Ligufalimab

Over 120 Pipeline Therapies Target Acute Myeloid Leukemia as Research Intensifies

3 months ago

• DelveInsight's latest report reveals a robust pipeline with 110+ companies developing 120+ therapies for acute myeloid leukemia (AML), showing significant investment in this aggressive blood cancer. • Several promising candidates are advancing through clinical trials, including GlycoMimetics' uproleselan in Phase III, BioSight's aspacytarabine (BST-236) in Phase II, and novel approaches like Senti Biosciences' logic-gated CAR-NK cell therapy. • Recent developments include Moleculin Biotech's Phase III MIRACLE trial for annamycin, Qurient's adrixetinib IND approval, and Rigel Pharmaceuticals' trial of REZLIDHIA in combination therapy for IDH1-mutated AML.

EPCORE NHL-2 Trial Shows Promise Combining Chemotherapy and Immunotherapy for DLBCL

3 months ago

• A phase Ib/II clinical trial led by Mount Sinai researchers demonstrates successful outcomes in combining chemotherapy with immunotherapy for diffuse large B-cell lymphoma treatment. • The groundbreaking research, published in Blood journal, was conducted under the leadership of Dr. Joshua Brody, director of the Lymphoma Immunotherapy Program at the Tisch Cancer Institute. • The study represents a significant advancement in lymphoma treatment, supported by the Leukemia & Lymphoma Society's research initiatives, which have invested over $600 million in hematologic oncology research.

Akeso Completes Patient Enrollment in Phase III Trial Comparing Ivonescimab for First-Line Squamous NSCLC Treatment

4 months ago

• Akeso has completed enrollment for the HARMONi-6 Phase III trial comparing ivonescimab plus chemotherapy to tislelizumab plus chemotherapy for first-line squamous non-small cell lung cancer treatment. • Ivonescimab, a novel PD-1/VEGF bispecific antibody, is currently being evaluated in six Phase III lung cancer trials globally, with potential applications across multiple cancer types. • The drug addresses a significant unmet need among 520,000 annual cases of advanced sq-NSCLC patients, offering a promising alternative for those ineligible for current anti-angiogenesis treatments.

Akeso's Phase 3 Trial Begins for Ivonescimab and Ligufalimab Combination in Head and Neck Cancer

7 months ago

• Akeso initiates a Phase 3 trial (AK117-302) evaluating ivonescimab plus ligufalimab versus pembrolizumab for first-line treatment of PD-L1 positive recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). • This study marks the first global Phase 3 investigation of a CD47 monoclonal antibody therapy (ligufalimab) in solid tumors, highlighting Akeso's commitment to innovative cancer immunotherapy. • Preliminary data from the combination therapy of ivonescimab and ligufalimab presented at ESMO 2024 showed significant tumor reduction and survival benefits in HNSCC patients. • The trial aims to address the critical unmet need for more effective therapies in HNSCC, where the five-year survival rate for recurrent/metastatic cases is only 3.6%.

Akeso Initiates Phase 3 Trial of Ivonescimab Plus Ligufalimab in Head and Neck Cancer

7 months ago

• Akeso has enrolled the first patient in a Phase 3 trial (AK117-302) evaluating ivonescimab combined with ligufalimab for head and neck squamous cell carcinoma (HNSCC). • The study compares the combination therapy to pembrolizumab as a first-line treatment for PD-L1 positive recurrent/metastatic HNSCC. • Ivonescimab is a PD-1/VEGF bispecific antibody, and ligufalimab (AK117) is a next-generation CD47 monoclonal antibody. • Preliminary data from the combination therapy presented at ESMO 2024 showed significant tumor reduction and survival benefits, surpassing previous PD-1 studies.

Summit Therapeutics' Ivonescimab Shows Promise in NSCLC Trials

7 months ago

• Ivonescimab monotherapy demonstrated a 49% reduction in disease progression or death compared to pembrolizumab in PD-L1 positive advanced NSCLC patients in the HARMONi-2 trial. • Enrollment is complete in the global Phase III HARMONi trial for 2L+ EGFRm advanced NSCLC, with topline data expected in mid-2025, and Fast Track Designation from the FDA. • Summit plans to expand the HARMONi-3 global Phase III trial in 1L metastatic NSCLC to include non-squamous histology patients, updating primary endpoints to PFS and OS. • A new global Phase III HARMONi-7 trial is set to begin in early 2025, evaluating ivonescimab monotherapy in 1L PD-L1 high, metastatic NSCLC patients.

