Biodesix Announces Issuance of Two U.S. Patents, Expands Coverage of Diagnostic Methods to Improve Care for Cancer Patients

On April 6, 2021 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported that the United States Patent and Trademark Office (USPTO) has issued two patents that will enhance its ability to develop blood-based immunotherapy and pipeline testing strategies (Press release, Biodesix, APR 6, 2021, View Source [SID1234577622]). These developments further improve Biodesix’s ability to offer rapid, accurate assessment of patients, which guide physician treatment strategies for their cancer patients.

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U.S. Patent 10,950,348, titled, "Predictive Test for Patient Benefit from Antibody Drug Blocking Ligand Activation of the T-Cell Programmed Cell Death 1 (PD-1) Checkpoint Protein and Classifier Development Methods," covers a test that classifies patients based on their responses, or failures to respond, to immunotherapies. This diagnostic methodology is designed to stratify patients with lung cancer based on their likelihood to respond to immunotherapies.

"Immunotherapy drugs have made tremendous headway in the treatment of many types of cancers, including lung cancer and melanoma," said Robert Georgantas, III, Ph.D., Senior Vice President of Research and Translational Science at Biodesix. "However, only a subset of patients benefits from these treatments. Predicting who will or will not respond to immunotherapy is imperative for better stratification of patients by immune response to foster treatment personalization and optimal outcome. Additionally, response prediction can help our biopharma research partners develop drug regimens to improve patient survival with these types of drugs."

U.S. Patent 10,870,891, "Diagnostic Test System for Specific, Sensitive and Reproducible Detection of Circulating Nucleic Acids in Whole Blood," covers a novel method for detecting fragmented ribonucleic acid (RNA) in whole blood samples. The method uniquely purifies and amplifies RNA once it is isolated and can ultimately be used in tests that identify or quantify tumor genes and mutations in a host of downstream applications.

"This method is especially valuable because it further improves the performance of our blood-based technologies," Gary Pestano, Ph.D., Chief Development Officer at Biodesix, said of the novel diagnostic test method. "The method is incorporated into multiple diagnostic tests, such as the GeneStrat test and other pipeline tests. Specifically, the patented methods have applicability across a number of technologies that purify, transcribe and amplify nucleic acids, including polymerase chain reaction (PCR) and next-generation sequencing (NGS), allowing Biodesix to gather important data in a robust and efficient way that can be used to support physicians and patients in making timely treatment decisions."

"Patents have historically driven the biotechnology industry forward, but conversely have become harder than ever to obtain. Our recent issuances, across diverse technology fields are good news in light of the increasingly fast pace of the diagnostics sector," said Scott Hutton, Chief Executive Officer at Biodesix.

"Patents have historically driven the biotechnology industry forward, but conversely have become harder than ever to obtain. Our recent issuances, across diverse technology fields are good news in light of the increasingly fast pace of the diagnostics sector," said Scott Hutton, Chief Executive Officer at Biodesix. "There is significant ongoing research activity at Biodesix, which will lead to future patent filings that will continue to strengthen and broaden our position in the market."

Curis to Present at 20th Annual Needham Virtual Healthcare Conference

On April 6, 2021 Curis, Inc. (NASDAQ: CRIS), a biotechnology company focused on the development of innovative therapeutics for the treatment of cancer, reported that James Dentzer, President and Chief Executive Officer of Curis, will present a company overview at the 20th Annual Needham Virtual Healthcare Conference on Tuesday, April 13, 2021 at 10:15 am ET (Press release, Curis, APR 6, 2021, View Source [SID1234577621]).

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A live webcast of the presentation will be available under "Events & Presentations" in the Investors section of the Company’s website at www.curis.com. A replay of the webcast will be available on the Curis website for approximately 90 days following the event.

CRISPR Therapeutics to Participate in the 20th Annual Needham Virtual Healthcare Conference

On April 6, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of its senior management team are scheduled to participate in the 20th Annual Needham Virtual Healthcare Conference on Monday, April 12, 2021 at 9:30 a.m. ET (Press release, CRISPR Therapeutics, APR 6, 2021, View Source [SID1234577620]).

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A live webcast of the event will be available on the "Events & Presentations" page in the Investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 14 days following each presentation.

Overland ADCT BioPharma Appoints Eric Koo as Chief Executive Officer

On April 6, 2021 Overland ADCT BioPharma, a joint venture created by Overland Pharmaceuticals and ADC Therapeutics SA (NYSE: ADCT), reported the appointment of Eric Koo, BSc, MBA, as Chief Executive Officer (Press release, ADC Therapeutics, APR 6, 2021, View Source [SID1234577619]). Mr. Koo brings more than 25 years of pharmaceutical industry and business management experience to Overland ADCT BioPharma with a proven track record of executing successful drug approvals and launches across Asia.

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"Overland ADCT BioPharma has a tremendous opportunity to bridge the clinical gap between the U.S., Europe and Asia through the expanded reach of innovative cancer medicines like antibody drug conjugates," said Eric Koo, BSc, MBA. "It is an honor to assume the role of Chief Executive Officer and I look forward to working closely with both teams at Overland Pharmaceuticals and ADC Therapeutics to develop and commercialize the pipeline in greater China and Singapore."

Mr. Koo most recently served as Vice President, Head of Oncology Business Unit at Takeda China focusing on multiple myeloma and lymphoma. Prior to Takeda China, Mr. Koo served as Director, Oncology Business Unit and Director, Market Access, External Affairs & Key Account Management at Merck, Sharp and Dome (MSD) Taiwan. Prior to MSD, he served as Regional Marketing Director for APAC & Specialty Care BU Head, Malaysia/Singapore at Bayer APAC. Mr. Koo started his pharmaceutical career at Pfizer, spending 16 years in various sales, product management and marketing positions at both Pfizer Taiwan and Pfizer Emerging Market Asia & China, including six years as the China/APAC Regional Marketing Director for Oncology.

Mr. Koo earned his BSc in Pharmacy from Taipei Medical University and his MBA from the University of North Carolina at Charlotte, Belk College of Business.

"Eric joins Overland ADCT BioPharma at an important time in the joint venture’s evolution as the U.S. PDUFA date for Lonca quickly approaches this May," said Chris Martin, Chief Executive Officer of ADC Therapeutics. "We are thrilled to welcome a highly qualified, respected and visionary leader like Eric to lead Overland ADCT BioPharma in its quest to develop and commercialize Lonca and other ADCs for difficult-to-treat hematologic and solid tumor indications in greater China and Singapore."

"Eric’s deep expertise and history of expanding access to life-changing cancer therapies in greater China and beyond gives me great confidence in Overland ADCT Biopharma’s ability to fulfill its mission of bringing innovative ADC medicines to patients in Asia and around the world," said Ed Zhang, MBA, Co-founder of Overland Pharmaceuticals. "Since its launch in December 2020, Overland

ADCT BioPharma has submitted two clinical trial applications to evaluate Lonca, underscoring the differentiated scale, speed and execution of this strategic business model. We look forward to supporting the advancement of Overland ADCT BioPharma’s pipeline under Eric’s leadership."

The lead program in the Overland ADCT BioPharma pipeline is Lonca, an ADC composed of a humanized monoclonal antibody directed against human CD19 and conjugated to a pyrrolobenzodiazepine (PBD) dimer cytotoxin. Lonca has been evaluated by ADC Therapeutics in a pivotal Phase 2 clinical trial in patients with relapsed or refractory DLBCL and is in two ongoing trials – a Phase 1/2 trial in combination with ibrutinib in patients with relapsed or refractory DLBCL or mantle cell lymphoma and a Phase 3 confirmatory trial in combination with rituximab in patients with relapsed or refractory DLBCL. The Overland ADCT BioPharma portfolio also includes the clinical-stage candidates ADCT-602 targeting CD22, which is currently in a Phase 1/2 clinical trial in patients with relapsed or refractory acute lymphoblastic leukemia, and ADCT-601 targeting AXL, which is currently in a Phase 1 clinical trial in patients with selected advanced solid tumors. ADCT-901 targeting KAAG1 is in preclinical development for the treatment of advanced solid tumors with high unmet medical needs.

Ribon Therapeutics Announces Upcoming Presentations at the AACR 2021 Virtual Annual Meeting

On April 6, 2021 Ribon Therapeutics, a clinical stage oncology company developing therapeutics targeting stress support pathways, reported that it will present one oral and four poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Virtual Annual Meeting (Week 1), taking place from April 10 to 15, 2021 (Press release, Ribon Therapeutics, APR 6, 2021, View Source [SID1234577618]). Abstracts are available at: www.aacr.org.

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"The breadth of new pre-clinical data that we are presenting this year at AACR (Free AACR Whitepaper) further validates our BEACON+ platform targeting novel cellular stress pathways," said Heike Keilhack, Ph.D., Senior Vice President of Biological Sciences, Ribon Therapeutics. "We are particularly encouraged by our research further elucidating the mechanism of action of our PARP7 inhibitor and lead asset, RBN-2397, and its potential for efficacy in numerous types of cancer."

