Clinical Catch-up from Last Week: May 5-10

Biospace | May 13, 2019

Almost every week, biopharma companies release results from ongoing clinical trials. Here’s a roundup of some of the top clinical trial news from the previous week. AveXis, a Novartis company, released interim data from the Phase I STRONG trial, additional data from the STR1VE trial, and the first data from the Phase III SPR1NT trial for Zolgensma (onasemnogene abeparvovec-xioi) in spinal muscular atrophy (SMA) Type 1. Zolgensma is a gene therapy in development as a one-time infusion for SMA Type 1. It uses a virus vector to deliver a copy of the human SMA gene. SMA is a severe neuromuscular disease noted by the loss of motor neurons, which leads to progressive muscle weakness and paralysis. Neurocrine Biosciences presented data from two Phase III clinical trials of opicapone, a once-daily, oral catechol-O-methyltransferase (COMT) inhibitor for Parkinson’s disease. They found that patients receiving opicapone 50 mg with levodopa, the standard of care, had a significant and sustained improvement in symptoms. Neurocrine reported on two Phase III studies, BIPARK-1 and BIPARK-2. BIPARK-1 looked at about 600 patients with Parkinson’s and motor fluctuations. BIPARK-2 looked at about 400 patients with Parkinson’s and motor fluctuations. They received once-daily doses of opicapone of either 25 mg or 50 mg or placebo for 14 to 15 weeks. The data from these two Phase III trials showed that adding once-daily opicapone to levodopa significantly increased ON time without troublesome dyskinesia.

Spotlight

Many men may be surprised to learn that they can get breast cancer. Although breast cancer in men is uncommon, it is important to know the risk factors, as well as the signs and symptoms, of the disease.

Spotlight

Many men may be surprised to learn that they can get breast cancer. Although breast cancer in men is uncommon, it is important to know the risk factors, as well as the signs and symptoms, of the disease.

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INDUSTRIAL IMPACT

BioConsortia Showcases Breakthrough Microbial Products and Pipeline of Innovation

BioConsortia, Inc. | September 05, 2022

BioConsortia’s innovative microbial products and technical capabilities were on full display August 30th at its Davis, CA headquarters in an investor-focused Technology Showcase event. BioConsortia demonstrated rapid advancements in microbial product and pipeline developments for reducing nitrogen fertilizers, controlling soil pests and plant diseases for larger and better-quality crop yields, as well as protecting crops post-harvest to avoid food waste, while minimizing environmental impact and protecting our planet. The Showcase event reintroduced CRIMSON™ fungicide and biostimulant ZAFFRE™, two products currently awaiting final registrations, and highlighted BioConsortia’s new fungicides, nematicides and nitrogen fixing products that are progressing through registration and commercialization and moving into evaluation with potential partners, as follows: NO-NEM™ bionematicide advances: BioConsortia highlighted progress in bringing novel, safe and effective nematocidal microbes to market. Experts estimate global crop losses of $125 billion or 14% of crop value each year. Currently available chemical controls like methyl bromide, organophosphates and carbamates have an unacceptable level of toxicity to non-target organisms and are being withdrawn from use. NO-NEM is BioConsortia’s first nematicide product heading into full development phase. It has shown excellent performance against economically important pests in row crops, as well as fruits and vegetables, such as soybean cyst nematodes and root knot nematodes. “Today we highlight the breadth of innovations developed to replace chemical crop inputs with superior microbe-based solutions for nitrogen fixing, disease control, nematode control, crop yields and post-harvest food safety. The recent progress of our pipeline – including some exciting technology breakthroughs - means we are ready to advance multiple major products into the commercialization phase with marketing partners.” Marcus Meadows-Smith, CEO of BioConsortia R&D Pipeline Expanded through Technical Innovation Additions to BioConsortia’s R&D pipeline aim to leapfrog currently available microbial products, providing improved efficacy, increased shelf-stability, and reduced field use rates, as follows Leveraging GenePro™ microbe editing platform for nitrogen-fixing breakthroughs: BioConsortia’s proprietary genomics and gene-editing platform, GenePro™, facilitates the discovery and engineering of a wide diversity of microbes faster and more efficiently. BioConsortia’s scientists affirmed GenePro has resulted in the discovery of novel genetic components driving nitrogen-fixation. BioConsortia’s proprietary bacterial strains fix nitrogen under conditions other N-fixing strains will not. This discovery validates the company’s position as a leader in microbe-derived alternatives for agriculture, has resulted in proprietary intellectual property, and will continue to drive our research focus. Expanding library through AMS: BioConsortia’s patent-protected “AMS” - Advanced Microbial Selection™ platform uses evolutionary biology practices to find beneficial microbes that the plant has selected for specific gains. AMS underpins the breadth, depth, and success of BioConsortia’s product pipeline. The company announced the addition of more than 2000 rice diazotrophic microbial strains to its library, following a research program using AMS. This large addition to the library has greatly accelerated BioConsortia’s nitrogen-fixation project for rice, a crop with a paddy production model that represents a unique opportunity to impact the sustainability practices of both large and small growers of one of the world’s most fertilized crops. Novel Bactericide Project: BioConsortia also introduced a new project focused on optimizing microbes for the production of metabolites active against bacterial disease. Project leaders highlighted early technological success within this project – again reliant on the GenePro platform, which focuses on utilizing novel tools to address evolving bacterial disease resistance and increasing bacterial pest pressure resulting from climatic challenges and global trade flows. Novel Multi-spectrum Insecticide: Additionally, the company updated progress on a novel, developmental microbial active ingredient designed to deliver broad-spectrum control of both nematodes and critically important coleopteran and lepidopteran pests. The project aims to deliver a novel mode of action to support and extend crop trait lifecycles in the face of emerging insect resistance. Nematicide leads were originally characterized as strong root colonizers employing the company’s RhizoViz™ system, which uses proteins to visualize colonization robustness in different soils and environmental conditions. BioConsortia’s nematicide pipeline is now among the most expansive in agricultural research. “BioConsortia’s pipeline progress highlights the strengths of the company’s R&D platform – unique in the industry in terms of discovery of plant-affiliated microbes and their optimization as solutions for agriculture,” said Dr. Hong Zhu, Senior VP of Research and Development at BioConsortia. About BioConsortia BioConsortia, Inc. develops superior microbial products that protect plants, enhance fertility, and increase yields while improving the sustainability of agriculture for our environment. Pioneering the use of directed selection within microbial communities, our patented Advanced Microbial Selection process and cutting-edge GenePro genomics and gene-engineering platform enable us to predict, design, and unleash the natural power of microbes.

