On May 26, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) has published an abstract disclosing new predictive biomarker data from the GLORIA Phase 1/2 clinical trial of NOX-A12 in brain cancer (glioblastoma) (Press release, TME Pharma, MAY 26, 2023, View Source [SID1234632162]). The data will be presented in a poster presentation at the ASCO (Free ASCO Whitepaper) Annual Meeting by Dr. Frank A. Giordano, the lead investigator of the GLORIA trial, on Saturday June 3, 2023, starting at 01:15 p.m. CST (08:15 p.m. CEST) in Chicago, Illinois, US.

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The abstract highlights biomarker analyses of 10 glioblastoma patients from the GLORIA trial treated with radiotherapy (RT) and NOX-A12. The patients with higher biomarker scores at baseline had a significantly longer PFS than those with lower scores (6.0 vs. 3.0 months; p = 0.031) and a trend towards prolonged OS (15.8 vs. 11.1 months; p = 0.075). In contrast, these correlations were not seen in the reference cohort patients treated with standard of care (PFS: 4.6 vs. 6.0 months; p = 0.502; OS: 9.6 vs. 10.0 months; p = 0.243).

The fact that there is a correlation to clinical outcomes when NOX-A12 is used but not with standard of care means that this biomarker specifically predicts response to NOX-A12. These data show superior clinical efficacy of the NOX-A12 and RT treatment in patients with a high biomarker score, suggesting the score can be used as a novel predictive biomarker for CXCL12-directed therapies, like NOX-A12, in glioblastoma.

"We are thrilled to announce these groundbreaking new data from the GLORIA trial, which identify a new biomarker that can predict the clinical responses of brain cancer patients to NOX-A12-based therapies," said Aram Mangasarian, CEO of TME Pharma. " Beyond the relevance of the therapeutic choice for the patient, having a predictive biomarker is very positive and could be decisive on several levels if validated in future studies. First, having the ability to select patients who will benefit most from NOX-A12 will increase our chances of achieving regulatory approval and commercial success, while at the same time substantially de-risking the clinical development of NOX-A12, which is important for investors and pharma partners in difficult to treat indications like the brain cancer, glioblastoma. Further, in the future, it would give NOX-A12 a significantly improved position for pricing and reimbursement discussions with payers, since we could say with high likelihood that our therapy will benefit patients. Sharing our latest development from GLORIA at ASCO (Free ASCO Whitepaper), one of the most renowned cancer conferences in the world, further highlights the significance of the results emerging from this trial and the progress TME Pharma is making in the treatment of this very complicated and debilitating disease."

The biomarker is calculated by analyzing the frequency of expression of the target of NOX-A12 (CXCL12, or "12") on two types of cells in the tumor microenvironment (TME): 1) blood vessels (endothelial or "E") cells and 2) cancer (glioma or "G") cells. Combining CXCL12 expression on these two key cell types in the TME give the EG12 score, essentially the fraction of endothelial and glioma cells expressing CXCL12. This EG12 score is significantly correlated with PFS (r = 0.87; p = 0.005) in patients treated with NOX-A12 and RT. This correlation was not seen in a reference cohort of 15 glioblastoma patients treated with standard of care (SOC) (r = -0.10; p = 0.724).

Details of the poster presentation at ASCO (Free ASCO Whitepaper) are as follows:

Title: Potential predictive biomarker for response to radiotherapy and CXCL12-inhibition in glioblastoma in the phase 1/2 GLORIA trial (abstract #2048)
Abstract: view on the ASCO (Free ASCO Whitepaper) website
Presenter: Dr. Frank A. Giordano, Professor and Chair of the Department of Radiation Oncology at the University Medical Center Mannheim, Germany, and the lead investigator of the GLORIA trial.
Session Type: Poster Session
Session Title: Central Nervous System Tumors
Session Date and Time: June 3, 2023, 01:15-04:15pm CST

The poster will be made available on the TME Pharma website on June 03, 2023.

