Presenting Companies

Aethlon Medical is focused on addressing unmet needs in global health.  The Aethlon Hemopurifier® is a clinical-stage immunotherapeutic device designed to combat cancer and life-threatening viral infections. In cancer, the Hemopurifier® depletes the presence of circulating tumor-derived exosomes that promote immune suppression, seed the spread of metastasis and inhibit the benefit of leading cancer therapies. The Hemopurifier® is also an FDA designated "Breakthrough Device" related to the treatment of life-threatening viruses that are not addressed with approved therapies. Additionally, Aethlon owns 80% of Exosome Sciences, Inc., which is focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disease progression.

Allevi, Inc. believes 3D tissues will have a huge impact on humanity and create an entire new industry. We help scientist print personalized patient tumor organoids unseen before in the lab. We have shipped our solutions to all corners of the globe. We are helping make personalized prognostics a reality.

Alpha Cancer Technologies Inc. (ACT) is a private clinical stage biotechnology company with products under development in oncology and auto-immune disease indications. The company’s drug products use our proprietary recombinant human alpha fetoprotein (AFP) with unique immuno-oncology properties.  ACT has exclusive worldwide rights to the targeted delivery platform Alpha Fetoprotein with over $100 million spent on the development of the in-licensed technology. Clinical studies of AFP have demonstrated safety in over 300 patients and established a robust Drug Master file with the FDA including manufacturing, toxicology, and human safety.

Aphios® Pharma LLC is dedicated to the discovery, development and commercialization of FDA-approved cannabis-based drugs for cancer and supportive care, central nervous system (CNS) disorders and other debilitating diseases. We will discover, manufacture and deliver pharmaceutical-grade natural cannabinoids in stable, bioavailable nanoformulations, following current good manufacturing practices (cGMP) of the FDA under Schedule 1 licenses from the Drug Enforcement Agency (DEA). These cannabinoid nanoformulations will be used to establish clinical evidence for treating highly unmet diseases such as cancer, cancer induced peripheral neuropathic pain (CIPNP), cachexia related to cancer and/or cancer therapy, and chemotherapy induced nausea and vomiting (CINV) as well as CNS disorders such as opioid addiction, epilepsy and multiple sclerosis that are only partially and anecdotally addressed by medical marijuana.

Apricity Health’s mission is to improve the quality and experience of care for both patients and their healthcare providers. Apricity Health has harnessed the knowledge and experience of the world’s experts in cancer and IO therapy, adopted best practices in privacy and security to develop ApricityCare™ with advanced analytics, mobile and cloud technology. ApricityCare™ is an intelligent and interactive care pathway that: 1) facilitates early detection and timely intervention of irAEs by empowering patients and their clinical team with longitudinal monitoring and communication tools, and 2) disseminates best practices in irAE management by putting world-class expertise in the hands of practicing oncologists in the community.

Cambium Oncology LLC is a pre-clinical start-up founded early 2018 focused on the development and commercialization of novel immune-oncology therapeutics. The Company’s lead compound has demonstrated significant improvement in survival rates in animal studies for pancreatic cancer, melanoma, leukemia and lymphoma. This compound also has potential for viral infection and auto-immunity. Cambium Oncology seeks a $10M Series A to fund a Phase I clinical trial for pancreatic cancer as its first application of one of 14 technologies licensed from Emory University and Georgia Tech.

