Natick, MA, October 29, 2020—AffyImmune Therapeutics today announced enrollment of the first patient in its Phase I clinical study evaluating AIC100, the company’s novel affinity-tuned CAR-T cell product, in patients with advanced, refractory thyroid cancer. The trial is designed to test safety, biological activity and real-time assessment of CAR T cell localization in patients.
The study, entitled: ‘Phase I study of AIC100 in relapsed and/or refractory advanced thyroid cancer and anaplastic thyroid cancer’ is being conducted at Weill Cornell Medicine. Unlike most CAR-T cell products, AIC100 was designed to specifically target tumor cells overexpressing the target (ICAM-1) while avoiding normal cells expressing lower levels. This was accomplished by lowering the affinity of the targeting portion of the chimeric antigen receptor (CAR) of AIC100 through directed evolution to levels more comparable to physiological levels governing T cell interactions with their targets. Prior studies in animal models clearly showed that that these lower affinity CAR T cells not only spared normal cells but also persisted longer having greater anti-tumor activity in animal models.
Eric von Hofe, President of AffyImmune Therapeutics, stated: “After overcoming a few COVID-19 related delays we are excited to announce the enrollment of our first patient in the AIC100 trial, this marks another important step for us. Affinity tuning clearly provides a number of advantages over the traditional approach of designing CAR-T cells.” He continued, “the resulting CAR-T cells are able to discriminate based on target expression, persist longer for better tumor cell killing and open the door to targeting antigens previously avoided for fear to on-target off-tumor toxicity. We are gratified in being able to bring this novel CAR-T product to the clinic for refractory thyroid cancers, which are notoriously aggressive with no good treatment options.”
About AffyImmune Therapeutics, Inc.
AffyImmune is realizing the potential of cancer immunotherapy by extending the anti-cancer activity of CAR-T cell therapy to solid tumors, improving the safety and efficacy of CAR-T treatment. Based on Professor Moonsoo Jin’s work at Weill Cornell Medicine, AffyImmune’s proprietary technology allows fine-tuning of the affinity of CAR-T cells to selectively kill tumor cells while sparing healthy cells to reduce toxicity. AffyImmune scientists have also developed a tracking system that can be engineered into any CAR-T cell to allow for real-time localization of cells after administration to patients.
AffyImmune’s lead asset, AIC100, is an affinity-tuned, 3rd generation CAR-T cell therapy co-expressing SSTR2. Preclinical studies in various solid tumor models demonstrated AIC100’s robust and enduring tumor eradication and superior safety profile compared to standard, high-affinity CAR T cell therapy. In 2019, AffyImmune received Orphan Drug Designation by the FDA for AIC100 and began recruitment for a Phase 1 trial to treat advanced thyroid cancer.
Founded in 2016, AffyImmune is headquartered in Natick, MA and is incubated by ORI Capital.
About ORI Healthcare Fund L.P.
ORI Healthcare Fund is a $200 million venture capital fund focused on investing in innovative companies with disruptive technologies in the healthcare industry globally. The General Partner of the Fund was founded by Ms. Simone (Hong Fang) Song, the former head of China Healthcare Investment Banking at Goldman Sachs.
Eric von Hofe
AffyImmune Therapeutics, Inc.
12 Michigan Drive
Natick, MA 01760
+1 (617) 699-1965