CAN-10

LUND, SE / ACCESS Newswire / January 23, 2026 / Cantargia AB (Publ) (STO:CANTA) today reported that the first patient has been dosed in a Phase 1b/2 clinical trial investigating nadunolimab in combination with checkpoint inhibitor therapy in up to 24 patients with chemotherapy-refractory metastatic microsatellite stable (MSS) colorectal cancer (CRC). The study is an investigator-led initiative in collaboration with Dr. Dan Fang at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. "Building on the exciting clinical results generated in patients with solid tumors and strong preclinical data, we look forward to providing nadunolimab for evaluation in this new patient group. We are excited that a high-pro like the Tisch Cancer Institute views nadunolimab as a novel and promising therapy and are looking forward to offering patients this treatment option" said Hilde Steineger, CEO of Cantargia. " Microsatellite stable colorectal cancer remains one of the most challenging solid tumors to treat with immunotherapy ," said Dr. Dan Fang, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai. " The scientific rationale for using a novel IL1RAP-targeting approach with nadunolimab is compelling, and we look forward to generating translational insights that could inform future immunotherapy strategies ." Nadunolimab has been investigated by Cantargia in approximately 300 patients with solid tumor indications and has shown signals of clinical activity in pancreatic cancer and non-small cell lung carcinoma. Researchers at the Tisch Cancer Institute have a long-standing interest in developing new therapies for the treatment of CRC and have performed preclinical work strongly implicating IL-1 signaling in immune suppressive and treatment resistant pathways in this disease. The new phase 1b/2a investigator-initiated trial will be conducted at Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York. The study ( NCT07281716 ), led by principal investigator Dr. Dan Feng, is designed to investigate nadunolimab in combination with an anti-PD-1 inhibitor in up to 24 patients with MSS CRC. In addition to investigating anticancer effects, the study will include a comprehensive biomarker assessment package. For further information, please contact Hilde Steineger, CEO Telephone: +46 (0)46-275 62 60 E-mail: info@cantargia.com About Cantargia Cantargia AB (publ), reg. no. 556791-6019, is a biotechnology company that develops antibody-based treatments for life-threatening diseases and has established a platform based on the protein IL1RAP, involved in a number of cancer forms and inflammatory diseases. Cantargia's oncology program, the antibody nadunolimab (CAN04), is being studied clinically, primarily in combination with chemotherapy with a focus on pancreatic cancer and non-small cell lung cancer. Positive data for the combinations indicate stronger efficacy than would be expected from chemotherapy alone. Cantargia's second development program, the antibody CAN10, blocks signaling via IL1RAP in a different manner than nadunolimab and addresses treatment of serious autoimmune/inflammatory diseases. In September 2025, the acquisition of CAN10 by Otsuka Pharmaceutical was completed. Cantargia is listed on Nasdaq Stockholm (ticker: CANTA). More information about Cantargia is available at . About nadunolimab (CAN04) Nadunolimab is an antibody that binds strongly to its target IL1RAP and functions by inducing ADCC and blocking IL-1α and IL-1β signaling. Nadunolimab can thereby counteract the IL-1 system which contributes to the immune suppressive tumor microenvironment and the development of resistance to chemotherapy. Nadunolimab has been investigated in multiple clinical trials; the phase I/IIa trial CANFOUR, NCT03267316 , evaluated nadunolimab in combination with standard chemotherapies in patients with pancreatic ductal adenocarcinoma (PDAC) (gemcitabine/nab-paclitaxel) or non-small cell lung cancer (NSCLC) (platinum-based chemotherapies). Positive data show durable responses for combination therapy in 73 PDAC patients, resulting in a median iPFS of 7.2 months and median OS of 13.2 months. An even higher median OS of 14.2 months was observed in a subgroup of patients with high tumor levels of IL1RAP. Intriguing efficacy was observed in a small group of non-squamous NSCLC patients post PD(L)-1 therapy. Attachments Cantargia Reports First Patient Dosed in New US Investigator-Initiated Colorectal Cancer Study SOURCE: Cantargia View the original press release on ACCESS Newswire

