On June 2, 2021 As part of the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting, precision oncology company Lucence reported that it is sharing real-world data supporting clinical applications of its amplicon-based liquid biopsy assay (Press release, Lucence, JUN 2, 2021, View Source [SID1234583415]). The data will be presented in on-demand virtual poster sessions, available beginning June 4 at 9 AM EDT.

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Lucence is also announcing the formation of a medical advisory board in the United States. Lucence’s Medical Advisory Board will be tasked with providing strategic, patient-centered guidance on research, development, and clinical applications of amplicon-based liquid biopsy tests. Dr. Gilberto Lopes of the University of Miami will join as an advisor.

Gilberto de Lima Lopes Jr., MD, MBA, FAMS is Interim Chief for the Division of Medical Oncology, Medical Director for International Programs and Associate Director for Global Oncology at the Sylvester Comprehensive Cancer Center, and Professor of Clinical Medicine at the Miller School of Medicine at University of Miami. Dr. Lopes’ career spans North America, Latin America, and Asia, and he has dedicated much of his time to the issues of cancer control and access to medications in low- and middle-income countries. Dr. Lopes is the Editor-in-Chief of ASCO (Free ASCO Whitepaper)’s Journal of Global Oncology.

"Dr. Lopes is a world-leading oncologist and is committed to the shared vision of accurate, accessible, and affordable precision cancer care for patients everywhere. We are honored to have him join Lucence’s Medical Advisory Board in the United States and know his insights will help inform our clinical approach in the months and years to come," said Min-Han Tan, Founding CEO and Medical Director of Lucence.

Lucence will be sharing two abstracts as part of Virtual 2021 ASCO (Free ASCO Whitepaper) highlighting the use of its ultrasensitive amplicon-based next-generation sequencing (NGS) assay, LiquidHALLMARK, for advanced cancers in real-world settings. Findings of both abstracts support the clinical utility of circulating tumor DNA (ctDNA) detection for non-small cell lung cancer (NSCLC) diagnosis and treatment selection.

The first abstract (#3062), authored by Jonathan Poh and contributors, Comprehensive molecular profiling of advanced cancers in a real-world setting using an ultrasensitive amplicon-based next-generation sequencing (NGS) liquid biopsy assay, detected ctDNA in 70% of cancer samples. In ctDNA-positive lung cancer (n=484), 75% of samples harbored one or more actionable targets for an FDA-approved therapy. Of the 392 patients being treated with EGFR tyrosine kinase inhibitors (TKIs), 29% harbored a mutation associated with EGFR TKI resistance. The data show how liquid biopsy can detect emerging resistance to therapy and suggest that LiquidHALLMARK can be a useful clinical tool in monitoring response to treatment.

The second abstract to be presented (#3042), in collaboration with the Bivona Lab at UCSF, is authored by Wei Wu and contributors. Targeted ctDNA sequencing analysis reveals concurrent genomic alterations and its impact on TKI and immune checkpoint inhibitor therapy in advanced NSCLC from an Asian population characterizes the ctDNA-derived genetic landscape of advanced NSCLC from a real-world population. Using Lucence’s LiquidHALLMARK assay, 76% of lung cancer patients were found to have at least 1 actionable mutation relevant to targeted therapy. Investigators also reported the finding of a novel PD-L1 structural rearrangement potentially associated with immune evasion.

As a follow up to Lucence’s programming for 2021 ASCO (Free ASCO Whitepaper), on June 29, 2021 at 8:30 PM EDT, Lucence will host New Frontiers in Liquid Biopsy for Lung Cancer, a webinar covering current and cutting-edge applications of liquid biopsy in thoracic oncology. Panelists will include Narjust Duma, MD, Assistant Professor of Medicine and Thoracic Oncology at the University of Wisconsin Carbone Cancer Center, Professor Tony Mok, MD, FRCPC, FASCO, Chairman of the Department of Clinical Oncology at the Chinese University of Hong Kong, and Christine M. Lovly, MD, PhD, Co-Leader of the Translational Research and Interventional Oncology Research Program and Associate Professor of Medicine at Vanderbilt University. Gilberto Lopes, MD, MBA, Interim Chief of Medical Oncology and Professor at the Miller School of Medicine of the University of Miami will moderate. For more information and to register for the webinar, please visit the Zoom registration page or email [email protected].

