Latest news with #MEK
Yahoo
26-05-2025
- Politics
- Yahoo
Kansas City leaders from both parties want a free Iran. We all should
This month, a bipartisan majority in the U.S. House of Representatives supported Iranian dissident Maryam Rajavi's 10-point plan for a free Iran. The initiative — House Resolution 166 — was cosponsored from both sides of the aisle, representing an array of ideological leanings. From the Greater Kansas City area, Missouri Reps. Emanuel Cleaver and Sam Graves and Kansas' Sharice Davids are among them. It was led by California Reps. Tom McClintock, a Republican, and Brad Sherman, a Democrat. The legislators recognize the right of the people of Iran — especially the rebellious youth, led by the Mojahedin-e-Khalq or MEK, the pivotal opposition — to confront the suppressive forces of the Islamic Revolutionary Guard Corps inside Iran. This is consistent with the inalienable rights that the U.S. Constitution recognizes for people to choose their destiny and a government to serve them — if needed by abolishing the existing regime. These lawmakers fully understand that a viable change has to come from within Iran, and the change can happen when led by an organized resistance. Building upon the support from the Iranian American community, Congress has closely monitored the organized movement for freedom inside Iran, led by MEK. The movement enjoys a vast network of devoted resistant units, whose main function is to defend people against the repressive forces of the regime and to tear down the wall of repression. This is going to pave the way for a continuous wave of uprisings when the people reclaim the streets — leading up to the regime's fall. An absolute requirement for the toppling of the Mullahs' regime is a democratic political alternative equipped with an organization of thousands of committed members. And no one has ever understood this better than the mullahs' regime. To curb this real existential threat — embodied in the movement led by Rajavi — the mullahs' regime advanced two propaganda objectives: to suggest the regime can reform through its so-called reformist factions, and to demonize MEK — labeling it a cult, terrorist and unpopular. The above propaganda provided the appeasement policy in the West ammunition to appease the mullahs. Additionally, the narrative has served the regime advancing repression inside and terrorism outside against the dissidents. The recent uprisings in Iran, however, put an end to the claim that the regime can reform. In search of an alternative, the focus has naturally turned to beyond the regime. Feeling the existential threat from the MEK, the pivotal organization of the National Council of Resistance of Iran, led by Rajavi, the mullahs see the only way out by propping up the remnants of the deposed monarchy — abolished through the 1979 revolution — as an alternative. The objectives are to prevent the support for NCRI from reaching a critical mass, to push aside the people yearning for freedom by limiting their choices to the dictatorships of the past (monarchy) and the present (theocracy), and to assist the appeasers arguing there is no viable alternative to the regime. In light of the above, H.R. 166 discredits the regime's propaganda, which uses it cyber-army and political affiliates advocates for the remnants of the monarchy. The legislators stress that a free Iran is possible through a secular democratic republic — an absolute no to dictatorships under the monarchy and Mullahs. Former Secretary of State Mike Pompeo has argued the same: 'Iran will never return to the dictatorship of Shah … The remnants of the past monarchy failed to gain any traction during the (2022-2023) uprising. … Shah's supporters were exposed for heavily relying on collaboration with IRGC.' This resolution recognizes Maryam Rajavi as the embodiment of the organized freedom movement in Iran, adamant about a regime change by the people. It advocates her platform for complete gender equality, freedom of expression and assembly, separation of religion and state, secular democracy and a non-nuclear Iran. An official dialogue with this important voice of political reform sends the message that the U.S. stands with the people for a free Iran. Saeid Sajadi is a practicing physician from Overland Park and a representative for the Iranian-American community for a free Iran.
