Booster Therapeutics Launches to Pioneer New Class of Proteasome Activator Medicines for the Treatment of a Range of Complex Diseases

  • $15 million seed financing led by Apollo Health Ventures and Novo Holdings
  • New approach aims to expand the ability of therapeutics to degrade harmful proteins in the body
  • Booster small molecules re-activate cellular ‘quality control’ machinery of proteasomes, which is impaired in complex diseases
  • Dr. Patrick Trojer appointed as Chair of the Board of Directors

BERLIN–(BUSINESS WIRE)–Booster Therapeutics, a biotechnology company pioneering a new class of proteasome activator medicines to treat neurodegenerative and other diseases, launched today with the support of a $15 million financing led by noted life sciences investors Apollo Health Ventures and Novo Holdings. Booster was founded by Dr. Diogo Feleciano, Prof. Dr. Darci Trader, and Apollo Health Ventures, emerging from Apollo’s company creation investment strategy. The company is developing small molecule therapeutics that boost the innate activity of proteasomes to restore the body’s ability to remove a wide range of disease-causing proteins.


“Proteasome activation offers important advantages over more limited conventional protein degradation approaches and provides a powerful lever to combat the effects of the many types of deviant proteins that can accumulate in cells when proteasome function declines through age or disease. The implications for solving major degenerative conditions, such as Parkinson’s and Alzheimer’s, are enormous,” said Dr. Diogo Feleciano, Co-Founder and Chief Scientific Officer. “We’re grateful for the support of our investors, who have enabled us to assemble a world-class team to realize the untapped potential of proteasome activation against a range of difficult-to-treat diseases.”

Proteasomes, the cell’s natural quality control machinery, play a critical role in removing damaged or misfolded proteins. When their function is impaired, misfolded proteins accumulate and increase the risk of serious disease. Booster’s approach is a departure from current targeted protein degradation methods, which tag single disease proteins with the marker protein ubiquitin, leading to their degradation via 26S proteasomes. This can be effective, particularly in diseases driven by a single errant protein. But complex diseases are often driven by multiple protein dysfunctions. To achieve more widespread degradation of unwanted proteins, Booster’s compounds directly activate 20S proteasomes, which naturally recognize disordered proteins without the need for ubiquitin tagging.

“Booster exploits the cell’s universal protein surveillance machinery to drive restoration of protein homeostasis in various disease contexts,” said Dr. Patrick Trojer, Chair of Booster’s Board of Directors and Chief Executive Officer of TRIANA Biomedicines. “The application potential of this therapeutic frontier is highly attractive, and given the broad-spectrum activity of proteasome activators, we see opportunities for both monotherapy and combination approaches where increased proteasome activity may enhance the efficacy of other therapeutics.”

Booster is discovering small molecules through its DGRADX™ platform, which combines proprietary methods for automated high-throughput screening with advanced structural and computational tools. The company has built an extensive library of activator compounds with therapeutic potential and aims to develop a multi-disease pipeline to address proteinopathies.

“Emerging from Apollo’s company creation engine, Booster has made remarkable strides in pioneering this exciting new field of medicine. Booster’s focus on activating the 20S proteasome directly addresses a critical mechanism involved in the cellular stress of aging, offering us a new therapeutic perspective on major disease areas,” said Dr. Marianne Mertens, Partner at Apollo, Managing Director, and Board Member of Booster Therapeutics. “We look forward to working with the team and the strong syndicate to advance toward proof-of-concept and develop a pipeline of potential first-in-class medicines.”

“The pioneering work of Prof. Trader and Dr. Feleciano completely transformed our approach to protein degradation in proteinopathies. Booster’s data support the ability of the 20S proteasome to safely, effectively and specifically degrade a wider set of pathological proteins.” said Dr. João Ribas, Principal at Novo Holdings, Seed Investments and Interim Chief Business Officer and Board Member, Booster Therapeutics. “Proteinopathy is core to many of the most challenging complex diseases, so the potential to address them with a single agent is incredibly promising and could reshape the treatment landscape. We’re excited to join Apollo and help advance this novel therapeutic concept to the clinic.”

About Booster Therapeutics

Booster Therapeutics is pioneering a new class of medicines that activate the cell’s natural quality control machinery to treat a range of complex indications. Booster’s small molecule therapeutics, discovered through the DGRADX™ platform, are designed to directly boost the activity of 20S proteasomes to restore the body’s ability to clear disease-causing proteins. The company is developing a multi-disease pipeline, with an initial focus on neurodegenerative diseases associated with impaired proteasome function such as Parkinson’s disease and Alzheimer’s disease. Booster is based in Berlin, Germany. For more information, visit www.boostertx.com.

About Apollo Health Ventures

Apollo Health Ventures is a transatlantic venture capital firm specialized in developing and investing in data-driven biotechnology and health tech ventures. Apollo Health Ventures invests in game-changing companies at the seed or early stage and builds companies within the aging sector. Apollo’s team consists of entrepreneurs, seasoned biotech investors and scientists with remarkable track records in life science investments and venture creation. www.apollo.vc

About Novo Holdings

Novo Holdings is a holding and investment company that is responsible for managing the assets and the wealth of the Novo Nordisk Foundation. The purpose of Novo Holdings is to improve people’s health and the sustainability of society and the planet by generating attractive long-term returns on the assets of the Novo Nordisk Foundation.

