On October 19, 2023 Scholar Rock (NASDAQ: SRRK), a Phase 3 clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that it will present data from DRAGON, a Phase 1 study of SRK-181 in patients with advanced solid tumors at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 38th Annual Meeting in San Diego on November 1-5 (Press release, Scholar Rock, OCT 19, 2023, View Source [SID1234636162]). In one poster presentation, Scholar Rock will share preliminary biomarker data from Part B of the trial, and in a second poster presentation, provide safety, efficacy, and biomarker results of SRK-181 in anti-PD-1 resistant metastatic clear cell renal cell carcinoma (ccRCC) patients from both Parts A and B.

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"We are excited to present clinical and biomarker updates on the DRAGON study, which build upon the safety and efficacy data to date in the ccRCC cohort of the trial and support our goal of establishing the proof of mechanism of SRK-181," said Jay Backstrom, M.D., MPH, President and Chief Executive Officer of Scholar Rock. "As a selective latent TGFβ1 inhibitor, SRK-181 has the potential to transform cancer immunotherapy by helping to overcome resistance to checkpoint inhibitor therapy. This investigational medicine demonstrates the promise of Scholar Rock’s unique discovery platform."

Details of the presentations are as follows:

Title: Establishing Proof of Mechanism in Patients: Preliminary Biomarker Data of SRK-181 (a latent TGFβ1 inhibitor) from DRAGON Study
Presentation Type: Poster 726
Presenter: Susan Henry, PhD, Senior Director, Translational Sciences, Scholar Rock, Inc.
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PDT and 7 – 8:30 PM PDT

Title: Safety, efficacy, and biomarker results of SRK-181, a latent TGFβ1 inhibitor, in anti-PD-1 resistant metastatic ccRCC patients
Presentation Type: Poster 666
Presenter: Timothy Yap, MBBS, PhD, FRCP, Medical Oncologist and Physician-Scientist; and Associate Professor, Department of Investigational Cancer Therapeutics, University of Texas MD Anderson Cancer Center
Location: Exhibit Halls A and B1, San Diego Convention Center
Date/Time: November 4, 11:55 AM – 1:25 PM PDT and 7 – 8:30 PM PDT

The abstracts for these presentations will be available on SITC (Free SITC Whitepaper)’s website on Oct 31, 2023: View Source

The presentations will be made available in the Publications & Posters section of Scholar Rock’s website following the conference.

For conference information, visit View Source

About SRK-181

SRK-181 is a selective inhibitor of TGFβ1 activation being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies, in advanced cancer. TGFβ1 is the predominant TGFβ isoform expressed in many human tumor types. Based on analyses of various human tumors that are resistant to anti-PD-(L)1 therapy, data suggest that TGFβ1 is a key contributor to the immunosuppressive tumor microenvironment, excluding and preventing entry of cytotoxic T cells into the tumor, thereby inhibiting anti-tumor immunity. (1) SRK-181 specifically targets the latent TGFβ1 isoform in a context-independent manner, designed to enable complete inhibition of TGFβ1 in all compartments within the tumor microenvironment. Scholar Rock believes that SRK-181 has the potential to overcome this immune cell exclusion and induce tumor regression when administered in combination with anti-PD-(L)1 therapy while potentially avoiding toxicities associated with non-selective TGFβ inhibition. The DRAGON Phase 1 proof-of-concept clinical trial (NCT04291079) in patients with locally advanced or metastatic solid tumors is ongoing. The trial is currently enrolling and dosing patients in multiple proof of concept cohorts conducted in parallel, including urothelial carcinoma (UC), cutaneous melanoma (MEL), non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and clear cell renal cell carcinoma (ccRCC). SRK-181 is an investigational product candidate and its efficacy and safety have not been established. SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

On October 19, 2023 To support emerging precision therapies and improve patient outcomes by increasing access to reliable genomic testing needed to match patients with targeted cancer treatments, Thermo Fisher Scientific reported a companion diagnostic (CDx) partnership with Boehringer Ingelheim (Press release, Thermo Fisher Scientific, OCT 19, 2023, View Source [SID1234636161]). Through this collaboration, the companies will work to develop CDx tests to help identify patients with non-small cell lung cancer (NSCLC) with specific genomic mutations.

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Lung cancer is one of the most common cancers, with 2.2 million cases worldwide in 2020 and is the leading cause of cancer death in both Japani and the U.S.ii The collaboration will leverage the Oncomine Dx Express Test* on the Ion Torrent Genexus Dx System* as well as the Oncomine Dx Target Test.**

"Our proven track record of co-developing CDx tests reinforces our commitment to working with leading pharma companies to ensure patients may have immediate access to these targeted therapies once approved," said Garret Hampton, president of clinical next-generation sequencing and oncology at Thermo Fisher Scientific. "Boehringer Ingelheim has made a generational commitment to transforming cancer care, and we’re excited to be supporting their pipeline as they work to ensure the appropriate tests are available to match eligible patients with emerging targeted therapies."