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CELL AND GENE THERAPY

Sesen Bio and Carisma Therapeutics Announce Merger Agreement

Sesen Bio and Carisma Therapeutics | September 22, 2022

Sesen Bio, Inc. and Carisma Therapeutics Inc. a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol “CARM”. Carisma has also secured commitments from a syndicate of investors for a $30 million financing, including HealthCap, AbbVie, Wellington Partners, SymBiosis, Penn Medicine, TPG Biotech, MRL Ventures Fund, the therapeutics-focused corporate venture arm of Merck & Co., Agent Capital, Solasta, Livzon, Pictet Alternative Advisors and 4Bio, which is expected to close concurrently with the completion of the merger. With the cash expected from both companies at closing and the proceeds of the concurrent financing, the combined company is expected to have approximately $180 million in cash, cash equivalents and marketable securities. These cash resources are expected to be used to advance Carisma’s pipeline through multiple ongoing and planned key data readouts across several clinical trials and to fund operating expenses and capital expenditure requirements through 2024. The merger and related financing are expected to close in the next three to four months. “The proposed merger represents an exciting opportunity for shareholders of each company, and we believe it gets us one step closer to our goal of revolutionizing the field of immunotherapy. This transaction will provide us with financial strength to not only continue to develop our lead candidate CT-0508, but also allow us to accelerate the growth of our platform and pipeline within and outside of oncology and develop additional strong strategic partnerships beyond those we already have with Moderna and Novartis. Carisma is focused on delivering cutting-edge technology for patients in a way that has never been done before, and we look forward to advancing this important mission.” Steven Kelly, President and Chief Executive Officer of Carisma “This transaction represents the result of a thoughtful and careful review of strategic alternatives over the past four months, during which Carisma’s clinical programs, management team, and corporate strategy stood out amongst the 42 bids reviewed,” said Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio. “Carisma is an exciting clinical-stage company with groundbreaking science and an impressive management team, which we believe makes them the optimal partner to provide value for our shareholders. Our mission at Sesen Bio has always been to save and improve the lives of patients with cancer, and we believe Carisma has the science and the unwavering patient focus required to make that mission a reality.” About the Proposed Merger Pre-merger Sesen Bio stockholders are expected to own approximately 41.7% and pre-merger Carisma stockholders are expected to own approximately 58.3% of the combined company, in each case before giving effect to the concurrent financing described above and the conversion of the outstanding Moderna convertible note. Under the terms of the merger agreement, stockholders of Carisma will receive newly issued shares of Sesen Bio common stock pursuant to an exchange ratio formula set forth in the merger agreement. The percentage of the combined company that Sesen Bio stockholders will own upon the closing of the merger is further subject to adjustment based on the amount of Sesen Bio’s net cash at the time of closing. Immediately prior to the closing of the proposed merger, Sesen Bio stockholders of record will be issued a contingent value right (CVR) for each outstanding share of Sesen Bio common stock held by such Sesen Bio stockholder as of such date, representing the right to receive certain cash payments from proceeds received by Sesen Bio related to the Roche Asset Purchase Agreement, if any, subject to customary deductions, including for expenses and taxes. SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore Group LLC is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore Group L.L.C. are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel. About Sesen Bio Sesen Bio, Inc. is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. Sesen Bio’s most advanced product candidate, Vicineum™, also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of non-muscle invasive bladder cancer. On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the US. The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase 3 clinical trial, following Sesen Bio’s discussions with the United States Food and Drug Administration. Sesen Bio has turned its primary focus to assessing potential strategic alternatives with the goal of maximizing shareholder value. Additionally, Sesen Bio intends to seek a partner for the further development of Vicineum. About Carisma Therapeutics Carisma Therapeutics Inc. is a biopharmaceutical company dedicated to developing a differentiated and proprietary cell therapy platform focused on engineered macrophages, cells that play a crucial role in both the innate and adaptive immune response. The first applications of the platform, developed in collaboration with the University of Pennsylvania*, are autologous chimeric antigen receptor (CAR)-macrophages for the treatment of solid tumors. Carisma Therapeutics is headquartered in Philadelphia, PA.