Wholly owned by the Novo Nordisk Foundation, Novo Holdings is the controlling shareholder of Novo Nordisk A/S and Novonesis A/S and manages an investment portfolio with a long-term return perspective. Novo Holdings is a world-leading life sciences investor. Through its Seed, Venture, Growth, Principal Investments, Planetary Health Investments and Asia teams, Novo Holdings invests directly in life science companies at all stages of development. In addition, it manages a broad portfolio of Capital Investments, including equities, bonds, fixed income, real estate, and infrastructure assets. As of year-end 2023, Novo Holdings had total assets of EUR 149 billion. www.novoholdings.dk

Contacts

Kit Rodophele

Ten Bridge Communications

617-999-9620

krodophele@tenbridgecommunications.com

GSK and CureVac to Restructure Collaboration into New Licensing Agreement

  • GSK acquires full rights to develop, manufacture and commercialize globally mRNA candidate vaccines for influenza and COVID-19, including combinations
  • CureVac receives €400 million upfront and up to an additional €1.05 billion in development, regulatory and sales milestone payments as well as tiered royalties; all previous financial considerations from the prior collaboration agreement replaced
     

London UK; TÜBINGEN, Germany/BOSTON, MA, USA July 3, 2024 – GSK plc (LSE/NYSE: GSK) and CureVac N.V. (Nasdaq: CVAC) today announced they have restructured their existing collaboration into a new licensing agreement, allowing each company to prioritize investment and focus their respective mRNA development activities.

Since 2020, GSK and CureVac have worked together to develop mRNA vaccines for infectious diseases. Through this collaboration, GSK and CureVac currently have vaccine candidates for seasonal influenza and COVID-19 in Phase 2 and avian influenza in Phase 1 clinical development. All candidates are based on CureVac’s proprietary second-generation mRNA backbone. Data generated to date for these candidate vaccines are promising and demonstrate their potential to be best-in-class new vaccines.

Under the terms of the new agreement, GSK will assume full control of developing and manufacturing these candidate vaccines. GSK will have worldwide rights to commercialise the candidate vaccines. The agreement represents the latest step in GSK’s ongoing investment in vaccine platform technologies, matching the best platform to each pathogen to develop best-in-class vaccines. mRNA is an adaptable vaccine technology with demonstrated application in emerging and constantly changing viral pathogens due to its ability to support rapid strain change. GSK continues to develop and optimize its mRNA capabilities through investments and partnerships, including in AI/ML-based sequence optimisation, nanoparticle design and manufacturing.

CureVac will receive an upfront payment of €400 million and up to an additional €1.05 billion in development, regulatory and sales milestones and tiered royalties in the high single to low teens range. The new agreement replaces all previous financial considerations from the prior collaboration agreement between GSK and CureVac. CureVac further retains exclusive rights to the additional undisclosed and preclinically validated infectious disease targets from the prior collaboration together with the freedom to independently develop and partner mRNA vaccines in any other infectious disease or other indication. CureVac’s ongoing patent litigation against Pfizer/BioNTech is unaffected by the new agreement.

Tony Wood, Chief Scientific Officer, GSK said: “We are excited about our flu/COVID-19 programs and the opportunity to develop best-in-class mRNA vaccines to change the standard of care. With this new agreement, we will apply GSK’s capabilities, partnerships and intellectual property to CureVac’s technology, to deliver these promising vaccines at pace.”

Alexander Zehnder, Chief Executive Officer, CureVac said: “The collaboration with GSK has been instrumental in developing promising, late clinical-stage vaccine candidates, leveraging our proprietary mRNA platform. This new licensing agreement puts us in a strong financial position and enables us to focus on efforts in building a strong R&D pipeline.”

Completion of the new agreement remains subject to certain antitrust and regulatory approvals and customary closing conditions.

About GSK
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com.

About CureVac
CureVac (Nasdaq: CVAC) is a pioneering multinational biotech company founded in 2000 to advance the field of messenger RNA (mRNA) technology for application in human medicine. In more than two decades of developing, optimizing, and manufacturing this versatile biological molecule for medical purposes, CureVac has introduced and refined key underlying technologies that were essential to the production of mRNA vaccines against COVID-19, and is currently laying the groundwork for application of mRNA in new therapeutic areas of major unmet need. CureVac is leveraging mRNA technology, combined with advanced omics and computational tools, to design and develop off-the-shelf and personalized cancer vaccine product candidates. It also develops programs in prophylactic vaccines and in treatments that enable the human body to produce its own therapeutic proteins. Headquartered in Tübingen, Germany, CureVac also operates sites in the Netherlands, Belgium, Switzerland, and the U.S. Further information can be found at www.curevac.com.

CureVac Media Contact
Patrick Perez, Junior Manager Public Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1831
patrick.perez@curevac.com

CureVac Investor Relations Contact
Dr. Sarah Fakih, Vice President Corporate Communications and Investor Relations
CureVac, Tübingen, Germany
T: +49 7071 9883-1298
M: +49 160 90 496949
sarah.fakih@curevac.com

 

Medigene Presents Superior TCR-T Cell Functionality by Inclusion of a Costimulatory Switch Protein

Planegg/Martinsried, May 2, 2024. Medigene AG (Medigene or the “Company”, FSE: MDG1, Prime Standard), an immuno-oncology platform company focusing on the discovery and development of T cell immunotherapies for solid tumors, presented superior T cell receptor engineered T (TCR-T) cell functionality upon combination of optimal affinity 3S (sensitive, specific and safe) TCRs with the PD1-41BB costimulatory switch protein (CSP) at the 7th International Neoantigen Summit held in Amsterdam, Netherlands from April 29 – May 1, 2024.

