CAMBRIDGE, Mass.–(BUSINESS WIRE)–Xeno Biosciences Inc., a clinical stage drug discovery and development company advancing therapeutics for the treatment of obesity and metabolic diseases, announced today a change in executive leadership as of September 2023, and the completion of an additional financing round in February of 2024. This financing of $1.15M will fund a Phase 1b trial of the company’s lead compound, Xen-101, in obese individuals. The trial is expected to have top line results by the end of the year.
The new president and CEO, Dennis D. Kim, MD, MBA, has 25 years of obesity and metabolic drug development expertise experience and has brought multiple obesity and metabolic disease drugs to the clinic and to market, including Byetta® (exenatide), Symlin® (pramlintide), Contrave® (bupropion/naltrexone), and seladelpar. He has been involved in numerous IPO’s/secondary offerings and has been the chief medical officer of multiple public companies, most recently at CymaBay Therapeutics, where he oversaw the design and execution of seladelpar Phase 3 Pivotal Program.
“I’m excited to be spearheading the development of Xeno’s new oral obesity drug which has been shown to have high tolerability in initial Phase I trial and has a novel mechanism of action.” said Dr. Dennis Kim. “I have dedicated my career to this area of science and medicine. After many years of development, I am truly gratified to see obesity pharmaceuticals as having the potential to impact the lives of billions of people around the world. There is a strong unmet need for a drug with the profile of Xen-101 and I look forward to our Phase 1b clinical trial results in obese adults in the near future.”
“Dennis has an extraordinary depth of knowledge and is highly respected in the obesity field; I could not imagine anyone more perfect to lead our company,” said Jeff Arnold, Chairman and a Director at Xeno since 2017. “We are delighted that he has decided to join us and lead this exciting project.”
For more information about Xeno Biosciences please contact Dr. Dennis Kim at dk23@xenobiosciences.com.
About Xeno Biosciences Inc.
Xeno Biosciences Inc. is a privately held drug development company dedicated to finding safe and effective treatments for obesity and metabolic diseases. Xeno is advancing its lead development candidate, XEN-101, to address the unmet need for an effective, well-tolerated, orally administered obesity treatment. With a new understanding of the underlying mechanism of action of Roux-en-Y Gastric Bypass Surgery (RYGB), Xeno has developed a substitute for gastric bypass in a daily oral pill. XEN-101 has been shown to have wide safety margins and high tolerability in initial clinical trials.
Dennis D. Kim, MD, MBA
Dr. Dennis Kim is a scientist and a physician executive who brings 25 years of clinical research and biopharmaceutical industry experience to Xeno Biosciences. Dr. Kim served in a variety of senior executive positions in the industry, most recently as Chief Medical Officer at CymaBay, Emerald Biosciences, and Zafgen, Inc., as well as at Orexigen Therapeutics as the Senior Vice President of Medical Affairs. He also held various senior management positions at Amylin Pharmaceuticals, Inc. for over 7 years, including Executive Director of Corporate Strategy and Program Medical Lead for the development and commercialization of Byetta® (exenatide) for the treatment of type 2 diabetes.
Dr. Kim completed his fellowship in Endocrinology/Metabolism at the University of California, San Diego (UCSD) School of Medicine during which time he investigated the pathophysiology of diabetes and metabolic syndrome. He is extensively published in top peer-reviewed medical and scientific journals with over 50 publications to his name. Dr. Kim also received an MBA degree with honors from UCSD Rady School of Management with an emphasis on biotech structure and strategy.
The securities sold in the aforementioned private placement have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States in the absence of an effective registration statement or an applicable exemption from the registration requirements of the Securities Act. This press release shall not constitute an offer to sell or the solicitation of an offer to buy the aforementioned shares. In addition, this press release contains certain forward-looking statements regarding, among other things, statements relating to goals, plans and projections regarding the company’s financial position, results of operations, market position, product development and business strategy. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statements can be guaranteed and actual results may differ materially from such statements. The information in this release is provided only as of the date of this release, and the company undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.
WOBURN, Mass.–(BUSINESS WIRE)–Javelin Biotech, Inc., a leading technology company specializing in human tissue chip platforms for biopharma research, is delighted to announce the appointment of Jacques Banchereau, PhD as its Chief Scientific Officer (CSO). Banchereau is an internationally recognized immunologist and molecular biologist, renowned for his groundbreaking contributions to the field of immunology and drug discovery.
Over his distinguished 35-year career, Dr. Banchereau has shown exceptional leadership in both academic and industrial research. Having held esteemed roles such as Professor and Director of Immunological Sciences at the Jackson Laboratory for Genomic Medicine, Chief Scientific Officer at Hoffman-La Roche, CSO at Immunai, and Adjunct Professor of Immunobiology at Yale School of Medicine, he has consistently demonstrated his expertise in driving forward scientific inquiry and pharmaceutical innovation.
In his role at Javelin Biotech, Banchereau will oversee the company’s scientific strategy, leveraging his vast experience and expertise to drive the development of cutting-edge technology for the modeling of human diseases. His appointment underscores Javelin Biotech’s commitment to innovation and scientific excellence in the field of biotechnology.
