Delphinus Raises $30 Million in Series D Funding to Transform Dense Breast Screening

On September 29, 2022 Delphinus Medical Technologies, Inc. reported the closing of a $30 million Series D financing to fuel worldwide commercialization of its SoftVue 3D Whole Breast Ultrasound Tomography System (SoftVue) (Press release, Delphinus Medical Technologies, SEP 29, 2022, View Source [SID1234621568]). The round drew participation from both new and existing investors, including Arboretum Ventures, Beringea, North Coast Technology Investors, Venture Investors, Hopen Life Science Ventures and Waycross Ventures. The fund’s closing comes on the heels of the announcement that the first SoftVue System was sold, and will go to Karmanos Cancer Institute, Detroit, where the technology was originally conceived.

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"Every day it becomes increasingly obvious that we have delivered a game changer technology to transform dense breast screening," said Mark J. Forchette, president and CEO of Delphinus Medical Technologies. "When potential customers hear that SoftVue finds more cancers, delivers an exceptional patient experience and efficient patient workflow the same day as the mammogram without costly staff additions, they recognize the value for their patients. Our series D will support the robust commercial strategies and efforts needed to help sites quickly adopt this solution for their patients."

Forty percent of women in the U.S. have dense breast tissue, and they have a four-to-six-time greater risk of developing breast cancer. Mammography alone misses about half the cancers in women with dense breasts, as dense tissue and cancer both appear white on mammogram images. SoftVue was developed to address this unmet clinical need and provides a new annual screening solution for this historically underserved population.

SoftVue is indicated for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone. The SoftVue exam is completed with no compression or radiation, and its PMA indication for use allows SoftVue exams to be performed at the same appointment as screening mammograms, facilitating a streamlined workflow and rapid delivery of results.

"Our board of directors and investors are very excited to launch into commercial activities with SoftVue," said Paul McCreadie, Delphinus Medical Technology’s board chairman and Partner and Chief Operating Officer at Arboretum Ventures. "The successful completion of a rigorous clinical study that resulted in the PMA approval we received last year for dense breast screening will allow the Delphinus team to leverage the unique technology of SoftVue to change the paradigm for dense breast screening and help millions of women receive superior care. We invest to allow breakthrough innovations to serve patients, and Delphinus is perfectly poised to do exactly that."

Long-Term Data from Omidubicel Phase 3 Trial Demonstrates Overall Survival and Sustainable Durable Outcomes for Patients with Blood Cancers at the Society of Hematologic Oncology Meeting

On September 29, 2022 Gamida Cell Ltd. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, reported the presentation of new long term follow-up data and health-related quality of life scores of patients treated with omidubicel at the Tenth Annual Meeting of the Society of Hematologic Oncology (SOHO), being held in Houston, Texas (Press release, Gamida Cell, SEP 29, 2022, View Source [SID1234621567]).

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"These data reinforce our commitment to advance transformational cell therapy research and underscore the potential of our NAM technology platform. Our lead stem cell therapy candidate, omidubicel, addresses the unmet need for patients with hematologic malignancies, demonstrated by the robust and growing body of encouraging clinical evidence, including the long-term follow up data and quality of life improvement," said Ronit Simantov, M.D., Chief Medical Officer of Gamida Cell. "As we approach the PDUFA date of January 30, 2023, and upon potential FDA approval, we are prepared to execute our plan that ensures access to those patients who can benefit from omidubicel as quickly as possible."

The long-term, durable clinical benefit of omidubicel was observed at three years across a patient population that typically has a poor prognosis. A study titled, "Multicenter Long-Term Follow Up of Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel: A Pooled Analysis of Five Prospective Clinical Trials," highlighted long-term follow-up of 105 patients transplanted with omidubicel between 2006-2020 (median follow-up of 22 months). The data demonstrated an overall survival and disease-free survival of 63% (95% CI, 53%-73%) and 56% (95% CI, 47%-67%) at three years, respectively, as well as durable long-term hematopoiesis and immune competence. Learn More

Overall well-being health-related quality of life scores for patients treated with omidubicel demonstrated clinical benefit compared to standard of care. A study titled, "Health-Related Quality of Life Following Allogeneic Hematopoietic Stem Cell Transplantation with Omidubicel Versus Standard Umbilical Cord Blood" featured an analysis of 108 patients that completed validated health-related quality of life (HRQL) surveys on screening and days 42, 100, 180, and 365 post-transplant. Measures of physical and functional well-being and other HRQL scores were more favorable with omidubicel. These data suggest clinically meaningful and sustained improvements in physical, functional, and overall well-being compared to umbilical cord blood transplantation. Learn More

About NAM Technology

Our NAM-enabling technology is designed to enhance the number and functionality of targeted cells, enabling us to pursue a curative approach that moves beyond what is possible with existing therapies. Leveraging the unique properties of NAM (nicotinamide), we can expand and metabolically modulate multiple cell types — including stem cells and natural killer cells — with appropriate growth factors to maintain the cells’ active phenotype and enhance potency. Additionally, our NAM technology improves the metabolic fitness of cells, allowing for continued activity throughout the expansion process.

