University of Kansas Medical Center

MADISON, Wis.--( BUSINESS WIRE )--Nimble Therapeutics announced that Dan Flynn and Brian Cali have joined the company’s Board of Directors. Both bring deep entrepreneurial and drug development track records that will guide Nimble as it continues to pursue its internal pipeline. Dr. Flynn has over 40 years of experience in the discovery and development of high-impact medicines. He recently retired from Deciphera Pharmaceuticals, a company he founded in 2003. At Deciphera, Dr. Flynn held positions of Chief Executive Officer, Executive Vice President, and Chief Scientific Officer where he oversaw the progression of several molecules through clinical trials, including Qinlock® for the treatment of gastrointestinal stromal tumors. Before founding Deciphera, Dr. Flynn held senior roles with various companies including Millennium Pharmaceuticals, Amgen Inc. and the Monsanto Company, G.D. Searle Unit. Dr. Flynn is currently Adjunct Professor of Medicinal Chemistry at the University of Kansas-Lawrence. He has served as the National Chair for the Division of Medicinal Chemistry of the American Chemical Society, is an American Chemical Society Fellow, and founder of the Bioorganic and Medicinal Chemistry Foundation. He is a member of the Board of Directors and Scientific Advisory Boards of several biotech companies. Dr. Flynn received both his B.S. in pharmacy and Ph.D. in medicinal chemistry from the University of Kansas and completed post-doctorate training in synthetic organic chemistry at Indiana University. Dr. Cali has over 25 years of pharma biotech experience. He co-founded Ironwood Pharmaceuticals in 1998 where he held leadership roles across R&D and corporate development and helped drive the company’s transformation from an early discovery stage startup to a commercial stage company with a market leading gastrointestinal (GI) disease product (Linzess ® ) and a diverse pre-commercial pipeline. Brian also led the investor engagement and financing efforts that enabled the creation of Cyclerion, an Ironwood spinout, in 2019. He currently serves on the Board of Directors of Jnana Therapeutics, a role he has held since 2018. He holds a B.S. from Cornell University, a Ph.D. in Cell and Molecular Biology from the University of Wisconsin-Madison and was a postdoctoral fellow at the Whitehead Institute. "We are pleased to welcome Daniel and Brian to our Board of Directors at this important stage of Nimble’s evolution," said Jigar Patel, founder & CEO of Nimble Therapeutics. "Both are renowned pharma biotech entrepreneurs, having founded and successfully led companies that have developed novel small molecule or peptide-based drugs. We look forward to their guidance as we work to bring breakthrough medicines into clinical development, and ultimately to patients in need.” "Daniel and Brian are valuable additions to Nimble’s board, and their expert guidance will be paramount to the company as it continues to concentrate on developing and progressing its internal pipeline,” said Board Chair Dan Zabrowski. “It is an exciting time to be joining Nimble as they seek to leverage their incredibly versatile technology and team to develop best-in-class / first-in-class peptide-based medicines for the treatment of important diseases.” said Dr. Flynn. “Nimble has a paradigm shifting platform and I am impressed with what they have already accomplished. I look forward to helping the company as their efforts toward their own pipeline intensify, and they push towards the clinic and beyond.” said Dr. Cali. About Nimble Therapeutics Nimble is a biotechnology company dedicated to delivering on the promise of peptide therapeutics. Leveraging a paradigm-shifting peptide drug discovery and development engine, Nimble is advancing its internal pipeline and continues to support several partnered programs. The Nimble platform combines massively parallel solid-phase synthesis, unrivaled chemical and structural diversity, sophisticated assays, and powerful machine learning and computational methods. Nimble is located in Madison, WI and Philadelphia, PA. For more information, visit www.nimbletherapeutics.com .