“We are thrilled to welcome Jacques to the Javelin Biotech team,” said Murat Cirit, PhD, CEO of Javelin Biotech. “His outstanding achievements and leadership in immunology and drug discovery make him a valuable addition to our company. We are confident that his expertise will play a pivotal role in advancing our research efforts and driving our mission to support the development of novel treatments for organ-specific diseases.”
Banchereau expressed his excitement about joining Javelin Biotech, stating, “I am honored to be part of a company that is dedicated to pushing the boundaries of scientific research. Javelin Biotech’s innovative technology has the potential to revolutionize the way we understand and treat complex diseases, and I look forward to contributing to its success.”
About Javelin Biotech:
Javelin Biotech is a biotechnology company focused on humanizing preclinical drug discovery with a predictive platform that merges human tissue chips with digital twin technology to develop better medicines faster. The Javelin platform enables the creation of accurate and physiologically relevant models of human tissues, providing valuable insights into disease mechanisms and drug responses, allowing biopharmaceutical companies to reduce their reliance on animal studies and develop better drugs faster.
Extends expected cash runway in advance of AUDACITY FDA trial read-out
Strengthens long-term partnership with RTW Investments.
NATICK, Mass.–(BUSINESS WIRE)–Allurion Technologies, Inc. (NYSE: ALUR) (“Allurion” or the “Company”), a company dedicated to ending obesity, today announced the closing of a $48 million convertible senior secured note financing with certain entities managed by RTW Investments, LP (“RTW”). Proceeds will be used to repay in full the Company’s obligations under its existing term loan with Fortress Credit Corp., reducing the Company’s interest expense and increasing operational flexibility.
Management anticipates this transaction will better position the business for the future. Of note, the convertible notes reduce the interest rate on the Company’s debt to 6%, lengthen the maturity over Allurion’s existing term loan by nearly four years, from June 2027 to April 2031, and allow for interest payments to be made in-kind for the first three years. The net benefit of these changes, together with the amended terms of Allurion’s existing Royalty Interest Financing Agreement with RTW, extends the Company’s expected cash runway in advance of the AUDACITY FDA trial read-out, which is anticipated by year-end.
“RTW’s investment underscores our shared belief in the long-term potential of the Allurion Program,” said Dr. Shantanu Gaur, Founder and CEO of Allurion. “Our impressive clinical results and continued growth in procedural volume in our foreign markets give us confidence that Allurion will be a significant player in obesity management. The investment furthers our long-term partnership with RTW and provides us additional flexibility to achieve our long-term goals,” Dr. Gaur continued.
“We are pleased to strengthen our relationship with Allurion as it continues its mission to end obesity around the world. The Allurion Program is a proven weight-loss method, and we eagerly await the results of its U.S. FDA trial,” said Roderick Wong, M.D., Managing Partner and Chief Investment Officer of RTW Investments, LP.
About the Notes
The notes bear interest at the rate of 6% per annum, with the Company’s option to pay interest in kind for the first three years, and mature on April 16, 2031. The notes may be converted at the option of the noteholders into common stock of Allurion, subject to certain conditions and limitations, at a 35% conversion premium to the lower of (i) the 30-day VWAP at signing and (ii) the price per share in the Company’s next equity offering. The Company has agreed to customary registration rights with respect to the shares of common stock issuable upon conversion of the notes. The notes may be redeemed by Allurion at its option under certain circumstances following the fourth anniversary of the date of issuance.
This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.
Additional information about the notes and the terms of the note purchase agreement will be filed with the U.S. Securities and Exchange Commission (the “SEC”) and will be available on the SEC’s website at www.sec.gov.
About Allurion
Allurion is dedicated to ending obesity. The Allurion Program is a weight loss platform that features the Allurion Gastric Balloon, the world’s first and only swallowable, procedure-less intragastric balloon for weight loss, and offers access to the Allurion Virtual Care Suite, including the Allurion Mobile App for consumers, Allurion Insights for health care providers featuring the Coach Iris AI Platform, and the Allurion Connected Scale. The Allurion Virtual Care Suite is also available to providers separately from the Allurion Program to help customize, monitor and manage weight loss therapy for patients regardless of their treatment plan: gastric balloon, surgical, medical or nutritional. The Allurion Gastric Balloon is an investigational device in the United States.
For more information about Allurion and the Allurion Virtual Care Suite, please visit www.allurion.com
Allurion is a trademark of Allurion Technologies, Inc. in the United States and countries around the world.
About RTW
RTW Investments, LP is a global, full life-cycle investment firm and company builder that focuses on identifying transformational and disruptive innovations across the biopharmaceutical and medical technologies sectors. As a leading partner of industry and academia, RTW combines deep scientific expertise with a solution-oriented investment approach to support emerging medical therapies and the companies and/or academics developing them.
