On April 26, 2023 Autolus Therapeutics plc (Nasdaq: AUTL), a clinical-stage biopharmaceutical company developing next-generation programmed T cell therapies, reported the publication of a paper in Molecular Therapy Nucleic Acids1, titled ‘Novel Fas-TNFR chimeras that prevent Fas ligand-mediated kill and signal synergistically to enhance CAR T-cell efficacy (Press release, Autolus, APR 26, 2023, View Source [SID1234630556]).’

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CAR T cells have shown remarkable efficacy against hematological cancers, but their effectiveness in solid tumors has been limited by inhibitory factors expressed by the tumor or its microenvironment. One such inhibitory factor is Fas ligand (FasL), which binds to the Fas receptor (CD95) on the surface of an activated T cell and triggers the CAR T cell to die by apoptosis.

The research group at Autolus tested several Fas chimeras which consist of the extracellular domain of Fas fused to the intracellular domain from different TNF receptor superfamily members. Expression of these chimeras in a CAR T cell not only blocks apoptosis triggered by FasL, but results in co-stimulation, which promotes CAR T cell survival and proliferation.

A small subset of these chimeras, best exemplified by Fas-CD40 fusion, were found to be particularly effective at promoting CAR T cell survival and anti-tumor cytotoxicity in the presence of FasL. These data support the potential of this Fas-CD40 chimera to render T cell therapies resistant to FasL-mediated cell death and improve their effectiveness against solid tumors.

Martin Pule, Chief Scientific Officer and Founder of Autolus said, "Development of Fas-CD40 adds to our growing toolkit of T-cell engineering modules and aligns with Autolus’ strategy for increasing the Company’s capabilities, with particular application against complex and immunologically hostile cancers, including solid cancer applications."

1. Novel Fas-TNFR chimeras that prevent Fas ligand-mediated kill and signal synergistically to enhance CAR T-cell efficacy

On April 26, 2023 NexImmune, Inc. (Nasdaq: NEXI), a biotechnology company developing a novel approach to immunotherapy designed to orchestrate a targeted immune response by directing the function of antigen-specific T cells for liquid and solid malignancies, reported that clinical data from its Phase 1/2 dose escalation study of NEXI-001 will be presented in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2023 Annual Meeting in Chicago, June 2 – June 6, 2023 (Press release, NexImmune, APR 26, 2023, View Source [SID1234630555]).

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Poster Presentation:

Title: An Analysis of a First-In-Human Study of NEXI-001 Donor-Derived Antigen-Specific CD8+ T-Cell Treatment of Relapsed AML after Allogeneic Hematopoietic Cell Transplantation (HCT)

Abstract #: 7043 (Poster Board #173)

Session Title: Hematologic Malignancies – Leukemia, Myelodysplastic Syndromes, and Allotransplant

Authors: Monzr M. Al Malki, MD1, Juan C. Varela MD, PhD2, Sumithira Vasu, MBBS3, Dipenkumar Modi, MD4, Suzanne Afonso-Smith, PhD5, Sojung Kim, PhD5, Emily Lu, PhD5, Robert D. Knight, MD5, and Mathias Oelke, PhD5

(1)Hematology/Hematopoietic Cell Transplant, City of Hope National Medical Center, Duarte, CA, (2)Advent Health Blood and Marrow Transplant Program, Orlando, FL, (3)Division of Hematology, Department of Internal Medicine, The Ohio State University, Columbus Ohio, (4)Division of Oncology, Karmanos Cancer Center/Wayne State University, Detroit, MI, (5)NexImmune, Inc., Gaithersburg, MD

On April 26, 2023 Novartis reported that it will present new data from its oncology portfolio at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, including advancements in breast cancer, prostate cancer and lung cancer from more than 40 Novartis-sponsored and investigator-led trials (Press release, Novartis, APR 26, 2023, View Source [SID1234630554]). Primary results from the NATALEE trial evaluating Kisqali (ribociclib) plus endocrine therapy in patients with stage II and stage III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer at risk of cancer recurrence, regardless of nodal involvement, will be presented.

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"We look forward to sharing the primary analysis from the Phase III NATALEE trial of Kisqali in the investigational setting in a broad population of patients with early-stage breast cancer at ASCO (Free ASCO Whitepaper)," said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. "These promising data, together with other key updates, illustrate how we continue to advance our pipeline in oncology, with the potential to help address the significant unmet needs of patients living with cancer."

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

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

Phase III NATALEE trial of ribociclib + endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer

Abstract #LBA500
Oral presentation:
Friday, June 2, 2:45 – 5:45pm CDT
Kisqali (ribociclib)*  Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2- advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial

Abstract #1063
Poster available:
Sunday, June 4, 8:00 – 11:00am CDT
Kisqali (ribociclib)* 

Ribociclib (RIB) vs. palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC): A head-to-head phase III study. HARMONIA SOLTI-2101 / AFT-58

Abstract #TPS1125
Poster available:
Sunday, June 4, 8:00 – 11:00am CDT
Pluvicto (lutetium Lu 177 vipivotide tetraxetan)

Building a predictive model for outcomes with [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer using VISION data: Preliminary results

Abstract #5028
Poster available:
Saturday, June 3, 8:00 – 11:00am CDT
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Tumor dosimetry of [177Lu]Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer: results from the VISION trial sub-study

Abstract #5046
Poster available:
Saturday, June 3, 8:00 – 11:00am CDT
JDQ443 KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC)

Abstract #9007
Oral presentation:
Tuesday, June 6, 9:45am – 12:45pm CDT

 
PHE885 Updated phase I study results of PHE885, a T-Charge manufactured BCMA-directed CAR-T cell therapy, for patients (pts) with r/r multiple myeloma (RRMM) Abstract #8004
Oral presentation:
Saturday, June 3, 1:15 – 4:15pm CDT
Product Information
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On April 26, 2023 Blueprint Medicines Corporation (NASDAQ: BPMC) reported the acceptance of clinical abstracts for multiple programs across its precision therapy portfolio at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, June 2 to 6 (Press release, Blueprint Medicines, APR 26, 2023, View Source [SID1234630553]). The presentations showcase Blueprint Medicines’ next wave of therapeutic candidates in its robust clinical pipeline, and highlight ongoing progress as the company seeks to pioneer innovative combination strategies and advance development of its programs into earlier lines of treatment.

