Neurocrine Biosciences and Xenon Launch Up-to-$1.7B Epilepsy, Neuroscience Collaboration

GEN | December 02, 2019

Neurocrine Biosciences has agreed to exclusively license and co-develop Xenon Pharmaceuticals’ Phase I epilepsy candidate XEN901 as a treatment for children—as well as develop three preclinical compounds, the companies said today—through a collaboration that could generate up to $1.7 billion for Xenon. XEN901 is designed as a highly selective Nav1.6 sodium channel inhibitor being developed to treat children with SCN8A developmental and epileptic encephalopathy (SCN8A-DEE) and other potential indications, including adult focal epilepsy. Xenon has completed a Phase I trial of a powder-in-capsule formulation of XEN901 in healthy adults. However, Xenon has also developed a pediatric-specific, granule formulation of XEN901, and has completed juvenile toxicology studies intended to support pediatric development of the drug candidate. “With its proven expertise in developing and commercializing treatments for neurological disorders, we believe Neurocrine Biosciences is an ideal partner to maximize the potential value of XEN901 for patients,” Xenon CEO Simon Pimstone, MD, PhD, FRCPC, said in a statement.

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Biotechnology jobs are expected to increase by 12% from 2012 to 2020. View the infographic below to see the types of careers, fields, and salaries for biotechnology. The Biomanufacturing Education and Training Center at WPI is where biotechnology professionals gain an edge. It’s an innovative partnership between academia and industry that creates customized workforce development solutions for forward-thinking biotechnology companies across the region and around the world

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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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INDUSTRIAL IMPACT

Naveris Inc. Raises $51 Million to Advance Commercialization of NavDx

Naveris, Inc. | September 20, 2022

Naveris, Inc., a commercial-stage life sciences company dedicated to improving patient care through earlier detection of viral-driven cancers, today announced a $33.4 million expansion of its Series A financing, bringing the total investment in Naveris to $51 million. The financing was led by Gurnet Point Capital, joined by TechU Ventures and BrightEdge, the impact and venture capital arm of the American Cancer Society. Naveris’ blood tests for earlier cancer detection use proprietary patented DNA fragmentomics technology to distinguish between viral DNA arising from cancers versus infection. Proceeds from this financing will be used to advance commercialization of NavDx, Naveris’ flagship blood test for the early detection of cancers caused by the human papillomavirus (HPV), and to generate the clinical data needed to expand into other cancer types and indications. “We are delighted to have the continued support of Gurnet Point Capital and TechU Ventures, and to welcome Alice Pomponio and the rest of the BrightEdge team, who collectively bring a deep understanding of both the oncology space and commercial-stage businesses. We founded Naveris on the belief that advances in molecular diagnostics will play a vital role in improving cancer outcomes. This new investment underscores NavDx’s commercial success and potential, and our experienced team’s ability to transform this vision into a reality for patients and oncologists.” Piyush B. Gupta, Ph.D., Naveris founder and Chief Executive Officer "Since our initial investment in 2020, we have been impressed by the Naveris team's vision and their ability to commercially execute on a differentiated strategy in the rapidly developing field of blood-based cancer detection,” said Travis Wilson, Partner at Gurnet Point Capital. “We are pleased to be providing additional capital to ensure that their transformative technology for early cancer detection will benefit as many patients as possible." “We could not be more excited to back Piyush and his team as Naveris works to increase access to diagnose, detect, and monitor viral cancers” said Alice Pomponio, BrightEdge Managing Director. “We understand the burden of HPV related cancers on patients. And we seek to build on the years of research and advocacy of the American Cancer Society to support the next generation of mission aligned companies reducing patient burden.” Along with Naveris' commercial activities, more than 25 medical institutions have partnered with the company to conduct clinical studies and trials utilizing its technology. The company has also partnered with biotechnology companies developing immunotherapies for HPV-related cancers. About Naveris, Inc. Founded in 2017, Naveris is a privately held biotechnology company with facilities in Massachusetts and North Carolina. The company’s mission is to improve outcomes for the millions of people at risk of developing viral cancers through novel molecular diagnostics that enable earlier cancer detection. Naveris’ clinical laboratory is certified for high complexity testing under CLIA, and is accredited by the College of American Pathologists and the New York State Department of Health Wadsworth Center. About Gurnet Point Capital Gurnet Point Capital is a leading healthcare fund that invests in de-risked life sciences companies. Gurnet Point primarily focuses on businesses that have high growth potential in the late product development and commercialization stages of their evolution. These companies become partners not just because of their capacity to generate economic value, but also because of their potential to deliver social impact. Gurnet Point’s team of highly experienced industry executives work closely with its portfolio companies, with an active approach driving operational transformation and outsized returns.

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CELL AND GENE THERAPY

Hamilton and BioFluidica Pen Next Generation Liquid Biopsy Platform Co-Marketing Agreement

BioFluidica, Inc. | September 28, 2022

Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips. This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy. "LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system." Rolf Muller, BioFluidica CEO About Hamilton Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions. Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world. About BioFluidica BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.

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