Candidate: ALVR109

Type: Allogeneic, off-the-shelf, virus specific T-cell therapy designed to target SARS-CoV-2 by restoring natural T-cell immunity to fight off viral infections and diseases in immunocompromised patients, including recipients of stem cell and solid organ transplants

Status: AlloVir said September 17 that it won FDA clearance for its IND application for ALVR109, allowing a proof-of-concept clinical trial (BATIT, NCT04401410) to begin in the fourth quarter of 2020.

AlloVir also acknowledged that its IND application was placed on clinical hold due to questions related to raw materials used in the manufacturing process for ALVR109, adding: “BCM submitted a complete response to the questions identified in the clinical hold and the FDA has removed the hold, allowing the clinical study to start.”

A study published May 1 in Frontiers in Immunology by a team of Chinese researchers provided meaningful evidence supporting the rationale for the company’s program to develop T cell therapies designed to target coronaviruses. The study showed that counts of T cells, which play a role in viral clearance, were reduced significantly in patients with COVID-19, and in some cases, their T cells were functionally exhausted—suggesting a need, according to AlloVir, for therapeutic approaches that could improve T cell response against the virus: “perhaps these are necessary even early on to preempt disease progression in higher-risk patients with low T cell counts.”

In March, AlloVir expanded its R&D collaboration with Baylor College of Medicine to include the discovery and development of allogeneic, off-the-shelf, virus specific T-cell therapies to combat SARS-CoV-2. The company aims to develop a therapy for multiple coronaviruses—including SARS-CoV and MERS-CoV—that can be used as a standalone treatment or incorporated into its multi-respiratory virus therapy candidate, ALVR106. The allogenic, off-the-shelf multi-specific T cell (VST) is being developed as a treatment for respiratory syncytial virus (RSV), influenza, parainfluenza virus (PIV), and human metapneumovirus (HMPV).

COVID-19: 200 Candidates and Counting

To navigate through the >200 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:

FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.

DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data

KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.

TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.

GEN has also tagged the most common treatment types:


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