Forward-Looking Statements
This press release may contain certain forward-looking statements within the meaning of the U.S. federal and state securities laws. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions and include statements regarding the simplification of Allurion’s capital structure, availability of cash runway, operational flexibility, procedure growth, Allurion’s expectations for, and market acceptance of, the Allurion Program, and Allurion’s ability to compete with other weight loss products, improve its market position, scale its business and achieve long-term goals. Forward-looking statements are predictions, projections and other statements about future events that reflect the current beliefs and assumptions of Allurion’s management based on information currently available to them and, as a result, are subject to risks and uncertainties. Many factors could cause actual future results or developments to differ materially from the forward-looking statements in this communication, including but not limited to (i) the ability of Allurion to obtain and maintain regulatory approvals for and successfully commercialize the Allurion Program, including the Allurion Balloon and the Allurion Virtual Care Suite (“VCS”), (ii) the timing of, and results from, our clinical studies and trials, (iii) the evolution of the markets in which Allurion competes, (iv) the ability of Allurion to defend its intellectual property, (v) the impact of the COVID-19 pandemic, the Russia and Ukraine war, and the Israel-Hamas conflict on Allurion’s business, (vi) Allurion’s expectations regarding its market opportunities, including those for the VCS platform, (vii) the risk of economic downturns and a changing regulatory landscape in the highly competitive industry in which Allurion operates, and (viii) the ability of Allurion to comply with the covenants and terms and conditions of the note purchase agreement. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of Allurion’s Annual Report on Form 10-K filed on March 26, 2024 and other documents filed by Allurion from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Allurion assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Allurion does not give any assurance that it will achieve its expectations.
VENT-02 demonstrated robust pharmacodynamic modulation, a broad therapeutic index, and potential for once-daily dosing
VENT-02 provided full target coverage with a single dose
No dose-limiting toxicities or serious adverse events observed
Initiation of clinical trials in CNS diseases expected beginning in the second half of 2024
WALTHAM, Mass. & MONTREAL–(BUSINESS WIRE)–Ventus Therapeutics, a clinical-stage biopharmaceutical company utilizing its proprietary structural biology and computational chemistry platform, ReSOLVE™, to develop differentiated small molecule therapeutics, today announced results from its Phase 1 clinical trial of VENT-02, a novel, oral, brain-penetrant NLRP3 inhibitor. The Phase 1 trial evaluated the pharmacodynamics, pharmacokinetics, safety, and tolerability of VENT-02 across a broad range of single and multiple ascending doses in adult healthy volunteers.
“We are pleased with the results of this trial in which VENT-02 demonstrated a broad therapeutic index and complete target coverage, underscoring its potential to treat diseases of the CNS as well as peripheral diseases with high unmet needs,” said Xavier Valencia, M.D., Head of Clinical Development at Ventus. “Our next trial for VENT-02, a Phase 1b trial in patients with Parkinson’s disease, will evaluate multiple doses and dose regimens against a placebo control and assess a collection of markers that map multiple components of inflammation to disease activity. Based on the promising pharmacodynamic and safety data from this Phase 1 trial and our clinical development plans, we believe VENT-02 is poised to demonstrate best-in-class potential.”
In this Phase 1 clinical trial, VENT-02 was well-tolerated, with no dose-limiting toxicities or serious adverse events reported and only mild or moderate treatment-related adverse events observed. The moderate adverse events included headache and nausea and were only observed at a dose multiple times higher than the intended therapeutic doses.
VENT-02 demonstrated full target engagement through 100% inhibition of IL-1ß in the blood in an ex vivo whole blood challenge assay, significant drug levels in the CSF for 24 hours, and robust reduction of inflammatory biomarkers such as hsCRP. Based on the half-life and target coverage observed in the trial, VENT-02 has demonstrated the potential for once-daily dosing.
“The excellent properties of VENT-02 are a reflection of Ventus’ industry-leading exploration of NLRP3, including demonstrating proof-of-concept in preclinical studies in multiple disease-relevant models, validating biomarkers, and collaborating with academic institutions and the Michael J. Fox Foundation,” said Ventus President and CEO, Marcelo Bigal, M.D., Ph.D. “As a result, we are ready to bring VENT-02 into Parkinson’s disease and other pre-defined diseases where the CNS plays an important role, capitalizing on innovative trials that we are crafting to be informative in reducing risk in the future steps of clinical development. In addition, we expect that our planned trials will allow us to explore the potential impact of NLRP3 inhibition across multiple patient populations suffering from serious diseases.”
Ventus expects to initiate a Phase 1b trial of VENT-02 in patients with Parkinson’s disease in the second half of 2024 and a Phase 2 trial in patients with treatment-refractory epilepsy in 2025.
About NLRP3
NLRP3 is the best understood member of a family of proteins known as inflammasomes. Inflammasomes are multiprotein complexes that regulate the innate immune system and are involved in intracellular surveillance of danger and pathogen signals that trigger an intense inflammatory response, including the release of IL-1β and IL-18 and the induction of pyroptosis, an inflammatory form of cell death. Therapeutic inhibition of NLRP3 can prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL-18 as well as pyroptosis. Aberrant activation of the NLRP3 inflammasome has been associated with systemic conditions, including fibrotic, dermatological, and rheumatological diseases, and is a key driver of disease pathology in several neurological disorders, including Parkinson’s disease, Alzheimer’s disease, and treatment-refractory epilepsy.
