Search

Contact Us

RESOURCES

Where research scientists come to find up to date resources on antibody discovery against challenging membrane protein targets.

Category: News

Integral Molecular Awarded $1 Million by Commonwealth of Pennsylvania to Support Biotechnology Pandemic Research Center

Integral Molecular group lab photoPHILADELPHIA–Integral Molecular is proud to announce that the Commonwealth of Pennsylvania has awarded the company $1M of funding through the Redevelopment Assistance Capital Program (RACP) that will be used to support the further expansion of the company’s new headquarters and buildout of its Pandemic Research Center in Philadelphia. Integral Molecular recently inaugurated its new headquarters at One uCity Square in Philadelphia, and the upcoming expansion will add an additional 16,000 square feet of office space and laboratory facilities to continue the company’s development and manufacturing of research reagents to study emerging viruses. The fully expanded facility enables the company to double its present workforce in the region, reaching a total of 200 technology jobs.

With 20+ years of experience studying viruses, Integral Molecular has been on the forefront of biotechnology and innovation in Pennsylvania’s response to the COVID-19 crisis. Integral Molecular has developed over 75 variants of safe SARS-CoV-2 “pseudovirus” for researchers seeking an alternative to working with “live” virus capable of causing disease. These research tools are enabling laboratories around the world to develop vaccines and antiviral therapeutics. The company recently expanded its virology offerings to include influenza, Ebola, Marburg, dengue, and Zika pseudovirus reporter particles for safe laboratory testing.

“Scientific discoveries in Philadelphia have had a major impact on our community. We are proud of having the region dubbed ‘Cellicon Valley’ as the birthplace of cell and gene therapy, as well as revolutionary technologies like RNA immunization,” said Vincent Hughes, State Senator of Pennsylvania. “We are thrilled to support Integral Molecular in their mission of pandemic-preparedness and recognize the value of their expansion along with the jobs it will create in the region.” Integral Molecular’s $1M funding received is part of nearly $29M in RACP funding announced by Senator Hughes’ office.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 500 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn
Follow Integral Molecular on Twitter

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Genetic Engineering and Integral Molecular Present – Specificity Testing of Antibody and CAR-T Cell Therapies for IND Using the Membrane Proteome Array

 

Thursday, June 22, 2023
Watch the webinar

Rigorous specificity analysis is critical for successful drug development and a safety requirement for antibody-based therapies, such as CAR-T, entering IND. Tissue cross-reactivity (TCR) studies have been traditionally used to screen for off-target binding; however, their predictive value for in vivo safety and toxicity is poor. Integral Molecular has developed the Membrane Proteome Array (MPA) platform to de-risk antibody-based therapeutics by testing specificity across the full human membrane proteome expressed in live cells. Using sensitive high-throughput flow cytometry to identify binding interactions on a protein level, this technology has emerged as the leading solution for antibody specificity profiling.

In this GEN webinar, our panelists will discuss their experiences using the MPA to rapidly identify potential off-target interactions, resulting in successful IND filings for CAR-T cell therapies where conventional approaches did not suffice. We will also describe the newest additions to this 6,000-protein cell array and the status of its consideration by the FDA as a qualified Drug Development Tool.

With a focus on specificity screening, this webinar assembles experts in antibody discovery and development and features presentations from Integral Molecular, Cabaletta Bio, and The University of Pennsylvania.

  • Understand how Integral Molecular’s MPA is used to identify potential off-target binding liabilities
  • Learn how MPA data supports IND submissions with advantages over traditional tissue cross-reactivity studies
  • Discover how the MPA was used to rapidly evaluate the specificity of novel CAR-T cell therapies for autoimmunity and cancer

 

GEN and Integral Molecular Webinar- Specificity Testing of Antibody and CAR-T Cell Therapies for IND Using the Membrane Proteome Array. Headshots of webinar speakers: Rachel Fong of Integral Molecular, Darshil Patel of Cabaletta Bio and Donald Siegel of University of Pennsylvania.

Integral Molecular Opens New Research Center in Philadelphia Encompassing Pandemic Preparedness Laboratories
Integral Molecular Ribbon cutting at uCity Square
Integral Molecular inaugurates its new research center on April 20, 2023.
The ribbon-cutting ceremony brought together the company’s co-founders and leaders, Ben Doranz, Sharon Willis, Joseph Rucker, and Ross Chambers, elected government officials Philadelphia Mayor Jim Kenney and Pennsylvania State Senator Vincent Hughes, along with current and retired members of the University City Science Center, Tiffany Wilson and Curt Hess.

Pictures by Todd

PHILADELPHIA–Integral Molecular, a founding member of Philadelphia’s biotech community, announces the official opening of its 32,000 square foot headquarters and integrated research facilities that will include its pandemic preparedness laboratories. Integral Molecular is the first tenant to move into One uCity, a 13-story, 400,000 square foot commercial research building that will celebrate its opening later this year.