About Omidubicel

Omidubicel is an advanced cell therapy candidate developed as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with blood cancers. Omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment in comparison to standard umbilical cord blood in an international, multi-center, randomized Phase 3 study (NCT0273029) in patients with hematologic malignancies undergoing allogeneic bone marrow transplant. The Phase 3 study also showed reduced time to platelet engraftment, reduced infections and fewer days of hospitalization. One-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by significant reduction in infectious complications as well as reduced non-relapse mortality and no significant increase in relapse rates nor increases in graft-versus-host-disease (GvHD) rates. Omidubicel is the first stem cell transplant donor source to receive Breakthrough Therapy Designation from the FDA and has also received Orphan Drug Designation in the US and EU.

Omidubicel is an investigational stem cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. For more information about omidubicel, please visit View Source

Meliora Therapeutics Raises $11M Seed Financing to Develop First Mechanism Of Action Atlas in Oncology

On September 29, 2022 Meliora Therapeutics, a biotech company pioneering a machine learning-driven platform to decipher oncology drugs’ true mechanisms-of-action, reported the close of an $11M seed financing round led by HOF Capital and ZhenFund, with participation from Obvious Ventures, Village Global, BrightEdge (the impact investment arm of the American Cancer Society), Pebblebed (fund of Keith Adams, former Chief Architect at Slack), Axial, Olive Capital, and prominent individual investors Michael Polansky (co-founder of Parker Institute for Cancer Immunotherapy and ArsenalBio), Wes Sterman (founding investor for Gilead), and others (Press release, Meliora Therapeutics, SEP 29, 2022, View Source [SID1234621566]).

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Founded in September 2021, Meliora’s computational platform enables researchers to develop a precise understanding of a drug’s true mechanism of action (MOA) based on data and not guesswork. The company aims to improve the current success rate of oncology drugs in development by building the industry’s first atlas of drug mechanisms and their impact on cancer biology through the use of machine learning. The founding team includes David Li, CEO & Co-Founder, Jason Sheltzer, Ph.D., Scientific Co-Founder and Joan Smith, Technical Co-Founder.

Out of all the areas of medicine, clinical trials in oncology have the absolute lowest success rate—3%. One reason for the high failure rate is that many cancer drugs in development have an incorrect characterization of their mechanism of action, according to a paper published by Meliora co-founder Jason Sheltzer, Ph.D., in Science Translational Medicine.

"Modern cancer drug development is often not mechanism driven, leading to clinical development failures down the line. Meliora is using a novel molecular fingerprint matching method to determine the true mechanism of action of precision cancer therapies," said David Li, CEO & Co-Founder, Meliora Therapeutics. "By using machine learning to connect MOA with specific therapeutic molecules, we will increase the overall probability of success. We’re thrilled to have the support of this top-tier investor syndicate, and the funds will be used to expand our team and accelerate development of our proprietary computational platform."

"We believe AI will bring revolutionary changes to the drug discovery industry, and are impressed by Meliora’s approach to develop a mechanism fingerprint atlas. We are glad to have the opportunity to partner with the amazing team at Meliora," said Anna Fang, CEO and founding partner at ZhenFund.

"Meliora’s computational platform allows companies to identify the true mechanism of action in small molecule compounds, and uncover mischaracterized compounds in the process," said Jason Sheltzer, Ph.D., Co-Founder, Meliora Therapeutics. "By expanding the therapeutic window of these molecules with known safety profiles, the Meliora team has built a flywheel of precision medicine oncology assets with a higher potential for clinical success by understanding how the drug really works."

"We are excited about Meliora’s machine-learning-based approach to mechanism-driven drug discovery. We believe that their novel approach will be a game-changer in the oncology drug development space," said Fady Yacoub, Co-Founder, Managing Partner at HOF Capital.

"With better knowledge of a drug’s unique mechanism, scientists can improve drug discovery and increase the success rate of precision therapies in oncology. Additionally companies may also find new vulnerabilities in cancer cells to target or new ways to identify patients who are most likely to respond to a particular targeted therapy. We believe Meliora’s novel approach will be highly impactful in the oncology drug development space," said Michael Polansky, co-founder of Parker Institute for Cancer Immunotherapy and ArsenalBio.

