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Exscientia to Present New Preclinical Data for AI-designed LSD1 and MALT1 Inhibitors at ESMO 2023

On October 16, 2023 Exscientia plc (Nasdaq: EXAI) reported that two abstracts to be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023 from October 20-24, 2023 in Madrid, Spain (Press release, Exscientia, OCT 16, 2023, View Source [SID1234636043]).

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"We are excited to share new preclinical data on our precision-designed LSD1 and MALT1 inhibitors, which we introduced to our oncology pipeline earlier this year," said Professor Andrew Hopkins FRS FMedSci, founder and Chief Executive Officer of Exscientia. "We believe these compounds bear strong potential for differentiation, patient benefit and value creation. This data underlines how Exscientia can bring together AI design and novel translational research capabilities to create better quality drug candidates. This also allows us to systematically identify those patient populations who have the most potential benefit well before we start clinical trials."

Both ESMO (Free ESMO Whitepaper) posters will be available on the Exscientia website from their time of presentation.

Poster Presentations

Title: Determining anti-cancer efficacy of a reversible LSD1 inhibitor, EXS74539, in primary AML tissues with limited thrombocytopenic effects
Session Title: Translational research (agnostic)
Abstract Number: 2289P
Date/Time: Saturday, October 21 / 12:00 PM – 1:00 PM CEST

‘539 is a novel, potent, selective and reversible LSD1 inhibitor under preclinical investigation as a monotherapy or in combination with standard of care for oncology and haematology indications including acute myeloid leukaemia (AML) and small cell lung cancer (SCLC)
Leveraging primary human material and Exscientia’s proprietary precision medicine platform, the Company confirmed ‘539’s general efficacy, demonstrating that ‘539 induces AML cell differentiation marker expression when used on primary AML patient tissue ex vivo
Combination data with first line AML and targeted therapies will be presented
Title: Characterisation of EXS73565, a potent and selective MALT1 inhibitor with low drug-drug interaction risk and potential in lymphoma
Session Title: Haematological malignancies
Abstract Number: 832P
Date/Time: Monday, October 23 / 12:00 PM – 1:00 PM CEST

Exscientia utilised generative design, machine learning and molecular dynamics approaches to precision-design ‘565, a potent and selective allosteric MALT1 inhibitor with a differentiated profile exhibiting low drug-drug interaction and hyperbilirubinemia risk
Preclinically, ‘565 exposure resulted in limited inhibition of UGT1A1, an enzyme involved in bilirubin metabolism. This approach has the potential to offer safety benefits compared to other clinical stage MALT1 inhibitors which carry a high UGT1A1 inhibition and hyperbilirubinemia risk
Significant tumour growth inhibition was observed for ‘565 in vivo in activated B-cell diffuse large B-cell lymphoma (ABC-DLBCL) xenograft models. Significant synergistic effects were observed for combination ‘565 and the BTK inhibitor ibrutinib in a xenograft model with low sensitivity to either single agent
Overall, the profile of ‘565 offers the potential for clinical exploration of MALT1 inhibition as a monotherapy and/or in combination with other targeted agents in haematological malignancies

Incyte Announces New Data from across its Oncology Portfolio to be Presented at ESMO Congress 2023

On October 16, 2023 Incyte (Nasdaq:INCY) reported that abstracts featuring new data from its oncology portfolio will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, held October 20-24 in Madrid (Press release, Incyte, OCT 16, 2023, View Source [SID1234636042]).

"We look forward to sharing data from our oncology portfolio with the scientific community at this year’s ESMO (Free ESMO Whitepaper) Congress"

"We look forward to sharing data from our oncology portfolio with the scientific community at this year’s ESMO (Free ESMO Whitepaper) Congress," said Steven Stein, M.D., Chief Medical Officer, Incyte. "Presentations, including results from studies of retifanlimab and capmatinib, focused on patients with endometrial cancer, Merkel cell carcinoma and non-small cell lung cancer, showcase our continued efforts to pursue innovative therapies for patients with cancer."

Key abstracts from Incyte-sponsored and partner programs include:

Poster Presentations

Immuno-oncology (IO)

Retifanlimab in Patients with Recurrent Microsatellite Instability-High (MSI-H) or Deficient Mismatch Repair (dMMR) Endometrial Cancer: Final Results from the POD1UM-101 Study (Cohort H) (Abstract #755P. Topic: Gynecological Cancers. Sunday, October 22, 6:00 a.m. – 7:00 a.m. ET)

Updated Results from POD1UM-201: A Phase 2 Study of Retifanlimab in Patients with Advanced or Metastatic Merkel Cell Carcinoma (MCC) (Abstract #1146P. Topic: Melanoma and Other Skin Tumors. Sunday, October 22, 6:00 a.m. – 7:00 a.m. ET)

Capmatinib

Efficacy of Capmatinib Compared to Standard of Care for German Patients with Locally Advanced or Metastatic NSCLC Harboring METex14 Mutations: Results from the RECAP Study1 (Abstract #1383P. Topic: NSCLC, Metastatic. Monday, October 23, 6:00 a.m. – 7:00 a.m. ET)

Capmatinib vs Docetaxel as Second- or Third-line (2/3L) Therapy in Patients (Pts) with METex14-Mutated Advanced NSCLC (aNSCLC): The GeoMETry-3 Trial1 (Abstract #1391P. Topic: NSCLC, Metastatic. Monday, October 23, 6:00 a.m. – 7:00 a.m. ET)

For full session details and data presentation listings, please see the ESMO (Free ESMO Whitepaper) Congress 2023 (View Source) online program.

About Zynyz (retifanlimab-dlwr)

Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor indicated in the U.S. for the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered into an exclusive collaboration and license agreement with MacroGenics, Inc. for global rights to retifanlimab.

Zynyz is a trademark of Incyte.

About Tabrecta (capmatinib)

Tabrecta is approved in several countries including the EU, United States (U.S.), Japan and Switzerland. It is the number one prescribed targeted therapy for patients with advanced non-small cell lung cancer (NSCLC) with alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping globally2.

Tabrecta is a kinase inhibitor that targets mesenchymal-epithelial transition (MET). Tabrecta was discovered by Incyte and licensed to Novartis in 2009. Under the agreement, Incyte granted Novartis worldwide exclusive development and commercialization rights to capmatinib and certain back-up compounds in all indications.

Daiichi Sankyo Showcases Progress in Developing New Standards of Care for Patients with Industry-Leading DXd ADC Portfolio Across Multiple Cancers at ESMO

On October 16, 2023 Daiichi Sankyo (TSE: 4568) reported that it will present new clinical research across its DXd antibody drug conjugate (ADC) portfolio in multiple types of cancer at the 2023 European Society for Medical Oncology (#ESMO23) Congress to be held October 20 – 24, 2023 (Press release, Daiichi Sankyo, OCT 16, 2023, https://www.businesswire.com/news/home/20231013885880/en/Daiichi-Sankyo-Showcases-Progress-in-Developing-New-Standards-of-Care-for-Patients-with-Industry-Leading-DXd-ADC-Portfolio-Across-Multiple-Cancers-at-ESMO [SID1234636041]). Three late-breaking abstracts, including two Presidential Symposia presentations, are among the more than 20 abstracts showcasing Daiichi Sankyo’s leadership and progress in developing new standards of care for patients with cancer.

Data at ESMO (Free ESMO Whitepaper) will highlight results from the TROPION-Breast01 and TROPION-Lung01 phase 3 trials (LBA11 and LBA12) evaluating datopotamab deruxtecan (Dato-DXd) versus chemotherapy in patients with HR positive, HER2 low or negative metastatic breast cancer and advanced non-small cell lung cancer (NSCLC) during back-to-back presentations at the Presidential Symposium 3. These data will be featured in an ESMO (Free ESMO Whitepaper) press briefing.

Other late-breaking data includes a mini-oral session featuring the first presentation of progression-free and overall survival results from the DESTINY-PanTumor02 phase 2 trial (#LBA34) evaluating ENHERTU (trastuzumab deruxtecan) across multiple HER2 expressing solid tumors, including biliary tract, bladder, cervical, endometrial, ovarian, pancreatic and other cancers.

Updates from other trials across Daiichi Sankyo’s DXd ADC portfolio include mini-oral sessions presenting an exploratory analysis of the intracranial efficacy of patritumab deruxtecan (HER3-DXd) in patients with EGFR-mutated metastatic NSCLC from the HERTHENA-Lung01 phase 2 trial, and updated data from an ongoing first-in-human phase 1 trial of raludotatug deruxtecan (R-DXd) in patients with previously treated ovarian cancer. A poster presentation also will feature updated clinical and biomarker results of ifinatamab deruxtecan (I-DXd) in patients with advanced solid tumors from an ongoing phase 1/2 trial.

"We continue to bring forward new research that demonstrates how our industry-leading DXd antibody drug conjugate portfolio has the potential to transform the current standards of care for patients across multiple tumor types and treatment settings. Data from TROPION-Breast01 and TROPION-Lung01, the first two pivotal trials from our datopotamab deruxtecan clinical development program, underscore the potential to change the way certain patients with HR positive, HER2 low or negative metastatic breast cancer as well as advanced non-small lung cancer are treated," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "Additionally, data from our other ongoing trials of ENHERTU, patritumab deruxtecan, raludotatug deruxtecan and ifinatamab deruxtecan showcase our continued efforts to apply our DXd antibody drug conjugate technology to different targets and types of cancer with the goal of bringing new treatments to patients."