Rising biotech deals involving Chinese drugs, Takeda's positive OX2R readouts, and LaNova's acquisition by Sino Biopharm made our news this week. Biotech deals involving assets developed in China are surging, a Jefferies report shows. Takeda is preparing its narcolepsy candidate oveporexton for an FDA filing after two positive phase 3 readouts. Merck & Co.'s PD-1xVEGF partner is being acquired. And more.1. China biotechs ‘reshaping’ US biopharma as outlicensing deals rise 11%: Jefferies reportAbout a third of biopharma’s outlicensing deal value in the first quarter of 2025 centered on Chinese assets, versus 21% during the same period in both 2024 and 2023, according to Jefferies. Since 2022, China biotechs have developed 639 first-in-class drug candidates, a sharp rise compared with prior years, Jefferies tallied.2. Takeda’s narcolepsy blockbuster hopeful secures double phase 3 wins, teeing up FDA filingTakeda’s OX2R agonist oveporexton has hit the mark in two phase 3 narcolepsy trials. The FirstLight and RadiantLight trials met their primary endpoints showing statistically significant improvements for the drug compared with placebo in excessive daytime sleepiness, as measured by the Maintenance of Wakefulness Test at week 12. The company is now preparing for an FDA approval filing.3. Sino Biopharm buys Merck's PD-1xVEGF bispecific partner LaNova for up to $951MLaNova Medicines, from which Merck & Co. recently licensed a PD-1xVEGF bispecific candidate, is being bought out by Chinese compatriot Sino Biopharmaceutical in a deal worth up to $951 million. In addition, LaNova also provided AstraZeneca with a GPRC5D-targeting antibody-drug conjugate. Before the LaNova transaction, very few, if any, Chinese pharmas have acquired innovative domestic biotechs.4. For Lundbeck and Otsuka's PTSD filing, FDA questions Rexulti efficacy after failed phase 3For an upcoming advisory committee meeting, the FDA flagged “discordant results” from two phase 3 trials that Lundbeck and Otsuka are using in their application for Rexulti, in combination with Viatris’ Zoloft, as a treatment for post-traumatic stress disorder. The FDA is asking experts to weigh in on whether an exploratory phase 2 study can overcome one negative phase 3.5. Otsuka inks $613M deal for Swedish biotech's autoimmune antibodiesOtsuka is paying $33 million upfront for Cantargia’s IL1RAP antibody, CAN10, as well as a backup candidate, against autoimmune and inflammatory disorders. The deal also includes up to $580 million in milestone payments and gives the Japanese drugmaker exclusive first rights of negotiation for Cantargia’s next-gen IL1RAP programs.6. Sun Pharma's alopecia med Leqselvi hits US market after Incyte patent settlementSun Pharma has reached a patent settlement with Incyte so the Indian company can launch its JAK inhibitor Leqselvi in the U.S. for severe alopecia areata. Sun will pay an undisclosed upfront payment plus royalty payments until the related patents expire. The deal ended a lawsuit in which Incyte claimed that Leqselvi would infringe on patents around its blockbuster ruxolitinib.7. FDA hands down citations to 3 drugmakers after inspections found contamination, testing concernsMeanwhile, a Sun Pharma plan in Gujarat, India was subject to a 19-page, eight-observation Form 483 following an FDA inspection in June. Some citations, such as “poor aseptic behavior and inadequate environmental monitoring,” had previously been flagged in an FDA warning letter in 2022. Separately, a Daewoo Pharm site in Busan, Korea, and a Glenmark facility in Madhya Pradesh, India, received FDA warning letters.Other News of Note:8. Astellas reports 22% sales bump for Izervay, expects trend to continue this year9. China sentences Astellas exec to 3.5 years in prison for espionage (Bloomberg)10. Hengrui's GLP-1/GIP agonist reports 18% weight loss in phase 3 trial, readies China push11. Acumen taps JCR’s blood-brain barrier tech for $555M Alzheimer’s deal12. GSK expands Medicines Patent Pool deal to allow generic production of cabotegravir for HIV treatment13. Kowa licenses Nicox’s intraocular pressure eye drop for up to €191.5M (release)14. Korea’s Illimis raises $42M series B to advance Alzheimer’s candidate (release)