Another effort on pancreatic cancer flops, as Boston Biomedical cans phase 3 combo test

Boston Biomedical | July 02, 2019

Boston Biomedical is halting a late-stage study of its investigational drug, alongside older chemo therapies, after it failed to help pancreatic cancer patients. The phase 3 trial was combining traditional cancer chemo agents Abraxane and gemcitabine with Boston Biomedical’s experimental oncology drug napabucasin, an oral therapy that is bioactivated by NQO1, which generates reactive oxygen species to affect multiple oncogenic cellular pathways, including the STAT3 pathway, which is expected to result in cancer cell death. But this triple cocktail failed to move the needle for Boston, owned by Japanese-based parent company Sumitomo Dainippon Pharma (buying back in 2012 for up to $2.6 billion), and the trial will now be stopped.

Spotlight

Meet the NeatCell C-Pro application. It automates the mononuclear cell fraction enrichment from diverse cellular products, and is designed for use with a density-gradient medium like Ficoll-Paque media with the Sepax C-Pro instrument and CT-90.1 single-use kit.

Spotlight

Meet the NeatCell C-Pro application. It automates the mononuclear cell fraction enrichment from diverse cellular products, and is designed for use with a density-gradient medium like Ficoll-Paque media with the Sepax C-Pro instrument and CT-90.1 single-use kit.

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INDUSTRIAL IMPACT, MEDICAL

Bicycle Therapeutics Announces a Strategic Collaboration with Novartis to Discover, Develop and Commercialize Bicycle® Radio-Conjugates

Businesswire | March 29, 2023

Bicycle Therapeutics plc a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle®) technology, today announced that it has entered into a strategic collaboration agreement with Novartis to develop, manufacture and commercialize Bicycle® radio-conjugates (BRCs) for multiple agreed upon oncology targets. “This collaboration builds on the groundbreaking clinical work we have been doing in the toxin conjugate field and provides new and additional validation for this unique technology,” said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. “We look forward to working closely with Novartis to pioneer the discovery and development of potential new cutting-edge radiopharmaceutical cancer treatments based on Bicycles. We believe the properties of Bicycles make them well suited for the development of precision guided radiopharmaceuticals and represents the next leg in the application of our proprietary discovery platform in oncology.” Under the terms of the agreement, Bicycle will utilize its proprietary phage platform to discover Bicycles to be developed into BRCs. Novartis will be responsible for further development, manufacture and commercialization of the BRCs. Novartis will fund all pre-clinical and clinical development and commercialization activities. Bicycle will receive a $50 million upfront payment and is eligible for development and commercial-based milestone payments totaling up to $1.7 billion. Bicycle will also be eligible to receive tiered royalties on Bicycle-based medicines commercialized by Novartis. About Bicycle Therapeutics Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycles, for diseases that are underserved by existing therapeutics. Bicycles are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry. This constraint facilitates target binding with high affinity and selectivity, making Bicycles attractive candidates for drug development. Bicycle is evaluating BT5528, a second-generation Bicycle Toxin Conjugate targeting EphA2; BT8009, a second-generation BTC targeting Nectin-4, a well-validated tumor antigen; and BT7480, a Bicycle TICA™ targeting Nectin-4 and agonizing CD137, in company-sponsored Phase I/II trials. In addition, BT1718, a BTC that targets MT1-MMP, is being investigated in an ongoing Phase I/IIa clinical trial sponsored by the Cancer Research UK Centre for Drug Development. Bicycle is headquartered in Cambridge, UK, with many key functions and members of its leadership team located in Cambridge, MA.

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INDUSTRY OUTLOOK

Monte Rosa Therapeutics Advances Second Development Candidate, MRT-6160, a Novel, Highly Selective Molecular Glue Degrader Targeting VAV1

