Johnson & Johnson Bets $780M on Cidara's Universal Flu Therapy CD388

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As Johnson & Johnson rolled out the first batches of its COVID-19 vaccine in the United States, it was already looking ahead to the next pandemic. The company is willing to place a bet of up to $780 million on a novel drug that Cidara Therapeutics claims can eliminate all influenza strains.

Recently, Janssen, a subsidiary of Johnson & Johnson, will invest $27 million to purchase Cidara Therapeutics’ leading antiviral conjugate CD388, which can treat and prevent all influenza strains with a single dose. Unlike vaccines and monoclonal antibodies, AVC is a long-acting drug that combines an antiviral agent with a human antibody fragment (Fc), aiming to inhibit viral replication while also activating the immune system.

Current influenza vaccines have several major limitations. They are effective against only three or four strains, some individuals do not respond to them, and their efficacy gradually wanes in the elderly. Cidara’s antiviral conjugates (AVCs) have shown promise in mouse infection models with severely compromised immune systems, which are designed to represent high-risk populations such as the elderly or immunocompromised individuals. Furthermore, while conventional vaccines may take 14 days to become effective, AVCs are expected to act “almost immediately.” In terms of therapeutic application, preclinical studies have demonstrated that AVCs may provide benefits for up to 24 hours compared with existing treatments.

Cidara is responsible for research, development, and manufacturing through Phase II, with plans to submit an Investigational New Drug (IND) application by the end of this year and initiate clinical trials in early 2022. Janssen will reimburse Cidara’s R&D expenses and, on this basis, guide the candidate product through late-stage development and manufacturing, potentially advancing to commercialization if all goes well.

Jeffrey Stein stated during a conference call with investors on Monday morning that Cidara still has $753 million in R&D budget and milestones pending, along with "mid-to-high single-digit" tiered royalties. Cidara holds an option to co-promote the candidate in the United States. Cidara’s stock (CDTX) surged 15% in pre-market trading but retreated to $2.67 by late Monday morning.

The Janssen agreement also includes another of Cidara’s antiviral compound (AVC) candidates, CD377, which has a slightly shorter duration of action. The only difference between CD377 and CD388 lies in the nature of their Fc domains; the former is expected to last approximately 4 months, while the latter lasts about 6 months.

In addition to the 2019 agreement between Cidara and Mundipharma regarding its lead antifungal candidate, rezafungin, the biotechnology company is eligible to receive up to $1.3 billion in research and development funding and milestone payments. The company is also investigating antiviral compounds (AVCs) targeting HIV, respiratory syncytial virus (RSV), and SARS-CoV-2 strains.

Reference source: With one pandemic still raging, J&J bets $780M on a potential flu therapy for the next