A company that less than a year ago had biotech’s largest ever initial public offering has moved several new drug candidates into the clinic while advancing another into mid-stage clinical testing.
Cambridge, Massachusetts-based Moderna said Wednesday that it had started four new Phase I clinical trials, including two in immuno-oncology and two in infectious diseases. In addition, the first patient in a Phase II study of a vaccine for melanoma provided consent for the trial. The announcement was included in the company’s second quarter 2019 earnings.
Shares of Moderna climbed 14 percent on the Nasdaq in the hours following the news. The company made its stock market debut in November 2018, raising more than $600 million in what was deemed the largest ever initial public offering by a biotechnology company.
The company said it dosed the first patients in its Phase I studies of mRNA-1172, a vaccine for respiratory syncytial virus, or RSV, and mRNA-1893, a vaccine for Zika virus. In the area of immuno-oncology, the company dosed the first patients in its Phase I study of the KRAS cancer vaccine mRNA-5671 and an mRNA-encoding IL12 therapy.
The RSV vaccine and KRAS cancer vaccine are being developed in partnership with Merck & Co., while the IL12 is being developed under a partnership with British drugmaker AstraZeneca’s MedImmune subsidiary, under the development name MEDI1191.
MEDI1191 is being co-administered in patients with various solid tumors together with AstraZeneca’s Imfinzi (durvalumab), a PD-L1 checkpoint inhibitor. The KRAS protein has been an area of growing interest among drugmakers, as it is widely expressed in multiple solid tumors, but is regarded as “undruggable” given its structure. Amgen has been developing the drug AMG 510, which targets a form of KRAS known as KRAS G12C and has shown efficacy in a number of patients. Numerous startups have been investigating product candidates targeting KRAS mutations as well.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Meanwhile, mRNA-5671 – which carries the Merck development name V941 – is being administered as a single agent and together with Merck’s PD-1 checkpoint inhibitor Keytruda (pembrolizumab).
The Phase II study is testing the drug mRNA-4157, a personalized cancer vaccine for high-risk melanoma. Moderna is the primary sponsor of the trial, called KEYNOTE-942 as it is co-sponsored by Merck and involves administration of the vaccine together with Keytruda. The trial will enroll 150 patients and is anticipated to reach final completion around the end of 2021.
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