KANSAS CITY, Mo., Feb. 29, 2024 /PRNewswire/ -- Today, researchers at Vivacelle Bio, Inc., a pioneering biotechnology company revealed the compelling outcomes of their phase 2a clinical trial of the investigational cardiovascular support fluid, VBI-S, in patients with severe septic shock. This landmark study now published in the Lancet's eClinicalMedicine , showcases the potential of VBI-S in transforming the treatment landscape for refractory hypotension in these critically ill patients. Unlike previous septic shock trials, this study, conducted in collaboration with the University of Missouri- Kansas City School of Medicine, there were no restrictions on the severity or duration of the illness or the cardiorespiratory stability of the enrolled patients. Some patients were unstable when given VBI-S. Yet the primary endpoint was achieved in each case. Twenty patients with high doses of vasopressors, multiple organ system failure, and a severely dysregulated response to infection were enrolled in the study. Patients, after failing standard fluids, received intravenous VBI-S, a revolutionary composition of phospholipid nanoparticles that reversibly absorb nitric oxide. The results were astonishing, with VBI-S proving 100% effective in elevating mean blood pressure by 10 mmHg or more. Within just 48 hours of the infusion, there were statistically significant improvements across multiple parameters, including oxygenation, renal function, inflammation, lactic acid levels, prothrombin time, and international normalized ratio. Furthermore, the sequential organ failure assessment (SOFA) score, a key indicator of illness severity, showed a notable decrease, signifying improved patient conditions. Remarkably, no serious adverse events were attributed to VBI-S. Sepsis, affecting 49 million people worldwide and claiming eleven million lives annually, poses a significant global health challenge. In the United States alone, 357,000 people succumb to sepsis each year. The efficacy and safety demonstrated by VBI-S in reversing hypotension, inflammation, and organ failure in septic shock patients suggest a potential paradigm shift in treating sepsis with its associated high mortality and morbidity. Dr. Cuthbert Simpkins, MD, the Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri Kansas City School of Medicine and Chief Innovation Officer of Vivacelle Bio, Inc. stated, "This study was initially intended as a pilot to determine the variability of VBI-S effects. We did not expect the convincing results that we obtained. These results fuel our optimism that at last we may have an effective and safe intervention for these very sick patients." Harven DeShield, J.D., Ph. D., CEO of Vivacelle Bio, added, "Ultimately, the availability, affordability, and accessibility of VBI-S would represent a paradigm shift, substantially transforming how septic shock is treated both in the US and globally upon FDA's clearance of VBI-S to be marketed to the public." In a statement, Rod Cotton, 2Flo Ventures Advisory Board Member said, "The publication of these clinical trial results in such a highly regarded peer reviewed journal is evidence of the importance of Vivacelle Bio's technology. This article is the introduction of a new concept of medical intervention that will revolutionize the treatment of sepsis and a broad-spectrum of medical conditions bringing hope to patients and their families." 2Flo Ventures is a startup studio and venture capital firm, and investor in Vivacelle Bio. This groundbreaking research opens new possibilities for the treatment of septic shock, offering hope and potential survival for millions of patients worldwide. The implications of VBI-S in reshaping the landscape of septic shock treatment are promising, marking a significant step forward in the fight against this life-threatening condition. This work was supported by the Naval Medical Research Command (NMRC) - Naval Advanced Medical Development (NAMD) Program under MTEC award 20-02-NavyMultiTopic-002. About MTEC The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org. About 2Flo Ventures 2Flo Ventures is a startup studio and venture capital firm dedicated to accelerating equitable innovation in healthcare. They invest in diverse healthcare entrepreneurs and companies built to close gaps in health outcomes for underserved communities. About Vivacelle Bio Vivacelle Bio ( ) is a life sciences company that utilizes patented phospholipid nanoparticle technology to design products that increase the survivability of critically-ill patients. In addition to VBI-S and VBI-1, Vivacelle Bio has a pipeline of products at various stages of development applicable to a range of health areas including reperfusion injury, organ preservation and transplantation, multiple organ dysfunction syndrome and hyperprocalcitonemia. Vivacelle Bio has raised approximately $10.9M in seed and Series A1-A3 funding, including from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures. Forward looking statements This press release may contain certain forward-looking statements. Although the Company believes its expectations are based on reasonable assumptions, all statements other than statements of historical fact included in this press release about future events are subject to (I) change without notice, (ii) factors beyond the Company's control and (iii) the financial capabilities of the Company. These statements may include, without limitation, any statements preceded by, followed by or including words such as "target," "believe," "expect," "aim," "intend," "may," "anticipate," "estimate," "plan," "project," "will," "can have," "likely," "should," "would," "could" and other words and terms of similar meaning or the negative thereof. Forward looking statements are subject to inherent risks and uncertainties beyond the Company's control that could cause the Company's actual results, performance or achievements to be materially different from the expected results, performance or achievements expressed or implied by such forward-looking statements. Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

