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Credevo is a global clinical research and development company that acts as an extended arm of Biopharma companies to facilitate clinical development and product registrations worldwide.

There is a high unmet need for central nervous system (CNS) diseases in the growing aging population. Genervon is bringing GM6, a new clinical-stage drug asset, to regulatory approval and commercialization in China for CNS diseases including Parkinson’s disease (PD), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), Multiple Sclerosis (MS), and other neurodegenerative diseases. Most clinical trials for drugs developed through the traditional single-target drug approach have failed to treat the complex neurological disorders that involve multiple interrelated pathways. GM6 is neither an antibody nor a single-target agonist or antagonist. It is a pleiotropic regulator which simultaneously regulates multiple pathological pathways. Genervon has validated GM6’s target engagement of multiple targets and druggability. GM6 has been de-risked for toxicity in animal studies and safety in three clinical trials. IND documents filed with the FDA can be used to support regulatory filing in China for clinical trials. Genervon is interested to partner through licensing or merger and acquisition. 
Genervon Biopharmaceuticals discovered an endogenous embryonic-stage regulator, Motoneuronotrophic Factor (MNTF), and developed from it the pleiotropic drug GM6. Chronic inflammation is associated with a broad spectrum of neurodegenerative diseases related to aging. GM6 simultaneously modulates multiple biological mechanisms (MOA) in the CNS and immune system to increase neurogenesis and lower inflammation. The MOAs include oxidative Stress, protein aggregation, kinase dysfunction, cholinergic signaling, extracellular matrix stability, and intrinsic apoptosis. GM6 reduces Beta Amyloid and phosphorylated tau in AD, reduces SOD1 in ALS, and reduces inflammation in animal models. GM6 passes through the blood-brain barrier and has good drug-like properties. GM6 has been studied in a Phase 1 and two Phase 2A trials and was shown to be safe and tolerable with positive clinical outcomes and favorable shifts in biomarkers SOD1, Tau and TDP43 in patients. A complete CMC package is ready for technology transfer.

One Top Chinese Pharma

JOT is a virtual company with its base operation in Jupiter, FL. JOT is in position to quickly come to market with a platform product effective to treat 12 or more indications including Alzheimer’s Disease. The proprietary patented product, JOTROL, is very safe, oral, naturally based and multi-functional. JOTROL will be very effective with high social and economic impact within a reasonable timeframe. Relationships have been developed with scientists at various institutions, such as University of Miami (“UM”), MIT, Harvard, Georgetown University and Murdoch Childrens Research Institute, AU. This setup has made it possible to gain access to laboratory work, scientific information, pre-clinical development and scientific expertise in an extremely cost effective and efficient way. JOT will conclude clinical trials by utilizing a contract manufacturer and Clinical Research Organizations, involvement by its scientific advisors as well as support from patient organizations thereby keeping its fixed overhead extremely low for a Biotech company. A Phase I trial is presently ongoing with results expected in Q1,2021. Two Phase II rare disease trials, are expected to be started in H2 of 2021 with possible accelerated approvals from FDA. Partial financing for those are expected to be received from NIH. A Phase II trial in Alzheimer’s is also planned to be executed in parallel. Financing for the Phase I study has been granted by NIA (National Institute of Aging). Financing for a larger Phase II study is also expected to be financed by a NIA consortium (up to $75 million). JOT is prepared to add a commercial organization to market its product in North America while out-licensing marketing and sales operations for the rest of the world.

Luye Pharma Group is an international pharmaceutical company dedicated to the R&D, manufacturing and sale of innovative medications. The company has established R&D centers in China, the U.S. and Europe, with a robust pipeline of over 30 drug candidates in China and more than 10 drug candidates in other international markets. Along with a number of new drugs and new formulations in the central nervous system and oncology therapeutic areas under study in the U.S. Europe and Japan, Luye Pharma has reached high-level international standards in novel drug delivery technologies including microspheres, liposomes, and transdermal drug delivery systems, as well as actively making strategic developments in the fields of biological antibodies, cell therapies and gene therapies, among others.

