AFM-24

In 33 heavily pretreated NSCLC EGFR wild-type (EGFRwt) patients the combination of AFM24 and atezolizumab shows an overall response rate (ORR) of 21% (6 confirmed responses, 1 response awaiting confirmatory scan) and a disease control rate (DCR) of 76%; tumor shrinkage was observed in 48% of patients; preliminary median progression free survival (PFS) is 5.6 months and 36% of patients remain on treatment In 17 heavily pretreated NSCLC EGFR mutant (EGFRmut) patients the combination shows an ORR of 24% and a DCR of 71%; tumor shrinkage was observed in 41% of patients; median PFS is 5.6 months and 5 patients (29%) are on treatment for over 10 months Both cohorts demonstrated a well-manageable side effect profile with no new safety signals identified A post hoc analysis demonstrated that patients who achieve higher exposure of AFM24 had significantly higher response rates and improved PFS and survival compared to patients with lower exposure Company to review results on a webcast today at 8:30 am EST / 14:30 CET Dec. 17, 2024 -- 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, today announced updated clinical data from the ongoing AFM24-102 trial of AFM24/atezolizumab combination therapy in heavily pretreated NSCLC patients. Results continue to demonstrate meaningful clinical activity in both NSCLC EGFRwt and EGFRmut patients with good tolerability. In addition, the Company reported findings from a post-hoc exposure-response analysis in patients treated with 480 mg AFM24 showing higher AFM24 exposure is associated with significantly better response rates, improved PFS and overall survival (OS). Based on these data, the future development program for AFM24 will use a dose of 720 mg weekly, a dose that has already been successfully tested in the phase 1 study of AFM24 showing a manageable safety profile. “With the compelling data from both EGFR wild-type and mutant cohorts, along with the exposure-response analysis we are unlocking the possibilities for the AFM24/atezolizumab combination in treating heavily pretreated NSCLC patients,” said Dr. Shawn Leland, PharmD, RPh, Chief Executive Officer of Affimed. “These findings highlight our opportunity to further refine and advance this treatment with a clear focus on patients who stand to benefit the most. We are excited about the path ahead and are committed to exploring innovative strategies to bring this promising therapy to those in need.” Patient population: As of the November 14, 2024 data cut, there were 43 patients in the full analysis set (FAS) and 33 patients in the per protocol set (PPS), defined as having one post baseline scan according to RECIST. Reasons for non-evaluability were early symptomatic deterioration (6), non-related AEs (2), too early (2). Patients had a median of 2 prior lines of therapy (range: 1–7). All patients had received platinum-based combinations and PD(L) 1 targeting checkpoint inhibitors (CPIs), and two-thirds had received taxanes. Importantly, all but one patient discontinued their previous CPI because of progression. Safety: The AFM24 and atezolizumab combination therapy was well tolerated with no unexpected safety findings. Infusion related reactions (IRRs) were the most common adverse event (AE) reported, in 54% of patients; IRRs were manageable, mostly present during the first infusion, and fully resolved. Elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST), a known side effect of atezolizumab, were reported in 21% and 16% of patients respectively. Anti-tumor activity and durability (N=33, PPS): The combination demonstrated an ORR of 21% (7 responses: 1 complete response (CR), 5 partial responses (PR) and 1 additional not yet confirmed PR), tumor shrinkage in 48% of patients (16/33 patients) and a DCR of 76%. In the 7 responders, 5 had never achieved an objective response on prior CPIs and only 2 patients had a PR on previous CPI containing treatment (both to a triplet of platinum, pemetrexed and CPI). The preliminary median PFS is 5.6 months, and 36% of patients are currently on treatment. Patient population: As of the November 14, 2024 data cut, 28 patients were in the FAS (reasons for non-evaluability at the cut-off were: ongoing with no scan yet 5, early deterioration 4, non-related AEs 2), with updated results presented for the first 17 patients in the PPS. All patients had received prior EGFR specific TKI therapy, and 77% had received platinum-based chemotherapy. Anti-tumor activity and durability (N=17, PPS): AFM24 combined with atezolizumab showed promising activity in refractory NSCLC EGFRmut patients achieving an ORR of 24% (4 confirmed responses: 1 CR, 3 PRs), a DCR of 71% and tumor shrinkage in 41% of patients. With a median follow-up of 9 months, the median PFS was 5.6 months. Five (29%) patients are on treatment for over 10 months, demonstrating long term tumor control. Analysis process: A post-hoc exposure-response analysis was conducted including NSCLC EGFRwt and EGFRmut subjects (n= 44) treated with 480 mg AFM24 in both the AFM24-101 monotherapy study or the AFM24-102 AFM24 combination with atezolizumab study. Low and high exposure groups were calculated using a median cut-point of patient`s mean trough values. Safety, anti-tumor activity and durability: Baseline characteristics were balanced between the high and low exposure groups and there were no differences in body mass index or percentage of administered dose that would explain differences in exposure. The high exposure group showed an ORR of 46% and a PFS of 7.4. A sensitivity analysis using quartiles of exposure supported a clear relationship between exposure and outcome indicating that higher