MEDICAL

CosmosID® Enters Microbiome Partnership with Locus Biosciences

CosmosID | June 22, 2022

Cosmos_ID_Enters
CosmosID®, an American provider of end-to-end microbiome platforms and award-winning metagenomics services, announced entering into a microbiome partnership with a clinical-stage biotechnology company developing a new class of precision-engineered bacteriophage treatments, Locus Biosciences, Inc.  With this partnership, CosmosID focuses on providing its GCP-compliant and CLIA-certified laboratory services for Locus' clinical trial initiatives in the microbiome field.

Locus is developing two innovative biotherapeutics categories to meet significant unaddressed medical needs. First, engineered bacteriophage therapies that use bacteria resident in specific body locations to dispatch therapeutic molecules. Second, precision CRISPR-enhanced bacteriophage (crPhage®) products to combat fatal infections, including the ones caused by multi-drug resistant bacteria.

Locus is able to swiftly recognize, distinguish, engineer, and produce bacteriophage products against bacterial targets involved in the pathogenesis of numerous diseases by collaborating discovery automation, industry-leading informatics, synthetic biology, and sophisticated in-house manufacturing.

CosmosID's infrastructure for providing access to compliant, higher resolution, and robust microbiome analysis will allow Locus to enhance its capability and add insight into precision therapeutics platforms. With its shotgun metagenomics, the company will assist Locus in understanding its products' effectiveness through CosmosID's robust resolution microbiome analysis, commencing with its urinary tract infection clinical program.

We're thrilled to partner with Locus on its groundbreaking clinical pipeline as we help the company better understand the impact of these phages on the microbiome, Locus' robust and diligent approach to this study is much needed in the field and we look forward to helping them build a strong clinical data package."

Manoj Dadlani, CEO of CosmosID.

This partnership with CosmosID will allow Locus to monitor microbiome changes upon treatment of patients with antibiotics and with crPhage, helping us to evaluate the impact of preserving and protecting their microflora while clearing their infections."

Paul Garofolo, CEO of Locus Biosciences.

Spotlight

ACP ile elden edilen Büyüme Faktörleri, Biyoaktif Kolajen Pepdit, Magnezyum ve C Vitamini kombinasyonu sonucu açığa çıkan Fibroblast hücreler Tendonda doku rejenerasyonu sağlayarak tendona ideal yapısına kazandırır.


Other News
MEDTECH, INDUSTRIAL IMPACT

Ribbon Biolabs Reaches Key Milestone with Automation of InfiniSynthTM Platform for Commercial-scale, Unlimited Length DNA Synthesis

Ribbon Biolabs | December 21, 2022

Ribbon Biolabs, the DNA synthesis company announced the successful implementation of their innovative InfiniSynthTM platform for the automated assembly of sequence-agnostic and long DNA. Ribbon Biolabs achieved this milestone in collaboration with HighRes® Biosolutions, a leading laboratory automation technology company. The InfiniSynthTM platform enables Ribbon Biolabs to enter the market in 2023 with a highly differentiated approach to providing critical tools for life science research and biopharmaceutical development. Ribbon Biolabs has developed a novel technology for the fast, automated and high-throughput synthesis of complex DNA. By addressing the growing market for synthetic DNA of multi-kbp to sub-genomic size, an essential component for biopharmaceutical research and development, Ribbon Biolabs aims to become the leading partner for DNA-based solutions and thereby materialize on the disruptive potential of synthetic biology. “The successful setup of our first automated production line for synthetic long DNA is another milestone allowing us to bring DNA-based solutions to the biotechnology industry on a commercial scale. We value the collaboration with HighRes® Biosolutions that supported the achievement of this milestone which positions us to enable the next wave of innovation in biotech.” Marc J. Brehme, Ph.D. Chief Technology Officer of Ribbon Biolabs The InfiniSynth™ platform synergizes algorithmic sequence processing by combinatorial optimisation of the synthesis process and leverages robotic automation for exponential enzymatic DNA assembly. This allows for the rapid and reliable production of DNA molecules of more than 10,000 base pairs (bp) in length. With the automated InfiniSynth™ platform, Ribbon Biolabs is now able to offer commercial-scale synthetic DNA, independent of length and complexity, with a fast turnaround time to its partners. “Synthetic biology is ripe for innovation to expand its potential as an enabler for future life-science discoveries and successful research in the biopharmaceutical industry. Ribbon Biolabs has developed an approach to synthesize long and complex synthetic DNA and we welcomed the chance to collaborate with them,” said Brian J. O’Sullivan, Senior Vice President of Commercial at HighRes® Biosolutions. “With our strength and depth of knowledge in laboratory design and automation, we could contribute to the realization of Ribbon’s technological advances and vision.” About Ribbon Biolabs Ribbon Biolabs is a synthetic biology leader driving DNA synthesis beyond the limits of current technologies. With our automated, enzyme-based InfiniSynthTM platform, Ribbon Biolabs can provide DNA molecules without size or sequence limitations, at a high level of accuracy and at unprecedented speed. We are pioneering a highly differentiated approach to create value for our partners and for the next wave of innovation in the biopharmaceutical industry. About HighRes® Biosolutions HighRes® Biosolutions is a leading global laboratory automation company whose products and people empower scientists to create data factories that connect instrumentation with informatics–from anywhere in the world. By doing so, scientists achieve unprecedented levels of productivity while continually adapting to dynamic scientific, technological, and organizational structures.

