Biodesix Announces New Clinical Utility Evidence for the Nodify XL2® Nodule Risk Assessment Test to be Presented at ATS 2022 International Conference

On May 12, 2022 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported new clinical utility data highlighting the impact of the Nodify XL2 Risk Assessment Test on clinical management decisions in patients with lung nodules will be presented at the American Thoracic Society (ATS) 2022 International Conference (Press release, Biodesix, MAY 12, 2022, View Source [SID1234614416]). The meeting will take place May 13-18, 2022, in San Francisco, California.

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Data from the abstract titled, The Impact of Plasma Proteomics Biomarker on Clinical Management Decision in Lung Nodules, presented by Dr. J. P. Uribe of Deaconess Medical Center, Boston, Massachusetts, United States, will highlight data that show the impact of the Nodify XL2 integrated proteomic classifier on management decisions in a "real world" clinical setting. Conclusions show that when used in patients with lung nodules with a nodule probability of malignancy (pCA) of ≤ 50%, the blood-based lung nodule risk assessment test was able to support a decrease in chest imaging, outpatient clinic visits and additional invasive procedures without misclassifying benign lung nodules.

An additional presentation titled, ALTITUDE trial design: A Multicenter, Randomized Controlled Trial, Prospectively Evaluating the Clinical Utility of the Nodify XL2 Proteomic Classifier in Incidentally Discovered Low to Moderate Risk Lung Nodules, will review the ALTITUDE study, a first-in-class biomarker study which aligned with the recommendations from the official 2018 American Thoracic Society (ATS) policy statement on the early detection of lung cancer. The abstract, authored by Michael N. Kammer, Ph.D. of Vanderbilt University Medical Center, Nashville, Tennessee, Steve Springmeyer, MD, Biodesix, Boulder, Colorado and Gerard Silvestri, MD of Medical University of South Carolina, Charleston, South Carolina will be presented at ATS by Dr. Michael Kammer.

Both poster presentations will occur during ATS discussion Session B30 – THE QUEST FOR THE HOLY GRAIL: MODELING AND BIOMARKERS FOR NODULES AND LUNG CANCER. The session, moderated by Edwin Ostrin, MD, PhD. from MD Anderson Cancer Center, Houston, Texas and Adam Fox, MD, from Medical University of South Carolina, Charleston, South Carolina, will occur at the ATS meeting on May 16th, 2022, from 9:30-11:00AM PT, Room 203-204 (South Building, Level 2), Moscone Center.

Autolus Therapeutics to Present Four Clinical Data Updates at the European Hematology Association Congress

On May 12, 2022 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the online publication of four abstracts submitted to the European Hematology Association (EHA) (Free EHA Whitepaper) Congress to be held June 9-12, 2022. Autolus plans to present more detail on these programs and the next steps in a conference call following the EHA (Free EHA Whitepaper) presentations, on June 13, 2022, details below (Press release, Autolus, MAY 12, 2022, View Source [SID1234614415]).

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"We are delighted to be presenting encouraging early clinical data from four of our pipeline programs, including important additive safety and efficacy data from our lead asset obe-cel in indications beyond adult r/r B-ALL. These data demonstrate the inherent value in both our pipeline and our technology base from which it originates," said Dr. Christian Itin, Chief Executive Officer of Autolus. "With oral presentations on the early safety, tolerability, feasibility and preliminary efficacy of AUTO4 and AUTO1/22, we’re in a great place to evaluate the next strategic steps for these candidates and further build on the data presented here."

