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Ratutrelvir was well-tolerated for 10 days and achieved consistent plasma levels in the predicted therapeutic window, without the need for co-administration of ritonavir Phase 2a study expected to begin in H1 2025 in patients with COVID Improving COVID care is an ongoing need, with approximately 50,000 US deaths in 2023 NEWTOWN, Pa., Sept. 30, 2024 (GLOBE NEWSWIRE) -- Traws Pharma, Inc. (NASDAQ: TRAW) (“Traws Pharma”, “Traws” or “the Company”), a clinical-stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases, today announced positive topline Phase 1 results for its potential best-in-class COVID (SARS-CoV-2) candidate, ratutrelvir, an oral inhibitor of the Main protease (Mpro). “Topline data indicate that administration of ratutrelvir, our product candidate for COVID, as monotherapy, for 10 days to healthy volunteers, showed no treatment related adverse events and demonstrated consistent plasma drug levels in the predicted therapeutic window. We are especially pleased by ratutrelvir’s ability to achieve plasma concentrations that are considerably above the EC90 against a comprehensive panel of SARS-CoV-2 viruses, without the need for ritonavir co-administration that can be a source of drug-drug interactions and potential severe side effects,” said Werner Cautreels, PhD, Chief Executive Officer of Traws Pharma. “These data provide us with further indication that ratutrelvir has the potential to be a potent, best-in-class, once-a-day, single-dose, 10-day antiviral therapy for COVID. This profile contrasts with Paxlovid™, an approved Mpro inhibitor, which requires co-administration of ritonavir, a metabolic inhibitor. We believe that ratutrelvir’s ritonavir-free regimen has the potential to reduce the burden of treatment, especially for patients with underlying medical conditions. Based on the Phase 1 data, we have selected the dose for our Phase 2a study, expected to begin in H1 2025.” “As we near the fifth anniversary of the pandemic, it is notable that, despite the wide availability of approved antiviral therapies, COVID was a major cause of mortality in the US in 2023, with approximately 50,000 deaths1,” said Robert R. Redfield, MD, Chief Medical Officer for Traws Pharma and former Director of the U.S. Centers for Disease Control and Prevention (CDC). “We believe it is important for new COVID therapies to have a simple treatment regimen that can be used broadly, especially in patients who are at higher risk of serious symptoms or who are over 65 years of age with underlying medical conditions including heart disease, kidney disease, and chronic lung disease2. In addition, we consider activity against resistant viruses and low risk of clinical rebound to be important features of potential new COVID therapies. Our enthusiasm for ratutrelvir’s potential to meet the need for improved COVID treatment has been enhanced by the Phase 1 data.” “Our goal for ratutrelvir is to effectively treat COVID, limit the symptoms of infection, and lower the risk for clinical rebound,” said C. David Pauza, PhD, Chief Scientific Officer for Traws Pharma. “Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir monotherapy has differentiated activity compared to nirmatrelvir against a range of drug-resistant viruses. Also, preclinical testing in animal models showed that levels of ratutrelvir in the lung were higher than in plasma. Phase 1 data show that ratutrelvir achieved consistent plasma levels in the predicted therapeutic window, with a pharmacokinetic profile that may reduce the likelihood of clinical rebound.” Topline Phase 1 ResultsThe Phase 1 trial (NCT06402136, conducted in Australia) was designed as a randomized, double-blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single- and multiple ascending doses (SAD and MAD) of ratutrelvir, administered as a capsule formulation in 56 healthy, COVID-negative, adult volunteers, randomized three-to-one (eight subjects per dosing group). The SAD portion of the study evaluated five ratutrelvir dose levels; the MAD segment evaluated two ratutrelvir dose levels, administered once daily for 10 days. This first-in-human study showed no treatment related adverse events reported up to the highest dose. Topline data also showed that once-daily administration of ratutrelvir maintained plasma drug levels within the predicted therapeutic window. Preclinical studies, presented at the annual International Conference on Antiviral Research in 2024 (ICAR2024), showed that ratutrelvir demonstrated differentiated activity compared to nirmatrelvir against a range of SARS-CoV-2 variants, based on a comparison of EC50 values. About RatutrelvirIndustry data indicate that COVID treatment represents a potential multi-billion dollar market opportunity. Ratutrelvir (also previously known as 83-0060 or TRX-01) was designed as an inhibitor of the SARS-CoV-2 Main protease (Mpro or 3CL protease). It has demonstrated in vitro activity against the original strain of the virus as well as the delta and omicron variants, and is more active than nirmatrelvir (Pfizer’s Mpro inhibitor, co-packaged with ritonavir as PAXLOVID™) in preclinical studies. Based on preclinical studies, ratutrelvir did not require co-administration with a metabolic inhibitor, such as ritonavir, which inhibits human cytochrome P450 (CYP) 3A4. Because