About Ventus Therapeutics
Ventus Therapeutics is a clinical-stage biopharmaceutical company deploying deep protein science expertise and a proprietary computational chemistry platform to develop novel small molecule therapeutics for immunology, inflammation, and neurology disorders. Using its proprietary drug discovery platform, ReSOLVE™, the company screened its first target in 2020, selected three development candidates in 2022, and advanced its two wholly-owned product candidates into the clinic in 2023: VENT-03, a potent, selective, oral cGAS inhibitor in Phase 1, and VENT-02, a potent, brain-penetrant, oral NLRP3 inhibitor in Phase 1. In addition, Ventus has out-licensed VENT-01, a peripherally-restricted NLRP3 inhibitor, to Novo Nordisk A/S. These programs exemplify Ventus’ robust discovery capabilities and focus on differentiated programs for multi-indication immunology and neurology targets. For more information, please visit www.ventustx.com and engage with Ventus on LinkedIn.
Forward-Looking Statements
This press release contains forward-looking statements. These statements involve known and unknown risks, uncertainties, and other important factors that may cause Ventus’ actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential,” or “continue” or the negative of these terms or other similar expressions. All statements other than statements of historical facts contained in this press release are forward-looking statements, including statements regarding the timing, progress, and results of Ventus’ clinical trials, the anticipated timing of initiation and completion of trials, the period during which the results of the trials will become available, and Ventus’ development plans. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond Ventus’ control, you should not rely on these forward-looking statements as predictions of future events. Such risks include, but are not limited to, the risk that Ventus is unable to further advance VENT-02 and VENT-03 in clinical development, obtain regulatory approval, and ultimately commercialize VENT-02 and VENT-03, or experience significant delays in doing so; that Ventus will require substantial additional funding to finance its operations; that the development and commercialization of pharmaceutical products is subject to extensive regulation, and the regulatory approval processes of the U.S. Food and Drug Administration and comparable foreign authorities are lengthy, time-consuming, and inherently unpredictable; and that Ventus’ success depends on its, its current and future licensors’, and its exclusive licensees’ ability to obtain, maintain, enforce, and protect its intellectual property and its proprietary technologies. Forward-looking statements included herein are based upon information available to Ventus as of the date of this press release, and while Ventus believes such information forms a reasonable basis for such statements, such information may be limited or incomplete, and Ventus’ statements should not be read to indicate that it has conducted an exhaustive inquiry into, or review of, all potentially available relevant information. The events and circumstances reflected in the forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. Except as required by applicable law, Ventus does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances, or otherwise.
Oxford, UK April 17th, 2024. Theolytics, a biotechnology company developing next-generation oncolytic viral therapies, today announced it has successfully closed its latest financing round, raising a total of £19M ($24.5M) with the addition of Sound Bioventures as a new investor. Sound Bioventures joins a strong international syndicate of existing investors participating in the round that includes M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises and the University of Oxford.
The proceeds from this financing round further strengthen the company’s position as it advances its lead oncolytic adenovirus – THEO-260 – into clinical trials in ovarian cancer. The first trials are planned for this year and will aim to demonstrate safe, effective administration, and provide insight to the candidate’s dual cancer/cancer-associated fibroblast-killing and immunomodulatory mechanism of action when administered by intravenous or intraperitoneal routes in platinum-resistant ovarian cancer patients.
Following this investment, Thomas Tan, Principal at Sound Bioventures, will join Theolytics’ Board of Directors.
Charlotte Casebourne Stock, Chief Executive Officer of Theolytics, said; “We’re on the brink of a potential step-change for the oncolytic adenovirus field. Our lead asset THEO-260 will be entering the clinic this year, and at this key juncture we are pleased to complete this significant financing and welcome Sound Bioventures as a new investor alongside our existing investors. Sound Bioventures’ extensive oncology experience, network, operational expertise and collaborative approach will bring important benefits to Theolytics and I am delighted to welcome Thomas Tan to our Board.”
Thomas Tan, Principal at Sound Bioventures, added; “The oncolytic virus modality is rapidly evolving, and we believe that Theolytics is well positioned at the forefront of this exciting therapy area. With THEO-260 about to enter the clinic, we see a significant opportunity to help bring an important and potentially practice-changing therapy to the many women suffering from this fatal disease. I look forward to working with the Board and management team bringing our hands-on approach to support the company’s unwavering fight against cancer.”
“THEO-260 has the potential to bring a much-needed new therapy to ovarian cancer patients and their families that are impacted by this devastating disease,” said Mike Grey, Executive Chair of the Board. “Theolytics is at a pivotal point as it approaches its first clinical trial and we are delighted to welcome Sound Bioventures, a highly knowledgeable and experienced investor with extensive oncology and company building expertise, to our group of leading international investors.”
About Ovarian Cancer (OC)
It is estimated that around 7,500 women in the UK and 20,000 women in the US will be diagnosed with ovarian cancer in 2024. More than 75% of cases will be diagnosed at an advanced stage (grade-III/IV) with less than 25% of patients expected to survive for more than five years.
