CD47

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. 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 , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. 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. 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

Gilead is withdrawing the accelerated approval for its blockbuster antibody-drug conjugate Trodelvy for bladder cancer after it failed to improve survival odds for patients in a Phase 3 study earlier this year. The company decided to voluntarily pull the drug’s accelerated label after consulting with the FDA, according to Friday’s announcement . Trodelvy’s bladder cancer indication makes up a small percentage of its overall sales since the drug is primarily used to treat breast cancer, but the withdrawal occurs amid mounting criticism of Gilead’s business decisions. Much of Wall Street’s concern centers around the company’s $21 billion buyout of Immunomedics in 2020 that brought it Trodelvy, a drug that generated $1.1 billion in sales last year and that Gilead has described as a “cornerstone” of its cancer portfolio. The FDA in 2021 granted accelerated approval to Trodelvy for patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-based chemotherapy and a checkpoint inhibitor. However, in May, Gilead disclosed that Trodelvy did not improve survival in bladder cancer patients compared to chemotherapy, and there were more deaths in the Trodelvy arm than the chemo control arm primarily due to infections from low white blood cell counts, a known serious side effect of the drug. Gilead said it plans to share detailed bladder cancer data at an upcoming medical meeting. Back in January, the company said Trodelvy also failed a pivotal study in non-small cell lung cancer, dealing a blow to its expansion plans for the antibody-drug conjugate. And earlier this year, Gilead recorded a $2.4 billion loss related to assets from the Immunomedics deal. The company has stumbled as it has tried to build out its cancer pipeline. It spent $4.9 billion in 2020 to buy Forty Seven for its experimental CD47-targeted cancer drug, but the company this year stopped work on the drug, called magrolimab, after it failed to improve survival odds in pivotal blood cancer studies and came with worrying safety risks. Gilead announced in July that its chief medical officer Merdad Parsey would be leaving in early 2025.

SAN DIEGO, CA, USA I October 8, 2024 I Phanes Therapeutics, Inc. (Phanes), a clinical stage biotech company focused on innovative drug discovery and development in oncology, announced today that the first patient has been dosed in the clinical study of PT886 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA ® (pembrolizumab). The dosing was conducted in a cohort of gastric and gastroesophageal junction cancers. As previously announced, Phanes is conducting this study under a clinical trial collaboration agreement with Merck (known as MSD outside the US and Canada). PT886 is a first-in-class native IgG-like bispecific antibody (bsAb) targeting claudin 18.2 and CD47. It was granted orphan drug designation (ODD) for the treatment of pancreatic cancer by the FDA in 2022 and Fast Track designation for the treatment of patients with metastatic claudin 18.2-positive pancreatic adenocarcinoma earlier this year. PT886 is currently being evaluated as monotherapy and in combination with pembrolizumab, or with chemotherapy, either alone or in combination with pembrolizumab. The multi-center Phase I/II clinical trial of PT886 (NCT05482893), known as the TWINPEAK study, is currently evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT886 in patients with locally advanced or metastatic gastric, gastroesophageal junction and pancreatic cancers. A Phase I clinical trial of PT886 is also ongoing in China (CTR20241655). KEYTRUDA ® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. ABOUT PHANES THERAPEUTICS Phanes Therapeutics, Inc. is a clinical stage biotech company focused on innovative drug discovery and development in oncology. Currently, it is conducting three Phase I clinical trials, including the MORNINGSTAR study with its best-in-class monoclonal antibody (mAb) program, PT199, the TWINPEAK study with PT886 and the SKYBRIDGE study with PT217. Both PT886 and PT217 are first-in-class bispecific antibodies and have been granted orphan drug designation as well as Fast Track designation by the FDA. The company has built a strong pipeline by leveraging its proprietary technology platforms: PACbody ® , SPECpair ® and ATACCbody ® to develop novel biologics that address high unmet medical needs in cancer. For more information about Phanes Therapeutics, please visit www.phanesthera.com For business development or media inquiries, please contact bd@phanestx.com or media@phanestx.com , respectively. SOURCE: Phanes Therapeutics