Can Fite Biopharma's anti-cancer drug candidate Namodenoson is in Phase II clinical trial for the treatment of patients with advanced liver cancer. The drug is a small molecule orally bioavailable with an excellent safety profile and lack of hepatotoxicity. Drug proof of concept has been demonstrated in a former Phase I/II study. The drug targets the A3 adenosine receptor, highly expressed in cancer but not in normal body cells, with high affinity and selectivity. Data from the ongoing Phase II study are expected to be released in the next couple of weeks. Orphan and fast track status have been granted by FDA

Capella Therapeutics' lead drug candidate LL-191, for the treatment of non-small cell lung cancer and resulting brain metastasis, holds the potential to be a first-in-class drug for one indication and a best-in-class drug for another. LL-191 has clearly demonstrated superior efficacy over Tagrisso™ in eliminating brain metastases in several mice models. Additionally, LL-191 demonstrated great in vivo safety and tolerability, mainly resulting from a superior wild-type EGFR selectivity. In contrast to Tagrisso™ and other potential competitors who target one single resistant mutation only (EGFR T790M), LL-191 additionally targets resistant tumors driven by HER2 overexpression/amplification, which constitutes a second largest Tarceva (or Iressa)-resistant population and treatment for these patients under a background of EGFR mutant driven NSCLC is a highly unmet medical need

CONCARLO Holdings, LLC, a pre-clinical stage drug development company, is committed to addressing unmet needs in oncology. Our first therapeutic candidate, IpY, is effective at inhibiting tumors in a variety of breast cancers. IpY disables the “on-off “switch that regulates cyclin-dependent kinases which are integral to tumor growth and metastasis.

Founded in 2013 and headquartered in Raleigh, North Carolina,  FLAG Therapeutics, Inc is an early-stage oncology company focused on the development of therapies based on two investigational product platforms--the Anti-angiogenic & Anti-tubulin (AA/AT) platform and Purine Synthesis Inhibitor (PSI) platform - designed to harness the power of multiple therapeutic actions targeted by highly water-soluble small molecule compounds.  Engineered to specifically overcome the shortcomings of conventional cancer therapies, namely efficacy, tolerability and drug resistance issues, FLAG’s investigational compounds hold the potential to treat multiple cancer types, including brain, lung, ovarian, and pancreatic.   To date, over $25 million in non-dilutive funding has been used to synthesize, optimize and screen compounds in vitro and in vivo, resulting in a library of thousands of promising compounds. 

Geneius is a private biopharmaceutical company run by the Former CEO of Bluebird Bio focused on the discovery and clinical development of adoptive T cell therapy products that address the treatment of cancer and infections. The company has created a good manufacturing process, or GMP, for the production of T cells from peripheral blood for infusion into the patient, allowing for manufacturing at a price of 1/10th that of traditional CAR-T.  Geneius' targeted DiversiTy™ platform is a novel ex vivo approach that re-educates T cells to become responsive to multiple, previously overlooked tumor antigens. Geneius' lead product candidate, GNS-TEBV-001, is currently in preclinical testing for EBV+, NHL, gastric and nasopharyngeal cancers.  Geneius also has two additional products, GNS-TGBM-002 and GNS-TPC-003, in preclinical testing for glioblastoma and pancreatic cancer, respectively.

Genomic Expression is finding the best drug for the patient and the best patient for the drug by sequencing RNA. Analyzing RNA is able to tell if the tumor will respond to the new immune therapies, which is the only kind of therapy that is a potential cure. We entered into a strategic relationship with IBM to provide our analytics in a HIPAA compliment environment.  Genomic Expression started as the diagnostic partner in the $32M Danish “Genome Denmark" project, and we have subsequent developed our platform with the goal of improving outcomes for cancer patients.

GLAdiator Biosciences is based upon a novel delivery platform that targets a foundational biological property of tumor cells, the exposure of phosphatidylserine (PS) on the surface of the tumor cell. Our novel delivery platform addresses existing challenges to antibody drug conjugates, cell penetrating peptides and the delivery of novel therapeutic formats - namely poor targeting and inefficient transport into the tumor microenvironment and tumor cells, leading to off target toxicity and suboptimal dosing. The target specificity for cell surface exposed PS and subsequent internalization into the cell affords the potential to develop more effective and targeted therapies, including the targeted delivery of nucleotides.

