Trastuzumab botidotin

DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. LAS VEGAS, Aug. 23, 2022 /PRNewswire/ -- DelveInsight's ' Bladder Cancer Pipeline Insight 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline bladder cancer therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the bladder cancer pipeline domain. Key Takeaways from the Bladder Cancer Pipeline Report DelveInsight's bladder cancer pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for bladder cancer treatment. Leading bladder cancer companies such as CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co., Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others are evaluating novel bladder cancer drugs candidate to improve the treatment landscape. Key bladder cancer pipeline therapies in various stages of development include CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. In July 2022, The FDA accepted for review a Biologics License Application (BLA) from ImmunityBio, Inc. (NASDAQ: IBRX), for its antibody cytokine fusion protein as a treatment for patients with BCG-unresponsive non-muscle-invasive bladder cancer carcinoma in situ (CIS) with or without Ta or T1 disease. ImmunityBio, a leading clinical-stage immunotherapy company, filed the BLA based on positive results from a series of studies of the investigational treatment, including the ongoing QUILT 3.032 trial. The Prescription Drug User Fee Act (PDUFA) target action date is May 23, 2023. In June 2022, CG Oncology announced the interim data on two ongoing clinical studies to be presented at The American Society of Clinical Oncology (ASCO) 2022 Annual Meeting.The first poster presentation reports on efficacy and safety data from a global Phase 2 study (CORE1) of CG0070 in combination with Merck's anti-PD-1 therapy KEYTRUDA® (pembrolizumab), for the treatment of patients with Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). The second poster presentation centers on a Phase 1b/2 study (CORE2) of CG0070 in combination with OPDIVO®(nivolumab), as a neoadjuvant immunotherapy for Muscle-Invasive Bladder Cancer (MIBC) in cisplatin-ineligible patients. In May 2022, Asieris Pharmaceuticals announced that the ANTICIPATE Study will be presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting on June 3-7, 2022, in Chicago. This is a study of taking oral APL-1202 in combination with BeiGene's tislelizumab compared to just taking tislelizumab alone as neoadjuvant therapy (NAC) in patients with muscle invasive bladder cancer (MIBC). In March 2022, Protara Therapeutics, Inc. announced that the Company had dosed the first patient in ADVANCED-1, its Phase 1 clinical trial evaluating TARA-002, an investigational cell-based immunopotentiator, for the treatment of non-muscle invasive bladder cancer (NMIBC). In January 2022, Vaxiion Therapeutics, announced the U.S. Food and Drug Administration had cleared the company's Investigational New Drug application (IND) for VAX014 for investigational use in the intralesional treatment of solid tumors refractory to standard treatment options. VAX014 is a first-in-class recombinant bacterial minicell-based oncolytic immunotherapy. In December 2021, LintonPharm Co., Ltd., announced that the first patient had been dosed in the Company's Phase 1/2 clinical trial program for catumaxomab (clinicaltrials.gov: NCT04799847), a monoclonal bispecific antibody being studied for the treatment of Non-Muscle-Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG). Request a sample and discover the recent advances in bladder cancer treatment @ Bladder Cancer Pipeline Report The bladder cancer pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage bladder cancer drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the bladder cancer pipeline landscape. Bladder Cancer Overview Bladder cancer usually starts in the cells that line the inside of the bladder. It typically affects adults over the age of 70 and is more common in men. Bladder cancer is the fifth most prevalent type of cancer in the general population and the fourth most common in males. When detected early, bladder cancer usually responds well to bladder cancer treatment. Smoking is among the most common bladder