MANNHEIM, Germany - The U.S. Food and Drug Administration (FDA) has granted Fast Track designation to a novel lung cancer treatment developed by Affimed N.V. (NASDAQ:AFMD), a clinical-stage immuno-oncology company. The treatment combines AFM24, an innate cell engager (ICE®), with atezolizumab, a checkpoint inhibitor, for patients with advanced non-small cell lung cancer (NSCLC) that lacks EGFR mutations after previous therapies have failed.
This regulatory milestone follows the review of encouraging initial efficacy data from the ongoing AFM24-102 phase 1/2a study, specifically targeting the EGFR wild-type cohort. The Fast Track process aims to expedite the development and review of drugs that address serious conditions and fulfill unmet medical needs.
Dr. Wolfgang Fischer, Chief Operating Officer at Affimed, stated that the combination therapy has shown promising responses in patients who are resistant to checkpoint inhibitors. The Fast Track designation is a testament to the potential of this treatment approach for patients with life-threatening NSCLC who have exhausted standard care options.
Fast Track status allows for more frequent communication and meetings with the FDA, eligibility for Accelerated Approval and Priority Review, and the possibility of a Rolling Review, where sections of the drug's application can be submitted and reviewed sequentially rather than waiting for the complete submission.
AFM24 is a tetravalent, bispecific ICE® that binds to CD16A on innate immune cells and EGFR on solid tumors, promoting cancer cell destruction through immune cell activation. This approach could offer a new avenue for treating a variety of hematologic and solid tumors.
The information in this article is based on a press release statement from Affimed N.V.
InvestingPro Insights
Amid the exciting news of the FDA's Fast Track designation for Affimed N.V.'s (NASDAQ:AFMD) lung cancer treatment, investors may want to consider the company's financial health and market performance. With a market capitalization of 61.98 million USD, Affimed holds a modest position in the biotech industry. Notably, the company has more liquid assets than short-term obligations, suggesting a degree of financial stability in the near term. This is particularly relevant as the company progresses with its clinical trials and seeks to bring its novel treatment to market.
However, it's important to note that analysts are anticipating a sales decline for the current year, which could impact the company's financial trajectory. Moreover, the company's stock has experienced significant volatility, with a one-month price total return of -25.87% and a one-year price total return of -50.83%, reflecting investor uncertainty and the high-risk nature of biotech investments.
Investors looking for deeper insights into Affimed's performance and potential can find additional "InvestingPro Tips" on the company at https://www.investing.com/pro/AFMD. For instance, the Relative Strength Index (RSI) suggests that the stock is currently in oversold territory, which could be of interest to those considering entry points. Subscribers to InvestingPro can access a comprehensive list of tips, including 11 more on Affimed, to better inform their investment decisions. Moreover, by using the coupon code PRONEWS24, readers can get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, offering valuable investment support at a reduced cost.
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