Life Sciences on AVX

The pivotal challenges in emerging therapies, such as gene therapy, CAR-T/stem cell therapy, immunotherapy, and regenerative medicine, include daunting characterization, manufacturing, and chemistry (CMC), poor quality control (QC), costs, and biosafety. The CLE technology harnesses a paradigm-shifting approach by chemically, physically blebbing desired cells to produce cell-like vesicles that fully replicate the structure and function of the parent cells. The CLE technology achieves significantly higher yield in a substantially shorter time via incredibly simpler concentration and purification processes than conventional extracellular vesicle (EV) method, resulting homogeneous, stable, and economically competitive products. Additionally, all types of cells are subject to the CLE technology with consistently high efficiency.

Conquering Cancer Metastasis

Recent developments in cancer research have discovered drugs that block kinase pathways that spur cancer growth, and agents that activate the immune system to eradicate tumors. These approaches have revolutionized the treatment of cancer, but are effective in less than half the cases. A critical step in the progression of tumors is when cancer cells gain the ability to metastasize. Here we have developed a class of small molecules that can block two critical steps in metastasis- the movement of cancer cells and thier ability to recruit blood and lymphatic vessels. These therapies could be used to inhibit metastasis of a broad variety of cancer types, with proof of concept data provided for melanoma.

Siege Pharmaceuticals

University of California, Los Angeles

At least half of the US adult population is predicted to have obesity by 2030. While new drugs are coming to market and even more are in the pipeline, they focus on satiety without doing anything to treat the root causes of metabolic disease. Siege’s compounds act through a novel mitochondrial mechanism to not only induce weight loss but also directly address drivers of obesity’s lethal co-morbidities including type 2 diabetes, fatty liver disease, cardiovascular disease, and chronic kidney disease. Templated off of natural molecules, our compounds hit a unique constellation of targets to safely and effectively treat multiple facets of metabolic disease. These same targets have been validated in cancer, where we have shown that daily administration reduces growth of an autochtonous prostate cancer model by 82%.

Precision Surgery Technologies LLC

Tumor margin detection is difficult in head and neck and breast procedures, inadequate resection yields local recurrence, and broad resections are morbid procedure DOCI technology allows the detection of tumor margins without the need for injecting fluorescing material. Currently, there is no validated intraoperative technology to help surgeons identify precise cancer margins. There is a significant gap in the areas of intraoperative cancer margin delineation and precise surgical treatment of head and neck and breast cancer patients. We have developed a solution for this unmet clinical need.

Bio-Zipper

University of California, Los Angeles

The Bio-Zipper has been developed to improve post-surgical patient outcomes and reduce the frequency of surgical complications following lower urinary tract reconstructive surgeries. Current standard-of-care closures have high complication rates (30-day range from 30-68%), and are limited by surgeon experience with the technology (e.g., robotics) and the complexity of the procedure. Staples or adhesives are currently unavailable alternatives for the urinary tract, as they fail to adhere in moist conditions and/or increase the risk of infections, wound breakdown, or stone formation. There are currently 680,000 annual urologic reconstructions performed in the U.S. which would be the initial market for this device. Within this context, the Bio-Zipper has been designed to reinforce suture lines in these complex surgical reconstructions. By doing so, it will decrease 30-day complications (with a mean hospital cost of nearly $30,000 per incidence) by 20%. This will result in a mean savings of $5,600 per procedure.

Neurodegenerative Disease Treatment (RFUMD)

(Note: No company is formed yet. Seeking entrepreneur to lead.) An alternative approach to treatment of AD and other neurodegenerative diseases is to target aberrant pathogenic calcium signaling cascades. Stabilization of calcium signaling targets a pathogenic mechanism that is tied to many major features and risk factors of Neurodegenerative diseases. Compounds and methods for treating neurological diseases by normalizing neuronal calcium dyshomeostasis.

