RESOURCES

Integral Molecular Expands Partnership with Japan’s Life Sciences Distributor Funakoshi to Provide Access to Antibody Specificity and Epitope Mapping Services

PHILADELPHIA – Integral Molecular has expanded its partnership with Funakoshi, a leader in distributing life science research reagents and services, to be the exclusive provider of Integral Molecular’s therapeutic antibody characterization technologies in Japan. The partnership will provide researchers with access to antibody characterization technologies optimized to deliver IND-ready results in as little as 4 weeks, including off-target specificity profiling using the Membrane Proteome Array and high-resolution epitope mapping using Shotgun Mutagenesis.

Detailed specificity and epitope analysis are critical for therapeutic antibody success and intellectual property protection. Integral Molecular’s antibody characterization platforms are designed to succeed even with structurally complex targets such as membrane proteins, have been used by over 400 companies, and are published in over 300 peer-reviewed publications.

“We have a long-standing partnership with Integral Molecular, having distributed their Lipoparticle products for more than 8 years,” said Tetsuya Ikeda, President and CEO of Funakoshi. “We are pleased to extend our offerings to include Integral Molecular’s unique antibody characterization services.”

Off-target antibody binding can result in severe adverse events, especially when antibodies are used to direct cell killing, as with CAR-T therapeutics. The Membrane Proteome Array (MPA) was developed by Integral Molecular to detect binding of antibodies, cells, and other biologics to 6,000 native proteins, comprising 94% of the human membrane proteome.

Epitope data support antibody patents by demonstrating antibody novelty, differentiating from prior art, and supporting written description requirements. Integral Molecular’s Epitope Mapping platform provides mapping at single amino acid resolution using comprehensive mutagenesis and is >95% successful even when working with complex targets and conformational epitopes.

About Integral Molecular

Integral Molecular (www.integralmolecular.com) is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. 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 Funakoshi

Funakoshi Co., Ltd. (www.funakoshi.co.jp) is the leader in distributing reagents and instruments for researchers in the life science fields. Their corporate mission is to provide high quality products to a broad range of customers throughout their domestic and international network.

Integral Molecular Webinar & User Group Towards IND: Specificity Profiling of Antibody Therapies Using the Membrane Proteome Array

Tuesday, June 15, 2021
Watch video

Mistargeted therapies can cause serious side effects and clinical failures. Learn about using the Membrane Proteome Array to identify off-target reactivities of antibody and cell therapies and the importance of these data for lead selection and regulatory submissions.

Webinar Agenda

• Re-examine the long-held assumption that antibodies are exquisitely specific
• Learn what to do next if your molecule shows detectable off-target binding
• Discover how Membrane Proteome Array specificity data is used to satisfy regulatory requirements

We share your commitment to developing therapeutics for difficult-to-treat diseases. With 20 years of experience, our research team is dedicated to helping programs like yours succeed.

Context Therapeutics and Integral Molecular Enter Collaboration and License Deal for Novel Claudin 6 Antibodies for Gynecologic Cancer Therapeutic Program

PHILADELPHIA, PA—APRIL 8, 2021—Context Therapeutics, a clinical-stage women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers, and Integral Molecular, the leader in discovering antibodies against multipass membrane proteins, today announced a research collaboration and licensing agreement for the development of an anti-claudin 6 (CLDN6) bispecific monoclonal antibody (BsMAb) for gynecologic cancer therapy.

CLDN6 is a membrane protein expressed in multiple cancers, including ovarian, endometrial, lung and gastric cancers. The protein is absent from healthy adult tissues and high levels in patient tumors are correlated with poor prognosis.

Under the terms of the agreement, Integral Molecular and Context will develop CLDN6 bispecific antibodies that trigger the activation of T cells and eliminate cancer cells displaying CLND6. Context will conduct preclinical and all clinical development, as well as regulatory and commercial activities through exclusive worldwide rights to develop and commercialize the novel CLDN6 candidates. Integral Molecular will receive an undisclosed upfront payment and will be eligible to receive development, regulatory and sales milestone payments and high-single-digit to low-double-digit percent royalties on net sales. IND-enabling studies of the first BsMAb candidate are expected to commence in 2022, with advancement to clinical stage anticipated in 2023.

“The structural complexity of CLDN6 and its similarity to proteins expressed on healthy tissue have previously limited its exploitation for targeted oncology therapies,” said Martin Lehr, chief executive officer of Context. “By combining Integral Molecular’s expertise in the field of antibody discovery and Context’s experience developing therapies for women’s cancers, we hope to develop a best-in-class targeted therapeutic for CLDN6-positive gynecologic tumors.”

To overcome the challenges associated with antibody discovery against CLND6, Integral Molecular employed its MPS antibody discovery platform designed to isolate antibodies against the most challenging membrane protein targets.

“Our CLDN6 monoclonal antibody exhibits best-in-class target selectivity,” said Benjamin Doranz, Ph.D., chief executive officer of Integral Molecular. “There is a strong need for therapies that provide more specific and less toxic treatments for gynecologic cancers, and we look forward to our partnership with Context that will enable better treatments for women.”

About Context Therapeutics®

Context Therapeutics LLC is a women’s oncology company developing advanced small molecule and immunotherapy treatments to transform care for hormone-driven breast and gynecological cancers. The company’s robust clinical program for lead candidate onapristone extended release (ONA-XR) comprises four ongoing Phase 2 clinical trials in hormone-driven breast, ovarian and endometrial cancer, as well as a window of opportunity trial in breast cancer. ONA-XR is a novel, first-in-class complete antagonist of the progesterone receptor, a key unchecked mechanism in hormone-driven women’s cancers. Also nearing the clinic is a cutting-edge bispecific antibody targeting Claudin 6, a potential revolutionary immunotherapy for gynecological cancers. Context is headquartered in Philadelphia, PA. For more information, visit www.contexttherapeutics.com.

About Integral Molecular

Integral Molecular (www.integralmolecular.com) is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. 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 virus.

Integral Molecular Announces Best-in-Class Antibodies Against Complex Oncology Target Claudin 18.2

PHILADELPHIA – Integral Molecular, the leader in discovering antibodies against multipass membrane proteins, announces fully optimized, high-affinity lead monoclonal antibodies (MAbs) against Claudin 18.2 (CLDN18.2), a structurally complex oncology target overexpressed on numerous solid tumors. The CLDN18.2 antibodies discovered using the company’s MPS antibody discovery platform are ready to progress towards preclinical studies and are completely humanized, unlike the Phase 3 clinical benchmark.

“The structural complexity of CLDN18.2 and the widespread expression of closely related family members has made discovery of highly specific antibodies against CLDN18.2 challenging,” said Ross Chambers, VP of Antibody Discovery. “Our exquisitely specific, picomolar affinity lead candidates show stronger binding than the most advanced clinical antibody and are a testament to the ability of our platform to yield antibodies against difficult targets.”

Integral Molecular’s MPS platform combines multiple proprietary technologies that enable antibody discovery against otherwise intractable targets. This includes Lipoparticles to present complex antigens for immunization and phage panning, immunization of divergent species and Humanized Chicken Antibody Technology (hCAT), which delivers simultaneous humanization and affinity maturation.

Integral Molecular showcased its CLDN18.2 MAbs at the virtual PEGS Europe (Protein & Antibody Engineering Summit) earlier this month. CLDN18.2 is expressed in multiple cancers, including lung, pancreatic and esophageal cancers, but shows limited expression in healthy adult tissue. The company is currently isolating MAbs against dozens of membrane protein targets for internal and external discovery partners.

About Integral Molecular
Integral Molecular (www.integralmolecular.com) is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. 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 virus.

Integral Molecular Partners with China’s Leading Preclinical CRO JOINN for Comprehensive Specificity Testing of Antibodies and CAR-T Therapeutics

PHILADELPHIA – JOINN Laboratories, China’s leading preclinical contract research organization (CRO), has partnered with Integral Molecular to provide researchers in China with rapid antibody specificity testing against the entire human membrane proteome using Integral Molecular’s Membrane Proteome Array (MPA) technology. The ability to select lead candidates with high specificity will reduce safety liabilities prior to clinical development of therapeutic antibodies and CAR-T cancer treatments.

Off-target binding of antibodies can result in severe or life-threatening adverse events, especially when antibody binding is used to direct cell killing, as with CAR-T cell therapeutics. Specificity testing using Integral Molecular’s MPA is now routinely included in investigational new drug (IND) applications submitted to regulatory agencies.

“At JOINN, we provide preclinical research services for most of the CAR-T cell therapeutics being developed in China,” said Mr. Leon (Jingliang) Gu, EMT & VP of JOINN Laboratories. “We understand the possible consequences of misdirected cell killing and why MPA data represents a valuable component of preclinical packages submitted to the U.S. FDA and the National Medical Products Administration (NMPA) in China.”

The MPA antibody specificity profiling service was developed by Integral Molecular as a comprehensive approach to detect binding of antibodies, cells, and other biologics to membrane protein targets for early de-risking of drug development. The MPA is the largest library of human membrane proteins, covering 94% of the membrane proteome and includes nearly all G protein-coupled receptors (GPCRs), ion channels, and transporters expressed in live cells.

About Integral Molecular
Integral Molecular (www.integralmolecular.com) is the industry leader in discovering and characterizing therapeutic antibodies against membrane proteins, an important group of drug targets found on the surfaces of cells and viruses. 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 virus.

About JOINN Laboratories
JOINN Laboratories is the pioneer of commercial GLP laboratories in China and was the first preclinical CRO to be inspected by the U.S. FDA for GLP compliance in China. JOINN has an excellent track record spanning over two decades in efficacy studies and IND enabling GLP toxicology studies and is the oldest privately-owned non-clinical safety evaluation institute.