Fycompa® is the 16th Captisol-enabled™ product approved worldwide SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Inc. (Nasdaq: LGND) today announced that its partner Eisai Co., Ltd. obtained marketing authorization approval in January 2024 from the Japanese Ministry of Health, Labour and Welfare for the injection formulation of its in-house discovered antiepileptic drug (AED) Fycompa® (perampanel) in Japan as an alternative therapy when oral administration is temporarily not possible. Fycompa is formulated with Captisol®, a Ligand technology. Fycompa is a first-in-class AED discovered at Eisai’s Tsukuba Research Laboratories. The agent is a highly selective, noncompetitive AMPA receptor antagonist that is postulated to reduce neuronal hyper-excitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Two oral formulations of Fycompa are available in Japan: a tablet and a fine granule formulation. “It is essential that patients with epilepsy continue with their course of treatment, even when they are not able to take their medication orally,” said Todd Davis, CEO of Ligand. “We are excited that our longtime partner Eisai is the company that is making this possible, and that Captisol is once again proving to be an invaluable building block in drug development by enabling a new formulation that will make a major difference in people’s lives.” Ligand first entered into an agreement with Eisai on this product in 2017. Under the terms of the agreement, Ligand is entitled to a royalty on sales of intravenous Fycompa. About perampanel (Fycompa®) Perampanel is a first-in-class anti-epileptic agent (AED) discovered and developed by Eisai. With epileptic seizures being mediated by the neurotransmitter glutamate, the agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at AMPA receptors on postsynaptic membranes. Perampanel is currently approved in more than 75 countries and territories, including Japan, China, and other countries in Europe and in Asia as an adjunctive treatment for partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 12 years of age and older. In addition, perampanel has been approved in more than 70 countries, including Japan, in Europe and in Asia for treatment as an adjunctive therapy for primary generalized tonic-clonic seizures in patients with epilepsy 12 years of age and older. In Japan and China, perampanel is approved for monotherapy and adjunctive use in the treatment of partial-onset seizures (with or without secondarily generalized seizures) in patients with epilepsy 4 years of age and older. In Europe the approved age range is 4 years of age and older for the adjunctive treatment of partial-onset seizures (with or without secondarily generalized seizures) and 7 years of age and older for the treatment as an adjunctive therapy for primary generalized tonic-clonic seizure. A tablet, fine granule formulation and injection formulation have been approved in Japan. An oral suspension formulation and tablet have been approved in Europe and China. In January 2023, the commercial rights in the United States were transferred to Catalyst Pharmaceuticals, Inc. About Captisol® Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas' Higuchi Biosciences Center, for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen's Kyprolis®, Baxter's NEXTERONE, Acrotech Biopharma's EVOMELA®, Sage Therapeutics' ZULRESSO®, and Merck's NOXAFIL®. There are more than 40 active Captisol-enabled™ partnered programs in various stages of development. More information is available at . About Ligand Pharmaceuticals Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Our business model seeks to generate value for stockholders by creating a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Our business model is based on funding programs in mid- to late-stage drug development in return for economic rights and licensing our technology to help partners discover and develop medicines. We partner with other pharmaceutical companies to attempt to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate our revenue. Our Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. We have established multiple alliances, licenses and other business relationships with the world’s leading pharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences and Baxter International. For more information, please visit . Follow Ligand on X (f/k/a Twitter) @Ligand_LGND. We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts. Forward-Looking Statements This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include: the potential that Fycompa can benefit patients who would otherwise be treated via oral administration; and the potential royalties to be paid on sales of Fycompa by Eisai. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Eisai Co., Ltd. may not be able to successfully commercialize Fycoma which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for Fycoma may be smaller than estimated; Ligand is dependent on Eisai Co., Ltd. for the commercialization of Fycoma; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at . Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.