BioSpecimen Technologies, LLC

BioSpecimen Technologies (BST) is a medical device development company with revolutionary patented technologies that greatly improve the quality of patient blood testing in clinical labs, hospitals and RNA/DNA research and testing centers.

MCW Gene Therapy

The Medical College of Wisconsin Office of Technology Development (MCW’s “Tech Transfer Office”) seeks an experienced biotechnology leader to start a new company, license gene therapy IP described below, raise the funding needed and to bring one or more products to Phase I clinical testing. The ideal candidate will have experience with the earliest stages of gene therapy (or other complex biologic) product development and testing. They would understand how to develop a plan, raise funding (whether SBIR, Angel, VC), work with investors, build an effective team and engage with CROs.

ImmunoBlue

University of Pennsylvania

GW researchers developed a cell therapy manufacturing platform that avoids genetic engineering and activates immune cells against multiple, patient-specific target antigens simultaneously. A sample of a patient’s cancer cells obtained by surgery or biopsy is treated with photothermal therapy (PTT) in vitro, delivered by Prussian blue nanoparticles (PBNPs) at an immunogenic thermal dose. Immune cells (e.g. T cells, NK cells) from the patient are then exposed to the PBNP-PTT-treated cancer cells in vitro to activate them against multiple patient-specific, tumor antigens. The activated immune cells are then re-infused to the patient. Preliminary ex vivo data and studies in xenograft animal models show superior specificity of T cells generated through this novel immuno-engineered platform against glioblastoma, over T cells generated through traditional methods.

LignaMed

[Update (8.2023): SBIR/STTR funding total - $7M, NIH Contract - $5.2M] LignaMed is dedicated to developing breakthrough treatments for severe asthma, organ transplant viability, and fibrosis. Its lead drug compound, LGM1506, is a single isomer synthetic small molecule with a unique mechanism of action proven to Improve asthma based on statistically significant data from its completed phase II NIH grant. The company is on track to achieve key inflection points for two of its programs: severe Asthma, with Phase I studies in man possible in 2024 and ex vivo lung perfusion for human donor lungs, with potential market approval under a drug as device pathway in 2024.

CardiacTEEM

Brown University

Cardiotoxicity of pharmaceutical drugs, industrial chemicals, and environmental toxicants can be severe, even life threatening, which necessitates a thorough evaluation of human response to chemical compounds. Predicting risks for arrhythmia and sudden cardiac death accurately is critical for defining safety profiles. Currently available approaches have limitations including a focus on single select ion channels, the use of non-human species in vitro and in vivo, and limited direct physiological translation. CardiacTEEM has developed in vitro 3D models of atrial and ventricular tissues from human induced pluripotent stem cell (hiPSC)-derived cardiomyocytes that can be used to evaluate chamber-specific responses without the need for animals. This self-assembled 3D microtissue technology provides a straightforward way to analyze physiologically relevant metrics like action potential patterns. CardiacTEEM is exploring applications in pharmaceutical development as well as environmental chemical toxicity testing.

SOMA

Brown University

The prevalence of chronic pain is currently on the rise, however, there are few effective and accessible cognitive-behavioral interventions that are widely available to the population experiencing chronic pain. Limited healthcare system capabilities and high treatment costs prevent many patients from receiving or even seeking non-pharmaceutical care. Therefore, there is a need for a more accessible, affordable, and efficacious technology that will allow individuals with acute or chronic pain to track and manage their pain symptoms and triggers. The SOMA Pain Manager is a smartphone application that allows acute and chronic pain patients to track and predict pain. Further, a digital therapeutic program is currently being integrated into the application that will deliver cognitive-behavioral interventions. Overall, the SOMA app provides an easy and accessible option for individuals seeking to manage and treat their pain symptoms.

