#China #Leads Biolabs #Nanjing #Clinical Trials #Opamtistomig

Leads Biolabs Achieves Milestone in Pivotal Trial of Opamtistomig

Nanjing Leads Biolabs Co., Ltd. has announced a significant milestone by completing patient enrollment for its pivotal trial of Opamtistomig (LBL-024), which is a novel bispecific antibody targeting PD-L1 and 4-1BB for treating extrapulmonary neuroendocrine carcinoma (EP-NEC). This trial marks the world's first registration-focused clinical evaluation of a monotherapy specifically designated for EP-NEC, filling a critical gap in cancer treatment.

The trial, overseen by noted cancer specialist Professor Shen Lin from Peking University Cancer Hospital, involves multiple medical centers aiming to assess the safety and efficacy of Opamtistomig in patients who have not responded to at least two lines of chemotherapy. EP-NEC is notorious for its aggressive nature and is categorized as an immunologically 'cold' tumor, presenting considerable treatment challenges.

Currently, the primary treatment for advanced EP-NEC is typically platinum-based chemotherapy, which only yields an objective response rate ranging from 30% to 50% with a median overall survival of about one year. Given the absence of a second-line standard treatment for platinum-resistant patients, this trial's commencement is of paramount importance to address the unmet clinical needs.

Dr. Charles Cai, the Chief Medical Officer of Leads Biolabs, stated that the completion of enrollment, which was achieved months ahead of schedule, underscores strong confidence in the trial's design and the urgent need for effective therapy options for patients. He emphasized, "Opamtistomig has shown promising antitumor activity and an acceptable safety profile in early trials, paving the way for what could become a transformative therapy for patients with EP-NEC."

Under the leadership of Dr. Xiaoqiang Kang, the Founder and CEO, Leads Biolabs has built a robust clinical pipeline aiming to innovate in areas where existing treatments fall short. Dr. Kang noted, "Every data point from our trials signifies hope for patients facing serious health challenges. We are resolute in our mission to revolutionize the treatment landscape for this disease through staunch commitment to research and development."

Understanding Opamtistomig

Opamtistomig stands out as a potential first-in-class bispecific antibody engineered to simultaneously inhibit PD-L1 and activate the 4-1BB co-stimulatory pathway. This dual-targeting approach presents a promising avenue to reactivate T cells that have become exhausted due to prior treatments, thereby enhancing anti-tumor efficacy, particularly in cases of PD-1/PD-L1-resistant tumors.

In preclinical and phase I/II clinical trials within China, Opamtistomig demonstrated commendable efficacy and safety, both as a monotherapy and in synergy with chemotherapy. Its potential in EP-NEC is now being critically evaluated in the pivotal single-arm registrational study, offering a glimpse of hope for patients with no established standard therapies.

Recently, Opamtistomig won the Breakthrough Therapy Designation by the National Medical Products Administration (NMPA) in China in October 2024, along with Orphan Drug Designation from the U.S. FDA in November 2024 for neuroendocrine carcinoma, a testament to its clinical promise.

Additionally, the therapeutic use of Opamtistomig extends beyond EP-NEC, as it is now approved for clinical examination in various malignancies with significant unmet medical needs, including small cell lung cancer, biliary tract cancer, and several others. Early encouraging results observed in these diseases strengthen Opamtistomig’s positioning as a versatile oncology treatment.

The Challenge of EP-NEC

Neuroendocrine carcinoma encompasses a range of high-grade malignancies that arise from neuroendocrine cells and can manifest across various anatomical sites. The classification includes both pulmonary and extrapulmonary types, with EP-NEC exhibiting aggressive and metastatic behavior akin to small cell lung carcinoma. Unfortunately, patients often present with advanced disease, leading to grim prognoses.

With the prevailing chemotherapy regimens yielding limited results in advanced EP-NEC, the urgent demand for innovative treatment strategies cannot be understated. Leads Biolabs is at the forefront of this critical endeavor, fully committed to providing effective solutions for this debilitating disease.

About Leads Biolabs

Established in 2012, Leads Biolabs is committed to discovering and developing groundbreaking therapies for cancer and other pressing health issues. The company boasts a diverse pipeline of innovative drug candidates and has developed several proprietary technologies to make headway in immuno-oncology. Their comprehensive approach encompasses all stages of drug development, from discovery and clinical trials to commercial viability, showcasing their dedication to advancing healthcare globally. For further details about their pioneering work, visit Leads Biolabs.