Docetaxel

HONG KONG, Sept. 9, 2025 /PRNewswire/ -- Akeso Inc. (9926.HK) announced that data from a Phase Ib/II clinical study evaluating the combination of cadonilimab and pulocimab (an anti-VEGFR-2 antibody) in patients with immunotherapy (IO)-resistant NSCLC were presented in a Mini Oral session at the 2025 World Conference on Lung Cancer (WCLC). This marks the first clinical data release for cadonilimab in IO-resistant lung cancer. The cadonilimab combination therapy for advanced squamous non-small cell lung cancer (NSCLC) progressing after PD-(L)1 inhibitor treatment, has previously received Breakthrough Therapy Designation from the NMPA. The combination of cadonilimab and pulocimab also offers a potentially chemo-free option for advanced IO resistant NSCLC patients. The data presented at the 2025 WCLC demonstrated that the cadonilimab plus pulocimab regimen shows encouraging efficacy and broad clinical potential in patients with advanced or metastatic NSCLC who progressed after first-line standard immunotherapy-based treatment, offering a promising effective and safe therapeutic option for IO-resistant lung cancer patients: As of January 13, 2025, with a median follow-up of 16.7 months, the cadonilimab-based combination achieved a median overall survival (mOS) of 15.6 months and a median progression-free survival (mPFS) of 5.8 months in IO-resistant NSCLC. In the squamous NSCLC (sqNSCLC) subgroup, mOS was 16.7 months, mPFS was 7.1 months, the disease control rate (DCR) reached 96.2%, and the objective response rate (ORR) was 11.5%. In the non-squamous NSCLC (nsq-NSCLC) subgroup, mOS was 12.8 months, mPFS was 5.5 months, DCR was 95.2%, and ORR was 14.3%. Based on the promising clinical efficacy and safety data, preparation is underway for a Phase III clinical study evaluating the combination of cadonilimab and pulocimab for IO-resistant lung cancer. Additionally, ivonescimab (PD-1/VEGF), another novel bispecific antibody developed by Akeso, has shown unique efficacy and significant expansion potential in the IO-resistant NSCLC population. A registrational Phase III trial for ivonescimab has already been initiated. As first-in-class bispecific antibodies, both cadonilimab and ivonescimab are showing increasing advantages across a broadening range of disease areas. By leveraging dual-targets with synergistic mechanisms, they both address critical clinical challenges, such as limited efficacy or resistance to single-target agents like PD-1 inhibitors. This positions the bispecific antibodies as superior treatment options for patients worldwide. In recent years, immunotherapy has made significant progress in lung cancer treatment. PD-1/L1 inhibitors, either alone or with platinum-based chemotherapy, are the first-line treatment for driver-negative advanced NSCLC. However, 60%–70% of patients experience disease progression within a year. Docetaxel is the standard therapy for IO-resistant patients, but its effectiveness is limited. Improving outcomes for NSCLC patients after IO resistance remains a critical unmet need. Previous Phase III trials for IO-resistant lung cancer, including those with PD-1 inhibitors and ADCs, have not demonstrated meaningful clinical benefits. There is currently no approved standard treatment for NSCLC after resistance to IO therapies. The combination of cadonilimab and pulocimab has shown strong clinical potential in IO-resistant lung cancer, notably extending patient survival. The cadonilimab and pulocimab combination has also shown promising clinical data in other treatment-resistant cancers, including IO-resistant hepatocellular carcinoma and gastric cancer. Cadonilimab's proven efficacy for patients across all levels of PD-L1 expression, positions it as a key solution for IO-resistant cancers. This breakthrough offers a potentially new option for NSCLC patients that currently have limited treatment options after resistance to cancer immunotherapies. Forward-Looking Statement of Akeso, Inc. This announcement by Akeso, Inc. (9926.HK, "Akeso") contains "forward-looking statements". These statements reflect the current beliefs and expectations of Akeso's management and are subject to significant risks and uncertainties. These statements are not intended to form the basis of any investment decision or any decision to purchase securities of Akeso. There can be no assurance that the drug candidate(s) indicated in this announcement or Akeso's other pipeline candidates will obtain the required regulatory approvals or achieve commercial success. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in P.R.China, the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Akeso's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the Akeso's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Akeso does not undertake any obligation to publicly revise these forward-looking statements to reflect events or circumstances after the date hereof, except as required by law. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions. With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them, 24 candidates have entered clinical trials (including 15 bispecific/multispecific antibodies and bispecific ADCs. Additionally, 7 new drugs are commercially available. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. For more information, please visit and follow us on Linkedin. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