FUSONEX

Familial adenomatous polyposis (FAP) is a hereditary disease that affects ~50,000 families in the United States and causes the development of hundreds to thousands of adenomas in the rectum and colon. When left untreated, 100% of FAP patients develop colorectal cancer by the age of 45. Although small molecules and monoclonal antibodies targeting mTOR and IL-23 are be tested to treat FAP, these approaches are not specific to polyps and therefore cause a variety of unintended side-effects. Additionally, although genetics studies have identified variants in the APC gene as the causal mutation for FAP, gene therapy technologies need to be optimized to achieve the precision and efficacy necessary to serve as a viable therapeutic option for FAP. This technology is a monoclonal antibody targeting the Annexin A1 (ANXA1) protein complex that may be useful in treating FAP and other cancers related to ANXA1 activity.

Haystack Medical

Haystack Medical is developing microneedles that allow drug delivery into the inner ear. Over 30M US patients need a way to diagnose and treat inner ear disorders - a number that will only grow as the population ages. To date, we've proven Haystack microneedles to be safe, effective, and minimally invasive in guinea pig and human cadaver studies. Our technology is supported by 20+ peer reviewed papers and multiple granted and pending patents. Our team (Aykut Aksit, PhD, Anil Lalwani, MD; Jeffrey Kysar, PhD) has spent a decade developing this technology at Columbia University combining our experience in otolaryngology and surgery as well as in mechanical engineering and materials science.

Sibel Health

Northwestern University

[Update (7.2023) SBIR/STTR funding total: $1.3M] Sibel Health revolutionizes patient care with their bio-integrated, wearable sensors such as the ANNE® Chest Sensor, ANNE® Limb Sensor, and ADAM Sensor. These devices offer clinical-grade monitoring and transmit real-time data for comprehensive clinical care. They measure parameters such as heart rate, respiratory rate, temperature, activity, SpO2 pulse rate, and perfusion index. The wearables are lightweight, flexible, and invisible to wear, making healthcare monitoring both comfortable and efficient. They offer dedicated solutions for adult, maternal, and neonatal monitoring, and specific medical conditions, transforming patient data management.

BiomeSense

University of Chicago

[Update (8.2023): The company raised $6 million through a combination of Seed 3, and Seed 4 funding on February 14, 2023] Integrating proprietary technologies, the GutLab, “smart bathroom” technology for continuous patient microbiome tracking & MetaBiome, a cloud-based bioinformatics platform. Novel tools to continuously track, analyze, and store individual microbiome profiles, providing vastly more data than, and at a fraction of the cost of, current practice. Creating the GutLab, a novel “smart bathroom” technology for continuous, at-home microbiome tracking & MetaBiome, a cloud-based bioinformatics platform. This platform is a generational leap over existing measurement tools: (1) much cheaper and more scalable, (2) produces & analyze dense time-series data, unlocking an entire dimension of never-before-accessible biomarkers, and (3) has far higher accuracy & precision, ensuring all data generated can be stored in a single, standardized database – a first for the microbiome field.

CDR3 Therapeutics, Inc.

University of California, Los Angeles

CDR3 Therapeutics is a pioneer in developing stem cell-based immunotherapies to revolutionize cancer treatment. The company's unique, patented technology overcomes the limitations of current CAR-T therapies, such as reduced functionality and persistence. By using hematopoietic stem cells (HSCs) sourced from patients and adding either CAR or TCR genes, CDR3 creates a self-renewing source of gene-targeted immune cells. The modified cells engrafted into the patient's bone marrow, maintain their performance over time, thus addressing the challenge of solid tumors, an area currently unmet by FDA-approved therapies.

SPARKBio

Over 30% of such withdrawals are due to cardiac toxicity (pro-arrhythmic effects mediated by cardiac ion channels), therefore regulatory agreements mandate the testing of all new drugs for cardiac liability. GW researchers developed the first scalable automated all-optical system for high-throughput cardiac electrophysiology and electromechanics. The system includes a method for combined optical pacing and optical recording from a variety of primary and stem-cell-derived cells and tissues. This platform allows for active dynamic interrogation, such as robust pacing protocols that can reveal Vm, [Ca2+]i or contraction’s frequency response (restitution) and temporal instabilities. The researchers also developed “spark-cell” spheroids which can be used as a reagent that can be frozen, transported, and deployed on-site to confer optical pacing of cardiac cells.