Standard-of-care, first-line treatments combine cytoreductive-surgery, platinum-based chemotherapies, and paclitaxel. Although initially effective, more than 70% of patients relapse within three years and become resistant to platinum-based therapies. There are no effective treatments for platinum-resistant OC and at this point patients have a life-expectancy of less than 12 months.
About THEO-260
THEO-260 is a next-generation oncolytic adenovirus for the treatment of (platinum-resistant) ovarian cancer. It is highly efficacious in killing cancer cells and cancer-associated fibroblasts in ovarian cancer patient tumour samples. The destruction of cancer-associated fibroblasts, in addition to cancer cells, is a potentially differentiating feature of THEO-260 as cancer-associated fibroblasts in stromal-rich tumours are a barrier to the effectiveness of many cancer treatments. THEO-260 is being explored as a therapeutic for intravenous and intraperitoneal delivery.
About Theolytics
Theolytics is working to develop next-generation oncolytic viral therapies. The company has pioneered a new approach to develop efficacious, targeted candidates suitable for systemic intravenous delivery.
The company is focused on the advancement of its lead program THEO-260 into the clinic with the ambition of providing better outcomes for patients with ovarian cancer, for whom current treatment options are limited. Additional pipeline programmes in preclinical development include novel candidates developed for colorectal cancer and hematological malignancies where there remains significant unmet need.
Theolytics, which was founded in 2017 and is headquartered in Oxford, UK, is backed by international life sciences investors M Ventures, Taiho Ventures, Epidarex Capital, Oxford Science Enterprises, Sound Bioventures and the University of Oxford.
Medincell will receive an upfront payment of $35 million and is eligible for up to $1.9 billion in potential development and commercial milestones, plus royalties on worldwide sales.
Medincell and AbbVie will co-develop, and AbbVie will commercialize up to six cutting-edge long-acting injectables (LAI).
The first LAI program candidate has been selected and formulation activities are underway.
This pivotal alliance leverages Medincell’s commercial-stage LAI technology and development know-how, and AbbVie’s extensive clinical development and commercialization expertise, to deliver innovative therapeutic solutions to patients globally.
MONTPELLIER, France–(BUSINESS WIRE)–Medincell (Paris:MEDCL) today announced a collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials. AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization.
Christophe Douat, Medincell’s CEO said: “This will be an exciting partnership with one of the most innovative and successful pharmaceutical companies. Medincell has entered a new period of growth following the FDA approval of the first product using our technology in April 2023. The full potential of long-acting injectable therapies is getting increasingly recognized.”
Sébastien Enault, Medincell’s Chief Business Officer added: “Our business development is accelerating following FDA approval of our first product. Our technology can help harvest the full potential of many known or yet untapped drugs. We are ready to make this exciting partnership very successful.”
Under the terms of the co-development and licensing agreement covering up to 6 programs, Medincell will receive a $35 million upfront payment and is eligible to receive up to $1.9 billion in development and commercial milestones ($315 million for each program). Medincell is also eligible to receive mid-single to low-double-digit royalties on net sales.
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.
UZED® and SteadyTeq™ are trademarks of Teva Pharmaceuticals
A public-private consortium formed by the biotech company Hemostatics, located in the Barcelona science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ) will accelerate the development of a next generation drug to tackle severe haemorrhagic processes, such as those associated with major surgery, trauma or intracranial haemorrhage, without effective treatment.
The aim of the consortium, which has obtained €2.5 M from the Spanish Research Agency, is to reach the clinical phase of the antifibrinolytic agent CM-352, a drug with a revolutionary therapeutic approach in this field. Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds.
According to SEMICYUC, haemorrhage accounts for 50% of deaths within 24 hours of traumatic injury, and of up to 80% of intra-operative trauma mortality. It is a very common complication in clinical situations, such as surgeries, and in cardiovascular patients and patients with certain rare genetic diseases. WHO also warns that postpartum haemorrhage (PPH) affects 14 million women each year and is the world’s leading cause of maternal death.
Barcelona, 20 March 2024. A public-private consortium formed by the biotech Hemostatics, based at the Barcelona Science Park, the Clínica Universidad de Navarra (CUN) and the Institute of Chemical Research of Catalonia (ICIQ), has received 2.5 million euros from the Spanish Research Agency (AEI), under the call for grants for Public-Private Collaboration Projects, to accelerate the development of an innovative treatment aimed at controlling disabling and lethal haemorrhage.
The aim of the project, led by Hemostatics – a spin-off from Cima Universidad de Navarra, attached to the CUN – is the preclinical and clinical development of the antifibrinolytic agent CM-352, a first-in-class drug that represents a pioneering therapeutic approach to control severe bleeding in unmet medical needs, such as those associated with major surgery, trauma or intracranial haemorrhage (ICH).
The CM-352 compound is the result of a long research process led by Dr. Josune Orbe (CSO of Hemostatics), head of the CIMA’s Atherothrombosis research group, and Dr. José Antonio Páramo (CMO) of the Hematology Service of the Clínica Universidad de Navarra and member of the Spanish Society of Thrombosis and Haemostasis (SETH).