The presentation with the title “KRAS Mutation-Specific TCR-T Cells are Empowered for Improved Multi-Functionality & Durability by Inclusion of a Costimulatory Switch Protein” is available on Medigene’s website: https://medigene.com/science/abstracts/

Overcoming the immunosuppressive solid tumor microenvironment (TME) stands as a major hurdle for durable TCR-T therapies in patients. The PD-1/PD-L1 axis suppresses T cell activation, proliferation, survival, cytokine secretion and cytotoxicity in a TME with tumor cells that express PD-L1. The Company´s PD1-41BB CSP effectively counters this tumor self-defense mechanism against T cell attack by replacing the inhibitory signaling domain of PD-1 expressed by TCR-T cells with the activating signaling domain of 4-1BB, thereby improving TCR-T cell functionality.

“Our PD1-41BB CSP, a proprietary component of our End-to-End (E2E) Platform, provides an innovative technology that can be paired with diverse optimal affinity 3S-TCRs that target cancer-testis antigens or neoantigens generated using our high-throughput TCR discovery process,” said Dr. Selwyn Ho, Chief Executive Officer at Medigene. “Extensive in vitro assessments underscore the significant advantages of armoring and enhancing 3S-TCRs with our PD1-41BB CSP, showcasing the potential to surmount the immunosuppressive TME of solid tumors. This breakthrough combination promises enhanced and persistent efficacy of TCR-T therapies in difficult-to-treat solid tumors. The PD1-41BB CSP can be used not only to improve TCR-T therapies but also holds potential to improve functions in other cell types as well as for application in chimeric antigen receptor T cell therapies.”
“Notably, our innovative TCR discovery method allowed us to identify TCRs possessing distinctive supplementary qualities, demonstrating functionality even in absence of the CD8 co-receptor, normally an important component of immune defense.“

The data presented displayed the exceptional specificity and sensitivity of TCR-T cells co-expressing the PD1-41BB CSP with three different 3S-TCRs that recognize the mKRAS (mutant Kirsten rat sarcoma viral oncogene homologue) G12V neoantigen. This was seen by elevated interferon gamma (IFNγ) secretion, which was solely observed following TCR-T cell stimulation with mKRAS G12V-positive tumor cells but not by stimulation with any tumor or healthy cell type expressing naturally occurring wild-type KRAS protein. Each of the three 3S TCRs displayed exceptionally high sensitivity for the mKRAS G12V neoantigen, as evidenced by their response to activation by exceedingly low levels of mKRAS-G12V peptide. Coexpression of the PD1-41BB CSP strongly enhanced TCR-T cell functionality and allowed sustained cytotoxicity to be directed against 3D tumor spheroids through multiple rounds of tumor exposure, underscoring the potent anti-cancer activity of the TCR-T cells.

Finally, all three 3S TCRs exhibited excellent safety profiles. TCR-T cells expressing each of the 3S TCRs, in combination with the PD1-41BB CSP, were not activated to secrete IFNγ nor to mediate killing upon exposure to healthy cells from major tissues or organs, confirming their selective cytotoxicity towards cancer cells without toxicity for healthy tissue.

About Medigene AG

Medigene AG (FSE: MDG1) is an immuno-oncology platform company dedicated to developing differentiated T cell therapies for treatment of solid tumors. Its End-to-End Platform is built on multiple proprietary and exclusive technologies that enable the Company to generate optimal T cell receptors against both cancer testis antigens and neoantigens, armor and enhance these T cell receptors engineered (TCR) -T cells to create best-in-class, differentiated TCR-T therapies, and optimize the drug product composition for safety, efficacy and durability. The End-to-End Platform provides product candidates for both its own therapeutics pipeline and partnering. Medigene’s lead TCR-T program MDG1015 is expected to receive IND/CTA approval in the second half of 2024. For more information, please visit https://medigene.com/

About Medigene’s TCR-T Cells

T cells are at the center of Medigene’s therapeutic approaches. Medigene’s immunotherapies help activate the patient’s own defense mechanisms, and harness T cells in the battle against cancer. Medigene’s therapies arm the patient’s own T cells with tumor-specific T cell receptors (TCRs) creating TCR-modified T cells with enhanced potential to detect and efficiently kill cancer cells.
Medigene’s approach to immunotherapy is designed to overcome the patient’s tolerance of cancer cells and tumor-induced immunosuppression. By activating the patient’s T cells outside the body, genetically modifying them with tumor-specific TCRs and expanding the resultant activated TCR-T cells, patients can rapidly be given large numbers of tumor-specific T cells to fight their cancer.

About Medigene’s PD1-41BB Costimulatory Switch Protein

Checkpoint inhibition via PD-1/PD-L1 pathway:

Cells of solid tumors are sensitive to killing by activated T cells but can escape this killing activity by producing inhibitory molecules known as ‘checkpoint proteins’, such as the Programmed Death Ligand 1 (PD-L1), on their surface. When this occurs, activated T cells which express PD-1, the natural receptor for PD-L1, are inactivated. The expression of PD-L1 is an adaptive immune resistance mechanism for tumors that can help them survive and grow.

The 4-1BB (CD137) costimulatory signaling pathway:

Effective T cell immune responses to antigens typically require both a primary antigenic stimulation via the T cell receptor (TCR) and costimulatory signals. The intracellular signaling domains of the 4-1BB protein offer a well-characterized pathway to costimulation and enhanced T cell responses.