cancer causes. Blood in the urine is usually the first sign of bladder cancer. Other bladder cancer symptoms may include urine pain or burning, as well as a change in urinary habits. This can include frequent urination or the need to urinate but being unable to do so. The tests used for bladder cancer diagnosis include biopsy, cystoscopy, urine cytology, imaging tests, and others. Find out more about bladder cancer drugs in development @ Bladder Cancer Drugs A snapshot of the Bladder Cancer Pipeline Drugs mentioned in the report: Learn more about the novel and emerging bladder cancer pipeline therapies @ Bladder Cancer Clinical Trials Bladder Cancer Therapeutics Assessment The bladder cancer pipeline report proffers an integral view of the bladder cancer emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Bladder Cancer Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Parenteral, Oral, Intravenous, Subcutaneous, Intramuscular Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem cell, Vaccine Therapeutics Assessment By Mechanism of Action: Cell death stimulants, Granulocyte macrophage colony stimulating factor agonists, Interleukin-15 receptor agonists, DNA synthesis inhibitors, Cyclin-dependent kinase 4 inhibitors, Cyclin-dependent kinase 6 inhibitors, Gene transference, IFNA2B expression stimulants, Antibody-dependent cell cytotoxicity, Programmed cell death-1 receptor antagonists, T lymphocyte stimulants Key Bladder Cancer Companies: CG Oncology, FKD Therapies, Bristol-Myers Squibb, LintonPharm Co.,Ltd., ImmunityBio, Inc., Hamlet Pharma AB, Asieris Pharmaceuticals, Pfizer, Taizhou Hanzhong biomedical co. LTD, Protara Therapeutics, CicloMed LLC, enGene, Inc., Emtora Biosciences, Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Astellas Pharma, RemeGen Co., Ltd., UroGen Pharma Ltd., Flame Biosciences, Aura Biosciences, BeiGene, Incyte Corporation, QED Therapeutics, G1 Therapeutics, AN0025, Kyowa Kirin, Inc., Infinity Pharmaceuticals, Shanghai Hengrui Pharmaceutical Co., Ltd., HiberCell, Inc., Ikena Oncology, Genentech, Fusion Pharmaceuticals, GI Innovation,SOTIO Biotech AG, Celon Pharma SA, 4D Pharma PLC, Keythera Pharmaceuticals, Quadriga Biosciences, Inc., NeoTX Therapeutics Ltd., Mirati Therapeutics, NGM Biopharmaceuticals, TransThera Biosciences, Ocellaris Pharma, Palleon Pharmaceuticals, Medicenna Therapeutics, Klus Pharma, Novartis, Toray Industries, Carisma Therapeutics, Avacta Life Sciences Ltd, Seagen Inc., Elevation Oncology, Corvus Pharmaceuticals, ADC Therapeutics S.A., IO Biotech, Byondis B.V., Takara Bio, Seven and Eight Biopharmaceuticals, Dragonfly Therapeutics, InnoCare Pharma, and others Key Bladder Cancer Pipeline Therapies: CG0070, ADSTILADRIN, Nivolumab, Catumaxomab, N-803, alpha1H, APL-1202, PF-07225570, HX008, TARA-002, CPX-POM, EG-70, eRapa, TLD-1433, VAX014, Erdafitinib, Enfortumab vedotin, RC48-ADC, TAS 102, UGN-102, FL-101, AU-011, Tislelizumab, Pemigatinib, Infigratinib, Trilaciclib, AN0025, KHK2455, IPI-549, SHR-1501, HC-7366, IK-175, ado-trastuzumab emtansine, FPI-1966, GI-101, SO-C101, CPL304110, MRx0518, KF-0210, QBS10072S, Naptumomab Estafenatox, Sitravatinib, NGM120, TT-00420, OC-001, E-602, MDNA11, A166, Spartalizumab, TRK-950, CT-0508, AVA6000, SEA-TGT, Seribantumab, CPI-006, ADCT-301, IO 102, SYD985, TBI-1301, BDB001, DF1001, ICP-192, and others. Dive deep into rich insights for bladder cancer drugs, visit @ Bladder Cancer Treatment Table of Contents For further information on the bladder cancer pipeline therapeutics, reach out @ New Drug for Bladder Cancer Treatment Related Reports Bladder Cancer Market Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key bladder cancer companies including RemeGen Co., Ltd., Taiho Oncology, Inc., Xennials Therapeutics, Flame Biosciences, among others. Bladder Cancer Epidemiology Forecast Bladder Cancer Epidemiology Forecast to 2032 report delivers an in-depth understanding of the disease, historical and forecasted bladder cancer epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Muscle Invasive Bladder Cancer Pipeline Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key muscle invasive bladder cancer companies, including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Muscle