Boehringer Ingelheim has the aspiration to transform the lives of people with cancer by delivering meaningful advances, with the ultimate goal of curing a range of cancers. By partnering with Thermo Fisher, Boehringer Ingelheim aims to develop multiple companion diagnostic tests to ensure that labs using a variety of testing technologies will have the ability to match eligible patients with emerging NSCLC treatments as they become available.

A recently published, real-world study in stage 4 NSCLC found that patients whose treatments were initiated before genomic insights were available experienced inferior outcomes, supporting the need for more rapid molecular testing.iii Thermo Fisher’s Oncomine Dx Express Test in combination with the Genexus Dx System offers a fully integrated, NGS platform that can test a patient’s tumor biopsy or blood specimen, returning actionable results in as little as 24 hours. The Genexus Dx System delivers a turnkey, end-to-end NGS system that requires as little as 10 minutes of hands-on time, simplifying the testing workflow and making this technology feasible for more labs.

The Oncomine Dx Target Test remains the only distributed NGS CDx kit that has received regulatory approval and is available in 18 countries worldwide for 17 targeted therapies.

*The Genexus Dx instrument and the Oncomine Dx Express Test are currently CE-IVD and only available to those countries who accept the CE-IVD mark.

**The Oncomine Dx Target Test is for In Vitro Diagnostic use

On October 19, 2023 Biological Dynamics, Inc., a leader in exosome-isolation technology for early disease detection, reported a newly published study in Nature’s Communications Medicine titled "Development of a Blood-Based EV Classifier for Detection of Early-Stage Pancreatic Ductal Adenocarcinoma (Press release, Biological Dynamics, OCT 19, 2023, View Source [SID1234636160])." The research demonstrates the effectiveness of exosome-isolation technology in detecting Stage I and II pancreatic ductal adenocarcinoma (PDAC), using an independent validation cohort.

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"Pancreatic cancer is one of the deadliest cancers and is often detected at a late stage, limiting treatment options and reducing survival rates–the 5-year survival rate is just 12.5%," said Juan Pablo Hinestrosa, Ph.D., V.P. of Research at Biological Dynamics. "The results of this study show that by analyzing the critical information provided by exosomes and employing machine learning to develop a classifier, our technology platform can detect early-stage pancreatic cancer with high sensitivity and specificity."

Exosomes are tiny circulating particles naturally released from cells into the bloodstream. Historically, isolating these nanoparticles has been challenging due to their low levels, small sizes, and low buoyant density. Biological Dynamics’ ExoVita Pancreas assay, powered by the ExoVerita platform, uses the AC Electrokinetics method for exosome isolation. The proprietary technology is proving to be a precise, automated, and cost-effective method for capturing these particles and analyzing the biomarkers they carry to provide useful information about tumors.

The study, led by Dr. Hinestrosa in collaboration with Rosalie Sears, Ph.D., Oregon Health & Science University (OHSU), used the ExoVerita platform to isolate exosomes from blood samples collected from individuals with pancreatic cancer along with healthy donors and donors at high-risk for pancreatic cancer. A training set of samples was used to develop the ExoVita Pancreas assay, which assesses cancer risk based on a multi-biomarker signature and a machine learning-based classifier scoring. The assay was subsequently validated on an independent cohort of 113 subjects (30 PDAC cases stages I and II, 83 controls), with a performance of 90.0% sensitivity and 92.8% specificity.

"Now that we are beginning to understand the important story that exosomes tell when it comes to human health and disease, novel tools and biomarker approaches are opening new frontiers for early disease detection," said Paul R. Billings, M.D., Ph.D., CEO and Director of Biological Dynamics. "Driven by our Verita technology, the ExoVita test can detect challenging diseases like pancreatic cancer earlier than ever. With further testing in real-world settings, we are confident our exosome enabled test will be useful for high-risk surveillance and early detection of pancreatic cancer, resulting in improved patient outcomes."

On October 19, 2023 MAIA Biotechnology, Inc. (NYSE American: MAIA), a clinical stage company developing telomere-targeting immunotherapies for cancer, reported that preliminary safety and efficacy data from its ongoing Phase 2 clinical trial, THIO-101, was accepted for poster presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2023, being held in Madrid, Spain, October 20-24, 2023 (Press release, MAIA Biotechnology, OCT 19, 2023, View Source [SID1234636159]). THIO-101 is evaluating THIO in patients with advanced Non-Small Cell Lung Cancer (NSCLC) in sequential combination with Regeneron’s anti-PD-1 cemiplimab (Libtayo).

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"We look forward to presenting THIO data at the esteemed ESMO (Free ESMO Whitepaper) Congress, where we will have the opportunity to update global leaders in cancer research from around the world on the only direct telomere targeting agent currently in clinical development," said Vlad Vitoc, M.D., Chairman and Chief Executive Officer of MAIA Biotechnology.