Medigene’s PD1-41BB switch receptor turns the tumor’s attempted self-defense mechanism against the tumor by substituting the inhibitory signaling domain of PD-1 with the activating signaling domain of 4-1BB. Therefore, instead of inactivating T cells, the switch receptor delivers an activating signal to TCR-T cells. PD1-41BB-modified TCR-T cells proliferate strongly in the presence of PD-L1-positive tumor cells and kill more tumor cells upon repeated exposure. Additionally, switch receptor signals enable TCR-T cells to function better with low levels of glucose or high levels of TGFß, two conditions characteristic of strongly hostile tumor microenvironments.

About KRAS

KRAS (Kirsten rat sarcoma viral oncogene homologue) belongs to the group of small so-called Guanosine-5′-triphosphate (GTP)-binding proteins, known as RAS-like GTPases. Under physiological conditions KRAS tightly regulates cell proliferation and survival.
In cancer, KRAS is found frequently altered, in a wide variety of often fatal solid cancer types like pancreatic ductal adenocarcinoma, non-small-cell lung cancer, and colorectal cancer. Mutations in the KRAS gene result in the creation of neoantigens which drive uncontrolled proliferation of cancer cells. These mutations within the KRAS gene are unique to cancer cells and absent in healthy normal tissue, making KRAS an attractive target for TCR-T therapies. T cell receptor engineered T cell therapies offer a promising approach to targeting these mutations and addressing the challenges posed by solid tumors. Unlike CAR-T cells, which require surface antigens for recognition and may have limitations in target accessibility, TCR-T cells recognize a broader range of targets including intracellular proteins like neoantigens. This unique ability makes TCR-T therapies particularly well-suited for targeting KRAS mutations and other challenging neoantigens.

This press release contains forward-looking statements representing the opinion of Medigene as of the date of this release. The actual results achieved by Medigene may differ significantly from the forward-looking statements made herein. Medigene is not bound to update any of these forward-looking statements. Medigene® is a registered trademark of Medigene AG. This trademark may be owned or licensed in select locations only.

Medigene AG

Pamela Keck
Phone: +49 89 2000 3333 01
E-mail: investor@medigene.com

In case you no longer wish to receive any information about Medigene, please inform us by e-mail (investor@medigene.com). We will then delete your address from our distribution list.

SCHOTT Pharma appoints Tobias Erfurth as Head of Investor Relations

  • Tobias Erfurth will lead Investor Relations Team starting in August 2024.
  • He brings more than 20 years of experience in finance, capital markets and investor relations.

SCHOTT Pharma, a pioneer in pharma drug containment solutions and delivery systems, today announced the appointment of Tobias Erfurth as Head of Investor Relations effective August 2024. He will strengthen and expand the Investor Relations team at SCHOTT Pharma and will report to CFO Almuth Steinkühler. “Tobias joining our finance team is a real win for SCHOTT Pharma. With his extensive expertise and DAX40 experience, we look forward to further growing SCHOTT Pharma’s presence in the capital markets and showcasing our attractive financial profile,” said Dr. Almuth Steinkühler, CFO of SCHOTT Pharma.

Tobias Erfurth has gained more than 20 years of experience in finance, capital markets and investor relations, both from corporate positions and roles in banking. In his most recent position as Head of Investor Relations at Symrise AG for over 13 years, Erfurth was responsible for managing all investor activities during the company’s development from a small cap to a member of the DAX40. Prior to that, Erfurth accompanied the IPO of Crop Energies AG and subsequently built up the investor relations department. Erfurth also has extensive experience in corporate finance and equity capital markets gained in his previous role as analyst at Dresdner Bank.

“With its convincing equity story, dynamic growth, attractive margins, SCHOTT Pharma is a true success story, and I look forward to joining the team. Together, we will continue to deepen the established relationships with investors and analysts and help key stakeholders to understand SCHOTT Pharma’s strategy and its role as a pioneer in one of the fastest growing markets of the pharma industry,” said Tobias Erfurth.

For additional news about SCHOTT Pharma please visit our media center.

About SCHOTT Pharma

Human health matters. That is why SCHOTT Pharma designs solutions grounded in science to ensure that medications are safe and easy to use for people around the world. The portfolio comprises drug containment solutions and delivery systems for injectable drugs ranging from prefillable glass and polymer syringes to cartridges, vials, and ampoules. Every day, a team of over 4,600 people from over 60 nations works at SCHOTT Pharma to contribute to global healthcare. The company is represented in all main pharmaceutical hubs with 16 manufacturing sites in Europe, North and South America, and Asia. With over 1,000 patents and technologies developed in-house and a state-of-the-art R&D center in Switzerland, the company is focused on developing innovations for the future. SCHOTT Pharma AG & Co. KGaA is headquartered in Mainz, Germany and listed on the Frankfurt Stock Exchange as part of the SDAX. It is part of SCHOTT AG, which is owned by the Carl Zeiss Foundation. In light of this spirit, SCHOTT Pharma is committed to sustainable development for society and the environment and has the strategic goal of becoming climate-neutral by 2030. Currently, SCHOTT Pharma has over 1,800 customers including the top 30 leading pharma manufacturers for injectable drugs and generated revenue of EUR 899 million in the fiscal year 2023.

