Presenting Companies

Fall 2019 Conference

AgilVax is a biopharmaceutical company developing antibody-based products to treat multiple types of cancer in combination with existing chemotherapies, radiotherapies, or emerging therapies. The Company has three programs in development; a monoclonal antibody (mAb), an ADC-mAb, and a VLP-based vaccine.

AIVITA Biomedical is a privately held company specializing in the advancement of commercial and clinical-stage programs utilizing curative and regenerative medicines. The Company has a cell therapy platform with 4 distinct subsidiaries, separated by therapeutic category. AIVITA currently has assets in immuno-oncology, retinal degeneration, neurodegeneration, and dermatology.

Aleta Biotherapeutics has developed a unique approach to CAR-T cell therapy. Our novel bridging protein strategy employs payloaded CAR-CD19 T cells to kill any tumor cell type while supporting multi-antigen targeting. The bridging protein platform provides unmatched flexibility and capability to address two critical issues facing cell therapy: CAR-T persistence and antigen escape. We have built a robust package of in vitro and in vivo data that provide strong validation of the bridging protein concept for both hematologic and solid tumor indications. Three programs are entering clinical development in 2019-20 that will yield clinical data in four indications over the next several years.

Arrien Pharmaceuticals is a TMFIELDS Technology Driven Clinical Stage Biopharmaceutical Company. Seeking milestone driven financing for transformative clinical products in $Multi-Million in existing markets with unmet medical needs. Company currently focused on one first-in-class Novel, Oral Small Molecule Immuno-Oncology (I-O) agent ARN-3261 to Clinical Trials and second agent ARN-0953 for Leukemia cancers into IND stage of development. Successfully partnered (Global License Deal in Mid-2017) – Autoimmune/Psoriasis agent ARN-6039/BOS-172767 & 2 others in Pre-IND stage of development.

• ™FIELDS Technology Driven Pipeline, integrates >4600 Fragment Library with rich Empirical/Real-Data driven Fragments against 119 Druggable Targets with 547,400 Data points in IC50/Ki/Kd/EC50.

• Strong, Comprehensive 100% Owned IP with World-Wide filings.

• Clean cap table with common stock, no preferred, no debt.

• Proven management team with significant prior transactions. • Currently raising Series A.

Biomarck Pharmaceuticals; A N.C. based Biopharmaceutical company in Phase 2 clinical development for the treatment of advanced NSCLC and ARDS. Patents issued to 2035. Good safety profile in >200 patients and significant efficacy (ORR=0.02) in NSCLC compared to SOC (pemetrexed/carboplatin). Placebo controlled study ongoing with completion anticipated end 2019. Both indications have block buster potential in the US alone.

Bionetix, Inc. (“Bionetix”) is a development stage biotech focusing on the development of innovative small molecule based new drugs. With the aim of providing novel solutions to patients with high unmet medical needs, Bionetix was founded in 2017 and is developing 2 IND-ready stage candidates (NTX-301 oral targeted anti-cancer agent and NTX-101, topical glaucoma treatment) along with other early stage programs in oncology area. NTX-301 is an orally available Best-in-class DNMT1 inhibitor targeting MDS and AML. NTX-301’s unique property, high potency/excellent safety profile/ease of administration, makes NTX-301 as an attractive preclinical candidate.

Cambium Oncology LLC (“CO”), founded in January 2018, is a pre-clinical start-up focused on developing and commercializing new immuno-oncology therapeutics that target a novel checkpoint pathway. The company has licensed a patented technology from Emory University to use inhibitory peptides designed against immuno-suppressive vasoactive intestinal peptide (VIP) to cause both in vitro and in vivo activation and proliferation of T cells. Administration of VIP-antagonist peptides trigger a robust cytotoxic T-cell mediated immune response in tumor-bearing animals that resulted in reduction of tumor size and increase in survival time. Treatment with a lead peptide (VIP-ANT008) candidate significantly improved anti-tumor activity in animals with pancreatic cancer, melanoma and leukemia. The company is working to raise series A funding to proceed to the next stages of drug discovery and development using VIP antagonists against pancreatic cancer, a $4 billion indication that is in need of efficacious and safe therapeutics.

Cellestia is a privately-owned clinical-stage biopharma active in the field of precision oncology, led by an experienced team of scientists, drug developers and business professionals. Our patented drug, CB-103 along with its companion diagnostic, is a small molecule with an innovative mode of action targeting NOTCH-driven cancers and providing hope for patients with no other treatment options.

