Concert crushed on PhII schizophrenia flop; Amgen’s sotorasib gets BTD in China

Concert Pharmaceuticals stock tanked nearly 40% on Monday morning when a major Phase II flop left the biotech no choice but to ax its schizophrenia program.

The move leaves Concert with just one Phase III candidate for alopecia areata in the pipeline, which CEO Roger Tung says is now the focus of their efforts. Shares $CNCE hovered at around $6.90 on the news — a sharp drop from Friday’s close at $10.47.

The candidate, a deuterated form of the endogenous amino acid D-serine dubbed CTP-692, failed both the primary and secondary endpoints in a proof-of-concept study with 325 patients, Concert said. The participants, who were already on a stable course of antipsychotic medication, randomly received either 1, 2 or 4-gram doses of CTP-692 once daily. The primary endpoint was measured as change in the Positive and Negative Symptom Scale (PANSS) total score at 12 weeks compared to baseline. But unfortunately, no significant improvement over placebo was seen at any of the doses.

“Unfortunately, we didn’t see the results we hoped for to support continuation of this program,” Tung said in a statement. He laid out plans to shelf CTP-692, and instead focus on the company’s Phase III alopecia areata candidate, CTP-543.

While CTP-543 has seen some setbacks, the JAK inhibitor scored a win when it received breakthrough therapy designation back in July. The drug, which blocks JAK1 and JAK2, was placed on a brief clinical hold back in 2017 so the FDA could review “certain recently completed non-clinical toxicology studies.” Concert fixed the issue and completed a Phase IIa study in 2018. It’s now racing to beat Pfizer’s PF-06651600, which inhibits JAK3, and PF-06700841, which targets TYK2 and JAK1. — Nicole DeFeudis

Amgen’s sotorasib gets BTD in China after latest KRAS data

Only a day after presenting the latest round of data for its KRAS inhibitor sotorasib, Amgen has received a good sign from the Chinese government.

The investigational drug notched a breakthrough therapy designation from China’s NMPA for the treatment of KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer, Amgen announced Friday. The BTD is for patients who have received at least one prior systemic therapy.

Last week’s data came in advance of the scheduled release for the World Conference on Lung Cancer, courtesy of an embargo break on the PR for the data. According to Amgen, their one-year followup on the pivotal Phase II found a 37.1% overall response rate among 126 patients, with 3 complete responses and 43 partials. The median duration of response was 10 months.

Sotorasib had previously received a breakthrough designation from the FDA, and the Phase II data lined up right alongside the Phase I numbers. — Max Gelman

Gilead fronts $220M for Arcus in exchange for larger ownership stake

Gilead is increasing its ownership stake in Arcus Biosciences just a few weeks after its stock price hit a record high.

The cash infusion will total roughly $220 million, the companies said Monday. Gilead’s stake will increase to 19.5%, from approximately 13%, with the purchase of 5,650,000 additional Arcus shares at a price of $39 per share.

Some of the funding will go toward Arcus’ CD73 inhibitor for pancreatic cancer, for which Arcus presented new data that earned rave reviews from analysts a few weeks ago. Researchers tracked a 41% overall response rate across all dose-escalation cohorts, according to Arcus. And on Monday, Mizuho’s Mara Goldstein said the Gilead buy-in further validates the strength of the data.

“We see the deal increasing our confidence for this to be an inflection-potential year for RCUS ahead of key data readouts in 2021 from multiple studies,” Goldstein wrote to investors.

Gilead’s ability to increase its stake stems from a May 2020 agreement that allows the company to raise its Arcus ownership to 35% over a 5-year period. — Max Gelman

Illumina and Sequoia launch new genomics-focused incubator 

Illumina and Sequoia Capital National are unveiling an incubator to build new Chinese companies in the bustling genomics field.

The companies announced on Monday the Sequoia Capital China Intelligent Healthcare Genomics Incubator, Powered by Illumina, which will begin its inaugural funding cycle this fall.

During two six-month funding cycles a year, selected startups will get access to investment and business guidance from Sequoia Capital China, and access to Illumina sequencing systems and reagents and fully operational lab space in Shanghai.

“Illumina has a successful track record of creating venture-backed genomics startup companies through Illumina Accelerator in the U.S. and UK,” Illumina CEO Francis deSouza said in a statement. — Nicole DeFeudis 

Applications are open until June 1.