Integral Molecular has been at the forefront of Pennsylvania’s response to the COVID-19 pandemic, and the company’s technologies for studying viruses have contributed to its extraordinary growth since 2020. When fully occupied, the company’s new site will accommodate 200 employees and add 100 new technology-based jobs to the region. This growth doubles the footprint of Integral Molecular’s headquarters and comes just a few years after its last expansion in 2019, which saw the opening of a second research facility.

“Our expansion in uCity Square marks a new and exciting time for Integral Molecular,” said Ben Doranz, co-founder and CEO of Integral Molecular. “Throughout the pandemic we have provided safe ‘pseudovirus’ particles as a critical reagent to vaccine developers seeking alternatives to ‘live’ virus. With our expanded infrastructure, we have more capacity for R&D and manufacturing and can quickly mobilize our technologies to combat future viral threats.”

Integral Molecular inaugurated its new site yesterday in an event attended by Philadelphia Mayor Jim Kenney and local leaders. The company’s new laboratories at One uCity are now fully operational, and planning is underway for a second phase of expansion.

“Integral Molecular is a long-time leader of Philadelphia’s biotech community and we are thrilled to see the company expand in our booming life sciences hub,” said Philadelphia Mayor Jim Kenney. “Philadelphia is the birthplace of cell and gene therapy. Currently, there are billions of dollars of life science projects in various stages of planning and development in Philadelphia, setting the stage for tremendous growth in jobs and scientific advances. Integral Molecular continues to produce innovative research solutions and help companies around the world advance therapeutics while expanding skills-based job training opportunities for Philadelphians of all ages.”

“Integral Molecular has been at the forefront of Philadelphia’s burgeoning life sciences community for over two decades and embodies all that our ecosystem has to offer in terms of talent, research, and collaboration,” said Pete Cramer, Vice President, Development at Wexford Science & Technology. “We are thrilled to support and celebrate Integral’s continued growth and expansion at uCity Square.” One uCity is the newest addition to the uCity Square innovation community being developed by Wexford Science & Technology, Ventas, Inc. (NYSE: VTR), and the University City Science Center.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 500 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn
Follow Integral Molecular on Twitter

About uCity Square
Located in Philadelphia’s University City neighborhood, uCity Square is an 8.0 million-square-foot mixed-use community consisting of laboratory, clinical, office, retail, and residential space. As the central hub for medical and life science innovations, particularly in cell and gene therapy, uCity Square is surrounded by top-tier colleges and universities, independent research institutions, world-renowned hospitals, and is a center of connectivity for residents, students, professionals, and entrepreneurs alike. The project is a joint development by developer Wexford Science & Technology, LLC, real estate investment trust and capital partner Ventas, Inc. (NYSE: VTR), and the University City Science Center.
For more info: www.ucitysquare.com.

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
One uCity Square, 25 N. 38th St., Philadelphia, PA 19104
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Integral Molecular Reveals Mechanism Underlying Exquisite Specificity of Claudin 6 Therapeutic Antibody Being Developed for Solid Tumors

PHILADELPHIA–Integral Molecular, the industry leader in antibody discovery for membrane proteins, has published the targeting mechanism enabling best-in-class specificity of its Claudin 6 (CLDN6) antibody CTIM-76 being developed for cancer therapy with Context Therapeutics. CLDN6 is a tumor-specific protein found in multiple solid tumors—including ovarian, endometrial, lung, gastric, and testicular—but absent from healthy adult tissues. Until now, its structural complexity and similarity to related proteins has hindered efforts to develop safe and selective therapeutics, with most CLDN6 antibody clinical trials being halted due to specificity-related safety issues. The similarity of the target to widely expressed Claudins 3, 4 and 9 means that non-specific binding could kill otherwise healthy tissues.

Publication Details
In their recent publication (Screnci et al., iScience December 2022), Integral Molecular scientists describe the isolation of highly specific CLDN6 antibodies that use a single atomic contact point centered around amino acid 156 to derive exquisite specificity. This interaction site allows the antibody to bind CLDN6 but not any of the other 24 claudin family members.

Key findings include:

  • Best-in-class specificity of CLDN6 antibodies compared to clinical benchmarks
  • Unusual steric hindrance mechanism of the gamma carbon on Q156 discovered as critical for absolute specificity of antibodies for CLDN6 versus CLDN9
  • CLDN6 antibodies exhibited excellent developability

“We are thrilled to be progressing high-specificity antibodies to safely target Claudin 6-positive tumors,” said Ross Chambers, PhD, VP of Antibody Discovery at Integral Molecular. “The ability of our antibodies to interact specifically with Claudin 6 is extraordinary since the target and related proteins differ by just a few atoms at the binding site.”