On May 26, 2023 Takeda (TSE: 4502/NYSE:TAK) reported that it will present data from its expanding oncology pipeline and established product portfolio at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) being held June 2-6, 2023, in Chicago, Ill. and the 31st Congress of the European Hematology Association (EHA) (Free EHA Whitepaper), June 8-11, 2023, in Frankfurt, Germany (Press release, Takeda, MAY 26, 2023, View Source [SID1234632161]).

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The company’s presence at ASCO (Free ASCO Whitepaper) 2023 will underscore Takeda’s growing solid tumor portfolio, with research focused on improving treatment for metastatic colorectal cancer (CRC), as well as rare forms of oncogene-driven non-small cell lung cancer (NSCLC). Within its hematology portfolio, Takeda will present data in oral sessions at both ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) on a head-to-head Phase 3 study comparing targeted treatments in newly diagnosed patients with Philadelphia-positive acute lymphoblastic leukemia (Ph+ ALL).

"Over the past year, we have made significant advancements with our pipeline – both in progress with our innate immunity enhancers and in further diversifying our pipeline – aiming to ultimately deliver transformative medicines to patients who need them most," said Awny Farajallah, M.D., head, global medical affairs, oncology at Takeda. "With our aspiration to cure cancer in mind, we are excited to share data from our newly expanded solid tumor portfolio featuring results in colorectal cancer, as well as research from our established hematological portfolio where we continue to explore the potential for a new standard of care treatment in acute lymphoblastic leukemia."

A full list of company-sponsored abstracts are available for ASCO (Free ASCO Whitepaper) (here) and EHA (Free EHA Whitepaper) (here).

On May 26, 2023 Genexine (KQ 095700, CEO Neil Warma), a publicly traded, clinical-staged Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of unmet medical needs, reported the publication of an abstract of its phase 2 clinical trial on triple combination neoadjuvant therapy for HNSCC (head and neck squamous cell carcinoma) in the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) (Press release, Genexine, MAY 26, 2023, View Source [SID1234632160]). The study evaluated the DNA vaccine GX-188E (tirvalimogene teraplasmid) and the lymphopenia-correcting immune-oncology drug GX-I7 (efineptakin alfa) in combination with immune checkpoint inhibitor Keytruda (pembrolizumab).

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"Head and neck cancer remains such a serious unmet need and we believe there is potential to expand the label for GX-188E beyond cervical cancer to include HNSCC."

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The phase 2 investigator-initiated clinical trial (IIT) being conducted in South Korea led by Professor Hye-Ryun Kim, Division of Medical Oncology of Yonsei University Severance Hospital, and jointly conducted with a research team of Professor Yoon Woo Koh, Department of Otolaryngology, enrolled a total of 11 patients with HPV-positive cervical cancer who were scheduled for surgery. The patients received Keytruda 200mg on day 1 and 22, Genexine’s GX-188E DNA vaccine 2mg on day 1, 8, 22 and GX-I7 on day 8 to amplify the number of T cells before surgery. The primary endpoint evaluated the major pathological response (MPR) and other evaluation criteria included safety, recurrence rate and survival rate.

All 11 patients who participated in the trial underwent surgery as planned after neoadjuvant therapy with no increase in surgical delay or surgical complications. Seven patients (63.6%) showed a major pathological response (MPR), and four patients (36.3%) achieved a pathological complete response (pCR), indicating satisfactory primary evaluation variables. Furthermore, comparative analysis of the tissue before and after combination therapy revealed an increase in follicular helper T cells (CD4+) and reactivation of killer T cells (CD8+) in the tumor microenvironment.

Using AI-based analysis technology, the triple combination therapy was found to increase the density of tumor-infiltrating lymphocytes (TIL) and completely transform tumors classified as immune-desert or immune-excluded types into inflamed tumors.

