Covid-19 roundup: Adagio plans to submit EUA by Q2 in 2022; HIPRA to enter PhII trials
Adagio plans to submit an EUA for its monoclonal antibody against Covid-19 in Q2 2022, the company announced in its Q3 update.
The submission will be based on the company’s STAMP trial of newly diagnosed Covid-19 patients. The investigational mAb is designed to offer broad neutralizing activity against SARS-CoV-2, including many of the dominating variants.
Adagio has also touted ADG20 as an alternative treatment for those who will be bad candidates for the pills Merck and Pfizer have brought forward. But new pills brought forward from these companies have the potential to cut into its market. And they’ve noted their injectable formulations than monoclonal antibodies that have to be given by IV, although rivals such as Vir and Regeneron are working on similar formulations.
“Our single injection delivery avoids the inconveniences associated with IV administration or multiple injections,” said CMO Lynn Connolly in a press release. “The world continues to face a host of challenges in fully addressing the COVID-19 crisis. Alternatives or supplements to vaccines for the prevention of COVID-19 are needed for immunocompromised individuals and those who remain hesitant to receive a vaccine or to vaccinate their children.
CEO Tillman Gerngross said in a press release that the company has gotten clear feedback from the FDA on a strategy to submit an EUA, and has expanded its clinical program to add additional patient subsets, such as including immunocompromised individuals and children.
“Our commercial-readiness efforts are well underway and with a strong balance sheet, we are ready to move quickly to enable access to individuals in need of COVID-19 prevention and treatment options, if authorization and/or approval is granted,” he said.
The treatment is enrolling participants for trials evaluating the success at preventing the virus as well. As of Sept. 30, Adagio is valued at $666.3 million, and R&D expenses were $49.4 million, the company reported.
In July, Gerngross inked a deal to make and commercialize a treatment similar to ADG20 in southern Asia. Adagio will provide Biocon with materials and know-how to make the therapy, including data from ongoing Phase II/III trials and access to its potential EUA package.
HIPRA to enter PhII trials
The Catalonia-based company HIPRA has gotten the OK from Spanish regulators to start a Covid-19 vaccine trial, Spain Prime Minister Pedro Sánchez said Monday.
The Phase II trial will test the vaccine in more than 1,000 volunteers in 10 hospitals across the country. Sánchez called the news of the vaccine’s development “extraordinary” at an event, and said that the government has given a 15 million euro grant to help develop the drug. Hipra has been working on two Covid-19 shots, one that uses mRNA and another that uses a recombinant protein similar to Novavax’s jab.
Hipra expects to produce 600 million doses in 2022, Reuters said.