Integral Molecular’s MPS Antibody Discovery Platform is tailored to discover rare antibodies with maximal epitope diversity. Integral Molecular is co-developing CTIM-76 with Context Therapeutics to treat ovarian cancer and other solid tumors. CTIM-76 is a CLDN6xCD3 antibody that brings cytotoxic T cells into proximity with CLDN6-expressing tumor cells to initiate cell killing. Investigational New Drug (IND)-enabling studies are currently underway, and Context expects to submit an IND application for CTIM-76 to the U.S. Food and Drug Administration for first-in-human trials in the first quarter of 2024.

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn
Follow Integral Molecular on Twitter

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Public Relations
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

Genetic Engineering and Integral Molecular Present – Reporter Virus Tools to Combat Current Viral Threats and the Next Pandemic

 

Thursday, November 10, 2022
Watch the webinar

The COVID-19 pandemic has brought virology to the forefront of many research programs. But how do we get ahead of the next viral threat? Limited commercial labs are licensed to conduct research using BSL-3 or BSL-4 pathogens. However, reporter virus tools such as ready-to-use Reporter Virus Particles (RVPs, i.e., pseudoviruses) have enabled virus research in a BSL-2 environment, allowing testing of sera and antibodies in high-throughput, safe neutralization assays to accelerate virology research.

In this GEN webinar, of our distinguished speakers, Dr. Hayley Crawford, will discuss Integral Molecular’s broad catalog of RVPs, including influenza A and B, Marburg virus, and the latest variants of SARS-CoV-2. Moreover, she will discuss Integral Molecular’s expertise in custom RVP projects. Additionally, panelists Dr. Sheila Keating and Dr. Natalie Anosova will describe how Integral Molecular’s extensive collection of SARS-CoV-2 variant RVPs enabled them to meet the most recent FDA guidance for variant testing of vaccines and therapeutic antibodies.

Learn more about how RVPs have enabled therapeutic research during the COVID-19 pandemic and how they can enhance virology research on current and emerging viral targets.

GEN and Integral Molecular 2022 webinar

Integral Molecular Licenses Claudin 18.2 Monoclonal Antibodies to CARTEXELL for Oncology Cell Therapies

PHILADELPHIA—Integral Molecular, the industry leader in discovering antibodies against complex membrane protein targets, has licensed a panel of monoclonal antibodies (MAbs) to CARTEXELL, enabling CARTEXELL to develop CAR-T cell therapies using Integral Molecular’s Claudin 18.2 (CLDN18.2) MAbs.

Under the terms of the agreement, Integral Molecular will provide an exclusive worldwide license to CARTEXELL to use the panel of high-affinity, high-specificity, and fully humanized CLND18.2 MAbs for the development of CAR-T cell therapies against solid tumors including gastric, lung, pancreatic and esophageal cancers. CARTEXELL will be solely responsible for all research, development, and commercial activities.

The CLND18.2 MAbs were isolated using Integral Molecular’s MPS Antibody Discovery platform which is uniquely tailored to deliver high-specificity, high-affinity antibodies against the most structurally challenging membrane protein targets including GPCRs, ion channels, transporters, and tight junction proteins.

“Claudin 18.2 is an exciting target for oncology therapeutics since it’s highly expressed in cancers such as gastric and esophageal cancers that are difficult to treat”, said Joseph Rucker, PhD, Vice President of R&D at Integral Molecular. “We look forward to the synergy of our high-specificity MAbs with CARTEXELL’s CAR-T cell therapy technology to bring new therapies to patients.”

“CAR-T cell therapy has revolutionized treatment options for blood cancers, but has been ineffective for solid tumors”, said Jehee Suh, CEO of CARTEXELL. “We are excited by the promise of these Claudin 18.2 antibodies for targeting our CAR-T 2.0 technology which uses engineered cells and vectors to overcome the tumor microenvironment and provide more effective therapies.”

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

About CARTEXELL
CARTEXELL was established by Helixmith’s immunocyte therapy team, which has developed CAR-T treatment technology since 2013, and is the first bio company in Korea to export CAR-T products to biotech companies in the United States. As a leader in the development of next-generation CAR-T treatments for the cancer, we selectively introduce more effective strategies than existing CAR-Ts, such as comparing and selecting the CAR structure, introducing additional genes other than CAR, and selecting the route of administration. CARTEXELL will continue to grow into a global biotech company in the field of gene and cell therapy.

Follow Integral Molecular on LinkedIn
Follow Integral Molecular on Twitter

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Communications
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

FDA Accepts Integral Molecular’s Letter of Intent (LOI) on Membrane Proteome Array Antibody Specificity Test Into ISTAND Drug Development Tools Pilot Program

PHILADELPHIA—Integral Molecular, the leader in antibody discovery against membrane proteins, has been accepted into the U.S. Food & Drug Administration (FDA)’s ISTAND pilot program. This program supports Innovative Science and Technology Approaches for New Drugs and was created to expand the drug development tool types listed in the 21st Century Cures legislation. A major goal of the pilot program is to qualify these tools, thus facilitating regulatory review by allowing them to be used in regulatory (IND, NDA or BLA) applications without needing the FDA to reconsider and reconfirm their suitability.