Abstracts to be presented:

Title: Safety and preliminary efficacy findings of AUTO4, a TRBC1-targetting CAR, in relapsed/refractory TRBC1 positive selected T Cell Non-Hodgkin Lymphoma LINK
Session Title: Gene therapy and cellular immunotherapy – Clinical 2
Session date and time: Saturday, June 11 – 16:30 – 17:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S261
Presenting Author: Kate Cwynarski
Summary: Peripheral T cell lymphomas (PTCL) are typically aggressive, treatment resistant, and associated with poor prognosis. Finding the right target is challenging because there is a lack of tumor-specific antigens, and pan-T cell depletion leads to immunosuppression. T cell lymphoma is clonal, and tumor cells express either TRBC1 or TRBC2. AUTO4 targets TRBC1+ cells, which allows part of the T cell compartment to be retained. As of 9 February 2022, 9 patients screened for r/r TRBC1+ peripheral T-cell lymphoma have been treated with AUTO4. Two patients had prior stem cell transplantation. After lymphodepletion with Flu/Cy, 3 patients received 25 x 106 CAR T cells, 2 patients received 75 x 106 CAR T cells, 1 patient received 225 x 106 CAR T cells and 3 patients received 450 x 106 CAR T cells. AUTO4 demonstrated a tolerable safety profile, with no patient experiencing any dose limiting toxicities, and no neurotoxicity/immune effector cell-associated neurotoxicity (ICANS). Three patients experienced cytokine release syndrome (CRS) (1 patient with Grade 1, 1 patient with Grade 2 and 1 patient with Grade 3). Of the 9 patients treated, 5 patients had achieved complete metabolic responses (CMR) by PET-CT at Month 1, 1 patient remains with a partial response (PR) 6 months post AUTO4 infusion, and 3 patients did not respond. All 3 patients at the highest dose level achieved a CMR at Month 1.

Title: Dual antigen targeting with co-transduced CD19/22 CAR T cells for relapsed/refractory ALL (AUTO1/22) LINK
Session Title: Gene therapy and cellular immunotherapy – Clinical 1
Session date and time: Saturday, June 11 – 11:30 – 12:45 CEST
Session room: Hall Strauss 1-2
Final Abstract Code: S259
Presenting Author: Sara Ghorashian
Summary: CD19 negative escape is a major cause of relapse after CD19 CAR T cell therapy for relapsed/refractory (r/r) pediatric ALL. To overcome this challenge, AUTO1/22 builds on the favorable safety profile and excellent persistence of obe-cel by combining it with an additional CD22 targeting CAR. As of 8 February 2022, 10 pediatric ALL patients have been treated with AUTO1/22 and 8 are evaluable with >1 month follow-up. 5 of 8 patients had relapsed post allogeneic stem cell transplant (SCT), 4 had received prior Blincyto and 3 had relapsed after prior Kymriah. CRS occurred in 7/8 patients (grade 1 n=2, grade 2 n=5), but severe CRS was not seen. 7 of 8 evaluable patients achieved MRD negative complete response (CR) at 1 month post infusion. Overall, at a median follow up of 4.8 months, 5/8 patients remain in MRD negative CR at last follow up. The study results demonstrate that dual CD19/22 targeting CAR T cells generated by co-transduction show an acceptable safety profile, with robust expansion/persistence and early efficacy in a heavily pre-treated cohort. To date with limited follow-up we have not observed antigen negative relapse but longer follow up is needed.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory Primary CNS Lymphoma LINK
Session Title: Poster session
Session date and time: Friday, June 10 – 16:30 – 17:45 CEST
Final Abstract Code: P1460
Presenting Author: Claire Roddie
Summary: Relapsed/refractory primary central nervous system lymphoma (PCNSL) has a median overall survival of 2-8 months and few therapeutic options. obe-cel (AUTO1) has previously demonstrated high remission rates, low incidence of CRS/ICANS and long-term persistence, making it a viable treatment option for PCNSL. As of 14 February 2022, the CAROUSEL study enrolled 6 patients with r/r PCNSL where the median prior lines of treatment was 2. 5 patients were infused with IV AUTO1 and 1 patient with intraventricular AUTO1. Following CAR T infusion, Grade 1 and 2 CRS affected 1 and 3 patients respectively and any Grade ICANS was observed in 2 patients with 2 Grade 3 events. AUTO1 engraftment and response was evaluable in 4 patients at 1 month following iv infusion. 2 of 4 patients had no measurable disease at 2 and 6 months of follow up respectively. AUTO1 showed encouraging remission rates and excellent CAR T engraftment/expansion in the blood and CSF. Intraventricular administration was well-tolerated and showed that AUTO1 has activity via that route in a patient who failed IV therapy. Additional patients updated biological data and longer follow up will be presented.

