Candidate: CYNK-001

Type: Allogeneic, off-the-shelf natural killer (NK) cell therapy developed from placental hematopoietic stem cells; also being developed in multiple myeloma, acute myeloid leukemia, glioblastoma multiforme, and various blood and solid tumors.

Status: Celularity on April 2 won FDA clearance for its IND of CYNK-001 in adults with COVID-19, allowing the company to begin a Phase I/II trial of up to 86 patients. The IND followed high-profile efforts to promote CYNK-001, including a March 13 op-ed commentary by CEO Robert J. Hariri, MD, PhD, in The Wall Street Journal, and public support by President Donald Trump’s personal lawyer Rudy Giuliani, who invited Hariri onto his “Common Sense podcast: “Trials need to be EXPEDITED,” he tweeted on March 27.

In a February presentation, Celularity stated that its anti-COVID-19 construct had been generated within weeks, and that its DAR-T and DAR-NK cells “will soon be produced for anti-COVID-19 activity testing.” The companies in January launched a clinical and manufacturing collaboration designed to expand the therapeutic use of Celularity’s CYNK-001 to COVID-19. Sorrento and Celularity agreed to assess CYNK-001 as a potential novel therapy for coronaviruses, specifically SARS-CoV-2.

Sorrento—which owns 25% of Celularity—agreed to use current existing capacity in its cGMP cell therapy manufacturing facilities in San Diego to supplement Celularity’s new cGMP facility in Florham Park, NJ. Sorrento said it is already in contact with “leading” scientists and local Chinese experts to discuss clinical validation and logistics requirements for fast-tracking CYNK-001 in China.

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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