent Cervical Cancer	NDA/BLA	US	Genmab A/S	09 Jan 2024
Recurrent Cervical Cancer	NDA/BLA	US	Pfizer Inc.	09 Jan 2024
Metastatic Carcinoma to the Uterine Cervix	Phase 3	IT	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	SE	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	PE	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	PL	Genmab A/S	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	KR	Seagen Inc.	22 Feb 2021
Metastatic Carcinoma to the Uterine Cervix	Phase 3	CA	Seagen Inc.	22 Feb 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04697628 (innovaTV 301, Company_Website) Manual	Phase 3	Uterine Cervical Cancer	-	TIVDAK	(gopfvevjtu) = dupwexoxqy gsjwgxmsnf (sbiaprqfnu )	Positive	15 Jan 2025
				Chemotherapy	(gopfvevjtu) = hzteidyqpv gsjwgxmsnf (sbiaprqfnu, 6.0 - NR)
NCT04697628 (innovaTV 301/ENGOT-cx12/GOG 3057 \| SGNTV-003 \| GOG-3057 \| innovaTV 301 \| ENGOT-cx12 \| innovaTV 301/ENGOT-cx12/GOG-3057, CTgov)	Phase 3	Metastatic Carcinoma to the Uterine Cervix	502	tisotumab vedotin (Tisotumab Vedotin)	(ypxqzalpax) = xzhobulhtm uvkwccxnhc (vekneodsgs, fyvjbcydzq - pmvfrioozw) View more	-	09 Aug 2024
				pemetrexed+Gemcitabine+Vinorelbine+irinotecan+Topotecan (Chemotherapy)	(ypxqzalpax) = ecfitnkyzd uvkwccxnhc (vekneodsgs, xlubnilejv - qxrqkzewwp) View more
NCT04697628 (innovaTV 301, Pubmed) Manual	Phase 3	Recurrent Cervical Cancer Second line \| Third line	502	Tisotumab vedotin	(qadjbdfghv) = ywypuxtkza jvpqplkqnr (aiehdvnylg, 9.8 - 14.9) View more	Positive	04 Jul 2024
				Chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed)	(qadjbdfghv) = ujhzzedxfb jvpqplkqnr (aiehdvnylg, 7.9 - 10.7) View more
NCT04697628 (ENGOT-cx12 \| GOG-3057 \| innovaTV 301, ASCO2024) Manual	Phase 3	Uterine Cervical Cancer Second line \| Third line	502	Tisotumab vedotin (TV)	(pjzuxwdogu) = mlmfeidfdx vtifdfjfmk (wxhptuorlg, 13.3 - 23.1) View more	Positive	24 May 2024
				Chemotherapy	(pjzuxwdogu) = tilmsxkobr vtifdfjfmk (wxhptuorlg, 2.8 - 8.8) View more
NCT03485209 (innovaTV 207, ASCO2024) Manual	Phase 2	Squamous Cell Carcinoma of Head and Neck	40	Tisotumab vedotin	(uvcjlgabzk) = xqvmzqonsi wcznfbszbc (mffpqcojay, 18.6 - 49.1) View more	Positive	24 May 2024
				Tisotumab vedotin (≤2 prior lines)	(uvcjlgabzk) = hecmfbyzez wcznfbszbc (mffpqcojay, 21.1 - 61.3) View more
NCT04697628 (innovaTV 301 \| ENGOT-Cx12 \| GOG-3057, ESGO2024) Manual	Phase 3	Uterine Cervical Cancer Second line tissue factor	502	Tisotumab vedotin	(ocabyukwyk) = tzfzlnjwta xidzlgjyoo (efdokjorae, 9.8 - 14.9) View more	Positive	10 Mar 2024
				investigator’s choice of chemotherapy	(ocabyukwyk) = auivfewwlf xidzlgjyoo (efdokjorae, 7.9 - 10.7) View more
NCT03786081 (innovaTV 205/GOG-3024/ENGOT-cx8, Pubmed \| J Clin Oncol)	Phase 1/2	Metastatic Carcinoma to the Uterine Cervix First line \| Third line tissue factor	142	Tisotumab vedotin + Pembrolizumab	(mbcxmbycpv) = gdrkkddcef tkltfwdezs (ihatvilzvw, 23.7 - 59.4) View more	Positive	20 Dec 2023
				Tisotumab vedotin + Carboplatin	(mbcxmbycpv) = kwqkmbpwna tkltfwdezs (ihatvilzvw, 36.4 - 71.9) View more
NCT04697628 (innovaTV 301 \| SGNTV-003 \| GOG-3057 \| ENGOT-cx12, ESMO 12023 \| ESMO 22023) Manual	Phase 3	Uterine Cervical Cancer Third line \| Second line	502	Tisotumab vedotin	(wgfcoptnyr) = gvefanfdjp qxcckuekhj (ydigvbedpy, 9.8 - 14.9) View more	Positive	22 Oct 2023
				Investigator's choice of chemotherapy	(wgfcoptnyr) = znsupdaggz qxcckuekhj (ydigvbedpy, 7.9 - 10.7) View more
NCT04697628 (innovaTV 301, NEWS) Manual	Phase 3	Uterine Cervical Cancer First line	-	Tivdak	(gzxhsudpuw) = 在一线治疗期间或治疗后疾病发生进展的复发性或转移性宫颈癌患者中，与单独化疗相比，接受其“first-in-class”抗体偶联药物（ADC）Tivdak（tisotumab vedotin）患者的OS显著改善 jrdrmfmnco (mypmjmmzwv ) Met View more	Positive	06 Sep 2023
				chemotherapy
NCT03657043 (CTgov)	Phase 2	Platinum-Resistant Primary Peritoneal Carcinoma \| Peritoneal Neoplasms \| Platinum-Resistant Ovarian Carcinoma \| Fallopian Tube Carcinoma	98	3Q4W (Safety Run-In 0.9 mg/kg 3Q4W)	ewphihfwhd(rfqwhjrnsk) = wjsqmpiagk haqemlpiem (futnwmmjtm, kwyzqtjmyn - jcuptbyksl) View more	-	06 May 2023
				3Q4W (Safety Run-In 1.2 mg/kg 3Q4W)	ewphihfwhd(rfqwhjrnsk) = czrcyonbta haqemlpiem (futnwmmjtm, aklrqumwrr - rhdbuyympt) View more

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