Archives for April 2020

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc., (“ITI”) a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, announced today the close of a $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs. This represents the second closing in the investment process for the HLB Consortium, ($10M was placed in February 2020), and substantially increases their holding in Immunomic Therapeutics to 47.6% of the common stock. HLB also secured an option to make further investment into the company in the months ahead.

“We are pleased to welcome HLB as a significant shareholder of Immunomic Therapeutics and look forward to working with them within the framework of the HLB Bio family of companies. They have a proven track record of success in Asia and share our commitment and passion for developing best-in-class therapies for cancer and other serious diseases,” said Dr. William Hearl, CEO of Immunomic Therapeutics. “With HLB’s support, we are well-positioned to accelerate our efforts in immuno-oncology, in particular glioblastoma multiforme, and rapidly advance other key candidates in our pipeline, including our most recent initiative into infectious diseases with development of our vaccine candidate for COVID-19.”

Proceeds from the financing will support the acceleration of ITI’s Phase II clinical trial of ITI-1000 for the treatment of glioblastoma multiforme (GBM), advance its emerging pipeline, and expand upon the current applications of its UNITE platform. The financing will also enable Immunomic to expand its team and infrastructure to support the future growth of the company.

In addition, ITI and HLB intend to establish an Asian Brain Cancer Research Center in Seoul that will bring together the world’s leading experts and cutting-edge science to advance research in the GBM field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by ITI’s UNITE platform that is currently being evaluated in a Phase II clinical trial (ATTAC-II) in collaboration with researchers at the University of Florida (Dr. Duane Mitchell) and Duke University (Dr. John Sampson). ITI-1001 is an alternative, cell-free approach to treating GBM. The company held a successful pre-IND meeting earlier this year for ITI-1001 and expects to be able to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA) by the end of 2020.

Concurrent with the financing, five (5) members from HLB Co., LTD will be joining the Immunomic Therapeutics Board of Directors.

About UNITE

ITI’s investigational UNITE platform, or UNiversal Intracellular Targeted Expression, works by fusing pathogenic antigens with the Lysosomal Associated Membrane Protein, an endogenous protein in humans, for immune processing. In this way, ITI’s vaccines (DNA or RNA) have the potential to utilize the body’s natural biochemistry to develop a broad immune response including antibody production, cytokine release and critical immunological memory. This approach could put UNITE technology at the crossroads of immunotherapies in a number of illnesses, including cancer, allergy and infectious diseases. UNITE is currently being employed in Phase II clinical trials as a cancer immunotherapy. ITI is also collaborating with academic centers and biotechnology companies to study the use of UNITE in cancer types of high mortality, including cases where there are limited treatment options like glioblastoma and acute myeloid leukemia. ITI believes that these early clinical studies may provide a proof of concept for UNITE therapy in cancer, and if successful, set the stage for future studies, including combinations in these tumor types and others. Preclinical data is currently being developed to explore whether LAMP nucleic acid constructs may amplify and activate the immune response in highly immunogenic tumor types and be used to create immune responses to tumor types that otherwise do not provoke an immune response.

About Immunomic Therapeutics, Inc.

Immunomic Therapeutics, Inc. (ITI) is a privately-held, clinical stage biotechnology company pioneering the development of vaccines through its proprietary technology platform, UNiversal Intracellular Targeted Expression (UNITE), which is designed to utilize the body’s natural biochemistry to develop vaccines that generate broad immune responses. UNITE has a robust history of applications in various therapeutic areas, including infectious diseases, oncology, allergy and autoimmune diseases. ITI is primarily focused on applying the UNITE platform to oncology, where it could potentially have broad applications, including viral antigens, cancer antigens, neoantigens and antigen-derived antibodies as biologics. The Company has built a large pipeline from UNITE with six oncology programs and two allergy programs. ITI has entered into a significant allergy partnership with Astellas Pharma and has formed several academic collaborations with leading Immuno-oncology researchers at Fred Hutchinson Cancer Research Institute, Johns Hopkins University of Medicine, and Duke University. ITI maintains its headquarters in Rockville, Maryland. For more information, please visit www.immunomix.com.