Yahoo
20-05-2025
- Health
- Yahoo
Pasithea Therapeutics Announces Preclinical Data that Shows PAS-004 Inhibits ETS2 Signaling, a Key Driver of Inflammation in IBD and Other Large Addressable Market Diseases
-- Demonstrates PAS-004's potential as a differentiated MEK inhibitor for immune-mediated inflammatory diseases such as IBD and ankylosing spondylitis – -- Positions PAS-004 for potential expansion beyond MAPK pathway driven tumors into inflammatory diseases – -- PAS-004 outperforms FDA-approved MEK inhibitor selumetinib in targeting ETS2 pathway – -- Study conducted at Francis Crick Institute by lead author of 2024 Nature paper that identified ETS2 as a central regulator of macrophage-driven Inflammation in IBD -- MIAMI, May 20, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ('Pasithea' or the 'Company'), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced new preclinical data demonstrating that PAS-004 provides superior inhibition of ETS2-driven inflammatory responses compared to selumetinib in a human macrophage model of chronic inflammation that mimics the inflammatory milieu seen in inflammatory bowel disease (IBD). This study was conducted at the Francis Crick Institute in London, U.K. by Dr. James Lee, a gastroenterologist and Clinician Scientist Group Leader at the Genetic Mechanisms of Disease Laboratory. Dr. Lee was the lead author of a landmark 2024 Nature paper that identified ETS2 as a master regulator of inflammatory responses in IBD, and uncovered a novel genetic mechanism behind the disease, which pointed to a new, potentially effective treatment strategy through MEK inhibition. In this new study RNA sequencing was used to measure gene expression, with PAS-004 consistently outperforming the FDA-approved MEK inhibitor selumetinib across all tested doses (0.01 μM, 0.1 μM, and 1 μM), showing greater downregulation of ETS2 target genes, as well as experimentally validated MEK1/2 pathway genes. These data suggest more robust and durable MEK inhibition by PAS-004 under inflammatory conditions. Key findings of this study are: - : At all doses, PAS-004 showed greater downregulation of ETS2-regulated genes than selumetinib. - : PAS-004 significantly reduced ETS2-dependent functions such as cytokine production, phagocytosis, and reactive oxygen species (ROS) generation, all known to be central to chronic inflammation. - : Gene Set Enrichment Analysis revealed that PAS-004's effects more closely mirrored ETS2 knockout profiles, with a higher normalized enrichment score (-3.96 vs -3.56) and greater statistical significance (1.2 x 10⁻²⁵⁰ vs 3.7 x 10⁻⁷⁴) as compared to selumetinib. Dr. Lee commented, 'Collectively, these in vitro data suggest that, compared to selumetinib, PAS-004 is likely to provide superior inhibition of the macrophage inflammatory pathways orchestrated by ETS2. Blocking single cytokines is a common strategy used to treat chronic inflammatory diseases, but growing evidence suggests that targeting several at once may be a better approach. Blocking ETS2 signaling through MEK1/2 inhibition affects multiple cytokines, including TNFα and IL-23, which are individually targeted by existing therapies, and IL-1β, which has been implicated in treatment resistance and is not directly modulated by JAK inhibitors.' 'JAK inhibitors have dominated the IBD oral treatment landscape over the last few years and we now have genetic evidence that MEK inhibition should affect a broader range of pathogenic cytokines including IL-1β, a critical cytokine that JAK inhibitors do not impact,' commented Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. Dr. Marques continued 'Based on the low level of adverse events and tolerable safety data we have observed in our Phase 1 clinical trial in advanced cancer patients, we believe PAS-004 has the potential to be a new oral treatment option for those suffering from inflammatory diseases such as IBD and we look forward to continuing to demonstrate proof-of-concept for PAS-004 in these additional indications.' Dr. Larry Steinman, Executive Chairman of Pasithea, added, 'I have studied inflammation and inflammatory pathways for over 50 years and today's results are exciting as we consider better drugs targeting inflammatory conditions. These preclinical results suggest PAS-004's ability to block ETS2 signaling and target multiple cytokines opens the potential for testing PAS-004 in large market inflammatory indications.' About Pasithea Therapeutics Corp. Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors. Forward Looking Statements This press release contains statements that constitute 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company's ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company's Phase 1/1b clinical trial of PAS-004 in adult NF1 patients, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company's current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company's plans, assumptions, expectations, beliefs and objectives, the success of the Company's current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Pasithea Therapeutics Contact Patrick GaynesCorporate Communicationspgaynes@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Telegraph
