FEN Industries | February 22, 2022
FEN announced today that it has earned the U.S. Department of Agriculture (USDA) Certified Biobased Product label. The product, Terreplenish®, has 97% biobased content.
Third-party verification for a product's biobased content is administered through the USDA BioPreferred Program, an initiative created by the Farm Bill. The primary goal of the BioPreferred Program is to increase the development, purchase, and use of biobased products.
Biobased products have played an increasingly important role in reducing greenhouse gas (GHG) emissions that exacerbate global climate change. Biobased products are cost-comparative, readily available, and perform as well as or better than their conventional counterparts.
"Terreplenish® Soil Regenerating Microbes sequester 45-60lbs of nitrogen per growing season, providing an alternative to petroleum derived fertilizer products,"
Cathy Scratch, FEN Founder
"We applaud FEN Industries for earning the USDA Certified Biobased Product label," said Kate Lewis, USDA BioPreferred Program. "Products like Terreplenish® contribute to an ever-expanding marketplace that adds value to renewable agriculture commodities and decreases our reliance on petroleum."
According to a report that USDA released in 2019, biobased products contributed more than $500 billion to the U.S. economy and estimated reduction of fossil fuels associated GHG emissions from biobased products equivalent to approximately 12 million metric tons of carbon dioxide (CO2). The increased production of biobased products contributes to the development and expansion of the U.S. bioeconomy - where society looks to agriculture for sustainable sources of fuel, energy, chemicals, and products.
About FEN Industries: A fen is a unique ecosystem that nurtures bio-nutrient diversity and conserves water as a necessary buffer between habitats that naturally siphons toxins. FEN Industries is an accelerated composting technology company that creates Terreplenish® - an OMRI Listed, 97% certified biobased product and approved by California Department of Agriculture.
The high cost of nitrogen fertilizer can be reduced significantly with the addition of Terreplenish® soil regenerating microbes while providing many other benefits like pathogen control, phosphorous control, and better plant emergence scores. Additional revenue can be generated by participating in the many phosphorous reduction programs and carbon sequestration projects.
Harbour BioMed | February 28, 2022
Harbour BioMed announced that, it has been approved by the Institutional Review Boards to commence phase I trial of its B7H4x4-1BB bispecific antibody in Australia. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of HBM7008 in patients with solid tumors.
HBM7008 is generated from our unique and innovative HBICE® platform. It targets Tumor Associated Antigen mediated crosslinking T cell activation through 4-1BB. B7H4 is overexpressed on a variety of solid malignancies, including breast, ovarian, endometrial and non-small cell lung cancers. With its crosslinking dependent specificity on tumors and potent immune modulation activity, HBM7008 has shown excellent safety profile with strong anti-tumor efficacy in the pre-clinical study, including completed response observed in mouse tumor model.
"4-1BB is one of the most promising anti-tumor immune targets, providing new solutions for tumor treatment. Based on preclinical study data, we are highly confident in B7H4x4-1BB bispecific antibody. We will efficiently promote this clinical study to provide an novel, effective and safe treatment for patients, so that more tumor patients can benefit from the innovative therapeutic."
Dr. Xiaoxiang Chen, Chief Development Officer of Harbour BioMed
HBM7008 is a bispecific antibody targeting Tumor Associated Antigen B7H4x4-1BB that not only displays high potency in the T cell co-stimulation and tumor growth inhibition, and potentially may also translate to better safety due to its strict dependency of TAA-mediated crosslinking T cell activation. HBM7008 is one of the fully human bispecific antibodies developed from the HBICE® platform of the Company. It is the only bispecific antibody against these two targets globally. Its unique specificity on tumors and immune modulation activity makes it a promising therapeutics in PD-L1 negative or PD-1/PD-L1 resistant patients. It also has the potential to avoid 4-1BB liver toxicity risk observed in other products with the benefit of its innovative biology mechanisms and bispecific design.
About Harbour BioMed
Harbour BioMed is a global biopharmaceutical company committed to the discovery, development and commercialization of novel antibody therapeutics focusing on immunology and oncology. The Company is building its robust portfolio and differentiated pipeline through internal R&D capability, collaborations with co-discovery and co-development partners and select acquisitions.
