Atezolizumab

BioNTech disclosed on Friday that it has ended a Phase II study of personalised mRNA cancer vaccine autogene cevumeran (BNT122), which it's developing in partnership with Roche's Genentech unit. The biotech's stock fell about 8% on the news.The clinical stumble comes shortly after BioNTech's shares had gotten a boost from positive sentiment for autogene cevumeran. Last week, Moderna reported Phase III findings for its mRNA-based individualised neoantigen therapy intismeran autogene, which led to statistically significant and clinically meaningful improvements in recurrence-free survival and distant metastasis-free survival in patients with resected stage III or IV melanoma (see – Spotlight On: mRNA breaks from vaccine stable as Moderna, Merck & Co. deliver breakthrough melanoma results).The results sent Moderna's shares soaring about 177%, with BioNTech also seeing a lift that day as investors upped the odds of success for autogene cevumeran, its entrant in the neoantigen space (see – Vital Signs: Merck & Co. enters Moderna's latest vaccine bubble). Survival imbalance Now, however, that confidence in autogene cevumeran appears to have been misplaced, at least in the colorectal cancer (CRC) setting. The BNT122-01 trial was evaluating whether the immunotherapy, which encodes patient-specific tumour neoantigens, could be used as an adjuvant monotherapy to prevent disease recurrence in patients with ctDNA-positive, surgically resected stage II or stage III CRC. The current standard-of-care treatment for this patient population is "watchful waiting." According to BioNTech, the study's futility boundary was crossed in Oct. 2025, at which time a data safety monitoring board (DSMB) concluded that the data "were not sufficiently mature to support reliable conclusions regarding efficacy." Because there were no safety signals linked to autogene cevumeran, and no objections from the DSMB, the biotech elected to continue the BNT122-01 trial.   However, at the most recent data review, the DSMB flagged a "numerical imbalance" in overall survival between patients receiving autogene cevumeran and those being observed with watchful waiting. Because continuing the trial was unlikely to change its efficacy outcome, the DSMB recommended discontinuing treatment with the mRNA therapy and terminating the study. "While this outcome is not what we had envisioned…it provides scientific insight into the challenges of treating immunotherapy-insensitive tumour types with immune-suppressive microenvironments and will help inform the further development of investigational mRNA cancer immunotherapies," said BioNTech's Chief Medical Officer Özlem Türeci in a company statement. The DSMB did not find any new safety concerns in its review. BioNTech will continue to analyse the data to inform its clinical strategy and patient selection for any future mRNA cancer immunotherapy development. BioNTech noted that its decision to end the CRC trial will not affect the ongoing Phase II IMcode003 study of autogene cevumeran in combination with Roche's PD-L1 inhibitor Tecentriq (atezolizumab) and chemotherapy in adjuvant pancreatic ductal adenocarcinoma.

HONG KONG, Aug. 27, 2026 /PRNewswire/ -- Akeso, Inc. (9926.HK) ("Akeso" or the "Company") announced its 2026 interim results. During the reporting period, the Company achieved record-high drug sales revenue, further advanced its global immuno-oncology (IO) 2.0 strategy, progressively built its IO2.0 + ADC2.0 therapeutic matrix, and continued orderly development of bispecific antibodies in major chronic disease areas, including autoimmune, respiratory, and central nervous system (CNS) disorders Commercialization Reaches Record High Commercial sales revenue for the first half of 2026 reached approximately RMB 1,803.2 million, representing a 28.7% increase year-over-year. As of the reporting date, the Company's total cash and cash equivalents, together with other short-term financial assets, stood at RMB 9,160.0 million. By the end of 2025, all 12 indications across the Company's five self-commercialized innovative drugs had been included in China's National Reimbursement Drug List (NRDL). These include two non-small cell lung cancer (NSCLC) indications for ivonescimab (PD-1/VEGF bispecific antibody) and three cervical and gastric cancer indications for cadonilimab (PD-1/CTLA-4 bispecific antibody). NRDL inclusion has significantly expanded market coverage and patient access. In August 2026, the National Medical Products Administration (NMPA) approved ivonescimab in combination with chemotherapy for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC), providing a new growth driver for commercialization. Since the beginning of 2026, the Company has continued to strengthen its commercialization capabilities, with steady progress in market access, coverage, and