Intract Pharma London, UK (“Intract”) has today announced a publication on the collaboration with Merck & Co., Inc., Rahway, NJ, USA, on the pre-clinical proof-of-concept study evaluating colon targeted delivery of JAK inhibitor using the Phloral® technology in the journals of Pharmaceutics (https://www.mdpi.com/1999-4923/14/11/2385).
The study demonstrated the validation of gastric emptying and lower GI release of enteric Phloral coated capsules in a rat model, enhanced tissue PK and reduced systemic PK of tofacitinib when delivered to the lower GI compared to immediate-release formulations which led to superior downregulation of proinflammatory IL6 in a LPS induced rat colitis model.
The research conducted over 3 years between scientists from Intract and Merck & Co. successfully demonstrates the potential for oral targeted delivery of JAK inhibitor to achieve improved efficacy through enhanced colon tissue concentration, and better safety profile by minimizing systemic exposure since JAK inhibitors have been linked to serious cardiovascular and cancer events1.
“This research is another example of how targeted delivery of commercially available therapies can improve upon their safety and efficacy currently being achieved by conventional formulations,” said Vipul Yadav, CEO at Intract Pharma. “We look forward to building further on this research and validating the concept in large animals and eventually in patients suffering from moderate-to-severe ulcerative colitis where there is a critical need for safer JAK inhibitor medicines to allow improved patient access.”
About Intract Pharma
Intract Pharma is biopharmaceutical company bringing disruptive oral small molecule and biologics delivery solutions to significantly improve the efficacy and safety of emerging and established biotherapeutics and improve patient experience and outcome. The platform leverages the advantage of delivering large proteins/antibodies to the colon, while also protecting the biologics from enzymatic breakdown allowing tissue/systemic uptake to create next generation oral biologic medicines. For more information visit us at www.intractpharma.com.
Intract Media Contact
Dr Vipul Yadav
CEO
Intract Pharma Limited London, UK (“Intract”), and Elasmogen Limited, Aberdeen, Scotland (“Elasmogen”) have announced a global license agreement that gives Elasmogen exclusive access to Soteria® and Phloral® technologies for oral colonic delivery of therapeutic proteins, deriving from Elasmogen’s soloMER™ platform, for an undisclosed target for treatment of Crohn’s disease and ulcerative colitis.
The license agreement builds upon the research collaboration the two companies entered in to in May 2020 that involved pre-clinical evaluation of Soteria® and Phloral® technologies utilising Elasmogen’s multi-valent, novel inflammatory cytokine binding soloMER™ protein therapeutics. Acceleration of this research and development effort is facilitated by a recent £8M funding round announced by Elasmogen and a £1.5M Innovate Future Leaders grant. This grant funding in particular is specifically focused on Elasmogen’s auto-immune programs.
Under the terms of the agreement, Intract will receive an undisclosed upfront payment followed by development milestone payments and royalties on product sales. Elasmogen will have the option to expand the license agreement for up to four additional targets.
‘’We are excited to build on our ongoing partnership with Elasmogen to create new transformative delivery options for innovative protein medicines to meet the unmet needs of millions of patients suffering from chronic inflammatory bowel disease,’’ said Vipul Yadav, CEO at Intract Pharma. ‘’We believe oral targeted protein medicines are the future of IBD therapies and our collaboration with Elasmogen keeps building on our mission to bring innovative oral biologic therapies to patients.’’
“Securing this agreement with Intract enables us to deliver our incredibly potent anti-inflammatory soloMERs directly where they are needed in the GI tract, minimizing off-site adverse effects and maximizing clinical outcomes” said Caroline Barelle, CEO of Elasmogen. “We are really looking forward to working with the Intract team to expand our growing, differentiated pipeline of therapeutic biologics”.
About Intract Pharma
Intract Pharma is biopharmaceutical company bringing disruptive oral biologics delivery solutions to significantly improve the efficacy and safety of emerging and established biotherapeutics and improve patient experience and outcome. The platform leverages the advantage of delivering large proteins/antibodies to the colon, while also protecting the biologics from enzymatic breakdown allowing tissue/systemic uptake to create next generation oral biologic medicines. For more information visit us at www.intractpharma.com.
About Elasmogen
Elasmogen is a privately held biopharmaceutical company located in the thriving biologics cluster in Aberdeen, Scotland. The company is rapidly progressing a pipeline of next-generation soloMER products for the treatment solid-tumour cancers, systemic inflammatory diseases and inflammatory conditions of the gut. The company’s proprietary technology is protected by a robust and layered IP portfolio covering the generation, humanization, half-life extension, products and product formats.
