Taking back a failed drug from one of biopharma’s biggest players and making it a winner is never an easy task. But in the go-go world of Chinese oncology, any risk is worth taking – and the biotech gamble may soon pay off.
Adlai Nortye, a Hangzhou, China-based biotech that operates in northern Brunswick, New Jersey, applied to trade on the Hong Kong Stock Exchange just days after winning a fundraiser to continue its licensing-based business model, according to a brief released Tuesday.
Biotech last week scored a $ 100 million Series D to advance its clinical pipeline, including the leading PI3K inhibitor, buparlisib (AN2025), an older drug from Novartis that Adlai Nortye exclusively licensed after that the Swiss drug manufacturer scrapped it in mid-2018.
Now Adlai will be looking to score a big public offering on HKEX, which has been especially kind to oncology startups in recent months, with upstarts like Zai Lab and Hutchmed earning big increases and sky-high valuations.
Buparlisib is the flagship drug on the company’s record, with Adlai Nortye launching a global Phase III registration study in squamous cell carcinoma of the head and neck (HNSCC) in April that will seek to enroll approximately 490 patients at 150 sites. test. Switching to HNSCC could prove successful after buparlisib noticeably fails its advanced stage lung cancer test, leaving Novartis with few options but to offload development.
In her brief, Adlai Nortye touted the drug’s early and mid-stage data and its market potential in metastatic or refractory patients who fail or do not respond to PD- (L) 1 therapy, which is quickly becoming the standard for Care in HNSCC Patients. There are five PI3Ks currently approved around the world, Adlai said, but none are on the market for HNSCC.
A possible approval of buparlisib could kick-start what Adlai sees as its R&D strategy focused on drug cocktails. Biotechnology has three other molecules in its clinical pipeline, including a new EP4 licensed from Eisai and an oncolytic virus HER2-, HR + from Oncolytics Biotech. Meanwhile, the company is also internally developing a small anti-PD-L1 molecule dubbed AN4005 which recently achieved IND in solid tumors.
The final strategy is to create multi-drug cocktails mixed between these candidates and the seven preclinical drugs swimming around the Adlai pipeline, the biotech said – with a cocktail defined as an anti-PD- (L) 1 added to a or several other cancer therapies. .
The 68-member biotech team is led by U.S. subsidiary CEO Lars Birgerson, a Big Pharma veteran and clinical program specialist who has toured Bristol Myers Squibb, Pfizer and others, and Nanhei He , the global head of biotechnology drug discovery, who was a post-doctoral fellow at the Salk Institute before helping launch the company in 2016. The largest shareholder in biotechnology with 51% of the voting rights is Yang “Carsten” Lu, founding CEO and chairman of the board of directors of the company.
Adlai Nortye comes to HKEX at an opportune time for oncology R&D in China, which has seen growing international interest and direct and indirect Western pharma participation.
Earlier this week, another Chinese startup, Beijing Mabworks Biotech, filed for its own stock exchange listing with a “third generation” CD20 antibody that seeks to challenge a market dominated by Roche’s Rituxan and its biosimilars. Both biotechnologies fit the mold of the current state of Chinese oncology work, which has focused on bringing key “me too” drugs to global markets with new molecules further down the pipeline.