Additional datopotamab deruxtecan data at ESMO (Free ESMO Whitepaper) includes the first presentation from the TROPION-Lung05 phase 2 trial in patients with previously treated NSCLC with actionable genomic alterations and updated data from the BEGONIA phase 1b/2 trial in patients with previously untreated advanced/metastatic triple negative breast cancer during two mini-oral sessions.

Other ENHERTU data to be highlighted in proffered paper or mini-oral sessions include the primary results from the DESTINY-PanTumor01 phase 2 trial in patients with solid tumors with HER2 activating mutations and a pooled analysis from the DESTINY-Lung01 and DESTINY-Lung02 phase 2 trials in patients with HER2 mutant metastatic NSCLC with and without brain metastases. A proffered paper session also will include updated survival results from the DESTINY-Breast04 phase 3 trial in patients with HER2 low metastatic breast cancer as well as pooled exploratory efficacy and safety analysis from the DESTINY-Breast01, DESTINY-Breast02 and DESTINY-Breast03 trials in patients with HER2 positive metastatic breast cancer with brain metastases.

Daiichi Sankyo will hold a virtual conference call for investors on Tuesday, October 24, 2023 at 8:00-9:30 am ET / 9:00-10:30 pm JST. Executives from Daiichi Sankyo will provide an overview of the ESMO (Free ESMO Whitepaper) research data and address questions.

Highlights of late-breaking data across Daiichi Sankyo’s DXd ADC portfolio at 2023 ESMO (Free ESMO Whitepaper) include:

Presentation Title

Lead Author

Abstract

Presentation

Datopotamab deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan (Dato-DXd) vs chemotherapy in previously-treated inoperable or metastatic hormone receptor-positive, HER2 negative breast cancer: primary results from the randomized phase 3 TROPION-Breast01 trial

A. Bardia

LBA11

Presidential 3
Monday, October 23
4:30 – 4:42 pm CEST

Lung

Datopotamab deruxtecan (Dato-DXd) vs docetaxel in previously treated advanced/metastatic non-small cell lung cancer (NSCLC): results of the randomized phase 3 study TROPION-Lung01

M. Ahn

(presented by A. Lisberg)

LBA12

Presidential 3
Monday, October 23
4:42 – 4:54 pm CEST

ENHERTU (trastuzumab deruxtecan; T-DXd)

Pan-Tumor

Trastuzumab deruxtecan (T-DXd) for pretreated patients with HER2 expressing solid tumors: primary efficacy analysis from the DESTINY-PanTumor02 study

F. Meric-

Bernstam

LBA34

Mini-Oral Session
Monday, October 23
4:40 – 4:45 pm CEST

Additional highlights of data to be presented at 2023 ESMO (Free ESMO Whitepaper) include:

Presentation Title

Lead

Author

Abstract

Presentation

Datopotamab deruxtecan (Dato-DXd)

Breast

Datopotamab deruxtecan (Dato-DXd) + durvalumab as first-line treatment for unresectable locally advanced/metastatic triple-negative breast cancer: updated results from BEGONIA, a phase 1b/2 study

P. Schmid

379MO

Mini-Oral Session
Sunday, October 22
8:30 – 8:35 pm CEST

Lung

TROPION-Lung05: datopotamab deruxtecan (Dato-DXd) in previously treated non-small cell lung cancer with actionable genomic alterations

L. Paz-Ares

1314MO

Mini-Oral Session
Saturday, October 21
9:30 – 9:35 am CEST

TROPION-Lung07: a phase 3 trial of datopotamab deruxtecan (Dato-DXd) plus pembrolizumab with or without platinum chemotherapy as first-line therapy in advanced/metastatic non-small cell lung cancer with PD-L1 expression

I. Okamoto

1505TiP

Poster Presentation
Monday, October 23

ENHERTU (trastuzumab deruxtecan; T-DXd)

Breast

Trastuzumab deruxtecan vs treatment of physician’s choice in patients with HER2 low unresectable and/or metastatic breast cancer: updated survival results of the randomized, phase 3 DESTINY-Breast04 study

S. Modi

376O

Proferred Paper Session
Saturday, October 21
10:25 – 10:35 pm CEST

A pooled analysis of trastuzumab deruxtecan in patients with HER2 positive metastatic breast cancer with brain metastases from DESTINY-Breast-01, -02, -03

