Genexine Announces Merger with EPD Biotherapeutics to Strengthen Drug Development Pipeline

  • Merger with EPD Bio, a biotech developing a target protein degrader (TPD) platform technology
  • Jaehyun Choi, Ph.D. founder and CEO of EPD Bio, joins Genexine as head of R&D

SEOUL, South Korea–(BUSINESS WIRE)–Genexine (KOSDAQ: 095700), a publicly-listed, clinical-stage Korean biopharmaceutical company committed to the discovery and development of novel biologics for the treatment of serious unmet medical needs, announced a merger with EPD Biotherapeutics (hereinafter referred to as ‘EPD Bio’), a company developing an innovative targeted protein degradation (TPD) bioPROTAC platform technology, to strengthen its research workforce with expertise in PROTAC technology and enhance Genexine’s drug pipeline.

“Through this merger, Genexine has secured key talent with innovative technology that can lead the global market and at the same time added innovative new drugs based on bioPROTAC technology. Combining EPD Bio’s bioPROTAC technology with Genexine’s clinical and CMC development capabilities will enable us to continue pursuing the development of innovative new drugs that can lead the global market,” said Sungjune Hong, CEO of Genexine.

EPD Bio founder and CEO Dr. Jaehyun Choi, an expert in the field of targeted protein degradation technology, previously worked at Arvinas, a global leader in PROTAC (Proteolysis targeting chimera) technology and held research and scientific positions at Samsung Advanced Institute of Technology and Trillium Therapeutics. Following the merger, Dr. Choi will join Genexine as a representative director in charge of R&D along with EPD Bio’s core research team. Mr. Hong will continue as a representative director overseeing corporate development and business management.

Genexine announced that, at the board of directors meeting held on June 26th, it decided to merge with EPD Bio through a small-scale merger. The merger ratio is 1:6.1924079, and Genexine will issue new shares to the existing shareholders of EPD Bio according to the merger ratio. Detailed merger procedures are scheduled to be completed by early October.

EPD Bio is developing EPDegTM, an mRNA-based bioPROTAC technology that can overcome the limitations of existing small molecule- based PROTAC technology. The platform creates fusion-protein degraders delivered as mRNA-LNP whereby they remove the dependence on tissue specific expression of E3 ligase. As a unique technology with a potential to be first-in-class, it can generate a diverse pipeline of TPDs for multiple undruggable targets in different disease indications. EPD Bio has been receiving significant attention from the industry domestically and internationally as EPD Bio won the ‘Korea Startup/Biopharma Acceleration Program 2023’ led by the Korea Health Industry Development Institute and Takeda Pharmaceutical which supports domestic bio pharmaceutical companies to discover and develop innovative technologies.

RM Global Partners LLC acted as Genexine’s strategic advisor.

About Genexine

Genexine, Inc. is a publicly traded, clinical-stage biotechnology company focused on developing and commercializing immunotherapeutics and next-generation long-acting biologics. Its primary technology platforms are Therapeutic DNA vaccine technology and hyFc® fusion technology. The company has multiple products in clinical development including several undergoing Phase 3 registration trials. The company’s proprietary pipeline includes GX-188E (tirvalimogene teraplasmid) for head and neck cancer and cervical cancer, GX-I7 (efineptakin alfa) for multiple cancers, GX-H9 (eftansomatropin alfa) for Pediatric Growth Hormone Deficiency and GX-E4 for CKD-induced anemia, among others. Genexine has established multiple partnerships with global companies in order to expedite product development and commercialization and create significant value. Genexine is listed on the Korean exchange (KOSDAQ: 095700) and is headquartered in Seoul, Korea. Genexine is committed to the well-being and care of patients worldwide. For more information about Genexine, please visit at www.genexine.com.

About EPD Bio

EPD Bio is an early-stage biotech company dedicated on developing novel engineered protein degraders that selectively degrade the most undruggable disease-causing proteins that cannot be targeted by current small molecule-based PROTAC (PROteolysis TArgeting Chimera). The company was founded in 2021 and is based in Seoul, South Korea.

Contacts

Investor Contact:
Genexine Inc.

