Laekna Therapeutics and Innovent Biologics received IND approval for combined treatment of patients with specific types of solid tumors that have failed PD-1/PD-L1 inhibitor therapy – QNT Press Release

China Shanghai and Warren, New Jersey, January 9, 2022 /PRNewswire/–Today, Laekna Therapeutics announced that an investigational new drug (IND) combination therapy in the phase 1/2 clinical trial of PD-1/PD-L1 for the treatment of patients with refractory solid tumors has won the country Approval by the Center for Drug Evaluation (CDE) of the Drug Administration (NMPA) China. Laekna Therapeutics is an emerging innovative biopharmaceutical company focused on the development of breakthrough innovative therapies for the treatment of cancer and liver diseases. The approval of IND marks an important milestone for Laekna and Innovent in the clinical research partnership July 2021.

The upcoming Phase 1/2 dose escalation study will evaluate the efficacy and safety of afuresertib (LAE002), sintilizumab, and chemotherapy in combination with PD-1/PD-L1 inhibitors in patients with specific types of solid tumors. The lead researcher of the study is a professor Shen Lin, Deputy Dean and Director of the Department of Gastroenterology, Peking University Hospital Cancer Institute. Combination therapies include Laekna Therapeutics’ pan-AKT kinase inhibitor afresertib, Innovent’s sintilimab, and albumin-conjugated paclitaxel or docetaxel.

The first phase of the study aims to evaluate the safety of the three-drug combination and determine the recommended phase two dose (RP2D). This phase 2 study aims to evaluate the clinical efficacy and safety of combination therapy in patients with PD-1/PD-L1 inhibitors (monotherapy or in combination with other oncology drugs) that are ineffective and have one disease. The following five types of tumors:

  • Non-small cell lung cancer (NSCLC)
  • Gastric Cancer/Gastroesophageal Junction Cancer (GC/GEJC)
  • Esophageal cancer (EsC)
  • Cervical cancer (CC)
  • Endometrial cancer (EC)

professor Shen Lin Explains, “As a serine/threonine kinase, AKT is a potential new target for cancer treatment. The results of multiple preclinical studies have shown that inhibiting AKT may restore the sensitivity of cancer cells to tumor treatment. Treatment resistance remains It is a common problem to further apply…clinical problems and challenges

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