S. Hurvitz

377O

Proferred Paper Session
Saturday, October 21
10:55 – 11:05 pm CEST

Lung

Trastuzumab deruxtecan in patients with HER2 (ERBB2)-mutant metastatic non-small cell lung cancer with and without brain metastases: pooled analyses from DESTINY-Lung01 and DESTINY-Lung02

D. Planchard

1321MO

Mini-Oral Presentation
Sunday, October 22
9:05 – 9:10 am CEST

Phase 1b multicenter study of trastuzumab deruxtecan and immunotherapy with or without chemotherapy in first-line treatment of patients with advanced or metastatic non squamous non-small cell lung cancer and HER2 overexpression: DESTINY-Lung03

D. Planchard

1507TiP

Poster Presentation
Monday, October 23

Pan-Tumor

DESTINY-PanTumor02 study of trastuzumab deruxtecan in patients with HER2 expressing solid tumors: exploratory biomarker analyses of HER2 expression and gene amplification in tissue and plasma

V. Makker

148P

Poster Presentation
Saturday, October 21

Efficacy and safety of trastuzumab deruxtecan (T-DXd) in patients with solid tumors harboring specific HER2 activating mutations: primary results from the international phase 2 DESTINY-PanTumor01 study

B. Li

654O

Proffered Paper Session
Sunday, October 22
9:20 – 9:30 am CEST

Patritumab Deruxtecan (HER3-DXd)

Lung

Intracranial efficacy of HER3-DXd in patients with previously treated advanced EGFR-mutated NSCLC: results from HERTHENA-Lung01

M. Johnson

1319MO

Mini-Oral Session

Sunday, October 22
9:00 – 9:05 am CEST

Raludotatug Deruxtecan (R-DXd)

Ovarian

Raludotatug deruxtecan (R-DXd; DS-6000) monotherapy in patients with previously treated ovarian cancer: subgroup analysis of a first-in-human phase 1 study

K. Moore

745MO

Mini-Oral Session
Sunday, October 22
11:35 – 11:40 am CEST

Ifinatamab Deruxtecan (I-DXd)

Pan-Tumor

Ifinatamab deruxtecan (I-DXd; DS-7300) in patients with advanced solid tumors: updated clinical and biomarker results from a phase 1/2 study

M. Patel

690P

Poster Presentation
Monday, October 23

A2 Bio Announces Oral and Poster Presentations at the 2023 Society for Immunotherapy of Cancer (SITC) Annual Meeting

On October 16, 2023 A2 Biotherapeutics, Inc. (A2 Bio) a clinical-stage cell therapy company developing first-in-class logic-gated cell therapies for solid tumors, reported an oral presentation and two poster presentations of trial-in-progress data from their pre-screening (BASECAMP-1) and first-in-human Phase 1 study (EVEREST-1) at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting November 1-5, 2023, in San Diego, CA (Press release, A2 Biotherapeutics, OCT 16, 2023, View Source [SID1234636040]).

Oral presentation

BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials
Presenter: Diane Simeone, MD – NYU
Session: Rapid Oral Abstract-Clinical | Session 105b
Date and time: Friday, November 3; 12:15pm – 1:15pm PT
Location: Ground Level – Exhibit Hall C – San Diego Convention Center

Poster presentations

EVEREST-1: A seamless phase 1/2 study of CEA logic-gated Tmod CAR T-cell therapy (A2B530) in patients with solid tumors associated with CEA expression also exhibiting HLA loss of heterozygosity (LOH)
Abstract: 634
Presenter: Salman Punekar, MD – NYU
Date and time: Saturday, November 4, 2023; 9am – 8:30pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center

BASECAMP-1: A master prescreening study to identify patients with high-risk or metastatic solid tumors with HLA loss of heterozygosity (LOH) in preparation for Tmod CAR T-cell therapy trials
Abstract: 636
Presenter: Diane Simeone, MD – NYU
Date and time: Saturday, November 4, 2023; 9am – 8:30pm PT
Location: Exhibit Halls A and B1 – San Diego Convention Center

Natera to Present New Signatera™ MRD Data at ESMO 2023, Featuring Large, Updated Analysis from CIRCULATE-Japan Study

On October 16, 2023 Natera, Inc. (NASDAQ: NTRA), a global leader in cell-free DNA testing, reported that it will present new data on its personalized and tumor-informed molecular residual disease (MRD) test, Signatera, at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, taking place Oct. 20-24 in Madrid, Spain (Press release, Natera, OCT 16, 2023, View Source [SID1234636039]).