17-05-2025
- Politics
- Telegraph
Get tough on Iran, 550 MPs and peers tell Starmer
Sir Keir Starmer has been told by more than 550 MPs and peers to proscribe Iran's Islamic Revolutionary Guard Corps (IRGC) amid national security concerns. The cross-party group wrote to the Prime Minister to call again for the IRGC to be deemed a terror group. The letter came after three Iranian former asylum seekers appeared in court on Saturday accused of spying for Tehran. The IRGC coordinates a network of regional allies and proxies which includes Hamas in Gaza, the Houthis in Yemen and Hezbollah. Labour is now facing fresh pressure to proscribe the group after David Lammy, the Foreign Secretary, promised to do so during the party's time in opposition. Signatories to the letter include Suella Braverman, the former home secretary, and Lord Kinnock and Sir Iain Duncan Smith, the former Labour and Tory leaders. The letter reads: 'Appeasing this faltering regime betrays democratic values, emboldens its repressive policies, and undermines global security as Tehran continues its nuclear ambitions and terrorism. 'Given the regime's complete blockade of all avenues for political activity, the international community must recognise the Iranian people's right to regime change. 'The right of MEK [Mojahedin-e-Khalq] resistance units, who play a key role in this popular push for change, to fight the IRGC must also be acknowledged, and the IRGC should be designated as a terrorist organisation.' It also notes that the human rights crisis in Iran is worsening. Volker Türk, the UN's human rights chief, said 901 people were reportedly executed in Iran in 2025. As well as making frequent use of the death penalty, the Iranian regime continues to enforce the mandatory wearing of the hijab and has suppressed attempts to protest against this. The attempt to convince Sir Keir to outlaw the IRGC was sponsored by Bob Blackman, the chairman of the influential 1922 Committee of backbench Conservative MPs. Mr Blackman said: 'It is time to change course on Iran policy. We should align our policy with the major shifts that have occurred in Iran and the region. 'Our ally, the US, rightly designated the IRGC as a terrorist entity several years ago. 'While the regime has never been weaker, we must set aside all wrong-headed political and diplomatic calculations and proscribe the IRGC as a terrorist entity – an action long overdue.' David Jones, a former Tory Cabinet minister, added that there was a 'growing consensus' across the political divide on the need to act. 'No more procrastination – it only aggravates the problem,' Mr Jones said. 'We must act decisively and stand with the Iranian people and the organised resistance, most notably Maryam Rajavi's 10-point plan. ' The signatories also include Lord Triesman, a former chairman of the Football Association who served as a Labour minister, and Lord Goldsmith, a former Labour attorney general. It is understood that Foreign Office officials have previously opposed proscription as it would prevent the UK from maintaining its back channel to Iran, which is also used by the US. Earlier this month, a suspected Iranian terror attack on British soil was foiled with just hours to spare. Five men, including four Iranian nationals, were arrested at locations across England on May 4, in one of the biggest counter-terror operations of recent years. On Saturday, Scotland Yard said all of the men had been released, with one remaining on bail, but the investigation remained active. Ken McCallum, the director-general of MI5, said last year that police and his organisation had responded to no fewer than 20 Iran-backed terror plots since January 2022. Pouria Zeraati, a journalist for UK-based Iran International, was stabbed outside his London home in March 2024. Two Romanian nationals have since been charged. Negotiations are ongoing between the US and Iran over a nuclear deal, after Donald Trump said he wanted the 'total dismantlement' of Tehran's nuclear programme.
Yahoo
14-05-2025
- Business
- Yahoo
Pasithea Therapeutics Announces Initiation of Phase 1/1B Study of PAS-004 in Adult NF1 Patients and Activation of First Clinical Trial Site
-- First patient expected to be dosed during Q2 2025 ---- Trial will evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy in both plexiform neurofibromas and cutaneous neurofibromas ---- Starting dose of 4mg tablet QD (once daily) ---- First trial site in Australia. Four additional sites planned for Australia, South Korea, and U.S. –-- Australian R&D Tax Incentive refund of up to 48.5% of eligible study-related costs expected -- MIAMI, May 14, 2025 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ('Pasithea' or the 'Company'), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor today announced initiation of its Phase 1/1b open label study to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of PAS-004, in adult participants with neurofibromatosis type 1 (NF1) with symptomatic and inoperable, incompletely resected, or recurrent plexiform neurofibromas. The study will also assess