On June 2, 2021 Intensity Therapeutics, Inc. ("Intensity"), a clinical-stage biotechnology company developing proprietary, intratumoral products to kill tumors and increase immune system recognition of cancers, reported data from its on-going Phase 1/2 clinical trial in refractory patients demonstrating efficacy and tolerability of INT230-6, either as monotherapy or in combination with checkpoint inhibitors (pembrolizumab or ipilimumab), in patients with relapsed, refractory and metastatic solid tumors (Press release, Intensity Therapeutics, JUN 2, 2021, View Source [SID1234583414]). These posters will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held virtually from June 4 to 8.

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"INT230-6 is our novel, proprietary, locally-delivered anti-cancer product candidate that has shown favorable clinical results as monotherapy in a basket study of patients with advanced and refractory disease," said Lewis H. Bender, President and CEO of Intensity Therapeutics. "The results of these studies to be presented at ASCO (Free ASCO Whitepaper) provide increased evidence and support of the potential of INT230-6. The data in the first poster show that INT230-6, either as monotherapy or in combination with pembrolizumab, is well tolerated and elicits both direct tumor killing and abscopal effects. The second presentation reports similar results of INT230-6 with or without ipilimumab in patients with advanced sarcoma, a cancer type with high unmet medical need."

INT230-6 +/- pembrolizumab

Title: A Phase 1/2 Study of Intratumoral INT230-6 Alone (IT-01) or in Combination with Pembrolizumab [KEYNOTE-A10] in Adult Subjects with Locally Advanced, Unresectable and Metastatic Solid Tumors Refractory to Therapy
Authors: El-Khoueiry, A.B., et al.
Session: Developmental Therapeutics – Immunotherapy
Session type: Poster Session
Abstract: 2592

The poster reports results from 72 subjects on the preliminary efficacy and safety of either INT230-6 alone (n=58) or in combination with the anti-PD-1 antibody, pembrolizumab (n=14) from an ongoing open-label Phase 1/2 clinical trial. Patients had a variety of relapsed, refractory metastatic solid tumors and progressed following a median of three prior therapies. INT230-6 was administered intratumorally every two weeks for five doses either alone or with 200 mg pembrolizumab dosed every three weeks. Preliminary efficacy results such as disease control rate and median overall survival (mOS) are being reported. Additional outcome measures included overall safety, and the pharmacokinetic profile.

Sixty-two percent of INT230-6 monotherapy subjects were alive at one year and median OS was not reached with 221 days of median follow-up. When the dose of INT230-6 relative to the subject’s tumor burden (TB) was analyzed, subjects receiving a dose ≥50% of TB had not reached mOS with a median of 342 days of follow up (estimated to be 78% one-year OS). Subjects receiving a dose <50% of TB had an mOS of 95 days. This survival result achieved using INT230-6 compares favorably to historical survival data using the Royal Marsden Hospital Index (RMHI), a validated score that uses 3 incoming enrollment criteria to assess a patient’s likelihood of survival in phase 1 basket studies (Cancer 2012;118:1422–8). One year survival of the INT230-6 with pembrolizumab combination arm was 88%; however, these data are still maturing.

There were nine patients in the monotherapy arm that demonstrated abscopal effects (i.e., shrinkage of multiple non-injected tumors). Together with the immunohistochemistry biomarker findings, the results suggest a systemic immune system activation. Eight of these nine monotherapy patients received an INT230-6 dose ≥50% of the TB further emphasizing the importance of proper dosing.

INT230-6, either as monotherapy or in combination with pembrolizumab, was well tolerated. The most common adverse events (AEs) were localized tumor-related pain, nausea, fatigue and vomiting. AEs were mainly mild to moderate with no Grade 4 or 5 AEs.