Globenewswire | May 29, 2023

Monte Rosa Therapeutics, Inc. a clinical-stage biotechnology company developing novel molecular glue degrader (MGD)-based medicines, announced its second development candidate, MRT-6160, a novel, potent, and selective molecular glue degrader of VAV1. The Company plans to file an Investigational New Drug (IND) application for MRT-6160 in the first half of 2024 and to develop the molecule as a potential treatment for autoimmune diseases. “MRT-6160 is a potent, orally bioavailable MGD designed to degrade VAV1, an important protein involved in the signaling pathways of T and B cells. Our in vitro studies have shown that MRT-6160 selectively degrades VAV1 without detectable effects on other proteins. By targeting VAV1, MRT-6160 attenuates multiple aspects of T- and B-cell function and inhibits disease progression in established in vivo models of autoimmunity,” said Owen Wallace, Ph.D., Chief Scientific Officer of Monte Rosa. “The underlying biology and our preclinical data both demonstrate that MRT-6160 acts as an immune modulator, which has the potential to avoid the broad immune suppression seen with other approaches. We look forward to progressing our clinical plan developed with the goal of providing early insights into safety, PK and PD, and proof of concept regarding differentiated effects on key immunomodulatory signaling pathways.” “Our goal centers on pioneering therapeutically meaningful new drugs for patients with serious diseases. By addressing VAV1, a validated but previously undruggable target, we believe we've created a potentially groundbreaking therapy for patients suffering from a range of serious autoimmune conditions, particularly those involving both T- and B cell-mediated autoimmunity,” said Markus Warmuth, M.D., CEO of Monte Rosa. “MRT-6160 is expected to be our second MGD to enter clinical trials, showcasing the continued productivity of our QuEEN™ platform. We anticipate significant progress and milestones in our portfolio in the upcoming year, including initial clinical data from our GSPT1 MGD, MRT-2359, in the second half of this year and filing of an IND application for MRT-6160 in the first half of next year.” About Monte Rosa Monte Rosa Therapeutics is a biotechnology company developing novel molecular glue degrader (MGD) medicines for patients with serious diseases such as oncology, autoimmune and inflammatory diseases. MGDs are small molecule protein degraders that employ the body’s natural mechanisms to selectively eliminate therapeutically relevant proteins. The Company’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) platform enables it to rapidly identify protein targets and design highly selective degraders by combining diverse libraries of proprietary MGDs with in-house proteomics, structural biology, AI/machine learning, and computational chemistry capabilities.

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INDUSTRIAL IMPACT, DIAGNOSTICS

PathAI and ConcertAI Partner to Create First-in-class Histopathology and Clinical Real-World Data Solutions

Prnewswire | April 26, 2023

PathAI, a global leader in AI-powered pathology, and ConcertAI, a leader in AI software-as-a-service technology and real-world evidence solutions for life sciences and healthcare, today announced a strategic partnership to launch a first-in-class quantitative histopathology and curated clinical real-world data (RWD) solution combining PathAI's PathExplore™ tumor microenvironment panel with ConcertAI's Patient360™ and RWD360™ products. Utilizing real world H&E-stained samples from PathAI's pathology laboratory, PathExplore extracts quantitative measures of the tumor microenvironment, known as human interpretable features (HIFs), from whole slide images. These data are linked to Patient360's reference-standard abstracted clinical EMR, medical claims, and Social Determinants of Health data, allowing direct insights into current standards of care and treatment dynamics. Similarly, the data are also linked to RWD360, which provides scaled insights from structured EMR data, medical claims, and Social Determinants of Health for large populations. "Real world data products include clinical and outcomes data, but are missing a critical component that links these, namely pathology, which has historically been non-standardized or with limited quantification," said Andy Beck, CEO and co-founder of PathAI. "Our collaboration with ConcertAI will offer access to a uniquely linked quantitative pathology dataset, allowing researchers to explore hypotheses far beyond the scope of small, controlled datasets, such as identifying and analyzing novel histological biomarkers correlated with patient treatment and outcomes." "Analysis of tumor microenvironment characteristics is critical to understanding why certain patients respond to a specific therapy and others do not. It further allows the definition of clinical strategies that might increase the numbers of patients benefiting from current medicines and improve the effectiveness of new ones," said Jeff Elton, PhD, CEO of ConcertAI. "With PathAI we are creating the first large scale clinical datasets linking pathology HIFs with EMR-derived clinical data, greatly enhancing the armamentarium of the translational and clinical development research communities." ConcertAI and PathAI will jointly offer these combined solutions to biopharma customers, including translational research and real-world data teams. The initial solutions focus on bladder cancer, colorectal cancer, prostate cancer, and melanoma. For more information, contact us at PathAI or ConcertAI, or visit us at PathAI's exhibit and ConcertAI's exhibit at ASCO in Chicago, IL, on June 2-6, 2023. PathAI and PathExplore are a registered trademark and trademark respectively of PathAI. ConcertAI, Patient360, and RWD360 are registered trademarks or trademarks of ConcertAI. All rights reserved. About ConcertAI ConcertAI is a leader in Real-World Evidence (RWE) and AI Software-as-a-Service solutions for life sciences and healthcare. Our mission is to accelerate insights and advance clinical outcomes for patients through advanced AI technologies, multi-modal real-world data, and scientific expertise in partnership with the leading biomedical innovators, healthcare providers, and medical societies.

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