A biotechnology company focused on transforming approved drugs with proprietary, targeted transdermal infusion technology. We are focused on bringing new indications or superiority on label to patients for FDA approved products with an initial focus on cancer and cancer supportive care.

At Cognos Therapeutics, our mission is to develop and commercialize medical products that merge therapeutic and diagnostic and sensing technologies using a closed loop Sinnais smart implantable pump utilizing local delivery with metronomic and biofeedback system to treat and achieve and management early detection of disease through personalized healthcare.

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Cue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the body to transform the treatment of cancer and autoimmune diseases. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), is designed to harness the body’s intrinsic immune system without the need for ex vivo manipulation.

EnGeneIC is a clinical stage biopharmaceutical company focused on developing a proprietary, first-in-class nanocell cyto-immunotherapy platform (EDVTM: EnGeneIC Dream Vector) for the targeted delivery of anti-cancer drugs and functional nucleic acids directly inside cancer cells, thereby not harming normal cells, and at the same time stimulating the cancer killing cells of the immune system to achieve dramatic anti-tumor efficacy even in late stage cancer patients. The EDV technology addresses a completely unmet medical need where cancer patients have run out of treatment options and even at such a late stage, the disease can be stabilized and overall survival can be dramatically increased. The EDV also has the potential to achieve a durable anti-cancer response and even remission, all with minimal toxic side effects. Proof-of-concept has been achieved and in 2019, EnGeneIC was presented the prestigious “Most Innovative Company in Australia and New Zealand” award by the Australian Financial Review.

EpiVax Oncology (‘EO’), a precision cancer immunotherapy company, is developing mutanome-directed, neo-epitope personalized immunotherapies. EpiVax Oncology’s immunotherapies are customized and specifically designed for each patient’s tumors, leveraging advances in next generation sequencing and computational immunology. EO’s superior neo-epitope selection process is based on Ancer™, advanced in-silico machine-learning algorithms, exclusively licensed to EpiVax Oncology by EpiVax. EO is addressing major unmet medical needs inadequately addressed by existing immuno-oncology approaches. Incorporated in 2017 and based in New York City, EpiVax Oncology Inc. is a spin-out of EpiVax Inc. EpiVax Oncology leverages EpiVax’s world class excellence in computational-immunology, genomics and vaccine design, built over the last 20 years.

Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen – the Immune Switch Antibody, is a novel anti-Clever-1 mAb with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development.Faron (AIM:FARN) is a clinical stage biopharmaceutical company developing novel treatments for medical conditions with significant unmet needs. The Company currently has a pipeline based on the endothelial receptors involved in regulation of immune response, in oncology and organ damage. Clevegen – the Immune Switch Antibody, is a novel anti-Clever-1 mAb with the ability to switch immune suppression to immune activation in various conditions, with potential across oncology, infectious disease and vaccine development.

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.  IND-Enabling Studies.

Hemogenyx Pharmaceuticals plc ("Hemogenyx") is a publicly traded company (LSE: HEMO) headquartered in London, with its wholly-owned US operating subsidiaries, Hemogenyx LLC and Immugenyx LLC, located at its state-of-the-art research facility in New York City. Hemogenyx is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood diseases and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases. Hemogenyx is developing several distinct and complementary products, as well as a platform technology that it uses as an engine for novel product development. Hemogenyx's main product candidate is a bi-specific antibody CDX for the treatment of relapsed/refractory acute myeloid leukemia (AML) and for conditioning of bone marrow transplants. For more than 50 years, bone marrow transplantation has been used to save the lives of patients suffering from blood diseases. The risks of toxicity and death that are associated with bone marrow transplantation, however, have meant that the procedure is restricted to use only as a last resort. Hemogenyx's technology has the potential to enable many more patients suffering from devastating blood diseases such as leukemia and lymphoma, as well as severe autoimmune diseases such as multiple sclerosis, aplastic anemia and systemic lupus erythematosus (Lupus), to benefit from bone marrow transplantation.

HYD Pharma Inc is a clinical stage biotech company pioneering the use of deuterium in research and development of drugs for the prevention and treatment of various kinds of cancer. HYD Pharma Inc has completed the pre-clinical studies necessary for clinical trial application. HYD Pharma has built up the facility (GMP) able to produce the deuterium depleted active pharmaceutical ingredients (API) for clinical trials. The European Medicinal Agency (EMA) has registered deuterium depleted water (DDW) as API. The deuterium depleted drugs will bring a real solution in the 21st century to treat and cure cancer and metabolic diseases. Founder and CEO of HYD Pharma is Gábor Somlyai, PhD; a Hungarian molecular biologist who is the author of numerous articles and papers in peer-reviewed journals. Somlyai is considered the father of deuterium depletion.

