CELL AND GENE THERAPY

iTolerance to Collborate with LyGenesis for Joint Research

iTolerance | July 01, 2022

iTolerance_to_Collborate
iTolerance, Inc., an early-stage privately held regenerative medicine company developing technology to enable organoid, tissue, and cell therapy, announced entering into a joint collaboration with LyGenesis, Inc., a clinical-stage biotechnology company with an organ regeneration technology platform. The joint collaboration is aimed at evaluating the potential of iTOL-201, a product candidate being developed combining LyGenesis' LYG-LIV-100 liver cell therapy and iTolerance's SA FasL microgel immune tolerance platform to permit the growth of ectopic livers without the requirement for immune suppression.

The joint research effort of iTolerance and LyGenesis has produced in vitro data using iTOL-201 and is now moving toward small animal proof of concept work to assess the potential of the combined technology for producing ectopic livers capable of saving the animals from fatal liver disorders without the requirement for immune suppression.

With our lead therapy now in the clinic in a Phase 2a trial in patients with End Stage Liver Disease, we have turned our attention toward a second-generation therapy capable of growing ectopic organs without the need for immune suppression. iTolerance's platform holds enormous promise in this respect and we look forward to the results from our joint proof of concept work."

Dr. Michael Hufford, Co-Founder and Chief Executive Officer of LyGenesis.

While long-term immunosuppression continues to be an obstacle for the use of cell and regenerative therapies, the research being conducted between both LyGenesis and iTolerance could allow for a major advancement in organ regeneration, As we advance our own pipeline of therapies focused on supporting pancreatic islet engraftments, I believe this synergistic collaborative research with LyGenesis has the potential to successfully combine technologies to drive significant value for both biotech companies and importantly, the patients we work to serve."

Dr. Anthony Japour, Chief Executive Officer of iTolerance.

Spotlight

Over the last five years, the global biotech and pharmaceutical landscape has witnessed continued growth. The analysis period (2017-2022) encompasses a unique timeframe including the global COVID-19 pandemic.

Spotlight

Over the last five years, the global biotech and pharmaceutical landscape has witnessed continued growth. The analysis period (2017-2022) encompasses a unique timeframe including the global COVID-19 pandemic.

Related News

MEDTECH, INDUSTRIAL IMPACT

Oxford Biomedica Solutions forms new partnerships with three biotechnology companies

Oxford Biomedica Solutions LLC | December 15, 2022

Oxford Biomedica Solutions LLC, an AAV manufacturing and innovation company, announced today that it has signed agreements with three additional U.S. based, biotechnology companies. This places Oxford Biomedica Solutions ahead of the previously stated target of two new partners by the end of the calendar year. Under these additional agreements, Oxford Biomedica Solutions will provide its full platform offering to support the new partners’ gene therapy programs, which cover a broad range of indications, including CNS, autoimmune, oncology, muscular, and rare metabolic disease. Oxford Biomedica Solutions’ proven platform has demonstrated consistent bioreactor titers of E15 vg/L and achieved over 90% fully intact vector for multiple constructs. Oxford Biomedica Solutions’ innovative platform potentially enables accelerated drug development of high quality products produced at significantly more doses per batch. The platform drives down the number of batches needed, as well as the cost, for both clinical and commercial operations, to deliver much needed therapies to patients sooner. In line with preparing and managing the increasing activities and demand, we have recently opened a new 24,000sqft expansion space that includes dedicated analytical development lab space to accommodate the growth in new projects and partners, as well as continued development innovation. Additionally, this new space will also house a commercial GMP Drug Substance footprint that will incorporate multiple 500L bioreactors and allow Oxford Biomedica Solutions to offer a single facility option for both clinical and commercial supply of high quality and high titer vector. “These new partnerships are a true validation of the Oxford Biomedica Solutions team, our capabilities, and AAV plug-and-play platform. We started this endeavor because we were confident that we can help develop successful gene therapy products with our platform, expertise, and the care that our team delivers on every product. We are excited this is now coming to fruition, and we are giving our new partners and their patients access to high quality product with the efficiency and productivity of our platform addressing the increase in demand that we are seeing.” Tim Kelly, Chair and CEO of Oxford Biomedica Solutions About Oxford Biomedica Solutions Oxford Biomedica Solutions offers a platform that can achieve both high titer and high product quality vector for partners. The platform has already been proven with six separate new product INDs and CTAs. High titer, high product quality, proven expertise, and speed are the foundation of the platform. This unique platform and fully integrated end-to-end capabilities, from vector design and process development through to clinical trials, are now available to partners.

Read More

INDUSTRIAL IMPACT

ImaginAb Executes New License and Supply Agreement for CD8 ImmunoPET Technology with TriSalus Life Sciences

ImaginAb | November 23, 2022

ImaginAb Inc., a global biotechnology company developing 89Zr crefmirlimab berdoxam imaging agent and radiopharmaceutical therapy products, is pleased to announce the signing of a new non-exclusive License and Supply Agreement with TriSalus Life Sciences, Inc. an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors. Under the terms of the agreement, ImaginAb will license and supply clinical doses of ImaginAb's investigational CD8 ImmunoPET to TriSalus for use in its clinical trials using its proprietary Pressure-Enabled Drug Delivery™ method for intravascular delivery of its investigational SD-101 compound. "We are delighted that TriSalus will use our investigational CD8 ImmunoPET technology in an imaging sub-study within its PERIO-01 clinical trial which leverages its PEDD™ methodology and SD-101, a novel therapeutic candidate designed to re-activate the immune system within the liver and pancreas. Our agreement with TriSalus highlights our expanding partnership network and showcases the increasing adoption of our CD8 ImmunoPET technology." Ian Wilson, Chief Executive Officer of ImaginAb About ImaginAb ImaginAb is a clinical stage, revenue-generating global biotechnology company developing the next generation of imaging agents and radiopharmaceutical therapy products through its proprietary minibody and cys-diabody platforms. The lead candidate 89Zr crefmirlimab berdoxam imaging agent is currently in Phase II clinical trials and has been licensed by numerous pharmaceutical and biotech companies for imaging in their immunotherapy clinical trials, primarily in oncology. About 89Zr crefmirlimab berdoxam CD8 ImmunoPET is an 89Zr-labelled minibody that has been designed to bind to the CD8 receptor on human T cells for quantitative, non-invasive PET imaging of CD8+ T cells. CD8+ T cells are the main effector cells involved in the immune response against tumour cells induced by immunotherapies and they also play a key role in multiple autoimmune diseases. As such, quantitative imaging of CD8+ T cells is currently being researched to determine whether it may be used to diagnose the immune status of a patient, to measure the efficacy of immunotherapies and predict patient outcomes. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology therapeutics company integrating immunotherapy with disruptive delivery technology to transform the treatment paradigm for patients with liver and pancreatic tumors. The company works to enable more patients to benefit from established and emerging cancer treatments by overcoming intratumoral pressure and immunosuppression, significant barriers that can limit delivery and efficacy. The proprietary TriSalus delivery method—Pressure-Enabled Drug Delivery™—modulates pressure and flow within blood vessels to improve therapy uptake and tumor response in ways traditional approaches cannot. Two FDA-cleared devices utilize TriSalus' proprietary approach to delivery of therapeutics: the TriNav® Infusion System and the Pancreatic Retrograde Venous Infusion™ System. Currently, in clinical trials across multiple indications, the TriSalus™ Platform uses PEDD™ to administer the company's investigational immunotherapy, SD-101, through a regional intravascular approach with the goal of strengthening immunotherapy responses for liver and pancreatic cancer patients. In partnership with leading cancer centers across the country, and by leveraging deep immuno-oncology expertise and inventive technology development, TriSalus is committed to advancing innovation that improves outcomes for patients. About PERIO-01 The Pressure-Enabled Regional Immuno-Oncology™ PERIO™-01 clinical trial is studying a new investigational drug, SD-101, delivered intravascularly by the TriNav® Infusion System using the Pressure-Enabled Drug Delivery™ method of administration. The study will evaluate if this platform approach can improve the performance of systemic checkpoint inhibitors in treating uveal melanoma with liver metastases.

