Favorable conditions in China encouraged biotech veterans Jerry Wang, Bing Yan and Lihua Zheng to co-found Anheart Therapeutics Co. Ltd. in November 2018 to focus on oncology. On Monday, the Chinese startup in-licensed a mIDH-1 inhibitor and an AXL inhibitor from Daiichi Sankyo Co. Ltd. to expand its pipeline, less than two years after it obtained the global rights of its first asset, AB-106 (taletrectinib), from the Japanese firm to establish its footing.
“Daiichi Sankyo conducted in-depth due diligence on us and we eventually won their trust in our capability to advance their compounds globally,” Anheart CEO Jerry Wang told BioWorld in an exclusive interview. This is the second deal between the two companies in two years.
Under the new licensing deal, Anheart will obtain the ex-Japan rights of AB-218, a highly selective mutant IDH-1 inhibitor, as well as the global rights to AB-329, a highly selective AXL inhibitor, both for all indications. Financial terms were not disclosed.
AB-218 has a high permeability of the blood-brain barrier and has demonstrated safety and efficacy signals in a phase I trial in glioma patients. Anheart plans to develop the compound for glioma and potentially other indications such as acute myeloid leukemia and cholangiocarcinoma.
Meanwhile, AB-329 has the potential to be used in combination with checkpoint inhibitors or third-generation EGFR inhibitors in non-small-cell lung cancer (NSCLC), other solid tumors and hematological malignancies.
Anheart started first with AB-106, a ROS1/NTRK inhibitor originating from Daiichi Sankyo in 2018. Now the leading program of the company, AB-106 won IND clearance to enter phase II trials in NSCLC with ROS1 fusion in China. In July, Anheart licensed out the rights to develop and commercialize the compound in South Korea to Bucheon-based Newg Lab Co. Ltd.
“By mid-2021, we will have early readouts for AB-106 in 30 to 40 NSCLC patients with ROS1 fusion in our phase II trial. Hopefully by late 2021 or early 2022, we will have the interim data so we can submit an NDA by the end of 2022,” Wang said.
Anheart’s chief medical officer, Bing Yan, told BioWorld that the company is looking to develop the three drug candidates globally. “Our goal is to establish ourselves as a global biotech company with capabilities of developing a drug globally,” he said.
Anheart plans to start a phase II trial in China of AB-106 in locally advanced or metastatic solid tumors with NTRK fusions. It is also preparing for global phase II trials in NSCLC with ROS1 fusions and solid tumors with NTRK fusions in Japan, Korea, the U.S. and the EU. As for AB-218 and AB-329, Yan said the team is currently formulating a final global development plan.
Right from the start, Anheart has looked beyond its home market. It is headquartered in Hangzhou and has offices in Beijing, Shanghai and New York to assist operations in both China and the U.S. Both Wang and Yan previously served at multinational pharmaceutical companies such as Bristol Myers Squibb Co., Merck & Co. Inc. and Pfizer Inc., so they have first-hand experience in pushing for global drug development. Zheng, the firm’s chief business officer, was a life sciences attorney in the U.S., with experience in aiding venture capital funds to navigate the U.S. biotech environment. That experience bolsters the company’s ability to participate in cross-border transactions.
“Most of the time the challenge is just the networks,” Wang said. “Many U.S. biotech startups do not have the right networks in China or other regions. But we have them in China, the U.S. and even Japan, so we have adequate resources to carry out global development.”
Speaking about how to maximize the clinical value of their assets, Wang said he believes speed is the company’s biggest strength. After in-licensing AB-106 from Daiichi Sankyo in December 2018, Anheart finished the transfer of manufacturing process and got the capsules ready for trials in six months, when the process normally takes up to 18 months.
The five Rs
For now, Anheart is focused on bringing in promising assets from partners to build its pipeline. It prefers to obtain the global rights instead of just the China rights, Zheng, told BioWorld.
“We’re interested in oncology assets, preferably those in clinical stage because it is our sweet spot. We also look at preclinical-stage assets with innovative targets that have first-in-class potential,” he said.
Zheng further explained that the team adheres to the “five Rs” principle when deciding what to bring in – the right target, right molecule, right regulatory pathway, right patients and right economics.
“If the biological mechanism is not clear, there will be an inherent risk. And if the molecule is difficult to manufacture, the cost of goods may be too high,” he said. “We also prefer a clear and straightforward regulatory pathway that preferably leads to a fast-track drug approval. We need the right patients to address real unmet medical needs. Whenever we in-license an asset from other companies, the financial terms must make sense and we also look at the potential market share and pricing to estimate the net present values.”
From those principles, Anheart’s management is able to identify the right asset and leverage the right regulatory environment and patient resources that China offers. China’s regulatory reform in 2015 was one of the catalysts that encouraged the three executives to co-found Anheart.
The three-year plan
The deals with Daiichi Sankyo have boosted investors’ confidence in Anheart. The startup raised $15 million in a series A round in November 2018, then another $20 million in a series A+ round last month to acquire AB-218 and AB-329, as well as supporting the global development of AB-106.
“We will initiate the next round of financing in late September to support the global development of our three compounds,” Wang told BioWorld. As more data on AB-106 will be available later, the company has plans to start more financing rounds and also go the IPO route within two years.
Anheart aims to build up internal innovation as well as commercialization capabilities in the next three years. In addition, the company intends to expand its presence in the U.S. The current strained U.S.-China relations and their potential impact on China’s biotech innovation so far do not overly worry the co-founders.
“If we consider China’s biotech innovation’s connection to U.S. technology, there might be some impacts. But the pursuit of good medicine and wellness is shared across the borders,” said Zheng.
Yan added: “I still believe no matter how the political situation unfolds, science will still proceed. We will still advance science as needed.”