On April 5, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the company and its collaborators will present a total of 10 studies at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 14-19 in Orlando, Florida (Press release, Foundation Medicine, APR 5, 2023, View Source [SID1234629852]).

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Presentation highlights:

Over the past several years, there has been great progress in the ability to identify shed pieces of tumor, called circulating tumor DNA (ctDNA), within a cancer patient’s blood. In partnership with South Australian Immunogenomics Cancer Institute, Saint Bartholomew’s Hospital and Genentech, Foundation Medicine researchers used its novel methylation sequencing research platform to detect ctDNA as a prognostic biomarker in overall survival for patients with metastatic castrate resistant prostate cancer (mCRPC). Results from ctDNA evaluation as early as 6 weeks post treatment initiation were comparable to prostate specific antigen (PSA) response in second line mCRPC, providing an early non-invasive readout that is independent of PSA for monitoring therapy response in late stage mCRPC.
Historical barriers in the study of small cell lung cancer (SCLC) include the relative lack of human tumors studied, limited real-world data, and the lack of access to longitudinal samples to understand tumor evolution. In partnership with Stanford University and Vanderbilt University Medical Center, Foundation Medicine researchers conducted what is believed to be the largest SCLC study known to date to provide an improved understanding of genetic subtypes in SCLC, including patient ancestry and biopsy site-specific patterns, and better inform mechanisms of transformation to SCLC from non-small cell lung cancer that may further guide the development of personalized therapies for subsets of patients with this fatal tumor.
"Our experience sequencing over one million patient samples has allowed us to continuously improve our approach and have high confidence in the genomic abnormalities we detect and the results we deliver," said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. "We are committed to bringing high-quality, differentiated and sustainable solutions, like options for sensitive ctDNA monitoring, to our physician and researcher partners so that they can provide all patients with the best treatment options for their unique cancers."

The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at AACR (Free AACR Whitepaper), please visit AACR (Free AACR Whitepaper).org.

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #AACR23 and visit us in person at Booth #3053.

Abstract #

Title

Collaborator

Product

Posters

305

Sunday, April 16

1:30 – 5:00 PM

POLE variant detection and classification is critical for identifying patients who may benefit from immunotherapy

FoundationOneCDx and FoundationOneLiquid CDx

228

Sunday, April 16

1:30 – 5:00 PM

Recurrent mitochondrial mutations in thyroid cancer

FoundationOneCDx

931

Sunday, April 16

1:30 – 5:00 PM

Comprehensive analysis of 3,600 small cell lung cancer cases reveals rare genetic subtypes and multiple mechanisms of histological transformation

Stanford University & Vanderbilt University Medical Center

FoundationOneCDx,

Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database

933

Sunday, April 16

1:30 – 5:00 PM

The landscape of treatment patterns in non-small cell lung cancer post EGFR TKI treatment described by real world data from 428 patients

Flatiron Health, One Oncology

Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database

938

Sunday, April 16

1:30 – 5:00 PM

Outcomes of Molecular Tumor Board recommendations for cancer patients with progression on standard of care therapies in Saudi Arabia

King Abdulaziz Medical City, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center

FoundationOneCDx

966

Sunday, April 16

1:30 – 5:00 PM

Exploration of a novel HRD signature (HRDsig) as a biomarker for rucaparib benefit in ARIEL2

Clovis Oncology, Imperial College London

FoundationOneCDx

305

Monday, April 17

9:00 a.m. – 12:30 p.m.

Co-occurrence of alterations impacting telomere elongation

FoundationOneCDx

2289

Monday, April 17

9:00 a.m. – 12:30 p.m.

Predicting tumor somatic vs versus clonal hematopoiesis (CH) origin for short variants (SV) with FoundationOneLiquid CDx assay

FoundationOneLiquid CDx

3362

Monday, April 17

1:30 – 5:00 p.m.

Evaluation of circulating tumor DNA kinetics as a prognostic biomarker for overall survival in metastatic castrate resistant prostate cancer using a novel methylation sequencing research assay

South Australian Immunogenomics Cancer Institute, Genentech, St. Bartholomew’s Hospital

Research methylation assay

3395

Monday, April 17

1:30 – 5:00 p.m.

Clinical Impact of FGFR inhibitors on FGFR2 Fusion Positive Pancreatic Cancer

Ohio State University

FoundationOneCDx

On April 5, 2023 Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, reported that the first patient has been dosed in the fifth cohort of the first-in-human phase I trial (ALS-6000-101) of AVA6000 (Press release, Avacta, APR 5, 2023, View Source [SID1234629851]). This follows the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA) to allow for higher levels of dosing.

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Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has recommended that the phase Ia dose escalation clinical trial continues to a fifth dose cohort at 250mg/m2, following the favourable safety profile of AVA6000 generated in the study to date. Escalation to this level of dosing falls outside of the original clinical trial protocol, and therefore the protocol required amendment and approval by the MHRA, which has now been completed. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: "We are very much encouraged by the positive safety and tolerability data emerging from the dose escalation phase 1a study of AVA6000. Following the recommendation from the SDMC, and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial. The recent confirmation of release of active chemotherapy in the tumour tissue and the safety data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISION platform which add significant value to the technology and confirm the tumour targeting potential of the pre|CISION platform."

This announcement has been approved for release by Alastair Smith, Chief Executive Officer of Avacta Group plc.

On April 5, 2023 Simcha Therapeutics ("Simcha"), a clinical-stage immunobiology company pioneering first-in-class cytokine treatments in cancer, reported a clinical trial collaboration with Merck (known as MSD outside the US and Canada) to evaluate clinical safety and benefits of ST-067, Simcha’s decoy resistant IL-18 agent, in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in patients with solid tumors (Press release, Simcha Therapeutics, APR 5, 2023, View Source [SID1234629850]). In conjunction with this collaboration, Dr. Emmett Schmidt, vice president of early oncology development for Merck, will join Simcha’s scientific advisory board.

