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Category: News

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

Integral Molecular and Optimeos Life Sciences Enter Partnership to Develop mRNA and DNA-Based Gene Therapies Using Molecular Targeting

PHILADELPHIA—Integral Molecular and Optimeos Life Sciences announce a partnership to develop next-generation mRNA and DNA therapeutics that will use antibody-based molecular targeting to direct vaccines and gene therapies to relevant tissues in a patient’s body. This partnership combines Integral Molecular’s experience in antibody discovery and mRNA immunization with Optimeos’ technology for nanoparticle-based drug delivery systems.

DNA and mRNA therapeutics harness a patient’s own molecular machinery to encode proteins. Integral Molecular and Optimeos plan to encapsulate these therapeutic molecules within nanoparticle spheres that are decorated with antibodies on the outer surface. The antibodies can then target the particles to specific tissues. Currently, gene therapies and mRNA vaccines are delivered into the body via infusion or injection, but only a fraction of the molecules arrive at their intended site. The proposed molecular targeting strategy has the potential to transform the delivery of vaccines and therapeutics by dramatically reducing dosages, decreasing toxicity, and enabling scalable administration.

Integral Molecular will apply its industry-leading antibody discovery expertise against complex cell-surface proteins to provide targeting moieties for the therapies. Its specialized MPS Antibody Discovery platform is tailored to work with challenging membrane protein targets and routinely uses mRNA-based immunization strategies. “Precision targeting of an isolated cell type with gene therapy holds great promise for genetic diseases and may provide brand-new directions in cancer immunotherapy including in vivo CAR-T cell therapeutics,” said Joseph Rucker, Co-founder and VP of R&D at Integral Molecular.

Optimeos’ technology allows the robust and scalable incorporation of mRNA and DNA therapeutics and other biologics into customizable nanoparticles. “We are excited to work with Integral Molecular towards the next generation of gene-therapy that no longer relies on viral-based delivery systems,” said Robert Prud’homme, Co-founder and Chief Technical Officer of Optimeos.

Integral Molecular and Optimeos will be attending BIO International Convention in San Diego later this month.

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 Optimeos Life Sciences
Optimeos Life Sciences (optimeos.com) has developed a novel, highly differentiated, non-viral, nanoparticle technology, (iFNP) for delivery of new therapeutic drugs to address important unmet medical needs. The technology is a patented and scalable polymeric drug delivery system, which was developed and refined in Professor Prud’homme’s lab at Princeton University over 20 years. Optimeos’ technology enables encapsulation of mRNA, DNA, peptides, proteins or small molecules, as well as their targeted delivery to cells and tissues beyond the liver.

Pfaff-Kilgore and colleagues describe a comprehensive mutagenesis and functional study of the E1E2 protein of Hepatitis C virus in Cell Reports

Cell Reports Publication HCVPublished in Cell Reports, Pfaff-Kilgore and colleagues describe a comprehensive mutagenesis and functional study (545 individual mutants) of the E1E2 protein of Hepatitis C that enabled us to develop a model of how each amino acid is used in the function of this virus.

Thank you to our scientific team at Integral Molecular and collaborators in the laboratories of Drs. Nicasio Mancini, Justin Bailey, James Crowe, and Mansun Law who made this study possible.

Highlights

  • Test 545 hepatitis C virus (HCV) E1E2 envelope mutations for infectivity and antibody binding
  • Identify residues important for HCV E1E2 folding, interaction and infectivity
  • HCV E1E2 is a fragile protein complex where most mutations compromise function
  • Functional residues of E1E2 are highly conserved across genotypes

See article online

Integral Molecular Breaks Ground on New Headquarters, Doubling in Size

uCity Square Ground Breaking New Integral Molecular SpacePHILADELPHIA—Integral Molecular, the industry leader in membrane protein solutions, announced today that it is starting construction of its new scientific and operational headquarters at One uCity Square, Philadelphia’s largest commercial lab building. This expansion doubles the capacity for the company’s MPS Antibody Discovery pipeline and partnered programs.

The new state-of-the-art facility will encompass 50,000 square feet of combined office and laboratory space, housing up to 200 employees and advanced instrumentation to enable the discovery and development of therapeutic antibodies. The company is a founding member of Philadelphia’s biotech community and recently celebrated its 20th anniversary. Integral Molecular’s current growth phase comes just a few years after its last expansion in 2019, which saw the opening of a second research facility that more than doubled its footprint within the uCity Square community.

“Integral Molecular is a long-time leader of Philadelphia’s biotech community and we are thrilled to see the company’s continued progress and expansion in our city,” said Philadelphia Mayor Jim Kenney in a statement.

