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A Shot in the Arm for Flu Research: Integral Molecular Introduces Off-the-Shelf Reagents to Evaluate 2023/2024 Influenza Vaccine Efficacy

PHILADELPHIA–Integral Molecular, a leader in providing safe, off-the-shelf Reporter Virus Particles (RVPs) to study vaccine efficacy, has expanded its extensive portfolio with RVPs for influenza strains recently recommended by WHO for 2023/2024 seasonal influenza vaccines. These RVPs offer researchers a ready-to-use reagent to reliably test vaccinee serum for influenza neutralization, providing an alternative to the standard assay method requiring laborious preparation of live viruses in cells or eggs.

RVPs are “pseudoviruses” lacking viral components that enable replication, and so are safe under standard (BSL2) laboratory conditions, unlike many viruses or pandemic strains that require restrictive and limited (BSL4) facilities. RVPs display a quantitative and reproducible readout, enabling simple virus infectivity neutralization assays.

Integral Molecular has 20+ years’ experience in RVP production, and all of the company’s RVPs are extensively quality-controlled and validated. With excellent reproducibility and ease of use, RVPs are commonly used as critical reagents for high-throughput testing of hundreds or thousands of samples in vaccine efficacy trials.

“Our experience supplying the industry with RVPs reflecting the rapidly mutating SARS-CoV-2 virus enhanced our ability to quickly respond to evolving viral threats,” said Kyle Doolan, PhD, Director of Research at Integral Molecular. “Our ability to generate a panel of Influenza RVPs so quickly after the WHO announcement, again demonstrates our ability to respond rapidly with research tools that alleviate the burden of producing ‘live’ viruses.”

Integral Molecular’s seasonal Influenza RVPs represent specific strains for influenza A H1N1 and H3N2 and influenza B. Integral Molecular also offers a broad range of RVPs for other influenza strains including A H5N1 and H7N9, along with RVPs for an extensive selection of SARS-CoV-2 variants, and dengue, Zika, chikungunya, Ebola, and Nipah viruses.

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.

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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
8 am PT, 11 am ET, 17:00 CET
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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.

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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.

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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.

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

Integral Molecular Partnership: Context Therapeutics® Nominates CTIM-76 Bispecific Antibody Candidate to Develop Treatment for Claudin 6-Positive Solid Tumors

CTIM-76 named as lead candidate to target Claudin 6 positive cancers

IND submission expected in Q1 2024

Context to host webinar on Thursday, December 1, 2022, at 11 a.m. ET

PHILADELPHIA, Nov. 29, 2022 (GLOBE NEWSWIRE) — Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, today announced the selection of CTIM-76, a T cell-engaging bispecific antibody, as its lead clinical development candidate to target Claudin 6 (CLDN6) positive cancers, resulting from its research collaboration and licensing agreement with Integral Molecular.

CLDN6 is differentially expressed on cancer cells with no or very low expression in normal, healthy tissue. CLDN6-enriched cancers include ovarian, endometrial, testicular, and gastric, among others. With the potential to reach a large patient population and selective expression on cancer cells, CLDN6 has emerged as an exciting drug target.

Context’s lead candidate, CTIM-76, is a CLDN6 x CD3 bispecific antibody that incorporates a highly selective CLDN6 binding arm and a CD3 binding single-chain Fv domain in an IgG format with a silenced Fc that is designed to be functionally monovalent to avoid aberrant T-cell activation and to enhance the safety profile. Research has demonstrated that CTIM-76 is potent with specific lysis of CLDN6+ cancer cells over normal cells and can activate cytotoxic T cells without concomitant activation of free cytokines – critical determinants of immunotherapy safety and activity. Preclinical studies suggest the potential for convenient dosing with low immunogenicity risk and manufacturing can be scalable to address the significant number of patients who are potentially eligible for CTIM-76 therapy.