doses of AFM24 will likely result in improved efficacy. The PK profile of 720 mg AFM24 weekly, as tested successfully in the phase 1 trial and further pharmacokinetic modelling indicate that 720 mg will achieve exposure levels that are equal or above the plasma concentrations observed for the high exposure group. “Advanced-stage NSCLC remains one of the most challenging cancers to treat, and our findings bring new hope,” said Dr. Andreas Harstrick, MD, Chief Medical Officer of Affimed. “We see compelling efficacy results with the AFM24/atezolizumab combination in heavily pretreated NSCLC patients, independent from the mutational status. The results are remarkable as we achieve this with a purely immunotherapy-based approach in patients that are often not able or not willing to take additional toxic therapies. The insights in the relation of exposure and efficacy will allow us to further improve on the efficacy and provide a clear path forward as we strive to unlock new possibilities for EGFR NSCLC patients.” AFM24 is a tetravalent, bispecific ICE® that activates the innate immune system by binding to CD16A on innate immune cells and epidermal growth factor receptors (EGFR), a protein widely expressed on solid tumors, to kill cancer cells. Generated by Affimed’s fit-for-purpose ROCK® platform, AFM24 represents a distinctive mechanism of action that uses EGFR as a docking site to engage innate immune cells for tumor cell killing through antibody-dependent cellular cytotoxicity and antibody-dependent cellular phagocytosis. Affimed (Nasdaq: AFMD) is a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer by actualizing the untapped potential of the innate immune system. The Company’s innate cell engagers (ICE®) enable a tumor-targeted approach to recognize and kill a range of hematologic and solid tumors. ICE® are generated on the Company’s proprietary ROCK® platform which predictably generates customized molecules that leverage the power of innate immune cells to destroy tumor cells. A number of ICE® molecules are in clinical development, being studied as mono- or combination therapy. Headquartered in Mannheim, Germany, Affimed is led by an experienced team of biotechnology and pharmaceutical leaders united by the bold vision to stop cancer from ever derailing patients’ lives. For more about the Company’s people, pipeline and partners, please visit: www.affimed.com. The content above comes from the network. if any infringement, please contact us to modify.

Plus, news about Akamis Bio, Tenaya Therapeutics, Reviva, Actuate Therapeutics, CG Oncology and Candel Therapeutics: Affimed shares early lung cancer data: In a Phase 1/2a trial, its bispecific innate cell engager, called AFM24, plus Roche’s Tecentriq reached a 21% overall response rate in 33 people with pretreated EGFR wild-type non-small cell lung cancer. The ORR was 24% in 17 EGFR-mutant patients. Affimed said it has selected the 720 mg dose for further development. Affimed’s shares $AFMD were down about 22% on Tuesday morning after it announced the data. — Ayisha Sharma Indapta Therapeutics gets $22.5M: The Houston and Seattle biotech raised the new round to fund clinical development of its allogeneic natural killer cell therapy. The biotech emerged with a $50 million Series A in February 2022. — Kyle LaHucik Oncolytic virus biotech has new funding and a deal in China: Akamis Bio announced that it raised new funding plus inked an out-licensing deal with Xuanzhu Biopharma for its lead candidate for up to $60 million. That figure includes private funding, the upfront for the outlicensing deal and biobucks, though CEO Howard Davis declined to disclose how much each portion is. Akamis, which rebranded from PsiOxus in 2023, is developing a gene therapy called NG-350A that is designed to target tumor cells and drive expression of CD40 agonist antibodies. The hope is that by engaging these key immune proteins, the therapy can trigger the immune system to attack the cancer. The company plans to use the funds to study the therapy in a Phase 1b rectal cancer trial. — Lei Lei Wu Tenaya’s shares slide: The company reported early results for an AAV therapy for three patients with a genetic heart condition called MYBPC3-associated hypertrophic cardiomyopathy. It pointed to biomarkers that suggested the therapy was having an initial effect, though it said “longer-term data are needed to characterize TN-201’s activity.” Tenaya said longer follow-up data as well as results from a higher dose cohort are expected next year. The company’s shares $TNYA fell 47% on Tuesday morning. — Lei Lei Wu Reviva’s long-term results for its schizophrenia drug: The Cupertino, CA-based biotech said brilaroxazine administered once daily showed sustained efficacy over one year in the open-label extension portion of a Phase 3 trial. There were no side effects with an incidence of more than 5%, but there was a 35% treatment discontinuation rate. Its stock $RVPH fell about 44% in trading on Tuesday morning. — Ayisha Sharma Actuate’s pancreatic cancer asset boosts survival: The drugmaker’s elraglusib in combination with gemcitabine and nab-paclitaxel (GnP) almost doubled the one-year survival rate versus GnP alone in a Phase 2 trial, good for a p-value of 0.002. Actuate said that 38% of treated patients were still alive at the cutoff date in November, compared with 19% of the control cohort. The company’s share price $ACTU was up 14% at market open on Tuesday. — Ayisha Sharma CG Oncology raised $238 million in its public offering, up from the $204 million it planned to bring in. — Jaimy Lee Candel ended up raising $92 million in its public offering. — Jaimy Lee