Aurinia’s Lupkynis for Lupus; FDA Fast Track Designation for Toripalimab; Wren Therapeutics’ Financing; Merck’s Covid-19 Vaccine Program End

Posted on Jan 26, 2021 by Delveinsight

Aurinia's Lupkynis for Lupus; Toripalimab; Merck’s Covid-19 Vaccines fail

Hot on the heels, Aurinia launches its drug in the Lupus market after GSK

Aurinia Pharmaceuticals has recently got the USFDA approval for its Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active Lupus nephritis (LN). Lupkynis is the first oral therapy to receive FDA nod for Lupus nephritis, a condition that causes inflammation of kidneys. It is one of the most common and serious complications of the autoimmune disease systemic lupus erythematosus (SLE). 

Lupus has been a challenging condition to treat for decades with only a limited number of therapeutic options. However, Aurinia is not the only player offering the cure. A month ago, GlaxoSmithKline earned the approval for its Benlysta, intravenous and subcutaneous option for Lupus, and became the first-ever therapy to get an approval for the indication. 

Although GSK has had an upper hand at the early launch of the drug, Aurinia has reported a significantly improved renal response rate of 40.8% versus 22.5% in the control arm while Benlysta’s difference with control was smaller (43% vs 32%). Furthermore, the company does not shy away from saying that its drug works rapidly and its oral RoA is another added benefit that makes it stand tall in the Lupus nephritis market. 

FDA Fast Track Designation to Toripalimab for Mucosal Melanoma

The USFDA granted Fast Track Designation to Junshi BiosciencesToripalimab for the first-line treatment of mucosal melanoma. Toripalimab is the first domestic anti-PD-1 monoclonal antibody to get commercial approval in China. 

The regulatory agency has also approved the Investigational New Drug (IND) application for a global Phase III trial of Toripalimab in combination with Axitinib versus Pembrolizumab for the first-line treatment of patients with advanced mucosal melanoma (Combination Clinical Trial). The trial investigated more than fifteen indications sponsored by over thirty pharmaceutical companies conducted globally, including in China and the United States. 

In 2018, Toripalimab had already obtained conditional approval from the National Medical Products Administration (the “NMPA”) for the second-line treatment of unresectable or metastatic melanoma. Further, it was included in the Guidelines of Chinese Society of Clinical Oncology (CSCO) for the Diagnosis and Treatment of Melanoma in 2019 and 2020 respectively. It also has received two supplemental New Drug Applications (NDAs) for the third-line treatment of recurrent/metastatic nasopharyngeal carcinoma and the second-line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020, respectively.

Wren Therapeutics Announces Financing of £12.4 Million 

Wren Therapeutics has announced the closing of a £12.4 million (c. $17.0 million) financing raising the total capital to approximately £33 million (c. $45 million). The financing was led by existing shareholder The Baupost Group, along with the participation from existing investors including LifeForce Capital and new investors including Schooner Capital and Industry Ventures.

The company plans to use the proceeds to accelerate two of its leading small-molecule programs towards the clinical development for the potential treatment of Alzheimer’s disease and various synucleinopathies including Parkinson’s disease

Merck Makes a Quick Exit in the COVID-19 Vaccine Development Fight 

The pharma goliath, Merck has decided to discontinue the development of its two experimental Covid-19 vaccines after the results from early trial gave some lacklustre results. Merck has taken a different approach from its rivals namely Pfizer, Moderna and Johnson & Johnson who were also in the domain developing vaccines against COVID-19

Merck had undertaken two programs, V590, which is based on the borrowed technology from Merck’s Ebola inoculation, whereas the second one, V591, is based on a measles vaccine used in Europe. However, both failed to cut the mustard this time and proved to be a blot in the company’s long history of successful vaccine development. 

Merck was a late-entrant in the development of the COVID-19 vaccine. The company had finished the recruitment of the first participants for early-stage safety studies at the time when its rivals were gearing up for presenting and demonstrating the efficacy of their candidates in late-stage trials. And the weak results took everyone by surprise. However, early or say quick fails are not as bad as the failure in the end-stage trials as they help the company to recover sooner from the grief and loss. 

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