"Despite significant innovation in immunotherapeutic and checkpoint inhibitor therapy approaches for cancer treatment, patients with metastatic and refractory disease continue to have poor survival and response rates remain low in most tumor types," said Anthony B. El-Khoueiry, M.D., Director of the Phase I Program and Associate Professor of Clinical Medicine, Keck School of Medicine of the University of Southern California (USC). Dr. El-Khoueiry is also an oncologist at the USC Norris Comprehensive Cancer Center. "While this analysis is exploratory, intratumoral injection of INT230-6, in which the active drug agents remain in the tumor as demonstrated by this study and cause cancer cell death, appears to have a positive impact on the tumor immune microenvironment and to be a promising approach in metastatic disease alone and in combination."

INT230-6 +/- ipilimumab

Title: Early Results of Intratumoral INT230-6 Alone or in Combination with Ipilimumab in Subjects with Advanced Sarcomas
Authors: Ingham, M., et al.
Session: Sarcoma
Session type: Poster Session
Abstract: 11557

As of the April 1, 2021, cutoff, the Phase 1/2 clinical trial evaluated 18 subjects with sarcoma/chordoma on the preliminary efficacy and safety of either INT230-6 alone (n=13) or in combination with the anti-CTLA-4 antibody, ipilimumab (n=5). Patients were treated with and progressed following a median of three prior therapies. INT230-6 was administered intratumorally every two weeks for five doses either alone or with 3 mg/kg of ipilimumab dosed every three weeks for four doses. Preliminary efficacy measured disease control rate (DCR) and median overall survival (mOS). Additional outcome measures included safety/tolerability, response in the injected tumor and the pharmacokinetic profile.

In the overall sarcoma/chordoma population INT230-6 monotherapy and combination subjects showed a disease control rate (DCR) at > 50 days (approximate 2 months assessment) of 60% and an estimated mOS of 23.6 months with 75% of subjects having a Royal Marsden Hospital index (RMHI) score of 2. Based on historical controls, a RMHI score of 2 is associated with an overall survival of between 3 and 6 months in sarcoma (Oncotarget, Vol. 7, No 39. July 2016). In addition, there were four INT230-6 monotherapy subjects who showed abscopal effects in multiple deep and distal tumors.

INT230-6, either as monotherapy or in combination with ipilimumab, was well tolerated. The most common adverse events (AEs) were localized tumor-related pain, nausea, fatigue and vomiting. AEs were mild to moderate (24% grade 3) with no Grade 4 or 5 AEs.

"Sarcoma has been a very challenging cancer to treat and has proven resistant to checkpoint blockade. Novel immunotherapy-based approaches are needed, and sarcoma is an attractive cancer for intratumoral injection," said Matthew Ingham, M.D., Assistant Professor of Medicine in the Division of Hematology and Oncology, Columbia University Irving Medical Center. "Although early, the results from this ongoing study are showing compelling early efficacy with this intratumoral approach as monotherapy, and we look forward to seeing if antigen presentation with this approach will be enhanced by combination with a checkpoint inhibitor."

To assess drug response the study employed RECIST and then iRECIST, which measure the change in longest diameter of tumors. An increase in diameter of 20% is considered progressive disease. RECIST methodology may not be a good measure of clinical benefit with intratumoral INT230-6 given that drug dosing is based on tumor volume. Evaluation of tumor enlargement is complicated by the amount of INT230-6 injected. During the first two months (5 sessions) of INT230-6 treatment patients could have received an intratumoral dose of drug equivalent from 25 to 250% of their tumor’s volume depending on the cohort. The potential to retain a significant percentage of the fluid prior to the first scan is high. There is also the possibility for immune infiltration, which can also increase tumor size. As a result, overall survival may be a more appropriate endpoint to assess efficacy of this novel treatment modality.

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug is composed of two proven, potent anti-cancer agents, cisplatin and vinblastine, and a penetration enhancer molecule that helps disperse the drugs throughout tumors for diffusion into cancer cells.

