Laekna Inc., a Shanghai-based company that recently completed an $18.5 million series A financing led by Orbimed Asia, has licensed rights to develop and commercialize two cancer-focused oral Akt kinase inhibitors from Novartis AG. The deal gives the Swiss drugmaker an equity stake in the Chinese company as well as undisclosed up-front and development milestone payments, plus potential royalties on future sales. Laekna, which has indicated plans to seek regulatory approvals in China and beyond, said that it has "mapped out several clear registration paths for NDA approval" for the drugs.

Both assets arrived in Novartis' portfolio by way of a complex acquisition of Glaxosmithkline plc oncology assets initiated in 2014. One, uprosertib, has been tested in ovarian and gastric cancers, multiple myeloma (MM), melanoma and other indications. The other, afuresertib, was tested in ovarian cancer and MM before Novartis discontinued development efforts. Laekna struck its first deal with Novartis in 2017, acquiring global rights to develop the CYP17 inhibitor CFG-920, to treat prostate cancer.

In a statement explaining the latest deal, Laekna said the Pten/PI3K/Akt signaling axis "is one of the most critical oncogenic pathways driving cancer growth" and that "inhibiting it has been proven to be effective for many cancer patients."

Indeed, awareness of the pathway's importance has grown for more than a decade, at least since the publication of a highly cited review in the May 2008 edition of Current Cancer Drug Targets. In that publication, Spanish National Cancer Centre researchers identified it as "regulating the signaling of multiple biological processes such as apoptosis, metabolism, cell proliferation and cell growth."

Early clinical results for afuresertib and uprosertib have been "extremely promising," Laekna said. According to Cortellis Clinical Trials Intelligence, for uprosertib, those trials have included two phase II studies in combination with trametinib, one in patients with metastatic triple-negative breast cancer and another in patients with acute myeloid leukemia. Phase II trials of afuresertib have included tests in blood cancers and solid tumors, as well as the treatment of relapsed and refractory chronic lymphocytic leukemia. In January 2017, Novartis said development of the drug in solid and hematological tumors had been discontinued. It did not disclose a reason for the move.

Novartis likely picked up both assets from GSK in 2014 during a complicated three-way deal it fashioned that year. The agreement announced at the time obliged Novartis to pay $16 billion for GSK's marketed oncology portfolio while GSK acquired Novartis' vaccines arm for $5.25 billion. In a separate transaction, Novartis divested its animal health business to Eli Lilly and Co. for $5.4 billion. (See BioWorld Today, April 23, 2014.)

Laekna previously acquired the global rights from Novartis to develop, manufacture and commercialize the small-molecule candidate LAE-001 (previously known as CFG-920) for prostate cancer. It announced that deal in January, ahead of its June series A round.

The company, founded as Laekna Therapeutics in December 2016, has applied for investigational new drug applications to initiate multiple trials in China, it said in June. At the time, it also revealed having multiple drug discovery programs, targeting cancers and liver diseases, including nonalcoholic steatohepatitis and hepatic cirrhosis, though details on the latter programs are scarce.

Laekna was founded by its CEO, Chris Lu, a former Novartis executive who worked in that company's R&D center in both Cambridge, Mass., and Shanghai. Other members of its leadership team include Vice President of Operations Amy Xie, who has worked at both Novartis and Boehringer Ingelheim International GmbH, as well as several other former Novartis and GSK staffers. In addition to Orbimed, the company also has support from Anlongmed, a venture capital fund anchored by the Chinese Academy of Sciences.

Laekna did not return a request for further information on Wednesday. Novartis spokesman Eric Althoff said the company is constantly evaluating its pipeline, both in terms of acquiring new potential medicines and giving those that do not fit with its strategy the best chance of being developed elsewhere.

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