Despite their reputation for ‘exquisite specificity’, antibodies and antibody-based therapies, such as CAR-T cells, frequently demonstrate unexpected off-target binding. Integral Molecular’s Membrane Proteome Array (MPA) for antibody specificity and safety profiling intends to address ICH-FDA’s in vitro testing recommendations to assess unintended binding of monoclonal antibodies that can result in safety and toxicity issues.

The MPA is one of the largest collections of membrane proteins used for specificity profiling of antibody-based therapeutics, with over 6,000 native-conformation membrane proteins encompassing nearly the entire human membrane proteome. This technology is intended to be compatible with numerous biotherapeutic modalities, including monoclonal antibodies, bispecifics, and CAR-T therapeutics.

“We are thrilled to be working with the FDA’s ISTAND program,” said Benjamin Doranz, CEO of Integral Molecular. “We share the FDA’s interest in developing in vitro technologies to better assess the safety of antibody drugs at an earlier and less costly stage of development.”

FDA has posted a statement on this LOI acceptance to the ISTAND Pilot Program: https://www.fda.gov/drugs/drug-safety-and-availability/cder-and-cber-accept-first-submission-istand-pilot-program

About Integral Molecular
Integral Molecular (integralmolecular.com) is the industry leader in developing and applying innovative technologies that advance the discovery of therapeutics against difficult protein targets. With 20 years of experience focused on membrane proteins and antibodies, Integral Molecular’s technologies have been integrated into the drug discovery pipelines of over 400 biotech and pharmaceutical companies to help discover new therapies for cancer, diabetes, autoimmune disorders, and viral threats such as SARS-CoV-2, Ebola, Zika, and dengue viruses.

Follow Integral Molecular on LinkedIn
Follow Integral Molecular on Twitter

Press Contact:
Integral Molecular, Inc.
Soma Banik, PhD, Director of Communications
215-966-6061
info@integralmolecular.com
www.integralmolecular.com

FDA Announcement: CDER and CBER accept first submission to ISTAND Pilot Program

See statement on FDA website.

[9/7/2022] FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) have accepted the agency’s first submission into the Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.

FDA launched ISTAND in 2020 to support development of drug development tools (DDTs) that are considered novel to be used in regulatory applications for new medical products.

DDTs are methods, materials or measures that can facilitate drug development. Certain DDTs, such as biomarkers and clinical outcome assessments, have clearly established pathways for evaluation and application. ISTAND opens additional opportunities for unconventional approaches to be reviewed and accepted by FDA. If qualified, these tools can help optimize drug development and evaluation, potentially expediting the availability of safe and effective drug and biologic products.

ISTAND’s first accepted Letter of Intent (LOI) submission is for a tool that proposes to evaluate off-target protein binding for a variety of biotherapeutic modalities, potentially reducing or eliminating the need to conduct some of the more standard nonclinical toxicology tests. The tool’s developers hope it will improve the accuracy, sensitivity and overall utility of specificity testing of biotherapeutics to support investigational new drug applications.

The LOI acceptance is the first step of the three-step qualification process in the DDT qualification programs, and it is based on several factors, including the scientific merit of the submission, the ability of the DDT to address a specified drug development need, the availability of information and resources that support the proposed qualification effort and demonstration that the DDT is feasible and practical within the proposed context of use. FDA will now work with the applicant to provide feedback on the next qualification step—a qualification plan.

CDER and CBER are excited to kickstart the future of novel DDT development with the first ISTAND LOI acceptance. We look forward to ISTAND’s continued support of innovative approaches to drug development and to the program’s contributions to bringing effective therapies to patients faster.

Genetic Engineering and Integral Molecular Present – Towards IND: Specificity Profiling of Antibody-Based Therapies

 

Thursday, July 14, 2022
Watch the webinar

Rigorous specificity analysis is critical for successful drug development and a safety requirement for monoclonal antibody (mAb) based therapies, such as CAR-T, entering IND. Tissue cross-reactivity (TCR) studies have been traditionally used to screen for off-target binding, however, with poor predictive value for in vivo safety and toxicity.

Integral Molecular has developed the Membrane Proteome Array (MPA) platform to de-risk mAb-based therapeutics by testing specificity across the full human membrane proteome expressed in live cells. Using sensitive high-throughput flow cytometry to identify binding interactions on a protein level, this technology has emerged as the leading solution for antibody specificity profiling.

Towards IND: Specificity Profiling of Antibody-Based Therapies SPeakers

Search