China’s CStone ramps up yet another PD-1 clinical trial for solid tumors; Takeda faces profit decline on loss of Velcade exclusivity

→ Just how many PD-1/L1s does the world need to treat cancer? 

With Regeneron and Sanofi within quick reach of their PDUFA date for number 6, and several under regulatory review in China, we may find that out fairly quickly. But as we’ve seen from research at Cancer Research Institute, there are some 164 projects around the world. And a high profile China startup called CStone just launched another clinical program for their PD-1.

Just days after announcing a $260 million venture round backed by some marquee investors like Arch and GIC, CStone says it has begun its Phase I study of CS1003 in solid tumors in Australia. The Suzhou-based startup has also executed on a slate of preclinical combination projects as they prep a bevy of combos for the clinic as well. The trial launch comes weeks after it began another early stage study for a CTLA-4 checkpoint in Australia, which also aims to build on the drugs now on the market or in development.

This study raises new questions about whether an influx of PD-1/L1 drugs will spur the commoditization of the field, where Merck and Bristol-Myers have been earning billions for their leading checkpoint therapies.

Takeda beat expectations in its latest quarterly report, but projected a decline in operating profits for the year ahead as Velcade faces an expected loss in exclusivity in the key US market.

AbPro became the latest startup to postpone plans for an IPO. The Woburn, MA-based biotech is developing antibody drugs for cancer and vascular eye disease and had planned to raise about $69 million in the offering. Several biotechs have now had to delay or drop IPOs, a sign of weakness that could also affect others after a strong run of offerings over the past 9 months.

→ Recent trouble on Nasdaq isn’t stopping Scholar Rock’s IPO plans. The biotech $SRRK has posted its terms, looking to raise about $75 million through the sale of 5.4 million shares at $13 to $15 each.

→ Another biotech looking for an IPO liftoff this week is Kiniksa Pharmaceuticals, which plans to raise $126 million through the sale of 7 million shares at $17 to $19 each.

→ After tackling a number of oncology programs at Astellas Pharma, Pfizer and Eli Lilly, Stephen Eck will now zero in on T cell therapies as CMO of Immatics. The biotech is based in Houston, with substantial ties to the MD Anderson Cancer Center — a collaborator Eck has gotten to know while coordinating clinical trials for Astellas. Eck is tasked with steering the preclinical-heavy pipeline toward clinical development.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
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Catalytic Data Science Charleston, SC
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Flatiron Health New York City or San Francisco

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