Intract Media Contact
Dr Vipul Yadav
CEO
Elasmogen Media Contact
Dr Caroline Barelle
CEO
April 1st, 2022
London, April 01, 2022 – Intract Pharma, an innovative oral protein delivery company, today announced the appointment of Dr Vipul Yadav as Chief Executive Officer of the company, effective April 1st, 2022. Dr Yadav, who has been serving as the Director of Research for over 5 years, also joins Intract Board of Directors. Dr Bill Lindsay who co-founded and led Intract since incorporation in 2015 will remain with the company as Director of Business Development.
On the appointment, Bill Lindsay said “It is with great satisfaction that I hand over management of Intract to Dr Yadav, who has been a major driving force in development of the company to date, in particular in pioneering our biotherapeutics development platform, Soteria”.
Dr Yadav said ‘’I am excited to transition into this role at such a critical junction of the company’s journey towards progressing its oral protein technology platform into clinical development with multiple pharma partners. I would like to thank the current management and board for entrusting me with this role and I look forward to working alongside the Intract board, management, and R&D staff to lead the company to the next phase of growth and realise the potential of our innovative technologies’’.
Dr Vipul Yadav joined Intract following completion of his PhD and since then has served as the Director of Research. During his tenure the company advanced into the oral biologic delivery space for treatment of gastrointestinal and systemic immunoinflammatory diseases and established multiple pharma partnerships to advance the technology deeper into preclinical with early and late-stage biologic candidates.
Dr Yadav received his PhD from University College London, School of Pharmacy working in the lab of Intract founder Prof Abdul Basit where he researched gastrointestinal stability and tissue uptake mechanisms involved in oral delivery of peptides and monoclonal antibodies.
London, UK. September 27th 2021.
GUANGZHOU, China, September XX, 2021 (BUSINESSWIRE) – Bio-Thera Solutions, Ltd. (688177.SH, “Bio-Thera”) and Intract Pharma (“Intract”) announced a global collaboration and licensing agreement that gives Bio-Thera access to Intract’s Soteria® and Phloral® drug delivery technologies to develop novel oral monoclonal antibody (mAb) treatments for chronic gastrointestinal (GI) inflammatory diseases. Bio-Thera is a global pharmaceutical company developing innovative therapeutics and biosimilars for oncology, autoimmune diseases, cardiovascular diseases, and other serious unmet medical needs.
Under the terms of the agreement, Intract has granted Bio-Thera a worldwide license to Intract’s oral biologics drug delivery platform for a single undisclosed mAb product. Intract will receive an undisclosed upfront payment, with potential development and commercial milestone payments along with royalties on product sales. Intract will lead preclinical research of the product and Bio-Thera will have the option to expand development of the product for multiple GI indications and will be responsible for manufacturing and commercialization of any approved products.
Intract’s oral biologics delivery platform includes Soteria® a technology which protects proteins such as mAbs from degradation in the intestinal lumen. The platform also includes Phloral®, a clinically-validated technology that utilizes both pH and the enzymes produced by colonic bacteria as a trigger mechanism to allow accurate release of payloads in the colon, a suitable site in the GI tract for targeting of biologics for local and systemic delivery.
“Developing oral biologics is the next step in advancing compliance and access to innovative monoclonal antibodies for chronic diseases,” said Dr. Shengfeng Li, CEO of Bio-Thera Solutions. “We believe that combining Bio-Thera’s antibody expertise with Intract’s oral delivery platform will lead to a great advance in the treatment of gastrointestinal disease.”
“Intract Pharma is delighted to be partnering with Bio-Thera to address the significant challenge of delivering powerful biologics orally” said Dr Bill Lindsay, CEO of Intract. “We believe that our technologies will allow development of a more effective therapeutic for the treatment of IBD, while also increasing drug safety and reducing cost.”
About Bio-Thera Solutions, Ltd.
Bio-Thera Solutions, Ltd., a leading commercial-stage biopharmaceutical company in Guangzhou, China, is dedicated to researching and developing novel therapeutics for the treatment of cancer, autoimmune, cardiovascular diseases, and other serious unmet medical needs, as well as biosimilars for existing, branded biologics to treat a range of cancer and autoimmune diseases. As a leader in the next generation antibody discovery and engineering, the company has advanced six candidates into late-stage clinical trials and one of which, QLETLI® (格乐立®), a biosimilar to adalimumab, is available to patients in China. In addition, the company has multiple candidates in early stage clinical or entering clinical studies, including differentiated and innovative anti-OX40, anti-TIGIT, and anti-PD-L1/CD47 bispecific antibodies. For more information, please visit www.bio-thera.com/en/ or follow us on Twitter (@bio_thera_sol) and WeChat (Bio-Thera).
