Latest news with #Nectin-4
Business Wire
22-05-2025
- Health
- Business Wire
Bicycle Therapeutics Announces Poster Presentations at the 2025 ASCO Annual Meeting
CAMBRIDGE, England, & BOSTON--(BUSINESS WIRE)-- Bicycle Therapeutics plc (NASDAQ: BCYC), a pharmaceutical company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle ®) technology, today announced the poster presentation of two abstracts at the 2025 American Society for Clinical Oncology (ASCO) Annual Meeting, taking place May 30-June 3 in Chicago. Poster Presentation Details: Title: Phase 1/2 Duravelo-1 study: Preliminary results of Nectin-4-targeting zelenectide pevedotin (BT8009) plus pembrolizumab in previously untreated, cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer Poster Session: Genitourinary Cancer—Kidney and Bladder Date and Time: Monday, June 2, at 9 a.m.-12 p.m. CT Abstract Number: 4567 Lead Author: Patrizia Giannatempo, M.D., Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan, Italy Title: A phase 2/3 study of Bicycle ® Drug Conjugate zelenectide pevedotin (BT8009) targeting Nectin-4 in patients with locally advanced or metastatic urothelial cancer (la/mUC; Duravelo-2) Poster Session: Genitourinary Cancer—Kidney and Bladder Date and Time: Monday, June 2, at 9 a.m.-12 p.m. CT Abstract Number: TPS4619 Lead Author: Yohann Loriot, M.D., Ph.D., Gustave Roussy Institute, University Paris-Saclay, Villejuif, France The posters will be made available in the Publications section of the Bicycle Therapeutics website at the beginning of the poster session. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage pharmaceutical company developing a novel class of medicines, referred to as Bicycle ® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycle molecules attractive candidates for drug development. The company is evaluating zelenectide pevedotin (formerly BT8009), a Bicycle ® Drug Conjugate (BDC ®) targeting Nectin-4, a well-validated tumor antigen; BT5528, a BDC molecule targeting EphA2, a historically undruggable target; and BT7480, a Bicycle Tumor-Targeted Immune Cell Agonist ® (Bicycle TICA ®) targeting Nectin-4 and agonizing CD137, in company-sponsored clinical trials. Additionally, the company is developing Bicycle ® Radioconjugates (BRC ®) for radiopharmaceutical use and, through various partnerships, is exploring the use of Bicycle ® technology to develop therapies for diseases beyond oncology. Bicycle Therapeutics is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, Mass. For more information, visit
Business Wire
29-04-2025
- Business
- Business Wire
Innate Pharma Highlights Preclinical Anti-Tumor Efficacy Data of Its Antibody Drug Conjugate IPH4502 at the AACR 2025 Annual Meeting
MARSEILLE, France--(BUSINESS WIRE)--Regulatory News: Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) (' Innate ' or the ' Company ') today shared new preclinical data for IPH4502, its novel and differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) targeting Nectin-4. The data were presented at the American Association for Cancer Research (AACR) Annual Meeting 2025. Nectin-4 targeting is validated by enfortumab vedotin (EV), an ADC with a monomethyl auristatin E (MMAE) payload, approved for urothelial carcinoma (UC), an indication with high Nectin-4 expression. However, EV discontinuation due to toxicity, disease relapse, or treatment ineligibility, along with its limited efficacy in tumors with lower Nectin-4 expression, underscores the need for a differentiated Nectin-4 ADC with improved therapeutic window and improved mechanisms of action. IPH4502 demonstrated anti-tumor activity in EV-resistant patient-derived xenograft (PDX) model with upregulation of multi-drug resistance protein 1 (MDR1), supporting its potential to overcome resistance mechanisms in EV-refractory disease. Beyond UC, IPH4502 also exhibited anti-tumor activity in preclinical models of triple-negative breast cancer, head and neck squamous cell carcinoma, and esophageal cancer, suggesting broader potential clinical applicability. In addition, in preclinical tumor models with low Nectin-4 expression, IPH4502 showed superior anti-tumor activity compared to a clinical-stage Nectin-4-exatecan ADC supported by higher internalization, cytotoxicity, and bystander killing effect. ' We are highly encouraged by these preclinical data, which suggest that IPH4502 has the potential to translate into improved clinical benefit in indications with unmet medical need. These findings also reinforce the rationale for our ongoing Phase 1 trial. We look forward to sharing initial clinical