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"ST-067, with its ability to stimulate both adaptive and innate immunity, has potential in a broad range of tumor types, and preclinical experiments combining ST-067 with immuno-oncology agents such as Keytruda have generated encouraging results," said Sanuj Ravindran, M.D., CEO of Simcha Therapeutics. "I’m excited to work with Dr. Schmidt, and we are eager to leverage Merck’s expertise to evaluate the clinical benefits of ST-067 in combination with Keytruda in hopes of bringing transformational medicines for cancer patients."

"I am delighted to join the Scientific Advisory Board at Simcha," commented Dr. Schmidt. "I look forward to directly contributing to the development of agents with the potential to benefit patients receiving Keytruda in combination with emerging combination agents."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About ST-067

ST-067 is the first "decoy-resistant" variant of IL-18, designed to be impervious to the decoy receptor IL-18BP, which blocks IL-18 from interacting with its receptor, thereby blocking the cytokine’s immunostimulatory activity. ST-067 has been shown in preclinical studies to maintain strong immune stimulation in the tumor microenvironment and is currently in Phase 1a/2 clinical development as a monotherapy in solid tumors. Additional clinical studies of ST-067 as both a monotherapy and in combination with other therapies such as Keytruda (pembrolizumab) are planned.

On April 5, 2023 Certis Oncology Solutions ("Certis"), a precision oncology and translational science company focused on combining functional assays and artificial intelligence to advance personalized medicine, reported that three abstracts have been accepted for presentation at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in Orlando, Fla. from April 14-19, 2023 (Press release, Certis Oncology Solutions, APR 5, 2023, View Source [SID1234629849]).

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"Immunotherapy development to date has largely focused on hematological cancers. As cancer researchers turn their attention to applying immuno-oncology to solid tumors, the need for preclinical models that recapitulate tumor microenvironment is becoming critical," said Peter Ellman, Certis President and Chief Executive Officer. "Our science shows that immune response to cancer therapies is dramatically different in humanized subcutaneous and orthotopic PDX models—a likely cause of false positives in preclinical immuno-oncology studies. We’re excited to showcase this and other important areas of cancer research at Certis."

Certis scientists will highlight research in humanized cancer models for immunotherapy, artificial intelligence and circulating DNA as a clinically relevant biomarker. Session titles and information for the three abstracts are listed below and are now available on the AACR (Free AACR Whitepaper) online itinerary planner.

Abstract 4299/30-Section 32: Gene Expression-Based Machine Learning Classifier to Predict and Validate Cancer Type in Patient-Derived Xenograft (PDX) Models
Poster session: April 18, 2023, 9:00 a.m.-12:30 p.m. EDT
Abstract: Patient-derived xenograft (PDX) models are increasingly utilized in translational research and drug development. Characterizing the genomic features of PDX is essential to establishing reliable models for cancer research. Despite great interest, problems remain in PDX tumor data banks, including improper cancer type diagnosis and sample mix-ups. To improve annotation and quality of PDX models, Certis developed a machine learning model trained on gene expression data from the Cancer Genome Atlas (TCGA). Certis then applied the model to corresponding data collected from nearly 300 Certis PDX models as well as the National Cancer Institute’s (NCI) Patient-Derived Models Repository (PDMR). The model shows high precision and variable recall and provides a fast and accurate method for cancer type diagnosis.

Abstract 4762/10-Section 6: In Vivo Tumor Implantation Site Exhibits Differential Immune Response in Solid Tumors
Poster session: April 18, 2023, 1:30 – 5:00 p.m. EDT
Summary: Successful discovery and development of cancer therapeutics depend on testing agents in the most clinically relevant translational models. Emerging evidence highlights the importance of the local tumor microenvironment in evaluating the efficacy of new therapeutics, especially for immunotherapies. Historically, PDX modeling involves subcutaneous implantation which minimally represents the actual human tumor site. Here, Certis uses peripheral blood mononuclear cell (PBMC) humanized PDX models to demonstrate differences in the tumor microenvironment, overall immune response, and the pharmacological outcome, between subcutaneous and orthotopic PDX models. These findings highlight the importance of testing new therapies in the most clinically relevant setting for greater translation into clinical success.

Abstract 6690/10 – Section 40: Monitoring Drug Response with Circulating Tumor DNA in a Non-Small Cell Lung Cancer (NSCLC) Patient-Derived Xenograft Model
Poster session: April 19, 2023, 9:00 a.m.-12:30 p.m. EDT
Abstract: Circulating tumor DNA (ctDNA) has been shown as a clinically relevant biomarker for non-invasive monitoring of therapy response, disease burden and disease progression in cancer patients. Patient-derived xenograft (PDX) mice are essential preclinical models to evaluate therapeutic response. Patients with a KRAS G12 mutation in Non-Small Cell Lung Cancer (NSCLC) have been shown to be resistant to EGFR inhibitors. Here, Certis reports Whole Genome Sequencing (WGS) of ctDNA from PDX for the monitoring of therapeutic response and demonstrates measurable ctDNA changes concordant with therapeutic response. Altogether, the isolation of ctDNA from PDX models is a robust methodology for interrogating therapeutic efficacy, response and resistance in a preclinical setting that can be translated as a viable biomarker for non-invasive monitoring in patients.

For more information, visit View Source

On April 5, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for cancer, reported that its management team will participate in a fireside chat at the 22nd Annual Needham Virtual Healthcare Conference on Wednesday, April 19 at 3:00 p.m. Eastern Time (Press release, Personalis, APR 5, 2023, View Source [SID1234629848]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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