Phase I

Advantagene Inc., of Auburndale, Mass. (dba Candel Therapeutics)

GMCI (aglatimagene besadenovec plus prodrug)

Gene-mediated cytotoxic immunotherapy

High-grade glioma

Treated first patients in BrTK04 trial testing combination with Opdivo (nivolumab, Bristol-Myers Squibb Co.), standard-of-care surgery, radiation and temozolomide; primary endpoint is to determine safety

Kaleido Biosciences Inc., of Lexington, Mass.


Microbiome metabolic therapy

Urea cycle disorders

Initiated dosing in non-IND study in 5 patients, 14 and older, on standard of care, to receive oral drug for 21 days to evaluate safety and tolerability, as well as its effect on ammonia levels as measured by nitrogen metabolism in blood and urine

Kaleido Biosciences Inc., of Lexington, Mass.


Microbiome metabolic therapy


Initiated dosing in non-IND study in about 36 patients with well-compensated cirrhosis to compare KB-174 to negative control maltodextrin on nitrogen metabolism in blood and urine, as well as safety and tolerability; a separate non-IND study in healthy subjects also is underway

Lead Pharma Holding BV, of Oss, the Netherlands


Inverse agonist of nuclear hormone receptor RORyt


Dosed first healthy volunteers in study to assess tolerability, safety and pharmacokinetics of single and ascending once-daily oral dosing

Phase II

Adrenomed AG, of Hennigsdorf, Germany


Monoclonal antibody targeting vasoprotective peptide adrenomedullin

Early septic shock

Trial will continue as intended after completion of planned interim analysis for 50% of randomized subjects; decision was made after evaluation of Sepsis Support Index, a secondary endpoint, indicated positive outcome for whole study

Aerie Pharmaceuticals Inc., of Durham, N.C.

Netarsudil ophthalmic solution 0.02%

Rho kinase inhibitor

Reduction of elevated intraocular pressure in open-angle glaucoma or ocular hypertension

Started patient dosing in trial designed in accordance with requirements of Japan's PMDA

Innovent Biologics Inc., of Suzhou, China


Recombinant fully human anti-PCSK9 monoclonal antibody


First patient dosed in phase IIa trial in China; about 60 patients will be enrolled in study designed to test efficacy, safety, tolerability, pharmacokinetics and pharmacodynamics of repeatedly different doses

Modra Pharmaceuticals BV, of Amsterdam


Oral therapeutic based on docetaxel

Recurrent or metastatic HER2-negative breast cancer

First patients treated in phase IIa study; primary endpoint is objective response rate according to RECIST, while secondary endpoints include progression-free survival and safety

Opko Health Inc., of Miami


Once-weekly injectable oxyntomodulin compound with dual GLP-1/2 agonist activity

Type 2 diabetes and obesity

Top-line results showed phase IIb study met primary objective with a statistically significant lowering of HbA1c after 30 weeks of treatment vs. placebo, as well as secondary endpoint of statistically significant weight loss vs. placebo; study enrolled 113 patients with inadequate glucose control with metformin and/or diet and exercise

Phase III

AB2 Bio Ltd., of Lausanne, Switzerland

Tadekinig alfa

Recombinant human interleukin-18 binding protein

Autoinflammatory disease

FDA approved amended protocol under which all patients will be initially treated with study drug rather than just half

Biogen Inc., of Cambridge, Mass.; Eisai Co. Ltd., of Tokyo


Recombinant chimeric human IgG1 mAb targeting beta-amyloid

Alzheimer's disease

Discontinued phase III trials ENGAGE and EMERGE based on results of futility analysis by DMC indicating the trials were unlikely to meet their primary endpoint

Evolus Inc., of Newport Beach, Calif.

Jeuveau (prabotulinumtoxinA-xvfs)

Botulinum toxin type A formulation

Severe glabellar lines

Highlighted publication of phase III TRANSPARENCY trial data in Dermatologic Surgery; noted pending publication on head-to-head trial vs. Botox (onabotulinumtoxinA)

Samsung Bioepis Co. Ltd., of Incheon, South Korea

Ontruzant (trastuzumab)

Biosimilar trastuzumab

Breast tumor

Reported 3-year follow-up data showed comparable OS between biosimilar Ontruzant and Herceptin (trastuzumab) in early and locally advanced HER2-positive breast cancer; OS was 97% in the biosimilar trastuzumab group and 93.6% in the reference medicine group (HR 0.39, 95% CI, 0.14-1.12)


For more information about individual companies and/or products, see Cortellis.


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