Read More

MEDICAL

Cajal Neuroscience Launches with $96 Million to Transform Target and Drug Discovery in Neurodegeneration

Cajal Neuroscience | November 30, 2022

Cajal Neuroscience, a biotechnology company integrating human genetics, functional genomics and advanced microscopy to discover novel targets and therapeutics for neurodegeneration, launched today with the completion of a $96 million Series A financing. Cajal is uniquely focused on the mechanistic, spatial and temporal complexity of neurodegeneration, integrating deep expertise in neuroscience, neuroanatomy and computational biology with state-of-the-art technologies for high-throughput functional validation. The financing was led by The Column Group and Lux Capital, with additional participation from Two Sigma Ventures, Bristol Myers Squibb, Evotec, Alexandria Venture Investments, Dolby Family Ventures and other investors. “We’ve all seen the challenges that face drug discovery in neurodegeneration. Cajal was founded to meet those challenges head-on by convening some of the best minds in the field and integrating a suite of cutting-edge technologies to identify and advance therapies for neurodegeneration in a completely new way. I truly believe our approach can revolutionize neurodegeneration drug discovery by understanding disease mechanisms with spatial and temporal resolution at unprecedented scale,” Ignacio Muñoz-Sanjuán, Ph.D., Chief Executive Officer at Cajal “We want to get to the ground truth of neurodegenerative diseases. Cajal was started from grassroots, bringing together an incredible team of scientists, advisors and investors who share the long-term vision of building foundational systems to explore new pathways and targets and making a difference for patients suffering from neurodegeneration,” said Rob Hershberg, M.D., Ph.D., Co-founder and Executive Chairman of the Board at Cajal. Inspired by the pioneering work of Santiago Ramón y Cajal, whose discoveries on the structural and functional organization of the brain became the foundation of modern neuroscience, Cajal seeks to transform the field of neurodegeneration by revealing the complex and dynamic mechanisms driving disease. Cajal’s platform combines state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, highly multiplexed functional genomics and industrialized whole brain imaging. Through this approach, Cajal is systematically validating the thousands of targets implicated in diseases such as Parkinson’s and Alzheimer’s and creating a comprehensive understanding of neurodegeneration that reveals how, where and when different mechanisms contribute to disease. “The legendary neuroscientist Santiago Ramón y Cajal said that all outstanding work, in art as well as science, results from immense zeal applied to a great idea. That’s precisely why we raced to fund this team,” said Josh Wolfe, Co-founder and Managing Partner at Lux Capital. “When you get the rare combination of the leading scientific minds in neuroscience teaming up to work with cutting-edge visualization, sequencing and computational techniques, and to apply a never-before taken approach to discovering targets and drugs for neurodegenerative disease, you don’t walk slowly toward it -- you sprint for your life.” Cajal’s leadership team includes world-class scientists and experienced biotechnology entrepreneurs who bring scientific rigor, drug development expertise and commitment to advancing therapies for neurodegenerative diseases. About Cajal Neuroscience Cajal Neuroscience is a biotechnology company committed to discovering novel therapeutics for neurodegeneration by leveraging a powerful platform designed to reveal the mechanistic, spatial and temporal complexity of disease at unprecedented scale. Cajal combines a suite of state-of-the-art approaches and technologies, including integrative human genetics and multi-omics, high-throughput functional genomics and advanced microscopy, to accelerate neurodegeneration target and drug discovery. Cajal is headquartered in Seattle, WA.