Immix Biopharma, Inc. is a privately held, biopharmaceutical firm focused on developing safe and effective therapies for cancer patients.  In preclinical studies, Immix flagship, platform candidate, Imx-110,  demonstrated efficacy against gliobastoma, triple negative breast, colorectal and ovarian cancer models.  Imx-110 is a first-in-class combination therapy designed to inhibit cancer resistance and evolvability, while inducing apoptosis, encased in a nano-sized delivery system. The nanoparticle payload is expandable in that it can be bound to any targeting moiety to create a cancer-seeking therapy - delivering even more payload to tumors, if needed.  By targeting the fundamental pathways that are core to evolvability of cancer, Immix hopes to change poor outcomes by enabling therapies to work much more effectively even at lower doses.  The Company recently enrolled its first to Phase I patients.

Immunicom has leveraged the latest, cutting-edge clinical research in immune regulatory pathways and their role in cancer and autoimmune disease to develop a revolutionary immunotherapy platform (Immunopheresis™) for treating cancer and other terminal diseases through a BLOOD FILTERING DEVICE.  We filter a patient’s blood of "blocking proteins" released by cancer cells that suppress the immune system.  Once these proteins are removed, the immune system naturally attacks the tumor and cancer.  Immunicom is led by Amif Jafri, the Former Head of R&D of Cardinal Health.  The company first target is STNFr.  Immunicom is in patient in Mexico, and recently received breakthrough device designation from the FDA.

Immunomic Therapeutics’ was founded in 2005 with leading industry experts including scientific founder, Dr. J. Thomas August from John Hopkins (JHU) to advance its foundational vaccine technology platform, LAMP-vax (“LAMP”). LAMP is an intracellular protein that can act as an “immunological potentiator” when incorporated into nucleic acid vaccines. The LAMP signal sequences can direct the antigen / allergen chimeric protein to activate an important subset of T cells resulting in immune activation and memory, key events for any successful vaccine.

ImmunSYS is a clinical stage immunotherapeutic drug and device company focused on the development of a new late stage metastatic prostate cancer therapy system. The ImmunSYS Phase I data is compelling in that the therapy has delivered a 35% complete response rate in very late stage metastatic prostate cancer patients. The complete responses have been durable, with the longest patient treated over 3.5 years ago and still disease-free. These Phase I results are even more impressive considering that prostate cancers have not responded well to any of the numerous published systemically administered immunotherapy studies completed to date. The Phase I study included treatment of some additional adenocarcinomas which also produced comparable results; therefore, we believe that the ImmunSYS technology potentially represents a major breakthrough in solid tumor cancer therapy.

Incysus is a biotechnology company focused on delivering a novel off-the-shelf product for the treatment of cancer.  By using genetically modified gamma-delta (γδ) T cells, our technologyaddresses the challenges that immunotherapies face when targeting cold, low mutation cancers.  Incysus received approval of an investigational new drug (IND) application by the U.S. Food and Drug Administration (FDA) to test the safety and activity of an allogeneic donor γδ T cell infusion for cancer immunotherapy in a Phase I trial.  Incysus continues to advance our novel Drug Resistant Immunotherapy (DRI) platform with the submission of its second IND filing with the FDA.  Our unique DRI technology offers an elegant approach to immuno-oncology that deals with multiple mechanisms of tumor resistance and immunosuppression. 

From a biopsy, LLTech’s technology determines in 2 minutes and with accuracy of 96% or higher (published papers) if the cells are a benign tumor, malignant tumor, inflammation or normal cells. This avoids the delay of sending the sample to a lab and waiting days for a report. The time saved and ability to begin necessary treatment immediately can greatly benefit patients and reduce costs. LLTech is the only company able to create cellular activity data that identify cells types and enable machine learning automated diagnosis. This is very important for both personalized medicine (biopsy adequacy), surgery (margins) and drug development (monitoring of a drug efficacy on cells / tissue culture).