Title: Safety and efficacy findings of AUTO1, a fast off-rate CD19 CAR, in relapsed/refractory B-Cell Non-Hodgkin’s Lymphoma (B-NHL), and chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) LINK
Session Title: Poster session
Session date and time: Friday, June 10 – 16:30 – 17:45 CEST
Final Abstract Code: P1459
Presenting Author: Claire Roddie
Summary: obe-cel (AUTO1) has demonstrated an excellent safety profile in previous trials, with low levels of CRS/ICANS and long-term engraftment of CAR T cells, making it an ideal CAR T candidate to evaluate in B-NHL, CLL/SLL. As of 8 February 2022, 19 patients had been infused with AUTO1; 10 with low grade NHL, 6 with DLBCL and 3 with CLL. Patients treated had received a median of 3 prior lines of treatment. Grade 1 CRS was reported in 6/19 and Grade 2 CRS in 3/19. No ICANS was observed in the B-NHL and CLL cohorts. In the lg-NHL and DCBCL cohorts, 10/10 and 4/5 evaluable patients respectively were in CMR post-treatment. Responses were ongoing in 9/10 lg-NHL at 12 months and in 4/4 DLBCL at months 1,3,3 and 6. In the CLL cohort, 2/3 evaluable patients achieved MRD negative remission in the bone marrow with residual small volume lymph nodes by CT at 6 and 3 months of follow up respectively. AUTO1 demonstrated a tolerable safety profile in patients with r/r B-NHL and CLL despite high disease burden. Early data shows excellent complete remission rates and CAR engraftment/expansion. Additional patients, updated data and longer follow up will be presented.
Conference Call

Management will host a conference call and webcast on June 13, 2022 at 7:30 am ET/12:30 pm BST to discuss the EHA (Free EHA Whitepaper) data. To listen to the webcast and view the accompanying slide presentation, please go to the events section of Autolus’ website.

The call may also be accessed by dialing (866) 679-5407 for U.S. and Canada callers or (409) 217-8320 for international callers. Please reference conference ID: 6594553. After the conference call, a replay will be available for one week. To access the replay, please dial (855) 859-2056 for U.S. and Canada callers or (404) 537-3406 for international callers. Please reference conference ID: 6594553.

Mustang Bio Announces Results from Follicular Lymphoma Cohort of Ongoing Phase 1/2 Clinical Trial of MB-106, CD20-Targeted CAR T Therapy, Selected for Oral Presentation at European Hematology Association 2022 Hybrid Congress

On May 12, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that results from the follicular lymphoma ("FL") cohort of the ongoing Phase 1/2 clinical trial of MB-106, a CD20-targeted, autologous CAR T cell therapy, in patients with relapsed or refractory B-cell non-Hodgkin lymphomas ("B-NHLs") and chronic lymphocytic leukemia ("CLL") were selected for an oral presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress ("EHA2022") taking place June 9-12, 2022, both virtually and in Vienna, Austria (Press release, Mustang Bio, MAY 12, 2022, View Source [SID1234614413]).

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The on-site presentation by Mazyar Shadman, M.D., M.P.H., Associate Professor and physician at Fred Hutchinson Cancer Center ("Fred Hutch") and University of Washington will provide updated data on patients with FL beyond what is available in the abstract published today on the EHA (Free EHA Whitepaper)2022 website and what was presented at the recent Tandem meetings. MB-106 is being developed in a collaboration between Mustang and Fred Hutch.