Imago Systems (Lansdowne, VA) has developed a platform software solution, which utilizes the latest in machine learning to re-visualize existing medical/mammography images. Using the existing workflow, Imago ICE will provide a series of visualizations enabling unprecedented levels of detail. It reveals recognizable patterns, enabling clinicians to see lesions that would have been missed (false negatives) and bypass objects they might have mistaken for cancer (false positives). Clinicians will be better equipped to make timely and accurate recommendations for optimal diagnosis and treatment.

Immunophotonics is an early clinical stage biotech company that is developing an intratumoral immuno-oncology drug (IP-001; a carbohydrate polymer) for use in conjunction with standard of care tumor ablation or radiation procedures to induce a systemic anti-tumor immune response. Immunophotonics has received clinical trial approval (CTA) in Switzerland, and is currently preparing for IND submission in the USA.

ImpriMed develops a personalized drug test service designed for pets with cancer. The company's services provide uses of precision medicine techniques to allow veterinary oncologists to find out appropriate chemotherapies by building up a patient-derived database for pet cancer treatment which can be eventually translated into human cancer care, enabling doctors to decide a final treatment regimen based on a data-driven prediction of response success in each individual patient body.

Incysus is a biotechnology company focused on delivering a novel off-the-shelf cell therapy for the treatment of cancer. By using genetically modified gamma-delta (γδ) T cells, the Company’s technology addresses the challenges that immunotherapies face targeting cold, low mutation cancers. Incysus’ immuno-oncology programs include activated and gene-modified adoptive cellular therapies that protect cells from chemotherapy and allow novel combinations to disrupt the tumor microenvironment and more selectively target cancer cells. Since the Company’s inception in early 2016, Incysus has received approval of two Investigational New Drug applications (IND) and has initiated several cancer programs in early pre-clinical stages, including a checkpoint combination program. The Company’s first program is targeted to leukemia and lymphoma and its second program is targeted to the treatment of newly-diagnosed glioblastoma (GBM). In collaboration with our academic partners, including UAB, Incysus has advanced its technology and expects to begin both Phase 1 trials during 2019. For more information, visit www.incysus.com.

KIYATEC leverages its proprietary ex vivo 3D cell culture technology platform to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors.  Our ex vivo 3D cell culture platform enables us to derive live cancer cells from surgical or biopsy tissue specimens in order to create a patient-specific in vivo-like tumor and immune microenvironment in which to accurately model and assess response to investigational and approved cancer therapies.  We’re constantly expanding the scientific boundaries of ex vivo 3D cell culture capability. Our evidence base spans the majority of solid tumor types and cancer drug classes, offering unparalleled predictive utility in the clinic and in drug development.  Our Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory.  Our Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.

Lexent Bio is building novel liquid biopsy technology to change the way we manage cancer. A dedicated team of experienced scientists, clinicians, and engineers, the company works at the intersection of unexplored cancer biology, data science, and clinical medicine. Lexent Bio’s first product is the ConferaDx liquid biopsy system, a therapy response-monitoring liquid biopsy system designed to inform patients and clinicians on the individual response to late stage cancer therapy, weeks to months faster than is possible via imaging or clinical presentation.

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 use of its therapy in patients undergoing surgery for breast, ovarian, prostate, brain, colorectal, esophageal and pancreatic cancers. Additional indications are planned to include surgeries for lung and liver cancer.

Nammi Therapeutics is an Immuno-Oncology company with a mission of expanding the benefits of immunotherapy to all cancer patients. Our strategy is to rewire the tumor environment by using proven liposome technology to co-deliver multiple immune-modulating agents to the tumor. By simultaneously and selectively knocking out the immune escape mechanisms of tumors we can turn immunologically "cold" tumors "hot" and provide both superior efficacy and safety for our products. Finally, our relatively low CoGs and multi-mechanism products will provide an economically feasible and sustainable alternative to current immunotherapies.

