On March 10, 2021 Veracyte, Inc. (Nasdaq: VCYT) reported the U.S. Preventive Services Task Force (USPSTF) for its new, revised recommendations that expand eligibility for lung cancer screening (Press release, Veracyte, MAR 10, 2021, View Source [SID1234576406]). The updated recommendations lower the age for current and former smokers to begin screening from 55 to 50 years and reduces smoking intensity – from a 30 "pack-year" history to 20. The independent expert panel’s final recommendations appear online in the Journal of the American Medical Association and are expected to increase the number of people in the United States who are eligible for annual screening with low dose CT (LDCT) scans to nearly 15 million.

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"We commend the USPSTF for their new lung cancer screening recommendations, which will help ensure that more lives are saved through early detection," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "Lung cancer is the leading cause of cancer death in the United States because too often the disease is found after it has spread and is less treatable. Expanding screening eligibility – as well as the number of people who actually undergo screening – will be key to saving lives.

"Much work remains in the fight against lung cancer, including ensuring that physicians have optimal tools to help guide patient care when potentially cancerous lung nodules are found through screening. We are proud to be part of the healthcare sector that is utilizing novel genomic science to improve lung cancer early detection, diagnosis and treatment."

Veracyte’s Percepta Genomic Sequencing Classifier is available to improve the diagnosis of potentially cancerous lung nodules found on CT scans. The company is developing a first-of-its-kind, noninvasive nasal swab test to help determine which patients with lung nodules should undergo additional diagnostic procedures and which can simply be monitored. Additionally, the company is developing a comprehensive genomic profiling test to inform treatment decisions at the time of diagnosis. Both tests are scheduled for introduction in the second half of 2021.

About Lung Cancer

Lung cancer is the deadliest cancer globally, killing more than 1.75 million people worldwide each year, according to the World Health Organization. Early detection is key, with a five-year survival rate of nearly 60 percent when the cancer is found early, compared to six percent when it is found at a later stage, according to the American Lung Association. Lung nodules are typically the first sign of lung cancer. While the vast majority of lung nodules ultimately prove to be benign, physicians currently lack clear diagnostic tools to determine which patients have cancer and which do not. This can lead to unnecessary invasive biopsies, which are costly and risky, as well as to delayed diagnosis and treatment.

On March 10, 2021 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported the presentation of new preclinical data on AO-176 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Arch Oncology, MAR 10, 2021, View Source;utm_medium=rss&utm_campaign=arch-oncology-announces-two-new-preclinical-data-presentations-on-highly-differentiated-anti-cd47-antibody-ao-176-at-aacr-2021 [SID1234576405]). AO-176 is an anti-CD47 antibody with a potential best-in-class profile that works by blocking the "don’t eat me" signal and also by directly killing tumor cells, with preferential binding to tumor versus normal cells. Currently, AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies.

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"At AACR (Free AACR Whitepaper) this year, we will present two new nonclinical datasets demonstrating AO-176’s strong therapeutic potential in lymphoma and pediatric T-ALL" said Daniel Pereira, Ph.D., Chief Scientific Officer of Arch Oncology. "In lymphoma, we are presenting AO-176’s potent in vivo activity in a lymphoma xenograft, where induction of inflammatory cytokines and immune infiltrates is also observed. Enhanced binding and phagocytosis of lymphoma cells at acidic pH will also be shown in vitro by AO-176 or in combination with rituximab. Finally, AO-176’s unique ability to induce Annexin V positivity and DAMPs that ultimately may aid in inducing immunogenic cell death of the lymphoma cells will also be presented. Additionally, we look forward to sharing new nonclinical data in pediatric T-ALL during a late-breaking poster presentation at AACR (Free AACR Whitepaper) next month. Data continue to support AO-176’s highly-differentiated mechanisms, reinforcing our therapy’s potential to offer an improved efficacy and safety profile among anti-CD47 agents in development for patients with solid tumors and hematologic malignancies."

AACR Annual Meeting 2021

Late-Breaking Poster Presentation Title: The differentiated CD47 monoclonal antibody AO-176 exhibits significant in vivo activity against xenograft models of pediatric acute lymphoblastic leukemia (ALL) (Abstract #LB171)
Session Category: Immunology
Session Title: Therapeutic Antibodies, Including Engineered Antibodies

Poster Presentation Title: AO-176, a highly differentiated clinical stage anti-CD47 antibody, is efficacious in pre-clinical models of lymphoma (Abstract #954)
Session Category: Experimental and Molecular Therapeutics
Session Title: Biological Therapeutic Agents

Information on the abstracts is available on AACR (Free AACR Whitepaper)’s website.

On Saturday, April 10, 2021 at 8:30 am ET when posters are available online for AACR (Free AACR Whitepaper) meeting participants, a copy of the poster presentations will be posted at View Source

About AO-176

AO-176 is a humanized anti-CD47 IgG2 antibody with a potential best-in-class profile. AO-176 is highly differentiated, with the potential to improve upon the safety and efficacy profile relative to other agents in this class of innate checkpoint inhibitors. AO-176 works by blocking the "don’t eat me" signal, the standard mechanism of anti-CD47 antibodies. Beyond blocking this signal, AO-176 has additional mechanisms, including directly killing tumor cells and inducing DAMPs (Damage Associated Molecular Patterns), resulting in Immunogenic Cell Death. Importantly, AO-176 binds preferentially to tumor cells, instead of to normal cells, and binds even more potently to tumors in their acidic microenvironment (low pH). Publications and presentations on AO-176 can be found at View Source

AO-176 is being evaluated in Phase 1/2 clinical trials for the treatment of patients with select solid tumors and multiple myeloma, both as monotherapy and in combination with standard therapies. In a Phase 1 trial in solid tumors, AO-176 demonstrated encouraging safety and evidence of anti-tumor activity when administered as a single agent. Additional information about these trials may be found at www.clinicaltrials.gov using the trial identification number NCT03834948 (solid tumors) or NCT04445701 (multiple myeloma).

On March 10, 2021 CRISPR Therapeutics (Nasdaq: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that it will present a poster at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, to be held in a virtual format from April 10 to 15 and May 17 to 21, 2021 (Press release, CRISPR Therapeutics, MAR 10, 2021, View Source [SID1234576404]).

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Title: CD70 knockout: A novel approach to augment CAR-T cell function
Session Title: Adoptive Cell Therapy
Session Category: Immunology
Abstract Number: 1537, e-poster
Date and Time: Saturday, April 10, 2021, 8:30 a.m. ET via the AACR (Free AACR Whitepaper) website, www.aacr.org

On March 10, 2021 LAVA Therapeutics B.V., a biotechnology company focused on applying its expertise in bispecific gamma-delta T cell engagers (bs TCE) to transform cancer therapy, reported that a poster featuring lead clinical candidate LAVA-051 will be presented at week 1 of the virtual American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, which will be held April 10-15, 2021 (Press release, Lava Therapeutics, MAR 10, 2021, View Source [SID1234576403]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The following abstract is now available on the AACR (Free AACR Whitepaper) website at www.aacr.org.

Title: Potent anti-tumor activity against patient CLL, MM and AML cells by LAVA-051, a bispecific Vγ9Vδ2-T and type 1 NKT cell engager targeting CD1d

Session Type: E-Poster Session

Session Title: Therapeutic Antibodies, Including Engineered Antibodies

Abstract Number: 1855

LAVA-051 is a humanized gamma-delta bsTCE which targets CD1d and the Vδ2 domain of the T cell receptor. It is the first antibody-based compound targeting CD1d to activate both Vγ9Vδ2-T and type 1 NKT cells. LAVA-051 exerted substantial antitumor activity against patient derived acute myeloid leukemia (AML), chronic lymphocytic leukemia (CLL) and multiple myeloma (MM) cells that express CD1d. In addition, improved survival was observed in in vivo AML and MM mouse xenograft models treated with LAVA-051.

LAVA-051 is planned to enter a Phase I/IIa study in hematologic malignancies in 1H 2021.

On March 10, 2021 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will present data in three poster sessions at the upcoming Virtual 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting being held from April 9-14, 2021 (Press release, Mersana Therapeutics, MAR 10, 2021, View Source [SID1234576402]).

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Details of the poster displays are as follows:

Poster Title: XMT-1660, a B7-H4-targeted Dolasynthen antibody-drug conjugate for the treatment of breast cancer
Abstract Number: 907
Abstract Summary: These data indicate that XMT-1660, a DAR 6 Dolasynthen ADC, exhibited a superior preclinical profile relative to DAR 2 and DAR 12 ADCs and thus support the clinical development of XMT-1660 for the treatment of B7-H4-expressing tumors such as breast cancer and other cancers. These results demonstrate the importance of DAR-ranging studies to identify the optimal ADC for a given target.
Date: April 10, 2021
Session Category: Experimental and Molecular Therapeutics
Session Title: Antibody Technologies

Poster Title: XMT-2056, a well-tolerated, Immunosynthen-based STING-agonist antibody-drug conjugate which induces anti-tumor immune activity
Abstract Number: 1738
Abstract Summary: These data demonstrate that XMT-2056 induced robust anti-tumor immune activity, with only minimal increases in systemic cytokine levels, and exhibited significant benefit over the benchmark IV administered free STING-agonist in mice. Additional studies demonstrate that Immunosynthen ADCs activate the STING pathway in both tumor-resident immune cells and tumor cells, offering a potential advantage over ADCs that modulate other innate immune activating pathways. XMT-2056 was well-tolerated in non-human primates at significantly higher exposure levels than those required for anti-tumor activity in mice and exhibited favorable pharmacokinetics after repeat doses. Together these data support the clinical development of XMT-2056.
Date: April 10, 2021
Session Category: Immunology
Session Title: Immunomodulatory Agents and Interventions

Poster Title: Tumor cell-intrinsic STING pathway activation leads to robust induction of Type III Interferons and contributes to the anti-tumor activity elicited by STING agonism
Abstract Number: 1773
Abstract Summary: The STING pathway induces anti-tumor immunity by upregulating an interferon response within the tumor microenvironment. Data presented in this study demonstrate that cancer cells activate a Type III interferon response downstream of STING pathway activation. Blocking Type III IFNs with neutralizing antibodies in cancer cell:immune cell co-cultures inhibits the production of key cytokines and cancer cell killing induced by STING-agonist ADC treatment. These results indicate that the Type III IFN response in cancer cells plays an important role in the anti-tumor activity induced by STING-agonist ADCs.
Date: April 10, 2021
Session Category: Immunology
Session Title: Innate Immunity to Tumors