Lumicell is a technology leader in the field of image-guided cancer surgery. The company is developing a novel system that enables real-time detection of tumor tissue in patients so that no cancer cells are left behind during surgery. The company’s LUM System has unprecedented ability to see and remove cancer cells remaining in the surgical cavity – beyond the margin of the specimen – and has the potential to significantly improve surgical outcomes and reduce healthcare costs by eliminating the need for repeat surgeries. Lumicell is investigating the LUM System in patients undergoing surgery for breast cancer, prostate cancer, colorectal, esophageal and pancreatic cancers. Additional future indications are planned to include surgeries for lung, ovarian, and brain cancers.

NuView Life Sciences is a biotechnology company based in Park City, Utah focused on precision cancer diagnostics and therapeutics improving patient outcomes and reducing healthcare costs.  Applications in development include: a Positron Emission Tomography (PET) imaging agent for the in vivo diagnosis of breast and prostate cancer and an in vitro diagnostic kit that may be used for detecting shed prostate and bladder cancer cells in voided urine.  US Radiopharmaceuticals, a subsidiary of NuView Life Sciences, has 85,000-square-feet of FDA-registered, cGMP medical isotope manufacturing and distribution facilities located in Denton, Texas.

Oncolize uses polymer-based technology that makes new formulation development simple, scalable and affordable.  The Company's InGell-technology consists of biodegradable polymers, that are safe, easy to scale-up and easy to formulate with very different types of drugs: small molecule drugs, peptides, hormones, proteins and anti-bodies, from poorly soluble to highly soluble, with Molecular weights from 100D to 150kD, and loading from 0.01% up to 25% drug weight/volume.    The products are easily injected through thin needles or cathters in any location. Upon injection, the formulation rapidly forms a stable matrix, resulting in the localized drug depot ‘in situ – in seconds’. As the depot degrades, the stored drugs are slowly released into the surrounding tumor.  OncoLize has full and exclusive licenses to the InGell-technology for several types of tumor diseases, and has selected a range of suitable oncology drugs, both generic and novel.

OTraces has developed patent-pending proteomic noise suppression techniques and cloud-based software that enhances blood test accuracy to levels well above the current industry norm.   OTraces is planning to launch a prostate cancer blood test in the U.S. for active surveillance (AS) that would detect the molecular often progression from moderate to aggressive and life-threatening tumors often missed by PSA and other conventional approaches.  The company has similar plans for AS tests both its prostate and breast cancer blood tests in China, subject to additional funding and collaboration with a suitable business partner most likely on a revenue-sharing basis. 

OBT has created, to our knowledge, the only existing detailed molecular library of the cancer-immune cell interface (or synapse). We have used this to develop a number of exciting novel drugs targeting various sub-types of different solid and hematological cancers, including those refractory to conventional and existing IO treatments. OBT will commence shortly a US trial on one of its lead assets (currently in EU trials as well) in high risk breast cancer patients.

SageMedic is creating a 3D micro-tumor assay to help physicians determine the best cancer treatment for their patient. To do so, we take a live tumor biopsy, create hundreds of 3D micro-tumors, expose them to a wide range of anti-cancer drugs (e.g. chemotherapy or targeted therapy), and measure the response to identify the most effective treatment that will be communicated with the treating oncologist.

 

SciTech has developed a unique nano-delivery system (SciTech Delivery Vehicle - SDV) to enable intravenous (IV) delivery of water-insoluble drugs. One such challenged drug is fenretinide which has been shown in extensive clinical trials to be a safe and effective anticancer therapy with targeted cancer destroying activity. The combination of the new SDV and fenretinide has led to SciTech’s first drug product, ST-001, that holds the promise of improving and saving many lives. Fenretinide was clinically tested in more than 3,000 women and was demonstrated to be safe after long periods of use. It subsequently evolved into a cancer therapeutic and was shown to be safe and effective in treating several other cancers. Fenretinide simply kills cancer cells while not harming healthy cells

SignPost - is at the very forefront globally - in the development of a molecular diagnostic test and screen for invasive breast cancers. SignPost can detect all invasive breast cancers, including all subtypes, and all stages from 1 thru 4., The accuracy of SignPost is greater than 99% (for both sensitivity and specificity).