Jongsoo Lee, Investor Relations

jongsoo.lee@genexine.com

Kyuri Kim, Investor Relations

kyuri.kim@genexine.com

Remepy Launches with $15 Million in Funding To Bring First Hybrid Drug To Market

Merck Global Head of R&D and Chief Medical Officer Danny Bar Zohar joins Former Israeli Prime Minister Naftali Bennett on Board of Directors

NEW YORK–(BUSINESS WIRE)–Remepy, a pioneer in “hybrid drugs,” today announced that it has successfully closed a $10M seed investment round, which together with earlier funding totals $15M. The round was led by NFX, joined by Vine Ventures, PsyMed Ventures, Supernode Ventures and Firstime Ventures, joining previous pre-seed lead investor TechAviv as well as Fresh.fund, Samsung Next, StageNext Fund and 97212 Ventures.

Remepy’s new hybrid drugs combine traditional drugs with its “digital molecules.” Digital molecules are therapeutic interventions that trigger physiological effects (aka MOAs, Mechanisms of Action) through the brain. These physiological changes have been known to enhance the effectiveness of traditional drugs.

The digital molecules are designed for hybrid drug experiences. They are based on non-invasive cognitive, psychological, and behavioral interventions that follow principles of sensory integration, sensory substitution and sensory deprivation. The interventions trigger multiple unique mechanisms of actions, including: changes to brain connectivity in important brain areas; changes to immune system blood biomarkers, and important behavioral changes.

Remepy has already demonstrated the effects of its digital molecule interventions in clinical trials using extensive fMRI imaging, blood and saliva samples analysis and standardized questionnaires. It is among the first in the world to show that its patent–pending digital therapies can modulate blood biomarkers.

Many diseases are better treated by combining drugs with non-pharmacological interventions. Remepy is making such combinations standardized, accessible and personalized at scale with the use of its digital molecules.

Remepy is targeting neurodegenerative diseases, cancer, autoimmune diseases, and degenerative eye diseases. Remepy’s innovative approach creates a new market for hybrid medications, and a whole new world of data and IP assets for pharmaceutical companies.

Dr. Danny Bar Zohar, Merck’s Global head of R&D and Chief Medical Officer, who shares the company’s vision for hybrid drugs states: “As a physician and drug developer, it is fascinating for me to see Remepy’s clinical data, which shows how these unique non-invasive digital interventions can modulate the immune system, make significant changes to brain plasticity, and drive behavioral changes. Remepy’s product has the potential to enhance immunotherapy for cancer, or improve existing drug therapy for neurodegenerative diseases such as Parkinson’s Disease and MCI (Mild Cognitive Impairment). These proprietary digital-drug combinations could significantly improve patient outcomes and create tangible value for patients and healthcare systems.”

Dr. Michal Tsur, Remepy Co-CEO: “I am thrilled that Dr. Danny Bar Zohar has joined us as a board member. Many industries have transformed by adopting a hybrid product approach, integrating new technology with traditional products.” Co-CEO Or Shoval added: “I am particularly excited about the prospects of improving Parkinson’s Disease patients’ lives with a hybrid PD drug that will better address cognitive, movement, speech, sleeping and psychological symptoms and has the potential of disease modification with changes to brain connectivity.”

“Remepy’s vision of enhancing drugs with digital companions is groundbreaking and their clinical proof that such enhancement is possible is incredibly exciting,” adds Gigi Levy-Weiss, Managing Partner at NFX “Remepy has an experienced team of entrepreneurs and world-class scientists that are defining a new category in pharma.”

About Remepy:

Remepy is pioneering Hybrid Drugs: traditional drugs combined with digital therapeutics that are personalized and enhance the effect of pharmaceutical treatments. Remepy has already proven in human studies the effect of its products, using extensive brain imaging, as well as blood and saliva samples, with promising results for Oncology, MCI, and Parkinson’s Disease. Their approach offers an efficient method to create new proprietary pharma assets, unlocking an entire new market and world of data. The Remepy team includes top scientists, physicians, and technologists.

Contacts

Michal Tsur

Press@Remepy.com

Hemostatics, CUN and ICIQ receive €2.5M to validate a revolutionary therapy against disabling and lethal haemorrhage

  • 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). Strong preclinical studies have been obtained with this compound.

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. This grant will be complemented by several other fundings, both healthcare investors private funding and public grants.

