Delhi, April 27, 2023 (GLOBE NEWSWIRE) -- Tifcemalimab also known as TAB004 and JS004 is the world’s first in human recombinant humanized anti- BTLA (B and T lymphocyte attenuator) monoclonal antibody against cancers. It is independently developed by shanghai junshi biosciences and so far, Tifcemalimab has entered phase Ib / II clinical studies and several trials of Tifcemalimab in combination with the company’s other successful products like Toripalimab for patients with different types of tumors are currently ongoing in China and the US, so as to generate a synergistic anti-tumor effect.
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The company believes that the combination of Toripalimab (TUOYI) with Tifcemalimab is a promising anti-tumor treatment strategy, which is expected to increase patients’ response to immunotherapy and expand the range of potential beneficiaries. Until now, there is no other disclosed anti-tumor product with the same target that has entered the clinical trial stage in China or in any other country. This gives Tifcemalimab and Junshi BioSciences an added advantage of securing themselves a significant market space in cancer immunotherapy treatment landscape.
Currently, Tifcemalimab is under the dose expansion stage in the phase Ib / II clinical study. In 2022, this monoclonal antibody presented its early stage clinical results for the treatment of lymphoma and solid tumors. As a first in class drug, the initial data release of Tifcemalimab was an important milestone event for BTLA targeted drugs in the field of cancer treatment. In a single arm, open label, multi centre, dose escalation phase I study, the safety and efficacy of Tifcemalimab monotherapy or Tifcemalimab in combination with Toripalimab for the treatment of patients with relapsed or refractory (R / R) lymphoma was evaluated in humans for the first time.
The research enrolled a total of 31 R /R patients who have previously received multiple lines of therapy. Results of the clinical trial demonstrated, among the 25 patients that were evaluated for monotherapy, the partial response (PR) was observed in one patient and stable disease (SD) was observed in seven patients. While, patients evaluated in combination therapy, three of them showed overall response rate of 50% and one patient showed stable disease.
The results indicated that Tifcemalimab monotherapy or Tifcemalimab in combination with Toripalimab for the treatment of patients with relapsed / refractory lymphoma showed good tolerability and demonstrated initial clinical efficacy. Positive preliminary data collected is credible to conduct further clinical development studies. Furthermore, research in relation to dose expansion phase under the combination therapy is currently underway, and a similar pattern of positive results is expected by the company as well as researchers.
Currently, PD-1 inhibitors are widely used in the treatment of lymphoma, particularly relapsed or refractory classical Hodgkin’s lymphoma. However, if PD-1 inhibitors fail, there is no standard treatment, therefore, creating a significant need for new treatment methods. Through extensive research conducted by Junshi Biosciences, patients who have not benefited from PD-1 inhibitors can benefit from the combination of Tifcemalimab and Toripalimab. As the world’s first in human anti-BTLA monoclonal antibody, Tifcemalimab has obtained Investigational New Drug (IND) approvals from the US FDA as well as China’s National Medical Products Administration (NMPA), indicating the clinical importance and significance of this drug. The updated preliminary data of Tifcemalimab in combination with Toripalimab phase I study in relapsed or refractory lymphoma patients, the objective response rate (ORR) was 39.3% and the disease control rate (DCR) was of 85.7%.
