Peplin, Inc.

REDWOOD CITY, Calif., Nov. 01, 2023 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a biotechnology company focused on the development of briquilimab, a novel antibody therapy targeting c-Kit (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), as well as lower to intermediate risk myelodysplastic syndromes (LR-MDS) and novel stem cell transplant conditioning regimens, today announced the appointment of Thomas G. Wiggans, a veteran biopharmaceutical executive, as Chairperson of Jasper’s Board of Directors (the Board), effective immediately. Bill Lis is stepping down as Chairperson and will retire from the Board in December of this year. “We are pleased to welcome Tom to our Board as Chairperson. He brings a very strong track record with him to our Board, having served in senior leadership positions for over four decades at multiple successful biopharmaceutical companies, particularly in the dermatology space,” said Ronald Martell, President and Chief Executive Officer of Jasper. “With our initial clinical study of briquilimab in CSU currently launching, Tom is joining at an important time in the growth of the company and I look forward to drawing on his expertise as we continue to expand our clinical programs. I’d like to thank Bill Lis for his years of service in helping to build Jasper as its founding CEO and for his partnership as Chairperson over the past year as we’ve prioritized our development efforts in mast cell diseases.” "I am excited to join Jasper’s Board at a transformative time in the company’s development,” said Mr. Wiggans. “I believe that briquilimab has the potential to serve as an important and differentiated treatment option across a number of indications with high unmet need, and I look forward to working with Ron and the team to bring value to both patients and shareholders.” “It has been a pleasure working with the Jasper team over the past several years, and I’m confident that the Board and company are under strong leadership as they advance briquilimab into a new stage of clinical development,” said Mr. Lis. “I will be supporting Tom, Ron, and the rest of Jasper as I transition off the Jasper Board to new company ventures.” Mr. Wiggans most recently served as Chairman and CEO of Pardes Biosciences. Prior to Pardes, he founded Dermira (NASDAQ: DERM) in 2010 and served as its Chairman and CEO until it was acquired by Eli Lilly and Company in February 2020. Prior to founding Dermira, Tom served as Chairman and CEO of Peplin, Inc. until Peplin’s acquisition by LEO Pharma A/S in 2009. He also served as Chairman and CEO of Connetics Corporation until it was acquired by Stiefel Laboratories, Inc. in 2006. Prior to Connetics, he served as President and COO of CytoTherapeutics Inc. and in various management positions at Ares-Serono S.A., including as president of its U.S. pharmaceutical operations and managing director of its U.K. pharmaceutical operations. He began his career with Eli Lilly & Co. Mr. Wiggans is currently on the Board of Directors of Annexon, Inc., and Cymabay Therapeutics Inc. He has previously served on the Board of Directors for various industry organizations, educational institutions, and both private and public companies, including service on the board of Forma Therapeutics, Onyx Pharmaceuticals, Sangamo Biosciences, Somaxon Pharmaceuticals, Inc., and the Biotechnology Innovation Organization (BIO). He is currently a member of the board of trustees of the University of Kansas Endowment Association. He holds a Bachelor of Science in pharmacy from the University of Kansas and an MBA from Southern Methodist University. About Jasper Jasper is a clinical-stage biotechnology company developing briquilimab, a monoclonal antibody targeting c-Kit (CD117) as a therapeutic for chronic mast and stem cell diseases such as chronic urticaria and lower to intermediate risk myelodysplastic syndromes (MDS) and as a conditioning agent for stem cell transplants for rare diseases such as sickle cell disease (SCD), Fanconi anemia (FA) and severe combined immunodeficiency (SCID). To date, briquilimab has a demonstrated efficacy and safety profile in more than 145 dosed participants and healthy volunteers, with clinical outcomes as a conditioning agent in SCID, acute myeloid leukemia (AML), MDS, FA, and SCD. For more information, please visit us at www.jaspertherapeutics.com. Forward-Looking Statements Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, the development of briquilimab for CSU, CIndU, LR-MDS and novel stem cell transplant conditioning regimens, Jasper’s growth, Jasper’s expansion of its clinical programs, Jasper’s intention to bring value to both patients and shareholders and the advancement of briquilimab into a new stage of clinical development. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2022 and any subsequent Quarterly Reports on Form 10-Q . If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements. Contacts: John Mullaly (investors)LifeSci Advisors617-429-3548jmullaly@lifesciadvisors.com Alex Gray (investors)Jasper Therapeutics650-549-1454 agray@jaspertherapeutics.com Lauren Barbiero (media)Real Chemistry646-564-2156lbarbiero@realchemistry.com