 

Press contact

Joana Kornblum

Media Relations

Tel.: +49 151/29223552

E-Mail: joana.kornblum@schott.com

Investor contact

Jasko Terzic, CFA

Senior Manager Investor Relations

E-Mail: ir.pharma@schott.com

 

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Protembis Announces Completion of € 30 Million Series B Financing Round and the Addition of Keith D Dawkins MD to the Board of Directors

AACHEN, Germany–(BUSINESS WIRE)–#CerebralProtection–Protembis GmbH (Protembis), a privately-held emerging cardiovascular medical device company, announced today the completion of a € 30 million Series B financing round to support the enrollment of the PROTEMBO Investigational Device Exemption (IDE) Pivotal Trial (NCT05873816). The funding round was structured in two separate capital increases which have both been completed. It was co-led by a European consortium of VC investors including Sweden-based Segulah Medical Acceleration, Italy-based XGEN Venture, and Germany-based TechVision Fund. Other investors include Coparion, several large family offices, angel investors and a multinational medical device strategic.

“We are delighted to announce the completion of the round and would like to thank our existing investors as well as the new investors for their trust and confidence,” said Karl von Mangoldt and Conrad Rasmus Co-CEOs of Protembis. “It reflects the fact that the field of cerebral embolic protection is buoyant, and that future growth will be driven by younger and lower risk patients who have zero tolerance for brain injury risk when selecting to undergo transcatheter aortic valve replacement.”

Additionally, Protembis is proud to announce the addition of Keith D. Dawkins, MD, to the Board of Directors. Dr Dawkins has more than 35 years’ experience in the cardiovascular environment. With over 20 years as a practicing interventional cardiologist in the UK he has held research roles as a Fulbright Scholar at Stanford University, served as President of the British Cardiovascular Intervention Society, and authored more than 750 academic publications and presentations. Dr Dawkins has been the Chief Medical Officer (CMO) of Shockwave (NASDAQ:SWAV) since 2019, and this was preceded by his role as Global CMO at Boston Scientific where he held senior positions since 2008. He also serves as a member of the boards of Ventric Health LLC and JenaValve Technology Inc., as well as Chairman of InnovHeart s.r.l. Dr Dawkins will contribute his significant expertise to the clinical strategies of Protembis and the pre-commercial programs as the IDE study reaches its conclusion.

“To have such a visionary leader as Dr Dawkins join our Board of Directors is an exciting indication of the opportunities that cerebral embolic protection holds for future transcatheter therapies. We look forward to close collaboration as the field develops and our superiority trial gains momentum,” said Azin Parhizgar, PhD, Chairwoman of the Board of Directors.

“As a long-term believer in the need to protect the brain from all new lesions during transcatheter aortic valve replacement, I am very pleased to join Protembis,” said Dr Dawkins. “The ProtEmbo System and the clinical trial design are both novel and I am confident that they will be highly disruptive to the field of cerebral embolic protection, removing or mitigating many of the current issues that concern the physician community.”

About ProtEmbo® and Protembis

The ProtEmbo® Cerebral Protection System is an intra-aortic filter device that protects the entire brain from embolic material liberated during transcatheter aortic valve replacement (TAVR). It is a low-profile non thrombogenic system that shields all cerebral vessels, delivered through the left radial artery for optimal placement and stability. This is an ideal access site enabling physicians to avoid interference with TAVR equipment typically delivered through the femoral artery.

Protembis is a privately held emerging medical device company that has developed the ProtEmbo® Cerebral Protection System. The company strives to provide a simple and reliable solution to protect patients from brain injury during left-sided heart procedures, improving patient quality of life and reducing overall healthcare costs associated with brain injury during such procedures. The ProtEmbo System is currently undergoing clinical investigations.

Contacts

Protembis GmbH

Conrad Rasmus & Karl von Mangoldt

+49(0)241 9903 3622

management@protembis.com
www.protembis.com

VERAXA Biotech AG acquires Synimmune GmbH to expand cancer pipeline

Zurich, 29th of December 2023: VERAXA Biotech AG, a pioneering company in the development of superior antibody-based cancer therapies and a portfolio company of Xlife Sciences AG (SIX: XLS), is proud to announce the acquisition of Synimmune GmbH and its innovative Phase I antibody (FLYSYN) for the treatment of Acute Myeloid Leukemia (AML). This marks a major milestone in the company’s history and with the expansion of VERAXA’s cancer pipeline it is hope for patients battling AML – one of the most common types of acute leukemia in adults.

The FLYSYN antibody was acquired by VERAXA Biotech AG from Xlife Sciences AG portfolio company Synimmune GmbH via a share deal. The deal included an upfront payment as well as several milestones and will reach a total deal value of up to 32 million EUR. With this clinical asset, VERAXA strengthens its internal cancer pipeline of innovative antibodies and antibody-drug conjugates (ADCs).

AML, characterized by its prevalence in individuals over the age of 68 and accounting for approximately 1% of all cancer occurrences, has long presented a challenge in the medical community, particularly for those under 45 where it is less common. The successful First-in-Man multicenter clinical study of FLYSYN focused on patients with AML who had measurable residual disease (MRD). The introduction of FLYSYN, is a testament to VERAXA Biotech AG’s commitment to advancing healthcare and providing innovative solutions for serious health conditions.

Oliver R. Baumann, CEO of Xlife Sciences AG comments: «Securing the innovative Phase I antibody, FLYSYN, for Acute Myeloid Leukemia (AML) treatment marks a significant step forward. This milestone reflects our commitment to advancing healthcare and sets the stage for a promising future in reshaping AML treatment. »

Dr. Christoph Antz, CEO of VERAXA Biotech AG, stated: «With FLYSYN, we are one step closer to offering better, more effective treatments for those affected by Acute Myeloid Leukemia. »

As we continue to navigate the complexities of AML treatment, VERAXA Biotech AG remains steadfast in its mission to transform the landscape of medical care. For more information about VERAXA Biotech AG and our work in AML treatment, please visit www.veraxa.com.

