'We continue to make remarkable progress across our three clinical programs, AFM24, acimtamig, and AFM28,' said Dr.
Program Updates
Acimtamig (AFM13; CD30 / CD16A)
Independent read data from the first 7 patients show an ORR of 85.7 % with 4 CRs and 2 PRs.
All patients were heavily pretreated with a median of 4 lines of prior treatment including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 71 % (5/7 patients) had also failed after prior autologous stem cell transplantation (ASCT).
Treatment related adverse events were consistent with previous experience and were mainly mild to moderate IRR/CRS in nearly two thirds of the patients (4/7). One patient developed a short-lasting grade 3 CRS but was also diagnosed to have acute cytomegalovirus infection. All side effects were well manageable with standard of care treatment and there were no treatment discontinuations due to acimtamig or AlloNK related adverse events. No cases of bleeding, immune effector cell-associated neurotoxicity syndrome or graft-versus-host disease were observed. Enrollment in cohorts 1 and 2 is completed; cohorts 3 and 4 are now open and enrolling.
Continued updates from the study to be provided on upcoming earnings calls and scientific conferences.
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab): 4 confirmed responses (1CR, 4PR) and 8SD in 17 heavily pretreated EGFRwt NSCLC patients; mPFS of 5.9 months; 3 out of 4 responses ongoing for more than 7 months.
All patients were pretreated with platinum-based chemotherapy and checkpoint inhibitors PD [L]-1.
On
In 13 response-evaluable, heavily pretreated EGFRmut NSCLC patients, the combination of AFM24 with atezolizumab showed encouraging signals of clinical activity, including 1 CR, 3 PRs and 6 SDs. All responses are ongoing and have been confirmed by follow up scan.
ORR and PFS data from the 25 patient EGFRmut NSCL cohort is expected in Q3 2024; data from the 40 patient EGFRwt cohort is expected in Q4 2024.
AFM28 (CD123 / CD16A)
Completed enrollment of the sixth and final cohort in the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r acute myeloid leukemia (AML).
Of 6 patients treated at dose level 6 at 300mg, 1 patient showed a CR, 1 patient a CRi and 3 patients achieved SD, a CR/CRi rate of 33%.
Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, ongoing after 5 months; 5 patients achieved a SD as best response.
No dose-limiting toxicities were reported in dose levels 5 and 6.
Data from the study is expected to be presented at a future scientific conference.
Further clinical development of AFM28 to be pursued in combination with an allogeneic, off-the-shelf NK cell product.
Upcoming Milestones
Data readout from the 12 patients in cohorts 1 and 2 of the LuminICE-203 (AFM13 combination with AlloNK cells) study in Q3 2024.
ORR and PFS data from the 25 patients in the EGFRmut cohort of the AFM24-102 study in Q3 2024.
ORR and PFS data from the 40 patients in the EGFRwt cohort of the AFM24-102 study in Q4 2024.
First Quarter 2024 Financial Highlights
Affimed's consolidated financial statements are prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standard Board (IASB). The consolidated financial statements are presented in Euros (EUR), the Company's functional and presentation currency.
As of
Net cash used in operating activities for the quarter ended
Total revenue for the quarter ended
Research and development expenses for the quarter ended
General and administrative expenses for the quarter ended
Net finance income/costs for the quarter ended
Net loss for the quarter ended
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Additional information regarding these results will be included in the notes to the consolidated financial statements as of
Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the IASB. None of the financial statements were prepared in accordance with
About
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,
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 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 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
Contact:
Alexander Fudukidis
Email: a.fudukidis@affimed.com
Tel: +1 (917) 436-8102
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