Professor Hye-Ryun Kim, who led the clinical trial, said, "Through this clinical study conducted for human papillomavirus (HPV)-positive HNSCC patients, the efficacy and safety of the triple combination therapy appear to be confirmed, and the therapy could become an effective new treatment strategy for HPV positive HNSCC patients in the future."

"We are pleased by these early data in this important trial as this is the first time this combination therapy has been used," said Neil Warma, President and CEO of Genexine. "Head and neck cancer remains such a serious unmet need and we believe there is potential to expand the label for GX-188E beyond cervical cancer to include HNSCC."

HNSCC cancer is one of the malignant tumors that occur on the patient’s facial area and is commonly caused by factors such as smoking and high-risk HPV infection. While various treatment methods such as surgery, radiation therapy and chemotherapy have been used in the past, the size of the surgical area can significantly impact the patient’s quality of life. Therefore, immunotherapy has been gaining attention as a treatment option along with the development of immune checkpoint inhibitors. The results of this study will be presented in a poster session at the ASCO (Free ASCO Whitepaper) 2023 Annual Meeting, which will be held in Chicago from June 2 to 6, 2023.

Details of the poster presentation are as follows:

Abstract Title

Neoadjuvant pembrolizumab, GX-188E, and GX-I7 in patients with human papillomavirus-16- and/or 18-positive head and neck squamous cell carcinoma: Single-arm, phase 2 trial with single cell transcriptomic analysis and artificial intelligence-powered spatial analysis.

Session Title

Head and Neck Cancer

Abstract Number

6075

Date and Time

June 5, 2023, 1:15 – 4:15 PM

On May 26, 2023 Foundation Medicine, Inc., reported that the company and its collaborators will present 21 abstracts demonstrating the value of high-quality tumor profiling tests to inform cancer care at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting from June 2-6 in Chicago (Press release, Foundation Medicine, MAY 26, 2023, View Source [SID1234632159]).

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Informing outcomes through ctDNA monitoring
Circulating tumor DNA (ctDNA) has emerged as a promising tool to support oncologists in monitoring their advanced cancer patients’ response to therapy. Two studies being presented at ASCO (Free ASCO Whitepaper) further define the clinical application of ctDNA monitoring and demonstrate the value of FoundationOneTracker to support and inform oncologists’ treatment planning.

Circulating tumor DNA (ctDNA) monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel (Abstract 9075)
Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo) (Abstract 9022)
New Capabilities of Liquid Biopsy
Several studies to be presented by Foundation Medicine at ASCO (Free ASCO Whitepaper) demonstrate the unique capabilities of the company’s FDA-approved liquid biopsy comprehensive genomic profiling (CGP) test, FoundationOneLiquid CDx. Foundation Medicine is unique in its ability to report ctDNA tumor fraction in clinical reports for more confident clinical decision making, and along with its collaborators, is presenting two studies highlighting the clinical utility and differentiating factors of FoundationOne Liquid CDx’s tumor fraction reporting. Foundation Medicine will also present new data describing FoundationOne Liquid CDx’s robust ctDNA-based detection of rearrangements and fusions. It is the only company with companion diagnostics for fusions on both its tissue and blood-based CGP tests, and this research at ASCO (Free ASCO Whitepaper) continues to demonstrate the clinical utility of FoundationOne Liquid CDx’s regulatory-grade fusion detection and bioinformatics.

Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC) (Abstract 9076)
The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP (Abstract 9035)
Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies (Abstract 4085)
Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer (mCRPC) (Abstract 5056)1
Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA) (Abstract 9082)
Driving innovation through development and validation of complex genomic biomarkers
Multiple lines of evidence, including what will be communicated in an oral presentation, demonstrate the validity and utility of Foundation Medicine’s complex genomic biomarkers, including tumor mutational burden (TMB) and a signature for homologous recombination deficiency (HRDsig).

Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types (Abstract 2503)
Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness (Abstract 4146)
Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study (Abstract 1036)
HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC) (Abstract 539)
Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice (Abstract 5583)
Addressing inequities in next generation sequencing for patients with NSCLC
Additionally, in partnership with The West Cancer Center, OneOncology, Flatiron Health and Genentech, a member of the Roche Group, there will be an oral presentation of joint research examining inequities in next generation sequencing (NGS) testing for patients with advanced non-small cell lung cancer being treated in the community setting in the United States.

Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients (Abstract 6508)
"Our data at ASCO (Free ASCO Whitepaper) demonstrates the expanded and differentiated capabilities of our monitoring and liquid biopsy tests, reinforces our leadership in detection of complex genomic biomarkers, and supports increased confidence and ease in our tests’ use by doctors and researchers," says Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. "Much of this research was conducted in collaboration with our partners across the oncology ecosystem, underscoring our commitment to working together in order to make faster, more impactful progress for patients."

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

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #ASCO23 and visit us in person at Booth #19081.

Abstract #

Title

Collaborators

Product

Orals

2503

Sunday, June 4

9:45 AM – 12:45 PM

Tumor Mutational Burden (TMB) Measurement from an FDA-Approved Assay and Real-World Overall Survival (rwOS) on Single-Agent Immune Checkpoint Inhibitors (ICI) in over 8,000 Patients across 24 Cancer Types

UC Davis Comprehensive Cancer Center, Flatiron Health and others

Foundation Medicine and Flatiron Health’s Joint Clinico-Genomic Database (CGDB)

6508

Tuesday, June 6

8:00 – 11:00 AM

Practice- and provider-level inequities in Next Generation Sequencing (NGS) by race/ethnicity for advanced non-small cell lung cancer (aNSCLC) patients

The West Cancer Center, OneOncology, Genentech Inc., Flatiron Health, Tennessee Oncology

Flatiron Health Database

Poster Discussions

9022

Sunday, June 4

4:30 – 6:00 PM

Circulating tumor DNA (ctDNA) dynamics and survival outcomes in patients (pts) with advanced non-small cell lung cancer (aNSCLC) and high (>50%) programmed cell death-ligand 1 (PD-L1) expression, randomized to cemiplimab (cemi) vs chemotherapy (chemo)

Third-party poster generated by Regeneron Pharmaceuticals, Inc., MD Anderson Cancer Center and others featuring results obtained through collaboration with Foundation Medicine, Natera Inc., and others

FoundationOneTracker

Posters

5056
Saturday, June 3
8:00 – 11:00 AM

Use of circulating tumor DNA (ctDNA) to complement tumor tissue homologous recombination repair (HRR) gene alteration testing in TALAPRO-2, a Phase 3 study of talazoparib (TALA) + enzalutamide (ENZA) versus placebo (PBO) + ENZA as first-line (1L) treatment in patients (pts) with metastatic castration-resistant prostate cancer)

Peter MacCallum Cancer Centre, Institute Gustave Roussy, Pfizer and others

FoundationOneCDx

FoundationOneLiquid CDx

11541

Saturday, June 3

1:15 – 4:15 PM

Clinical Utility of Liquid-based Comprehensive Genomic Profiling (CGP) in Gastrointestinal Stromal Tumors (GIST)

Boston University Medical Campus, OHSU Knight Cancer Institute, Boston Medical Center

FoundationOneCDx

FoundationOneLiquid CDx

TPS3166

Saturday, June 3

8:00 – 11:00 AM

SPARK, Studying Pathways of Resistance in KRAS-driven Cancers: A remote plasma ctDNA participation study to identify mechanisms of resistance to KRAS inhibitors

Dana-Farber Cancer Institute, Lowe Center for Thoracic Oncology, KRAS Kickers, GO2 Foundation for Lung Cancer, Addario Lung Cancer Medical Institute, Bonnie J Addario Lung Cancer Foundation, Addario Lung Cancer Medical Institute (ALCMI)