data in 2026 as the program advances, ' said Sonia Quaratino, Chief Medical Officer of Innate Pharma. IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors known to express Nectin-4 (NCT06781983). The poster is available on Innate Pharma's website. About IPH4502 IPH4502 is a differentiated topoisomerase I inhibitor Antibody Drug Conjugate (ADC) conjugated to exatecan targeting Nectin-4, a cell adhesion molecule that is overexpressed in several types of solid tumors, such as urothelial carcinoma, breast cancer, non-small cell lung cancer or gastro-intestinal tract cancer. IPH4502 is currently investigated in a Phase 1 trial in advanced solid tumors. The Phase 1 trial will assess the safety, tolerability, and preliminary efficacy of IPH4502 in different solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers. The study plans to enroll approximately 105 patients. In preclinical models, IPH4502 demonstrates strong bystander killing effect, and efficient internalization, enabling a potent anti-tumor activity in models with various Nectin-4 expression levels. Additionally, IPH4502 shows efficacy in models resistant to MMAE-ADC. These results support its potential for development beyond UC and in cancer patients treated with MMAE-based ADCs. About Innate Pharma Innate Pharma S.A. is a global, clinical-stage biotechnology company developing immunotherapies for cancer patients. Its innovative approach aims to harness the innate immune system through three therapeutic approaches: multi-specific NK Cell Engagers via its ANKET ® (Antibody-based NK cell Engager Therapeutics) proprietary platform and Antibody Drug Conjugates (ADC) and monoclonal antibodies (mAbs). Innate's portfolio includes several ANKET ® drug candidates to address multiple tumor types as well as IPH4502, a differentiated ADC in development in solid tumors. In addition, anti-KIR3DL2 mAb lacutamab is developed in advanced form of cutaneous T cell lymphomas and peripheral T cell lymphomas, and anti-NKG2A mAb monalizumab is developed with AstraZeneca in non-small cell lung cancer. Innate Pharma is a trusted partner to biopharmaceutical companies such as Sanofi and AstraZeneca, as well as leading research institutions, to accelerate innovation, research and development for the benefit of patients. Headquartered in Marseille, France with a US office in Rockville, MD, Innate Pharma is listed on Euronext Paris and Nasdaq in the US. Learn more about Innate Pharma at Follow us on LinkedIn and X. Information about Innate Pharma shares Disclaimer on forward-looking information and risk factors This press release contains certain forward-looking statements, including those within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. The use of certain words, including 'anticipate,' 'believe,' 'can,' 'could,' 'estimate,' 'expect,' 'may,' 'might,' 'potential,' 'expect' 'should,' 'will,' or the negative of these and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. These risks and uncertainties include, among other things, the uncertainties inherent in research and development, including related to safety, progression of and results from its ongoing and planned clinical trials and preclinical studies, review and approvals by regulatory authorities of its product candidates, the Company's reliance on third parties to manufacture its product candidates, the Company's commercialization efforts and the Company's continued ability to raise capital to fund its development. For an additional discussion of risks and uncertainties, which could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ('Facteurs de Risque") section of the Universal Registration Document filed with the French Financial Markets Authority ('AMF'), which is available on the AMF website or on Innate Pharma's website, and public filings and reports filed with the U.S. Securities and Exchange Commission ('SEC'), including the Company's Annual Report on Form 20-F for the year ended December 31, 2023, and subsequent filings and reports filed with the AMF or SEC, or otherwise made public by the Company. References to the Company's website and the AMF website are included for information only and the content contained therein, or that can be accessed through them, are not incorporated by reference into, and do not constitute a part of, this press release. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by the Company or any other person that the Company will achieve its objectives and plans in any specified time frame or at all. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in Innate Pharma in any country.