Ribon Therapeutics will present the following from its development program and platform:

Abstract Title: RBN-2397: A potent and selective small molecule inhibitor of PARP7 that induces tumor-derived antitumor immunity dependent on CD8 T cells
Presenter: Joseph M. Gozgit, Ph.D., Director, Biological Sciences, Ribon Therapeutics
Date & Time: Sunday, April 11, 2021 at 2:00 PM ET
Session Type: Minisymposium
Session Title: New Therapeutics Targeting Molecular Drivers in Cancer
Abstract ID: 48
Summary:

RBN-2397 restores Type I interferon (IFN) signaling in cancer cells and researchers demonstrate that this is an on-target effect of inhibiting the catalytic activity of PARP7 and not PARP1. Researchers further show that the adaptive immune response was required for the antitumor effects of RBN-2397.
Abstract Title: Elevated PARP7 expression in select cancers identifies a target population for RBN-2397 therapy
Presenter: Jodie Wong, Research Associate, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Biomarkers Predictive of Therapeutic Benefit
Abstract ID: 381
Summary:

RBN-2397 is a PARP7 inhibitor that induces cancer cell autonomous and immune stimulatory effects in preclinical models through enhanced Type I IFN signaling in cancer cells. Elevated PARP7 expression or amplification may identify cancer patients who could derive benefit from treatment with RBN-2397. Researchers showed the presence of PARP7 amplifications as well as high expression levels in several tumor types including non-small cell lung carcinoma, breast, and pancreatic ductal adenocarcinoma, providing evidence for the therapeutic relevance of PARP7 inhibition and highlighting potential patient selection strategies to identify those patients more likely to benefit from RBN-2397 treatment.
Abstract Title: Investigating the mechanism of PARP7 inhibition in Type I interferon signaling by arrayed CRISPR screening
Presenter: Bin Gui, Ph.D., Senior Scientist, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Cellular Responses to Anticancer Drugs
Abstract ID: 1021
Summary:

To investigate the underlying mechanism of PARP7 inhibition and to determine the drivers of the differential sensitivity across cell lines, researchers performed arrayed CRISPR knockout screens, targeting approximately 240 genes in the nucleic acid sensing and IFN signaling pathways, in the presence and absence of PARP7 inhibition. The arrayed screens confirmed multiple hits from a previous genome-wide pooled synthetic/lethal CRISPR dropout screen, shedding light on the mechanism by which PARP7 acts as a critical suppressor of the innate immune response in tumor cells and demonstrating both redundancy and crosstalk between different nucleic acid-sensing pathways.
Abstract Title: Targeted Degradation of PARP14 Using a Heterobifunctional Small Molecule
Presenter: Tim J. Wigle, Ph.D., Senior Director, Biochemical & Cellular Pharmacology, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Novel Targets and Pathways
Abstract ID: 1348
Summary:

RBN012811 is a heterobifunctional small molecule based on a catalytic inhibitor of PARP14 that binds in the enzyme’s NAD+-binding site and recruits the E3 ligase cereblon to ubiquitinate PARP14 and selectively target it for degradation. Researchers found that in PARP14 expressing cells, RBN012811 has a half-maximal degradation concentration (DC50) of 0.005 μM and it does not cause degradation of other PARP enzymes. In human primary macrophages, PARP14 degradation by RBN012811 led to a dose-dependent decrease of IL-10 release induced by IL-4 stimulation.
Abstract Title: Small molecule inhibitor of CD38 modulates its intra- and extracellular functions leading to antitumor activity
Presenter: Prashant B. Shambharkar, Ph.D., Senior Scientist, Ribon Therapeutics
Date & Time: Available for online viewing starting at 8:30 AM on Saturday, April 10
Session Type: E-Poster Session
Session Title: Novel Targets and Pathways
Abstract ID: 1344
Summary:

Inhibition of CD38 with a small molecule affects both intra- and extra-cellular CD38 activity and modulates key metabolites playing an important role in immunomodulation. Further, data indicate that CD38 is expressed at baseline in cancer and further increased by immune checkpoint inhibitor treatment. Finally, catalytic inhibition of CD38 can lead to antitumor activity in mouse cancer models.
Following its AACR (Free AACR Whitepaper) presentations, Ribon Therapeutics expects to make the poster presentations available on its corporate website via the following link: View Source

About RBN-2397

RBN-2397, is an orally available small molecule inhibitor of PARP7 that we are developing for the treatment of solid tumors. PARP7 is upregulated in response to cellular stress, including genomic instability in cancers, and acts as a brake on the cellular stress response by negatively regulating the Type I interferon response. By inhibiting PARP7 in tumor cells, RBN-2397 has been shown to directly inhibit cellular proliferation and restore interferon signaling to stimulate an innate and adaptive antitumor immune response. RBN-2397 is currently in a Phase 1 clinical trial as a monotherapy in patients with advanced solid tumors. PARP7 is overexpressed in a number of tumors, including squamous cell carcinoma of the lung, or SCCL, which represents approximately 30% of all non-small cell lung cancers.