Based on a technology transfer and exclusive patent licensing agreement, Hemostatics was born in 2020, promoted by CIMA and a team of experts from the health and business sector, led by Dr. Orbe, Dr. Páramo and Nicolas Saglio, CEO of Hemostatics and managing partner at biomedical innovation consultancy HealthTech180, with more than 20 years’ experience in strategic consulting and innovation for technology and healthcare companies.
Until now, the total capital raised to develop the compound amounts to €3M, including €0,3 M from the CDTI’s Neotec programme received in 2022, plus other private funds.
A global health and economic issue
Haemorrhage accounts for up to 50% of trauma deaths occurring worldwide within 24 hours of traumatic injury, according to SEMICYUC-Spanish Society of Intensive and Critical Care Medicine and Coronary Units, and up to 80% of intraoperative trauma mortality. It is a very common complication in cardiovascular patients, or patients with certain rare genetic diseases, as well as in different clinical situations, such as surgeries, or postpartum haemorrhage, which is estimated to affect 14 million women each year and represents the world’s leading cause of maternal death, according to WHO, with some 70,000 deaths annually.
“The socio-economic cost of acute bleeding in trauma cases alone is enormous and causes more than 6 million deaths per year (more than all communicable diseases combined, including COVID-19, malaria, tuberculosis, HIV/AIDS, etc.), and is responsible for a total cost of over $670 billion in the United States alone. However, an antihaemorrhagic agent, that can address the unmet medical needs of severe haemorrhagic processes and minimise the risk of possible side effects in the face of less severe haemorrhagic episodes, has not yet been found,” reveals Nicolas Saglio. “Our compound, CM-352, in addition to reducing this major burden of morbidity and mortality, will significantly reduce the healthcare cost of annual expenditure on blood and transfusion-related activities”.
Public-private partnership to create a next generation antifibrinolytic
CM-352 is a drug with a completely innovative mechanism of action, as it targets cessation of bleeding by inhibiting matrix metalloproteinases (MMPs), a revolutionary pharmacological strategy that promises to be more effective and safer than the current standard antifibrinolytics (TXA and EACA) used in clinical practice to control acute bleeding.
The regulatory preclinical phase will be coordinated by Hemostatics Pharmaceuticals and will involve the integration of the efforts of the Atherothrombosis Research Group (CIMA), led by Dr. Josune Orbe.
“We already have experimental results indicating that CM-352 is highly effective in all major bleeding scenarios, with no signs of toxicity, thrombosis, or off-target adverse effects. We will now complete efficacy, toxicity, pharmacodynamic and pharmacokinetic studies in several preclinical models required by regulatory agencies. Obtaining these results will allow us to reach a key milestone of the project: approval from the health authorities to test CM-352 in a phase I clinical trial. Our initial focus will be on the US FDA. Subsequently, we will also go to the EMA in Europe, and everything will be done in close collaboration with the Spanish agency, the AEMPS,” Saglio explains.
Through the Innovation and Valorisation Laboratory and the High Throughput Experimentation (HTE Laboratory), the ICIQ will address the identification and optimisation of a CM-352 synthesis route that improves the efficiency and reduces the cost of the production process of the molecule. The team involved in the project will be led by Dr. Fernando Bravo, manager of the Knowledge and Technology Transfer Department (KTT) and Industrial Projects, and Dr. Xisco Caldentey, manager of HTE.
“The current synthesis route of CM-352 has enabled us to obtain sufficient compound quantities to progress through the preclinical phases, and ICIQ’s involvement will focus on developing a synthetic process with a new optimised synthesis route, which also allows for robust, reproducible scaling with safety guarantees. This objective will be addressed through a combination of intelligent catalyst design and high-performance parallelisation techniques for reaction optimisation. In this regard, techniques involving the screening of hundreds of reactions using automated analysis systems will be applied, such as the one available at ICIQ’s HTE Laboratory, a unique facility in Spain, with few similar models worldwide. The selection of the final synthetic route for obtaining CM-352 will be based on techno-economic criteria (cost/kg), including the relative cost of purification processes, efficiency, safety, and minimization of environmental impact, thereby facilitating its future industrialization and commercialization”, says Dr. Bravo.
Finally, the CM-352 phase I trial will involve the active participation of CUN, with technical support from CIMA and will focus on severe haemorrhage in traumatology, where there is no treatment with proven clinical efficacy. The study will be carried out by the Haemostasis and Thrombosis Unit of the Haematology Department and the Department of Orthopaedic Surgery, under the coordination of Dr. José Antonio Páramo.
“Our objective will be to evaluate the tolerance and safety of CM-352 in patients undergoing scheduled total knee replacement surgery (total knee arthroplasty) to prevent possible hemorrhagic complications, which constitute a serious associated adverse event. This represents a very important milestone in the compound’s development since, in existing literature, no clinical study has reported the use of MMP inhibitors to treat hemorrhages. The absence of toxicity and secondary effects after treatment with CM-352 will also represent the first time such results are obtained for an MMP inhibitor in humans, allowing us to move to a Phase II focused on severe hemorrhages in traumatology, where there is currently no treatment with proven clinical efficacy”, noted Dr. Páramo.