ChemRes Therapeutics

Up to 80% of ovarian cancer patients develop resistance towards platinum based chemotherapy drugs which are most commonly used against cancer. There is an urgent need for therapeutic agents that overcome such drug resistance. We developed small molecule drugs that overcome platinum drug resistance in vivo and in vitro. These compounds inhibit Acidic nucleoplasmic DNA‐binding protein 1 (And1) or sentrin-specific protease 1 (SENP1) and re-sensitize platinum-resistant cancer cells to platinum drugs.

Enviar Therapeutics

Current delivery platforms for RNA and gene editing technologies induce off-target effects and fail to specifically target tissue types. Led by Columbia’s Dr. Fatemeh Momen-Heravi and Dr. Akiva Mintz, the Enviar team has recently developed a novel customizable delivery platform—called SafeExo—based on engineered exosomes. Exosomes naturally carry biomacromolecules including different RNAs (mRNAs, regulatory miRNAs, etc.), DNAs, lipids, and proteins and can deliver their cargoes to the recipient cells, elicit functions, and mediate cellular communications. SafeExo is the first engineered exosome platform capable of eliminating endogenous nucleic acids, which greatly reduces off-target effects. SafeExo is further optimized to enhance RNA stability, CRISPR efficacy, target uptake and specific cell/tissue delivery of large payloads, such as targeted CRISPR/CAS gene editing machinery and RNAi therapeutics. This platform has the potential to treat new diseases and improve current therapies.

Inleptin Therapeutics

Carnegie Mellon University

Note: No company is formed yet. Seeking entrepreneur to lead. Opioids remain an indispensable treatment for severe pain despite increased risk for obese patients with tolerance. Of particular concern is opioid-induced respiratory depression (OIRD), especially during sleep, due to comorbid obstructive sleep apnea common in obese patients. Naloxone is the only drug available that can reverse the adverse effects of opioids and prevent death. However, naloxone has limited use because it reverses analgesia and induces withdrawal. A preventive treatment for sleep-related OIRD that does not affect analgesia or induce withdrawal is critical in patients with obesity. GW and JHU researchers found that intranasal leptin can reverse morphine-induced apneas, hypoventilation, and upper-airway obstruction while enhancing analgesic effects in mice with obesity.

Impact Proteomics

Our company, Impact Proteomics, makes protein sample preparation kits to provide researchers in the pharmaceutical and biotechnology industries with high quality protein samples faster than ever, improving research reproducibility and saving time and money. High quality protein preparations are essential for drug and biomarker discovery, monitoring therapeutic efficacy, biologic drug quality control, and for understanding fundamental cellular processes. For decades, industry and academia have been hindered by incomplete and irreproducible protein sample preparation. These samples are often contaminated with other cellular components and incompatible reagents, such as DNA, salts, and the reagents used to break open cells. Fast, high quality sample preparation can mean the difference between finding a lifesaving drug target or wasting millions of dollars and decades of time on a failed drug discovery project. Impact Proteomics is here to ensure every project reaches its potential.

Vanish Therapeutics

Pain is the second largest burden on the US health care system, and with the advent of the opioid epidemic it has become apparent that patients with chronic pain do not have sufficient treatment options. A proven non-pharmaceutical method of pain treatment is through nerve and spinal cord stimulators, which are devices that are implanted in the body and use electrical signals to control and modulate the perception of pain. In addition, patients report that their pain is controlled long after electrical stimulation has stopped, and the nerve stimulator market has grown to over $3Billion per year. However, these stimulators often require surgery to implant, can cost more than $30,000 and have excessively high failure rates which are estimated to be over 30%, requiring revision operations and rapidly increasing costs to over $100,000 for a single device.

