Antengene Corporation Limited | June 27, 2022
Antengene Corporation Limited a leading innovative, commercial-stage global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced that it has entered into a clinical trial collaboration with BeiGene to evaluate the safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of selinexor in combination with BeiGene's anti-PD-1 checkpoint inhibitor, tislelizumab. This multi-center, open-label Phase I/II trial will evaluate the investigational combination as a potential treatment option for patients with T and NK-cell lymphoma.
"We are delighted to partner with BeiGene, a company that strives for innovation and excellence, and is committed to developing best-in-class or first-in-class anti-cancer therapies for patients across the globe. These qualities are very similar to those of our vision at Antengene. We look forward to advancing the combination of selinexor and tislelizumab to clinical development. With good data we will be able to bring this treatment regimen to patients with T and NK-cell lymphoma, diseases that are endemic in Asia but underserved by current therapies."
Dr. Jay Mei, Antengene's Founder, Chairman and CEO
"At Antengene, we believe that the combinational use of immuno-oncology drugs and Selective Inhibitor of Nuclear Export compounds possesses huge potential as novel treatment regimens for cancer patients," said Dr. Kevin Lynch, Antengene's Chief Medical Officer. "The mechanism of action of selinexor in inhibiting the nuclear export protein XPO1 facilitates the intranuclear accumulation of tumor suppressors, making it a good partner in multiple combination treatment regimens. Preclinical research we conducted demonstrated that selinexor combined with a checkpoint inhibitor increased anti-tumor activity in multiple tumor models. In addition, deep and durable responses were also seen in multiple case reports of patients with T and NK-cell lymphoma treated with selinexor in combination with an anti-PD-1 checkpoint inhibitor. We hope to confirm that selinexor can synergize with tislelizumab to deliver an effective treatment regimen and help address the huge unmet medical needs in T and NK-cell lymphoma in the Asia Pacific regions and around the world." continued Dr. Lynch.
Tislelizumab is a PD-1 inhibitor designed to help aid the body's immune cells to detect and fight tumors. Tislelizumab, a humanized monoclonal antibody, is specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells.
About T and NK-Cell Lymphoma
T and NK-cell lymphoma is a set of heterogeneous diseases, accounting for 25-30% of Non-Hodgkin Lymphoma cases in China and only about 10% in USA and Europe. There has been little improvement in the past decade when compared to B-cell Non-Hodgkin Lymphoma (B-NHL) as 5-year overall survival rate was only 30% in most common subtypes. The unmet medical needs remain as agents with new mechanism of action to be explored and possibility to improve the treatment paradigm for the disease.
About the SINE Compounds
Selective Inhibitor of Nuclear Export compounds are inhibitors of the major nuclear export protein Exportin 1 Currently, there are three oral SINE compounds, ATG-010 ATG-016 and ATG-527, under clinical development. Antengene has obtained exclusive development and commercialisation rights from Karyopharm Therapeutics Inc. to these three compounds in certain APAC markets.
XPOVIO® is the world's first approved orally-available, selective inhibitor of the nuclear export protein XPO1. It offers a novel mechanism of action, synergistic effects in combination regimens, fast onset of action, and durable responses.
XPOVIO® is approved in Australia for two indications
In combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor at least one immunomodulatory agent, and an anti-CD38 monoclonal antibody.
XPOVIO® is approved in Singapore for three indications
In combination with bortezomib and dexamethasone for treatment of adult patients with multiple myeloma (MM) who have received at least one prior therapy.
In combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (R/R MM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
As a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (R/R DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy who are not eligible for haematopoietic cell transplant.
Antengene Corporation Limited is a leading commercial-stage R&D-driven global biopharmaceutical company focused on the discovery, development, manufacturing and commercialization of innovative first-in-class/best-in-class therapeutics for the treatment of hematologic malignancies and solid tumors, in realizing its vision of "Treating Patients Beyond Borders".
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.
Charles River Laboratories International, Inc. and Valo Health, LLC, | January 20, 2022
Charles River Laboratories International, Inc. and Valo Health, LLC, the technology company using human-centric data and computation powered by artificial intelligence (AI) to transform the drug discovery and development process, today announced the formation of a multiyear strategic partnership. This agreement will combine Valo’s Opal Computational Platform with Charles River’s drug discovery and development capabilities to offer a new transformative, AI-enabled drug discovery and development platform.
