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Personal Genome Diagnostics Announces Medicare Coverage of PGDx elio™ tissue complete Assay for Patients with Advanced Cancer

On September 9, 2020 Personal Genome Diagnostics Inc. (PGDx), a leader in cancer genomics, reported that the CMS Molecular Diagnostics Program (MolDX) has issued a local coverage determination (LCD) for the FDA-cleared PGDx elio tissue complete assay (Press release, Personal Genome Diagnostics, SEP 9, 2020, View Source [SID1234564846]). The MolDX coverage determination establishes reimbursement for laboratory facilities across the 28-state MolDx jurisdiction, extending Medicare benefits for this comprehensive genomic test to patients living with advanced cancers.

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"The MolDx coverage decision is a major milestone toward enabling broader access to comprehensive genomic profiling for cancer patients," said Megan Bailey, Chief Executive Officer of PGDx. "Despite the well-understood and widely accepted benefits of tumor profiling in guiding optimal care, testing unfortunately remains low – less than 20% for some cancers – and this is especially true in the community setting. By establishing reimbursement at reasonable levels, MolDx’s decision will increase access to precision medicine for more cancer patients and eliminate a barrier to adoption by physicians across the country."

Cancer guidelines increasingly call for comprehensive molecular profiling to optimize treatment planning and inform care. PGDx elio tissue complete, the first FDA-cleared comprehensive genomic profiling kit, is used to identify alterations in the tumor and inform treatment decisions for patients with advanced solid tumors. The kitted system allows molecular laboratories anywhere to perform this advanced genomic testing of cancer in a more efficient, standardized, and accurate manner. By providing tests that can be run locally and automating the data analysis process, PGDx is enabling the adoption of precision medicine in healthcare systems across the country, no matter where a patient seeks treatment.

PGDx elio tissue complete

PGDx elio tissue complete is an FDA-cleared diagnostic kit and accompanying software for molecular labs that provides comprehensive genomic profiles of all solid tumors. PGDx elio tissue complete detects single nucleotide variants (SNVs) and small insertions and deletions (indels) in 500+ genes, select amplifications and translocations, and genomic signatures including microsatellite instability (MSI), and tumor mutation burden (TMB). Designed to be used locally at any laboratory across the country, PGDx elio testing and automated bioinformatics ensures both consistency and quality of results regardless of location.

Scholar Rock Announces First Patient Dosed in Part A2 of DRAGON Phase 1 Proof-of-Concept Trial of SRK-181 to Overcome Primary Resistance to Anti-PD-(L)1 Therapy

On September 9, 2020 Scholar Rock (NASDAQ: SRRK), a clinical-stage biopharmaceutical company focused on the treatment of serious diseases in which protein growth factors play a fundamental role, reported that the first patient has been dosed with SRK-181 in combination with anti-PD-(L)1 therapy in Part A2 of the DRAGON Phase 1 proof-of-concept trial (Press release, Scholar Rock, SEP 9, 2020, View Source [SID1234564845]). Part A1 of the DRAGON trial has successfully progressed dose escalation of SRK-181 monotherapy through 800 mg and continues to advance dose escalation . Part A1 and Part A2 are being conducted in a parallel but staggered fashion and will each evaluate doses up to 2400 mg. SRK-181 is a potent and highly selective inhibitor of latent TGFβ1 activation and is being developed to increase responses to immunotherapy by overcoming primary resistance to anti-PD-1 or anti-PD-L1 antibody therapy.

"We are encouraged by the dose escalation progress-to-date in Part A1 of the DRAGON trial, which has enabled us to begin the evaluation of SRK-181 in combination with anti-PD-(L)1 therapy," said Yung Chyung, M.D., Chief Medical Officer of Scholar Rock. "While checkpoint inhibitor therapies have become standard of care for a large number of cancer patients, there is still significant unmet need as many patients demonstrate resistance to this therapeutic class. It is our belief that SRK-181 could help overcome this immune exclusion and has the potential to increase the therapeutic benefit of this class of drugs."

The DRAGON Phase 1 open-label, dose escalation and dose expansion clinical trial consists of two parts to evaluate the efficacy, safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SRK-181 in adult patients with locally advanced or metastatic solid tumors enrolled across multiple sites in the U.S. The Part A dose escalation portion of the trial is evaluating SRK-181 as both a single agent (Part A1) and in combination with approved anti-PD-(L)1 therapy (Part A2). The Part B dose expansion portion of the trial is expected to initiate in the first quarter of 2021 and will evaluate SRK-181 in combination with approved anti-PD-(L)1 therapy in multiple tumor-specific cohorts, including urothelial carcinoma, cutaneous melanoma, non-small cell lung cancer, and other solid tumors. As is the case in Part A2, Part B of the trial will enroll patients with locally advanced or metastatic solid tumors who had a lack of response to anti-PD-(L)1 therapy. These patients will be treated with SRK-181 in combination with anti-PD-(L)1 therapy to evaluate if they are able to achieve an anti-tumor response. Intravenous (IV) SRK-181 is administered every 3 weeks (Q3W) and additional dosing regimens may be explored. An update on Part A dose escalation is expected in the fourth quarter of 2020 and efficacy and safety data from Part B of the trial is anticipated starting in 2021.