Malaysian Reserve
24-04-2025
- Business
- Malaysian Reserve
Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025
Interim results from Phase 1a dose escalation to be presented Data provide clinical proof of concept for Adcentrx's novel technology platform; highlight unique opportunity for ADRX-0706 to address significant unmet needs for patients with limited therapeutic options SAN DIEGO, April 23, 2025 /PRNewswire/ — Adcentrx Therapeutics ('Adcentrx'), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 – June 3, 2025) in Chicago, IL. Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx's ADC platform, including the i-Conjugation® technology and novel auristatin payload AP052. The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706's safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers. Details of the poster presentation at the ASCO Meeting are as follows: Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumorsAbstract Number: 3018Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CSTSession Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology The full abstract will be published by ASCO in conjunction with the Meeting. About i-Conjugation® TechnologyAdcentrx's proprietary i-Conjugation® technology platform is a core component in the design of the company's ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload. About ADRX-0706ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs. The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation® technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on About Adcentrx TherapeuticsAdcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@
Yahoo
23-04-2025
- Business
- Yahoo
Adcentrx Therapeutics to Present First Clinical Data for ADRX-0706 Nectin-4 ADC at ASCO 2025
Interim results from Phase 1a dose escalation to be presented Data provide clinical proof of concept for Adcentrx's novel technology platform; highlight unique opportunity for ADRX-0706 to address significant unmet needs for patients with limited therapeutic options SAN DIEGO, April 23, 2025 /PRNewswire/ -- Adcentrx Therapeutics ("Adcentrx"), a clinical-stage biotechnology company redefining Antibody-Drug Conjugate (ADC) therapies for cancer treatment and other life-threatening diseases, will present the first clinical data for ADRX-0706 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting (May 30 - June 3, 2025) in Chicago, IL. Adcentrx will deliver a poster presentation on ADRX-0706, a clinical-stage Nectin-4 ADC. The presentation will include interim clinical data from the Phase 1a portion of the ongoing trial (NCT06036121), demonstrating the best-in-class potential for ADRX-0706. The findings indicate a differentiated safety and pharmacokinetic profile, including a significantly lower incidence of critically meaningful adverse events such as peripheral neuropathy. Additionally, preliminary efficacy signals across different dose levels and tumor types provide strong clinical validation of Adcentrx's ADC platform, including the i-Conjugation® technology and novel auristatin payload AP052. The first-in-human Phase 1a/b study is an open-label, two-part trial being conducted at sites in the U.S. and China. The completed Phase 1a portion consisted of a dose escalation of ADRX-0706 to evaluate initial safety and tolerability in patients with select advanced solid tumors, and to identify the recommended dose to be used in Phase 1b. This ongoing second portion of the study aims to further evaluate ADRX-0706's safety and tolerability, preliminary efficacy, and optimal dose in urothelial, triple-negative breast and cervical cancers. Details of the poster presentation at the ASCO Meeting are as follows: Title: Preliminary results from a first-in-human phase 1 dose escalation trial of ADRX-0706, a next generation Nectin-4 ADC, in subjects with advanced solid tumorsAbstract Number: 3018Session Date & Time: Monday, June 2, 1:30 p.m. – 4:30 p.m. CSTSession Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology The full abstract will be published by ASCO in conjunction with the Meeting. About i-Conjugation® TechnologyAdcentrx's proprietary i-Conjugation® technology platform is a core component in the design of the company's ADCs. The platform utilizes protease-cleavable linkers and stable conjugation chemistry to enhance payload delivery. This advanced technology ensures a highly stable ADC with the desired linker-payload. About ADRX-0706ADRX-0706 is a fully proprietary ADC product candidate discovered by Adcentrx. The antibody component is a novel fully human IgG1 targeting Nectin-4, a cell surface adhesion protein with high expression in multiple solid tumors and limited expression in normal tissues. Nectin-4 is associated with poor disease prognosis and is a validated target for ADCs. The ADRX-0706 antibody is linked to a proprietary tubulin inhibitor payload, AP052, through Adcentrx's innovative i-Conjugation® technology using a cleavable linker and stable conjugation chemistry. This novel platform technology enables a highly stable ADC with a drug-antibody ratio of eight (DAR 8) with a substantially expanded therapeutic window as demonstrated in preclinical studies. ADRX-0706 has a favorable pharmacokinetic and safety profile in preclinical models and has demonstrated significant efficacy across a variety of