NBE-Therapeutics is a private, Basel-Switzerland based, Biotechnology company, focused on developing best-in-class immune-stimulatory antibody drug conjugates (iADCs) for the treatment of cancer. NBE is leveraging in-house developed, proprietary platforms for antibody discovery (Transpo-mAb Display), site-specific conjugation of payloads to antibodies (SMAC-technology) and a highly potent, novel anthracycline-based linker-toxin to develop iADC product candidates with best-in-industry therapeutic index. NBE’s lead ADC, NBE-002, targeting ROR1 is close to IND submission and will enter into first-in-human clinical trials in 2020 targeting solid tumor indications, like triple-negative breast cancer (TNBC), lung-adeno-carcinoma (LAC), and ovarian carcinoma.

Oncovir, Inc is developing the potent synthetic, stabilized dsRNA therapeutic viral mimic and broad, multifaceted host-defense activator Poly-ICLC (Hiltonol®), primarily for cancer indications. Oncovir’s extensive preclinical and clinical collaborations with Academia, Governments, and Industry have considerably leveraged resources, demonstrated Hiltonol’s clinical safety, and elucidated mechanisms of action and optimal Hiltonol® methods of use. This includes induction by Hiltonol® of a ‘natural mix’ of interferons, cytokines, chemokines, natural killer cells, myeloid dendritic cells via TLR3 and MDA5, CD8 T-cells, and various other costimulatory factors. Hiltonol’s standalone clinical immunomodulatory and potent vaccine adjuvant actions, and its synergy with aPD1 checkpoint blockers, thus place it at the center of the evolving cancer immunotherapy revolution. Oncovir’s patents, extensive FDA filings, cGMP manufacturing, and initial efficacy data position it favorably towards next steps in commercialization.

 OTraces has been developing its current cancer blood test technology for almost a decade -- keeping a low public and scientific profile in order to focus on building U.S. and international patent applications to support its ambitions of global technological leadership in blood-based cancer detection, diagnosis and screening. With the filing of the recent applications on pancreatic cancer and melanoma, the company’s patent portfolio is believed to have become one of the most extensive and potentially disruptive in the in vitro cancer diagnostic field --- for both active surveillance monitoring and screening tests. This patent portfolio is believed blocking of competition for the use of protein based, low cost, high automation testing. Competitors must collaborate with OTraces or run the risk of missing the big screening opportunity. In essence, the company’s approach is to use serum samples to track protein signatures in the tumor microenvironment (TME) to dramatically improve accuracy and diagnostic content as compared with ctDNA or other approaches. 

Pacylex is a Canadian oncology company exploiting a new discovery in cancer biology with a first in class, small, oral chemotherapeutic, PCLX-001, to turn on cell death selectively in cancer cells. The lead drug PCLX-001 completely eliminates tumors in 4 different animal models of leukemias and lymphomas. PCLX-001 also kills many solid tumor cancer cell lines and retards tumor growth in some animal models of lung and breast cancer. Pacylex completed a pre-IND meeting and is conducting IND enabling GLP tox studies later this year. It will file an IND in early 2020 and begin clinical studies.

Headquartered in Silicon Valley, Paragon Genomics is a fast-growing biotechnology company focused on developing and commercializing ease-to-use and high-quality assay technologies and products for the Next-Generation Sequencing (NGS) and precision medicine markets. Our patented CleanPlex™ technology delivers a 10x faster and 10x more sensitive targeted sequencing solution than existing methods, solving the urgent throughput and detection sensitivity bottlenecks of NGS workflows. Our technology is applicable to many fast growing NGS segments such as tumor profiling, cancer risk assessment, cancer liquid biopsy, pharmacogenetics, inherited disease testing, and immuno-oncology drug discovery.

pHLIP® is a platform technology of pH-sensitive peptides: pH (Low) Insertion Peptides that exploit pH differences between healthy and diseased cells as a biomarker for targeting imaging agents and delivering targeted therapy to cells in acidic diseased tissue, including tumors.  A pHLIP® peptide’s targeting responds to the pH at cell surfaces, where the pH is the lowest, thus providing high sensitivity. pHLIP® peptides exploit folding and insertion across the cell membrane, a cooperative process that gives high specificity.  pHLIP® peptides can be used to target and tether cargo molecules to the surfaces of cells in low pH environments of acidic diseased tissues. The cargo can be an optical marker, a PET, a SPECT, or a MR imaging agent, or an antigen or a protein delivered to induce certain cellular or immune responses.  pHLIP® peptides can also be used for the intracellular delivery of payloads, facilitating the translocation of therapeutic cargoes across the membranes of cells with low extracellular pH, such as those cells found in acidic diseased tissue. These payloads are conjugated to the membrane-inserting end of pHLIP® peptide, typically via a link that is unstable inside the cell.