About SRK-181

SRK-181 is a potent and highly selective inhibitor of TGFβ1 activation and is an investigational product candidate being developed to overcome primary resistance to checkpoint inhibitor therapy, such as anti-PD-(L)1 antibodies. TGFβ1 is the predominant TGFβ isoform expressed in many human tumors, particularly for those tumors where checkpoint therapies are currently approved. Based on analyses of human tumors that are resistant to anti-PD-(L)1 therapy, data suggests TGFβ1 is a key contributor to excluding immune cell entry into the tumor microenvironment, thereby preventing normal immune function. Scholar Rock believes 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. By specifically targeting the latent TGFβ1 isoform, Scholar Rock hypothesizes that SRK-181 can increase the therapeutic window by potentially avoiding toxicities associated with non-selective TGFβ inhibition. A Phase 1 proof-of-concept clinical trial in patients with locally advanced or metastatic solid tumors is ongoing. The effectiveness and safety of SRK-181 have not been established and SRK-181 has not been approved for any use by the FDA or any other regulatory agency.

TScan Announces Targets for Two Planned INDs in 2021 to Treat Liquid Tumors

On September 9, 2020 TScan Therapeutics, a biopharmaceutical company focused on the development of T cell receptor (TCR)-engineered T cell therapies in oncology, reported plans to file two Investigational New Drug (IND) applications in their liquid tumor program in 2021 (Press release, TScan Therapeutics, SEP 9, 2020, View Source [SID1234564844]). Their first product, TSC-100, targets HA-1 and is designed to treat patients receiving hematopoietic stem cell transplant therapy with the goal of preventing relapse, a high unmet need in this setting. TScan announced selection of their lead TCR and its advancement to IND-enabling activities. Simultaneously, TScan announced selection of their second target, HA-2, with plans to file a second IND in 2021. These products are the first two TCRs in a multi-TCR program designed to provide treatment options for the majority of patients receiving stem cell therapy.

"We are excited to progress this T cell therapy solution for patients receiving stem cell transplant therapy," said David Southwell, Chief Executive Officer at TScan. "TScan’s goal in both its liquid and solid tumor programs is to learn from patients who respond well to therapy to treat those who are less fortunate. This represents a significant step in the progression of TScan as a TCR therapy company. Our lead TCR, TSC-100, was discovered internally using our TCR discovery platform, R-Scan, and was significantly derisked using our proprietary genome-wide safety screening platform, T-Scan. By extending our liquid tumor program to also include HA-2, we are one step closer to providing a comprehensive solution for patients receiving stem cell therapy. We also remain on track to nominate solid tumor targets in 2021."

Leveraging its core TCR discovery platform, R-Scan, TScan identified its lead HA-1 TCR after screening over 100,000,000 T cells from HA-1-negative donors. In preclinical experiments, TSC-100 showed strong activity against HA-1-positive leukemia cells and a clean safety profile, with minimal off-target interactions or alloreactivity. TSC-100 will be used to engineer donor T cells in the context of a stem cell transplant, with the goal of preventing relapse in HA-1-positive patients with AML, MDS, or adult ALL. To expand this program to patients not expressing HA-1, TScan is developing a second TCR specific for HA-2, termed TSC-101.

"Our goal is to provide a therapeutic option for every patient," said Gavin MacBeath, Chief Scientific Officer. "Our discovery team is already identifying TCRs that will allow our products to address an even broader patient population. Expanding our repository of therapeutic TCRs also enables us to develop multiplexed TCR therapies, which better mimic natural immune responses and provide more robust treatments for heterogeneous cancers like AML, as well as a diverse range of solid tumors. Using our two core platforms, we remain on track to nominate our first solid tumor candidates in early 2021."

About HA-1

HA-1 is a well-characterized minor histocompatibility antigen that is expressed on all blood cells, including leukemia cells, but is not expressed at appreciable levels in other normal tissues. It is associated with clinical benefit by generating a ‘graft vs. leukemia’ effect in the context of hematopoietic stem cell transplants in which the patient is HA-1-positive and the donor is HA-1-negative. Over half of all patients express the HA-1 target.

About HA-2

Similar to HA-1, HA-2 is a minor histocompatibility antigen expressed specifically on blood cells and is associated with clinical benefit through a ‘graft vs. leukemia’ effect. Addition of TSC-101, an HA-2-specific TCR, will expand the pool of eligible patients for TScan’s liquid tumor program.

Repare Therapeutics to Participate at Morgan Stanley Annual Global Healthcare Conference

On September 9, 2020 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading precision oncology company enabled by its proprietary synthetic lethality approach to the discovery and development of novel therapeutics, reported that Lloyd M. Segal, President and Chief Executive Officer, will participate in a virtual fireside chat at the Morgan Stanley Annual Global Healthcare Conference on Tuesday, September 15 at 10:15 a.m. ET (Press release, Repare Therapeutics, SEP 9, 2020, View Source [SID1234564843]).

A live webcast of the fireside can be accessed in the Investor section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 30 days following the fireside chat.

F-star Therapeutics to Participate in H.C. Wainwright & Co. 22nd Annual Investment Conference

On September 9, 2020 F-star Therapeutics Ltd., a clinical-stage biopharmaceutical company focused on transforming the lives of patients with cancer through the development of innovative tetravalent bispecific (mAb2) antibodies, reported that Eliot Forster, Chief Executive Officer, will be presenting at the H.C. Wainwright & Co. 22nd Annual Global Investment Conference on September 14, 2020 (Press release, F-star, SEP 9, 2020, View Source [SID1234564842]).

Event: F-star Therapeutics Presentation
Time: 3:30 PM ET | 8:30 PM BST
Webcast Link: View Source

The Company will also be available for one to one meetings during the conference, September 14-16.