Heidelberg,
'In the past months, we have significantly expanded our efforts to ensure the development of our leading candidates, AFM13 and AFM24, which we believe will result in multiple catalysts over the next several quarters,' said
Clinical Stage Program Updates
AFM13 (CD30/CD16A)
Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in
REDIRECT is a phase 2, registration-directed study of AFM13 monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Affimed reported that there were no dose-limiting toxicities observed in the dose escalation part of the investigator sponsored study (IST) at
AFM24 (EGFR/CD16A)
For AFM24, an EGFR/CD16A targeted innate cell engager (ICE) for patients with EGFR-expressing solid tumors, Affimed is executing a strategy intended to deliver the highest probability of success. As such, the objective is to treat patients with EGFR-expressing tumors with AFM24 as monotherapy (AFM24-101) in 3 indications, with AFM24 in combination with an anti-PD-L1 antibody (AFM24-102) in at least 3 indications and with AFM24 in combination with autologous NK cells in 3 indications (AFM24-103).
In AFM24-101, the monotherapy phase 1/2a clinical trial, a weekly dose of 480 mg has been identified as the recommended phase 2 dose based on a comprehensive review of safety, pharmacokinetic and pharmacodynamic data, including exposure and NK cell CD16A receptor occupancy. Of note, four out of six patients dosed in the 480 mg cohort remain on therapy based on investigator assessment of clinical benefit; two of these patients have demonstrated stable disease beyond three months and continue on treatment. Affimed expects to start the dose expansion phase of the trial at the recommended phase 2 dose in the fourth quarter of 2021. The trial will include the following indications: Renal cell carcinoma (clear cell), failing standard of care (SoC) including TKIs and PD1 targeted therapy, Non-small cell lung cancer (EGFR-mutant), failing SoC TKIs and PD1 naive and Colorectal cancer, failing chemotherapy plus EGFR-targeted antibodies In parallel, Affimed will continue to evaluate higher doses of AFM24 to generate additional safety data, and enrollment has begun in a cohort to evaluate a weekly dose of 720 mg.
AFM24-102, the phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) in EGFR-expressing solid tumors, is on track to start in the fourth quarter of 2021. The combination trial will include the following indications: Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy, Gastric/gastroesophageal junction (GEJ) cancer failing chemotherapy and/or PD1 targeted therapy and A basket of EGFR-expressing tumors comprising pancreatic, hepatocellular and biliary tract cancer failing standard of care therapy for the respective disease
AFM24-103, the phase 1/2a combination study of AFM24 with NKGen Biotech's autologous NK cell therapy, SNK01, a first-in-human proof of concept trial in EGFR-expressing solid tumors, is now open to recruit patients. As previously announced, the combination trial will include the following indications: Non-small cell lung cancer (EGFR-wildtype), failing chemotherapy and PD1 targeted therapy, Squamous cell carcinoma of the head and neck, failing chemotherapy and PD1 targeted therapy and Colorectal cancer including those with mutations, failing standard of care therapy
Preclinical Program
AFM28 (CD123/CD16A)
Preclinical candidate AFM28, developed on the company's proprietary ROCK platform, is a bispecific, tetravalent ICE that targets CD16A on NK cells and macrophages, as well as CD123 on leukemic cells and leukemic stem cells that are prevalent in AML. The high affinity to CD16 and CD123 initiates antibody-dependent cell-mediated cytotoxicity (ADCC) against CD123+ tumor cells.
Preclinical data demonstrates that AFM28 induces tumor cell lysis more potently than conventional anti-CD123 antibodies, even at low CD123 expression. Further, AFM28 shows a 100-fold more potent NK cell activation in an ex vivo analysis, compared to Fc-enhanced IgG1 antibodies. In a preclinical toxicology study in cynomolgus monkey, AFM28 was safe and well-tolerated and exhibited the expected pharmacodynamic activity suggesting a good safety profile and the potential to eliminate CD123+ cells in vivo. Clinical investigation of AFM28 is planned to start in second half of 2022.
Third Quarter 2021 Financial Highlights
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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
A live audio webcast of the conference call will be available in the 'Webcasts' section on the 'Investors' page of the Affimed website at https://www.affimed.com/investors/webcasts_cp/. A replay of the webcast will be accessible at the same link for 30 days following the call.
About
Forward-Looking Statements
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 our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the potential of AFM13, AFM24, AFM28 and our other product candidates, the value of our ROCK platform, our ongoing and planned preclinical development and clinical trials, our collaborations and development of our products in combination with other therapies, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates, our intellectual property position, our collaboration activities, our ability to develop commercial functions, clinical trial data, our results of operations, cash needs, financial condition, liquidity, prospects, future transactions, growth and strategies, the industry in which we operate, the trends that may affect the industry or us, impacts of the COVID-19 pandemic, the benefits to Affimed of orphan drug designation and the risks, uncertainties and other factors described under the heading 'Risk Factors' in Affimed's filings with the
Contact:
Investor
Alexander Fudukidis
Director
Head of Investor Relations
E-Mail: a.fudukidis@affimed.com
Tel: +1 (917) 436-8102
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