CASI Pharmaceuticals, Inc. | January 19, 2022
CASI Pharmaceuticals, Inc. a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, announced today, that the U.S. Food and Drug Administration as granted Orphan Drug Designation for CNCT19, an investigational CD-19 directed CAR-T therapy, for the treatment of patients with Acute Lymphoblastic Leukemia.
CNCT19 is currently being developed independently by Juventas to meet the urgent clinical needs of patients with hematologic malignancies globally. The National Medical Products Administration has granted CTA approval for CNCT19 in two indications in Nov. 2019. Currently, the Phase II clinical trials of CNCT19 are in progress. Positive clinical data for adult and pediatric patients with relapsed/refractory B-ALL has been presented at the December 2021 ASH annual meeting, which further demonstrated its safety and efficacy profile. CNCT 19 is expected to be the first domestic CD19 directed CAR-T product in China with independent intellectual property rights.
"Our partner Juventas continues to make encouraging progress in developing their CD19 CAR-T therapy. The Orphan Drug Designation, from the FDA, and the Breakthrough Designation status, granted by the China Center of Drug Evaluation (CDE) in December 2020, represent significant milestones that demonstrate our belief that CNCT19's commercialization will not only be successful in China, but potentially on a global scale. CASI has worldwide co-commercial rights of CNCT19, and will start the global commercialization process according to CNCT19's regulatory progress outside China."
Dr. Wei-Wu He, CASI's Chairman, and CEO
Juventas is a biopharmaceutical company headquartered in China dedicated to the development and commercialization of cell therapies globally. Utilizing innovative and integrated technology platforms, the company has developed a diverse pipeline of cellular immunotherapies for treatment of hematological malignancies, solid tumors, and other non-oncological conditions both in China and globally. At present, the company is conducting two pivotal clinical trials of CNCT19 for treating adult r/r-B-ALL and r/r-B-NHL in China. CNCT19 has the potential to become the first launched domestically developed CD19 CAR-T therapy in China and the first CAR-T product for the treatment of adult R/R B-ALL in China.
About CASI Pharmaceuticals
CASI Pharmaceuticals, Inc. is a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products in China, the United States, and throughout the world. The Company is focused on acquiring, developing and commercializing products that augment its hematology oncology therapeutic focus as well as other areas of unmet medical need. The Company intends to execute its plan to become a leader by launching medicines in the greater China market leveraging the Company's China-based regulatory and commercial competencies and its global drug development expertise. The Company's operations in China are conducted through its wholly-owned subsidiary, CASI Pharmaceuticals (China) Co., Ltd., which is located in Beijing, China. The Company has built a commercial team of more than 100 hematology oncology sales and marketing specialists based in China.
PhaseBio Pharmaceuticals, Inc. | February 25, 2022
PhaseBio Pharmaceuticals, Inc. a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular diseases, today announced that Chief Executive Officer Jonathan P. Mow will participate in a panel discussion during Cowen’s 42nd Annual Health Care Conference taking place virtually on Tuesday, March 8, 2022 from 12:50 pm – 1:50 pm ET.
Interested parties can access the live and archived webcasts of the virtual session on the “Events and Presentations” page of the “Investors” section of the company’s website at www.phasebio.com. The webcast replay will be available for 90 days after the conclusion of the live presentation.
PhaseBio Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel therapies for cardiovascular and cardiopulmonary diseases. PhaseBio’s pipeline includes: bentracimab (PB2452), a novel reversal agent for the antiplatelet therapy ticagrelor; pemziviptadil (PB1046), a once-weekly VIP receptor agonist for the treatment of pulmonary arterial hypertension; and PB6440, an oral agent for the treatment of resistant hypertension. PhaseBio’s proprietary elastin-like polypeptide technology platform enables the development of therapies with potential for less-frequent dosing and improved pharmacok
Iktos | December 20, 2021
Iktos, a company specialized in Artificial Intelligence for new drug design, and The Drug Discovery Unit (DDU), School of Life Sciences, The University of Dundee, focused on the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery, announced entering a collaboration to apply Iktos’s generative modelling artificial intelligence (AI) technology in one of DDU’s drug discovery programs. Under the agreement, Iktos will apply its de novo ligand and structure-based generative modelling technologies, its AI-based retrosynthesis analysis and planning tool Spaya™, and know-how complementing DDU’s drug discovery capabilities to expedite the identification of potential pre-clinical candidates and to identify additional novel chemical matter with suitable properties.
The DDU was established in 2006 to respond to a lack of drug targets identified for neglected tropical diseases being translated into therapeutics for diseases impacting the poorest people in the world. The DDU translates basic science into lead compounds to validate putative drug targets, to use as tools to investigate disease pathways and, when appropriate, advance to pre-clinical drug candidates for multiple diseases, e.g. TB and cancer.
