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

Category: Publications

Webinar presented by Integral Molecular and Fierce Biotech – Redefining Antibody Specificity Profiling for IND

Thursday, June 6, 2024
8 am PT, 11 am ET, 17:00 CET

Assessment of antibody off-target reactivity is a regulatory requirement for clinical development. However, conventional screening methods, such as tissue cross-reactivity studies, are often ineffective in screening newer therapeutic modalities, and their predictive value for in vivo safety and toxicity is poor. So, what are the alternatives?

Join our webinar to learn about the new, innovative cell-based protein array approach to specificity profiling. We’ll take a deep dive into the Membrane Proteome Array (MPA), a 6,000-protein array platform that tests binding of biotherapeutics across the full human membrane proteome expressed in unfixed cells.

Attendees will learn how:

  • Integral Molecular’s MPA is used to rapidly and accurately identify potential off-target binding liabilities
  • MPA data support both lead selection and IND submissions with advantages over tissue cross-reactivity studies
  • Cell protein arrays, like the MPA, are rapidly progressing towards FDA endorsement through inclusion in CAR-T development guidelines and qualification as an antibody Drug Development Tool
 Integral Molecular and Fierce webinar 2024

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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
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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.

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.

Follow Integral Molecular on LinkedIn
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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.

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
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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