of this, ratutrelvir is expected to avoid ritonavir-associated drug-drug interactions and potential resulting severe side effects, which may permit wider patient use. The drug candidate’s pharmacokinetic (PK) profile, including the ability to achieve plasma levels within the predicted therapeutic window, as demonstrated in the Phase 1 study, may also enable a once daily treatment regimen and reduce the likelihood of clinical rebound. Source information: https://www.nbcnews.com/health/health-news/covid-fell-10th-leading-cause-death-last-year-4th-rcna165775https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/coronavirus-who-is-at-risk/art-20483301 About Traws Pharma, Inc.Traws Pharma is a clinical stage biopharmaceutical company developing potential oral small molecule therapies for the treatment of respiratory viral diseases and cancer. The viral respiratory disease program includes two Phase 1 potentially best-in-class oral small molecules in development: tivoxavir marboxil, a novel oral antiviral drug candidate for influenza and avian flu, targeting the influenza cap-dependent endonuclease, and ratutrelvir, targeting Mpro (3CL protease) for COVID. In the cancer program, Traws is utilizing a partnering strategy, supported by investigator sponsored studies, to advance two novel proprietary multi-kinase inhibitors, narazaciclib, targeting CDK4+, and rigosertib, targeting cell cycle proteins including PLK-1. Traws is committed to delivering novel compounds for unmet medical needs using state-of-the-art drug development technology. With a focus on product safety and a commitment to patients in need or that are specifically vulnerable, we aim to build solutions for important medical challenges and alleviate the burden of viral infections and cancer. Forward-Looking Statements Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, and involve risks and uncertainties including statements regarding the Company, its business and product candidates, including the potential opportunity, benefits and Traws regulatory plans for ratutrelvir. The Company has attempted to identify forward-looking statements by terminology including “believes”, “estimates”, “anticipates”, “expects”, “plans”, “intends”, “may”, “could”, “might”, “will”, “should”, “preliminary”, “encouraging”, “approximately” or other words that convey uncertainty of future events or outcomes. Although Traws believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including the success and timing of Traws’ clinical trials, collaborations, merger integration, market conditions and those discussed under the heading “Risk Factors” in Traws’ filings with the U.S. Securities and Exchange Commission (SEC). Any forward-looking statements contained in this release speak only as of its date. Traws undertakes no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events. Traws Pharma Contact:Mark GuerinTraws Pharma, Inc.267-759-3680www.trawspharma.com Investor Contact:Bruce MackleLifeSci Advisors, LLC646-889-1200bmackle@lifesciadvisors.com

AstraZeneca (AZ) has shared “unprecedented” overall survival (OS) results from a late-stage study of Imfinzi (durvalumab) plus Imjudo (tremelimumab) in advanced liver cancer. The phase 3 HIMALAYA trial has been evaluating a single 300mg priming dose of Imjudo added to Imfinzi 1500mg, followed by Imfinzi every four weeks, in patients with unresectable, advanced hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localised treatment. The results presented at this year’s European Society for Medical Oncology Congress showed that the combination, known as the STRIDE regimen, reduced the risk of death by 24% compared to sorafenib, a standard-of-care multi-kinase inhibitor, at five years of follow-up. An estimated 19.6% of patients receiving Imfinzi plus Imjudo were alive at five years versus 9.4% of those in the sorafenib group. Additionally, in a subgroup analysis of patients who achieved disease control, 28.7% of those being treated with STRIDE were alive at five years compared to 12.7% of those in the sorafenib cohort. AZ added that an exploratory analysis showed that more patients treated with Imfinzi plus Imjudo experienced deep responses leading to longer survival compared to sorafenib, and that safety profile of the regimen was consistent with the known profiles of each medicine. Almost 900,000 people worldwide are diagnosed with liver cancer every year, with HCC accounting for the majority of cases. More than half of patients are diagnosed with advanced disease, at which point the five-year survival rate is only 7%. Imfinzi is designed to block the interaction of PD-L1 with the PD-1 and CD80 proteins, countering tumours’ immune-evading tactics and releasing the inhibition of immune responses. Meanwhile, Imjudo blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. The combination already holds approvals to treat adults with advanced or unresectable HCC in the US, EU and several other countries. HIMALAYA lead investigator Lorenza Rimassa, Humanitas University and IRCCS Humanitas Research Hospital, said: “Treatment with [Imfinzi] plus [Imjudo] for patients with advanced liver cancer doubled the OS rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. “This data reinforces the use of this novel dual immunotherapy regimen and is an important milestone for patients with this devastating disease.”