FoundationOneLiquid CDx

9587

Saturday, June 3

1:15 – 4:15 PM

Comprehensive Genomic Profiling (CGP) of Clinically Advanced and Metastatic Cutaneous Adnexal Carcinomas (CAs; MCADCA): A Genomic Landscape Study

SUNY Upstate Medical University, Upstate University Hospital

FoundationOneCDx

5044

Saturday, June 3

8:00 – 11:00 AM

Penile Squamous Cell Carcinoma (PSCC) with Elevated Tumor Mutational Burden (TMB): A Genomic Landscape Study

SUNY Upstate Medical University, H. Lee Moffitt Cancer Center and Research Institute, University of Washington; Fred Hutchinson Cancer Center, The University of Texas MD Anderson Cancer Center, Vita-Salute San Raffaele University

FoundationOneCDx

4587

Saturday, June 3

8:00 – 11:00 AM

CDH1-Mutated Clinically Advanced Urothelial Bladder Cancer (UBC): A Genomic Landscape and Real-World Clinical Outcome Study (RWCOS)

Moffitt Cancer Center and Research Institute, Vita-Salute San Raffaele University, Saint Louis University Hospital, University of Washington; Fred Hutchinson Cancer Center, SUNY Upstate Medical University

FoundationOneCDx

CGDB

9075

Sunday, June 4

8:00 – 11:00 AM

Circulating Tumor DNA (ctDNA) Monitoring to inform maintenance outcomes in patients (pts) with advanced NSCLC treated with induction atezolizumab+carboplatin+nab-paclitaxel

H. Lee Moffitt Cancer Center and Research Institute, Natera, Inc., Genentech Inc., AdventHealth Cancer Institute

FoundationOneTracker

9076

Sunday, June 4

8:00 – 11:00 AM

Utility of ctDNA tumor fraction to inform negative liquid biopsy (LBx) results and need for tissue reflex in advanced non-small cell lung cancer (aNSCLC)

Icahn School of Medicine at Mount Sinai, UC San Diego Moores Cancer Center

FoundationOneCDx

FoundationOneLiquid CDx

CGDB

9082

Sunday, June 4

8:00 – 11:00 AM

Mobocertinib efficacy in patients with NSCLC and EGFR exon 20 insertion mutations (ex20ins) identified by next-generation sequencing (NGS) of circulating tumor DNA (ctDNA)

Third-party poster generated by Takeda Pharmaceuticals USA and others featuring FoundationOneLiquid CDx results obtained through collaboration with Foundation Medicine

FoundationOneLiquid CDx

9035

Sunday, June 4

8:00 – 11:00 AM

The effect of ctDNA Tumor Fraction (TF) on overall survival and concordance between tissue genomics and ctDNA in Lung-MAP

Mount Sinai Health System and others

FoundationOneCDx

FoundationOneLiquid CDx

9094

Sunday, June 4

8:00 – 11:00 AM

Characterization of diverse targetable alterations in ERBB2 and ERBB3 in 93,465 non-small cell lung cancers (NSCLC)

Memorial Sloan Kettering Cancer Center, University of California San Diego, Moores Cancer Center

FoundationOneCDx

FoundationOneLiquid CDx

539

Sunday, June 4

8:00 – 11:00 AM

HRD Signature and HRD Genomic Landscape of tumors from 896 Patients with Early-Stage Breast Cancer (BC)

Yale School of Medicine, Yale Cancer Center

CGDB

1036

Sunday, June 4

8:00 – 11:00 AM

Metastatic Breast Cancer (MBC) with Ultra-high Tumor Mutational Burden (UHTMB): A Comprehensive Genomic Profiling (CGP) Study

Lifespan Health System, Ohio State University Comprehensive Cancer Center, SUNY Upstate Medical University, Upstate University Hospital, Yale Cancer Center, Yale School of Medicine

FoundationOneCDx

4085

Monday, June 5

8:00 – 11:00 AM

Liquid-biopsy detection of FGFR2 and other actionable rearrangements in GI malignancies