Iktos’s AI technology, based on deep generative models, helps to bring new insights and directions into the drug discovery process based on a comprehensive data-driven chemical structure generation technology. This technology automatically designs virtual novel molecules with all of the characteristics of a successful drug molecule. This approach, validated through Iktos’s other collaborations, is a novel solution to one of the key challenges in drug design: rapid identification of molecules that simultaneously satisfy multiple parameters, such as potency, selectivity, safety, and project-specific properties. This approach uniquely enables the exploration of chemical space and produces innovative molecule designs with greater freedom to operate.
Iktos has recently diversified its R&D efforts into the development of an AI technology for retrosynthesis. Identifying and selecting synthetic pathways is one of the most challenging and time-consuming tasks in synthetic and medicinal chemistry. Iktos has developed AI based retrosynthesis analysis and planning tool Spaya™ by harnessing the power of data-driven retrosynthesis algorithm for systematic exploration and prioritisation of synthetic routes for a desired compound in minutes.
“We are thrilled to be working with Iktos to drive our projects towards drug candidates. Iktos AI platform combined with our own in-house computational and medicinal chemistry design teams provide a powerful combination for innovative new drug design.”
Professor Paul Wyatt, Head of the DDU
“We are thrilled and proud to join forces with DDU with the aim to help in the discovery of therapeutics for neglected diseases and the translation of novel biology through small molecule drug discovery,” commented Yann Gaston-Mathé, President and CEO of Iktos. “Pleased to have earned DDU’s trust, we are confident that together with DDU and their established R&D partners, we will be able to identify promising novel chemical matter and solve complex multiparametric optimisation problems. The feedback from DDU’s research team will be highly valuable as we improve our product offerings. Our strategy has always been to tackle challenging problems alongside our collaborators where we can demonstrate value generation for new and on-going drug discovery projects.”
The Drug Discovery Unit (DDU) (est. 2006) within the School of Life Sciences at The University of Dundee is a fully integrated, Biotech-style, drug discovery centre working across multiple disease areas. The DDU collaborates with partners to translate world-class biology research into novel drug targets and candidate drugs to address unmet medical need.
Incorporated in October 2016, Iktos is a French start-up company specialized in the development of artificial intelligence solutions applied to chemical research, more specifically medicinal chemistry and new drug design. Iktos is developing a proprietary and innovative solution based on deep learning generative models, which enables, using existing data, to design molecules that are optimized in silico to meet all the success criteria of a small molecule discovery project. The use of Iktos technology enables major productivity gains in upstream pharmaceutical R&D. Iktos offers its technology both as professional services and as a SaaS software platform, Makya™. Iktos is also developing Spaya™, a synthesis planning software based upon Iktos’s proprietary AI technology for retrosynthesis.
Elligo Health Research | April 21, 2022
Elligo Health Research, the largest healthcare-enabling research organization, announced they are expanding partnerships to include Peoples Rx, an Austin, Texas-based pharmacy chain.
“We’re in a unique position at Peoples Rx to help inform more people about how they can participate in clinical research opportunities. Working with Elligo to offer research as healthcare to our customers helps support our mission to empower people to make educated health decisions.”
Stephen Erickson, Peoples Rx president
One of the first studies Peoples Rx will be working to share with Elligo is a study for people to advance screening diagnostics for cancer. “Our patients may not hear about clinical research opportunities otherwise, and this empowers patients with knowledge to become more proactive in their own healthcare journey while simultaneously supporting the advancement of health sciences,” Erickson said.
Elligo began its mission to provide easy access to clinical research as care to more patients nearly six years ago. Specifically, Elligo is focused on accelerating clinical trials through healthcare by maintaining the integrity of the trusted patient and physician relationship, building local healthcare communities, and leveraging electronic health records.
“Accomplishing this mission is made possible by the partnerships we have with real-world healthcare,” said Elligo CEO John Potthoff, Ph.D. “Peoples Rx has a positive impact on our local community and is a trusted partner for healthcare. This is also Elligo’s first partnership with a pharmacy, and it is our hope that this will lead to further opportunities to collaborate with more providers in the healthcare spectrum on similar initiatives and continue contributing to the changing clinical research landscape.”
About Elligo Health Research®
Elligo Health Research accelerates clinical trials through healthcare with access to known patients and their HIPAA-compliant healthcare data, our IntElligo® Research Stack technology, and our hybrid enrollment model, PatientSelect. Coupled with the largest Known Patient Access Network, Elligo’s Site Solutions enable healthcare practices and research sites to participate in clinical trials. By adaptive engagement of known patients and physicians, we accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products.
About Peoples Rx
Peoples Rx has been the local favorite pharmacy and wellness headquarters in Austin for over 40 years. Our integrative approach to health and wellness starts with our knowledgeable and experienced pharmacists and wellness specialists, and our cutting-edge, holistic, and professional products. We also compound custom medications in our state-of-the-art lab to meet customers’ specific needs. And because food is medicine too, our own in-house delis serve up scratch-made meals and snacks with the highest quality ingredients. With a mission to empower people to make educated health choices, several of our 170+ employees, including clinical nutritionists, herbalists, naturopaths, and homeopaths also offer their expertise through private consultations and educational events.