Longest survival follow-up ever reported for a Phase III immunotherapy trial in this setting WILMINGTON, DE, USA I September 16, 2024 I Updated results from the HIMALAYA Phase III trial showed AstraZeneca’s IMFINZI ® (durvalumab) plus IMJUDO ® (tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment. These results from HIMALAYA will be presented today at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain (presentation 947MO). At five years of follow-up, this latest exploratory analysis showed that a single priming dose of IMJUDO added toIMFINZI, called the STRIDE regimen (Single Tremelimumab-actl Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI] 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% for those treated with sorafenib. In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib. Lorenza Rimassa, MD, Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy and a lead investigator in the HIMALAYA trial, said: “Treatment with durvalumab plus tremelimumab-actl for patients with advanced liver cancer doubled the overall survival rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. These data reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease.” Sarah Manes, Liver Cancers Program Director at Global Liver Institute, said: “Reaching the five-year survival milestone is both clinically significant and emotionally meaningful for people with advanced liver cancer and their families. We are thrilled to see this progress in improving outcomes with new treatment options, bringing new hope for long-term survivorship to patients in our community.” Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “It is remarkable to see nearly 20 percent of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about seven percent of patients living that long historically. This is a major step forward, setting a new survival benchmark. This underscores our commitment to following patients for the long term to help us better characterize the enduring clinical benefits of this innovative priming approach with an anti-CTLA-4 antibody added to PD-L1 blockade.” Summary of updated survival results: HIMALAYA The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, and no new safety signals were observed with longer follow-up. Serious treatment-related adverse events, defined as Grade 3 or 4 and including death, were experienced by 17.5% of patients treated with the STRIDE regimen versus 9.9% of patients treated with sorafenib, with no new events occurring after the primary analysis for STRIDE. IMFINZI in combination with IMJUDO is approved for the treatment of adults with advanced or unresectable HCC in the US, EU (in the 1st-line setting), Japan and several other countries. IMFINZI monotherapy is also approved in Japan in this setting. IMFINZI is indicated for the treatment of adult patients with unresectable Stage III non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy. IMFINZI, in combination with IMJUDO and platinum-based chemotherapy, is indicated for the treatment of adult patients with metastatic NSCLC with no sensitizing epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. IMFINZI, in combination with etoposide and either carboplatin or cisplatin, is indicated for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). IMFINZI, in combination with gemcitabine and cisplatin, is indicated for the treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC). IMFINZI in combination with IMJUDO is indicated for the treatment of adult patients with unresectable hepatocellular carcinoma (uHCC). IMFINZI in combination with carboplatin and paclitaxel followed by IMFINZI as a single agent is indicated for the treatment of adult patients with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Please see Full Prescribing Information including Medication Guide for IMFINZI and IMJUDO . Notes Liver cancer Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death, with nearly 900,000 people worldwide diagnosed each year and a high prevalence in certain regions of Asia. 1-2 An estimated 80-90% of all patients with HCC also have cirrhosis. Chronic liver diseases such as cirrhosis are associated with inflammation that over time can lead to the development of HCC. 3 Advanced-stage HCC prognosis is poor, with a five-year survival rate of only 7%. 4 More than half of patients are diagnosed at advanced stages of the disease, often when symptoms first appear. 5 The unique immune environment of liver cancer provides clear rationale for investigating medications that harness the power of the immune system to treat HCC. 5 HIMALAYA HIMALAYA is a randomized, open-label, multi-center, global Phase III trial of IMFINZI monotherapy and a regimen comprising a single priming dose of IMJUDO 300 mg added to IMFINZI1500mg followed by IMFINZIevery four weeks (STRIDE regimen) versus sorafenib, a standard-of-care multi-kinase inhibitor. The trial included a total of 1,324 randomized patients with unresectable, advanced HCC who had not been treated with prior systemic therapy and were not eligible for locoregional therapy (treatment localized to the liver and surrounding tissue). The trial was conducted in 181 centers across 16 countries, including in the US, Canada, Europe, South America and Asia. The primary endpoint was OS for the combination versus sorafenib and key secondary endpoints included OS for IMFINZIversus sorafenib, objective response rate and progression-free survival (PFS) for the combination and for IMFINZIalone. IMFINZI IMFINZI ® (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumor’s immune-evading tactics and releasing the inhibition of immune responses. IMFINZI is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer (BTC) and in combination with IMJUDO ® (tremelimumab-actl) in unresectable HCC. IMFINZI is also approved as a monotherapy in unresectable HCC in Japan and the EU and in combination with chemotherapy (carboplatin plus paclitaxel) followed by IMFINZI monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient in the US. In addition to its indications in gastrointestinal (GI) cancers, IMFINZI is the global standard of care in the