On March 21, 2023 EpicentRx Inc. ("EpicentRx"), a clinical stage biopharmaceutical company, reported the publication of a review article on its small molecule, RRx-001, a direct NLRP3 inflammasome inhibitor with activity in cancer, neurodegenerative diseases and other inflammatory conditions (Press release, EpicentRx, MAR 21, 2023, View Source [SID1234629107]). The article is entitled, A Review of RRx-001: A Late-Stage Multi-Indication Inhibitor of NLRP3 Activation and Chronic Inflammation.

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This is the first publication from the collaboration between EpicentRx and Associate Professor Richard Gordon’s team based at the Queensland University of Technology’s Centre for Microbiome Research (CMR) and the Translational Research Institute (TRI). Dr. Gordon is an internationally recognized expert on inflammasome signaling in neurodegenerative diseases. EpicentRx and Dr. Gordon’s team were awarded research grants from the Michael J. Fox Foundation (MJFF), Shake It Up Australia Foundation, and Fight MND to study the neuroprotective effects of RRx-001 in Parkinson’s Disease and Amyotrophic Lateral Sclerosis (ALS).

RRx-001 is one of the most advanced direct NLRP3 inflammasome inhibitors in clinical development and has been evaluated in over 300 multimorbid cancer patients both alone and in combination with other therapies. Currently in a Phase 3 trial for the treatment of small cell lung cancer, RRx-001 is also in late-stage development as an anti-mucositis agent in head and neck cancer and as a medical countermeasure against acute radiation syndrome (ARS) in the event of nuclear fallout. RRx-001 has been evaluated in multiple independent studies for conditions where immune and inflammasome activation contribute to disease pathology. These include cancer, myocardial infarction, pulmonary hypertension, acute kidney injury, acute radiation syndrome (ARS), malaria, multiple sclerosis, Parkinson’s disease, and Alzheimer’s disease.

Lead author Dr. Nanthini Jayabalan, a senior researcher working on the CNS RRx-001 program in Dr. Gordon’s lab said, "Our review article synthesizes the wealth of data on RRx-001 to date, which supports its disease-modifying potential in a range of conditions."

Added Dr. Gordon: "Emerging evidence suggests, chronic, unresolving inflammation is present in most if not all neurological diseases, and this makes RRx-001 an attractive therapeutic agent for neuroprotection given its track record in human studies."

On March 21, 2023 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using its proprietary RADR artificial intelligence ("AI") and machine learning ("ML") platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported that Lantern management and employees will be presenting at three upcoming events:

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Rare Disease Innovation & Partnership Summit in Philadelphia, PA on Wednesday, March 22 at 5:00 p.m. ET. Panna Sharma, CEO & President, will present.
Session Title: Using AI to Accelerate the Drug Discovery and Development Process for Rare Cancers
Registration Link: https://informaconnect.com/rare-disease-summit/pricing/
How Artificial Intelligence Is Changing Drug Discovery Webinar on Thursday, March 23 at 1:00 p.m. ET. Panna Sharma, CEO & President, will be a panelist. The free webinar is co-hosted by the Science History Institute and the American Chemical Society.
Webinar Link: View Source
Genomics in Precision Oncology Xchange East Coast in Boston, MA on Wednesday, April 5 at 9:05 a.m. ET. Peter Carr, Principal Software Architect, will moderate a session for genomics informed clinical decisions.
Session Title: Clinical trial design & its use in silico modeling for combination therapies
Registration Link: https://www.hub-xchange.com/genomics-in-precision-oncology-east-coast-2023/

On March 21, 2023 RayzeBio, Inc., a targeted radiopharmaceutical company developing innovative cancer drugs, reported the nomination of a first-in-class novel peptide drug candidate against GPC3 (Press release, RayzeBio, MAR 21, 2023, View Source [SID1234629133]). As GPC3 is selectively overexpressed in hepatocellular carcinoma and not expressed in normal liver and other tissues, it has a compelling profile for targeted cancer therapy. The proprietary GPC3 targeting agent was discovered through RayzeBio’s research partnership with PeptiDream, Inc. The drug candidate has demonstrated potent and selective GPC3 binding, rapid cellular internalization, and sustained tumor specific uptake and anti-tumor efficacy in preclinical models. Initial preclinical data will be presented at the EASL Liver Cancer Summit in Estoril, Portugal on April 20, 2023.

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"Liver cancer represents a significant unmet medical need globally, with over 29,000 deaths annually in the U.S. alone, and over 800,000 deaths worldwide," said Dr. Ken Song, M.D., President and CEO of RayzeBio. "GPC3 is a promising target for radiopharmaceutical therapy. Our discovery team has extensively profiled multiple series of compounds prior to nominating our drug candidate."

RayzeBio is advancing the GPC3 drug candidate into IND enabling studies as a targeted radiopharmaceutical therapy and plans to provide additional details on the program’s progress at various scientific meetings throughout the year. In addition to GPC3, RayzeBio has several other programs in various stages of discovery and development.

About Liver Cancer and Hepatocellular Carcinoma (HCC)

Liver cancer is the third most common cause of cancer death and sixth most diagnosed cancer globally. In the U.S., the incidence of liver cancer more than tripled over the past four decades. The American Cancer Society estimates over 41,000 new cases of liver cancer in 2023 and over 29,000 deaths from liver cancer. The 5-Year relative survival rate for all liver cancer patients is approximately 20% and the survival rate of patients with advanced stage liver cancer is significantly lower. HCC is the most common form of liver cancer, accounting for up to 85% of the cases. HCC represents a significant unmet medical need as current treatment options have limited efficacy with a narrow therapeutic index.

On March 21, 2023 Artera, the developer of multimodal artificial intelligence-based predictive and prognostic cancer tests, reported that it launches publicly today with $90M in funding (Press release, Artera, MAR 21, 2023, View Source [SID1234629131]). The investment comes from a syndicate of prominent tech and healthcare investors, comprised of seven institutions (Coatue, Johnson & Johnson Innovation – JJDC, Inc., Koch Disruptive Technologies, Walden Catalyst Ventures, TIME Ventures, Breyer Capital, The Factory) and 11 angel investors (Marc Benioff, Jim Breyer, Lip-Bu Tan, Chris Re, Andy Jacques, Amarjit Gill, Jeff Dean, Steve Blank, Dennis Wong, Clarence So, Michael Driscoll).

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Artera’s flagship test is the ArteraAI Prostate Test, the first test to predict therapy benefit in localized prostate cancer. The investment will help distribute this test in the U.S. and internationally. The company also plans to use the funding to invest in the development of tests to support therapy personalization in other cancers.

"The American Cancer Society estimates that more than 288,000 new cases of prostate cancer will arise in 2023, with more than 34,000 deaths. AI has given clinicians and patients a powerful weapon in the fight against this disease," said Andre Esteva, co-founder and CEO of Artera. "Clinicians can now leverage Artera’s unique test to prognosticate patient outcomes and personalize treatment decisions."

"We are honored to be part of what we believe to be one of the greatest advances in prostate oncology in the last 20 years," said Marc Benioff, CEO of Salesforce.

"In the last 18 months, Artera’s AI-informed approach to personalized cancer treatment has unlocked commercial and regulatory traction well ahead of genomic competitors," said Stephen Cho, Partner at Coatue. "We are thrilled to support Artera as a pioneer in computational diagnostics for an important therapeutic area."

This announcement comes on the heels of Artera’s recently released, positive data at ASCO (Free ASCO Whitepaper) GU 2023, highlighting that the prognostic biomarker was validated across six phase III randomized trials. The study further demonstrated the ability of Artera’s multimodal artificial intelligence prognostic biomarker to help enable personalized, shared decision-making for patients and clinicians.

The ArteraAI Prostate Test is a clinically available, laboratory-developed test. For more information or to order the test please visit artera.ai.

On March 21, 2023 Lumicell, Inc., a privately held company focused on innovative fluorescence-guided imaging technologies for cancer surgery, reported a New Drug Application (NDA) for its LUMISIGHT Optical Imaging Agent has been submitted to the U.S. Food and Drug Administration (FDA) (Press release, Lumicell Diagnostics, MAR 21, 2023, View Source [SID1234629130]).

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LUMISIGHT is intended for use with the Lumicell Direct Visualization System (DVS), an investigational system designed to assist in the detection of residual cancerous tissue within the lumpectomy cavity following removal of the primary specimen during breast conserving surgery.

"Lumicell is committed to revolutionizing the way breast cancer surgery is performed and bringing the benefits of the Lumicell Direct Visualization System to breast cancer patients," said Kevin Hershberger, president and chief executive officer of Lumicell. "Submission of the LUMISIGHT NDA is a significant step toward achieving this goal. We look forward to working with the FDA on acceptance of our LUMISIGHT application for review and submitting the PMA for the Lumicell DVS in the second quarter."

The LUMISIGHT NDA submission is supported by data from more than 700 breast cancer patients across five clinical studies at top academic and regional community cancer centers. Results from the Investigation of Novel Surgical Imaging for Tumor Excision (INSITE) pivotal trial (NCT03686215) of 406 patients at 14 sites will be presented at the upcoming American Society of Breast Surgeons (ASBrS) annual meeting. The FDA granted LUMISIGHT Fast Track designation and the Lumicell DVS Breakthrough Device designation in recognition of its potential benefit of identifying residual cancer after the initial lumpectomy.

"Data has shown that the risk of local recurrence is directly related to incomplete tumor removal. Currently, at least 20% of women having breast conserving surgery require a second surgery because of positive margins and 6-10% of women with breast cancer experience a local recurrence," said Barbara Smith, MD, PhD, director of the Breast Program at Massachusetts General Hospital, professor of surgery at Harvard Medical School and lead investigator of the INSITE clinical trial. "As surgeons, technology that helps ensure we are doing everything in our power to remove cancer during the initial lumpectomy gives us and patients greater piece of mind and has the potential to support improved outcomes."

About the Lumicell Direct Visualization System

The investigational Lumicell Direct Visualization System (DVS) is intended for use with the LUMISIGHT Optical Imaging Agent and features a hand-held imaging probe that is designed to go inside the breast cavity and a patient-calibrated cancer detection software to assist in the detection of residual cancer, thereby enabling a more complete resection. The safety and efficacy of the Lumicell DVS in detecting residual cancer left behind by standard of care surgical procedures has been evaluated in two studies: INSITE and a feasibility study of 234 patients at 16 sites, results of which were published in JAMA Surgery.

The Lumicell DVS and LUMISIGHT are limited by Federal (or United States) law to investigational use only. The Lumicell DVS is not commercially available.