Cadonilimab Plus Chemotherapy Shows Survival Benefit in Advanced Gastric Cancer

8 months ago

• Phase III trial data published in *Nature Medicine* highlights the benefits of cadonilimab combined with chemotherapy for advanced gastric cancer. • The study showed significant improvement in overall survival, regardless of PD-L1 expression levels in patients. • Cadonilimab, a PD-1/CTLA-4 bispecific antibody, addresses limitations of PD-1 inhibitors in PD-L1 low-expressing gastric cancer. • Approved in September 2024, cadonilimab is now used in clinical practice, offering a new immunotherapy option.

Ivonescimab Shows Promise in Combination Therapies for CRC, TNBC, and HNSCC

8 months ago

• Ivonescimab, a bispecific antibody, demonstrates encouraging anti-tumor activity and a manageable safety profile in Phase II trials for metastatic colorectal cancer (CRC). • In advanced triple-negative breast cancer (TNBC), ivonescimab combined with chemotherapy achieved a 72.4% overall response rate and 100% disease control rate in first-line treatment. • Ivonescimab, with or without ligufalimab, shows clinical benefit in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), with overall response rates of 30% and 60%, respectively. • Summit Therapeutics plans to expand clinical development of ivonescimab in solid tumors beyond non-small cell lung cancer, based on positive Phase II data.

Akeso's Bispecific Antibodies Show Promise in Lung and Colorectal Cancers

8 months ago

• Akeso's ivonescimab, a PD-1/VEGF bispecific antibody, gains approval in China for EGFR-mutated NSCLC and shows significant benefits in PD-L1 positive NSCLC compared to pembrolizumab. • Ligufalimab, a CD47 monoclonal antibody, enters Phase III trials for head and neck squamous cell carcinoma, marking the first CD47 mAb in Phase III for solid tumors. • Ivonescimab, combined with FOLFOXIRI, demonstrates high anti-tumor activity in first-line treatment of MSS/pMMR metastatic colorectal cancer, with a 88.2% objective response rate. • Akeso is advancing a diverse pipeline of innovative therapies, including bispecific antibodies and ADCs, with multiple Phase III trials underway across various cancer types.

Summit Therapeutics Completes Enrollment in Phase III HARMONi Trial and Receives FDA Fast Track Designation for Ivonescimab

8 months ago

• Summit Therapeutics has completed enrollment in the Phase III HARMONi trial evaluating ivonescimab plus chemotherapy for EGFR-mutated NSCLC after TKI failure. • The FDA granted Fast Track designation to ivonescimab in combination with platinum-based chemotherapy for EGFR-mutated NSCLC post EGFR-TKI therapy. • HARMONi is a multi-regional trial conducted in North America, Europe, and China, with topline data expected in mid-2025. • Ivonescimab, a bispecific antibody targeting PD-1 and VEGF, has shown promise in clinical trials, including HARMONi-2 where it outperformed pembrolizumab.

Akeso Highlights Bispecific Antibody Data at ESMO 2024, Demonstrating Promising Results in Multiple Cancers

9 months ago

• Akeso will present data from 13 clinical studies at ESMO 2024, featuring cadonilimab, ivonescimab, and ligufalimab across various advanced cancers. • Ivonescimab, alone or with ligufalimab, shows significant ORR, DCR, and PFS in MSS-type mCRC, surpassing current standards, particularly as a first-line treatment. • In first-line TNBC, ivonescimab combined with chemotherapy demonstrates robust ORR, DCR, and meaningfully significant PFS, even in PD-L1 negative patients. • Anlotinib plus penpulimab shows promise as a first-line therapy for advanced hepatocellular carcinoma compared to sorafenib, to be presented as a late-breaking abstract.

Ivonescimab and IBI363 Show Promise in Advanced Solid Tumors at ESMO 2024

9 months ago

• Ivonescimab demonstrates encouraging Phase II data in advanced triple-negative breast cancer, recurrent/metastatic head and neck squamous cell carcinoma, and metastatic microsatellite-stable colorectal cancer. • IBI363, a first-in-class PD-1/IL-2α-bias bispecific antibody fusion protein combined with bevacizumab, shows promising anti-tumor activity in advanced colorectal cancer. • Updated Phase 3 MARIPOSA study results reveal significant overall survival improvement with amivantamab plus lazertinib over osimertinib in EGFR-mutant advanced NSCLC. • Sacituzumab govitecan and ifinatamab deruxtecan demonstrate activity in extensive-stage small cell lung cancer, offering potential new treatment options.

Drug Development Updates