Globenewswire | July 03, 2023
Baudax Bio, Inc. a pharmaceutical company focused on innovative products for acute care and related settings, announced the acquisition of TeraImmune, a privately held a biotechnology company focused on discovery and development of novel Treg-based cell therapies for autoimmune diseases.
“This combination blends the world class scientific expertise of the TeraImmune team with the Baudax team’s proven ability to execute clinical development programs, which we believe is a win for the shareholders of both companies,” said Ms. Henwood. “This merger adds TeraImmune’s TI-168 asset to the Baudax portfolio—a promising next-generation, autologous FVIII TCR-Treg cell therapy candidate to eliminate clotting factor VIII (FVIII) inhibitors in Hemophilia A patients. Hemophilia A is a rare genetic bleeding disorder that is caused by a lack of FVIII, with an Investigational New Drug (IND) application already FDA-cleared. We believe this combination can enable, with a modest initial budget, activating the Phase 1/2a Clinical Trial of TI-168 for Treatment of HA. We believe this is an attractive therapeutic area, with established preclinical proof of concept in TI-168 through successes observed in hemophilic animal models. We believe this platform, with customization to the target condition, has potential for clinical application in management of Myasthenia Gravis, Pemphigus Vulgaris and combination therapies for other conditions such as Organ Transplantation, MS and other auto-immune disorders.”
“Concurrently, we intend to continue to progress the development of our existing Neuromuscular Blockade (NMB) portfolio at a prudent pace,” continued Ms. Henwood. “With the positive data obtained from our Phase 2 trial of BX1000, we continue to believe that when combined with our reversal agent BX3000 our NMB regimen may provide improved control of neuromuscular paralysis for surgical patients and deliver the first innovation in NMB in decades.”
“With IND clearance from the FDA already in hand for TI-168, this transaction permits the continued development of this promising asset,” said Yong Chan Kim, PhD, Co-Founder of TeraImmune. “We are looking forward to working with Gerri Henwood and the excellent clinical development team at Baudax to advance this asset to its full potential,” said Jihoon (Jay) Park, PhD, Co-Founder of TeraImmune. Daniel Chai, former Board Member of TeraImmune and managing partner of Turret Capital Management said, “We are very excited to see the results that will be driven by the combination of an impressive leadership team and how many lives that can be impacted by the development of this platform technology.”
Gerri Henwood, President and Chief Executive Officer of Baudax Bio, will continue as CEO of the combined entity. In conjunction with the transaction, Yong Chan Kim, Ph D, former Chief Executive Officer of TeraImmune, will be appointed to the Board of Directors of Baudax.
About the Transaction
The acquisition of TeraImmune was structured as a stock-for-stock transaction whereby all TeraImmune outstanding equity interests were exchanged for a combination of shares of Baudax common stock, shares of newly designated convertible Series X Non-Voting Convertible Preferred Stock. Subject to shareholder approval of the conversion, each share of Series X Non-Voting Convertible Preferred Stock will automatically convert into 1,000 shares of common stock, subject to certain beneficial ownership limitations set by each holder. On a pro forma basis and based upon the number of shares of Baudax common stock and preferred stock issued in the acquisition, Baudax equity holders immediately prior to the acquisition will own approximately 18% of the combined Company (on an as-converted, fully-diluted basis and excluding certain out-of-the-money warrants held by Baudax’ equity holders) immediately after these transactions. The acquisition was unanimously approved by the Board of Directors of Baudax and the Board of Directors of TeraImmune. The closing of the transaction was not subject to the approval of Baudax shareholders.
Nobel Capital provided a fairness opinion to the Baudax Board of Directors.
About Baudax Bio
Baudax Bio is a pharmaceutical company focused on innovative products for acute care and related settings. The Company has a pipeline of innovative pharmaceutical assets including two clinical-stage, novel neuromuscular blocking (NMBs) agents, one that recently completed a Phase II clinical trial and an additional unique NMB undergoing a dose escalation Phase I clinical trial, as well as a proprietary chemical reversal agent specific to these NMBs, which is currently undergoing nonclinical and manufacturing studies to prepare for an expected IND filing in the summer of 2023.
Globenewswire | July 14, 2023
Ardelyx, Inc. a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that a New Drug Application (NDA) for tenapanor has been accepted for review by China’s Center for Drug Evaluation of the National Medical Products Administration (NMPA) for the control of serum phosphorus in adult patients with chronic kidney disease on hemodialysis. This acceptance triggers a $2 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A potential approval of the NDA submission in China is expected by the end of 2024.