About Intract Pharma
Intract Pharma is a biotechnology company bringing disruptive oral biologics delivery solutions to significantly improve the efficacy and safety of emerging and established biotherapeutics and improve patient experience and outcome. The platform leverages the advantage of delivering large proteins/antibodies to the colon, while also protecting the molecules from enzymatic breakdown, allowing tissue/systemic uptake to create next generation oral biologic medicines. For more information visit us at www.intractpharma.com.
Bio-Thera Solutions Cautionary Note Regarding Forward-Looking Statements
This news release contains certain forward-looking statements relating to Bio-Thera Solutions’ collaboration with Intract or product pipelines in general. Readers are strongly cautioned that reliance on any forward-looking statements involves known and unknown risks and uncertainties. The forward-looking statements include, among others, those containing “could,” “may,” “should,” “will,” “would,” “anticipate,” “believe,” “plan,” “promising,” “potentially,” or similar expressions. They reflect the company’s current views with respect to future events that are based on what the company believes are reasonable assumptions in view of information currently available to Bio-Thera Solutions and are not a guarantee of future performance or developments. Actual results and events may differ materially from information contained in the forward-looking statements as a result of a number of factors, including, but not limited to, risks and uncertainties inherent in pharmaceutical research and development, such as the uncertainties of pre-clinical and clinical studies, for example, the development processes could be lengthy and in vitro or early, small scale clinical trial results may not translate into desired results in vivo or in large scale clinical studies. Other risks and uncertainties include challenges in obtaining regulatory approvals, manufacturing, marketing, competition, intellectual property, product efficacy or safety, changes in global healthcare situation, changes in the company’s financial conditions, and changes to applicable laws and regulations, etc. Forward-looking statements contained herein are made only as of the date of their initial publication. Unless required by laws or regulations, Bio-Thera Solutions undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, changes in the company’s views or otherwise.
Bio-Thera Solutions Media Contact
Bert E. Thomas IV
Senior Vice President, Business Development
+1 410 627 1734 (mobile) [email protected]
Intract Media Contact
Bill Lindsay
CEO
London, UK. April 1st 2021.
Intract Pharma Limited today announced the initiation of a collaborative research programme with Ferring Pharmaceuticals, to investigate oral delivery of a monoclonal antibody (mAb) targeting an undisclosed interleukin for treatment of inflammatory bowel disease (IBD). The research will focus on evaluation of Intract’s Phloral® and Soteria® technologies for precision oral delivery of the therapeutic mAb directly to GI tissue to improve efficacy and minimize systemic exposure.
Commenting on the collaboration, Bill Lindsay, Intract’s CEO, said “Intract’s technologies are unique in terms of precision targeting of biologic drugs, especially mAbs, via the oral route allowing the possibility for localized treatment of GI diseases without the risk of serious adverse effects resulting from high dose injections. We are excited to enter this collaboration with Ferring which has a long heritage in gastroenterology products and a commitment to continuous innovation for new therapies for patients suffering from chronic GI diseases”.
About Intract Pharma
Intract Pharma is a company which specializes in oral drug delivery, developing state-of-the-art formulation technologies and unique gastrointestinal models to develop advanced new therapeutics. Since its inception, Intract has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients. The drug delivery technologies Phloral® for precise colonic drug delivery, and Soteria® for delivery of biotherapeutics to gastrointestinal tissue, are available for license exclusively from Intract Pharma. For more information visit www.intractpharma.com
London, UK and Seoul, South Korea. 22nd April 2021.
Intract Pharma (Intract), an oral biologics delivery technology company, today announces entry into a research collaboration agreement with NIBEC (South Korea) to evaluate Intract’s proprietary oral biologics delivery platform technologies, Soteria® and Phloral®, to develop an oral, dual-targeting peptide therapeutic for local gut-restricted treatment of ulcerative colitis.
Under the agreement, Intract will optimise the peptide’s intestinal stability and tissue uptake and will develop oral formulations for in-vivo pre-clinical testing. Upon completion of the study, NIBEC will have an option to negotiate an exclusive worldwide license to Intract technologies for delivery of NIBEC’s peptide therapeutic.
Commenting on the collaboration, Bill Lindsay, CEO of Intract said “Intract is very pleased to enter this collaboration which will draw on Intract’s expertise in development of oral biologics to seek to create a new and exciting treatment for IBD”
Dr Chong Pyung Chung, CEO of NIBEC said “We are very delighted to increase the delivery efficacy of peptide therapeutic (NIPEP-IBD) as oral formulation by collaboration with Intract Pharma. We are looking forward to demonstrating proof of concept of oral formation of NIPEP-IBD and entering further human study.”