Invasive Bladder Cancer Market Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key muscle invasive bladder cancer companies including SOTIO a.s., Celon Pharma SA, Shanghai PerHum Therapeutics Co., Ltd., 4D Pharma PLC, among others. Non Muscle Invasive Bladder Cancer Pipeline Non Muscle Invasive Bladder Cancer Pipeline Insight, 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key non muscle invasive bladder cancer companies, including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. Non Muscle Invasive Bladder Cancer Market Non Muscle Invasive Bladder Cancer Market Insights, Epidemiology, and Market Forecast-2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key non muscle invasive bladder cancer companies including Theralase Inc., Vaxiion Therapeutics, Janssen Research & Development, LLC, Seagen Inc., among others. 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A166 is an antibody-drug conjugate (ADC) composed of an anti-HER2 antibody conjugated to Duostatin-5, a novel anti-microtubule Auristatin derivative, via a proprietary stable covalent linker.The ASCO meeting presentation (ASCO Poster# 415) includes A166 dose expansion data administered in 3-week cycles at doses of 4.8 mg/kg or 6.0 mg/kg in a total of 58 female patients with HER2-positive breast cancer.The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort, respectively.Median PFS was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort, respectively.Of 23 patients treated at 4.8 mg/kg cohort, one had a confirmed and sustained complete response (CR) lasting 7+ months. CHENGDU, China, and SAN DIEGO, June 01, 2022 (GLOBE NEWSWIRE) -- Sichuan Kelun-Biotech Biopharmaceutical Co, Ltd. ("Kelun-Biotech") and Levena Biopharma (“Levena”), a subsidiary of Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”), today announced the planned presentation of A166 data (Abstract #1037 and Poster #415) in patients with HER2-expressing locally advanced or metastatic solid tumors at the 2022 Annual Meeting of ASCO, the American Society of Clinical Oncology, to be held on June 3-7 in Chicago, IL. A166 is a HER2 antibody-drug conjugate (ADC) developed by Kelun-Biotech in a partnership with Levena Biopharma, which provided the patent-protected technologies for the generation and production of A166 in relation to (1) Duostatin-5, a proprietary tubulin inhibitor, (2) K-Lock, a site-specific conjugation technology, and (3) an enzymatically cleavable linker. As previously reported, in Phase 1 of the study, A166 demonstrated a safety profile that compared favorably to its commercial competitors and potentially superior efficacy as shown by the overall response rate (ORR) of 59.1% and 71.4% in the 4.8 mg/kg cohort and 6.0 mg/kg cohort, respectively, in heavily pretreated patients with HER2-positive breast cancer (data presented at the 2021 ASCO meeting [NCT05311397; J Clin Oncol 39, 2021 (suppl 15; abstr 1024)]. At the upcoming 2022 ASCO meeting, Kelun-Biotech will report updated data from this Phase 1 trial (Abstract #1037 and Poster #415). The Phase 1 dose expansion of the study was conducted in several sites in China and enrolled a total of 58 female patients (n=23 at 4.8 mg/kg and n=35 at 6.0 mg/kg) treated with A166 in 3-week cycles. The best ORR was 73.9% (17/23; 95% CI, 51.59 to 89.77) in the 4.8 mg/kg cohort and 68.6% (24/35; 95% CI, 50.71 to 83.15) in the 6.0 mg/kg cohort.Median progression free survival (PFS) was 12.3 months (95% CI, 6.00-not reached) in the 4.8 mg/kg cohort and 9.4 months (95% CI, 4.00 to 10.40) in the 6.0 mg/kg cohort.Of 23 patients treated in the 4.8 mg/kg cohort, one had a confirmed and sustained CR lasting 7+ months.Next generation sequencing was performed on tissue-derived DNA and blood-derived circulating tumor DNA.The detailed safety data, RECIST 1.1 response rate, and biomarker analyses will be presented in a poster (#415) at the 2022 ASCO meeting. About Sichuan Kelun-Biotech Biopharmaceuticals, Co. Ltd.Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. is a subsidiary of Sichuan Kelun Pharmaceutical Co., Ltd., founded in 2016. Kelun-biotech is committed to developing, and commercializing innovative drugs for the treatment of cancer, autoimmune and other diseases with unmet medical needs. Kelun-Biotech has developed a fully integrated multi-functional platform which includes R&D, CMC (Chemistry, Manufacturing, and Controls), and clinical development capabilities. Leveraging the platform, the company has built a robust pipeline, 1 I/O monoclonal antibody asset in NMPA NDA stage, 3 assets (including 1 monoclonal antibody and 2 ADCs) in Phase 3 or pivotal clinical trials, and an additional 10 molecules in clinical studies. For more information, please contact: China: klbio_bd@kelun.com, US: bd@kluspharma.com About Sorrento Therapeutics, Inc. Sorrento is a clinical and commercial stage biopharmaceutical company developing new therapies to treat cancer, pain (non-opioid treatments), autoimmune disease and COVID-19. Sorrento's multimodal, multipronged approach to fighting cancer is made possible by its extensive immuno-oncology platforms, including key assets such as fully human antibodies (“G-MAB™ library”), immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates (“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including Abivertinib, COVISHIELD™ and COVI-MSC™; and diagnostic test solutions, including COVIMARK™. Sorrento's commitment to life-enhancing therapies for patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule, resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, and to commercialize ZTlido® (lidocaine topical system) 1.8% for the treatment of postherpetic neuralgia (PHN). RTX has been cleared for a Phase II trial for intractable pain associated with cancer and a Phase II trial in osteoarthritis patients. Positive final results from the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for the treatment of lumbosacral radicular pain (sciatica), were announced in March 2022. ZTlido® was approved by the FDA on February 28, 2018. For more information visit www.sorrentotherapeutics.com Forward-Looking StatementsThis press release and any statements made for and during any presentation or meeting contain forward-looking statements related to Sorrento Therapeutics, Inc., under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding A166, an anti-HER2 ADC; the therapeutic and clinical potential of A166; the potential safety and efficacy of A166, including A166’s potential efficacy against HER2-positive breast cancer; and the potential advantages of A166 over its competitors. Risks and uncertainties that could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks related to Sorrento's technologies and prospects, including, but not limited to risks related to safety and efficacy for A166; clinical development risks, including risks in the progress, timing, cost, and results of clinical trials and product development programs; risk of difficulties or delays in obtaining regulatory approvals; risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; risks that prior test, study and trial results may not be replicated in continuing or future studies and trials; risks of manufacturing and supplying drug product; risks related to leveraging the expertise of its employees, subsidiaries, affiliates and partners to assist Sorrento in the execution of its product candidates’ strategies; risks related to the global impact of COVID-19; and other risks that are described in Sorrento's most recent periodic reports filed with the Securities and Exchange Commission, including Sorrento's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and we undertake no obligation to update any forward-looking statement in this press release except as required by law. Media and Investor RelationsContact: Brian CooleyEmail: mediarelations@sorrentotherapeutics.com Sorrento® and the Sorrento logo are registered trademarks of Sorrento Therapeutics, Inc. G-MAB™, DAR-T™, Seprehvec™, SOFUSA™, COVISHIELD™, COVIDROPS™, COVI-MSC™, COVIMARK™ and Fujovee™ are trademarks of Sorrento Therapeutics, Inc. SEMDEXA™ (SP-102) is a trademark of Semnur Pharmaceuticals, Inc. A proprietary name review by the FDA is planned. ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc. All other trademarks are the property of their respective owners. ©2022 Sorrento Therapeutics, Inc. All Rights Reserved.