About Hemostatics Pharmaceuticals
Hemostatics Pharmaceuticals S.L.(https://hemostatics.com/) is a biotechnology company created in 2020 by a highly experienced team that set up a strategic partnership and exclusive licence for the technology with the Foundation for Applied Medical Research (FIMA), which manages CIMA, the Centre for Applied Medical Research of the Clínica Universidad de Navarra (CUN). Hemostatics is developing a new proprietary antifibrinolytic agent, CM-352, to reduce bleeding in disabling and life-threatening haemorrhagic conditions and address a number of important unmet medical needs in trauma, surgery, intracranial haemorrhage (ICH), postpartum haemorrhage (PPH) and gastrointestinal bleeding.
About Clínica Universidad de Navarra (CUN)
With more than 2,800 full-time professionals at its Pamplona and Madrid sites, Clínica Universidad de Navarra (https://www.cun.es/) is an academic hospital and a benchmark in personalised medicine in Spain. Recognised for its research and teaching work, the prestige of its professionals and its experience in the diagnosis and treatment of highly complex pathologies, Clínica Universidad de Navarra is a hospital that produces results through speedy diagnoses, thanks to its multidisciplinary work and acquisition of the latest technology, that allow it to offer care in 46 medical and surgical specialities. Clínica Universidad de Navarra is among the world’s 50 best hospitals, according to the World’s Best Hospitals ranking, and among the 35 best oncology hospitals worldwide according to the World’s Best Specialized Hospitals ranking. For the sixth consecutive year, it has been the private hospital with the best reputation in Spain (according to the MRS ranking).
About the Institute of Chemical Research of Catalonia (ICIQ)
The Institute of Chemical Research of Catalonia (https://www.iciq.org/) is a research centre dedicated to advancing scientific knowledge to address social and economic challenges such as climate change and the sustainable supply of raw materials and energy. It has two Severo Ochoa accreditations as a centre of excellence, which underline its recognition as an international benchmark in frontier chemical research. The ICIQ’s research is based on three pillars: sustainable catalysis, renewable energies and health. Also noteworthy are the lines of collaboration with industry, transferring knowledge and promoting the development of innovative applications, with a special focus on patents and spin-offs.
Project CPP2022-009643 funded by:
For further information:
Azucena Berea • Press Officer • Barcelona Science Park • +34 93 403 46 62 • aberea@pcb.ub.es
Miguel García San Emeterio • Media Director • Clínica Universidad de Navarra • +34 948 255 400 • mgsanemeterio@unav.es
KYinno is a leading preclinical contract research organization (CRO) dedicated to providing tailored solutions in in vitro and in vivo pharmacology, cell line engineering, therapeutic target identification, and antibody discovery. Leveraging our proprietary assets, including over 3000 engineered cell lines, innovative bispecific and tri-specific antibody discovery mouse models, the comprehensive MPSA-AB5000 panel with screening capabilities for 5000 antibody specificities, and the cutting-edge KY-AITM antibody development artificial intelligence platform, we empower our clients to accelerate their research and development endeavors.
Located at F2 Building, Yizhuang Biomedical Park, No. 88, Kechuang Six Street, Beijing, P.R. China, 101111, and 204 Second Avenue, Waltham, MA 02451, USA, KYinno operates globally to serve the diverse needs of the biotechnology and pharmaceutical industries. Our team consists of highly skilled professionals committed to delivering exceptional results and exceeding expectations.
At KYinno, we are dedicated to advancing scientific discovery and therapeutic innovation. Learn more about how we can collaborate with you to achieve your research goals by visiting our website at www.kyinno.com.
KYinno – preclinical CRO – contract research organization – in vitro pharmacology – in vivo pharmacology – cell line engineering – therapeutic target identification – antibody discovery – engineered cell lines – bispecific antibodies – trispecific antibodies – antibody screening – antibody specificity screening – MPSA-AB5000 panel – KY-AITM antibody development platform – artificial intelligence platform
ADELAIDE, Australia–(BUSINESS WIRE)–Australian biotech company Ferronova has announced the initiation of a clinical trial of the company’s FerroTrace® nanoparticle technology in patients with gastric and oesophageal cancers. It follows the completion of a first-in-human trial in 2020-2022 in oral cancer patients.
The MAGMAP trial will enrol 60 patients and commenced today with the first patient at the Royal Adelaide Hospital, to be followed by Flinders Medical Centre and Queen Elizabeth Hospital in South Australia, and then expanding to the Peter MacCallum Cancer Centre and Austin Hospital/Olivia Newton John Cancer Centre in Victoria. Trial imaging is supported by the South Australian Health and Medical Research Institute (SAHMRI) and the National Imaging Facility.
The MAGMAP trial (Clinicaltrials.gov ID: NCT05899985) is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of FerroTrace® for mapping high-risk lymph nodes in subjects.