About Intensity Therapeutics’ Clinical Studies

INT230-6 is currently being evaluated in several Phase 2 cohorts (NCT03058289) in patients with various advanced solid tumors as part of Study IT-01. In 2019, the Company signed a clinical collaboration agreement with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity’s lead product candidate, and KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced pancreatic, colon, squamous cell and bile duct malignancies. In 2020, the Company executed a clinical collaboration agreement with Bristol-Myers Squibb to evaluate the combination INT230-6, with Bristol-Myers Squibb’s anti-CTLA-4 antibody, Yervoy (ipilimumab), in patients with advanced liver, breast and sarcoma cancers. Intensity is managing the individual combination arms separately with each respective partner via a joint development committee. In 2021 the Company executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in a randomized controlled neoadjuvant phase 2 study in women with early stage breast cancer (the INVINCIBLE study) (NCT04781725).

On June 2, 2021 CytRx Corporation (OTCQB: CYTR) ("CytRx" or the "Company"), a specialized biopharmaceutical company focused on research and development for the oncology and neurodegenerative disease categories, reported that Steven A. Kriegsman, Chairman and Chief Executive Officer of CytRx, is scheduled to present in the following upcoming conferences (Press release, CytRx, JUN 2, 2021, View Source [SID1234583413]):

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LD Micro Invitational XI Conference: June 8-10, 2021
Mr. Kriegsman will deliver a virtual presentation on Wednesday, June 9, 2021, at 10:30 a.m. PT. The event will be webcast live and available for registrants via the event homepage.
As a reminder, CytRx joined the LD Micro Index in 2021.
Global Chinese Financial Forum ("GCFF") Virtual Conference 2021 – Healthcare Investment Conference: June 10, 2021
Mr. Kriegsman will deliver a virtual presentation on Thursday, June 10, 2021, at 8:10 am PT. The event will be webcast live for registrants via the event page.
Mr. Kriegsman commented:

"CytRx is excited to be participating in the upcoming LD Micro Invitational XI Conference and the GCFF Conference, where we will be discussing our portfolio of high-potential licensing agreements and strategic assets. In particular, we are looking forward to connecting with Chinese investors to share CytRx’s developments surrounding our agreements with Orphazyme A/S and ImmunityBio, Inc., as well as Centurion Biopharma. We are pleased that Orphazyme is preparing for prospective regulatory approvals for arimoclomol in the treatment of Niemann-Pick disease Type C and ImmunityBio is expanding its scope of clinical trials involving aldoxorubicin to treat advanced pancreatic cancer."

On June 2, 2021 Agilent Technologies Inc. (NYSE: A) reported the release of SureSelect Human All Exon V8 – a new exome design that provides comprehensive content and up-to-date coverage of protein coding regions from RefSeq, CCDS, and GENCODE (Press release, Agilent, JUN 2, 2021, View Source [SID1234583412]). It also covers the TERT promoter and hard-to-capture exons that are omitted by other exomes on the market. The new design is available in three options – routine exome sequencing (Exome v8), clinical research sequencing (v8 Clinical Plus), and translational research (v8 UTR Plus) – allowing for content flexibility to meet our customer’s needs.

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"The SureSelect exome has been widely adopted in both clinical and translational research, and it has played an important role in shaping the rise of exome sequencing as a routine genomics technique"

Powered by machine learning-based probe design and an improved probe-printing process, the SureSelect Human All Exon V8 spans a 35.1 Mb target region of the human genome, with an efficient end-to-end design size of only 41.6 Mb. The panel delivers excellent enrichment performance for more uniform coverage, as well as efficient and cost-effective exome sequencing.

Kevin Meldrum, vice president and general manager for Agilent’s Genomics Division, discussed the impact of the release. "The SureSelect exome has been widely adopted in both clinical and translational research, and it has played an important role in shaping the rise of exome sequencing as a routine genomics technique," he said. "The SureSelect Human All Exon V8 provides best-in-class enrichment performance and sequencing efficiency, and it shows our commitment to exceed customer expectations and continue our legacy as the benchmark exome to the genomics community."

