BusStim’s Partner Companies

Intranasal Drug Delivery for Treatment of Concussion Neuronasal, LLC, is a biotech company based in Pennsylvania. Neuronasal’s lead compound is a clinical-stage repurposed (N-acetylcysteine, NAC) patent-protected out-patient drug treatment shown by the U.S Military to accelerate functional recovery after blast-induced concussion (mTBI). Because of poor oral bioavailability and brain penetration, the study by the Military required the use of 4 to 8 grams of NAC to achieve efficacy. Such high doses resulted in gastrointestinal upset including nausea and vomiting – mimicking some of the symptoms of concussion. A concussion is a major unmet medical need for which there is no approved therapy to speed recovery and reduce post-concussive symptoms. The treatment would have broad application in sports-related and accident-induced concussions as well as combat sustained head injuries. While many concussion patients recover uneventfully with bed rest, up to 40% of patients go on to experience protracted symptoms including cognitive impairment, depression, and loss of time from work. These symptoms can last from weeks to years. Neuronasal has a patent-protected non-invasive intra-nasal delivery method efficiently targeting well-tolerated doses of FDA-approved NAC directly to the brain where it exerts its neuroprotective effects with its antioxidant, anti-inflammatory, and anti- neuroexcitoxicity properties, and without the need for mega doses and associated gastrointestinal side-effects. Several productive meetings with leading sports-injury advocates and the US Army have elicited tremendous interest to support and partially fund confirmatory clinical study using the Neuronasal product

Learn  more: https://neuronasal.com/

Prevention of Ischemia-Reperfusion Injury Young therapeutics, LLC is a biotech company spun out of the Philadelphia College of Osteopathic Medicine by Dr. Lindon Young. Young Therapeutics is focused on IschemiaReperfusion Injury (IRI) - a phenomenon where the reestablishment of blood flow (and thus oxygen) after a period of ischemia causes additional damage to the tissue or organ. A primary example of this is in the setting of a heart attack when an artery in the heart is blocked, then blood flow is reestablished by the cardiologist in the cath lab. Preventing IRI can preserve 30% more cardiac tissue and function. IRI is not limited to the heart. Virtually any ischemia, reflow event can result in IRI. Another example is organ transplantation where an organ is removed from a donor (ischemia) and transplanted into the recipient (reperfusion). Transplant outcomes will improve significantly when IRI is prevented. Young Therapeutics has two novel compounds they are pursuing for the prevention of IRI. One is targeting IRI in the heart following a heart attack, and the other targeting Delayed Graft Function following a kidney transplant. There are over 800,000 eligible heart attack patients in the US alone. Delayed Graft Function is an orphan indication with 20,000 kidney transplants in the US each year.

A major mechanism underlying IRI involves the production of superoxide and hydrogen peroxide following the reintroduction of oxygen. These harmful molecules result from the uncoupling of nitric oxide synthase from citrulline. Our molecules inhibit this process, preventing the formation of superoxide and hydrogen peroxide. Failed attempts by others to prevent IRI damage have used oxygen-free radical scavengers, an intervention which we believe is too late. Once these free radicals are formed the damage is done. Our approach is to prevent the formation of these damaging molecules in the first place, before reperfusion. Young Therapeutics has generated extensive in vitro and in vivo data in cardiac ischemia models with dramatic results. Young Therapeutics was awarded a $300,000 NIH SBIR grant in June 2019 to study the effects of their molecules in models of kidney IRI.

To learn more: http://www.youngtherapeutics.com/

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Novel Antibiotics for Treatment of Drug-Resistant Pathogens StimBiotics is a start-up biotech company spun out of the New Mexico Institute of Mining and  Technology (New Mexico Tech) and created by BusStim, LLC. StimBiotics is developing unique compounds in the Gram-negative and Gram-positive antibiotic space for the treatment of drug-resistant pathogens. Antibiotic resistance is one of the most urgent crises facing global healthcare today. Particularly problematic is the treatment of Gram-negative pathogens that are becoming increasingly resistant to most currently available antibiotics. StimBiotics is offering an opportunity to partner at an early stage with a company that has a growing number of compounds with novel mechanisms showing great in vitro promise. This novel class of indole-based small molecule antibiotics has demonstrated in vitro efficacy with micromolar bactericidal activity against multi-drug-resistant Gram-negative, as well as Gram-positive, pathogens. These compounds kill bacteria individually and also synergize with existing antibiotics to kill drug-resistant bacteria even in the presence of serum. In addition, current data indicate that these molecules kill pathogens while preventing evolving resistance among targeted bacteria. The first patents covering this class of compounds were issued in the 4th quarter of 2017 with further filings planned. 