“This year has been marked by several exciting and significant milestones for Context, culminating in naming our lead CLDN6 clinical development candidate, CTIM-76, a bispecific antibody showing high selectivity for CLDN6,” said Martin Lehr, CEO of Context Therapeutics. “We selected this bispecific based on the specificity which suggests its potential to address the need for potent therapeutic modalities for cancer without compromising patient safety. With the selection of CTIM-76 as our lead CLDN6 candidate, we are well-positioned to rapidly advance our clinical development plan in CLDN6-positive tumors including, but not limited to, ovarian cancer. We have initiated IND-enabling studies and expect to submit our Investigational New Drug Application (IND) for CTIM-76 to the U.S. Food and Drug Administration in Q1 2024.”

“Despite being an attractive target, therapeutic monoclonal antibodies (MAbs) targeting CLDN6 are difficult to discover due to an abundance of closely related family members and an absolute need for high specificity. Context and Integral Molecular have been able to isolate and optimize rare antibodies against CLDN6 that do not cross-react with other CLDN family members,” said Joseph Rucker, Ph.D., VP of R&D at Integral Molecular.

R&D Webinar
On Thursday, December 1, 2022, at 11 a.m. ET, members of the Context team, including management, and Integral Molecular will host a webinar to discuss the selection process and nomination of CTIM-76. There will be a question-and-answer period following the formal presentation. To register for the webinar, please visit https://edisongroup.zoom.us/webinar/register/WN_Am1qwkDwRiSYJm51SpP-TQ.

About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage biopharmaceutical company committed to advancing medicines for female cancers. The Company’s pipeline includes small molecule and bispecific antibody drug candidates that target cancer signaling pathways. Onapristone extended release (ONA-XR), a novel, first-in-class potent and selective progesterone receptor antagonist, is currently in three Phase 2 clinical trials and one Phase 1b/2 clinical trial in hormone-driven breast, ovarian, and endometrial cancers. Context is also developing CTIM-76, a selective Claudin 6 (CLDN6) x CD3 bispecific antibody for CLDN6 positive tumors, currently in preclinical development. Context is headquartered in Philadelphia. For more information, please visit www.contexttherapeutics.com or follow the Company on Twitter and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the selectivity, dosing convenience, potency, binding, scalable manufacturing, and safety profile of CTIM-76, (ii) the expectation to have an IND submission for CTIM-76 in the first quarter of 2024, (iii) the results of our IND-enabling studies and clinical trials, (iv) the potential benefits of our product candidates, (v) the likelihood data will support future development, and (vi) the likelihood of obtaining regulatory approval of our product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise.

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

Integral Molecular Launches New Product Lines of Safe Reporter Viruses for Vaccine Development and Pandemic Preparedness

PHILADELPHIA–Using its extensive experience gained fighting COVID-19 and other virus threats for over 20 years, Integral Molecular has launched an expanded collection of its Reporter Virus Particles (RVPs) that offer a safe and rapid method to study some of the most virulent pathogens including influenza, Ebola virus, and SARS-CoV-2. These critical reagents are used to safely screen patient sera for neutralizing antibody responses generated by protective vaccines.

Integral Molecular’s new RVP offerings feature influenza A H5N1, Ebola virus, and Marburg virus. The company also offers over 70 SARS-CoV-2 RVPs covering all variants of concern and interest, including Omicron BA.4, BA.5 and BA.4.6 subvariants. Integral Molecular has also created custom variants, as well as thousands of mutations in this safe RVP format to enable prediction of viral escape and the creation of better vaccines.

RVPs are “pseudoviruses” that lack the viral components required to replicate and cause disease. Because they can’t replicate, RVPs are safe to use under standard (BSL2) laboratory conditions. In contrast, studying the most deadly ‘live’ strains of viruses such as Ebola virus or pandemic strains of influenza requires highly restrictive (BSL4) facilities, which relatively few laboratories in the world possess.

“With 20 years of experience studying viruses and vaccines, we are excited to launch new products that enable faster and safer vaccine development against the world’s deadliest viruses,” said Sharon Willis, PhD, co-founder of Integral Molecular. “With these safe research tools, the greater scientific community can ramp up studies of new viral threats as soon as they emerge.”

Integral Molecular’s broad range of RVPs also includes a selection of influenza A and B seasonal strains, dengue, Zika, and chikungunya viruses. The company will host a virtual panel discussion of RVP tools for virology research on November 10, 2022.

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.

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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.

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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

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