BIOTECH · @_B_I_O_T_E_C_H_
6th Apr 2022 from TwitLonger
$AFMD @ #AACR22 Affimed Focus on AFM13 Precomplexed Cord Blood NK Cells and AFM24Phase 1 Dose Escalation
At AACR, AFMD's academic collaborators at MD Anderson will present updated two-treatment cycleexpansion cohort data from the AFM13 precomplexed cord blood NK cell investigator initiated trial,AFM13-104. Recall, AFM13-104 at the recommended phase 2 dose (1x108) had a 100% (12/12)investigator-assessed objective response rate (ORR) and a 42% (5/12) complete response rate (CR) inadvanced HL (n=11) or non-Hodgkin lymphoma (n=1) after a single cycle. FDA recently approved theprotocol amendment allowing AFMD to increase the patient population treated at the recommendedphase 2 dose (RP2D - 1x108 cbNK/Kg) to 40 CD30+ve patients lymphoma patients including HodgkinLymphoma (n=~30), non-Hodgkin Lymphoma (n=~10), and allow for additional cycles beyond theoriginal two.
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Innate cell engager (ICE) AFM13 combined with preactivated and expanded cord blood (CB)-derived NK cells for patients with relapsed/refractory CD30+ lymphoma. Presentation, CD003.Oral presenter - Yago Nieto. April 10, 2022 in the Clinical Trials of Cellular ImmunotherapiesSession starting at 1:00 p.m. CDT.
For AFM24-101, AFMD established a recommend phase 2 dose (RP2D) in patients with EGFR+vesolid tumors 4Q21. At AACR the company will present dose escalation data with a 10/29/21 data cuto including patients dosed at the RP2D of 480mg once weekly - dosing at 720mg is ongoing withno data at AACR. Focus of the presentation will be on pharmaco-kinetics/dynamics, however a clinicalupdate on patients dosed at 480mg is expected at the investor event;
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A phase 1/2a rst-in-human study of AFM24, a CD16A/epidermal growth factor (EGFR) bispecicInnate Cell Engager (ICE), in patients with locally advanced or metastatic EGFR-expressing solidtumors: Preliminary ndings from the dose-escalation phase. Abstract CT149. Poster presenter -Anthony El-Khoueiry. April 11, 2022 in the Phase 1 Clinical Trials Session starting at 1:30 p.m. CDT
Recall on the 3Q earnings call, AFMD provided the following highlights from the trial:
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4/6 480mg patients remain on-study: >50 days (EGFR mutated NSCLC with clinical benetdespite progression) and >99 days (EGFRm NSCLC) and >92 days (KRAS wild type colorectal)all of whom would be considered eligible for the monotherapy expansion cohort having failed allavailable therapy including an EGFR inhibitor; 4th patient >1 day.
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480mg led to saturation of CD16A on peripheral NK cells with consistent elevation of targetcytokines and NK cell activation markers.
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Estimated serum half life is 11.2 days; dose escalation to 720mg will evaluate potential for onceevery 2 or 3-week dosing
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Trough concentration with 320mg and 480mg comparable to ERBITUX
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10% CD16A receptor occupancy required for full NK cell activation
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Assuming a worst case 200-fold reduction in intratumoral AFM24 concentration, threshold for fullNK cell activation achieved
Later in the year AFMD expects to announce initial data from one or more cohorts from the threeongoing AFM24 Simon 2-stage expansion studies:
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monotherapy in EGFR+ve solid tumors - renal cell carcinoma, non-small cell lung cancer (NSCLC),and colorectal cancer (CRC)
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combination with anti-PD-L1 checkpoint inhibitor TECENTRIQ (AFM24-102) - NSCLC, gastric,gastroesophageal junction adenocarcinoma, and pancreatic/hepatocellular/biliary tract cancer, and
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combination with autologous NK cell product, SNK01 dosed at 4x109 per week (AFM24-103) -2nd line + NSCLC, squamous cell head and neck or CRC.