FDA alignment on Phase 3 ozuriftamab vedotin (Oz-V) trial design, including dosing regimen and endpoints to support potential accelerated approval Company continues preparations for enabling initiation of the Phase 3 study with the goal of advancing the study with a strategic partner early next year Company maintains previous guidance for completion of a strategic partnership with one of our advanced clinical assets this year Sept. 08, 2025 -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics using its proprietary CAB platform for the treatment of solid tumors, today announced outcomes from its Type B meeting with the United States Food and Drug Administration (FDA). Ozuriftamab vedotin (Oz-V), CAB-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2 which is expressed across many different solid tumors including head and neck cancer. Overexpression of ROR2 is driven by E6 / E7 oncoproteins associated with human papillomavirus (HPV) infection and is associated with poor prognosis and resistance to chemo- and immunotherapies. OPSCC is recognized as a distinct anatomical entity within head and neck cancers with up to 80% of cases in the United States caused by HPV infection. As previously reported, Oz-V has demonstrated compelling clinical data in HPV+ OPSCC in a Phase 2 trial with an overall response rate (ORR) of 45% (confirmed and unconfirmed) and a median overall survival (OS) of 11.6 months, ongoing. Other studies using either cetuximab, docetaxel, or methotrexate monotherapy have reported an ORR of 0 - 3.4% and a median OS of 4.4 months in a similar patient population. OPSCC represents a sizable and rapidly growing patient population that is poorly served by EGFR inhibitors and other standard of care regimens. Pivotal Trial Design: For full approval, approximately 300 OPSCC patients prospectively randomized and stratified, one to one between two open label treatment arms. Oz-V Dose and Regimen: Patients randomized to the investigational arm will receive 1.8 mg/kg every other week. Investigator’s Choice (IC) control arm: Patients randomized to the control arm will receive either cetuximab, docetaxel, or methotrexate monotherapy. Accelerated Approval Endpoint: Based on interim analysis of enrolled patients, statistically significant improvement of confirmed ORR by Blinded Independent Central Review (BICR) supported by an adequately characterized Duration of Response (DOR) without detriment in OS. Full Approval Endpoint: Statistically significant improvement of OS. “The actionable regulatory alignment represents an important milestone for BioAtla as it enables initiation of the first Phase 3 study of a CAB ADC in an indication that represents a sizable and steadily growing population that is poorly served by current standard of care agents, including EGFR inhibitors,” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla, Inc. “Having a clear registrational path with the potential for accelerated approval is very positive for our near-term strategic partnering objectives and enabling initiation of the Oz-V Phase 3 study with a partner. This underscores the potential of the CAB platform technology, which includes clinical readouts on our dual CAB EpCAM T-cell engager (BA3182) later this year.” Ozuriftamab vedotin (Oz-V), CAB-Platform-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, is driven by oncoproteins associated with HPV infection and forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. The FDA granted Fast Track Designation to Oz-V for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. OPSCC is a subset of SCCHN arising from the squamous cells that line the oropharynx, the middle part of the throat. This anatomic region is located behind the oral cavity and OPSCC typically involves the tonsils, soft palate, pharyngeal walls, and/or the base of the tongue. A striking year-to-year increase in OPSCC is due to the rapidly increasing incidence of HPV infections which currently represents approximately 80% of OPSCC in the United States. The prognosis is currently poor for patients with recurrent/metastatic OPSCC who have previously received standard treatments including surgery, radiation, platinum-based chemotherapy, and PD-1 inhibitor therapy. BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients. BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. The content above comes from the network. if any infringement, please contact us to modify.