"Acceptance for oral presentation at major international meetings such as EHA (Free EHA Whitepaper)2022 is a prestigious accomplishment, and we’re pleased that the Scientific Program Committee has granted Dr. Shadman this highly visible opportunity to present Fred Hutch’s compelling data on patients with relapsed or refractory follicular lymphoma in the ongoing Phase 1/2 clinical trial of MB-106," said Manuel Litchman, M.D., President and Chief Executive Officer of Mustang. "Furthermore, as we present our data to more investigators at peer-reviewed meetings, we are encouraged by the enthusiasm of these investigators for the durability of the responses and for the expansion of enrollment at Fred Hutch from CAR T naïve follicular lymphoma patients to patients previously treated with CAR Ts and to patients with other CD20-positive histologies such as diffuse large B cell lymphoma, Waldenstrom macroglobulinemia and CLL. Finally, as Mustang continues to advance our CD20-targeted CAR T cell therapy program, we look forward to the planned dosing of the first patient in a multicenter Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL under Mustang’s IND this quarter."

Details of the presentation are as follows:

Title: Efficacy and Safety of a Third Generation CD20 CART (MB-106) for Treatment of Relapsed/Refractory Follicular Lymphoma (FL)
Session: Indolent and mantle-cell lymphoma
Session Date and Time: Saturday, June 11, 11:30 am – 12:45 pm Central European Time
Session room: Hall C1
Abstract Code: S207

For more information about EHA (Free EHA Whitepaper)2022, please visit: View Source

Scientists at Fred Hutch played a role in developing these discoveries, and Fred Hutch and certain of its scientists may benefit financially from this work in the future.

About MB-106 (CD20-targeted autologous CAR T Cell Therapy)
CD20 is a membrane-embedded surface molecule which plays a role in the differentiation of B-cells into plasma cells. The CAR T was developed by Mustang’s research collaborator, Fred Hutch, in the laboratories of the late Oliver Press, M.D., Ph.D., and Brian Till, M.D., Associate Professor in the Clinical Research Division at Fred Hutch, and exclusively licensed to Mustang in 2017. The lentiviral vector drug substance used to transduce patients’ cells to create the MB-106 drug product produced at Fred Hutch has been optimized as a third-generation CAR derived from a fully human antibody, and MB-106 is currently in a Phase 1/2 open-label, dose-escalation trial at Fred Hutch in patients with B-NHLs and CLL. The same lentiviral vector drug substance produced at Fred Hutch will be used to transduce patients’ cells to create the MB-106 drug product produced at Mustang Bio’s Worcester, MA, cell processing facility for administration in the planned multicenter Phase 1/2 clinical trial to be initiated shortly under Mustang Bio’s IND. It should be noted that Mustang Bio has introduced minor improvements to its cell processing to facilitate eventual commercial launch of the product. In addition, prior to commercial launch, Mustang Bio will replace the Fred Hutch lentiviral vector drug substance with vector produced at a commercial manufacturer. Additional information on the trial can be found at View Source using the identifier NCT03277729.

Novartis data at ASCO and EHA showcase latest oncology research and innovation, including in breast and prostate cancer

On May 12, 2022 Novartis reported that highlights data from across its oncology portfolio at the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and the European Hematology Association (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress (Press release, Novartis, MAY 12, 2022, View Source [SID1234614412]). With nearly 130 abstracts from Novartis-sponsored and investigator-initiated trials accepted, the data showcase research across over 20 compounds in key disease areas, including breast, lung and prostate cancers, leukemia, lymphoma, multiple myeloma and other blood disorders.

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"We continue to push the boundaries of science with advanced therapies and novel combinations to help address the individual needs of patients," said Marie-France Tschudin, President, Innovative Medicines International and Chief Commercial Officer, Novartis. "We are particularly excited about the latest data on CDK recycling with Kisqali, and first results for Tafinlar + Mekinist in a rare pediatric brain cancer."