preliminary anti-tumor activity and help determine a recommended dose for subsequent Phase 2 trials. Exploratory objectives include assessing the effects of PAS-004 on cutaneous neurofibromas. The first active clinical trial site is the Royal North Shore Hospital in Sydney, Australia, which is expected to begin patient enrollment in Q2 2025. Additional clinical trial sites in Australia, South Korea, and the United States are expected to be opened in the coming months. Pasithea has selected Novotech (Australia) Pty Limited as its clinical research organization (CRO) for this trial. The Company is conducting the study through its wholly owned subsidiary in Australia, Pasithea MacroMEK Pty Ltd, and anticipates eligibility for an Australian R&D Tax Incentive with a cash refund of up to 48.5% of the amount spent annually on eligible R&D activities (trial costs) in Australia. Dr. Rebecca Brown, M.D., Ph.D. a member of Pasithea's Scientific Advisory Board and Associate Professor of Neuro Oncology at The University of Alabama at Birmingham commented, 'I am pleased to have collaborated with the Pasithea team on the design of a comprehensive dose exploration and expansion study to assess the safety and tolerability of PAS-004 in adult NF1 patients. In addition to testing the effects of PAS-004 on plexiform neurofibromas, exploratory endpoints will also examine the effects of PAS-004 on cutaneous neurofibromas. The safety profile observed to date in advanced cancer patients is encouraging, and I look forward to seeing that profile translate to the NF1 population.' Dr. Brown added, 'One of the biggest challenges in treating plexiform neurofibromas associated with NF1 is ensuring that patients remain on MEK inhibitor therapy over the long-term. Real-world data shows that a significant proportion of NF1 patients discontinue treatment due to poor tolerability, including high rates of rash and gastrointestinal side effects. PAS-004 is also given as a once daily dose that offers a more convenient regimen than current FDA-approved therapies that are dosed twice a day and which could improve patient compliance.' Dr. Tiago Reis Marques, Pasithea's Chief Executive Officer, said, 'Following our recent financing, including the exercise of certain warrants, Pasithea is now funded to produce initial interim patient data in NF1. The initiation of this clinical trial in NF1, the initial indication we seek FDA marketing approval for, marks an important milestone for Pasithea and for patients living with NF1-related plexiform neurofibromas. Activating our first clinical trial site underscores our commitment to advancing PAS-004 as a potential best-in-class next-generation MEK inhibitor. We are encouraged by the safety and clinical data observed to date in oncology patients and are optimistic that PAS-004's tolerability profile will extend to the NF1 population. Importantly, our existing cancer data has enabled us to begin the NF1 trial at a higher dose than originally contemplated. In addition, we anticipate meaningful cash rebates of eligible trial costs through the Australian R&D Tax Incentive, further enhancing the efficiency of this program.' About the Phase 1/1b Clinical Trial in Adult NF1 Patients The primary objective of the Phase 1/1b study (NCT06961565) is to evaluate the safety and tolerability of PAS-004 when administered for one 28-day treatment cycle in adult NF1 participants with at least one and up to two additional target plexiform neurofibromas (PNs) that are symptomatic and inoperable, incompletely resected, or recurrent. Secondary objectives are (i) to identify the recommended Part B dose ('RPBD') or Maximum Tolerated Dose (MTD) of PAS-004, (ii) to characterize the PK and PD profile of PAS-004, (iii) to evaluate the preliminary efficacy of PAS-004 on target PN volume, (iv) to evaluate the preliminary efficacy of PAS-004 on the size, appearance, and associated symptoms of cutaneous neurofibromas (CNs), and (v) to evaluate the impact of PAS-004 on quality of life ('QOL') and any physical symptoms attributed to the target PN. Experimental objectives are (i) to evaluate the impact of PAS-004 on QOL and any physical symptoms attributed to CNs, (ii) to evaluate the impact of PAS-004 on pain and function attributed to PNs, and (iii) to investigate PAS-004 effects on CN tumor cellular and molecular biology. The trial will be conducted in two parts. In Part A, following a screening period of up to 28 days, up to 24 eligible participants will be enrolled sequentially to receive one of four planned dose levels of PAS-004 tablets (4mg, 8mg, 12 mg, 18mg) in a modified 3+3 design. Part A will identify the recommended RPBD. During Part B, up to 24 eligible participants will be enrolled in parallel to receive one of two planned dose levels of PAS-004 tablets. Participants will be dosed at the RPBD level and at a dose level below the RPBD for up to six continuous 28-day treatment cycles. Part B will identify the recommended phase 2 dose (RP2D). The study is planned to be conducted at five clinical trial sites in Australia, South Korea and the U.S. To learn more about the PAS-004 clinical trial in adults