tumor indications in vitro and in vivo. ADRX-0706 is currently being evaluated in a Phase 1a/b clinical trial. For more information about the ADRX-0706 Phase 1a/b clinical trial, please refer to the Study ID NCT06036121 on About Adcentrx TherapeuticsAdcentrx is a biotechnology company focused on accelerating breakthroughs in protein conjugate therapeutic development for cancer and other life-threatening diseases. Adcentrx has pioneered the development of an ADC technology platform addressing key components of protein conjugate design to solve challenges typically seen in ADCs. Adcentrx is developing a robust pipeline including two clinical-stage ADCs and multiple preclinical ADCs, all with first-in-class and best-in-class potential. For more information about Adcentrx and its innovative ADC technologies, please visit Contact Information:Investor Relationsir@ View original content to download multimedia: SOURCE Adcentrx Therapeutics Sign in to access your portfolio
Time of India
21-04-2025
- Business
- Time of India
PADCEV (enfortumab vedotin) Now Available in India for Locally Advanced or Metastatic Urothelial Cancer
Mumbai: Astellas Pharma India Pvt Ltd. today announced that PADCEVTM ( enfortumab vedotin ) is now available for prescription in India as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer (LA/mUC) who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor1 Enfortumab vedotin is a first-in-class antibody-drug conjugate that is directed against Nectin-4 , a protein located on the surface of cells and highly expressed in bladder cancer cells1Laboratory studies have shown that the anticancer activity occurs when it enters the cell and releases the cell-killing medicine that works to damage and kill the cell expressing nectin-4.1 In India, urothelial carcinoma patients who have progressed beyond platinum-containing chemotherapy and immunotherapy currently lack a standard of care. Treatment options for this population are limited and this launch will address a significant unmet need. The launch of PADCEVTM reinforces Astellas' commitment to expanding its oncology portfolio in India. Following the introduction of XospataTM (Gilteritinib) last April for relapsed or refractory FLT3+ acute myeloid leukemia (AML), PADCEVTM marks another step in the company's mission to deliver innovative cancer therapies to Indian patients. 'This launch marks a significant milestone for India. The approval of enfortumab vedotin provides a new treatment option for patients living with advanced urothelial cancer who have had limited treatment options thus far. It also further demonstrates our continued commitment to bringing global innovations to India and making a real impact on patient's lives,' said Sampada Gosavi, General Manager and Managing Director, Astellas India. About Urothelial Cancer Urothelial cancer is the most common type of bladder cancer (90 percent of cases) and can also be found in the renal pelvis (where urine collects inside the kidney), ureter (tube that connects the kidneys to the bladder) and urethra2. About the EV-301 Trial The EV-301 trial (NCT03474107) was a global, multicentre, open-label, randomised phase 3 trial designed to evaluate enfortumab vedotin versus physician's choice of chemotherapy (docetaxel, paclitaxel or vinflunine) in 608 patients with locally advanced or metastatic urothelial cancer who were previously treated with a PD-1/L1 inhibitor and platinum-containing therapies. The primary endpoint was overall survival and secondary endpoints included progression-free survival, overall response rate, duration of response and disease control rate, as well as assessment of safety/tolerability and quality-of-life parameters. Results were published in the New England Journal of Medicine. About PADCEV TM (enfortumab vedotin) PADCEV is a first-in-class antibody-drug conjugate (ADC) that is directed against Nectin-4, a protein located on the surface of cells and highly expressed in bladder cancer1,4. Nonclinical data suggest the anticancer activity of PADCEV is due to its binding to Nectin-4 expressing cells followed by the internalisation and release of the anti-tumor agent monomethyl auristatin E (MMAE) into the cell, which result in the cell not reproducing (cell cycle arrest) and in programmed cell death (apoptosis).1 About Astellas Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at For Further Information, Please Contact: Astellas Pharma India Private Limited 301, 3rd Floor, C & B Square, 127, Andheri Kurla Road, Andheri (East), Mumbai 400069 India, Customer care no. +91-22-61557600 REFERENCES 1. PADCEV India Prescribing Information. 2. American Society of Clinical Oncology. Bladder cancer: introduction (5-2019). Accessed March 2022. 3. Powles T, Rosenberg JE, Sonpavde GP, et al. Enfortumab Vedotin in Previously Treated Advanced Urothelial Carcinoma. N Engl J Med. 2021; 10.1056/NEJMoa2035807. 4. Challita-Eid P, Satpayev D, Yang P, et al. Enfortumab Vedotin Antibody-Drug Conjugate Targeting Nectin-4 Is a Highly Potent Therapeutic Agent in Multiple Preclinical Cancer Models. Cancer Res 2016;76(10):3003-13. Disclaimer - The above content is non-editorial, and ET Healthworld hereby disclaims any and all warranties, expressed or implied, relating to it, and does not guarantee, vouch for or necessarily endorse any of the content.