Website under development

Technology for Efficient Delivery of Therapeutics Into the Brain Ophidion, Inc. is a private biotechnology company with a platform technology called the Ophidion CNS Carrier Technology (OCCT), which uses a Trojan horse strategy to exploit an endogenous receptor-mediated transport system to deliver small molecule drugs, biologics, and nucleotide therapeutics into the brain. Ophidion believes this technology can be applied to deliver therapeutics for the treatment of various CNS disorders and brain malignancies. We are currently focused on developing a pipeline to deliver gene-silencing therapies to treat neurodegenerative diseases, including Huntington’s disease as well as diseases of Cognitive Impairment (e.g. Alzheimer’s disease, Parkinson’s disease, etc.). In addition, we have an analgesia program that involves a non-opioid mechanism of action. The platform technology is amenable to delivering multiple classes of drugs, including small molecules and macromolecules (gene therapeutics,siRNA’s, antibodies, peptides, and other macromolecules). Ophidion owns seven issued patents, four in the US, two in Japan, and one in Europe, and is prosecuting additional patents. We have MTAs with several Pharma companies assessing the ability of OCCT to deliver their molecules into the brain. In addition to its own therapeutic pipeline, Ophidian intends to make the OCCT platform available for licensing

Prima Innovations has developed a topical muscle relaxant, designed to relieve the pain, tenderness, limitation of motion, and restriction in activities of daily living associated with skeletal muscle spasm.  Since this product is applied topically, it will avoid the side effects often seen with orally administered or injected drugs such as drowsiness, headache, nausea, etc..  Hence, Prima’s product is positioned to fill one of the gaps in a multi-billion-dollar pain and muscle spasm market.  

We are very excited about the recent animal data we have generated with our molecule PI-002 (1,2 Hexanediol).  The data strongly suggest that topically applied PI-002 will have a significant benefit towards preventing and inhibiting skeletal muscle cramping and spasticity, with few if any systemic side-effects, while preserving normal muscle function.  As you know there is a large unmet medical need with only marginally effective products approved for this indication with serious side-effects, and there are NO topicals approved or in development that we are aware of.  We believe that PI-111 will be a useful and effective topical treatment to improve the quality of life in patients with with a variety of indications including neurological disorders such as multiple sclerosis to weekend warrior athletes who have over done it.  In addition, a number of these indications are orphan diseases and we would benefit from the regulatory benefits afforded orphan drugs. 

Our current strategy is to complete the studies required for clinical testing.  We believe we have the option of pursuing a traditional IND pathway or a 505b2 regulatory path which would be a faster and more economical path to approval.  Prima is seeking funding to advance this product towards achieving a muscle relaxation claim. They are seeking $500K seed capital. 

To Learn more: https://primainnovationsllc.com/

PepVax, Inc. is an early-stage biotechnology company developing a DNA-based drug delivery and development platform. Our novel DNA plasmid delivery system takes a simplified method to delivery and our “Trojan Horse” approach uses the patient’s own cells to manufacture the required proteins, T-cells and antibodies in vivo for cancers, infectious and genetic diseases.

PepVax, Inc. is an early-stage biotechnology company developing a DNA-based drug delivery and development platform. PepVax’ co-founder, Dr. Anton Dormer, is a leading expert in peptide design and protein development through computational biology, having developed bioinformatics tools for cancer drug development. Co-founder Mr. Mahesh Narayanan is an experienced entrepreneur in the field of biotechnology, leading the business development strategies for PepVax.

Nucleic and amino acid-based (NAA) drugs, which encompass vaccines, oncolytic viruses, adjuvants, siRNA, and adoptive t-cell technologies, could create a market of over $200 billion by 2025, changing the entire landscape of oncology and infectious diseases. PepVax will be addressing three problems that currently exist with immunotherapy: delivering the drugs effectively, boosting the immune system for better response, and creating new generation of immunotherapies for various diseases on a proven platform. PepVax is designed to enhance this market with its small core of key employees, strong outsourced partners.

