CEO exit, staff layoffs as Affimed grapples with setback

08 Jan 2024
Clinical ResultPhase 2Executive ChangeASHImmunotherapy
Affimed said Monday that Adi Hoess will be stepping down as CEO on January 15, to be replaced on an interim basis by chief medical officer Andreas Harstrick, as the company undertakes a sweeping round of layoffs. The moves come on the heels of mixed study results prompting Affimed to narrow the focus of the Phase I/IIa AFM24-102 cancer trial, which is testing the innate cell engager AFM24.
Staff cuts will affect up to 50% of Affimed's workforce via the shuttering of its research and preclinical development departments. The action is expected to free up funds to allow it to operate through to the second half of 2025.
The pending departure of Hoess caps a lengthy tenure at the company's helm, where he has been since 2011. Affimed says it will now focus on its clinical programmes, with AFM24-102 and the Phase II LuminICE-203 study on track to read out in the first half of 2024. "Given the clinical focus of the company, Andreas is well positioned to lead the company through the transition to a new CEO while continuing as CMO," the company stated.
Plug pulled on other tumour types
Last month, Affimed said data from the AFM24-102 combination study of AFM24 with Roche's immunotherapy Tecentriq (atezolizumab) produced "encouraging signals" in heavily pretreated patients with advanced EGFR-expressing non-small-cell lung cancer (NSCLC). Data as of December 6 included all 15 patients from the EGFR-wildtype NSCLC cohort. Affimed reported that there was 1 unconfirmed complete response, 3 partial responses and 7 patients with stable disease.
However, the company also said it was ending enrollment in the trial's gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer and hepatocellular carcinoma. "While clinical activity was observed in both cohorts, neither…is likely to achieve response rates that would meet [our] efficacy hurdle," Affimed said at the time, adding that its focus would be to advance the NSCLC programme "as fast as possible."
Eye on pivotal acimtamig data
Meanwhile, the LuminICE-203 study is evaluating Affimed's experimental drug acimtamig in combination with Artiva's NK cell product AlloNK (AB101) in relapsed/refractory Hodgkin's lymphoma. Acimtamig is a tetravalent bispecific innate cell engager designed to activate the innate immune system to destroy CD30-positive haematologic tumours.
According to an update from a Phase I/II study presented at the American Society of Hematology (ASH) last month, acimtamig combined with NK cells was associated with an objective response rate of 97% and a complete response rate of 78% based on data from 32 patients.
Stifel analysts called the findings "intriguing," but had "important questions about the clinical, regulatory and commercial viability of a multi-cycle regimen that requires rounds of lymphodepletion and concomitant IL-2." They suggested that pivotal data replication could allay these concerns if it shows a significant treatment-free durability period for roughly a third of patients.
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