Weill Cornell Medicine, Englander Institute of Precision Medicine, New York Presbyterian Hospital, Vanderbilt University Medical Center, The University of Texas MD Anderson Cancer Center

FoundationOneCDx

FoundationOneLiquid CDx

4146

Monday, June 5

8:00-11:00 AM

Tumor Mutational Burden (TMB) in Real-world Patients with Pancreatic Ductal Adenocarcinoma (PDAC): Differences in Genomic Alterations (GA) and Predictive Value for Immune Checkpoint Inhibitor (ICI) Effectiveness

University Hospital Seidman Cancer Center, Case Western Reserve University, Mayo Clinic

FoundationOneCDx

CGDB

5593

Monday, June 5

1:15 – 4:15 PM

Gynecologic-Cancer Analysis of ARID1A Alterations Detected in Both Tissue and Liquid Biopsies

National Cancer Institute

FoundationOneCDx

FoundationOneLiquid CDx

5583

Monday, June 5

1:15 – 4:15 PM

Effectiveness of PARP inhibitor maintenance therapy (mPARPi) in advanced ovarian cancer (OC) by BRCA1/2 and HRD signature in real-world practice

Stephenson Cancer Center/University of Oklahoma Health Sciences Center and Sarah Cannon Research Institute, University of Oklahoma, Flatiron Health

FoundationOneCDx

CGDB

4088

Monday, June 5

8:00 – 11:00 AM

ASCO Merit Award

Characterizing KRAS Allele Variants Within Biliary Tract Cancers

Princess Margaret Cancer Centre, MD Anderson Cancer Center University Health Network, University of Toronto, SUNY Upstate Medical University

FoundationOneCDx

On May 26, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-based therapeutics, reported that dosing in the Phase 1/2 first-in-human trial of PRO1160 (NCT05721222) has initiated in the US, and the company received approval from National Medical Products Administration (NMPA) to initiate the PRO1160 trial in China (Press release, ProfoundBio, MAY 26, 2023, View Source;pro1184-rinatabart-sesutecan-and-pro1160-in-the-clinic-301835477.html [SID1234632157]). The company also received NMPA approval to initiate the Rina-S Phase 1/2 first-in-human trial in China. Preliminary results from the on-going trial (NCT05579366) demonstrate a promising clinical profile, with anti-tumor activity observed at tolerable dose levels.

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"We continue to advance our next-generation antibody-drug conjugate (ADC) programs in our mission to bring new and better treatment options to patients with advanced cancers." said Naomi Hunder, MD, CMO of ProfoundBio. "Rina-S and PRO1160 have the potential to be best-in-class therapies; both leverage our novel hydrophilic linker and exatecan payload, designed to reduce off-target toxicities and improve anti-tumor activity through better exposure and stronger bystander activity. We are gratified to have enthusiastic support from global investigators as we gain experience with these novel agents to address high unmet needs."

About rinatabart sesutecan (PRO1184)

Rina-S is an ADC comprising a folate receptor alpha-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1/2 study will evaluate the safety, activity, and pharmacokinetics of Rina-S in patients with ovarian, endometrial, breast, non-small cell lung cancers and mesothelioma. This first-in-human study is actively enrolling with multiple clinical trial sites across the United States and China.

About PRO1160

PRO1160 is an ADC comprising a CD70-directed antibody conjugated to the exatecan payload with ProfoundBio’s novel, proprietary hydrophilic linker. The Phase 1/2 study will evaluate the safety, activity, and pharmacokinetics of PRO1160 in patients with metastatic renal cell carcinoma, metastatic or relapsed nasopharyngeal carcinoma, or advanced non-Hodgkin lymphoma. In preclinical studies, PRO1160 demonstrated the potential to be a first- and best-in-class CD70-directed ADC. The first-in-human study is actively enrolling with multiple clinical trial sites across the United States.