The abstract is available online at the ESMO (Free ESMO Whitepaper) Congress website, and MAIA is scheduled for poster presentation on Monday, October 23. Details of the presentation are as follows:

Abstract title: A Phase 2, Multi-Center, Open-Label, Dose-Optimization Study Evaluating Telomere Targeting Agent THIO Sequenced with Cemiplimab in Patients with Advanced NSCLC – Preliminary Results

Presenter: Tomasz Jankowski, M.D.

Presentation Number: 1493P

Session title: NSCLC, metastatic

About ESMO (Free ESMO Whitepaper) and the ESPO Congress

The European Society for Medical Oncology is the leading professional organization for medical oncology. With more than 30,000 members representing oncology professionals from 168 countries worldwide, ESMO (Free ESMO Whitepaper) is the society of reference for oncology education and information.

The ESMO (Free ESMO Whitepaper) Congress is one of the most influential oncology platforms for clinicians, researchers, patient advocates, journalists and healthcare industry representatives from all over the world. Only the highest quality studies are approved to be presented, supporting dissemination of the latest cutting-edge data, high quality education and unparalleled networking opportunities for oncologists and other stakeholders from all around the world.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for patients with advanced NSCLC who progressed after first line treatment regimens containing an immune check point inhibitor.

About THIO-101, Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to Regeneron’s anti-PD-1 cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing a checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On October 19, 2023 Adela, Inc., an innovator in blood testing for minimal residual disease monitoring and early cancer detection through a genome-wide methylome approach, reported data demonstrating the feasibility of using its platform for ctDNA quantification and prognostic prediction in head and neck cancer (HNC) and renal cell carcinoma (RCC), at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2023 Congress (Press release, Adela, OCT 19, 2023, View Source [SID1234636158]). In samples from patients with newly-diagnosed HNC and RCC, collected at Princess Margaret Cancer Centre at University Health Network and the Ontario Tumour Bank, ctDNA was detected and quantified using Adela’s platform, and progression- or recurrence-free survival was compared between samples with high and low ctDNA.

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"To improve patient outcomes by optimizing the treatment delivered, clinicians need additional tools to stratify patients with HNC and RCC based on their likelihood of relapsing," said Geoffrey Liu, MSc, MD, Senior Scientist, Princess Margaret Cancer Centre at University Health Network. "These initial results from the genome-wide methylome platform demonstrating the ability to predict the likelihood of recurrence or progression from samples at diagnosis are promising. Future studies in the post-treatment setting will be needed to confirm these results."

In individuals with newly diagnosed stage I-IV HNC, ctDNA was quantified in 91 biobanked pre-treatment samples with a median follow-up time of 50.6 months. Individuals with higher quantities of ctDNA prior to treatment had a significantly increased likelihood of recurrence or progression [hazard ratio (HR) 5.40 (95% CI 2.25, 12.95), log-rank P<0.001]. A multivariate analysis demonstrated that this higher likelihood of recurrence or progression was independent of cancer stage and clinical characteristics (sex, age, smoking history) [HR 5.24 (95% CI 2.05, 13.42), Wald test P=0.001].

Similarly, in individuals with newly-diagnosed Stage I-IV RCC, ctDNA was quantified in 148 biobanked pre-treatment samples with a median follow-up of 15.7 months. Individuals with higher quantities of ctDNA prior to treatment had a significantly increased chance of recurrence or progression [HR 11.81 (95% CI 4.96, 28.1), log-rank P<0.001]. Worse prognosis persisted in the higher ctDNA group in a sub-population of 89 individuals with Stage I-III RCC [HR 16.26 (95% CI 2.9, 91.15), log−rank P<0.001].

"We are highly encouraged by these results demonstrating the strong prognostic prediction of our tissue-agnostic genome-wide methylome enrichment platform in patients newly diagnosed with cancer," said Anne-Renee Hartman, MD, Chief Medical Officer, Adela. "Our goal is to increase the ease and accessibility of MRD testing for patients and clinicians through a blood test that detects clinically meaningful levels of ctDNA to predict outcomes and inform treatment decisions, without requiring tumor tissue. We are currently evaluating the potential of the platform for assessing prognosis, and monitoring for post-treatment recurrence, in samples from multiple cancer types. We are excited about the potential of our comprehensive methylome approach to be utilized across the cancer continuum."

Presentation Details

Liu, G, MD2, et al. Prognostic Performance of a Genome-Wide Methylome Enrichment Platform in Head and Neck Cancer

Presentation Number: 866P

Date and Time: Sunday October 22nd, 12:00 – 1:00 PM CEST

Session Location: Hall 8

Rini, B. MD 1, et al. Evaluation of a Genome-Wide Methylome Enrichment Platform for Circulating Tumor DNA Quantification and Prognostic Performance in Renal Cell Carcinoma (RCC)

Presentation Number: 1910P

Date and Time: Monday October 23rd, 12:00 – 1:00 PM CEST

Session Location: Hall 8