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CELL AND GENE THERAPY

Lunaphore and Nucleai announce a partnership to provide AIpowered spatial biology analysis to accelerate drug development

Lunaphore and Nucleai | September 09, 2022

Lunaphore, a Swiss life sciences company developing technology to enable spatial biology in every laboratory, and Nucleai, a leader in AI-powered spatial biology transforming precision medicine by unlocking the power of pathology data announced a collaboration to accelerate the discovery of novel biomarkers and drug targets using the latest spatial imaging and machine learning technologies. “We are thrilled to announce the partnership with Lunaphore and combine Lunaphore’s best-in-class flagship COMET™, a hyperplex staining and imaging platform, with Nucleai’s ATOM platform that uniquely supports multiplex, IHC, and H&E data. This strategic partnership will allow us to utilize multiplex technology and provide a complete, actionable, and scalable solution to improve drug target discovery and development of our pharma and biotech partners.” Avi Veidman, Chief Executive Officer of Nucleai Mapping biological microenvironments with spatial mapping technology is an exciting area of discovery. Lunaphore’s novel COMET™ technology unlocks the power of immunofluorescence spatial biology with a robust and user-friendly system, permitting the use of any non-conjugated antibodies and enabling the wide adoption of spatial biology in laboratories. Nucleai has built a platform that makes spatial analysis scalable and operational, enabling the next generation of actionable insights from massive pathology data sets that have not been analyzed to their fullest potential and could provide significant value to pharmaceutical companies and diagnostic labs. The partnership will utilize Lunaphore’s innovative COMET™ platform for hyperplex staining and imaging with Nucleai’s cutting-edge AI spatial models to derive new insights from tissue biopsies, including novel drug targets, mechanisms of action, and biomarkers to advance the field of precision medicine. The combined solutions will provide laboratories with an integrated end-to-end spatial biology workflow from automated, hyperplex sequential immunofluorescence staining and imaging to AI-enabled, state-of-the-art image processing, and data analytics. As part of the partnership, the companies also plan to develop predictive and prognostic spatial biomarker assays. “Our partnership with Nucleai is based on our shared vision to advance next-generation spatial multiplex immunofluorescence imaging to accelerate drug and biomarker discovery and development,” said Déborah Heintze, Chief Marketing Officer of Lunaphore. “Connecting Nucleai’s solution with COMET™, we have the potential to more precisely characterize the immune system and disease microenvironment to provide deeper biological insights to drug developers.” “Nucleai brings innovative spatial biology and machine learning platform (ATOM) to empower researchers with novel insights into drug discovery,” said Mridula Iyer, Ph.D., Vice President of Strategic Partnerships at Nucleai. “The technology is designed to unlock and analyze valuable data from pathology slides previously inaccessible, leading to the development of new precise targeted therapy that is important for patient outcomes. This collaboration is another example of how both Lunaphore and Nucleai are accelerating efforts to partner with pharmaceutical and biopharmaceutical companies, as well as medical research institutions and other biomedical organizations.” About COMET™ COMET™ is a fully automated sequential immunofluorescence instrument, able to perform hyperplex staining and imaging, producing high-quality data in a robust and reproducible manner. With superior tissue profiling capabilities, the system allows multiplex analysis of up to 40 different spatial markers per tissue slide without human intervention. COMET™ has a wide range of research applications, allowing for a dramatic improvement in the understanding of disease pathology in areas such as immuno-oncology, neuroscience, and infectious diseases. The technology has the ability to revolutionize clinical applications such as drug discovery and biomarker development. About Lunaphore Lunaphore Technologies S.A. is a Swiss company born in 2014 with the vision of enabling spatial biology in every laboratory. Lunaphore has developed a game-changing chip technology that can extract spatial proteomic and genomic data from tumors and transform any simple assay into multiplex spatial biology without complexity. Lunaphore empowers researchers to push the boundaries of research to ultimately develop the next generation personalized therapies. About Nucleai Nucleai is an AI-powered spatial biology company with a mission to transform drug development and clinical treatment decisions by unlocking the power of pathology data. Nucleai provides pharmaceutical companies, Contract Research Organizations, and diagnostics laboratories with a state-of-the-art AI platform to improve clinical trials and clinical decision-making.

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