By Dr. Adi Hoess, CEO of Affimed | July 23, 2021
I know how critical it is to be measured when setting expectations. In business, as in life, none of us aspire to overpromise and under-deliver.
Indeed, as any business venture must do when communicating with investors and the public, we at Affimed are careful to use so-called “forward-looking statements” in laying out business goals. For example, when we report on successful results — as we did in April, after initial data from an ongoing clinical trial showed a 100% response rate to Affimed’s approach to activating the innate immune responses in patients with advanced blood cancer — we include a disclaimer to qualify statements that include terms such as “anticipate,” “believe,” “intend” and “predict” and distinguish them from “statements of historical fact.”
Although it is necessary to attenuate these kinds of forward-looking statements, the imperative to innovate demands that leaders internalize them, believe in them and make them a shared mindset for imagining — and pursuing — what is possible.
Believing in the possible
The initial results we reported in April are a testament to the power of imagining and believing in new possibilities — in this case, the potential to restore patients’ innate ability to fight cancer.
Led by the University of Texas MD Anderson Cancer Center, the investigator-sponsored Phase 1 trial is studying the safety and efficacy of combining AFM13, Affimed’s first-in-class innate cell engager (ICE), with cord blood-derived allogeneic natural killer (NK) cells to patients with recurrent or refractory CD30-positive lymphomas. In this ongoing trial, the first four patients, all heavily pretreated and exhausting all treatment options, showed significant disease reduction with an objective response rate of 100% — two complete responses and two partial responses — and none observed incidences of cytokine release syndrome, neurotoxicity syndrome or graft-versus-host disease. An especially poignant outcome: one of the responsive patients had been advised to enter hospice care prior to participating in the trial.
The results validated and affirmed our conviction that the innate immune system can eliminate cancers — a view that the field of immuno-oncology had largely underestimated.
Apart from academic research into the innate immune system, companies over the past 10 years primarily focused on the adaptive immune system. This is because engaging adaptive immune cells such as T cells to fight tumors historically promised greater efficacy than engaging innate cells like NK cells and macrophages. Even though engaging T cells poses a risk of toxic — even deadly — side effects for patients, the view was that it was the only way to generate an efficacious immune response.
Our strategy was grounded in the possibility of increasing the efficacy of the innate immunity approach. We followed the biology — and the biology showed us not only that the efficacy of innate cell engagement doubled when applied to lymphoma patients with certain indications, but that a strong activation of innate immunity can induce a strong activation of adaptive immunity. And it appears to be much safer than T cell-directed products.
Validating the p