YouBiotics

73.6% (250m people) of the American Population is overweight or obese. Weight disorders place a significant burden on the healthcare system due to increased risk of deleterious disorders such as diabetes, kidney failure, liver failure, cardiovascular disease, and COVID-19. A key issue in reducing weight gain in the population is that weight loss therapies are not covered by insurance, unless patients are severely obese or possess multiple co-morbidities, requiring patients to pay nearly $1,500/month. Considering that persons in lower socio-economic standing are more likely to be overweight or obese, it is unsurprising that the prevalence of obesity continues to rise. These expensive weight loss therapies aim to alter an individual’s metabolism, which is very difficult to accomplish and often yields significant side effects with long-term use.

Reach Neuro

[Update (8.2023): Venture funding total - $750k] Stroke is an incredibly pervasive problem that directly affects one quarter of the world’s population. Unfortunately, many of these people are told they will never regain functional use of their arm or hand. With Reach, they will. One of our patients was able to cut food with a fork and knife and feed herself for the first time in 9 years since having her stroke. In contrast to existing assistive tools such as functional electrical stimulation, Reach’s device allows the user full control over complex and naturalistic movements. Advantages of the technology: • Assists movements in all upper limb joints • Restores naturalistic and voluntary movements • Immediate improvements • Assists users in performing tasks of daily living • Eligible for chronic stroke patients even years after their stroke • Uses standard implant device and surgical procedure • Does not require donning and doffing bulky equipment

Respair

University of California, Santa Barbara

Ventilator Associated Pneumonia (VAP) is viewed as an inevitable consequence of long-term ventilator support rather than a preventable infection. In fact, VAP develops in 1 out of 3 intubated patients in intermediate care units. Along with the high prevalence, VAP has an average mortality rate of almost 50%. As a result, hospitals utilize procedural steps to prevent VAP in patients (such as head elevation and maintaining oral hygiene), but these actions fail to adequately prevent the root cause of VAP which is that current endotracheal (ET) tubes, or breathing tubes, do not create a long-term and effective seal in the trachea to prevent bacteria from entering the lungs. These tubes fail to create a proper seal because they employ an inflatable cuff that (1) deflates over time, (2) does not maintain consistent contact with the airway surface, and (3) is susceptible to shifting position with every patient movement. These design flaws allow harmful bacteria to pass the cuff and enter the lungs of patients.

Milo Sensors

Millions of people all over the world face challenges with alcohol. One of the more traditional solutions people first consider is Alcoholics Anonymous. Through market research, we have learned that more and more non-traditional solutions are being sought out to supplement the recovery journey and we, at Milo Sensors, believe we can provide an option for the supervised or self-monitoring of alcohol consumption. Unlike other existing alcohol monitoring tools such as ankle bracelets, ION™ is designed for the wearer first, with discretion, comfort, and usability at the forefront. Common industries that benefit from similar monitoring devices, such as the criminal justice system or family law, seem to follow only after the recovery support network has failed and act as a punitive measure. In contrast, we aim to help anyone who seeks to improve their general wellness by focusing on their relationship with alcohol and then help rebuild trust with surrounding family members and supporters.

smartHER

smartHER is a mixed reality (MR/AR)-based medical device company focused on developing innovative solutions for gynecologic procedures, with an initial focus on rehauling how MRI scans are utilized for uterine fibroid removal. The company is spinning out of Weill Cornell Medicine (WCM) where it has gained significant traction by developing a MVP. It has received multiple awards for its novel product design, established strategic partners in several relevant domains (e.g., women med device, cloud computing, and MR software), and is in the process of validating the technology through a clinical study. smartHER is looking to hire its inaugural Chief Executive Officer (CEO).