“We have experienced extraordinary growth at Integral Molecular while operating under pandemic conditions and are proud of the business challenges that we have overcome,” said Benjamin Doranz, PhD, co-founder and CEO of Integral Molecular. “Despite uncertain times, we have launched technologies that have been instrumental in the fight against COVID-19 and discovered antibodies to combat intractable cancers.”

Integral Molecular’s new facility is being developed by Wexford Science & Technology and Ventas, in partnership with the University City Science Center. The buildout designed by Strada Architecture is being constructed by Turner Construction and managed by PurePM. The new space is expected to open at One uCity in December 2022.

About Integral Molecular
Integral Molecular 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.

Lonza Early Development Services and Integral Molecular to Offer Complementary Expertise to Enhance Early De-risking of Biotherapeutics

Basel, Switzerland and Philadelphia, USA, 25 April 2022 – Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, and Integral Molecular, an industry leader in discovering and characterizing antibodies against membrane proteins, announced today a strategy to offer complementary expertise to their respective customers to better assess the risks of off-target binding of biologic drug candidates.

Unwanted immunogenicity can have severe consequences for patients and jeopardize drug development programs. Therefore, de-risking therapeutics by assessing their immunogenicity potential early is not only a regulatory requirement to support First in Human studies but also an essential tool that can significantly improve a drug candidate’s chances of success further down the development and manufacturing pathway. Immunosafety risk assessments help to ensure that the target molecule has no unwanted immunogenicity, immunotoxicity, or cross-reactivity potential.

The respective expertise can benefit drug developers in the early de-risking of their drug candidates by allowing Lonza and Integral Molecular to complement each other’s offerings in the assessment of the potential for off-target binding and activation. Lonza’s Early Development Services focuses on cell-based assays to evaluate the activity of biologic therapies upon binding. Integral Molecular de-risks therapeutic molecules by detecting off-target binding liabilities using their Membrane Proteome Array platform.

Yvette Stallwood, Head of Early Development Services, Lonza, commented: “Early immunogenicity de-risking significantly increases chances of the future success of therapies as they progress through the development pathway. Lonza’s 14 years of expertise in in silico and in vitro immunogenicity and immunotoxicity assessments complements Integral Molecular’s valuable insights into off-target binding using their Membrane Proteome Array.”

Benjamin Doranz, CEO and co-founder, Integral Molecular, added: “We are pleased to offer complementary expertise to Lonza’s cell-based assay experience for preclinical safety profiling of biologics, thereby offering drug developers a more complete evaluation methodology to select the optimal candidate to move forward to IND filing.”

About the Complementary Offerings

The Lonza services will be provided under an agreement with Lonza and the Integral Molecular services will be provided under an agreement with Integral Molecular.

About Lonza Early Development Services

Lonza Early Development Services offers a comprehensive suite of in silico and in vitro early development services to assist pharmaceutical and biotech companies in de-risking and optimizing their late candidate selection and lead candidate development process. The group, based in Cambridge (UK), also provides early, phase-appropriate non-GMP protein expression via Lonza’s Light PathTM Discovery platform.

About Lonza

Lonza is a preferred global partner to the pharmaceutical, biotech and nutrition markets. We work to enable a healthier world by supporting our customers to deliver new and innovative medicines that help treat a wide range of diseases. We achieve this by combining technological insight with world-class manufacturing, scientific expertise and process excellence. Our unparalleled breadth of offerings enables our customers to commercialize their discoveries and innovations in the healthcare industry.

Founded in 1897 in the Swiss Alps, today, Lonza operates across five continents. With approximately 16,000 full-time employees, we comprise high-performing teams and individual talent that make a meaningful difference to our own business, as well as to the communities in which we operate. The company generated sales of CHF 5.4 billion with a CORE EBITDA of CHF 1.7 billion in Full-Year 2021. Find out more at www.lonza.com.

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About Integral Molecular

Integral Molecular is an 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

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Integral Molecular Partners with Philadelphia FIGHT Medical Clinic to Support Community Health
Integral Molecular participating in Philadelphia FIGHT.

Integral Molecular announces a partnership with Philadelphia FIGHT to provide financial and in-kind donations, as well as volunteer efforts to support healthcare access and equity in Philadelphia. An anchor of the Philadelphia biotech community, Integral Molecular has been an active community citizen throughout its 20-year history. Philadelphia FIGHT operates federally qualified community health centers that provide culturally competent and comprehensive health services to all — regardless of income, insurance, or immigration status.

Integral Molecular’s mission is to develop and apply innovative technologies for difficult-to-treat diseases, and more recently to apply their technologies to combat COVID-19. The racial inequities in healthcare and beyond were brought into sharp relief during the pandemic. In 2020, Integral Molecular’s employees collectively decided to help actively address these inequities, including through the mission of Philadelphia FIGHT.

