NeoTX Therapeutics Ltd.

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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Lund, June 1, 2022 - Active Biotech (NASDAQ STOCKHOLM: ACTI) and its partner NeoTX announce today the successful completion of the first stage of a Simon 2 stage phase IIa clinical trial of naptumomab estafenatox (NAP, naptumomab), in combination with docetaxel in patients with advanced or metastatic non-small cell lung cancer (NSCLC) who have been previously treated with chemotherapy and checkpoint inhibitors (CPIs). In the study, the patients are treated with NAP for 4 consecutive days and with docetaxel at a standard dose on day 5 in 21-day treatment cycles. The first stage of this trial required a minimum of two responses out of ten patients to move to the second stage of the trial, which is now enrolling. For more information about the trial, visit www.clinicaltrials.gov. NCT04880863 We are pleased by these early encouraging observations and are excited to follow the progress of the trial, which is now enrolling in its second stage, says Erik Vahtola, Chief Medical Officer at Active Biotech. Patients with advanced NSCLC who have progressed on CPI and standard chemotherapy currently have limited treatment options and new treatment alternatives are needed.See also www.neotx.com for NeoTX’s communication related to this information. Helén Tuvesson President & CEO For further information, please contact: Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com This information is information that Active Biotech is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 14.00 pm. CET on June 1, 2022. Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: The wholly owned small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is in a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. Please visit www.activebiotech.com for more information. About NeoTX NeoTX is a clinical-stage immuno-oncology company which is developing targeted anticancer immunotherapies utilizing its proprietary Tumor Targeted Superantigen (TTS) platform. TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells that are then redirected from the periphery to the tumor to mount an effective response. The company’s lead TTS molecule, naptumomab estafenatox is currently in clinical development for advanced solid tumors (clinicaltrials.gov/NCT039883954 and NCT04880863). Please visit www.neotx.com for more information. Naptumomab was licensed from Active Biotech to NeoTX Therapeutics Ltd in 2016. NeoTX is responsible for the global development and commercialization of naptumomab for the treatment of cancer under the license agreement. Active Biotech AB(Corp. Reg. No. 556223-9227)Scheelevägen 22, SE-223 63 Lund, SwedenTel: +46 (0)46 19 20 00 Attachment 220601_phase IIa clinical trial naptumomab in combination with docetaxel

Lund Sweden, October 3, 2021 - Active Biotech (NASDAQ STOCKHOLM: ACTI) today announces that the ongoing trial of tasquinimod in multiple myeloma has reached an important milestone. Ten patients have been treated with increasing doses of tasquinimod, which was generally well tolerated. The optimal dose and schedule of tasquinimod, when used as a single agent in patients with multiple myeloma has been established at 1 mg per day after a one-week run in of 0.5 mg daily. This is similar to the treatment schedule used in previous studies of tasquinimod. The trial will now advance to a previously planned combination part, in which treatment with tasquinimod will be tested in patients with multiple myeloma together with the orally administered antimyeloma agents ixazomib, lenalidomide, and dexamethasone (IRd). Once an optimal dose and schedule of tasquinimod for the IRd combination is established, an expansion cohort will be recruited to further document the biological activity of tasquinimod in myeloma patients. Key secondary endpoints will include antimyeloma activity using the response criteria of the International Myeloma Working Group. The study is conducted in a partnership with the Abramson Cancer Center of the University of Pennsylvania, with Dr. Dan Vogl as principal investigator. For more information about the study please visit clinical clinicaltrials.gov (NCT04405167). "We are pleased to have concluded the first part of this trial, confirming the previous safety pro tasquinimod in patients with multiple myeloma and defining an optimal dose and schedule for tasquinimod in this patient population. The patients included in this study phase were heavily pre-treated, with a median of 8 prior lines of therapy; 8 of the 10 patients were triple-class refractory to Imids, proteasome inhibitors, and anti-CD38 monoclonal antibodies. While none of the patients formally achieved a partial response, two patients with progressive myeloma at study entry achieved significant periods of stable disease on single-agent tasquinimod therapy. This suggests that tasquinimod has anti-myeloma activity in patients with advanced disease that is resistant to established therapies. These results enable us to advance into the combination part of the study, in which tasquinimod will be combined with a standard anti-myeloma treatment regimen. Our preclinical laboratory models suggest that this combination strategy may be a particularly effective way to utilize tasquinimod in myeloma therapy." says Dr. Dan Vogl, Principal Investigator. “We are enthusiastic to have reached this milestone and can conclude the first phase of this study. Based on the established safety data together with the encouraging anti-myeloma activities observed, we look forward to the continuation of the study. In the coming phase, tasquinimod will be evaluated in combination with ixazomib, lenalidomide, and dexamethasone (IRd), which already are established in the clinical practice. The use of tasquinimod, as a novel class of treatment for multiple myeloma, in combination with treatments used for earlier stage patients, is aligned with our current understanding of the mechanism of action of tasquinimod in these patients. ” says Helén Tuvesson, CEO, Active Biotech AB. Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 21:30 p.m. CET on October 3, 2021. About tasquinimod Tasquinimod is an oral immunomodulatory and anti-angiogenic investigational treatment, that affects the tumor's ability to grow and metastasize. Tasquinimod is developed as a new immunomodulatory treatment for multiple myeloma. Tasquinimod has previously been studied as an anti-cancer agent in patients with solid cancers, including a phase 3 randomized trial in patients with metastatic prostate cancer. The tolerability of tasquinimod is well-characterized based on these previous experiences. Tasquinimod has demonstrated a clear therapeutic potential in preclinical models of multiple myeloma, when used as a single agent and in combination with standard multiple myeloma therapy. About multiple myeloma Multiple myeloma is an incurable blood cancer in which abnormal plasma cells in the bone marrow grow uncontrollably while other blood forming cells such as white and red blood cells and blood platelets are suppressed. This leads to anemia, infections, destruction of bone tissue and progressive loss of renal function. Despite new treatments have greatly improved survival of multiple myeloma patients, the biological heterogeneity of the disease and the emergence of drug resistance is a major challenge, and the medical need of innovative treatment modalities remains high. In 2017, 81000 new cases of multiple myeloma were diagnosed in the eight major markets. The global sales of drugs for multiple myeloma totaled USD 16 billion in 2017 and sales are expected to increase 48% by 2026 (ref Global Data 2019). Active Biotech AB (publ) (NASDAQ Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a phase Ib/II clinical program in patients with advanced solid tumors. The small molecule immunomodulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is advancing to a clinical phase I study with a topical ophthalmic formulation, to be followed by phase II for treatment of non-infectious uveitis. Please visit for more information. Active Biotech AB (Corp. Reg. No. 556223-9227) Scheelevägen 22, SE-223 63 Lund, Sweden Tel: +46 (0)46 19 20 00 Attachment 211003_Tasquinimod clinical development in multiple myeloma