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The datasets to be reported at the ASCO (Free ASCO Whitepaper) Annual Meeting include:

Results from the ongoing dose escalation part of the VELA trial of BLU-222 in breast cancer and other cancers vulnerable to CDK2 inhibition, showing evidence of monotherapy safety and pathway modulation.

Updated results from the dose escalation part of the SYMPHONY trial showing the safety and tolerability of BLU-945 as a monotherapy and in combination with osimertinib in patients with late-line, EGFR-mutant non-small cell lung cancer (NSCLC).

Results from the ongoing dose escalation part of the CONCERTO trial of BLU-451 in EGFR exon 20 insertion-positive NSCLC showing early safety and clinical activity.
"These upcoming presentations reflect important clinical progress toward realizing the promise of our innovative precision therapies to help address complex medical needs in lung and breast cancer, leveraging our scientific and development expertise with the goal of overcoming traditional limitations of targeted therapy," said Becker Hewes, M.D., Chief Medical Officer at Blueprint Medicines. "Collectively, the datasets represent another step toward achieving our 2027 Blueprint for Precision at Scale – our five-year growth strategy to reach broad patient populations through the development of transformative precision therapies."

The accepted abstracts are listed below, and abstract titles are available today on the ASCO (Free ASCO Whitepaper) conference website: meetings.asco.org.

Data Presentations

Poster Presentation Title: BLU-222, an oral, potent and selective CDK2 inhibitor, in patients with advanced solid tumors: phase 1 monotherapy dose escalation
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date & Time: Saturday, June 3, 2023 from 8:00 a.m. — 11:00 a.m. CT (9:00 a.m. — 12:00 p.m. ET)
Abstract Number: 3095
Location: Hall A

Poster Presentation Title: Emerging phase 1 data of BLU-451 in advanced NSCLC with EGFR exon 20 insertions
Session Title: Lung Cancer—Non-Small Cell Metastatic
Session Date & Time: Sunday, June 4, 2023 from 8:00 a.m. — 11:00 a.m. CT (9:00 a.m. — 12:00 p.m. ET)
Abstract Number: 9064
Location: Hall A

Short Oral Presentation Title: BLU-945 monotherapy and in combination with osimertinib (OSI) in previously treated patients with advanced EGFR-mutant (EGFRm) NSCLC in the phase 1/2 SYMPHONY study
Session Title: Rapid Abstract Session: Lung Cancer
Session Date & Time: Monday, June 5, 2023 from 11:30 a.m. — 12:30 p.m. CT (12:30 p.m. — 1:30 p.m. ET)
Abstract Number: 9011
Location: S406

On April 26, 2023 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported that two abstracts with its innate cell engager (ICE) AFM24 have been accepted for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 2 – 6, 2023 in Chicago, IL (Press release, Affimed, APR 26, 2023, View Source [SID1234630552]).

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NSCLC Abstract and Presentation Details:
Title: Leveraging innate immunity with AFM24, a novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager: Interim results for the non-small cell lung cancer (NSCLC) cohort
Authors: Anthony B. El-Khoueiry, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Andrés Cervantes, Omar Saavedra Santa Gadea, Byoung Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada
Poster presentation session: Developmental Therapeutics—Immunotherapy, June 3, 2023, 8:00 – 11:00 a.m. CDT
Abstract Number for Publication: 2533

CRC Abstract Details:
Title: Investigating the novel CD16A and epidermal growth factor receptor (EGFR) bispecific innate cell engager, AFM24, to leverage the innate immune system: Interim results from the colorectal cancer (CRC) cohort
Authors: Andrés Cervantes, Delcia Rivas, Se Hoon Lee, Jacob Stephen Thomas, Yu Jung Kim, Omar Saavedra Santa Gadea, Byoung-Yong Shim, Laura Kohlhas, Gabriele Hintzen, Michael Emig, Pilar Nava-Parada, Anthony B. El-Khoueiry Abstract Number for Publication: e14508

The full abstracts will become public at 5:00 p.m. EDT on Thursday, May 25. More details about the programs for the ASCO (Free ASCO Whitepaper) Annual Meetings are available online at www.asco.com.

About AFM24
AFM24 is a tetravalent, bispecific innate cell engager (ICE) that activates the innate immune system by binding to CD16A on innate immune cells and 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 is evaluating AFM24 as monotherapy and in combinations with other cancer treatments in patients with advanced EGFR-expressing solid malignancies whose disease has progressed after treatment with previous anticancer therapies. AFM24-101, a monotherapy, first-in-human phase 1/2a open-label, is a non-randomized, multi-center, multiple ascending dose escalation and expansion study. Additional details may be found at www.clinicaltrials.gov using the identifier NCT04259450. AFM24 is also being evaluated in a phase 1/2a study in combination with Roche’s PD-L1 checkpoint inhibitor atezolizumab (AFM24-102, NCT05109442). Furthermore, Affimed and NKGen Biotech initiated a phase 1/2a study (AFM24-103), investigating AFM24 in combination with NKGen Biotech’s NK cell SNK01 (NCT05099549).