“Integral Molecular has deep ties to Philadelphia, and for the last 20 years we have been proud to give back through local educational programs including the University City Science Center’s BULB lab program, FirstHand STEM program, and the Wistar Institute’s Biomedical Technician Training Program,” said Sharon Willis PhD, co-founder of Integral Molecular. “We are excited to support FIGHT’s vital mission and continue our commitment to the community.”

Dr. Mario Cruz, MD, Philadelphia FIGHT’s Director of Pediatric and Adolescent Medicine has been working closely with Integral Molecular. When asked about working with the company he responded, “It’s rare to find a community partner that donates not just money, but also time. In addition to the funds, they donated 60 hours of their time and energy, physically helping to beautify our pediatric and adolescent practices — and they donated 300 books! It’s a genuine commitment to support our mission and it is very much appreciated. We are delighted to get to know this team, and the passion for healthcare that drives their research.”

Companies or individuals interested in supporting Philadelphia FIGHT should contact Michael A. Marsico, Chief of Staff, mmarsico@fight.org, 215-525-0784.

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 Philadelphia FIGHT

Philadelphia FIGHT (fight.org) is a Federally Qualified Health Center (FQHC) providing high-quality medical care, including HIV and Hepatitis C primary care, pediatrics, family dentistry, gender-affirming care, behavioral health services, consumer education, clinical research, and advocacy for individuals and families from all walks of life and at every stage of life, REGARDLESS OF ABILITY TO PAY. 

RVP Users’ Group: Omicron RVPs and their role in safe neutralization assessment | February 15th, 11am ET

Join this users’ group to learn about our extensive catalog of SARS-CoV-2 Reporter Virus Particles (RVPs, pseudotyped viruses) including Omicron, and how they enable researchers to rapidly test neutralization titers of antibodies and vaccine sera in a safe BSL-2 environment.

Watch the webinar

We will discuss:

  • Integral Molecular’s extensive catalog of >65 SARS-CoV-2 Reporter Virus Particles (RVPs) and how they can help you safely assess virus neutralization
  • New offerings including Omicron RVPs (available now), and specialized reagents coming soon
  • Case studies of antibodies that bind Spike but permit infection, highlighting the importance of assaying neutralization



Integral Molecular Adds Transgenic Humanized Mice to Expand its MPS Antibody Discovery Platform Through a Partnership with Alloy Therapeutics

PHILADELPHIA — Integral Molecular, the leader in discovering antibodies against multipass membrane proteins, has entered into an agreement to leverage Alloy Therapeutics’ transgenic humanized ATX-GxTM mice as an added strategy to rapidly isolate fully human monoclonal antibodies using Integral Molecular’s MPS Antibody Discovery platform. ATX-GxTM is a suite of immunologically robust transgenic mice that produce antibodies with fully human sequences. Lacking non-human sequences that can trigger severe immune side-effects, the resulting antibodies have high developability.

Integral Molecular’s MPS platform is optimized for discovering MAbs against structurally complex membrane proteins, a valuable group of therapeutic targets. With a 95% success rate in delivering antibodies targeting complex membrane proteins, MPS successes include antibodies recently licensed to Context Therapeutics (Nasdaq: CNTX) and AstraZeneca (LSE/STO/Nasdaq: AZN). Alloy’s ATX-GxTM mice complement Integral Molecular’s proprietary humanized chicken antibody technology (hCAT) now allowing partners to choose their preferred method to isolate fully humanized antibodies.

“We look forward to working with Integral Molecular as a Certified Service Provider to make our antibody discovery platform available to more drug discovery teams,” said Heather Schwoebel, Alloy Therapeutics’ Chief Operating Officer and Head of Business Development. “By harnessing Integral’s technologies, we have already seen exceptional immune responses to difficult targets, such as GPCRs, in the Alloy mice.”

Partners interested in antibody discovery should contact Integral Molecular.

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 Alloy Therapeutics

Alloy Therapeutics (alloytx.com) is a biotechnology ecosystem company empowering the global scientific community to make better medicines together. Through a community of partners, Alloy democratizes access to tools, technologies, services, and company creation capabilities that are foundational for discovering and developing therapeutic biologics. The company facilitates affordable, non-exclusive access to the entire drug discovery community from academic scientists, small and medium biotech, to the largest biopharma. Alloy’s lead offering, the ATX-Gx™ platform, is a human therapeutic antibody discovery platform consisting of a growing suite of proprietary transgenic mice strains. Alloy is headquartered in Boston, MA with labs in Cambridge, UK; Basel, CH; San Francisco, CA; and Athens, GA.

 

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