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Affimed stops enrolling multiple tumor types as data disappoint but forges ahead in other settings

Affimed is slashing the list of opportunities open to its bispecific innate cell engager AFM24. The failure of data in multiple tumor types to clear its bar for continuation drove the biotech to narrow its focus to lung cancer—but there are signs of encouragement in that setting and for lead candidate AFM13.

AFM24 is designed to turn the immune system against tumors by binding to CD16A on innate immune cells and EGFR on cancer cells. Evidence that the molecule drives an uptick in T-cell activity, while also activating the innate immune system, has led Affimed to identify opportunities to combine the therapy with checkpoint inhibitors.

The company is continuing to pursue some AFM24 opportunities but is pulling back from multiple indications. A look at phase 1/2a data from a gastric cancer arm and basket cohort, which targeted pancreatic cancer, biliary tract cancer and hepatocellular carcinoma, led the biotech to stop enrollment in the indications.

The early data revealed “clinical activity” in both cohorts, Affimed said, but the predicted response rates fell short of the biotech’s internal criteria for further development. Affimed also framed the jettisoning of the indications as supporting its desire to advance in another setting—non-small cell lung cancer (NSCLC)—as quickly as possible.

Affimed made NSCLC a priority for AFM24 after reviewing data on 15 patients from the EGFR-wildtype NSCLC expansion arm. The patients had received a median of two lines of prior therapy. All the subjects had previously progressed while on a PD-1/L1 checkpoint inhibitor. Affimed treated them with AFM24 and Tecentriq, Roche’s PD-L1 checkpoint inhibitor. 

The biotech saw four responses in the patients, although only one is confirmed. One of the unconfirmed responses is a complete response. Although there is no control arm to reveal what AFM24 is contributing to the efficacy of the combination, the fact the patients previously progressed after taking drugs similar to Tecentriq suggests Affimed’s asset may be enhancing the efficacy of the checkpoint inhibitor. 

Affimed shared the update alongside the latest data on AFM13, the CD30 innate cell engager also known as acimtamig. In 32 relapsed or refractory Hodgkin lymphoma patients, the biotech reported objective and complete response rates of 97% and 78%, respectively. The median duration of response in the heavily pretreated population was 8.8 months.

The findings, which are consistent with results shared last year, come from patients who received the recommended phase 2 dose. Affimed recently began a phase 2 trial of acimtamig that is shaping up to be a key event. The biotech’s stock has traded below $1 for much of the year, and fell 8% to below 40 cents in premarket trading Monday.

https://www.fiercebiotech.com/biotech/affimed-stops-enrolling-multiple-tumor-types-data-disappoint-forges-ahead-other-settings

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