curative-intent setting of unresectable, Stage III non-small cell lung cancer (NSCLC) in patients whose disease has not progressed after chemoradiotherapy. IMFINZI is also approved for the treatment of extensive-stage small cell lung cancer (SCLC) and in combination with a short course of IMJUDO and chemotherapy for the treatment of metastatic NSCLC. In limited-stage SCLC, IMFINZI demonstrated statistically significant and clinically meaningful improvements in the dual primary endpoints of OS and PFS compared to placebo in patients who had not progressed following standard-of-care concurrent chemoradiotherapy in the ADRIATIC Phase III trial. IMFINZI in combination with neoadjuvant platinum-containing chemotherapy before surgery and as adjuvant monotherapy after surgery has been approved for patients in the US and several other countries for the treatment of adult patients with resectable NSCLC and no known epidermal growth factor receptor mutations or anaplastic lymphoma kinase rearrangements. IMFINZI plus chemotherapy followed by IMFINZI alone was recently approved in the US for mismatch repair deficient patients with primary advanced or recurrent endometrial cancer. This regimen was also approved in the EU, in addition to IMFINZI plus chemotherapy followed by IMFINZI and olaparib for mismatch repair proficient patients. In muscle-invasive bladder cancer, IMFINZI in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival and the key secondary endpoint of OS versus neoadjuvant chemotherapy in the NIAGARA Phase III trial. Since the first approval in May 2017, more than 220,000 patients have been treated with IMFINZI. As part of a broad development program, IMFINZI is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, bladder cancer, breast cancer, several GI and gynecologic cancers other solid tumors. IMJUDO IMJUDO ® (tremelimumab-actl) is a human monoclonal antibody that targets the activity of cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). IMJUDO blocks the activity of CTLA-4, contributing to T-cell activation, priming the immune response to cancer and fostering cancer cell death. In addition to its approved indications in liver and lung cancers, IMJUDOis being tested in combination with IMFINZI across multiple tumor types including locoregional HCC (EMERALD-3), SCLC (ADRIATIC) and bladder cancer (VOLGA and NILE). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2022, GI cancers collectively represented approximately 4.9 million new cancer cases leading to approximately 3.3 million deaths. 6 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. In addition to its indications in BTC and HCC, IMFINZI is being assessed in combinations, including with IMJUDO, in liver, esophageal and gastric cancers in an extensive development program spanning early to late-stage disease across settings. The Company is also assessing rilvegostomig (AZD2936), a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC and as a 1st-line treatment in patients with HER2-negative, locally advanced unresectable or metastatic gastroesophageal junction cancers. Fam-trastuzumab deruxtecan-nxki, a HER2-directed antibody drug conjugate, is approved in the US, China and several other countries for HER2-positive advanced gastric cancer and is being assessed in colorectal cancer. It also has been assessed in multiple GI settings including BTC in the DESTINY-PanTumor02 Phase II trial, and it was recently approved in the US for the treatment of unresectable or metastatic HER2-positive solid tumors who have received prior systemic treatment and have no satisfactory alternative treatment options. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US, EU and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. AstraZeneca is advancing multiple modalities that provide complementary mechanisms for targeting Claudin 18.2, a promising therapeutic target in gastric cancer. These include AZD0901, a potential first-in-class antibody drug conjugate licensed from KYM Biosciences Inc., currently in Phase III development, AZD5863, a novel Claudin 18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development, and AZD6422, an armored autologous chimeric antigen receptor T cell (CAR-T) therapy, currently being evaluated in an Investigator Initiated Trial (IIT) in collaboration with AbelZeta in China. In early development, AstraZeneca is developing two Glypican 3 (GPC3) armored CAR-Ts in HCC. AZD5851, currently in Phase I development, is being developed globally, and C-CAR031 / AZD7003 is being co-developed with AbelZeta in China where it is under evaluation in an IIT. AstraZeneca in immuno-oncology (IO) AstraZeneca is a pioneer in introducing the concept of immunotherapy into dedicated clinical areas of high unmet medical need. The Company has a comprehensive and diverse IO portfolio and pipeline anchored in immunotherapies designed to overcome evasion of the anti-tumor immune response and stimulate the body’s immune system to attack tumors. AstraZeneca strives to redefine cancer care and help transform outcomes for patients with IMFINZIas a monotherapy and in combination with IMJUDO as well as other novel immunotherapies and modalities. The Company is also investigating next-generation immunotherapies like bispecific antibodies and therapeutics that harness different aspects of immunity to target cancer, including cell therapy and T-cell engagers. AstraZeneca is pursuing an innovative clinical strategy to bring IO-based therapies that deliver long-term survival to new settings across a wide range of cancer types. The Company is focused on exploring novel combination approaches to help prevent treatment resistance and drive longer immune responses. With an extensive clinical program, the Company also champions the use of IO treatment in earlier disease stages, where there is the greatest potential for cure. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines in Oncology, Rare Diseases and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 125 countries, and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on social media @AstraZeneca . References SOURCE: AstraZeneca