On May 29, 2024 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that the FDA has granted Fast Track designation to the combination of its innate cell engager (ICE) AFM24 with atezolizumab for the treatment of patients with advanced and/or metastatic non-small cell lung cancer (NSCLC) not harboring any activating EGFR mutations (EGFR wild-type) after progression on PD-(L)1 targeted therapy and platinum-based chemotherapy (Press release, Affimed, MAY 29, 2024, View Source [SID1234643804]). Data from the AFM24-102 study in this patient population will be presented at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) on June 1, 2024.
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"The clinical data of AFM24 in combination with the checkpoint inhibitor atezolizumab is compelling. We’re observing meaningful responses in patients resistant to prior checkpoint inhibitor treatment," said Dr. Wolfgang Fischer, Chief Operating Officer at Affimed. "The Fast Track designation emphasizes the belief in the potential of this combination therapy to address currently unmet needs of patients with this devastating, life threatening disease who have exhausted all standard of care options, including chemotherapy and checkpoint inhibitors."
Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat or prevent serious conditions and have the potential to address an unmet medical need. The FDA’s decision is based on initial activity observed in the first evaluable patients of the phase 2 part of the AFM24-102 study of AFM24 in combination with atezolizumab in heavily pretreated patients with NSCLC EGFRwt. With the Fast Track designation, the therapeutic development of the combination can benefit from more frequent engagement with the FDA, which will support the collection of appropriate data needed to accelerate its development.
About FDA Fast Track Designation
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. Its purpose is to get important new drugs to patients earlier. Fast Track addresses a broad range of serious conditions. With Fast Track designation, a new therapy is eligible for some or all of the following:
More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written communication from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biologic License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the NDA is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA.
Please refer to Fast Track | FDA for further information.
Conference Call and Webcast Information
Affimed will host a conference call and webcast for the financial community on June 1, 2024, at 6:00 p.m. CDT / 7:00 p.m. EDT. The conference call will be available via phone and webcast. The live audio webcast of the call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source To access the call by phone, please use link:
https://register.vevent.com/register/BIff607338e5d247f99b548240be2ad413, and you will be provided with dial-in details and a pin number.
About AFM24
AFM24 is a tetravalent, bispecific ICE that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis.