Abatacept

Senior R&D leader brings extensive expertise in immunology, clinical development and translational scienceSOUTH SAN FRANCISCO, Calif., June 13, 2024 (GLOBE NEWSWIRE) -- Nkarta, Inc. (Nasdaq: NKTX), a clinical-stage biopharmaceutical company developing engineered natural killer (NK) cell therapies today announced that translational immunology expert George Vratsanos, M.D., FACR, is joining its board of directors. Dr. Vratsanos currently serves as Chief Medical Officer and Head of R&D for Jnana Therapeutics where he oversees the company’s R&D work to treat phenylketonuria and a broad range of immune-mediated diseases. He previously held R&D leadership roles as Senior Vice President of Translational Science and Medicine, Immunology at Janssen Pharmaceuticals, Executive Global Program Head of the Immunology and Dermatology Franchise at Novartis, as well as a Translational Medicine Leader at Roche and a Group Director at Bristol Meyers Squibb. “George is an accomplished physician-scientist whose R&D leadership experience spans multiple autoimmune diseases areas and the successful development of approved therapies such as Orencia® and Cosentyx®,” said Paul J. Hastings, President and CEO of Nkarta. “He will be an enormous asset to the Nkarta board and executive team as we execute our bold, strategic path to pioneer safe and accessible cell therapy for people living with lupus and other autoimmune diseases.” Dr. Vratsanos graduated from New York University (NYU) School of Medicine with honors and completed a postdoctoral fellowship in investigative rheumatology/immunobiology at Yale University. He also earned a master’s degree in clinical investigation from Vanderbilt University, as well as a bachelor’s degree and master’s degree in biomedical engineering from Columbia University. “I’m excited to embrace this new leadership opportunity and support Nkarta’s ground-breaking clinical work to explore natural killer cell therapy for the treatment of lupus and other autoimmune diseases,” Vratsanos said. “Nkarta’s mission is my own. My passion is the translation of innovative immune science into approved therapies that transform patient care. NK cell therapy has breakthrough potential to treat debilitating autoimmune diseases without the safety concerns and logistical challenges of other cell therapies. I look forward to helping Nkarta leverage its strengths as it advances its cell therapy programs.” Nkarta is working to harness the body's natural killer (NK) cells – the immune system's first responders – to deliver a safe, well tolerated, accessible form of cell therapy to treat autoimmune disease. NKX019, an allogeneic, on-demand cell therapy candidate, is in development to treat lupus nephritis – a severe form of lupus in which the immune system attacks the kidneys and other healthy tissue and organs. About NKX019NKX019 is an allogeneic, cryopreserved, off-the-shelf immunotherapy candidate that uses natural killer (NK) cells derived from the peripheral blood of healthy adult donors. It is engineered with a humanized CD19-directed CAR for enhanced cell targeting and a proprietary, membrane-bound form of interleukin-15 (IL-15) for greater persistence and activity without exogenous cytokine support. CD19 is a biomarker for normal B cells as well as those implicated in autoimmune disease and B cell-derived malignancies. About NkartaNkarta is a clinical-stage biotechnology company advancing the development of allogeneic, off-the-shelf natural killer (NK) cell therapies. By combining its cell expansion and cryopreservation platform with proprietary cell engineering technologies and CRISPR-based genome engineering capabilities, Nkarta is building a pipeline of future cell therapies engineered for deep therapeutic activity and intended for broad access in the outpatient treatment setting. For more information, please visit the company’s website at www.nkartatx.com. Cautionary Note on Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. Words such as "anticipates," "believes," "expects," "intends," “plans,” “potential,” "projects,” “would” and "future" or similar expressions are intended to identify forward-looking statements. Examples of these forward-looking statements include, but are not limited to, statements concerning Nkarta’s expectations regarding any or all of the following: the value and benefits to Nkarta of Dr. Vratsanos joining Nkarta’s Board; Nkarta’s position, plans, and strategies for the continued and future clinical development and commercial potential of its product candidates, including NKX019, for the treatment of autoimmune disease; and the therapeutic potential, accessibility, tolerability, advantages, and safety profile of NK cell therapies, including NKX019 for the treatment of autoimmune diseases, such as lupus. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, among others: Nkarta’s limited operating history and historical losses; Nkarta’s lack of any products approved for sale and its ability to achieve profitability; the risk that the results of preclinical studies and early-stage clinical trials may not be predictive of future results; Nkarta’s ability to raise additional funding to complete the development and any commercialization of its product candidates; Nkarta’s dependence on the clinical success of NKX019; that Nkarta may be delayed in initiating, enrolling or completing its clinical trials; competition from third parties that are developing products for similar uses; Nkarta’s ability to obtain, maintain and protect its intellectual property; Nkarta’s dependence on third parties in connection with manufacturing, clinical trials and pre-clinical studies; and the complexity of the manufacturing process for CAR NK cell therapies. These and other risks and uncertainties are described more fully in Nkarta’s filings with the Securities and Exchange Commission (“SEC”), including the “Risk Factors” section of Nkarta’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed with the SEC on May 9, 2024, and Nkarta’s other documents subsequently filed with or furnished to the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Nkarta undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. Nkarta Media/Investor Contact:Greg MannNkarta, Inc.gmann@nkartatx.com

Data demonstrates halting of disease progression in patients with Amyotrophic Lateral Sclerosis (ALS) at 24 weeks (6 months) and a consistent reduction in inflammation, oxidative stress, and enhanced Regulatory T cell (Treg) number and suppressive function in patients who were administered a combination of CTLA4-Ig Fusion Protein (CTLA4-Ig) and Low Dose Interleukin-2 (LD IL-2); Prior to initiating treatment, patients were declining at an average rate of -1.1 points per month on the ALSFRS-R rating scale- At the end of 6 months of treatment, the mean rate of change on the ALSFRS-R was +0.04 points per month. HOUSTON--(BUSINESS WIRE)-- Coya Therapeutics, Inc. (NASDAQ: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologic intended to enhance regulatory T cell (Treg) function, announces the publication of a peer-reviewed manuscript titled, “A Phase 1 Proof-of-Concept Study Evaluating Safety, Tolerability, and Biological Marker Responses with Combination Therapy of CTLA4-Ig and Interleukin-2 in Amyotrophic Lateral Sclerosis,” in the medical journal Frontiers in Neurology. The publication can be viewed here. This press release features multimedia. View the full release here: Disease progression remained relatively unchanged during the first 6 months of CTLA4-Ig/LD IL-2 treatment (Graphic: Business Wire) Dr. Stanley Appel, MD, Edwards Distinguished Endowed Chair for ALS and Director, Johnson Center for Cellular Therapeutics at Houston Methodist stated, “The ability of the combination therapy to halt clinical progression in ALS for 24 weeks provides an important proof of concept for the protective role of Tregs while simultaneously suppressing inflammation. What is most gratifying is the concomitant reduction of the lipid peroxide 4-HNE as well as inflammatory cytokines. This study provides the basis for a large-scale double-blind placebo-controlled trial to establish potential therapeutic efficacy for ALS patients.” Dr. Howard H. Berman, CEO of Coya Therapeutics, stated: “This publication illustrates a promising clinical signal of a novel biologic combination immunotherapy in ALS, a truly devastating condition with high unmet need. Our development of our ALS program continues, and Coya remains on track to Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for its proposed randomized double blind placebo controlled study for LD IL-2 + CTLA4-Ig in ALS this month (June, 2024). Concurrently, our strong balance sheet ensures that we have adequate capital to execute on this upcoming study.” In this open-label study, four participants with ALS received subcutaneous injections of commercial LD IL-2 (1x106 IU/injection/day) for 5 consecutive days every 2 weeks and one subcutaneous injection of CTLA4-Ig (125 mg/mL/injection) every 2 weeks for a total of 24 treatment cycles during the 48-week treatment period. Study participants were followed for additional 8 weeks after treatment with LD IL-2 / CTLA4-Ig. Three participants were sporadic ALS while 1 participant (#1) had mutant C9ORF72-mediated ALS, and 3 participants had respiratory insufficiency according to a qualifying low maximal inspiratory pressure (MIP) value (≤ 60 cm H2O), 2 of which were already being treated with noninvasive ventilation. Prior to initiating treatment, patients had a documented average disease progression of -1.1 points per month in the ALSFRS-R score. Summary of Results: Safety and tolerability of CTLA4-Ig/LD IL-2 treatment: Treatment was well tolerated among all patients. There were no serious adverse events and only mild treatment emergent adverse events, and all patients completed the study. Treg Suppressive Function: Treg suppressive function was significantly increased compared to baseline at weeks 16, 24 and 48 and returned to baseline levels at 6 weeks after the final course of treatment (washout) Clinical Progression: For all 4 participants, the mean rate of change in the ALSFRS-R over the first 24 weeks was stable (+0.04 points/month). During this time period, the ALSFRS-R improved by 4 points in participant #1, improved by 3 points in participant #2, was unchanged in participant #3, and decreased by 6 points in participant #4. Participant #4 experienced a 4-point decrease at week 4, but then remained relatively stable from weeks 4 to 24. Over the 48-week treatment period, the average rate of change in the ALSFRS-R was -0.13 points/month. Biological Marker Changes: Biological markers of oxidative stress (4-HNE and ox-LDL), inflammation (IL-18), and structural degeneration (Nf-L) were assessed at baseline and throughout the course of the study. During the first 16 weeks of treatment, 3 participants showed a decreasing trend of 4-HNE, all 4 participants showed decreasing trend of ox-LDL, 3 participants showed a decreasing trend of IL-18, and 2 participants showed decreasing trend in Nf-L. These trends corresponded with the participants lack of observable disease progression during this time. About COYA 302 COYA 302 is an investigational and proprietary biologic combination therapy with a dual immunomodulatory mechanism of action intended to enhance the anti-inflammatory function of regulatory T cells (Tregs) and suppress the inflammation produced by activated monocytes and macrophages. COYA 302 is comprised of proprietary low dose interleukin-2 (LD IL-2) and CTLA4-Ig and is being developed for subcutaneous administration for the treatment of patients with ALS, FTD, and PD. These mechanisms may have additive or synergistic effects. In February of 2023, Coya announced results from a proof-of-concept, open-label clinical study evaluating commercially available LD IL-2 and CTLA4-Ig in a small cohort of patients with ALS conducted at the Houston Methodist Research Institute (Houston, Texas) by Stanley Appel, M.D., Jason Thonhoff, M.D., Ph.D., and David Beers, Ph.D. This study was the first-of-its-kind evaluating this dual-mechanism immunotherapy for the treatment of ALS. Patients in the study received investigational treatment for 48 consecutive weeks and were evaluated for safety and tolerability, Treg function, serum biomarkers of oxidative stress and inflammation, and clinical functioning as measured by the ALSFRS-R scale. During the 48-week treatment period, the therapy was well tolerated. The most common adverse event was mild injection-site reactions. No patient discontinued the study, and no deaths or other serious adverse events were reported. Patients' disease progression was measured using the ALSFRS-R scale, a validated rating tool for monitoring the progression of disability in patients with ALS. The mean (±SD) ALSFRS-R scores at week 24 (33.75 ±3.3) and week 48 (32 ±7.8) after initiation of treatment were not statistically different compared to the ALSFRS-R score at baseline (33.5 ±5.9), suggesting significant amelioration in the progression of the disease over the 48-week treatment period. Treg suppressive function, expressed as percentage of inhibition of proinflammatory T cell proliferation, showed a statistically significant increase over the course of the treatment period and was significantly reduced at the end of the 8-week washout post-treatment period. Treg suppressive function at 24 weeks (79.9 ±9.6) and 48 weeks (89.5 ±4.1) were significantly higher compared to baseline (62.1 ±8.1) (p<0.01), suggesting enhanced and durable Treg suppressive function over the course of treatment. In contrast, Treg suppressive function (mean ±SD) was significantly decreased at the end of the 8-week washout period compared to end-of-treatment at week 48 (70.3 ±8.1 vs. 89.5 ±4.1, p <0.05). The study also evaluated serum biomarkers of inflammation, oxidative stress, and lipid peroxides. The available data up to 16 weeks after initiation of treatment suggest a decrease in these biomarker levels, which is consistent with the observed enhancement of Treg function. The evaluation of the full biomarker data is ongoing. COYA 302 is an investigational product not yet approved by the FDA or any other regulatory agency. About Amyotrophic Lateral Sclerosis Amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig's Disease, is a rare neurological disease that affects motor neurons, the nerve cells in the brain and spinal cord that control voluntary muscle movement. About 20,000 people live with ALS in the United States and approximately 5,000 new cases are diagnosed every year. The disease is progressive, meaning the symptoms get worse over time. The functional status of ALS patients declines about 1 point per month on average, as measured by the Revised ALS Function Rating Scale1, or ALSFRS-R, a validated tool to monitor the progression of the disease. ALS has no cure, and the currently approved drug treatments provide limited benefit to patients. ALS is a type of motor neuron disease. As motor neurons degenerate and die, they stop sending messages to the muscles, which causes the muscles to weaken, start to twitch (fasciculations), and waste away (atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. Most people with ALS die from respiratory failure, usually within three to five years from when the symptoms first appear.2 References Atassi N, et al. The PRO-ACT database: design, initial analyses, and predictive features. Neurology, 2014;83:1719–1725. doi: 10.1212/WNL.0000000000000951. National Institutes of Health (NIH) Website ( ), accessed on January 8, 2024. About Coya Therapeutics, Inc. Headquartered in Houston, TX, Coya Therapeutics, Inc. (Nasdaq: COYA) is a clinical-stage biotechnology company developing proprietary treatments focused on the biology and potential therapeutic advantages of regulatory T cells (“Tregs”) to target systemic inflammation and neuroinflammation. Dysfunctional Tregs underlie numerous conditions, including neurodegenerative, metabolic, and autoimmune diseases, and this cellular dysfunction may lead to sustained inflammation and oxidative stress resulting in lack of homeostasis of the immune system. Coya’s investigational product candidate pipeline leverages multiple therapeutic modalities aimed at restoring the anti-inflammatory and immunomodulatory functions of Tregs. Coya’s therapeutic platforms include Treg-enhancing biologics, Treg-derived exosomes, and autologous Treg cell therapy. COYA 302 – the Company’s lead biologic investigational product or “Pipeline in a Product”– is a proprietary combination of COYA 301 (Coya’s proprietary LD IL-2) and CTLA4-Ig for subcutaneous administration with a unique dual mechanism of action that is now being developed for the treatment of Amyotrophic Lateral Sclerosis, Frontotemporal Dementia, Parkinson’s Disease, and Alzheimer’s Disease. Its multi-targeted approach enhances the number and anti-inflammatory function of Tregs and simultaneously lowers the expression of activated microglia and the secretion of pro-inflammatory mediators. This synergistic mechanism may lead to the re-establishment of immune balance and amelioration of inflammation in a sustained and durable manner that may not be achieved by either low-dose IL-2 or CTLA4-Ig alone. For more information about Coya, please visit Forward-Looking Statements This press release contains “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financial performance, business plans and objectives, current and future clinical and preclinical development activities, timing and success of our ongoing and planned clinical trials and related data, the timing of announcements, updates and results of our clinical trials and related data, our ability to obtain and maintain regulatory approval, the potential therapeutic benefits and economic value of our product candidates, competitive position, industry environment and potential market opportunities. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” and similar expressions are intended to identify forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to risks associated with the impact of COVID-19; the success, cost and timing of our product candidate development activities and ongoing and planned clinical trials; our plans to develop and commercialize targeted therapeutics; the progress of patient enrollment and dosing in our preclinical or clinical trials; the ability of our product candidates to achieve applicable endpoints in the clinical trials; the safety pro our product candidates; the potential for data from our clinical trials to support a marketing application, as well as the timing of these events; our ability to obtain funding for our operations; development and commercialization of our product candidates; the timing of and our ability to obtain and maintain regulatory approvals; the rate and degree of market acceptance and clinical utility of our product candidates; the size and growth potential of the markets for our product candidates, and our ability to serve those markets; our commercialization, marketing and manufacturing capabilities and strategy; future agreements with third parties in connection with the commercialization of our product candidates; our expectations regarding our ability to obtain and maintain intellectual property protection; our dependence on third party manufacturers; the success of competing therapies or products that are or may become available; our ability to attract and retain key scientific or management personnel; our ability to identify additional product candidates with significant commercial potential consistent with our commercial objectives; ; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed herein may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. We undertake no obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. View source version on businesswire.com: Contacts Investor Contact David Snyder, CFO david@coyatherapeutics.com CORE IR Bret Shapiro brets@coreir.com 561-479-8566 Media Contacts Kati Waldenburg media@coyatherapeutics.com 212-655-0924 Source: Coya Therapeutics, Inc. Smart Multimedia Gallery Photo Disease progression remained relatively unchanged during the first 6 months of CTLA4-Ig/LD IL-2 treatment (Graphic: Business Wire) View this news release and multimedia online at: