Industrial Impact, Medical

Caris Life Sciences and Flare Therapeutics Announce Strategic Preferred Portfolio Partnership to Advance Flare's Precision Oncology Pipeline

prnewswire | April 17, 2023 | Read time : 02:00 min

Caris Life Sciences

Caris Life Sciences® the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare, and Flare Therapeutics, a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, today announced a multi-year strategic collaboration to accelerate precision medicine approaches across five of Flare's therapeutic programs into clinical trials through advanced molecular profiling approaches that guide patient selection and participation.

The partnership reinforces Flare's commitment to longitudinal testing, leveraging Caris' comprehensive molecular tissue and liquid profiling services including whole exome sequencing and whole transcriptome sequencing for patients enrolled in Flare's clinical trials, while also applying Caris' data and analytics tools to bolster future clinical trial enrollment programs and companion diagnostics capabilities.

"We understand the importance of shaping translational insights early on as a major area of focus to help ensure efficient drug development at scale and clinical trial preparedness," said Michaela Bowden, Ph.D., Chief Development Officer at Flare. "With access to Caris' robust clinico-genomic real-world data, comprehensive molecular profiling and extensive precision oncology alliance network, we are well positioned to unlock the full potential of drugging transcription factors by further unraveling the molecular complexities of cancer at the patient level and successfully enter the next phase of our growth as a clinical stage company."

Through comprehensive molecular profiling and the application of advanced artificial intelligence and machine learning, Caris has created the largest clinico-genomic database coupled with cognitive computing to unravel the molecular complexity of disease. Under the terms of the agreement, Flare will leverage Caris' industry-leading next generation sequencing technology for the molecular testing of patients treated with Flare's assets. In addition, Flare will receive access to Caris' data insights and analytics capabilities to accelerate oncology drug discovery, identify novel biomarkers and optimize clinical positioning strategies for their pipeline. Flare will also leverage Caris' biomarker-driven patient selection for clinical trials, allowing Caris the first option to develop a companion diagnostic for any drug candidate developed as part of the collaboration.

"This broad partnership with Flare will leverage Caris' leading molecular science and technology solutions to support Flare's novel approach to decipher the biology of transcription factors to develop small molecule medicines," said Milan Radovich, Ph.D., Senior Vice President and Chief Scientific Officer of Caris Life Sciences. "The data accessibility and continuum across real world and clinical trial populations will provide Flare the necessary insights for successful molecule discovery and development."

About Caris Life Sciences

Caris Life Sciences® is the leading molecular science and technology company actively developing and delivering innovative solutions to revolutionize healthcare and improve patient outcomes. Through comprehensive molecular profiling (Whole Exome and Whole Transcriptome Sequencing) and the application of advanced artificial intelligence (AI) and machine learning algorithms, Caris has created the large-scale clinico-genomic database and cognitive computing needed to analyze and unravel the molecular complexity of disease. This information provides an unmatched resource and the ideal path forward to conduct the basic, fundamental research to accelerate discovery for detection, diagnosis, monitoring, therapy selection and drug development to improve the human condition.

With a primary focus on cancer, Caris' suite of market-leading molecular profiling offerings assesses DNA, RNA and proteins to reveal a molecular blueprint that helps patients, physicians and researchers better detect, diagnose and treat patients. The company's latest advancement, Caris Assure™, is a blood-based, circulating nucleic acids sequencing (cNAS) assay that combines comprehensive molecular analysis (Whole Exome and Whole Transcriptome Sequencing from blood) and serial monitoring

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AbCellera Expands Multi-Target Antibody Discovery Collaboration with Regeneron

businesswire | September 21, 2023

AbCellera announced that it has expanded its existing multi-target collaboration with Regeneron to discover therapeutic antibodies for up to eight targets selected by Regeneron, increased from the original four. “Having successfully delivered on two challenging discovery campaigns under the original agreement, we are excited to expand the scope of our collaboration with Regeneron to include up to four additional targets,” said Carl Hansen, Ph.D., founder and CEO of AbCellera. “We look forward to using our antibody discovery and development engine to bolster Regeneron’s preclinical portfolio and help identify promising candidates for their programs.” The collaboration, which began in March 2020, leverages AbCellera’s antibody discovery engine and Regeneron’s VelocImmune® mice to identify novel therapeutic antibodies. AbCellera has initiated programs for all four of the original targets, with Regeneron exercising its rights to advance antibody candidates into further preclinical development for the two programs that have been completed. Under the terms of the agreement, Regeneron has the right to develop and commercialize therapeutic antibodies resulting from the collaboration. AbCellera receives research payments and is eligible to receive downstream clinical and regulatory milestone payments and royalties on net sales of products. About AbCellera Biologics Inc. AbCellera is breaking the barriers of conventional antibody drug discovery to bring better medicines to patients, sooner. AbCellera’s engine integrates expert teams, technology, and facilities with the data science and automation needed to propel antibody-based medicines from target to clinic in nearly every therapeutic area with precision and speed. AbCellera provides innovative biotechs and leading pharmaceutical companies with a competitive advantage that empowers them to move quickly, reduce cost, and tackle the toughest problems in drug development.

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Industry Outlook

Cresilon Receives First FDA Clearance For Human Use of Hemostatic Gel Technology

PRNewswire. | July 03, 2023

Cresilon, Inc. a Brooklyn-based biotechnology company focused on hemostatic medical device technologies, announced that it has been granted 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for Cresilon Hemostatic Gel™ ("CHG™"). This marks Cresilon's first FDA clearance for human use, validating its revolutionary hemostatic gel technology and the company's global mission to transform wound care. CHG™ utilizes Cresilon's proprietary hemostatic gel technology that rapidly controls bleeding when applied to a wound ‒ without the need for manual pressure. In addition to its versatility, the plant-based gel is easy-to-use and works instantaneously to both stop and control bleeding at the point of care "The combination of these unique attributes will allow our technology to fill a critical unmet medical need while creating a significant and positive impact in helping to save lives and dramatically improving the standard of care in wound treatment." said Cresilon CEO and Co-Founder Joe Landolina. "The FDA clearance sets the predicate for our advanced technology and marks Cresilon's first step towards actualizing our long-term goal of expanding our technology within the broader human health market." CHG leverages Cresilon's in-house manufacturing capabilities, advanced engineering, and focused research teams. CHG is for prescription use only. As the first product in the Cresilon portfolio approved for human use, CHG is indicated for the local management of bleeding wounds such as minor cuts, minor lacerations, and minor abrasions. For additional important safety information, please see the CHG Instructions For Use. About Cresilon Cresilon® is a Brooklyn-based biotechnology company that develops, manufactures, and markets hemostatic medical devices utilizing the company's proprietary hydrogel technology. The company's plant-based technology has revolutionized the current standard by stopping traumatic and surgical bleeds in seconds without the need for manual pressure. The company's current and future product lines target veterinary, human trauma, and human surgical applications. Cresilon's mission is to save lives.