 

Luye Pharma is developing a global supply chain of 8 manufacturing sites with over 30 production lines in total, establishing GMP quality management and international standard control systems. With more than 30 products covering the central nervous system, oncology, cardiovascular, metabolism and other therapeutic areas, business is conducted in over 80 countries and regions around the world, including the largest pharmaceutical markets - China, the U.S., Europe and Japan, as well as in fast growing emerging markets.

MSL Pharma is an early-stage pharma company that performs ideation, analysis and identification of the underlying pathological pathways to determine how to treat diseases. The Company holds exclusive licenses from the Hebrew University & Ben-Gurion University of the Negev. There are data, patents and publications concerning the technologies.

As an early-stage company, in order to reduce overhead costs, we effectively act as the project manager – we plan the assays and subcontract the early development stages to university labs, and the later stages to CROs that specialize in the different fields. The Company monitors the results, determines next steps and fundraises for the next phases of development. We believe that working with leading experts at CROs is critical for success.

The Company has licenses for platform technologies which are progressing to several different projects; as such it is planning to out-license at various stages of development.

Synthesis of cyclic peptides which are peptidomimetics
MSL Pharma has the capability to identify “active regions” of proteins and peptides, to isolate them and to turn them into cyclic peptides which are selective for the desired receptors and stable, thereby preventing off-target activation and adverse effects (see Asset, Table 1).

Drug delivery systems for peptides and other molecules
MSL Pharma has two technologies for drug delivery (see Mode of Delivery, Table 1) that achieve unprecedented bioavailability:
1. Lipophilic prodrug charge masking (LPCM) technology for the oral delivery of peptides. This technology makes a chemical modification in a peptide to be converted to oral delivery, to produce a prodrug of this peptide. This causes it to be absorbed through the intestinal cell and once the prodrug enters the blood stream, it converts back to the original peptide. Typically, the Pgp Efflux system limits the prodrug absorption; we have overcome this with an approved self-assembling PNL (pro-nano liposphere) encapsulation system, itself a self-nanoemulsifying drug delivery system (SNEDDS), which increases prodrug solubility and inhibits the Pgp Efflux system.

2. A novel nanoparticle formulation called AmyloLipid Nanovesicles which is constructed of natural materials and therefore safe ,biodegradable and has an advantage for the delivery of peptides. This technology is used also for the delivery of other molecules, can be used for nose-to-brain, sublingual, transdermal and probably also oral delivery, and can be applied to our assets (Table 1) or existing assets (Table 2).

A novel smart multi-armed linker for targeted drug delivery
Our linker can be used for peptide-drug conjugates (PDCs), antibody-drug conjugates (ADCs) and nanoparticle-drug conjugates (NDCs). Our linker releases the payload (chemotherapeutic drug or fluorescent) only in the tumor cells and can bind up to three payloads (see Table 3). We have demonstrated that using two or three different drug payloads kills the tumor cells more potently and with less drug resistance developing.

Discovery of novel peptides for peptide-drug conjugates
We have technologies to synthesize novel peptides which will bind to receptors overexpressed in certain tumors so that we will be able to use them for synthesizing peptide-drug conjugates (PDCs) to diagnose and treat different tumors. We already have at our disposal peptides that bind to the five different somatostatin receptors (overexpressed in pancreatic, gallbladder, breast, ovary, prostate, melanoma, lymphoma, glioblastoma, colon and non-small-cell lung tumors) and to certain integrin receptors (overexpressed in tumors such as breast, glioblastoma, leukemic cells). 

Neuro-Zone, since 13 years, supports drug discovery, drug repurposing and research projects in the fields of inflammation and age-related pathologies.
In particular, we have developed pathology-specific platforms to generate rapid and informative data on efficacy, toxicity, metabolism and mechanism of action, supported by proprietary technologies such as MicroTISSUE (dissecting microenvironment-cell interaction in complex inflammatory scenarios) or MITOS (a comprehensive analytical platform for quantitative analysis of mitochondrial function ).
Our approach enables effective selection and ranking of the most promising candidates per indication.
Moreover, we profile candidates at different level of complexity starting from:
a) pharmacology profiling (GPCR; Ion Channel receptors)
b) identification of biochemical pathways responsible for therapeutic efficacy (transcriptomics)
c) disease modified barrier permeability (BBB and endothelial)