PIONYR Immunotherapeutics is creating a pipeline of antibody therapeutics that increase the body’s antitumor immunity by turbocharging the immune system within the tumor microenvironment (TME). Our initial approach, called “Myeloid Tuning”™, is designed to enhance the immune system’s anti-tumor response by specifically rebalancing the myeloid infiltrate in the TME.

Proscia is a software company that is changing the way the world practices pathology to transform cancer research and diagnosis. With the company’s Concentriq™ digital pathology platform and pipeline of AI algorithms, laboratories are leveraging new kinds of data to improve patient outcomes and accelerate discoveries. Proscia’s team of technologists, scientists, and pathologists is bringing a fresh approach to an outdated industry, helping the world to keep pace with the increasing demand for pathology services and fulfill the promise of precision care. For more information, please visit proscia.com.

SageMedic’s proprietary technology uses a biopsy of the patient’s own live cancer tissue to create hundreds of biologically similar 3D micro-tumors in our lab.  SageMedic’s 3D micro-tumors are then exposed to multiple treatment options, the responses are measured, and within a week the results will be sent to the physician.

Seneca Therapeutics' oncolytic immunotherapeutic (Seneca Valley Virus, SVV) has proven human safety and indications of efficacy in solid cancer clinical trials. STI's is preparing to reactivate an existing IND and initiate Phase II clinical trials to demonstrate a 2-3X increased response rate for checkpoint inhibitors in high-need indications. SVV has significant advantages over competitors. STI is targeting a high multiple exit with this data.

Shuttle Pharmaceuticals is a clinical-stage biopharmaceutical company developing novel therapies designed to improve cancer cures and clinical outcomes of patients treated with radiation therapy. Shuttle’s pipeline of drugs includes two clinical stage drug candidates and a pre-clinical proton radiation sensitizer and selective HDAC6 inhibitors to stimulate the immune response to antigens on cancer cells. By decreasing cancer recurrences and late-effects after treatment, short and long-term healthcare costs decreases are anticipated for oncology patients during treatment and long-term survivorship.

Brief Co. Description (3-5 sentences); Our humanized mAb, SIWA 318H, selectively targets a SIWA-identified antigen found on senescent cells (“SCs”) and cancer cells. Both cell types have (a) an abnormally high level of glycolysis (known as the Warburg effect in cancer) and (b) a SIWA-identified cell surface antigen which is product of glycolysis (our “Marker”) targeted by SIWA 318H. Our focus is on aggressive cancers that should allow FDA fast tracking. Having shown SIWA 318 binding in numerous cancer cell lines, we showed in vivo that a SIWA 318H mouse homolog statistically reduced SCs and metastatic lung foci while suppressing tumor growth (4T1 triple negative breast cancer model). SIWA 318H has a unique ability to attack tumor cells and clear the tumor microenvironment of senescent cancer associated fibroblast and endothelial cells that secrete immunosuppressive lactate and factors promoting invasiveness and metastasis.

SynDevRx is developing cancer treatments that potentiate the benefits of PI3K inhibitors, one of the most frequently mutated genes in solid tumors.  We are advancing to Phase 2 PoC trials to support our initial FDA registration strategy - SDX-7320 (lead drug) in combination with the PI3Ka inhibitor, alpelisib in 2nd line metastatic breast cancer. 

Intervention Insights is dedicated to giving patients the best possible chance to beat cancer by aligning the interests of providers, molecular labs, and payors in the appropriate, scalable use of precision medicine. Our innovative technology platform, Trapelo™ provides real-time, evidence-based information and full transparency to help oncologists make patient-based decisions with reimbursement assurance from the start.  We believe Trapelo is a win-win solution for oncologists, practices, labs, and payors that need real-time, evidence-based information and full transparency to make patient-based decisions. Everyone wants the best care for cancer patients. By providing access to the latest clinical evidence and facilitating network-wide collaboration, Trapelo makes it possible.

Travera has developed a universal companion diagnostic that personalizes cancer drugs to late-stage patients across multiple cancers and multiple drugs. We use a new measurement tool invented at MIT to directly measure the response of patient's cancer cells to a large panel of cancer drugs, including the 80+ FDA-approved targeted inhibitors. Our universal companion diagnostic guides oncologists to the most effective drugs for their patients, and provides late-stage cancer patients with new therapeutic options.

© 2019 Oncology Investor Conference Series