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Medical, Industry Outlook

TriSalus Life Sciences Completes Merger with MedTech Acquisition Corporation

Businesswire | August 11, 2023

TriSalus Life Sciences® Inc. an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today announced the completion of its previously announced merger with MedTech Acquisition Corporation (Nasdaq: MTAC) (MedTech). TriSalus’ common stock and warrants are expected to commence trading on the Nasdaq Global Market under the ticker symbols “TLSI” and “TLSIW,” respectively, on August 11, 2023. “Completing our merger with MedTech marks an important milestone in our efforts to bring to market innovative approaches to treating liver and pancreatic tumors,” said Mary Szela, President and CEO of TriSalus. “Over the last several months we have advanced our device business and generated positive clinical data that supports the potential of our immunotherapeutic program. We are moving forward with the financial resources needed to grow our commercial organization and fund our key milestones through mid-2024. We believe that we are poised to create shareholder value as we continue our work to bring hope and improved treatments to the lives of patients. Finally, I want to especially thank our MTAC and TriSalus shareholders for trusting us to create value for them. I also want to thank our employees, interventional radiologists, and clinical investors and particularly our patients for their unwavering support that has been instrumental in helping us to achieve this milestone.” “We are excited to complete this merger with TriSalus and support the growth of its innovative devices and treatments,” said Chris Dewey, CEO of MedTech. “We believe that TriSalus has significant near and long-term value creation opportunities through its commercialization strategy and the potential to deploy SD-101 into multiple indications across several lines of therapy. We have full confidence that Mary and the experienced TriSalus team will continue working to meet significant unmet medical needs and delivering value to shareholders.” The Company’s new board of directors consists of Mats Wahlstrom, Mary Szela, Sean Murphy, Kerry Hicks, Dr. Anil Singhal, Dr. Andrew C. von Eschenbach, Kelly Martin, David J. Matlin and Dr. Arjun (“JJ”) Desai. Szela continued, “We welcome Andy, Kelly, JJ and David to the Board and look forward to benefiting from their experience across the medical technology, pharmaceutical, healthcare and financial industries. Innovative Device Technology Combined with Immunotherapeutic Platform Creates Significant Upside Potential Fast-Growing Core Device Business: TriSalus' commercial stage, FDA cleared TriNav® Infusion System includes the proprietary SmartValve technology. SmartValve enables precision delivery of therapeutics to tumors using the Pressure-Enabled Drug Delivery™ (PEDD) approach. The PEDD approach has been shown to modulate pressure and flow, increasing therapeutic delivery to the tumor while decreasing exposure in normal tissue – an important goal for interventional radiologists focused on better outcomes with less toxicity. PEDD brings the potential to improve patient outcomes and also brings additional expansion opportunities through the delivery of a wide variety of therapeutics. TriNav achieved $8.4 million and $12.4 million in net sales in 2021 and 2022, respectively, and is on track to generate approximately $19.2 million in net sales in 2023. Robust Device Pipeline: TriSalus' technology pipeline includes a range of devices that use technology expected to substantially improve therapeutic delivery. An FDA cleared delivery system for infusing immunotherapy into pancreatic adenocarcinoma patients is currently under study at MD Anderson Cancer Center. The pipeline also includes a full suite of devices that allows interventional radiologists to optimize therapy delivery across the broad range of solid tumor types, vessel sizes, and with greater precision using intra-procedural flow dynamic data. The first new device expected in the expanded toolkit is the TriNav LV device, designed to optimally address larger vessel sizes, which received 510(k) clearance by the FDA in May 2023 and is targeted for commercial launch in the first half of 2024. To accelerate TriSalus’ strategy, James “Jim” Alecxih was recently appointed as President, Device Technology Business. Jim will oversee the development and expansion of the Company’s portfolio of innovative infusion technologies. Therapeutic Platform in Clinical Development: TriSalus is developing SD-101, an investigational immunotherapeutic designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors – an environment that can make current immunotherapies ineffective in the liver and pancreas. SD-101 is a class C TLR9 agonist with a dual mechanism of action and a differentiated profile versus other TLR agonists. In solid tumors, the drug alters the tumor microenvironment by reducing immunosuppressive myeloid-derived suppressor cells (MDSC) while simultaneously stimulating multiple immune cell types. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically. Currently SD-101 is being studied in three clinical trials for patients with uveal melanoma with liver metastases, intrahepatic cholangiocarcinoma, hepatocellular carcinoma, and pancreatic ductal adenocarcinoma. In the studies reported to date, SD-101 in combination with systemic checkpoint inhibition and delivered with PEDD, achieved high concentrations in the liver with minimal systemic exposure and was well tolerated based on a low SD-101 treatment related serious adverse event rate of 5%, and resulted in immune cell activation and natural killer cell expansion. The immune effects in liver metastases and the blood are consistent with broad tumor microenvironment modulation and the ability of SD-101 to deplete MDSCs in the liver. These findings were highlighted during an oral discussion session at ASCO 2023. Additional Phase 1 data readouts for the PERIO clinical trial program are planned in the fourth quarter of 2023 and a Phase 2 trial is scheduled to be initiated in the second half of 2023. Well Positioned with Cash Runway: Proceeds raised in connection with the merger with MedTech, including proceeds from the recently closed private placement transaction and amounts remaining in the MedTech trust account, along with cash on hand, provides a cash runway through mid-2024 to fund key milestones. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. SD-101, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and which can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically.

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