ModeX Therapeutics has launched a Phase 1 trial of MDX2301, a tetravalent bispecific antibody engineered to neutralize all known SARS-CoV-2 variants, with initial dosing in healthy and high-risk adults.

The study’s primary endpoints assess safety and tolerability, while secondary objectives examine pharmacokinetics, anti-drug antibodies, and neutralizing activity.

The trial is randomized, double-blind, placebo-controlled, and dose-escalation, evaluating safety and tolerability across intravenous, intramuscular, and subcutaneous administration in up to 80 participants.

The press release carries standard forward-looking statements caveats and provides regulatory disclosures along with investor and media contact information.

If successful, the ModeX multispecific platform could have broader applicability to other infectious threats beyond COVID-19.

ModeX Chief Scientific Officer John Mascola described this milestone as a pivotal step for the multispecific antibody platform, underscoring potential for expanded breadth and durable protection.

Executives from ModeX and OPKO Stress the public health importance of the trial and the prospect of broader protective strategies beyond traditional monoclonal antibodies.

ModeX Therapeutics is a clinical-stage company focused on multispecific biologics for cancer, immunology, and infectious diseases, based in Weston, Massachusetts, and operating as part of OPKO Health (NASDAQ: OPK).

Gary Nabel, ModeX President and CEO, highlighted the multispecific approach’s potential to address ongoing SARS-CoV-2 evolution with broader, more durable protection.

The trial is funded entirely by U.S. federal funds from HHS BARDA under contract 75A50123C00056, with funding described as non-dilutive and not an endorsement of results.

The study is identified as NCT07445971, with an enrollment target of 80 participants in this Phase 1 design.