Contacts

ITI Company:
Sia Anagnostou
aanagnostou@immunomix.com
717-327-1822

ITI Media:
Amy Conrad
Juniper Point
amy@juniper-point.com
858-366-3243

Harrisburg, PA – Today, Department of Community and Economic Development (DCED) Secretary Dennis Davin announced the creation of the Pennsylvania Manufacturing Call to Action Portal, which will mobilize manufacturers that are producing COVID-19-related products and supplies or can pivot to producing COVID-19-related supplies.  “As we work to protect public health and safety and create a robust supply chain, we know that there are manufacturers across the commonwealth who are willing and able to help,” said Sec. Davin. “This portal will help facilitate the connections businesses need to get critical COVID-19-related products to market or retrofit their operations to begin production of those products.”  The portal was developed through a joint effort between DCED, the Pennsylvania Manufacturers’ Association, the Pennsylvania Chemical Industry Council, Ben Franklin Technology Partners, the Hospital and Healthsystem Association of Pennsylvania, IRC Network, Life Sciences PA, Pennsylvania Life Sciences Greenhouses, and the PA Chamber of Business and Industry.  Last week, Governor Wolf announced the creation of the Commonwealth of Pennsylvania Critical Medical Supplies Portal to source the most needed supplies for medical providers, emergency responders, and health care professionals. The Pennsylvania Manufacturing Call to Action Portal builds on those efforts to help manufacturers produce COVID-19-related supplies or retool their operations to begin creation of those supplies.   The Pennsylvania Manufacturing Call to Action Portal will help facilitate business connections for expansion of supply chain capacity and manufacturing innovation. The goal is to match manufacturers and distributors to fill specific supply chain needs to meet increasing demands for medical supplies and related products, assist manufacturers that have workforce needs or gaps and aid them in identifying skilled workers, and identify manufacturers that can pivot or innovate to fulfill the demand for medical supplies and related products.  Pennsylvania’s manufacturers, distributors, and other suppliers should visit the portal to report their critical supply chain capabilities, needs, or workforce gaps or innovative opportunities, which will help DCED staff identify opportunities and solutions.  Questions can be directed to RA-DCEDPAMCTAP@pa.gov. For the most up-to-date information on COVID-19, Pennsylvanians should follow www.governor.pa.gov and www.doh.pa.gov.

Expansion Meets Industry Demand for Pre-Clinical Models for Cancer and Environmental Research

State College, PA (23 January 2020) – INDIGO Biosciences, the recognized industry leader in nuclear receptor research, has announced the addition of four zebrafish assays to its portfolio. These additions both expand INDIGO’s robust portfolio of in vitro animal model assay systems and offer a first-in-class zebrafish model – an animal model previously only available as a live-model system.

“The addition of zebrafish assays to INDIGO’s portfolio gives discovery scientists the ability to make key determinations on the correct animal model for their research with an ortholog that was not previously available before entering animal trials. We are dedicated to expanding the offerings available to our customers, ensuring that researchers can be confident that they are ready to take the next step in development,” says Dr. Jack Vanden Heuvel, Chief Scientific Officer of INDIGO.

Zebrafish are becoming an increasingly popular model system for environmental toxicology, developmental, and biological research as their easy maintenance, high reproduction rate, and transparent appearance makes them highly versatile. In addition, since most compounds can easily penetrate the skin of the zebrafish, drug and toxicological screenings are able to be performed simply by adding these test compounds to their water. For researchers looking at nuclear receptor activity, zebrafish provide an attractive model as nearly all of the 48 human nuclear receptors are also present in the animal model.

In vitro assays, such as those offered by INDIGO, allow researchers to determine the correct animal models before entering trials, by providing important early indications of that compound’s potential for downstream concerns. With animal studies required by the FDA, selecting the animal model that provides the most representative human-surrogate is critical to assessing a potential drug’s likelihood of unwanted effects. Cell-based assay models are crucial to help make this determination prior to entering ADMET studies.

The four new zebrafish nuclear receptor assays available from INDIGO include the Androgen Receptor (AR), Estrogen Receptor Alpha (ERa), Peroxisome Proliferator-Activated Receptor Gamma (PPARg), and Thyroid Receptor Beta (TRb). Each is available both as a screening service or as an all-inclusive assay kit, which includes: optimized media for use during cell culture and in preparation of test compound treatments, reference agonists, luciferase detection reagents, and an assay plate.

About INDIGO Biosciences, Inc.

INDIGO Biosciences, Inc. is a leading provider of nuclear receptor and in vitro toxicology solutions that accelerate scientific decision-making. INDIGO supplements the world’s largest portfolio of nuclear receptor kits and services and in vitro toxicology solutions with greater results readability, reproducibility, and faster turnaround times. Our solutions, plus supportive team and reliable science and platforms aim to reduce the time, cost, and risk associated with the discovery process. Learn more at www.indigobiosciences.com.