Futura

University of Minnesota

Due to the rapidly growing use of opioids and its analogs (and the increase of fatal drug overdoses), Narcan is rapidly becoming the new Kleenex. Vaccines offer a promising treatment alternative to counteract opioid use disorders (OUD) and fatal overdoses. Vaccines generate opioid-specific antibodies that bind the target opioid, reducing the drug's impact on the brain and preventing the drug-induced effects. Futura is developing vaccines, antibody-based strategies, and small molecules to counteract opioid use disorders and overdose. These approaches can improve the lives of people living with substance use disorders or who are at risk of fatal overdoses. The team is testing the first in-human vaccine against the euphoric and toxic effects of oxycodone and have initiated Phase I Clinical Trials. Futura and UMN is seeking a leader co-found the venture with Dr. Pravetoni.

synLubricin

Lubrication is critical in biology for tasks such as joint flexing and eye movement, but aging and disease can reduce natural lubrication. Current lubrication solutions either exhibit a short half-life (such as cortisone and hyaluronic acid) or poor long-term bio-compatibility (such as exogenous lubricants like glycerin-mineral oil), leaving a market opportunity to develop a durable, bio-compatible lubricant. synLubricin is a stable, and scalable, long-term bio-lubricant for joints, eyes, and medical devices. synLubricin has been developed in FDA-approved human cell culture systems and is able both to resist cellular adhesion and lubricate biological surfaces, such as cartilage. synLubricin is searching for a co-founder to help develop this venture opportunity.

EncapBio Systems

Cell replacement therapies hold tremendous promise for type 1 diabetes, hemophilia, lysosomal storage diseases and other cellular disorders. EncapBio Systems has developed technologies for safe and functional delivery of cell therapies ready for pre-clinical development. Most of our recent work, ranging from material synthesis and device fabrication to cell engineering and process integration, has been centered around the goal of successfully delivering safely insulin producing cells with long-term function for T1D patients. EncapBio Systems builds upon 10 years of research of high quality proof-of-concept publications and patent applications. EncapBio Systems is seeking co-founders and investors to help build the next biomaterial platform for cell therapy.

Aracari Biosciences

[Update (8.2023) SBIR/STTR funding total: $1.3M] Aracari’s vascularized microphysiological systems are leading the way in preclinical drug testing. Aracari’s vascularized 3D Vascularized Micro-Organ (VMO) and Micro-Tumor (VMT) models incorporate perfused human vasculature for the physiologic delivery of nutrients, drugs and immune cells to multiple tissue and tumor types. These powerful next-generation tools are accelerating development of immuno-oncological and other therapeutics for more optimal patient outcomes. Aracari is seeking a Chief Business Development Officer as they expand their C-level team. (Crunchbase 2021: $1.2M Funding from NSF.)

Carver Biosciences

Princeton University

(Update 9.22 - Closed $3M seed round by Khosla Ventures). Broad-spectrum antiviral therapies do not exist, tragically hindering our ability to respond to viral outbreaks and pandemics. We need new approaches to treat these diseases, as existing therapeutics are very narrow-spectrum and take many years to develop. Carver Biosciences is a startup company developing CRISPR-based therapies for RNA viruses that infect humans. Carver’s approach is a programmable, platform technology that could offer a generalizable solution for treating many viruses, as targeting is dictated by a guide RNA sequence. The underlying technology, CARVER, was developed by founder Cameron Myhrvold during his time as a postdoc at the Broad Institute of MIT and Harvard and was published in Molecular Cell in 2019.

cAPAcity Genomics

Genome-wide association studies (GWAS) have identified thousands of noncoding variants associated with human traits and diseases. However, translating these variants into therapies continues to be a significant challenge. Alpaca Genomics has constructed a multi-tissue atlas of human 3′ UTR alternative polyadenylation (APA) quantitative trait loci (3′aQTLs), connecting thousands of noncoding GWAS variants with the APA of target genes, identified in 49 tissues isolated from 838 individuals (sourced from the Genotype-Tissue Expression Project). Alpaca Genomics is using 3’aQTLs to discover novel APA-linked susceptibility for many human diseases, such as diabetes, prostate cancer, coronary artery disease (CAD), Alzheimer’s Disease (AD), Parkinson's disease, and Amyotrophic lateral sclerosis (ALS).

Velox Biosystems