 

Financial calendar

Annual Report 2023 23 April 2024
Annual Shareholders Meeting 2024 20 June 2024
Half-Year Report 2024 19 September 2024

Contact 
Information for investors and journalists: Xlife Sciences AG, Dr. Dennis Fink, dennis.fink@xlifesciences.ch
Information related to VERAXA Biotech AG: Dr. Christoph Antz, antz@veraxa.com

Xlife Sciences AG 
Talacker 35, 
8001 Zurich, Switzerland,
Phone +41 44 385 84 60
info@xlifesciences.ch, www.xlifesciences.ch 
Commercial Register Zurich CHE-330.279.788 
Stock Exchange: SIX Swiss Exchange


End of Inside Information


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Tryp Therapeutics Inc. Announces Signing of Definitive Agreement with Exopharm Limited

, 12/11/2023 / 04:00, EST/EDT – EQS Newswire – Tryp Therapeutics Inc. (Regulated Unofficial Market in Berlin, Frankfurt, Munich, Stuttgart, Tradegate Exchange; Canadian Stock Exchange, Nasdaq OTC)

KELOWNA, BC / ACCESSWIRE / December 11, 2023 / Tryp Therapeutics Inc. (“Tryp” or the “Company“) (CSE:TRYP), a clinical-stage biotechnology company focused on developing intravenous-infused psilocin (the active metabolite of psilocybin) for diseases with high unmet medical needs, is pleased to announce that the Company has entered into an arrangement agreement (the “Arrangement Agreement“) with Exopharm Limited ACN 163 765 991 (“Exopharm” or the “Purchaser“) dated as of December 8, 2023, pursuant to which Exopharm has agreed to acquire all of the issued and outstanding common shares in the capital of Tryp (the “Tryp Shares“) in consideration of the issuance of 4.52 ordinary shares in the capital of Exopharm (the “Exopharm Shares“) for each one (1) Tryp Share. The arm’s length transaction will be completed by way of a statutory plan of arrangement under the Business Corporations Act (British Columbia) (the “Arrangement“).

Key Transaction Highlights

  • The purchase price of CAD$0.08 represents a 78% premium to the closing price of $0.045 and a 112% premium to the 20-day volume weighted price of $0.0378 per Tryp Share on December 8, 2023
  • Tryp shareholders expected to receive 4.52 Exopharm Shares for each one (1) Tryp Share held, representing an aggregate transaction value of approximately $12.8 million.
  • Both the Board and the Special Committee unanimously recommend that Tryp securityholders vote in favor of the Arrangement.
  • The majority of the directors of the combined entity to be appointed by Tryp.
  • Tryp’s clinical programs and development strategy will remain as the foundation of the combined entity.
  • The combined entity is expected to relist on the Australian Securities Exchange (the “ASX“) in Q1 2024 subject to, among other conditions, receipt of the requisite approval of Exopharm shareholders and raising a minimum of AUD$6,000,000 under a public offering.
  • The Arrangement is subject to customary closing conditions, including approvals from Tryp securityholders and Exopharm shareholders, from the ASX and the Supreme Court of British Columbia (the “Court“).

Jason Carroll, Chief Executive officer of Tryp, said “joining forces with Exopharm heralds a new era for Tryp, where we expect our combined strength and shared vision to elevate us to the prominent platform of the ASX. With enhanced access to capital and the evolving landscape of the Therapeutic Goods Administration (TGA) regulations in Australia for select psychedelics, we see even more paths forward to innovate and grow. I am thrilled to emphasize that our ongoing clinical commitments and our TRP-8803 R&D program remain unchanged and will be pursued with the same vigor and dedication. It is not expected that Exopharm’s current R&D program will be pursued following completion of the transaction. With this merger, we’re even better positioned to serve our stakeholders.”

The Arrangement Agreement is the culmination of an extensive and robust review of strategic alternatives available to maximize shareholder value that was conducted by the Company’s board of directors (the “Board“) and a special committee of the Board (the “Special Committee“).

Pursuant to the terms and conditions of the Arrangement Agreement, Exopharm has agreed to acquire 100% of the issued and outstanding Tryp Shares in consideration of 4.52 Exopharm Shares per one (1) Tryp Share. The consideration reflects a 78% premium to the closing price of the Shares on the Canadian Securities Exchange (the “CSE“) of $0.045 on December 8, 2023, the last trading day of the Tryp Shares prior to the announcement of the Arrangement. Pursuant to the Arrangement Agreement, holders of convertible securities of Tryp, including stock options, common share purchase warrants, secured convertible debentures and unsecured convertible notes (collectively, the “Tryp Convertible Securities“) will receive replacement securities of Exopharm having substantially similar economic terms in accordance with the rules of the ASX.

The Board, after receiving the recommendation of the Special Committee, has determined that the Arrangement, including the transactions contemplated thereunder, is fair to holders of Tryp securities and is in the best interests of the Company. Accordingly, the Board approved the Arrangement Agreement and recommends that securityholders vote their securities in favour of the Arrangement.

Each of the directors and executive officers of Tryp have entered into voting and support agreements with the Purchaser and have agreed to, among other things, vote their securities in favour of the Arrangement.

The Arrangement Agreement

Pursuant to the Arrangement, each Tryp Share outstanding immediately prior to the effective time of the Arrangement will be transferred to and purchased by the Purchaser in consideration of 4.52 Exopharm Shares and each Tryp Convertible Security outstanding immediately prior to the effective time of the Arrangement will be exchanged for securities of Exopharm having substantially similar economic terms, in accordance with the rules of the ASX.