Alice Pomponio, Managing Director of BrightEdge, the impact investment arm of the American Cancer Society (ACS) said, "We celebrate the achievements of our ACS grantees and now, through BrightEdge, we are deepening our innovation acceleration capabilities that enable scientific founders like Dr. Jason Sheltzer to translate their research into emerging biotech companies that accelerate ACS’s mission to defeat cancer and advance health equity."

The seed funding will be used to expand Meliora’s computational platform, which includes building a proprietary data moat and selecting mischaracterized scaffolds as strong starting points for its lead precision therapeutic programs. The company has already built a computational prototype which identifies the correct mechanism of action (MOA) for small molecule drugs and generated in-vitro wet lab data for dozens of compounds computationally identified as having an alternate mechanism of action, with many of these compounds generating strong potency against the in silico predicted target. The funding will also be used to expand the team, operations, and build industry partnerships.

MAIA Biotechnology to Present at EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

On September 29, 2022, MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a targeted therapy, immuno-oncology company focused on developing potential first-in-class oncology drugs, reported that it will present the results of a study of the anticancer agent 6-thio-dG (THIO) in hepatocellular carcinoma (HCC) in vitro and in vivo models at the EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Symposium on Molecular Targets and Cancer Therapeutics. The symposium is taking place Oct. 26-28, 2022, in Barcelona, Spain (Press release, MAIA Biotechnology, SEP 29, 2022, View Source [SID1234621565]).

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The data to be presented outline high anticancer activity of THIO in HCC cancer cells. Notably, sequential administration of THIO followed by cemiplimab (cemi) demonstrated enhanced antitumor efficacy, including complete responses, in a syngeneic immunocompetent HCC mouse model, in comparison with either single agent used alone. Moreover, the treated tumor-free mice demonstrated a complete rejection of the same tumor type cells upon re-challenge: anticancer immune memory was confirmed.

MAIA received an Orphan Drug Designation from the US FDA for the treatment of HCC with THIO earlier in 2022. HCC currently makes up around 90% of liver cancer cases; by 2025, the global incidence of liver cancer is expected to eclipse 1 million cases.1

Presentation details:

Presentation title: The novel, telomerase-directed, telomere-targeted, anticancer agent 6-thio-dG (THIO) demonstrates potent activity and induces antitumor immunity in hepatocellular carcinoma (HCC) models
Abstract number: 86
Session title: New Drugs
Date: Wednesday, Oct. 26 at 12:00pm CEST
Presenting author: Sergei Gryaznov, Ph.D., Chief Scientific Officer, MAIA Biotechnology
Location: Exhibition hall
Additional meeting information is available on ENA’s website.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC), in sequential administration with cemiplimab (Libtayo), a PD-1 inhibitor developed by Regeneron. Telomeres play a fundamental role in the survival of cancer cells and their resistance to current therapies. THIO is being developed as a second or higher line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

Ultivue and ngTMA® Announce Collaborative Agreement to Provide Multiplex and Spatial Analysis for Clinical Research

On September 29, 2022 Ultivue, Inc. an industry leader in multiplexing tools and novel image analysis solutions for tissue biomarker studies and, the Translational Research Unit (TRU) platform of University of Bern, that develops novel workflows for tissue microarray (ngTMA) construction, reported a collaborative agreement to promote multiplexed immunofluorescence (mIF) assays and the use of next generation TMAs to unlock spatial analysis in scientific research and improve the quality of TMAs integrated in clinical and translational research (Press release, Ultivue, SEP 29, 2022, View Source [SID1234621564]).

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Ultivue develops unique solutions for use in mIF applications, imaging, and spatial phenomics. Its proprietary InSituPlex technology enabling improved signal to noise data is designed for fast and comprehensive exploration of biologically relevant targets, up to 12-plex, with same slide-H&E analysis in tissue samples combines the power of computational pathology & spatial biology to guide translational science in immuno-oncology.

ngTMA supports research collaborators with an interdisciplinary approach to studying tumor biology and disease states. Services include scientific consulting and TMA design, digital slide annotation, automated tissue punching and documentation for quality control. The ngTMA platform is embedded in an innovative research framework and as part of the Translational Research Unit (TRU), Institute of Pathology, University of Bern, with expertise in tissue-related technologies.

"We are thrilled to be partnering with ngTMA to jointly empower biopharma customers with tissue multiplex services. In addition, our scientific collaboration will investigate the relevance of the tumor microenvironment by characterizing clinically well-annotated cohorts using Ultivue reagents at ngTMA," said Florian Leiss, Ph.D. Vice President Product Strategy & Corporate Development at Ultivue.

"We are very excited to join forces with the Ultivue team and have their reagents in our pipeline in order to support translational research of our collaborators," Said Paulina Brönnimann, PhD, Head of Translational Research Unit.