Key highlights of data accepted by ASCO (Free ASCO Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Kisqali (ribociclib)*

A randomized phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor positive (HR+), HER2 negative metastatic breast cancer (MBC): MAINTAIN trial† Abstract # LBA1004
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT

Kisqali (ribociclib)* Impact of ribociclib (RIB) dose modifications (mod) on overall survival (OS) in patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA (ML)-2 Abstract #1017
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT
Kisqali (ribociclib)*

Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) vs abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor–positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC) Abstract #1015
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Piqray (alpelisib) Alpelisib (ALP) + Fulvestrant (FUL) in Patients (pts) With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2−), Advanced Breast Cancer (ABC): Biomarker (BM) Analyses by Next-Generation Sequencing (NGS) From the SOLAR-1 Study Abstract #1006
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT
Piqray (alpelisib)

Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), PIK3CA-mutated (mut) advanced breast cancer (ABC): Baseline biomarker analysis and progression-free survival (PFS) by duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in the BYLieve study Abstract #1018
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Scemblix (asciminib) Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib (BOS) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs): wk 96 update Abstract #7004
Oral Presentation:
Tuesday, June 7, 9:45 AM – 12:45 PM CDT
Tafinlar (dabrafenib) / Mekinist (trametinib) Primary analysis of a phase II trial of dabrafenib + trametinib (dab + tram) in BRAF V600–mutant pediatric low-grade glioma (pLGG) Abstract #2002
Oral Presentation:
Monday, June 6, 11:30 AM – 2:30 PM CDT
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617) 177Lu-PSMA-617 in PSMA-positive metastatic castration-resistant prostate cancer: prior and concomitant treatment subgroup analyses of the VISION trial

Abstract #5001
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT

Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Tolerability of 177Lu-PSMA-617 by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): a VISION study subgroup analysis Abstract #5047
Poster available:
Monday, June 6, 1:15 PM – 4:15 PM CDT
Locametz (kit for the preparation of gallium Ga 68 gozetotide injection)** 68Ga-PSMA-11 PET baseline imaging as a prognostic tool for clinical outcomes to 177Lu-PSMA-617 in patients with mCRPC: a VISION sub-study Abstract #5002
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT
Lutathera (lutetium Lu 177 dotatate)*** Effectiveness and safety of re-treatment with lutetium Lu 177 dotatate in patients with progressive neuroendocrine tumors in the United States: a retrospective real-world study Abstract #e16215

Key highlights of data accepted by EHA (Free EHA Whitepaper):

Medicine Abstract Title Abstract Number/ Presentation Details
Scemblix (asciminib) Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib in patients with chronic myeloid leukemia in chronic phase after ≥2 prior tyrosine kinase inhibitors: week 96 update Abstract #S155
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST
Scemblix (asciminib) Asciminib provides durable molecular responses in patients (Pts) with chronic myeloid leukemia in chronic phase (CML-CP) with the T315I mutation: Updated efficacy and safety data from a Phase 1 trial Abstract #P704
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST
Kymriah
(tisagenlecleucel) Tisagenlecleucel in pediatric and young adult patients (Pts) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Final analyses from the ELIANA study Abstract #S112
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST

YTB323 Phase I study of YTB323, a chimeric antigen receptor (CAR)-T cell therapy manufactured using T-Charge, in patients with relapsed/refractory diffuse large B-cell lymphoma Abstract #S212
Oral Presentation:
Saturday, June 11, 11:30 AM – 12:45 PM CEST
PHE885 Phase I study data update of PHE885, a fully human BCMA-directed CAR-T cell therapy manufactured using the T-Charge platform for patients with relapsed/refractory (R/R) multiple myeloma (MM) Abstract #P1446
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST
Sabatolimab First results of a Phase II study (STIMULUS-AML1) investigating sabatolimab + azacitidine + venetoclax in patients with newly diagnosed acute myeloid leukemia Abstract #P582
Poster available:
Friday, June 10, 4:30 PM – 5:45 PM CEST