penetration. These efforts lay a solid foundation for the sustained release of innovative drug value in the second half of the year and beyond. IO2.0 Global Strategy Advances Following the approvals of ivonescimab and cadonilimab - two first-in-class immuno-oncology (IO) cornerstone therapies - Akeso has continued to advance the Company's global IO2.0+ strategy. The Company is building a bispecific antibody-based IO therapeutic matrix designed to treat multiple tumor types through combining different types of therapy. Biliary tract cancer: In August 2026, the Phase III clinical study of ivonescimab plus chemotherapy versus durvalumab plus chemotherapy for the first-line treatment of advanced biliary tract cancer met its primary endpoint of overall survival (OS), demonstrating clinically meaningful and statistically significant OS benefit. This regimen represents a major advancement in first-line treatment of biliary tract cancer. Squamous NSCLC: In August 2026, ivonescimab plus chemotherapy received NMPA approval for first-line treatment of sq-NSCLC. Based on the HARMONi-6 study, this is the first regimen to achieve dual positive OS and progression-free survival (PFS) results versus a PD-1 monoclonal antibody plus chemotherapy in a randomized, double-blind Phase III trial. Ivonescimab combination therapy marks a significant advance in first-line sq-NSCLC treatment. EGFR-TKI-resistant NSCLC: In July 2026, an updated analysis of the global multicenter Phase III HARMONi study demonstrated continued OS improvement (HR = 0.76). The OS hazard ratio in Western patients was also 0.76, highly consistent with the China-conducted HARMONi-A study (HR = 0.74, P = 0.02). The Biologics License Application (BLA) for this indication is currently under review by the U.S. Food and Drug Administration (FDA). The HARMONi-A study is the first immuno-oncology trial globally to achieve dual positive OS and PFS results with both clinical benefit and statistical significance in this setting. Ivonescimab combination therapy represents a major advancement in the treatment of EGFR-TKI-resistant non-squamous NSCLC. PD-L1-positive NSCLC: In the HARMONi-2 study, ivonescimab became the first therapy globally to demonstrate positive results versus pembrolizumab in a Phase III trial, establishing a new benchmark in first-line treatment of PD-L1-positive NSCLC. Cadonilimab: Cadonilimab continues to advance across multiple indications, including gastric cancer and hepatocellular carcinoma (HCC). Key programs include an international multicenter Phase III study of cadonilimab plus chemotherapy versus nivolumab plus chemotherapy for first-line treatment of gastric/gastroesophageal junction (G/GEJ) adenocarcinoma, a perioperative Phase II study in collaboration with Memorial Sloan Kettering Cancer Center (MSKCC), and an international multicenter registrational study of cadonilimab plus lenvatinib in HCC patients who progressed after prior atezolizumab plus bevacizumab. As cornerstone agents of global IO2.0, ivonescimab and cadonilimab are establishing a combination therapy ecosystem through novel mechanisms, with the potential to elevate the standard of care across multiple tumor types. Ivonescimab is currently being evaluated in combination trials with Revolution Medicines' RAS(ON) inhibitor, ARCUS Biosciences' HIF-2α inhibitor, Virogin Biotech's VG201 oncolytic virus, and TransThera Biosciences' tinengotinib, spanning NSCLC, pancreatic cancer, colorectal cancer, clear cell renal cell carcinoma, and hepatocellular carcinoma. Cadonilimab is advancing multi-pathway combination strategies, including combinations with small molecules such as axitinib and tinengotinib in renal and liver cancers, as well as collaborations with the Dana-Farber Cancer Institute and Mass General Brigham to evaluate cadonilimab in combination with INOVIO's DNA medicine INO-5412 in glioblastoma (GBM). Ivonescimab is currently being evaluated in more than 17 registrational Phase II/III studies, including seven global registrational trials and 8 studies that use standard-of-care regimens as active comparators. These programs encompass 8 registrational/Phase III studies in lung cancer, as well as first-line MSS/pMMR colorectal cancer, first-line PD-L1-positive head and neck squamous cell carcinoma (in combination with CD47 antibody versus pembrolizumab), first-line biliary tract cancer (versus a durvalumab-based regimen), first-line triple-negative breast cancer, first-line pancreatic cancer, and first-line urothelial cancer (versus pembrolizumab plus a Nectin-4 ADC). Cadonilimab is being evaluated in more than 13 registrational/Phase III clinical studies covering major cancer types, including gastric cancer, HCC, lung cancer, cervical cancer, pancreatic cancer, and esophageal squamous cell carcinoma. Two of these are international