Affimed(US:AFMD)2022-03-30 16:00Product Development - The company is focused on developing innovative cancer immunotherapies using its ROCK® platform, which enables the creation of bispecific and trispecific antibodies [247]. - The lead product candidate, AFM13, is currently in a phase 2 registration-directed study for relapsed/refractory peripheral T-cell lymphoma (PTCL) and is being tested in combination with adoptive NK cells [260]. - AFM24, a bispecific innate cell engager targeting EGFR and CD16A, is undergoing a phase 1/2a study as monotherapy and in combination with NK cells and a PD-L1 inhibitor [261]. - The third candidate, AFM28, targets CD123 for acute myeloid leukemia (AML) and is expected to submit an IND application in the first half of 2022 [262]. - The company has three distinct product candidates in its development pipeline: AFM13, AFM24, and AFM28, targeting high unmet medical needs in salvage settings [291]. - The company is developing next-generation bispecific antibodies, known as innate cell engagers (ICE®), designed to create an immunological synapse between innate immune cells and cancer cells [273]. - AFM13 has shown a complete response rate of 7 out of 12 patients (58.3%) treated at the recommended phase 2 dose level of 108 cbNK cells per kg, with an overall response rate of 89.5% (17 of 19 patients) in a clinical study [303]. - In a phase 1b clinical study combining AFM13 with Keytruda®, the objective response rate was 88% (21 of 24 patients), with complete metabolic responses in 46% (11 of 24 patients) [305]. - AFM24 is being developed for advanced cancers expressing EGFR, with a recommended phase 2 dose identified as 480 mg based on safety and pharmacokinetic data [316]. - AFM28 is in preclinical development for acute myeloid leukemia, with an IND application expected to be filed in the first half of 2022 [322]. Collaborations and Partnerships - Collaborations with The MD Anderson Cancer Center and Genentech are aimed at enhancing the development of innate cell engagers and expanding the product pipeline [255]. - A strategic collaboration with Roivant Sciences included an upfront payment of $60 million and potential milestones of up to $2 billion [326]. - Genentech collaboration resulted in an upfront payment of $96 million for the development of NK cell engager-based immunotherapeutics [332]. - The company has received $4.4 million from The Leukemia & Lymphoma Society (LLS) for the clinical development of AFM13, with matching contributions from the company [344]. - Under the MDACC License Agreement, the company is eligible for milestone payments of up to $27 million for development, $52.5 million for regulatory, and $90 million for commercial milestones related to AFM13 [341]. Regulatory and Market Strategy - The company aims to establish a commercial sales force in the U.S. and/or Europe to support the commercialization of its product candidates upon approval [249]. - The company plans to explore the use of its product candidates as first- or second-line treatments in combination with existing standard care therapies upon approval [291]. - The company has received orphan drug status for AFM13 for the treatment of Hodgkin Lymphoma (HL) and T-cell lymphoma in the United States and the European Union [294]. - The FDA cleared an IND application for AFM24 in combination with SNK01 NK cells, with enrollment initiated in November 2021 [317]. - The company plans to take advantage of the accelerated assessment procedure for products of major public health interest, which requires an opinion within 150 days [427]. Financial and Operational Aspects - The company employs 197 people, with approximately 70% holding advanced academic degrees, indicating a strong talent pool for R&D efforts [252]. - The company is eligible to receive up to approximately $5.0 billion in total milestone payments, with $250 million related to development activities, $1.1 billion for regulatory approvals, and $3.6 billion for worldwide net sales thresholds [334]. - The company has retained exclusive commercialization rights to AFM13 and is subject to royalty payments to LLS based on net sales until certain caps are reached [345]. - The financial information is prepared in accordance with IFRS, which may differ from other jurisdictions' accounting principles [445]. Intellectual Property - The company has filed patent applications for its product candidates, including AFM13, AFM24, and AFM26, with various expiration dates ranging from 2026 to 2040 [352][355][356]. - The company has joint ownership of newly developed intellectual property with Genentech, with final decisions on patent prosecution made by the respective party owning the intellectual property [338]. - The company owns a patent portfolio for its immune cell engager platform, with patents expiring in 2019 and a pending application expected to expire in 2030 [358]. - A trispecific antibody format has been developed, with patents granted in Europe, Japan, and South Africa, and a pending application that could expire in 2036 [360]. Clinical and Safety Data - The safety profile of AFM13 is favorable, with infusion-related reactions being the main side effect, which were reduced following the introduction of mandatory premedication [298]. - Six of seven patients refractory to Adcetris® experienced stabilization of disease following AFM13 treatment, with one patient showing progressive disease [312]. - A dose-dependent effect was observed for AFM13, with the most active doses at or above 1.5 mg/kg, and a mean half-life of 9-19 hours for doses 1.5 mg/kg and above [312]. - In the phase 2a study, AFM13 will be administered at a dose of 1.5 mg/kg more frequently than previously, with treatment duration longer than four weeks [313]. Market Environment - The biopharmaceutical industry is characterized by intense competition, with many companies developing treatments for cancer using advanced technologies [370]. - Competitors may obtain regulatory approvals more rapidly, potentially establishing a strong market position before the company can enter the market [379]. - The company relies on contract manufacturing organizations (CMOs) for drug substance and product, ensuring compliance with Good Manufacturing Practice (GMP) regulations [368]. - Regulatory approval processes require substantial time and financial resources, with a focus on the United States and Europe, as well as other markets like Canada and Japan [382].