MedPath

Nadunolimab

Generic Name
Nadunolimab
Drug Type
Biotech
Unique Ingredient Identifier
ND296JF21I

Cantargia Expands CAN10 Development to Target Treatment-Resistant Atopic Dermatitis

• Cantargia has selected treatment-resistant atopic dermatitis as the second target indication for its antibody CAN10, focusing on patients who don't respond to first-line dupilumab therapy. • CAN10 works by blocking IL1RAP to inhibit multiple inflammatory pathways (IL-1, IL-33, IL-36), offering a novel mechanism distinct from current treatments targeting IL-4 and IL-13. • A pilot Phase 2 study will run parallel to CAN10's lead indication trial for hidradenitis suppurativa, with clinical results expected within 12 months of initiation.

Robust Pipeline of 200+ Therapies Targets Colorectal Cancer Treatment Landscape

• DelveInsight's latest report reveals a robust pipeline with over 195 companies developing 200+ therapies for colorectal cancer, highlighting significant innovation in targeted treatments and immunotherapies. • Key drug candidates include XL092 (Exelixis), Adagrasib (Mirati Therapeutics), Olaparib (Merck/AstraZeneca), and novel approaches like LYL845, an autologous tumor-infiltrating lymphocyte therapy from Lyell Immunopharma. • The metastatic colorectal cancer segment shows particular promise with 150+ companies advancing 180+ pipeline therapies, including innovative treatments targeting specific mutations and immune pathways.

Cantargia's Novel Anti-IL1RAP Antibody-Drug Conjugate Shows Promising Preclinical Efficacy Against Cancer

• Cantargia's anti-IL1RAP antibody-drug conjugate demonstrated potent anti-tumor activity across different IL1RAP expression levels in preclinical models, with a single dose achieving 100% survival in high-expressing tumors. • The ADC targets IL1RAP, a protein overexpressed in many tumor cells and their microenvironment, providing a dual-targeting approach that could potentially improve cancer treatment outcomes. • Preclinical safety data showed the ADC was well-tolerated with no significant changes in body weight, liver and kidney enzyme levels, or histological abnormalities in assessed organs.

Cantargia Initiates First Clinical Trial of Nadunolimab for AML and MDS Treatment

• Swedish biotech Cantargia has enrolled the first patient in a Phase Ib/IIa trial investigating nadunolimab in combination with standard chemotherapy for acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). • The US Department of Defense-funded study aims to enroll 40 patients and will assess safety, dosing recommendations, and efficacy measures including overall response rates and duration of response, with full recruitment expected by 2027. • This marks nadunolimab's first application in hematological malignancies, building on promising results in solid tumors and leveraging the discovery that leukemia stem cells express IL1RAP, the antibody's target protein.

Cantargia's CAN10 Shows Promising Phase 1 Results for Hidradenitis Suppurativa Treatment

• Cantargia reports positive pharmacokinetic data from the first multiple dose cohort of CAN10, supporting potential monthly dosing which would offer competitive advantages in hidradenitis suppurativa treatment. • FDA has provided favorable feedback on Cantargia's proposed Phase 2 study design for CAN10 in hidradenitis suppurativa, with the company on track for IND submission in the second half of 2025. • Clinical experts from the US and Europe have strongly endorsed CAN10's development for hidradenitis suppurativa, citing significant unmet medical needs despite recent treatment approvals.

Cantargia Expands Phase I Trial of CAN10 Antibody for Inflammatory Diseases

• Cantargia has dosed the first participant in the expanded Phase I trial of CAN10, an antibody targeting IL-1RAP. • The trial aims to build on observed safety, pharmacokinetic properties, and biomarker effects, suggesting potential for monthly dosing. • CAN10 will primarily target hidradenitis suppurativa and systemic sclerosis, addressing significant unmet medical needs. • Preclinical models indicate CAN10's surrogate antibody reduces disease development across several inflammatory conditions.

NK Cell Therapy Pipeline Shows Promise with Over 160 Therapies in Development

• The NK cell therapy field is experiencing significant growth, driven by its potential to address unmet needs in cancer treatment with safer, more targeted options. • Over 140 companies are actively involved in developing more than 160 NK cell therapies, indicating robust R&D investment and confidence in this therapeutic area. • Clinical trials are progressing for various NK cell therapies, including CAR-NK cell therapies and those targeting autoimmune disorders, showcasing versatility. • Regulatory support, such as FDA orphan drug designation and fast track designation, is facilitating the development and potential approval of NK cell therapies.

Nadunolimab Plus Chemotherapy Shows Promise in Advanced Pancreatic Cancer

• Nadunolimab in combination with gemcitabine/nab-paclitaxel demonstrates improved overall survival in metastatic pancreatic cancer patients. • Patients with high IL1RAP tumor expression showed a median overall survival of 14.2 months with the nadunolimab combination therapy. • The combination therapy presented a lower incidence of peripheral neuropathy than expected from chemotherapy alone, suggesting a protective effect. • The Phase 2 CANFOUR trial results support further development of nadunolimab as a potential new treatment option for pancreatic cancer.

Nadunolimab Shows Promise in Patients with Cancer Progression After PD-1 Inhibitor Therapy

• New data from two clinical trials reveal nadunolimab's potential in patients who have progressed on pembrolizumab treatment, a key immunotherapy. • The CANFOUR trial showed a 72% objective response rate in second-line NSCLC patients treated with nadunolimab plus chemotherapy after pembrolizumab failure. • CIRIFOUR trial data indicated a median survival of 19.7 months and a 60% disease control rate with nadunolimab and pembrolizumab in heavily pretreated patients. • Both studies suggest nadunolimab targets immunosuppressive cells within the tumor microenvironment, offering a new approach for overcoming immunotherapy resistance.
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