Read More

CELL AND GENE THERAPY

Healiva® Acquires Critical Cell Therapy Manufacturing Assets From B. Braun

Healiva | November 22, 2022

Healiva®, a patient-centric company delivering life-enhancing precision medicine for patients with chronic and acute wounds, announced today the acquisition of critical manufacturing assets from B. Braun Medical AG Switzerland, an affiliate of German medical and pharmaceutical device company, B. Braun SE. The acquisition includes a qualified cell bank, which is essential for the GMP-compliant manufacturing of Healiva’s first cell therapy product, EpiDex®: an autologous epidermis derived from the patient’s own hair cells. Financial details have not been disclosed. “This transaction will enable Healiva to accelerate the launch of EpiDex, which is projected for Q4 2023. This will allow us to deliver our clinically proven, surgery-free solution to patients with severe chronic wounds more promptly, shortening the path to market for EpiDex by approximately one year.” Priyanka Dutta-Passecker Co-founder and CEO of Healiva “To produce EpiDex, progenitor keratinocyte cells obtained from a patient’s hair are cultured in the presence of fibroblast feeder cells, generating small discs of autologous epidermis,” explained Eric Rolland Scientific Lead and Advisor at Healiva. “These discs are then applied onto the wound, where they promote the growth and healing of the skin.” “The acquisition of a qualified fibroblast cell bank that meets the regulatory requirements for Advanced Therapy Medicinal Products and has previously been approved for the commercial production of EpiDex is a key step in Healiva’s product development,” added Andreas Emmendoerffer Clinical Advisor at Healiva. EpiDex forms part of Healiva’s broad wound care portfolio, which combines cell therapy, medical devices, and enzyme technology to cover the whole wound healing process. EpiDex solves an urgent need for new solutions to treat chronic venous leg ulcers and other chronic wounds, which affect 60 million patients worldwide. With an aging population, combined with the growing incidence of metabolic diseases, this burden is growing. Today, the standard treatment for chronic wounds requires multiple procedures, with surgery required in the most severe cases. EpiDex is as effective as surgery for severe chronic wounds, while being more cost-effective and significantly preferred by patients. EpiDex had previously been approved for the Swiss market. EpiDex will be launched initially in Switzerland, pending approval by Swissmedic, followed by Germany and other EMEA countries. Healiva intends to first seek reimbursement in Switzerland for EpiDex, followed by other European countries. About Healiva Healiva is a patient-centric biotech company delivering life-enhancing precision medicine for patients with chronic and acute ulcers. The company was founded in 2020 by Bioseutica BV and Priyanka Dutta-Passecker.

Read More

CELL AND GENE THERAPY

Biodesix Announces Senior Secured Financing Agreement with Perceptive Advisors for Up to $50 Million

