A Novartis castoff with a troubled past headlines Chinese biotech's Hong Kong IPO quest
Taking on a failed drug from one of biopharma’s biggest players and spinning it into a winner is never an easy task. But in the go-go world of Chinese oncology, any risk is a risk worth taking — and one biotech’s gamble could soon pay off.
Adlai Nortye, a Hangzhou, China-based biotech with operations in North Brunswick, NJ, has applied to trade on the Hong Kong Exchange just days after scoring a fundraising round to pursue its license-heavy business model, according to a Tuesday filing.
Last week, the biotech scored a $100 million D series to advance its clinical pipeline, including lead PI3K inhibitor buparlisib (AN2025), a former Novartis drug that Adlai Nortye exclusively licensed after the Swiss drugmaker kicked it to the curb back in mid-2018.
Now, Adlai will look to score a big public offering on the HKEX, which has been particularly kind to oncology startups in recent months, with upstarts like Zai Lab and Hutchmed earning major raises and sky-high valuations.
Buparlisib is the lead drug on the company’s docket, with Adlai Nortye kicking off a global Phase III registrational study in squamous cell carcinoma of the head and neck (HNSCC) in April that will look to enroll around 490 patients in 150 trial sites. The move into HNSCC could prove fruitful after buparlisib notoriously flopped its late-stage test in lung cancer, leaving Novartis few options but to offload development.
In its filing, Adlai Nortye touted the drug’s early- and mid-stage data and its market potential in metastatic or refractory patients who fail or don’t respond to PD-(L)1 therapy, which is quickly becoming standard of care in advanced HNSCC patients. There are five PI3Ks currently approved around the globe, Adlai said, but none on the market for HNSCC.
An eventual approval for buparlisib could kickstart what Adlai views as its drug cocktail-focused R&D strategy. The biotech has three other molecules in its clinical pipeline, including a novel EP4 in-licensed from Eisai and an HER2-, HR+ oncolytic virus from Oncolytics Biotech. Meanwhile, the company is also developing an in-house, small molecule anti-PD-L1 dubbed AN4005 that recently earned an IND in solid tumors.
The eventual strategy is to create multi-drug cocktails mixed between those candidates and the seven preclinical drugs swimming around Adlai’s pipeline, the biotech said — with a cocktail defined as an anti-PD-(L)1 added to one or more other cancer therapies.
The biotech’s 68-member team is led by US affiliate CEO Lars Birgerson, a Big Pharma veteran and clinical program specialist who has made the rounds at Bristol Myers Squibb, Pfizer and others, and Nanhei He, the biotech’s global head of drug discovery, who was a postdoc at the Salk Institute before he helped kickstart the company in 2016. The biotech’s largest shareholder with 51% of voting rights is Yang “Carsten” Lu, the company’s founding CEO and board chairman.
Adlai Nortye is hitting the HKEX at an auspicious time for oncology R&D in China, which has seen booming international interest and both direct and indirect participation from Western pharma.
Earlier this week, another Chinese startup, Beijing Mabworks Biotech, applied for its own listing on the exchange with a lead “third-generation” CD20 antibody looking to challenge a market dominated by Roche’s Rituxan and its biosimilars. Both biotechs fit the mold of the current state of Chinese oncology work, which has focused on driving key “me-too” drugs into global markets with novel molecules following further down the pipeline.