China-based Biotech Laekna Acquires Global Rights to Develop and Commercialize anti-PD-L1 Antibody

Laekna Therapeutics, a China-based biotechnology company founded in 2016 has signed a new, exclusive, agreement with Novartis. Under the terms of the agreement, Laekna will receive exclusive global rights to FAZ053, an investigational anti-PD-L1 antibody being developed by Novartis for the treatment of patients with advanced forms of cancer.

The drug is a monoclonal antibody directed against a protein called programmed cell death-1 ligand 1 , also referred to as PD-L1. As a type of immunotherapy, this investigational drug activates the body’s own immune system to fight and kill cancer cells.

PD-L1 is a protein produced by healthy cells. It binds to the PD-1 receptor found on the surface of T-cells, a lymphocyte of a type produced or processed by the thymus gland and actively participating in the immune response, to suppress them. This process is known as an immune checkpoint and is a mechanism designed to ensures immune cells do not mistakenly attack healthy cells

However, some forms of cancer may also produce PD-L1, and, as a result, are able to evade being recognized by the immune system.

FAZ053 binds to PD-L1 on tumor cells, preventing it from binding to the PD-1 receptor on T-cells. By inhibiting this interaction, in which FAZ053 enhances the activation of T-cell-mediated anti-tumor response and renders cancer cells less able to evade that response, the investigational agent acts as an immune checkpoint inhibitor. This is expected to result in a reduction in tumor growth and size.

Clinical trials

FAZ053 is being evaluated in Phase I clinical trial (NCT02936102) to assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and antitumor activity of the investigational agent as a single agent and in combination with PDR001, another investigational immunotherapy being developed for the treatment of adult patients with advanced cancers.

The open-label, multi-center clinical study, with more than 300 patients, included a dose-escalation part of FAZ053 as a single agent and in combination with PDR001, which is followed by a dose expansion part of FAZ053 as a single agent and in combination with PDR001. In this trial, FAZ053 was dosed every three weeks and a regime dose of every six weeks also may be evaluated at the same time. Participating patients were able to continue the treatment with FAZ053 as a single agent or in combination with PDR001 until they experience unacceptable toxicity events and/or their disease progresses.

In patients with advanced cancer, the trial demonstrated positive proof-of-concept results for a tolerable safety profile and clinical efficacy of FAZ053 in diverse solid tumors.

With the exclusive rights to develop and commercialize FAZ053, Laekna Therapeutics aims to introduce pioneering new drugs to patients, including the rapidly growing cancer patient population, in China.

"A combination of PD-L1 Antibody with chemotherapy or targeted therapy can greatly improve treatment response and prolong survival," said Dr. Yong Yue, Chief Medical Officer of Laekna.

"We have mapped a number of combination strategies to treat a variety of cancers that do not respond or are resistant to checkpoint inhibitor treatments," Yue added.

Laekna plans to start trials on combination therapies as soon as possible in order to address the unmet needs of people with cancer and bring innovative, effective treatments to more cancer patients across China.

This is agreement is the third in a recent series of agreements between Laekna and Novartis. Laekna also obtained global rights for the small-molecule tumor treatment candidate LAE001, and two oral AKT pan inhibitors Afuresertib (LAE002) and Uprosertib (LAE003).

"Novartis is a global leader in oncology drug innovation and we believe that the three oncology assets we have acquired from Novartis have great synergistic anti-cancer effects," said Dr. Chris Lu, founder and Chief Executive Officer of Laekna.

"This synergy will allow us to apply various combinations to treat many cancer indications, including triple-negative breast cancer and prostate cancer," Lu concluded.

As part of this agreement, Novartis will receive an upfront payment, with additional payments at key development milestones as well as royalties on future sales.

In April 2019, Laekna also finished a B round financing for 27.5M USD, led by GP Healthcare.

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