Natera and its collaborators will present MRD data in a total of seven abstracts, including a mini-oral and several poster presentations. The mini-oral presentation will feature an updated analysis of more than 2,000 patients from the GALAXY observational arm of the CIRCULATE-Japan trial, one of the largest and most comprehensive prospective studies of MRD testing in resectable colorectal cancer (CRC). Other presentations will highlight new Signatera data in rectal cancer, appendiceal adenocarcinoma, hepatocellular carcinoma, renal cell carcinoma, and other solid tumors.

"We look forward to the presentation of updated data from the landmark CIRCULATE-Japan study. With twice the number of patients and significantly longer follow-up, this report reinforces earlier findings published in Nature Medicine that Signatera can help to identify those patients with resectable colorectal cancer who will benefit most from adjuvant chemotherapy," said Minetta Liu, MD, chief medical officer of oncology at Natera. "Other collaborative presentations at ESMO (Free ESMO Whitepaper) underscore the utility of MRD testing across multiple indications, including the prediction of clinical outcomes and improved risk stratification for rectal cancer patients treated with neoadjuvant therapy."

Below is the full list of Natera presentations at ESMO (Free ESMO Whitepaper):

Mini Oral Presentation:

Presentation #558MO | CRC | Presenter: Yoshiaki Nakamura, MD, PhD |
Oct 22, 14:45 – 16:20 – Lecture: 15:50-15:55
Circulating tumor (ct)DNA as a prognostic biomarker in patients (pts) with resected CRC: an updated 24 months (mos) disease free survival (DFS) analysis from GALAXY study (CIRCULATE-Japan)

An updated analysis from the CIRCULATE-Japan study builds on the existing evidence from the recently published, prospective, observational GALAXY study, demonstrating the prognostic value of ctDNA in >2,000 CRC patients at 24 months.

Poster Presentations:

Presentation #590P | Rectal Cancer | Oct. 22 | Presenter: Chiara Molinari, PhD
Assessment of ctDNA in pts with locally advanced rectal cancer (LARC) treated with neoadjuvant therapy (NAT)

These new data show that ctDNA monitoring may predict neoadjuvant treatment response and long-term survival outcomes in patients with LARC.

Presentation #649P | Appendiceal Cancer | Oct. 22 | Presenter: Michael G. White, MD, MSc
The genomic landscape of appendiceal adenocarcinoma (AA) revealed by 855 Whole Exome Sequences (WES)

The first large-scale genomic profiling study of AA demonstrates its mutational profile is distinct from rectal and colon cancer, suggesting a different oncologic pathway for this cancer type.

Presentation #1224P | Pan-Cancer | Oct. 22 | Presenter: Yoshiaki Nakamura, MD, PhD
Detection of ctDNA in untreated pts with cancer: implications for early cancer detection (ECD)

This study of treatment-naive cancer patients reveals that tumor-informed ctDNA detection varies by cancer type, stage, and driver mutations. These findings have implications for development of assays for ECD.

Presentation #960P | Hepatocellular Carcinoma | Oct. 23 | Presenter: Maen Abdelrahim, MD, PhD
Personalized ctDNA monitoring for recurrence detection and treatment response assessment in hepatocellular carcinoma (HCC)

These findings support a role for longitudinal ctDNA assessment in identifying early recurrence post-surgical resection in patients with HCC.

Presentation #114P | Biliary Tract Cancer | Oct. 23 | Presenter: Gentry King, MD
Prospective Longitudinal Tumor-Informed ctDNA in Resectable Biliary Tract Cancers (BTC)

In patients with BTC, ctDNA detection may help in evaluating clinical outcomes prior to radiographically evident disease.

Presentation #1908P | Renal Cancer | Oct. 23 | Presenter: Michael Smigelski, MD
Utility of ctDNA testing for MRD detection and treatment response monitoring in pts with renal cell carcinoma (RCC)

This study demonstrates that longitudinal ctDNA monitoring may be predictive of recurrence-free survival post-surgery in patients with RCC.

About Signatera

Signatera is a custom-built circulating tumor DNA (ctDNA) test for treatment monitoring and molecular residual disease (MRD) assessment in patients previously diagnosed with cancer. The test is available for both clinical and research use, and has been granted four Breakthrough Device Designations by the FDA for multiple cancer types and indications. The Signatera test is personalized and tumor-informed, providing each individual with a customized blood test tailored to fit the unique signature of clonal mutations found in that individual’s tumor. Signatera is intended to detect and quantify cancer left in the body, at levels down to a single tumor molecule in a tube of blood, to identify recurrence earlier and to help optimize treatment decisions. The test has not been cleared or approved by the US Food and Drug Administration (FDA).