This new exome design is already delivering promising results in genetics by supporting virtual analysis of targeted genes important in germline investigations through seamless integration with Alissa Interpret for variant interpretation and reporting. In cancer, exome sequencing is commonly used to identify mutations that contribute to tumor progression, and the sequencing efficiency and coverage achieved with this new design will enable customers to get more out of each exome capture than ever before to identify critical genomic targets. In addition, large-scale manufacturing ensures the panel will provide consistent results for many years, another critical need in clinical research laboratories.

These new Exome designs can be automated on the Bravo automated liquid handling platform for high throughput applications and the Magnis NGS Prep System for complete, walkaway automation. The complete, pushbutton automation provided by the Magnis system will allow laboratories to efficiently deploy exome sequencing while reducing labor and operational expenses.

On June 2, 2021 Naveris reported that A new clinically-validated saliva test has been shown to detect HPV-associated head and neck cancer with high accuracy, a first-of-its-kind study result (Press release, Naveris, JUN 2, 2021, View Source [SID1234583411]).

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Researchers at Washington University School of Medicine in St. Louis used the Naveris, Inc. test to analyze saliva for sequences of the human papilloma virus (HPV) genome that are specific for HPV DNA released from malignant tumors. The test successfully distinguishes this tumor-tissue modified virus from non-cancerous sources of HPV DNA and precisely measures the number of tumor-tissue modified viral HPV (TTMV-HPV) DNA strands present in a saliva sample.

The study results point to the potential for a significant improvement in early detection of the most common type of head and neck cancer, HPV-associated oropharyngeal squamous cell carcinoma.

"Naveris’ patient-friendly saliva test has the potential to radically advance early detection of HPV-positive head and neck cancer, which has been growing rapidly among men in the United States. Early detection of these cancers would make a dramatic difference in patient outcomes," said Piyush Gupta, PhD, CEO of Naveris.

The study quantified participants’ tumor-tissue modified viral HPV DNA in saliva samples and compared it to the levels found in their blood by utilizing Naveris’ NavDx test. The results showed that TTMV-HPV DNA was commonly found in the saliva of HPV-associated head and neck cancer patients (44/46 cases), and at 18 times higher levels in the saliva samples than in the blood samples. One sample had undetectable TTMV-HPV and one was indeterminate for HPV DNA.

Washington University researchers are presenting an abstract of the study at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2021 annual meeting.

"The results of our study highlight the potential of accurately analyzing saliva to improve the early detection of HPV-associated oropharyngeal squamous cell carcinoma. If validated in larger studies, this test could lead to earlier diagnosis and treatment," said the study’s principal investigator Jose P. Zevallos, MD, chief of the division of Head and Neck Surgery in the Department of Otolaryngology at Washington University School of Medicine.

Naveris’ new saliva test is based upon the proprietary technology employed by the NavDx blood test that is in use at centers of excellence treating HPV-associated oropharyngeal cancer across the United States. NavDx is a liquid biopsy test that detects HPV-associated head and neck cancer earlier than is possible with imaging and is provided exclusively in the United States through the Naveris national reference CAP-accredited laboratory.

About Oropharyngeal Cancer:

Oropharyngeal cancer, which can develop at the base of the tongue, tonsils, and the middle part of the throat, used to be closely associated with smoking and heavy drinking. Today, however, oropharyngeal cancer is primarily caused by human papillomavirus (HPV) infection, the most common sexually transmitted virus and infection in the United States. More than one of five U.S. adults are infected with a high-risk strain of HPV that can potentially develop into cancer.1

Cases of HPV-positive oropharyngeal cancer have been increasing at an exponential rate among men in the United States over the last two decades2. About 54,000 cases of oropharyngeal and oral cavity cancer are expected in the nation this year and more than 10,000 deaths.3

Oropharyngeal cancers usually are not identified early because they grow slowly in locations that are not easy to see. By the time the cancers are recognized they frequently have spread to the lymph nodes and are difficult to treat. Early detection, however, enables highly effective treatment.