Promacta/Revolade
(eltrombopag) Sustained response off treatment in eltrombopag-treated patients with ITP who are refractory or relapsed after first-line steroids: primary analysis of the phase II TAPER trial Abstract #S292
Oral Presentation
Saturday, June 11, 11:30 AM – 12:45 PM CEST
Product Information
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AFFIMED TO PRESENT PRECLINICAL DATA DEMONSTRATING CYTOTOXIC ACTIVITY OF ITS NOVEL INNATE CELL ENGAGER AFM28 AT THE ANNUAL MEETING OF THE EUROPEAN HEMATOLOGY ASSOCIATION (EHA)

On May 12, 2022 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, reported an upcoming poster presentation demonstrating the cytotoxic potential of its CD123/CD16A-targeting innate cell engager (ICE) AFM28 at the Annual Meeting of the European Hematology Association (EHA) (Free EHA Whitepaper) to be held in Vienna, Austria on June 9 – 12, 2022 (Press release, Affimed, MAY 12, 2022, View Source [SID1234614411]).

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AFM28 is designed as a novel treatment for patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS).

Redirecting innate immune cells, particularly NK cells, to CD123 is very attractive as a novel treatment strategy in AML because both leukemic blasts and leukemic stem cells express this receptor and an efficient depletion of both cell types is critical for inducing long-term remission.

The data to be presented in a poster session at the EHA (Free EHA Whitepaper) on June 10, 2022 summarize the preclinical proof-of-concept and toxicology studies for AFM28. The CD123 and CD16A targeting ICE exhibited high-affinity binding to CD16A expressed on NK cells and high avidity conferring long cell surface retention.

In in vitro assays, AFM28 engaged NK cells to destroy CD123-positive tumor cell lines and primary leukemic cells via antibody-dependent cell-mediated cytotoxicity (ADCC), even when CD123 was expressed at low levels.

Moreover, AFM28 demonstrated the ability to deplete leukemic cells from patient bone marrow without lysing CD34-positive/CD123-negative cells suggesting sparing of hematopoietic stem and progenitor cells. In toxicology models using cynomolgus monkeys, AFM28 demonstrated highly effective target cell depletion which was associated with good tolerability and only minimal release of the inflammatory cytokine IL-6.

"CD123 is a highly interesting tumor antigen in AML that hasn’t reached its full therapeutic potential. We believe that engaging innate immune cells represents a differentiated therapeutic strategy to access the value of this target. Building on the promising data we have seen with AFM28 to date, we are excited to be preparing a first-in-human clinical study to investigate the safety, efficacy and biological activity of AFM28 as monotherapy. In parallel, we are planning a study to investigate AFM28 in combination with adoptive NK cell therapies," said Dr. Arndt Schottelius, Chief Scientific Officer at Affimed. "NK cell therapies have already demonstrated promising clinical activity in relapsed/refractory AML and we believe that AFM28 will improve this effect."

The abstract is accessible here: View Source

Poster details:
Title: Novel bispecific innate cell engager AFM28 for the treatment of CD123-positive acute myeloid leukemia and myelodysplastic syndrome
Authors: Jana-Julia Siegler, Nanni Schmitt, Jens Pahl, Torsten Haneke, Izabela Kozlowska, Séverine Sarlang, Alexandra Beck, Stefan Knackmuss, Paulien Ravenstijn, Uwe Reusch, José Medina-Echeverz, Jan Endell, Thorsten Ross, Daniel Nowak, and Christian Merz
Final abstract code: P482
Session date and time: Poster session on Friday, June 10th, 10:30 – 11:45 a.m. EDT / 16:30 – 17:45 CEST

About AFM28
AFM28, a tetravalent, bispecific CD123- and CD16A-binding ICE developed on Affimed’s ROCK platform, is designed to bring a new immunotherapeutic approach to patients with CD123+ myeloid malignancies, including acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). It engages NK cells to initiate tumor cell killing via antibody-dependent cellular cytotoxicity (ADCC), even at low CD123 expression levels. Clinical development is planned as both monotherapy and in combination with allogeneic NK cells in patients with relapsed/refractory CD123+ leukemias.