On March 23, 2023 Affimed N.V. (Nasdaq: AFMD) ("Affimed" or the "Company"), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the year ended December 31, 2022, and provided an update on clinical and corporate progress (Press release, Affimed, MAR 23, 2023, View Source [SID1234629289]).
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"During 2022, we presented data across our pipeline that show our innate cell engagers can deliver unprecedented efficacy when combined with NK cells, can activate and direct cytotoxic T cells to tumor cells, and can deliver meaningful single agent activity with a differentiated safety profile," said Adi Hoess, Chief Executive Officer at Affimed. "Supported by a cash runway into 2025, our Company is well positioned to execute on our strategic imperatives, with multiple catalysts across our pipeline expected in 2023. We are excited about this next critical stage of development which we believe can unlock the tremendous value of our platform."
Program Updates
AFM13 (CD30/CD16A)
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In January 2023, Affimed received feedback from the Food and Drug Administration (FDA) to its pre-investigational new drug (IND) meeting request in support of a planned clinical study to investigate AFM13 in combination with Artiva’s AB-101 natural killer (NK) cells. The Company is on track to submit the IND in the first half of 2023. Pending IND clearance, Affimed expects to initiate the combination clinical trial in 2023.
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AFM13-104: In December 2022, at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting, Affimed reported updated data from AFM13-104, the investigator sponsored trial (IST) led by The University of Texas MD Anderson Cancer Center investigating the combination of AFM13 combined with cord blood-derived NK cells followed by AFM13 monotherapy.
AFM13 in combination with NK cells showed very high overall and complete response rates in 41 heavily pre-treated CD30-positive Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL) patients.
Patients in the study had a median of seven prior lines of treatment and all patients had failed to demonstrate objective response to immediate prior line of therapy.
In the 35 patients treated at the recommended phase 2 dose (RP2D), a 94% objective response rate (ORR) and a complete response (CR) rate of 71% were observed.
In 31 patients with Hodgkin lymphoma treated at the RP2D, an ORR of 97% and a CR rate of 77% were observed.
In four NHL patients treated at the RP2D, three objective responses, including one CR in a patient with peripheral T-cell lymphoma, were observed.
63% of patients treated at the RP2D with at least 6 months of follow-up after the initial infusion (n=24) remained in complete response for at least 6 months. In addition, the treatment was well tolerated with no cases of cytokine release syndrome, immune effector cell-associated neurotoxicity or graft versus host disease observed.
Affimed expects to present updated data from this combination study at a scientific conference later in 2023.
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AFM13-202: An abstract highlighting AFM13 data from the monotherapy study (REDIRECT) investigating efficacy in patients with CD30-positive relapsed/refractory peripheral T cell lymphomas (PTCL) has been accepted for an oral presentation at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting.
AFM24 (EGFR/CD16A)
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Affimed expects to provide data updates from the three ongoing studies at scientific conferences in Q2 or Q3 of 2023. For AFM24-101, the Company expects to present data from approximately 15 patients from each of the non-small cell lung cancer and colorectal cancer cohorts. For AFM24-102 and AFM24-103, the update is expected to include data from the dose escalation portion of the respective clinical trials.
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AFM24-101: Affimed continues to enroll patients in the expansion phase of the AFM24 monotherapy study at the RP2D. The expansion cohorts include patients with renal cell carcinoma (clear cell), non-small cell lung cancer (EGFR mutant) and colorectal cancer.
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AFM24-102: In the phase 1/2a combination study of AFM24 with the anti-PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in patients with advanced epidermal growth factor receptor-expressing solid tumors, a 480 mg weekly dose of AFM24 was confirmed as the R2PD.
The expansion cohorts for AFM24-102, which include patients with non-small cell lung cancer (EGFR wildtype), gastric and gastroesophageal junction adenocarcinoma, and a basket cohort evaluating pancreatic/hepatocellular/biliary tract cancer, are now open and enrolling patients. The treatment showed a well-managed safety profile to date.