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

Marina Vives • Corporate Communication • Institut Català d’Investigació Química (ICIQ) • +34 977 92 02 00 • comunicacio@iciq.es

Orbis Medicines Launches with €26 Million Seed Financing to Transform Macrocycle Drug Development through Next-Generation Orally Dosable ‘nCycles’

Financing led by Novo Holdings and Forbion

Orbis’ platform is first to systematically explore macrocycle chemical space using unique combination of high-throughput chemical synthesis and large-scale assaying, supported by machine learning

Pipeline to initially focus on high-value oral alternatives to blockbuster biologic drugs and opening new targets to therapeutic intervention

COPENHAGEN, Denmark–(BUSINESS WIRE)–Orbis Medicines, a leader in oral macrocycle drug discovery, today announces its launch with a 26 million financing led by global life sciences investor Novo Holdings and European life sciences venture firm Forbion. The funding will support Orbis’ expansion and advancement of its portfolio of next-generation macrocycle drugs it calls ‘nCycles’. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. nCycles are systematically designed by Orbis’ nGen1 platform to be orally bioavailable and membrane permeable, solving decades-long challenges in macrocycle drug design.

The Orbis pipeline includes programs against targets validated by blockbuster biologic drugs, with the goal of providing oral alternatives that will enable the treatment of many more patients. In addition, Orbis is developing a pipeline of nCycles for other attractive target classes, both intra- and extra-cellular. Oral macrocycle drugs can potentially address a very wide range of diseases based on their ability to target a majority of the potential molecular targets in the body.

“After decades of challenging de novo synthesis, the universe of potential macrocycle targets is now available for exploration. Not only can Orbis reach a wealth of new targets, both inside and outside cells, but we can do this while preserving an oral format to pioneer a new therapeutic class of oral macrocycles. It’s a milestone for drug development,” said Morten Døssing, Chair of the Orbis Board and Partner at Novo Holdings. “We believe Orbis has the premier chemistry-led approach in the field, which gives us a distinct data advantage. We can generate hundreds of thousands of diverse compounds in record time and immediately apply a range of functional assays in a high-throughput fashion to each individual compound to home in on winners. Establishing this robust, reliable engine for candidate design was crucial for us as we look to bring macrocycle drugs to major patient populations.”

Orbis was founded in 2021 by the Seeds Investment team of Novo Holdings, with Mr. Døssing as Executive Chair and João Ribas as interim CBO establishing the company’s team and building its corporate strategy. The scientific foundation of Orbis was developed by Prof. Christian Heinis and Sevan Habeshian at the Swiss Federal Institute of Technology in Lausanne (EPFL).

“The broad potential of oral macrocycle drugs to address challenging targets untouchable by small molecules, coupled with recent momentum in the field, makes this an incredibly exciting development,” said Marco Boorsma, Ph.D., General Partner at Forbion. “With a compelling AI-enabled platform technology, scientific expertise and a clear strategy for growth, Orbis is attracting strong interest for its approach to finally delivering on the promise of this class for medicine. We believe Orbis’ combinatorial approach and ability to continuously generate big data from real compounds gives them an undeniable opportunity to unlock the potential of orally available macrocycle drugs for significantly larger patient populations.”

The chemical methods by which Orbis rapidly generates vast libraries of diverse macrocycle compounds ready for immediate assay were previously published in Nature Communications. Authors of the paper, which included Orbis’ founders Professor Heinis and Dr. Habeshian, detail how the methods draw on a large range of components to build compounds, including both natural and synthetic amino acids, creating an extremely large chemical space for exploration. Additionally, research recently published in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.

About Orbis Medicines

Orbis Medicines is a biotechnology company focused on pioneering a new era for oral macrocycle drug discovery. Macrocycles are a large and diverse family of compounds with highly desirable therapeutic properties, defined by the presence of a cyclic structure. Orbis’ nGen platform is designed to systematically explore the macrocycle chemical space using a highly automated chemistry platform and deliver oral macrocycle drug candidates – nCycles – suitable for both intra- and extracellular targets. Orbis’ programs are focused on high-value oral alternatives to blockbuster biologic drugs and targets challenging for established modalities. Orbis was founded by Novo Holdings. For more information, please visit: www.orbismedicines.com

1About nGen

nGen is Orbis’ technology platform for generating oral macrocycle drug candidates, which it calls nCycles. It consists of multiple proprietary integrated elements starting with hit finding libraries of 100 billion compounds. Hits identified are progressed using Orbis’ highly automated chemistry-based platform that rapidly creates and tests hundreds of thousands of individual analogues with a full suite of assays to identify the most desirable ones. The scale and quality of the data produced from these real compounds, paired with machine learning, creates an industry-leading platform that de-risks and accelerates development. Recently published research in Nature Chemical Biology demonstrates nGen’s ability to deliver nCycles that are orally bioavailable, marking a new era for macrocycle drug discovery.