Ferronova Chief Executive Officer Mr Stewart Bartlett said it is potentially an important study offering the promise of an innovative approach for identifying and assessing lymph nodes at high risk of containing cancer.
“Gastric, gastric-oesophageal junction, and oesophageal cancers have very poor outcomes, even where the tumour is localised to a primary location and surrounding lymph nodes where surgery is intended to be curative, and this trial is an important step to test whether our novel technology can improve outcomes in this group of patients.”
Studies show following surgery, the 5-year relative survival rates for localised gastric and oesophageal cancers are approximately 74.7% and 48.5% respectively. Where the cancer has also spread to lymph nodes, the 5-year relative survival is only 34.6% and 27.7% [1][2].
Ferronova’s FerroTrace® product is a super-paramagnetic iron oxide nanoparticle targeting CD206 receptors found in lymph nodes. It offers a unique targeting mechanism designed to enable a longer lymph node retention time allowing the use of MRI and a handheld surgical magnetic detector to identify and assess lymph nodes containing FerroTrace®.”
Principal Investigator, Dr Markus Trochsler said the trial will investigate the feasibility of mapping lymph nodes directly draining a primary tumour which theoretically have the highest risk of containing metastasis.
“Gastric and oesophageal cancers are difficult to treat due to unpredictable and extensive lymphatic drainage network in this area of the body, which means lymph nodes containing cancer could potentially be found anywhere from the neck down to the abdomen. At present, when these metastases are very small, they cannot be detected with current imaging technology” Dr Trochsler said.
“This pilot study may lead to providing us with another alternative, being a more informed treatment plan. We are testing whether nanoparticles can identify lymph nodes which are at high-risk of containing cancer cells. It will support us to progress to larger randomised trials where we will investigate tailoring our treatment approach based on the identification and position of these nodes.”
Mr Bartlett said the study enrolment is predicted to take 12-15 months, and he hoped the results will lead to new methods of treating patients facing uncertain outcomes.
“The enrolment of the first patient is an important milestone for Ferronova,” Mr Bartlett said.
“We are incredibly thankful for the investigators and their support teams, led by Dr Trochsler, as well as Associate Professor Kanhere at the RAH, Professor Watson and Dr Bright at Flinders, Dr Liu at the Austin and Peter Mac, and Dr Dwyer at SAHMRI. They have all put in an incredible amount of work and planning to design and initiate this trial. We look forward to seeing the results when the trial is complete.”
About Ferronova
Ferronova is an Australian biotechnology company headquartered in Adelaide, South Australia. Shareholders include Renew Pharmaceuticals Limited, Uniseed, the University of South Australia, Artesian Venture Partners and the South Australian Venture Capital Fund (SAVCF), Powerhouse Ventures, the University of Wellington in New Zealand, the University of Sydney, PAN Ventures, Australian Unity, and ex-Macquarie Bank executive Allan Moss. Grant assistance has been provided by the SA Government since 2016 and the Federal Government’s BioMedTech Horizons Program, operated by MTPConnect. In 2023, Ferronova was awarded an Australian Government CRC-P grant to progress a nanoparticle formulation through to a Phase 1b brain cancer clinical trial. For more information go to: www.ferronova.com.au
LIVERMORE, Calif.–(BUSINESS WIRE)–S2 Genomics, a pioneer in tissue sample preparation systems, today announced the launch of its latest product, the Singulator™ 200+ System, an automated sample prep isolation system for single cell formalin-fixed, paraffin-embedded (FFPE) tissues. This cutting-edge solution addresses an unmet need in the market by automating sample preparation for the first time, offering a faster, more accurate, more efficient process for researchers and manufacturers.
The new FFPE sample prep isolation system is designed to isolate nuclei from FFPE tissue slices, enabling single-nucleus RNA sequencing (snRNA-Seq) for FFPE samples. This advancement is a game-changer for cancer-focused researchers who require precise and reliable sample preparation to drive forward their research and development efforts.
Jonathan Schimmel, President and CEO of S2 Genomics, expressed his enthusiasm for the new product: “The FFPE sample prep isolation system is a testament to our commitment to continuing innovation and excellence in the field of single cell genomics. By automating what was once a manual and time-consuming process, we are empowering researchers to conduct their work more effectively and efficiently than ever before.”
The introduction of the FFPE sample prep isolation product is expected to have a profound impact on the field of oncology research, where the quality and speed of sample preparation are crucial for the success of genomic assays.
Earlier this year, S2 Genomics announced that it had raised $16 million in Series A funding to accelerate commercial adoption of its benchtop Singulator platform, which uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions.
For more information about the FFPE sample prep isolation system and other S2 Genomics products, please visit us at s2genomics.com or connect with us on LinkedIn or Twitter.
About S2 Genomics: S2 Genomics, Inc. is a leader in the field of tissue sample preparation for single-cell genomics assays. The company’s innovative Singulator platform uses single-use cartridges to enable reproducible, rapid, and automated tissue dissociations into single cell or nuclei suspensions, advancing research in neuroscience and oncology.
[For Research Use Only, Not for Diagnostic Procedures]