Data from the first cohort (4 patients at 160 mg dose) of the phase 1 dose escalation study presented at the annual meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) in November 2022 showed that clinical activity was observed in two patients. A patient with gastric cancer and skin metastases who had rapidly progressed following four prior lines of therapy, including a PD-1 inhibitor, achieved a partial response. A second patient with pancreatic adenocarcinoma showed stable disease beyond four months. Patients being enrolled in the study are required to have progressed or relapsed on standard of care therapies.
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AFM24-103: In the phase 1/2a combination study of AFM24 with SNK01, NKGen Biotech’s ex vivo expanded and activated autologous NK cell therapy, enrollment has been completed in the dose cohort of 480 mg AFM24 weekly, with no dose- limiting toxicities (DLTs) observed to date. The Company is recruiting three additional patients to confirm the 480 mg dose as the RP2D.
AFM24-103 is focused on the treatment of patients with non-small cell lung cancer (NSCLC, EGFR-wildtype), squamous cell carcinoma of the head and neck, and colorectal cancer.
AFM28 (CD123/CD16A)
In December 2022, the Company announced that Clinical Trial Applications (CTAs) were cleared in France and Spain. Since then, Belgium and Denmark have also approved the Company’s CTAs. The phase 1 study is now open and recruiting patients.
AFM28 is Affimed’s tetravalent, bispecific CD123- and CD16A-binding innate cell engager (ICE) designed to bring a new immunotherapeutic approach to patients with CD123-positive myeloid malignancies, including Acute Myeloid Leukemia and Myelodysplastic Syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels.
Clinical development of AFM28 is planned as both single-agent and in combination with NK cells in patients with CD123+ myeloid disease.
Partnerships and Collaborations
Partnered programs with Genentech and Affivant Sciences (a Roivant company) continue to progress.
During 2022, Affimed continued to work with Genentech pursuant to the previously disclosed research collaboration and license agreement between the companies and handed over a number of product candidates for further investigation by Genentech.
Affivant Sciences submitted two preclinical abstracts for AFVT-2101 (formerly AFM32) which have been accepted for poster presentation at the AACR (Free AACR Whitepaper) annual meeting in April 2023. Affivant expects to submit an IND for AFVT-2101 in the first half of 2023.
Full Year 2022 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 December 31, 2022, cash and cash equivalents were €190.3 million, with an anticipated cash runway into 2025.
Net cash used in operating activities for the year ended December 31, 2022 was €104.9 million compared to €86.6 million in 2021.
Total revenue for the year ended December 31, 2022, was €41.4 million compared with €40.4 million for the year ended December 31, 2021. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for 2022 increased by 21.3% from €81.5 million in 2021 to €98.8 million in 2022. The increase was primarily due to higher expenses associated with the development of the AFM24 and AFM28 programs, a result of an increase in manufacturing of clinical trial material and costs for the preparation of the filing of the IND application, an increase in costs associated with other early-stage programs and infrastructure, and an increase in share-based payment expenses.
General and administrative expenses increased 32.4% from €24.2 million in 2021, to €32.1 million in 2022. The increase predominately relates to higher personnel and share-based payment expenses and an increase in insurance premiums and higher consulting costs.
Net finance income for the year decreased from €6.5 million in 2021, to €2.1 million in 2022. Net finance income is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of currency fluctuations between the U.S. dollar and Euro during the year.
Net loss for the year ended December 31, 2022, was €86.0 million, or €0.60 loss per common share compared with a net loss of €57.5 million, or €0.48 loss per common share, for the year ended December 31, 2021.
The weighted number of common shares outstanding for the year ended December 31, 2022 was 142.4 million.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of December 31, 2022, 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 Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.
Conference Call and Webcast Information
Affimed will host a conference call and webcast on March 23, 2023, at 8:30 a.m. EDT / 13:30 CET to discuss full year and Q4 2022 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/BIbfecf0c35a2946dc88d3ae439cb5d3e2, 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.