The Arrangement is subject to a number of closing conditions, including: the approval of the Court; the approval of the ASX and all other applicable third party and regulatory consents for the Arrangement; the Company obtaining the requisite approval of its securityholders; Exopharm obtaining the requisite approval of its shareholders; no more than 10% of the Company’s shareholders exercising their rights of dissent in connection with the Arrangement, and the satisfaction of certain other closing conditions customary for a transaction of this nature.

The Arrangement Agreement includes customary provisions, including non-solicitation, right to match, and fiduciary out provisions, as well as certain representations, covenants and conditions which are customary for a transaction of this nature. The Arrangement Agreement provides for a termination fee payable by either party in certain circumstances in the event the Arrangement does not close.

Further information regarding the Arrangement will be contained in a management information circular that Tryp will prepare, file and mail to the Tryp securityholders (the “Circular“) in connection with an annual and special meeting of the Tryp securityholders to be held to consider the Arrangement (the “Meeting“). All securityholders are urged to read the Circular once available as it will contain important additional important information concerning the Arrangement. The Arrangement Agreement will also be filed on SEDAR+.

Only the holders of Tryp Shares, Tryp option holders and Tryp warrant holders at the close of business on the record date will be entitled to vote at the Meeting. The Arrangement will require the approval of (i) at least 66⅔% of the votes cast by Tryp shareholders; and (ii) at least 66⅔% of the votes cast by holders of Tryp Convertible Securities, voting as a class.

Advisors and Counsel

Pushor Mitchell LLP is acting as legal counsel to Tryp in Canada and K&L Gates LLP is acting as legal counsel to Tryp in Australia in connection with the Arrangement.

Osler, Hoskin & Harcourt LLP is acting as legal counsel to Exopharm in Canada and Hamilton Locke Pty Ltd is acting as legal counsel to Exopharm in Australia.

ACNS Capital Markets Pty Ltd trading as Alto Capital acted as Tryp’s advisor to Tryp’s recently closed private placement of unsecured convertible notes which raised approximately AUD$3,390,000, and is acting Exopharm’s corporate advisor in connection with the Arrangements.

About Tryp

Tryp Therapeutics is a clinical-stage biotechnology company focused on developing proprietary, novel formulations for the administration of psilocin in combination with psychotherapy to treat diseases with unmet medical needs. Tryp’s lead program, TRP-8803, is a proprietary formulation of IV-infused psilocin (the active metabolite of psilocybin) that alleviates numerous shortcomings of oral psilocybin including: significantly reducing the time to onset of the psychedelic state, controlling the depth and duration of the psychedelic experience, and reducing the overall duration of the intervention to a commercially feasible timeframe. The Company has completed a Phase 2a clinical trial for the treatment of Binge Eating Disorder at the University of Florida, which demonstrated an average reduction in binge eating episodes of greater than 80%. The Company has also started a Phase 2a clinical trial with the University of Michigan for the treatment of fibromyalgia and is preparing to initiate a Phase 2a clinical trial (IND has been cleared to proceed) with Massachusetts General Hospital for the treatment of abdominal pain and visceral tenderness in patients suffering from IBS. Each of the studies are utilizing TRP-8802 (synthetic, oral psilocybin) to demonstrate clinical benefit in these indications. Where a positive clinical response has been demonstrated, subsequent studies are expected to utilize TRP-8803 (IV-infused psilocin), which has the potential to further improve efficacy, safety and patient experience. For more information, please visit www.tryptherapeutics.com.

About Exopharm

Exopharm (EX1) is a leader in advancing and manufacturing technologies for exosome-based medicines using exosomes or extracellular vesicles (EVs) as a chassis for improved and non- viral drug-delivery.
Exosomes can be loaded with a variety of active pharmaceutical ingredients (APIs) and can be targeted to selected cell-types and tissue types, improving the safety-profile of the APIs and providing better treatments. Exosomes can be used to deliver small molecule drugs, mRNA, DNA and other types of APIs. Currently Exopharm is executing a strategy to maximize the significant value of the company’s IP position in the exosome field.

The Exopharm Shares to be issued under the Arrangement have not been and will not be registered under the U.S. Securities Act of 1933 and may not be offered or sold in the United States absent registration or applicable exemption from registration requirements. It is anticipated that any securities to be issued under the Arrangement will be offered and issued in reliance upon the exemption from the registration requirements of the U.S. Securities Act of 1933 provided by Section 3(a)(10) thereof.

Completion of the Arrangement is subject to a number of conditions, including but not limited to, all requisite regulatory, court and exchange approvals, the approval of the Court as well as the approvals of the securityholders of Tryp and shareholders of Exopharm. The Arrangement cannot close until the required approvals are obtained. There can be no assurance that the Arrangement will be completed as proposed or at all.

Investors are cautioned that, except as disclosed in the Circular to be prepared in connection with the Arrangement, any information released or received with respect to the Arrangement may not be accurate or complete and should not be relied upon. Trading in the securities of the Company should be considered highly speculative.

Neither the CSE nor the Market Regulator (as that term is defined in the policies of the CSE) has in any way passed upon the merits of the Arrangement and associated transactions and neither of the foregoing entities accepts responsibility for the adequacy or accuracy of this release or has in any way approved or disapproved of the contents of this press release.