“The NDA acceptance for tenapanor for hyperphosphatemia in China marks a significant step forward in Ardelyx’s commitment to bringing our novel therapies to patients with unmet medical needs and our desire to expand internationally alongside best-in-class partners who complement our capabilities and share our mission,” said Mike Raab, president and chief executive officer of Ardelyx. “I commend our collaboration partner, Fosun Pharma, on the impressive clinical results they generated which demonstrate the important role that tenapanor can play in offering a new treatment option for patients with hyperphosphatemia. We look forward to further collaboration as Fosun Pharma brings this treatment to patients.”
Under the terms of its agreement with Fosun Pharma, Ardelyx received an upfront payment of $12 million and is eligible to receive additional developmental and commercialization milestones of up to $110 million and tiered royalty payments on net sales ranging from the mid-teens to 20 percent. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau.
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis, which has completed three successful Phase 3 trials. Ardelyx has a Phase 2 potassium lowering compound, RDX013, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in their respective territories.
About Fosun Pharma
Founded in 1994, Shanghai Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock code: 600196. SH, 02196. HK) is a global innovation-driven pharmaceutical and healthcare industry group. Fosun Pharma directly operates businesses including pharmaceuticals, medical devices, medical diagnosis, and healthcare services. As a shareholder of Sinopharm Co., Ltd., Fosun Pharma expands its areas in the pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented. The company continuously enriches its innovative product pipeline through independent research and development, cooperative development, license-in, and in-depth incubation. Fosun Pharma improves the research and clinical development capabilities of FIC (First-in-class) and BIC (Best-in-class) new drugs as well as accelerates the R&D and launch of innovative technologies and products.
PRNewswire | June 29, 2023
WCG, one of the world's leading providers of solutions that measurably improve the quality, efficiency, and safety of clinical research, recently announced a partnership with Mint Medical to leverage its mint Lesion™ radiology platform for oncology trials.
The mint Lesion™ software is used for standardized and computer-assisted review of medical imaging according to defined protocols, guidelines, and workflows. Compliant and highly configurable, mint Lesion™ is a trusted imaging software for oncology clinical trials, offering quick deployment and more than 20 standardized and configurable response criteria templates out of the box.
Through this partnership, WCG will combine its suite of clinical trial management solutions: operational processes, quality systems, imaging solutions, technology, and expansive reviewer network with mint Lesion's™ verified, read-ready platform, structured reporting, and site-specific workflows for a best-in-class solution for oncology trials.
"The combination of WCG and Mint Medical offers a powerful solution to the market. WCG's teams are experts in study management and have a proven record of managing international clinical trials across all therapeutic areas and indications, including oncology," said Terri Moench, president, WCG Clinical Research Solutions. "Our ISO-certified processes ensure the processing of participant images received from sites are meticulously planned, implemented, and monitored for success. Combine that with mint Lesion™, a technology built to keep pace with changing requirements and the demand for new response criteria, and you have a solution that is unmatched in the industry."
"WCG impressed us with their swift and sound implementation of our groundbreaking technology," said Matthew Hayden, executive director of Clinical Research Operations, Mint Medical. "After just one in-person meeting we crafted a fully operational, fully compliant reading platform that was built and ready for live trial use in just one month. Through this collaborative endeavor, we have forged a dynamic partnership that ensures rapid adaptability to our customers' evolving needs and requirements."
About Mint Medical
Mint Medical GmbH located in Heidelberg/Germany was founded in 2010 as a spin-off of German Cancer Research Center. The company commits itself to developing innovative software solutions in the field of medical imaging and combines image assessment and reporting in one system by considering guidelines for each clinical application context. A particular focus is currently being set on the field of oncology where the software platform mint Lesion™ is applied in clinical routine and clinical trials. Customers of Mint Medical are radiological practices, (university) hospitals, cancer centers, (Imaging) CROs, as well as pharmaceutical and biotech companies all over the world. In addition to the headquarters in Germany, the company has a subsidiary, Mint Medical Inc., in New Jersey, USA.
WCG is a global leader of solutions that measurably improve and accelerate clinical research. Biopharmaceutical and medical device companies, contract research organizations (CROs), research institutions, and sites partner with us for our unmatched expertise, data intelligence, and purpose-built technology to make informed decisions and optimize study outcomes, while maintaining the highest standards of human participant protection. WCG raises the bar by pioneering new concepts, reimagining processes, fostering compliance and safety, and empowering those who perform clinical trials to accelerate the delivery of medical therapies and devices that improve lives.