PepVax’ SMARTmid™ Vector design is our fully synthetic method for producing plasmid vector particles for mammalian cell transduction and is a powerful template in which to build a drug delivery and immuno-adjuvant platform that could be licensed to the biotechnology and pharmaceutical industry, giving them opportunity to develop in vitro proven treatments, establishing credibility of our rapid development model.

PepVax is current in a $4MM Series A.

To Learn more: http://www.pepvax.co/index.html

VivaVacs is an early-stage immunotherapy company that has completed testing of its cancer vaccines/therapies in mice with very promising results. VivaVacs is offering a DNA vector cancer immunotherapy that overcomes the previously low activity of these treatments. The novel approach combines the DNA vector with an activating adjuvant to prevent tumor resistance and reduce relapse. Our patented immune system activating immunotherapy prevents cancer progression in at least 4 different mouse cancer models: breast cancer, colon cancer and two different liquid cancers MDS and Leukemia. It has also the potential for application to other cancers. The VivaVacs vaccine has shown promising preclinical data and the next step is to bring these treatments to clinical human trials. Recent COVID related trials have further highlighted the potential of DNA/RNA vaccines.

Vivavacs is also considering accelerating its Orphan Drug Status currently “on hold” via a Compassionate Use protocol, as another Partnership opportunity.

They are seeking initially $700 and up to $1.25M to get into the Humans. VivaVacs is discussing with potential Pharma partners the possibility of a licensing event at that stage. If not, an additional $3M would allow us complete Phase 1-2.  

To Learn more: http://vivavacs.com/

NavIntus is an early-stage biotechnology company formed in 2021 to advance groundbreaking DNA-based drug delivery research in the management of chronic pain. Incorporating a “Trojan Horse” platform, this novel DNA plasmid delivery will target the NAv1.7 pathway to offer a non-opioid alternative to chronic moderate-to-severe pain using the patient’s own cells to manufacture the required proteins.

NavIntus’ mission is to advance the science of gene therapy in chronic pain for improved quality of life without the risks of dependence and addiction associated with opioids.  Following early development, NavIntus plans to sell or license its DNA-based drug delivery and development platform for chronic pain within 5 years.

They are conducting fundraising campaign of $3.5MM to clinical trials.

CaperRx, Inc. is a seed stage biopharmaceutical company focusing on a selective proprietary peptide inhibitor of a newly characterized single transduction target, CAPER, that when suppressed, facilitates killing of tumor cells leaving normal cells untouched.  We expect little to no off-target effects. 

CAPER is short for co-activator of AP-1 (activator protein-1) and Estrogen Receptor(ER) that has been shown to be involved in breast cancer pathogenesis.  CAPER is overexpressed in tumor cells. Suppression of CAPER, using our proprietary selective peptide, will block proto-oncogene DNA repair mechanisms in cancer cells resulting in cell death through apoptosis. CAPER should play a special important role in the response of TNBC (Triple negative breast cancer cells) to anti-cancer therapies that involve DNA damage/repair mechanisms.  It is feasible to assume inhibition of CAPER will directly alter the response to these therapies by preventing efficient DNA repair mechanisms. Other combinations, including immune-stimulation modulators will also be evaluated in combination. 

They are seeking $500K to complete POC Preclinical Studies.

Synergy Therapeutics was formed in 2020 to develop a new way to overcome resistance to conventional chemotherapy, with an immediate focus on the large class of oncology therapeutics called the Kinase Inhibitors.  Every cancer has one or more kinase inhibitors approved to treat it.  The challenge is that each of these choices only delays tumor progression for a few months, and while they slow down growth of tumors, none of these agents is a cure.  Nearly all Kinase failure is a consequence of acquired resistance during the treatment.  Synergy has developed a rapid means of detecting resistance to Kinase Inhibitors. Furthermore, when resistance is identified, Synergy has a treatment to offer that uses an albumin fusion protein that initiates p53 mediated apoptosis of kinase resistant tumor cells.  True synergy is achieved when the p53 fosters a programmed cell death in kinase resistant tumor cells.  The business model of Synergy Therapeutics is to offer its fusion p53 protein as a means of combination treatment with kinase inhibitors that are developing resistance in tumors, and to include an effective means of identifying target combinations for specific patients in a true personalized therapy environment.

They are seeking $500K to complete POC Preclinical Studies