Novartis’s Spartalizumab Combo Stumbles; Union Therapeutics Doses In COVID-19 Trial; Yumanity To Merge With Proteostasis

Novartis’s Spartalizumab Combo Fails To Meet The Primary Goal In The Melanoma Trial 

Novartis recently declared the results of its Phase III COMBI-I trial evaluating its experimental checkpoint inhibitor spartalizumab in combination with Tafinlar (dabrafenib) and Mekinist (trametinib) for patients, previously untreated, with unresectable or metastatic BRAF V600 mutation-positive melanoma compared to Tafinlar and Mekinist alone. The results announced that the spartalizumab combo stumbled in the trial and failed to hit the primary endpoint of investigator-assessed progression-free survival in melanoma.

The drug, Spartalizumab, is an experimental monoclonal antibody designed as immunotherapy to target the human programmed death-1 (PD-1) receptor. Tafinlar and Mekinist are prescription treatments targeting melanoma, and or other cancers, including thyroid cancer.

The company will review the data further and plans to assess spartalizumab in other tumor types. Earlier this month, Novartis received the FDA recommendation for its Kesimpta (ofatumumab) for subcutaneous use for relapsing forms of multiple sclerosis (RMS). Moreover, the company also announced positive data from the Phase II ELARA trial of Kymriah (tisagenlecleucel) in patients with relapsed or refractory (r/r) follicular lymphoma (FL).

Union Therapeutics A/S Announces Completion Of Dosing Of Healthy Volunteers With UNI911 For COVID-19

Union Therapeutics announced successful completion of dosing healthy volunteers with UNI911. The study was a double-blind, placebo-controlled, randomized study, where ascending single and multiple dosing regimens were given to 44 healthy volunteers. The goal of the study was to assess the efficiency and safety of UNI911 in COVID-19 patients. 

UNI911 was administered as an inhalation treatment candidate for COVID-19 across five cohorts. The drug uses an optimized salt form of niclosamide, which is a safe oral drug and is in use for decades as an anthelmintic drug. The drug is directly delivered to lungs via inhalation to achieve high local exposures, and address the concerns of low oral bioavailability linked to niclosamide. 

Yumanity Therapeutics Plans To Merge With Proteostasis Therapeutics To Advance Neurodegenerative Disorders Pipeline

Yumanity Therapeutics has decided to merge its operations with Boston-based Proteostasis Therapeutics. The duo plans to advance the pipeline for neurodegenerative disorders including Parkinson’s disease. 

Both the companies have candidates that address the misfolded proteins at the root of disease. The companies will focus on Yumanity’s YTX-7739, which is in a Phase I trial for Parkinsons’ disease. Yumanity is also running trials for its candidates which are in different stages of clinical development for dementia with Lewy bodies, multi-system atrophy, amyotrophic lateral sclerosis (ALS) and frontotemporal lobar dementia (FTLD). Proteostasis, on the other hand, is looking for another deal for its proprietary CFTR modulators.