About Intract Pharma
Intract Pharma is a company which specializes in oral drug delivery, developing state-of-the-art formulation technologies and unique gastrointestinal models to develop advanced new therapeutics. Since its inception, Intract has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients. The drug delivery technologies Phloral® for precise colonic drug delivery, and Soteria® for delivery of biotherapeutics to gastrointestinal tissue, are available for license exclusively from Intract Pharma. For more information visit www.intractpharma.com
About NIBEC
NIBEC is established as a spin-off venture from Seoul National University, South Korea at 2004 and listed in Korean Stock Market (KOSDAQ) at 2011. The company’s main technology is based on target-oriented peptide therapeutic discovery (TOPscovery) platform for drug discovery and delivery. The company’s focus of therapeutic area are inflammatory diseases (IBD, Ulcerative colitis, NASH, Fibrosis), oncology with specialized peptide drug formulation and new mode of action. In addition, NIBEC has specialized target tissue/cell penetrating peptide delivery platform to deliver protein/antibody/siRNA into the target tissue such as cancer. For more information is available at company website at www.nibec.co.kr.
Intract Pharma has announced signature to a joint development agreement with Celltrion Inc. and Celltrion Healthcare Co., Ltd. (Celltrion Group) for development of the world’s first oral antibody therapeutic for treatment of inflammatory bowel disease.
The oral product, along with intravenous and subcutaneous formulations (Remsima® IV and Remsima® SC) are expected to secure Celltrion’s leading position in the TNF-α inhibitor market.
Development of the product through clinical validation will be the responsibility of Intract, with support, including supply of drug material for generation of the oral product, from Celltrion Group. Celltrion Group retains the right to complete clinical development of the product following completion of Phase 2 clinical trials and to take to market.
The joint development is geared towards launch of the first orally administered antibody targeting inflammatory bowel disease (IBD), which is anticipated to impact not only the Infliximab market but more widely the market for treatment of IBD. Intract Pharma is at the forefront in the field of technology platforms that stably deliver antibodies to the intestine. Collaboration between the two parties is expected to open new doors for the development of additional orally-delivered antibodies.
The oral infliximab product has been cleared by the UK regulatory body (MHRA) to proceed to Phase 1b/2a clinical trials in IBD patients during the second half of 2021, without the requirement for further preclinical research or a clinical safety study. The product is likely to be stable at room temperature, offering simple distribution, storage and administration for patients at home.
Bill Lindsay, CEO of Intract said “We anticipate that the oral infliximab product which we will co-develop with Celltrion Group will have an improved safety profile and will offer a less expensive biotherapeutic treatment for IBD. We are hopeful that the product will address a large proportion of the IBD market, potentially replacing steroid and immune-suppressive drugs in addition to capturing a large share of the biologics market”.
Celltrion Group official said, “A technical alliance between Intract Pharma and Celltrion Group allows for the development of oral Infliximab that is safe, highly efficacious, and convenient”; “We are delighted to have this deal with Intract Pharma and we will continue on with further development starting with clinical design through close consultation”.
About Celltrion Group
Celltrion Inc. is headquartered in Korea is a leading biopharmaceutical company, specializing in research, development and manufacture of biosimilar and innovative drugs. Celltrion strives to provide more affordable biosimilar mAbs to patients who previously had limited access to advanced therapeutics. Celltrion previously received EMA approval for Remsima® which is the world’s first biosimilar mAb to receive approval from a regulatory agency in a developed country. For more information visit: www.celltrion.com.
Celltrion Healthcare Co., Ltd. is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us
About Intract Pharma
Intract Pharma is an oral drug delivery specialist, developing state-of-the-art formulation and unique gastrointestinal models to develop advanced new therapeutics. Since its inception, Intract has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients. The drug delivery technologies Phloral®, for precise colonic drug delivery and Soteria ® for delivery of biotherapeutics to gastrointestinal tissue, are available for license exclusively from Intract Pharma. For more information visit: www.intractpharma.com.
Intract Pharma Limited, London, UK (“Intract”) and North & South Brother Pharmacy Investment Co., Ltd, Hong Kong SAR, China (“N&S Pharmacy Investment”) enter a partnership to develop orally-delivered GLP-1R agonist peptide to address treatment of metabolic diseases. N&S Pharmacy Investment will fund the feasibility studies and has an exclusive option to a global royalty-based license to the new formulation and Intract’s associated Intellectual Property. When the development of the new formulation hits a specific development milestone, a pharmaceutical partner of N&S Pharmacy Investment in China, HEC Group, Dongguan, China (“HEC”) will be involved in the pre-clinical and clinical studies of the asset in China.
