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Affimed N.V. (Nasdaq: AFMD) is a clinical-stage biopharmaceutical company headquartered in Mannheim, Germany, with additional offices in New York, NY. Affimed is dedicated to leveraging the power of the innate immune system to develop innovative immuno-oncology therapies primarily aimed at treating various cancers. The company is at the forefront of developing its proprietary innate cell engagers (ICE®), which are designed to target and eliminate both hematologic and solid tumors.
At the core of Affimed's innovation is their ROCK® platform, a state-of-the-art technology that generates customized ICE® molecules. These molecules harness the natural power of immune cells, such as natural killer (NK) cells and T-cells, to target and destroy cancer cells. Affimed's lead products include AFM13 (acimtamig), AFM24, and AFM28, which are currently undergoing various stages of clinical trials.
AFM13, the company's flagship innate cell engager, shows promise in treating CD30-positive hematologic tumors. It has demonstrated significant clinical efficacy in heavily pretreated patients with refractory Hodgkin lymphoma, achieving high objective response rates (ORR) and complete response (CR) rates. AFM13 is being investigated in combination with NK cells in the LuminICE-203 study, with initial data expected in the first half of 2024.
AFM24 is another key candidate, targeting EGFR-expressing solid tumors. It is currently being tested in combination with atezolizumab, a checkpoint inhibitor, in the AFM24-102 Phase 1/2a study. Recent data showed a disease control rate of 73.3% in heavily pretreated patients with EGFR wild-type non-small cell lung cancer (NSCLC), including significant objective responses. The FDA has granted Fast Track designation for this combination therapy, highlighting its potential to meet unmet medical needs.
AFM28 targets CD123-positive acute myeloid leukemia (AML). Preclinical studies have shown that AFM28 can effectively reduce tumor growth and eliminate leukemic blasts and stem cells. The drug is currently in early clinical development, with future plans to test it in combination with allogeneic off-the-shelf NK cells.
Affimed is also committed to strategic collaborations and partnerships to advance its clinical programs. Notable collaborations include those with Artiva Biotherapeutics, The University of Texas MD Anderson Cancer Center, and Roche. These partnerships are aimed at enhancing the efficacy and safety profiles of Affimed's therapies and bringing innovative treatments to patients more quickly.
Despite facing challenges such as restructuring and a reduction in workforce, Affimed remains focused on advancing its clinical pipeline. The company's strong leadership team, extensive experience in biotechnology and pharmaceuticals, and a clear mission to revolutionize cancer treatment underscore its commitment to giving patients back their innate ability to fight cancer.
For more information about Affimed's people, pipeline, and ongoing projects, please visit www.affimed.com.
Affimed N.V. (Nasdaq: AFMD) presented new data on AFM24 and AFM28 at the NK2022 conference, highlighting their potential in cancer treatment. The AFM24 data showed its efficacy as a CD16A/EGFR-targeting bispecific innate cell engager, stimulating anti-cancer immunity in patients with EGFR-expressing tumors. Meanwhile, AFM28 demonstrated anti-leukemic effects when combined with NK cells, suggesting it could offer an off-the-shelf therapy for AML and MDS patients. Both compounds are currently undergoing phase 1/2a clinical studies.
Affimed N.V. (Nasdaq: AFMD) announced the upcoming first-in-human phase 1 study of its bispecific innate cell engager AFM28, targeting CD123 in patients with relapsed/refractory acute myeloid leukemia (AML). This innovative therapy showed promising results in preclinical studies, effectively destroying CD123-positive tumor cells while sparing healthy cells. Toxicology models indicated low risks of side effects such as cytokine release syndrome. The study is set to begin in the second half of 2022, with a poster presentation scheduled at the EHA Annual Meeting in June 2022.
Affimed N.V. (Nasdaq: AFMD) announced that the American Society of Clinical Oncology (ASCO) has removed the oral presentation of the AFM13-104 trial from its conference program. This decision was due to ASCO's embargo policy, following the recent data presentation at the AACR Annual Meeting on April 10, 2022. Affimed clarified that this removal is unrelated to the ongoing trial's status or results. The company is collaborating with The University of Texas MD Anderson Cancer Center to submit additional data on AFM13-104 to a future scientific forum.
Affimed N.V. (Nasdaq: AFMD) announced acceptance of four abstracts for the American Society of Clinical Oncology (ASCO) Annual Meeting, occurring June 3-7, 2022, in Chicago.
The presentations will cover phase 1/2 studies of AFM13 and AFM24, targeting CD30-positive lymphomas and advanced EGFR-expressing solid tumors, respectively. Notably, an oral presentation will detail AFM13 combined with NK cells in CD30-positive lymphoma patients, while three posters will outline the AFM24 studies involving monotherapy and combinations with other treatments.
Affimed N.V. (Nasdaq: AFMD) announced the successful closure of its public offering of 22,500,000 common shares at $4.00 per share. The underwriters exercised their option for an additional 3,375,000 shares, raising total gross proceeds to $103.5 million. The offering was facilitated by Jefferies LLC, SVB Leerink, Truist Securities, and Wells Fargo Securities, among others. Effective from April 6, 2022, the shelf registration statement allows the company to issue these securities. Funds raised will support Affimed's immuno-oncology initiatives.
Affimed N.V. (Nasdaq: AFMD) announced a public offering of 22,500,000 common shares priced at $4.00 each, with a potential additional 3,375,000 shares from underwriters. The offering is expected to generate approximately $84.6 million after discounts and is projected to close around April 18, 2022. This funding is aimed at supporting the company's clinical-stage immuno-oncology research and initiatives. Jefferies LLC and other firms are managing the offering, which will be conducted through a prospectus filed with the SEC.
Affimed (Nasdaq: AFMD), a clinical-stage immuno-oncology company, announced an underwritten public offering of common shares on April 12, 2022. The offering includes a 30-day over-allotment option for underwriters to purchase up to 15% more shares. Affimed will sell all shares in this offering, which depends on market conditions, with no guarantees on completion or terms. Jefferies LLC, SVB Leerink, Truist Securities, and Wells Fargo Securities are the joint book-running managers. A preliminary prospectus has been filed with the SEC and is available online.
Affimed N.V. has reported promising results from its ongoing Phase 1/2 study of AFM13 combined with cord blood-derived NK cells for treating refractory CD30-positive lymphomas. The study achieved a 100% objective response rate and a 62% complete response rate in 13 patients after two treatment cycles. Notably, seven patients maintained their complete response at a median follow-up of 6.5 months. Treatment was well tolerated, with minimal side effects. The FDA has approved an amendment to allow additional treatment cycles, potentially enhancing efficacy.
Affimed N.V. (Nasdaq: AFMD) announced progress in the phase 1/2a study of its Innate Cell Engager (ICE®) AFM24. The recommended phase 2 dose was established at 480 mg, demonstrating a well-managed safety profile and pharmacodynamic activity observed from 160 mg upwards. The maximum tolerated dose has not yet been reached, and dose escalation continues to 720 mg. In total, the clinical AFM24 program involves three studies across seven indications, focusing on patients with EGFR-expressing tumors. Updates on the studies are anticipated later in 2022.
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