Shares of Quince Therapeutics Inc. (NASDAQ:QNCX) plunged Jan. 29 by 91% and were trading today at 20 cents, down 7 cents, or 25% after the company made public top-line results from its pivotal phase III Neat trial evaluating lead asset dexamethasone sodium phosphate encapsulated in autologous erythrocytes (eDSP), in patients with ataxia-telangiectasia (A-T). Neat’s primary endpoint, which measured the change from baseline to last efficacy visit at month six using the Rescored modified International Cooperative Ataxia Rating Scale compared to placebo, did not reach statistical significance. The mean change from baseline to month six was 0.94 in the active arm compared to 2.24 in the placebo arm (p=0.0851). EDSP fell short of the key secondary endpoint, too: improvement in Clinical Global Impression of Severity measured from baseline to month six (p=0.522). A-T is an inherited autosomal recessive neurodegenerative and immunodeficiency disorder caused by mutations in the ATM gene.
EMA starts review of Amgen’s Tavneos
The EMA has started a review of Amgen Inc.’s Tavneos (avacopan) after questions were raised about the integrity of the data in the Advocate study that the agency assessed when granting approval of the vasculitis treatment in January 2022. There are no specific details of its concerns, but the EMA said they relate to how the Advocate data were handled, “which may have impacted the findings on the medicine’s effectiveness.” The EMA said it became aware earlier in January of new information which raised questions about the data integrity of the Advocate study.
Astrazeneca doubles down on China with $15B+ investments
Astrazeneca plc is investing $15 billion in China through 2030 to expand R&D and manufacturing, marking one of the largest long-term investments by a multinational pharma company in the country. The U.K.-based company also struck a deal worth up to $3.5 billion with China’s CSPC Pharmaceuticals Group Ltd. to accelerate the development of next-generation therapies for obesity and type 2 diabetes.
Elevar gets new CEO, files NDAs for lirafugratinib, rivoceranib
Elevar Therapeutics Inc. appointed Kim Dong-gun (DG) as CEO Jan. 29, as the company focuses on post-NDA strategies for lirafugratinib in bile duct cancer, and the twice-rejected rivoceranib-camrelizumab combination for liver cancer. Elevar submitted to the U.S. FDA an NDA seeking approval of lirafugratinib as a potential second-line therapy for FGFR2-driven cholangiocarcinoma Jan. 27. And it refiled its NDA of rivoceranib Jan. 23, for use in combination with anti-PD-1 antibody, camrelizumab, as a potential first-line combination therapy for unresectable hepatocellular carcinoma. Partner Jiangsu Hengrui Pharmaceutical Co. Ltd. resubmitted its BLA for camrelizumab on the same day.
Gut metabolites turn the immune system against metastasis
Chemotherapy is often seen solely as a tumor-targeting treatment, yet new evidence reveals a paradox: the tissue injury it causes can reprogram the body’s defenses, influencing the risk of metastasis. Researchers from the University of Lausanne and collaborators reported that chemotherapy reshapes the gut-immune axis by inducting microbiota-derived indole-3-propionic acid, which reprograms myelopoiesis to curb monocyte-driven immunosuppression and metastasis in colorectal cancer.
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Also in the news
Almirall, Alvotech, Aprea, Bayer, Breakthru, Chia Tai Feng Hai, Definium, Elevar, Enterome, Formation, Innocare, Ipsen, Omeicos, Palisade, Regeneron, Repare, Satellos, Sonoma, Summit, Tecregen, Tenpoint, Veradermics, Xeno