multicenter registrational studies. IO2.0 + ADC2.0 Therapeutic Matrix Akeso is the only company globally with two approved immuno-oncology bispecific antibodies and is actively exploring combination therapies of ivonescimab and cadonilimab with both proprietary and partnered antibody-drug conjugates (ADCs). The Company has developed a series of next-generation ADCs designed to address the narrow therapeutic window associated with the safety limitations of existing ADC therapies. Among these, the innovative TROP2/Nectin-4 bispecific ADC AK146D1, next-generation HER3 ADC AK138D1, next-generation B7H3 ADC AK157D1, and bispecific ADC AK158D1 have successively entered clinical development. Multiple Phase II studies evaluating AK146D1 in combination with ivonescimab in NSCLC, breast cancer, and urothelial cancer, as well as AK138D1 in combination with ivonescimab in lung and breast cancers, are underway, with a focus on first-line treatment of various solid tumors. In parallel, ivonescimab has entered combination therapy collaborations with high-potential ADCs from domestic and international partners, including Pfizer, GSK, Biokin, and MediLink. These collaborations cover agents such as EGFR/HER3 bispecific ADC, TROP2/HER3 bispecific ADC, B7H3 ADC, FGFR2b ADC, TROP2 ADC, and Nectin-4 ADC across high-incidence malignancies. Looking further ahead, the Company's frontier programs continue to push additional new therapies into the clinic. The global first-in-class trispecific antibody AK150 (ILT2/ILT4/CSF1R) has entered clinical development, with additional trispecific antibodies and T-cell engager (TCE) bispecific/multispecific candidates expected to enter the clinic in the next year. Entering the Bispecific Era in Immunology, CNS, and Respiratory Diseases In autoimmune, respiratory, and CNS diseases, Akeso is leveraging its expertise in bispecific and multispecific antibody development, with strategic momentum steadily building. A series of internally-developed novel candidates, including AK139, a bispecific antibody for Immunology & Inflammation that targets IL-4R and ST2, and AK152, a bispecific amyloid-beta + brain shuttle antibody for the treatment of Alzheimer's disease have entered or are preparing to enter clinical development. These programs form a complementary pipeline alongside the Company's already marketed non-oncology products: ebronucimab (PCSK9), ebdarokimab (IL-12/IL-23), gumokimab (IL-17), and manfidokimab (IL-4Rα). AI-Empowered Future Innovation Competitiveness Akeso has adopted the use of AI in its R&D efforts for the past few years. The Company is further expanding the implementation of AI in many new scientific directions and therapeutic platforms. Developed on Akeso's AI-driven drug discovery platform, AK139, an IL-4Rα/ST2 bispecific antibody, has advanced into 7 Phase II trials across respiratory and autoimmune indications. AK150, an ILT2/ILT4/CSF1R trispecific antibody, is in Phase I development. AK154, a personalized mRNA cancer vaccine that leverages AI-powered selection of high-affinity immunogenic mutations to create precision oncology therapies. A Phase I study of AK154 as monotherapy or in combination with cadonilimab or ivonescimab as adjuvant therapy in pancreatic cancer is currently ongoing. 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, Akeso has built a comprehensive R&D innovation ecosystem anchored by its proprietary Tetrabody antibody technology platform, AI-powered drug R&D platform, Dual-Shield ADC technology platform, Dual-Lock T-cell engager (TCE) technology platform, Tissue-Smart siRNA/mRNA technology platform, and cell therapy technology platforms. Backed by world-class GMP manufacturing facilities and a highly efficient, integrated commercialization system, Akeso has developed into a globally competitive biopharmaceutical enterprise. Leveraging its fully integrated, multi-functional platform, the company maintains a robust pipeline of more than 50 innovative assets targeting cancer, autoimmune diseases, inflammation, metabolic disorders, and other major therapeutic areas. Of these, nearly 30 candidates have advanced into clinical trials, including 15 bispecific or multispecific antibodies and bispecific ADCs. Eight innovative drugs are commercially available, and two additional drugs with three indications are currently under regulatory review for marketing approval. Akeso is committed to becoming a global leader in biopharmaceuticals through efficient and breakthrough innovation in R&D, developing novel therapies that are first-in-class or best-in-class, and providing better disease solutions for patients around the world. Forward-Looking Statements 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 the 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. SOURCE Akeso, Inc. 21% more press release views with Request a Demo