Recognizing the challenges of preclinical drug discovery, from high costs, time, and attrition rates, Valo and Charles River have joined forces to create enhanced drug discovery solutions that aim to transform the entire preclinical drug discovery process. Valo and Charles River intend to create and deliver offerings that produce preclinical assets with key performance characteristics optimized for client preferences.
The partnership’s combined offerings will utilize Valo’s Opal Platform for small molecule development, which leverages a “closed-loop” in silico-experimental platform that rapidly iterates using program data to identify novel compounds, and leverages Charles River’s capabilities in all aspects of discovery optimization, including medicinal chemistry, ADME, biology, pharmacology, and ultimately safety testing and IND submission.
The combination of Valo’s scientific innovation and deep technological expertise with Charles River’s end-to-end portfolio and industry-leading scientific bench has the potential to significantly accelerate a client’s discovery and development efforts by integrating data and compute to streamline and de-risk experimental science, enabling a faster and more effective process from de novo molecule design through lead optimization.
The combined offering will be launched in the first half of 2022 and will be available exclusively from Charles River.
About Valo Health
Valo Health, LLC is a technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence (“AI”) computation. As a digitally native company, Valo aims to full integrate human-centric data across the entire drug development lifecycle into a single unified architecture, thereby accelerating the discovery and development of life-changing drugs while simultaneously reducing the cost, time, and failure rate. The company’s Opal Computational Platform™ consists of an integrated set of capabilities designed to transform data into valuable insights that may accelerate discoveries and enable Valo to advance a robust pipeline of programs across cardiovascular metabolic renal, oncology, and neurodegenerative disease. Founded by Flagship Pioneering and headquartered in Boston, MA, Valo also has offices in Lexington, MA, San Francisco, CA, Princeton, NJ, and in Branford, CT.
About Charles River
Charles River provides essential products and services to help pharmaceutical and biotechnology companies, government agencies and leading academic institutions around the globe accelerate their research and drug development efforts. Our dedicated employees are focused on providing clients with exactly what they need to improve and expedite the discovery, early-stage development and safe manufacture of new therapies for the patients who need them.
Cascade Chemistry | February 19, 2021
Cascade Chemistry, a main pharmaceutical contract development and manufacturing organization, today declared inception of development of new offices intended to expand the organization's ability to manufacture APIs (dynamic pharmaceutical ingredients) under cGMP (current Good Manufacturing Practices standards and procedures).
The new offices, expected to be operational in the main quarter of 2022, will eventually expand the organization's floor space just about three-overlay and essentially add to its cGMP manufacturing limit and scale. The extension likewise incorporates 2,200 square feet of new insightful labs, a powerful quality framework and extra office space.
“This $14 million expansion reflects our growing success as a reliable, experienced and flexible outsourcing partner with exceptional chemistry problem-solving expertise,” said Jeremiah Marsden, PhD, President of Cascade Chemistry. “Our customers are increasingly requesting our assistance in producing APIs for their clinical trials, and demand has outstripped our cGMP manufacturing capacity. We were fortunate to acquire two suitable buildings just 10 minutes from our current facility, and construction of new cGMP manufacturing suites that will greatly increase our clinical trial API production capacity is now underway.”
The 28,000-square-foot fabricating currently under development will at first incorporate five suites for Phase 1 and Phase 2 cGMP manufacturing with stream hydrogenation and reactors up to 400 liters. Extra limit with respect to API Phase 3 and business scale cGMP manufacturing up to 1,000 liters will be included 2022. The subsequent structure, with 7,000 square feet, is saved for future development.
Dr. Marsden continued, “We ultimately will expand into the second new building to build further cGMP capacity for commercial-stage low-volume, high-value pharmaceuticals. We are grateful for the support from our customers that is driving this expansion, as well as our employees’ dedication to excellence and their creativity and hard work that make it all possible.”
About Cascade Chemistry
Cascade Chemistry specializes in active pharmaceutical ingredient (API) process development, scale-up and cGMP (current Good Manufacturing Practices) manufacturing. Most of our chemists have advanced degrees and are capable of crafting process solutions tailored to the specific needs of our clients, while adhering to strict FDA quality standards. We offer cost effective and rapid solutions for the development and manufacturing of API cGMP batches at 1-10 kg scale, and we will begin offering greater capacity at our new facility in 2022. It has been our philosophy for almost 40 years that quality is a key component of successful cGMP manufacturing. We view quality as a guiding principle, achieved by rigorous due diligence at each step of the development and manufacturing process. Cascade Chemistry is headquartered in Eugene, Oregon.