Under this partnership, N&S Pharmacy Investment, Intract will use its proprietary Soteria® and Phloral® technologies in combination with the designated GLP-1R agonist peptide candidate. Intract will receive an upfront technology access fee and will lead the pre-clinical development sponsored by N&S Pharmacy Investment. Intract will be eligible to receive milestone and tiered royalty payments upon achievement of various clinical and commercial milestones. The product is set to enter preclinical testing in Q2 2020 with clinical development anticipated in 2021 following successful preclinical validation.
Bill Lindsay, Intract’s CEO said “Intract is delighted to be funded by N&S Pharmacy Investment for the development of an orally-delivery formulation of GLP-1R agonist. Through this partnership we believe that Intract’s technology will provide a means to create an extremely successful orally-delivered biotherapeutic”
“Short-term GLP-1R agonist peptides are potent glycemic regulation agents but the subcutaneous injection formulation can reduce the compliance of diabetic patients. We believe that the combination of Intract’s Soteria® and Phloral® technology platforms could protect the GLP-1R peptide from degradation in alimentary tract and guarantee the delivery of the peptide to the colon, as well as enhance the peptide uptake in colon tissue.” said an Executive Director of N&S Pharmacy Investment. “N&S Pharmacy Investment team is glad to collaborate with Intract to exploit an oral formulation of GLP-1R agonist peptide. In the later stage of development, we may partner with China’s most established pharmaceutical company, HEC Group, for pre-clinical and clinical development in China. N&S Pharmacy hopes the orally administered GLP-1R agonist peptide co-developed with Intract will bring diabetics a new GLP-1R agonist peptide product with a much more convenient administration route and better safety profile”
Intract Pharma Limited London, UK (“Intract”), and Elasmogen Limited, Aberdeen, Scotland (“Elasmogen”) have announced an agreement to collaborate and develop novel orally-delivered protein therapeutics (biologics), incorporating proprietary technologies developed by each of the partners.
The collaboration combines Elasmogen’s soloMER™ technology, small (11 kDa) single-chain binding domains that can be rapidly re-formatted to generate super-neutralizers (bivalent, biparatropic) with Intract’s Soteria® and Phloral® technologies, a unique platform for oral delivery of biologics targeted to the lower GI tract. Combining the advantages of these platforms will allow the oral delivery of therapeutically active, highly potent and gut targeted proteins, initially focused on local GI indications such as inflammatory bowel disease.
Bill Lindsay, CEO of Intract, said “Collaboration with Elasmogen represents an exciting synergy of Intract’s expertise in the formulation of biologic drugs with Elasmogen’s unique multi-valent formats to allow the development of novel and potent oral therapeutics”.
Caroline Barelle, CEO of Elasmogen said “Achieving oral delivery of our soloMER products is a key differentiator for our technology and I am delighted that following very encouraging proof of concept studies with Intract’s Soteria technology we can now announce this extended and accelerating collaboration”
The collaboration will focus initially on a preclinically validated Elasmogen compound as treatment for inflammatory bowel disease, with the expectation that full clinical assessment of the oral formulation will begin in Q2 2021.
About Elasmogen Limited
Company Contact: Caroline Barelle, CEO, Elasmogen. [email protected]
Spun-out from the University of Aberdeen in 2016, Elasmogen is developing soloMERs™; fully humanized, next generation, single chain therapeutics for auto-inflammatory diseases and cancer. soloMERs™ are proprietary humanized clinical candidates derived from VNARS (variable new-antigen receptors) which exist naturally in sharks as high affinity binding domains. With a different ancestral origin from antibodies this example of 400 million year old convergent evolution places VNARs outside of the complex patent landscape that describes and protects antibody drug discovery and has produced the smallest (9% of the size of an antibody) and most robust naturally occurring binding domain. Elasmogen is unique in its capacity to isolate and develop soloMERs™, with a multi-layered IP position covering the platform, formats, products and process including an exclusive license to over 25 patents granted in the US, Europe and other territories.
About Intract Pharma Limited
Intract Pharma is an oral drug delivery specialist, developing state-of-the-art formulation technologies and unique gastrointestinal models to develop advanced new therapeutics. Since its inception, Intract has pursued innovation in oral drug delivery as a means to improve on current therapies, making them safer and more effective for patients. Soteria® is available for license exclusively from Intract Pharma. For more information visit http://www.intractpharma.com
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