About Novo Holdings A/S

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 Novozymes A/S and manages an investment portfolio with a long-term return perspective. In addition to managing a broad portfolio of equities, bonds, real estate, infrastructure and private equity assets, Novo Holdings is a world-leading life sciences investor. Through its Seeds, Venture, Growth, and Principal Investments teams, Novo Holdings invests in life science companies at all stages of development. As of year-end 2022, Novo Holdings had total assets of EUR 108 billion. www.novoholdings.dk

About Forbion

Forbion is a dedicated life sciences venture capital firm with offices in The Netherlands and Germany. Forbion invests in life sciences companies that are active in the biopharmaceutical space, managing €3 billion across multiple fund strategies that cover all stages of biopharmaceutical drug development. The firm’s current team consists of more than 30 life sciences investment professionals that have built an impressive performance track record since the late nineties with investments in over 100 companies across 8 funds. Forbion’s record of sourcing, building and guiding life sciences companies has resulted in many breakthrough therapies and valuable exits. In addition to its financial return objectives, Forbion selects investments that will positively affect the health and well-being of patients. The firm is a signatory to the United Nations Principles for Responsible Investment. More information can be found at www.forbion.com

Contacts

Media:
Kit Rodophele

Ten Bridge Communications

617-999-9620

krodophele@tenbridgecommunications.com

Alpha Cognition – developing novel treatments for neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis

Alpha Cognition is a clinical stage, biopharmaceutical company dedicated to developing novel treatments for under-served neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis (ALS).

Alpha Cognition - developing novel treatments for neurodegenerative diseases such as Alzheimer’s Dementia and Amyotrophic Lateral Sclerosis

ALPHA-1062, a patented new chemical entity that has demonstrated safety and improved ALPHA-1062, is a patented new chemical entity being developed as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer’s disease, with expected minimal gastrointestinal side effects. ALPHA-1062’s active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer’s dementia and as an intranasal formulation for traumatic brain injury.

ALPHA-0602 (Progranulin) is expressed in several cell types in the central nervous system and in peripheral tissues, promotes cell survival, regulates certain inflammatory processes, and plays a significant role in regulating lysosomal function and microglial responses to disease. Its intended use for the treatment of neurodegenerative diseases has been patented by the Company and Alpha-0602 has been granted an Orphan Drug Designation for the treatment of Amyotrophic Lateral Sclerosis by the FDA.

ALPHA-0702 and ALPHA-0802 are Granulin Epithelin Motifs, or GEMs, derived from full length progranulin which have therapeutic potential across multiple neurodegenerative diseases. Progranulin is comprised of 7½ Granulin Epithelin Motifs (GEMs). GEMs are important in regulating cell growth, survival, repair, and inflammation. Individual granulin domain peptides are approximately 60 amino acids in length (~7kDa). GEMs are metabolically stable and resistant to proteolysis (long half-life). Evidence suggests that not all GEMs are equally potent at promoting cell survival signaling or reducing proteinopathy, and may compete (e.g., binding to effectors) with active GEMs and effectively decrease their potency. Specific GEM combinations have been shown to be more effective than full length progranulin in promoting Cathepsin D maturation. GEMs have been shown to be important in regulating cell growth, survival, repair, and inflammation. Alpha-0702 and ALPHA-0802 are designed to deliver this with potentially lower toxicity, and greater therapeutic effect.

More info : http://www.alphacognition.com/

Keywords : Alpha Cognition , neurodegenerative diseases , dementia , Alzheimer’s Dementia , Alzheimer Disease , Amyotrophic Lateral Sclerosis , acetylcholinesterase inhibitor , orphan drug , CNS , neuroscience , traumatic brain injury , Granulin Epithelin Motifs , Gene Therapy

DDI-Predictor – predict drug drug interactions mediated by cytochromes

DDI-Predictor – predict drug drug interactions mediated by cytochromes

ddi-predictor

Continue reading

Aduro Biotech – engineered Immunotherapy for Cancer

Aduro Biotech is a clinical-stage cancer immunotherapy company with multiple therapeutic approaches in development that have the potential to yield powerful immunotherapy combinations.

Aduro Biotech – engineered Immunotherapy for Cancer

Aduro Biotech

Continue reading

Newron Pharmaceuticals – innovative therapies for Central Nervous System

Newron Pharmaceuticals is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the Central Nervous System (CNS) and pain.

Newron Pharmaceuticals – innovative therapies for Central Nervous System

Newron Pharmaceuticals

Continue reading

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