Aspect Biosystems | April 07, 2022
Aspect Biosystems ("Aspect"), a biotechnology company developing bioengineered tissue therapeutics to transform how we treat disease, is pleased to announce a partnership with JDRF, the leading global type 1 diabetes (T1D) research and advocacy organization.
The JDRF-Aspect partnership supports Aspect's focus on developing a bioengineered tissue therapeutic for type 1 diabetes that will provide insulin independence and control of blood sugar without the need for chronic immune suppression. In addition to funding, JDRF is also contributing strategic support through its deep expertise and vast network in the diabetes field.
Aspect is leveraging its proprietary bioprinting technology, therapeutic cells, and materials science to create a pipeline of cell-based tissue therapeutics that replace or repair damaged organ functions. These therapeutics are rationally engineered to be biologically functional, immune-protective, and suitable for surgical implantation to treat diseases such as type 1 diabetes.
For more than 20 years, JDRF has been a leader in cell-based tissue therapy research for type 1 diabetes, This funding partnership with Aspect Biosystems will support and continue scientific advancements in the field and undeniably take us closer to finding a cure."
Esther Latres, Assistant Vice President of Research at JDRF.
Together with JDRF, we are aligned on the mission to develop a curative therapy for the millions of patients around the world who are affected by type 1 diabetes, This partnership will help advance our cutting-edge pancreatic tissue program and bring us a step closer to human trials."
Tamer Mohamed, CEO at Aspect Biosystems.
About Aspect Biosystems
Aspect Biosystems is a biotechnology company creating bioengineered tissue therapeutics to transform how we treat disease. Aspect is applying its microfluidic 3D bioprinting technology internally to develop these advanced therapeutics and partnering with leading researchers and industry innovators worldwide to tackle the biggest challenges in regenerative medicine.
About JDRF International
JDRF's mission is to accelerate life-changing breakthroughs to cure, prevent and treat T1D and its complications. To accomplish this, JDRF has invested more than $2.5 billion in research funding since our inception. We are an organization built on a grassroots model of people connecting in their local communities, collaborating regionally for efficiency and broader fundraising impact, and uniting on a national stage to pool resources, passion, and energy. We collaborate with academic institutions, policymakers, and corporate and industry partners to develop and deliver a pipeline of innovative therapies to people living with T1D. Our staff and volunteers throughout the United States and our five international affiliates are dedicated to advocacy, community engagement and our vision of a world without T1D.
BeiGene | February 18, 2022
BeiGene a global, science-driven biotechnology company focused on developing innovative and affordable medicines, today announced that BeiGene’s BTK inhibitor BRUKINSA received approval from Swissmedic for the treatment of adult patients with Waldenström’s macroglobulinemia who have received at least one prior line of therapy, or for treatment-naïve patients who are not suited for standard chemo-immunotherapy. BRUKINSA had previously been granted orphan drug status.
“The authorization of BRUKINSA will bring a new option and an innovative medicine that has potential to offer deep and durable response for eligible patients with WM in Switzerland. BRUKINSA is a next-generation BTK inhibitor which has also provided meaningful improvements in tolerability for some patients with WM compared to ibrutinib, as treatment discontinuation remains a concern.”
Pr. Davide Rossi, Deputy Head of the Division of Hematology of the Oncology Institute of Southern Switzerland IOSI
Reto Kessler, Country Manager, Switzerland at BeiGene added, “This approval is a significant development for people living with WM in Switzerland and for BeiGene’s expansion in Europe. Our teams are committed to collaborating with the Federal Office of Public Health and healthcare professionals to ensure access to BRUKINSA for patients in Switzerland.”
