On September 5, 2024 Affimed, a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results and provided an update on clinical and corporate progress for the quarter ended June 30, 2024 (Press release, Affimed, SEP 5, 2024, View Source [SID1234646694]).
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"We continue to generate compelling data across our clinical programs," said Dr. Andreas Harstrick, Chief Medical Officer of Affimed. "In solid tumors, our combination study is making significant progress, and we are excited to see objective responses and meaningful tumor control, even in patients with EGFR mutant lung cancer — a disease often resistant to immunomodulation. It’s particularly encouraging that these outcomes are achieved without chemotherapy, which is important given the intolerance many pretreated patients have for such treatments. Our programs in hematologic malignancies are also advancing well. Recent updates from the 12 patients of the LuminICE-203 study reveal remarkable efficacy, in an advanced Hodgkin lymphoma population that had exhausted all approved treatment options. Additionally, AFM28 continues to show promise as a monotherapy in AML. The data shared today underscore our strategy of leveraging the innate immune system in our fight against cancer and reinforce our commitment to advancing these clinical programs."
Pipeline Highlights:
AFM24 (EGFR / CD16A)
In the AFM24-102 trial (combination with atezolizumab):
24 heavily pretreated EGFRmut NSCLC patients are in the trial; in 17 patients that are response evaluable per protocol, 1 CR, 3 PRs and 8 SDs were observed. All responses have been confirmed by follow-up scan. ORR is 23.5% (4/17) and DCR is 70.6% (12/17). Median follow-up is > 7 months and 8 out of the 17 patients continue on treatment. All 4 responders remained on treatment for at least 7 months. Final PFS data from the EGFRmut cohort is expected at a scientific conference in H1 2025.
All patients were pretreated with TKIs (~60% with third generation TKIs) and the majority (76%) had also received platinum-based chemotherapy.
The EGFRwt NSCLC cohort of patients who failed chemotherapy and PD-1/PD-L1 has continued enrollment, with 40 patients on trial. ORR and safety for this cohort is expected in Q4 2024.
In May, the Company received FDA Fast Track designation for the combination treatment of AFM24 with atezolizumab for EGFRwt NSCLC patients.
Acimtamig (AFM13; CD30 / CD16A)
High efficacy observed in the first 12 patients with advanced HL in cohorts 1 and 2 of the Phase 2 LuminICE-203 study showing an ORR of 83.3 % and CRR of 50%.
In the multi-center, multi-cohort, open-label Phase 2 LuminICE-203 trial, patients with advanced, treatment refractory Hodgkin Lymphoma receive combination of CD30-targeting innate cell engager acimtamig (AFM13) with AlloNK.
All HL patients were heavily pretreated with a median of 4 lines of prior therapy, having exhausted all standard of care treatment options, including combination chemotherapy, brentuximab vedotin and checkpoint inhibitors; 50% of patients had also failed prior autologous or allogeneic stem cell transplantation (SCT).
Enrollment in cohorts 1 and 2 (acimtamig doses of 200 mg or 300 mg; AlloNK 2×109 per week for 3 weeks) is completed: In the 12 patients, 6 CRs and 4 PRs were observed.
Enrollment in cohorts 3 and 4 (acimtamig 200 mg or 300 mg; 4×109 in week one and 2×109 AlloNK in weeks 2 and 3) has progressed well with 10/12 patients on study.
Treatment related adverse events were consistent with previous experience and side effects related to acimtamig and AlloNK were well manageable with standard of care treatment.
Data from the study is expected to be presented at a scientific conference in Q4 2024.
AFM28 (CD123 / CD16A)
In the sixth cohort (300 mg) of the multi-center Phase 1 open-label, dose-escalation study (AFM28-101), of AFM28 monotherapy in CD123-positive r/r AML, 3 out of 6 patients (50%) showed a CR or CRi.
Of 6 patients treated at dose level 6 at 300 mg, 1 patient showed a CR, 2 patients a CRi for a composite complete response rate (CRcR, defined as CR+CRi) of 50% (3/6) and 2 patients achieved SD.
Of 6 patients treated at dose level 5 at 250 mg, 1 patient showed a CR, lasting 6 months, a CRR of 17% (1/6) ; the other 5 patients achieved SD as best response.
No dose-limiting toxicities were reported in dose levels 5 and 6.
An additional 6 patients will be enrolled at 300 mg of AFM28.
Data from the study is expected to be presented at a scientific conference in Q4 2024.
Upcoming Milestones:
LuminICE-203: Efficacy update of cohorts 1-4 expected to be presented at a future scientific conference in Q4 2024.
AFM24-102: ORR and safety data from the EGFRwt cohort in Q4 2024.
AFM28-101: Data from the study is expected to be presented at a scientific conference in Q4 2024.
AMF24-102: Mature PFS data from EGFRmut and EGFRwt cohorts expected to be presented at a future conference in H1 2025.
Second 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 (€), the Company’s functional and presentation currency.
As of June 30, 2024, cash, cash equivalents and short-term investments totaled €34.4 million. Based on current operating and budget assumptions, the Company expects that cash, cash equivalents and investments, together with anticipated proceeds from its ATM program and the sale of AbCheck, will finance its operations into the second half of 2025.
Net cash used in operating activities for the quarter ended June 30, 2024 was €16.5 million compared to €33.2 million for the quarter ended June 30, 2023. The decline was mainly due to lower research and development expenditure and personnel expenses due to the reduction in head count.
Total revenue for the quarter ended June 30, 2024, was €0.2 million compared with €1.4 million for the quarter ended June 30, 2023. Revenue in 2024 only related to a platform license provided to Genentech and 2023 predominantly related to the Roivant research collaborations for which all work has been completed.
Research and development expenses for the quarter ended June 30, 2024, were €11.7 million compared to €25.3 million in 2023. The decrease was primarily a result of lower expenses associated with the development of acimtamig and AFM24, due to a decrease in procurement of clinical trial material, clinical trial costs and manufacturing costs, decrease in head count due to the corporate restructuring.
General and administrative expenses for the quarter ended June 30, 2024, were €4.0 million compared to €6.3 million for the quarter ended June 30, 2023. The decrease was due to declines in headcount, in legal and consulting expenses, insurance expenses and share-based payment expenses.
Net loss for the quarter ended June 30, 2024, was €15.5 million, or €1.01 loss per common share compared with a net loss of €29.4 million, or €1.97 loss per common share, for the quarter ended June 30, 2023.
The weighted number of common shares outstanding for the quarter ended June 30, 2024, was 15,300,912 shares.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of June 30, 2024, included in Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).
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 U.S. Generally Accepted Accounting Principles. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast on September 5, 2024, at 8:30 a.m. EDT / 14:30 CET to discuss second quarter 2024 financial results and corporate developments.
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/BI53034c7725d043b0854377307e1cd8a3, and you will be provided with dial-in details and a pin number.
Note: To avoid delays, we encourage participants to dial into the conference call 15 minutes ahead of the scheduled start time. A replay of the webcast will be accessible at the same link for 30 days following the call.