Biodesix | November 17, 2022

Biodesix, Inc. a leading data-driven diagnostic solutions company with a focus in lung disease, announced that it has obtained a term loan facility for up to $50 million from Perceptive Advisors, a leading healthcare investment firm focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. This debt capital, which is conditioned on the Company raising at least $30 million in gross proceeds through sale of its equity securities, is part of a strategic fundraising effort to strengthen the Company’s balance sheet, reduce near term cash use and enable the continued growth trajectory of the core lung diagnostics business. The proceeds from this debt offering will be used for repayment of existing debt facilities, working capital, and general corporate purposes, including expansion of the commercialization activities for the Company’s five Medicare reimbursed lung diagnostic tests. “This financing provides Biodesix with significant flexibility and strengthens our balance sheet thereby positioning us to continue building on the growth momentum we have seen the past few quarters. We are pleased to have the support from Perceptive, which is a recognized leader in growth capital financing.” Robin Harper Cowie, Chief Financial Officer of Biodesix “Perceptive is delighted to provide capital to support the continued growth of Biodesix’s lung diagnostics portfolio,” said Sam Chawla, Portfolio Manager of Perceptive Advisors. “With a comprehensive set of five Medicare covered tests on the market today that address the diagnostic needs of caregivers and patients across the lung continuum of care, Biodesix represents a unique opportunity to impact the lives of patients. We are excited to collaborate with Biodesix and look forward to participating in the Company’s growth.” Under the terms of the agreement, Biodesix will receive an initial $30 million funding, subject to closing conditions, including the equity issuance noted above. An additional $20 million will be available in two separate $10 million tranches under the same terms and collateral, subject to certain timelines and other defined criteria that will be subject to the lender’s approval. The credit facility is interest only for the term of the facility, which is five years from the initial funding date. The term loan bears interest at a per annum rate equal to the greater of the forward looking one-month SOFR and 3.00% per annum, plus an applicable margin of 9.00%, payable monthly in arrears. The term loan is secured by a first lien on all Company assets. In connection with the closing of the initial funding, the Company will issue to Perceptive warrants to purchase up to 5,000,000 shares of the Company’s common stock, with warrants exercisable into 3,000,000 shares of the Company’s common stock to be issued on the funding date of the initial $30 million funding (the “Initial Warrants”). The per share exercise price for the Initial Warrants will be equal to the lower of (i) the 10-day volume weighted average price (the “10-day VWAP”) ending on the business day immediately preceding the funding date of initial loan and (ii) the per share public offering price of the Company’s shares of common stock issued in connection with the required equity raise. In addition to the Initial Warrants, additional warrants will become exercisable into 1,000,000 shares of the Company’s common stock concurrently with the borrowing of each additional $10 million term loan funding. The per share exercise price for the additional warrants will be equal to the lower of (i) the Initial Warrant exercise price or (ii) the 10-day VWAP ending on the business day immediately preceding the funding date of each funding date. Each warrant will be exercisable, in whole or in part, until the 10th anniversary of the applicable date of issuance, subject to certain expiration events as set described in the warrants. Additional details of the loan agreement will be filed with the Securities and Exchange Commission on a Current Report on Form 8-K. About Perceptive Advisors Founded in 1999, Perceptive Advisors is a leading healthcare focused investment firm with approximately $9.5 billion of regulatory assets under management. Since inception, Perceptive Advisors has focused on supporting progress in the life sciences industry by identifying opportunities and directing financial resources toward the most promising technologies in modern healthcare. About Biodesix Biodesix is a leading data-driven diagnostic solutions company with a focus in lung disease. The Company develops diagnostic tests addressing important clinical questions by combining multi-omics through the power of artificial intelligence. Biodesix offers five Medicare-covered tests for patients with lung diseases. The blood based Nodify Lung® nodule risk assessment testing strategy, consisting of the Nodify XL2® and the Nodify CDT® tests, evaluates the risk of malignancy in incidental pulmonary nodules, enabling physicians to better triage patients to the most appropriate course of action. The blood based IQLung™ strategy for lung cancer patients integrates the GeneStrat® ddPCR™ test, the GeneStrat NGS™ test and the VeriStrat® test to support treatment decisions across all stages of lung cancer with results in an average of 36-72 hours, expediting time to treatment. Biodesix also leverages the proprietary and advanced Diagnostic Cortex® AI (Artificial Intelligence) platform, to collaborate with many of the world’s leading biotechnology and pharmaceutical companies to solve complex diagnostic challenges in lung disease.

Read More