Affimed Receives Fast Track Designation for Combination Therapy of AFM24 with Atezolizumab for EGFR Wild-Type Non-Small Cell Lung Cancer
Affimed has received FDA Fast Track designation for its combination therapy of AFM24 with atezolizumab for advanced and metastatic EGFR wild-type non-small cell lung cancer (NSCLC). This designation is based on initial efficacy data from the ongoing AFM24-102 phase 1/2a study, which evaluates this combination in patients who have progressed after PD-(L)1 therapy and platinum-based chemotherapy. Fast Track status is intended to expedite the development of drugs that address serious conditions with unmet medical needs. Affimed will present updated data from the AFM24-102 study at the American Society of Clinical Oncology meeting on June 1, 2024.
- FDA Fast Track designation for AFM24 and atezolizumab combination therapy.
- Initial efficacy data from AFM24-102 study shows meaningful responses in heavily pretreated NSCLC patients.
- Potential to address unmet medical needs in advanced/metastatic EGFR wild-type NSCLC.
- Fast Track status allows for more frequent FDA engagement and expedited development.
- Focus on initial efficacy data might imply that conclusive results are not yet available.
- The combination therapy is still under investigation and not yet proven to be effective for a broader patient population.
- Patients have already exhausted standard treatments, indicating high treatment resistance and a challenging patient population.
Insights
The FDA's Fast Track designation for Affimed's combination therapy of AFM24 with atezolizumab is a significant milestone in the treatment of advanced non-small cell lung cancer (NSCLC). This designation is particularly impactful because it addresses a substantial unmet need in patients who have progressed despite standard treatments like PD-(L)1 inhibitors and platinum-based chemotherapy.
Fast Track is designed to accelerate the development and review of drugs, enabling more frequent interactions with the FDA, which can streamline the approval process. For patients, this means quicker access to potentially life-saving therapies. The fact that the clinical data shows compelling responses in a cohort resistant to prior checkpoint inhibitors suggests that AFM24 in combination with atezolizumab could provide a viable treatment option for this difficult-to-treat population.
In oncology, it's important to find treatments that work for patients who have exhausted standard options. The data presented so far indicates a meaningful response, which is a promising sign. However, it's important to await more comprehensive data from the ongoing AFM24-102 study to fully understand the efficacy and safety profile of this combination therapy.
The designation of Fast Track by the FDA for AFM24 in combination with atezolizumab underscores the promising nature of the initial efficacy data in treating EGFR wild-type NSCLC patients. The Fast Track status not only accelerates the drug’s review process but also implies that the initial results from the AFM24-102 study are sufficiently positive to warrant expedited development.
From a market perspective, this move could boost Affimed's stock as it signals potential progress towards a new therapeutic option. The reference to a Phase 1/2a study indicates that while there is still a long way to go before this combination therapy can be commercially available, the early-stage results are encouraging enough to justify further development. Investors should keep an eye on upcoming presentations at key medical conferences, as these will provide deeper insights into the drug's performance and potential market impact.
For retail investors, understanding the Fast Track designation is key. It doesn't guarantee approval but does increase the chances of quicker development and review, which can lead to earlier market entry if subsequent trial results are positive.
Affimed's announcement of the FDA's Fast Track designation for their combination therapy has significant financial implications. This designation typically results in increased investor confidence due to the potential for accelerated approval and quicker market entry. The anticipated presentation at the American Society of Clinical Oncology (ASCO) meeting on June 1, 2024, is likely to be a critical event for Affimed, potentially driving stock volatility based on the new data unveiled.
From a financial perspective, the Fast Track status is a positive signal. It suggests that the FDA sees an unmet medical need being addressed by this therapy, which can result in a faster time to market and potentially quicker returns on investment. In terms of valuation, this can lead to upward revisions based on expected future cash flows from the therapy, should it be approved and commercialized successfully.
Investors should monitor the upcoming ASCO presentation for detailed clinical data, as this will provide more context on the therapy's potential efficacy and safety profile, impacting future revenue projections. It's essential to consider both the short-term stock movements and long-term growth potential as more data becomes available.
- Efficacy and safety of AFM24 in combination with atezolizumab, a checkpoint inhibitor, is being evaluated in non-small cell lung cancer patients with EGFR wild-type and EGFR mutant advanced/metastatic cancers in the ongoing AFM24-102 phase 1/2a study
- The FDA’s Fast Track designation was granted after its review of the initial efficacy data of the EGFR wild-type cohort from the AFM24-102 study
- 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
- Company to host a conference call / webcast on June 1, 2024 at 7:00 p.m. EDT to discuss the updated data from the AFM24-102 trial
MANNHEIM, Germany, May 29, 2024 (GLOBE NEWSWIRE) -- Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, today announced 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. 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 on June 1, 2024.
“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 https://www.affimed.com/investors/webcasts-and-corporate-presentation/. 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.
About Affimed N.V.
Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com.
Forward-Looking Statement
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Forward-looking statements appear in a number of places throughout this release and include statements regarding the Company’s intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of acimtamig (AFM13), AFM24, AFM28 and the Company’s other product candidates, the value of its ROCK® platform, its ongoing and planned preclinical development and clinical trials, its corporate restructuring, the associated headcount reduction and the impact this may have on Company’s anticipated savings and total costs and expenses, its collaborations and development of its products in combination with other therapies, the timing of and its ability to make regulatory filings and obtain and maintain regulatory approvals for its product candidates, its intellectual property position, its collaboration activities, its ability to develop commercial functions, clinical trial data, its results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which it operates, the macroeconomic trends that may affect the industry or the Company, such as the instability in the banking sector experienced in the first quarter of 2023, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation, the impact on its business by political events, war, terrorism, business interruptions and other geopolitical events and uncertainties, such as the Russia-Ukraine conflict, the fact that the current clinical data of acimtamig in combination with NK cell therapy is based on acimtamig precomplexed with fresh allogeneic cord blood-derived NK cells from The University of Texas MD Anderson Cancer Center, as opposed to Artiva’s AlloNK® NK cells and other uncertainties and factors described under the heading “Risk Factors” in Affimed’s filings with the SEC. Given these risks, uncertainties, and other factors, you should not place undue reliance on these forward-looking statements, and the Company assumes no obligation to update these forward-looking statements, even if new information becomes available in the future.
Investor Relations Contact
Alexander Fudukidis
Director, Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel.: +1 (917) 436-8102
Media Contact
Mary Beth Sandin
Vice President, Marketing and Communications
E-Mail: m.sandin@affimed.com
FAQ
What is the significance of FDA Fast Track designation for AFM24 and atezolizumab?
What is being evaluated in the AFM24-102 phase 1/2a study?
When will updated data from the AFM24-102 study be presented?
Why is the Fast Track designation important for Affimed's AFM24 combination therapy?