Read More

MEDTECH, INDUSTRIAL IMPACT

Puma Biotechnology Presents Updated Findings from the TBCRC-022 Trial at the 2022 San Antonio Breast Cancer Symposium

Puma Biotechnology | December 08, 2022

Puma Biotechnology, Inc. a biopharmaceutical company, presented updated findings from the Translational Breast Cancer Research Consortium Trial 022 at the ongoing 2022 San Antonio Breast Cancer Symposium in San Antonio, Texas. The poster entitled “Neratinib and ado-Trastuzumab-Emtansine for HER2+ Breast Cancer Brain Metastases Translational Breast Cancer Research Consortium Trial 022,” was presented by Rachel A Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women's Cancers, Dana Farber Cancer Institute, at Spotlight Poster Session 7 on December 7 from 5:00 p.m. – 6:15 p.m. CT. TBCRC-022 is a prospective, multicenter, Phase II study to evaluate the effect of neratinib plus T-DM1 in patients with HER2-positive breast cancer brain metastases. This presentation outlined updates from three cohorts: 4A – patients with previously untreated BCBM; 4B – patients with BCBM progressing after prior local CNS-directed therapy without prior T-DM1 exposure; and 4C – patients with BCBM progressing after prior local CNS-directed therapy with previous T-DM1 exposure. Data from previous cohorts from this study were reported at the 2017 ASCO Annual Meeting. Patients with measurable HER2-positive BCBM received neratinib 160 mg orally once daily plus T-DM1 3.6 mg/kg intravenously every 21 days in the three parallel-enrolling cohorts. Diarrhea prophylaxis with colestipol and loperamide was required during cycle 1. All enrolled patients underwent a brain MRI plus CT scan of the chest/abdomen/pelvis every 6 weeks for 18 weeks, followed by every 9 weeks thereafter. The primary endpoint, Response Assessment in Neuro-Oncology-Brain Metastases was evaluated in each cohort separately. The efficacy results from the trial showed that CNS Objective Response Rate by RANO-BM was 33.3% of patients in cohort 4A, 29.4% in cohort 4B, and 28.6% in cohort 4C. Rates of response + stable disease greater than or equal to 6 months were 50% in cohort 4A, 35.3% in cohort 4B, and 33.3% in cohort 4C. Intracranial activity was observed for the combination of neratinib plus T-DM1 in all three cohorts, including in patients with prior T-DM1 exposure, suggesting a reversal of resistance to T-DM1. Overall, the most frequently observed adverse event was diarrhea, grade 2 and grade 3. These data provide additional evidence for the consideration of neratinib-based combinations in patients with HER2-positive BCBM. “Neratinib given in combination with T-DM1 showed promising activity in patients with heavily pre-treated HER2-positive disease metastatic to the CNS including patients with prior T-DM1 exposure, which may suggest that neratinib is playing a role in reversing resistance to T-DM1. Despite the introduction of several new treatments for patients with HER2-positive metastatic breast cancer, CNS progression events remain a major source of patient morbidity and mortality. The data from this study provide additional evidence for consideration of neratinib- based combinations in patients with HER2-positive breast cancer brain metastases.” Rachel A. Freedman, MD, MPH, Breast Oncology Center, Susan F. Smith Center for Women’s Cancers, Dana-Farber Cancer Institute Alan H. Auerbach, CEO and President of Puma Biotechnology, added, “We are pleased with the results from the TBCRC-022 trial on the combination of neratinib and T-DM1. As a small molecule that can cross the blood brain barrier, neratinib potentially offers patients with HER2-positive metastatic breast cancer that has metastasized to the CNS a novel HER2 targeted treatment option. This data adds to the existing body of data that we have from the other previously presented arms from the TBCRC-022 trial that continue to demonstrate that neratinib is active in patients with HER2-positive breast cancer brain metastases.” About Puma Biotechnology Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 PB272 and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

Read More