Sonify Biosciences is building a device to gently heat and treat many kinds of cancer. This gentle heat is a kind of thermal therapy called hyperthermia, currently used in clinic to re-sensitize inoperable tumors to chemotherapy and radiation therapy. Despite decades of research, positive patient outcomes, and existing billing and Medicare reimbursement codes, less than 1% of eligible patients receive this lifesaving treatment because currently available devices have not met clinicians’ needs. Sonify uniquely combines well-understood technologies in one affordable, accurate, and noninvasive user-friendly package, redefining the state of the art of hyperthermia devices.

SynDevRx is the first mover in the emerging field of metabo-oncology - the cancer patient population defined by the nexus of cancer and obesity/metabolic dysfunction.  Cancer patients with obesity or metabolic complications like T2D have more aggressive cancer and die faster.  Further, obesity reduces the effectiveness of standard treatments (chemotherapy, immunotherapy, targeted).  Over 10 types of cancer are effected by metabolic dysfunction, making this a multi-billion dollar opportunity. SDX is the first-mover with a novel drug (SDX-7320) to treat these patients.   SDX-7320 has clinical data in late-stage cancer patients showing strong supporting biologic activity (anti-tumor, anti-metabolic) in a Phase 1 clinical trial.  SDX-7320 is protected with 12 granted patents (composition of matter and methods). 

“Veriskin is a medical device company dedicated to facilitating and improving the accuracy of skin cancer screening. Uncertainty in the initial assessment by non-specialist caregivers leads to failure to detect skin cancer at an early, more treatable stage, hundreds of malpractice claims due to false negative diagnoses and many unnecessary specialist referrals and biopsies. Overall, the lack of accurate, objective assessment tool for frontline caregivers leads to preventable loss of lives and costs the healthcare system more than $3B each year. The TruScore device is a proprietary, non-invasive, low-cost (COG<$250), hand-held unit that aids a non-expert user to rapidly (~2 min) and objectively determine whether a suspect skin lesion is cancerous, reducing the number of false negatives and eliminating unneeded escalation of care and biopsies. The patent pending technology works by detecting and analyzing force-induced hemodynamic abnormalities due cancer-induced angiogenesis which is a well-established hallmark of cancer. VeriSkin has developed a proprietary AI algorithm and protocols to achieve unparalleled screening accuracy in differentiating skin cancer from a variety of benign conditions. Pilot clinical studies performed in multiple dermatology clinics have demonstrated sensitivity of ~100% and specificity of 96.7% in screening for any type of skin cancer. The device is intended to be used as a decision support tool during routine physical exams by non-specialists, e.g. nurse practitioners or primary care physicians and eventually, consumers.”

Zomanex is a venture-backed Corporation focused on developing and commercialising of our innovative patent-protected technology, ORAZOM. ORAZOM is an enabling platform technology that improves the solubility and permeability of Biopharmaceutical Classification System (BCS) Class II (low soluble/high permeable) drugs and BCS Class IV (low soluble/low permeable) drugs. BCS Class II drug examples include Atorvastatin (Lipitor), Imatinib (Gleevec) and Ciprofloxacin (Cipro), to name a few, and BCS Class IV drug examples include Paclitaxel (Taxol), Ritonavir (Norvir) and Abiraterone (Zytiga), to name a few. To date, ZOMANEX has identified 60 drugs (40 Class II and 20 Class IV) that can be placed on the ORAZOM platform and has already successfully produced 4 products, namely, BCS Class II Amiodarone and Spironolactone plus Class IV Paclitaxel and Cyclosporine A.

© 2019 Oncology Investor Conference Series