The Marketing Authorization Application (MAA) is supported by data from the global Phase 3 ASPEN clinical trial, a Phase 3 randomized, open-label, multicenter trial (NCT03053440) that evaluated BRUKINSA compared to ibrutinib in patients with relapsed/refractory (R/R) or treatment-naïve (TN) WM who harbor a MYD88 mutation (MYD88MUT). In the ASPEN trial, BRUKINSA demonstrated a numerically higher very good partial response (VGPR) rate and a favorable safety profile over ibrutinib, although the primary endpoint of statistical superiority related to deep response (VGPR or better) was not met. As assessed by independent review committee (IRC) per adaptation of the response criteria updated at the Sixth International Workshop on Waldenström’s Macroglobulinemia (IWWM), the combined complete response (CR) + VGPR rate in the overall intention-to-treat (ITT) population was 29% with BRUKINSA (95% CI: 20, 40), compared to 19% with ibrutinib (95% CI: 12, 30).
In the ASPEN trial, of the 101 patients with WM randomized and treated with BRUKINSA, four percent of patients discontinued due to adverse events, including cardiomegaly, neutropenia, plasma cell myeloma, and subdural hemorrhage. Adverse events leading to dose reduction occurred in 14% of patients, with the most common being neutropenia (3%) and diarrhea (2%).
The recommended dose of BRUKINSA is either 160 mg twice daily or 320 mg once daily, taken orally with or without food. The dose may be adjusted for adverse reactions and reduced for patients with severe hepatic impairment and certain drug interactions.
About Waldenström’s Macroglobulinemia
WM is a rare B-cell lymphoma that occurs in less than two percent of patients with non-Hodgkin lymphomas.2 The disease usually affects older adults and is primarily found in bone marrow, although lymph nodes and the spleen may be involved.1 Throughout Europe, the estimated incidence rate of WM is approximately seven for every one million men and four for every one million women.2
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.
BRUKINSA is supported by a broad clinical program which includes more than 3,900 subjects in 35 trials across 28 markets. To date, BRUKINSA has received more than 20 approvals covering more than 40 countries and regions, including the U.S., European Union, China, Australia, Great Britain and Switzerland. Currently, more than 40 additional regulatory submissions are in review around the world.
BeiGene is committed to advancing best- and first-in-class clinical candidates internally or with like-minded partners to develop impactful and affordable medicines for patients across the globe. We have a growing R&D and medical affairs team of approximately 2,900 colleagues dedicated to advancing more than 100 clinical trials that have involved more than 14,500 subjects. Our expansive portfolio is directed predominantly by our internal colleagues supporting clinical trials in more than 45 countries and regions. Hematology-oncology and solid tumor targeted therapies and immuno-oncology are key focus areas for the Company, with both mono- and combination therapies prioritized in our research and development. BeiGene currently has three approved medicines discovered and developed in our own labs: BTK inhibitor BRUKINSA in the United States, China, the EU and U.K., Canada, Australia and additional international markets; and the non-FC-gamma receptor binding anti-PD-1 antibody tislelizumab as well as the PARP inhibitor pamiparib in China.
BeiGene also partners with innovative companies who share our goal of developing therapies to address global health needs. We commercialize a range of oncology medicines in China licensed from Amgen, Bristol Myers Squibb, EUSA Pharma and Bio-Thera. We also plan to address greater areas of unmet need globally through our other collaborations including with Mirati Therapeutics, Seagen, and Zymeworks.
In January 2021 BeiGene and Novartis announced a collaboration granting Novartis rights to co-develop, manufacture, and commercialize BeiGene’s anti-PD1 antibody tislelizumab in North America, Europe, and Japan. Building upon this productive collaboration, including a biologics license application (BLA) under FDA review, BeiGene and Novartis announced an option, collaboration and license agreement in December 2021 for BeiGene’s TIGIT inhibitor ociperlimab that is in Phase 3 development. Novartis and BeiGene also entered into a strategic commercial agreement through which BeiGene will promote five approved Novartis Oncology products across designated regions of China.
BeiGene is a global, science-driven biotechnology company focused on developing innovative and affordable medicines to improve treatment outcomes and access for patients worldwide. With a broad portfolio of more than 40 clinical candidates, we are expediting development of our diverse pipeline of novel therapeutics through our own capabilities and collaborations. We are committed to radically improving access to medicines for two billion more people by 2030. BeiGene has a growing global team of over 8,000 colleagues across five continents.