Evommune team/courtesy of Evommune Evommune’s novel human tissue-based assay system is proving to be a key differentiator as the company develops therapies to control chronic inflammation in autoimmune diseases. “Working with human tissue puts us closer to the target and yields a model that is much more predictive of outcomes in the human immune system,” said Luis Peña, CEO of Evommune, in an interview with BioSpace. “Skin has all of the cell types that are needed to induce specific inflammatory pathways,” said Eugene Bauer, M.D., CMO of Evommune. The company’s human tissue model is an ex vivo system that uses living skin from human donors, allowing the model to reflect all the immune responses that occur across various tissues in the body that drive inflammation. Consequently, in this context, it is more robust, predictive and relevant than animal modeling. This most closely mimics a “real-time” look at immune pathways and how to find the best way to target and modify inflammation. The miniaturized technology enables hundreds of assays to be conducted to study both systemic and topical therapies. Evolving Immunology In seeking to evolve immune therapy, Evommune is looking at the following opportunities in treating patients: early intervention in their disease state, improving efficacy, increasing response rates in patients and enhancing safety. “Autoimmune diseases are, in fact, systemic inflammatory conditions that are often associated with serious co-morbidities including infections, cardiovascular events, renal disease and mental health issues, making early intervention and preventing disease progression extremely important,” Peña said. “The entire body is in an accelerated immune-response mode. So, we are trying to modulate the immune system to dial down some of these responses. “Existing therapeutics have improved our ability to treat inflammatory conditions, but in most diseases, they still only elicit a response in about half the patients treated and achieve a great response rate in only one-third of those,” he continued. “Creating medicines that have better efficacy and that induce remission is the goal for us.” Improving the safety pro drugs that treat autoimmune diseases could make a meaningful impact in this space. “We want to develop therapies that improve patients’ quality of life without putting them at risk for other factors,” Peña said. Evommune’s senior leadership and scientific teams are primed to do just that. Throughout their careers, they have helped bring more than 25 medicines to patients in need. As Peña noted, “the combination of scientific insights, drug development expertise and building companies makes this team a unique group.” Accomplished Team of Experts A testament to this is that Peña and Bauer were co-founders of Dermira, which Eli Lilly acquired for $1.1 billion to get the rights to lebrikizumab. The two had originally helped acquire this asset from Genentech, despite the drug having failed in prior Phase III trials for a different indication. “We saw that lebrikizumab had promise in atopic dermatitis. We believed lebrikizumab had been under-dosed in previous atopic dermatitis trials, mostly because of a focus on asthma,” Peña explained. “We adjusted the dose in a Phase II atopic dermatitis program and delivered strong data. Lilly bought us because of that drug and since then, lebrikizumab has had great data from their Phase III studies. We believe lebrikizumab will become a significant therapy for atopic dermatitis and the team at Evommune had the vision to make that happen,” he said. Before Dermira, Bauer was president and CMO of Peplin, Inc. (acquired by LEO Pharma) and shepherded Picato® through a global submission, which included the FDA and resulted in an approval for actinic keratosis. Additionally, the Evommune development team has been responsible for multiple new drug applications or biologics license applications, several investigational new drug applications and numerous other interactions with regulators, including four global clinical development programs. “That combination of intimate knowledge of both immunology and drug development is what separates Evommune from other companies in terms of our ability to move these novel therapies forward,” Peña said. Evommune is committed to this promise with the ongoing expansion of the team, including new management positions across R&D, CMC, legal, strategy and finance who also bring a wealth of diverse drug discovery and development expertise. A Multifaceted Pipeline Evommune currently has four programs in the pipeline. "The goal for all of our programs is to be best in class,” Peña said. “EVO101 for atopic dermatitis is an IRAK4 inhibitor, which is a very novel target.” A randomized, blinded, placebo-controlled Phase IIa clinical trial for patients with mild-to-moderate atopic dermatitis was initiated in Q3 2022. “We define ‘mild-to-moderate’ atopic dermatitis as affecting between 4 and 12% of an individual’s body surface area. For perspective, the palm of your hand is 1%,” Bauer elaborated. “Study participants will apply a 0.1% cream to the lesions twice daily for eight weeks.” Results will be scored using the eczema area severity index (EASI), which measures redness, scaling and thickness of lesions, as well as the extent and severity of the disease. In EVO101’s development work, Evommune’s human tissue model enabled researchers to recapitulate disease pathology and inflammatory mediators of atopic dermatitis. “Adding low-, mid- and high-potency topical steroids (current standard-of-care therapeutics) to the human tissue model provided a control set of efficacy data – a baseline by which we could then compare the performance of EVO101,” Bauer explained. EVO101, at the dosage being used for patients in the clinical trial, lowered inflammation levels to those comparable with doses of ultra-high potency steroids, but with high selectivity. “We believe this could become an alternative to standard-of-care therapies for atopic dermatitis,” Bauer said, that may be used to treat both adult and pediatric patients. “In addition, we now have a development stage program that could potentially be a ground-breaking oral therapy for mast cell-mediated diseases,” he said. “EVO756 is a completely novel compound that will target the treatment of mast cell-mediated diseases and inflammatory itch,” Peña said. EVO756 targets MRGPRX2, a receptor that exists on mast cells and peripheral neurons and regulates mast cell degranulation. EVO756 is targeted for the treatment of mast cell-mediated disorders with highly prevalent populations such as chronic spontaneous urticaria, interstitial cystitis and hereditary alpha-tryptasemia. In addition, preclinical data have shown that itch can be completely eliminated in mice: knocking out that receptor made it impossible to induce itch. “For patients with inflammatory diseases, itch can be severe and have a significant, negative impact on a patient’s quality of life. We think EVO756 could be a great oral therapy, that can act quickly to relieve itch,” Peña continued. Another program, EVO390, is in development for the treatment of mild-to-moderate psoriasis in the hope of slowing or halting disease progression. This therapeutic agent targets RORγt and has the potential to be best-in-class and the agent of choice for these patients. It may also serve as an adjunct therapy in more severe cases. “We believe it could be a broadly used therapy for psoriasis,” Peña added. “Our fourth program, currently in discovery, targets protein kinase C (PKC) theta,” Peña continued. The company has identified several potent molecules that may have broad anti-inflammatory activity, highly targeted to T-effector cell inhibition and T-regulatory cell activation. This may have utility across a number of inflammatory conditions such as rheumatoid arthritis, IBD, atopic dermatitis and psoriasis. In addition, because it is highly targeted, it has the potential to be safer than the JAK inhibitors and other systemic anti-inflammatory agents. “As a company, we understand the importance of working on multiple targets and managing a portfolio of compounds. This approach provides the opportunity to work on different agents, impact many diseases and make a difference in patients’ lives,” Peña said. The company’s discovery engine is working to identify new targets so the team can extend its therapeutic impact.

Addition of Arthur P. Bertolino MD, PhD, MBA, Brings World Class Capabilities to Leadership Team, Positions CytoAgents for Phase 1b/2a Clinical Trials and Strategic Pharma Partnerships to Treat Cytokine Release Syndrome PITTSBURGH--(BUSINESS WIRE)-- CytoAgents, Inc., a clinical-stage therapeutics company developing a safe, effective treatment (CTO1681) for Cytokine Release Syndrome (CRS), today announced that it has strengthened its leadership team with the appointment of Arthur P. Bertolino MD, PhD, MBA, as Chief Medical Officer. Dr. Bertolino is a seasoned senior pharmaceuticals executive who has led clinical development and business growth for early-stage biotechnology as well as mid-sized and large pharmaceutical companies. Through extensive domestic and international management and drug development experience, including C-level roles in pharmaceuticals and boutique biotechnology, Dr. Bertolino combines science, medicine, and business administration, with leadership acumen and drive to efficiently deliver high-value pharmaceuticals. This press release features multimedia. View the full release here: Arthur P. Bertolino, MD, PhD, MBA, Chief Medical Officer, CytoAgents (Photo: Business Wire) Dr. Bertolino is highly regarded for his international clinical research and development. He most recently served as Chief Medical Officer at Innovation Pharmaceuticals Inc., where he had responsibility for clinical and operational guidance for drug development and accountability for all business functions and clinical activities. Previously, he served in roles at the Novartis Institutes for Biomedical Research (NIBR), as the Vice President & Global Head of Translational Medicine for Autoimmunity, Immunology and Dermatology; Chief Medical Officer at Revance Therapeutics; Chief Medical Officer and Vice President, Medical Affairs, for Peplin, Inc.; and, earlier, as Senior Director at Pfizer. “CytoAgents’ mission to develop novel therapies to address the life-threatening symptoms of CRS, especially in oncology, is truly inspirational and meeting an unmet need,” said Dr. Bertolino. “I have dedicated my career to clinical development and strategic pharma work and am excited to bring these capabilities to the CytoAgents’ leadership team and to the upcoming clinical trials,” said Dr. Bertolino. CytoAgents is developing innovative pharmaceutical products to treat life-threatening conditions, diseases and disorders associated with Cytokine Release Syndrome, or CRS. Commonly referred to as cytokine storm and clinically also known as hypercytokinemia, CRS is a potentially lethal condition associated with a range of diseases and treatments. With a well-established mechanism of action and a strong safety profile, CytoAgents’ lead compound, CTO1681, targets the underlying cause of life-threatening CRS and is positioned to be a new, breakthrough therapy. CT01681’s ability to safely modulate the cytokine response makes it an ideal solution to address CAR T-Cell Therapy-related CRS in oncology. “Our therapeutic, CTO1681, can unlock the clinical promise of CAR T-cell and Bispecifics Antibody therapies, which are currently limited by cytokine release syndrome,” said Teresa Whalen, RPh, CEO of CytoAgents. “The addition of Dr. Bertolino brings a powerful combination of biotech business and pharmaceutical clinical development to us at an opportune time as we embark on Phase Ib and Phase 2a clinical trials that will target CRS triggered by CAR T-cell therapy in oncology, and as we develop partnerships with strategic pharmaceutical companies also focused on this important medical need with limited treatment options.” About CytoAgents CytoAgents is a privately held, clinical-stage biotechnology company focused on the development of innovative pharmaceutical products for the treatment of life-threatening symptoms associated with Cytokine Release Syndrome (CRS), an overreaction of the immune system causing systemic inflammation. There are many causes of CRS, and our mission is to develop a broadly accessible treatment for multiple indications of high unmet need, including oncology CAR T-cell therapy and Bispecific Antibody Therapies, as well as COVID-19, and respiratory epidemics. Using a novel, host-directed approach, our lead compound, CTO1681, targets the underlying cause of life-threatening CRS, by modulating the body’s natural immune response to sickness or disease. We are committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future. Forward Looking Statements Some of the statements in this press release may be forward-looking statements or statements of future expectations based on currently available information. Such statements are naturally subject to risks and uncertainties. Factors such as the development of general economic conditions, future market conditions, unusual catastrophic loss events, changes in the capital markets, changes in governmental regulations and other circumstances may cause the actual events or results to be materially different from those anticipated by such statements. CytoAgents does not make any representation or warranty, express or implied, as to the accuracy, completeness, or updated status of such statements. CytoAgents will not be liable to anyone for any decision made or action taken in conjunction with the information and/or statements in this press release or for any related damages.