This press release is not an offer to sell or the solicitation of an offer to buy the securities in the United States or in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to qualification or registration under the securities laws of such jurisdiction. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent registration or an applicable exemption from U.S. registration requirements and applicable U.S. state securities laws.

Investor & Media Contact

Peter Molloy
Chief Business Officer
Tryp Therapeutics Inc.
pmolloy@tryptherapeutics.com

Forward-looking Statements:

Certain information in this news release is considered forward-looking within the meaning of certain securities laws and is subject to important risks, uncertainties and assumptions. This forward-looking information includes, among other things, information with respect to the Company’s beliefs, plans, expectations, anticipations, estimates and intentions. The words “may”, “could”, “should”, “would”, “suspect”, “outlook”, “believe”, “anticipate”, “estimate”, “expect”, “intend”, “plan”, “target” and similar words and expressions are used to identify forward-looking information. Forward-looking information in this news release relates to, among other things: anticipated benefits of the Arrangement to securityholders; the timing and receipt of required securityholder, Court, and regulatory approvals for the Arrangement; the ability of Exopharm to complete a prospectus offering and the amount to be raised thereunder, the composition of the board of directors of the combined entity, the ability of the Company and Exopharm to satisfy the other conditions to, and to complete, the Arrangement.

These statements reflect the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant uncertainties and contingencies. Many factors, both known and unknown could cause actual results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements or information and the Company has made assumptions and estimates based on or related to many of these factors. Such factors include, without limitation, the satisfaction or waiver of all applicable conditions to closing of the Arrangement including, without limitation, receipt of all necessary securityholder, court and regulatory approvals or consents and lack of material changes with respect to the Company and its business, all as more particularly set forth in the Arrangement Agreement. In respect of the forward-looking statements and information concerning the anticipated completion of the proposed Arrangement and the anticipated timing for completion of the Arrangement, the Company has made certain assumptions that management believes are reasonable at this time, including assumptions as to the time required to prepare and mail Meeting materials and the satisfaction of all closing conditions. These dates may change for a number of reasons, including unforeseen delays in preparing Meeting materials; inability to secure necessary securityholder, court and regulatory approvals in the time anticipated or the need for additional time to satisfy the other conditions to the completion of the Arrangement. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release concerning these times. In addition, in the event the Arrangement Agreement is terminated in certain circumstances, the Company may be required to pay a termination fee to the Purchaser, the result of which could have a material adverse effect on the Company’s financial position and results of operations and its ability to fund growth prospects and current operations.

The forward-looking information in this news release describes the Company’s expectations as of the date of this news release. Readers are cautioned against attributing undue certainty to forward-looking statements or information. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be anticipated, estimated or intended. The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affecting such statements or information, other than as required by applicable law.

SOURCE: Tryp Therapeutics

12/11/2023 EQS Newswire / EQS Group AG

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Cytena – single cells on demand

Cytena – single cells on demand

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Bavarian Nordic – poxviral-based vaccine

Bavarian Nordic is a fully integrated biotechnology company focused on the development, manufacturing and commercialization of cancer immunotherapies and vaccines for infectious diseases.

Bavarian Nordic – poxviral-based vaccine

Bavarian Nordic has built its foundation around two poxviral-based vaccine platform technologies, Modified Vaccinia Ankara – Bavarian Nordic (MVA-BN) and Vaccinia-Fowlpox-TRICOM (VF-TRICOM) that have the potential to support a broad product pipeline in both infectious diseases and cancer immunotherapies. Both technologies can be manufactured at commercial scale at Bavarian Nordic’s own facility, which was recently expanded to accommodate the production of multiple products. Bavarian Nordic focuses on developing product candidates to address cancer and infectious diseases by leveraging several core strengths:

  • Extensive R&D expertise in vaccines and immunotherapy
  • Broadly applicable platform technology
  • Multiple clinical stage development programs, including two Phase 3 trials
  • Flexible, commercial scale manufacturing facility
  • Significant financial resources resulting from IMVAMUNE supply contracts and government-funded R&D programs

Through a long-standing collaboration with the U.S. Government, Bavarian Nordic has developed a portfolio of biological countermeasures, including the non-replicating smallpox vaccine, IMVAMUNE, which is stockpiled for emergency use by the U.S. and other governments. The vaccine is approved in the EU (under the trade name IMVANEX) and in Canada. Bavarian Nordic and its partner Janssen are pioneering the development of an Ebola vaccine, which has been fast-tracked by authorities in response to the current situation in West Africa. Additionally, in collaboration with the National Cancer Institute, Bavarian Nordic has developed a portfolio of active cancer immunotherapies based on its versatile pox-virus based technologies, including PROSTVAC, which is currently in Phase 3 clinical development for the treatment of advanced prostate cancer. The company has partnered with Bristol-Myers Squibb for the potential commercialization of PROSTVAC.

Bavarian Nordic is a biotech company headquartered in Denmark, Germany and USA. Bavarian Nordic’s shares are listed on Nasdaq Copenhagen under the symbol BAVA (Reuters: BAVA.CO, Bloomberg: BAVA.DC). The company has a sponsored Level 1 ADR program listed in the US (OTC) under the symbol BVNRY.

More about Bavarian Nordic : www.bavarian-nordic.com

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE

Bavarian Nordic – poxviral-based vaccine – poxviral – vaccine – PROSTVAC – IMVANEX – IMVAMUNE

GNA Biosolutions – ultra-fast laser heating of nanoparticles

GNA Biosolutions – ultra-fast laser heating of nanoparticles

GNA Biosolutions

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