with NF1-associated plexiform neurofibromas, please visit About Pasithea Therapeutics Corp. Pasithea is a clinical-stage biotechnology company focused on the discovery, research and development of innovative treatments for central nervous system (CNS) disorders, RASopathies and MAPK pathway driven tumors. Forward-Looking Statements This press release contains statements that constitute 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the Company's ongoing Phase 1 clinical trial of PAS-004 in advanced cancer patients, the Company's Phase 1/1b clinical trial of PAS-004 in adult patients with NF1-associated plexiform neurofibromas, and the safety, tolerability, pharmacokinetic (PK), pharmacodynamics (PD) and preliminary efficacy of PAS-004, as well as all other statements, other than statements of historical fact, regarding the Company's current views and assumptions with respect to future events regarding its business, as well as other statements with respect to the Company's plans, assumptions, expectations, beliefs and objectives, the success of the Company's current and future business strategies, product development, pre-clinical studies, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities and other statements that are predictive in nature. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including risks that future clinical trial results may not match results observed to date, may be negative or ambiguous, or may not reach the level of statistical significance required for regulatory approval, as well as other factors set forth in the Company's most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and other filings made with the U.S. Securities and Exchange Commission (SEC). Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law. Pasithea Therapeutics Contact Patrick GaynesCorporate Communicationspgaynes@ in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
29-04-2025
- Business
- Yahoo
Aulos Bioscience Presents New Phase 2 Data for AU-007 Demonstrating Continued Strong Anti-Tumor Activity in Advanced Cancers at AACR Annual Meeting
Data show clear evidence of anti-tumor activity and durable partial and complete responses in heavily pre-treated patients with tumors that progressed through checkpoint inhibitors AU-007's unique clinical activity includes CD8 effector T cell expansion, corresponding Treg reduction and correlated increases in progression-free survival New Phase 2 combination cohort with anti-PD-1 nivolumab for second-line treatment of melanoma is now enrolling patients who have not received a prior BRAF/MEK inhibitor LARKSPUR, Calif., April 29, 2025--(BUSINESS WIRE)--Aulos™ Bioscience, an immuno-oncology company working to revolutionize cancer care through development of its lead immune-activating antibody therapeutic, today presented positive results from its Phase 1/2 dose escalation and cohort expansion study of its investigational candidate AU-007. The data were shared in a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting in Chicago, Illinois. The interim Phase 2 data demonstrate clear evidence of durable partial and complete tumor response in multiple cancer types, including patients with melanoma whose tumors had progressed through prior checkpoint inhibitors and who received a combination of AU-007 and low-dose, subcutaneous aldesleukin. Durable tumor shrinkages were also observed in patients with checkpoint inhibitor-resistant or progressed renal cell carcinoma (RCC) who received the same AU-007 and aldesleukin regimen. Additionally, AU-007 and low-dose, subcutaneous aldesleukin continues to demonstrate a unique pharmacodynamic (PD) profile in the interleukin-2 (IL-2) class, with regulatory T cells (Tregs) decreasing and CD8 effector T cells expanding at all AU-007 dose levels. "We are very pleased with the clinical activity observed with AU-007 and low-dose, subcutaneous aldesleukin without a checkpoint inhibitor, as it accentuates our confidence in AU-007 as a potential best-in-class therapeutic for multiple cancers," said Aron Knickerbocker, Aulos Bioscience's president and chief executive officer. "Deep and durable tumor shrinkages, including complete responses, are occurring in patients who were refractory to treatment and had achieved no responses from highly potent prior immuno-oncology regimens. Importantly, the results reinforce the previously reported observation that the CD8 effector T cell expansion and Treg reduction correlates with clinical efficacy. This key driver of Treg reduction coupled with CD8 effector T cell expansion and enhancement of the CD8/Treg ratio differentiates AU-007 from other IL-2 therapeutic programs. Today's data support further evaluation of AU-007 and low-dose, subcutaneous aldesleukin as a second-line treatment for melanoma, where limited treatment options exist. Our new Phase 2 cohort augmenting this regimen with anti-PD-1 nivolumab is now enrolling patients and we look forward to presenting preliminary data later this year." Key findings from interim results of the Phase 1/2 dose escalation and cohort expansion study of AU-007, with data available on 95 patients as of the data cutoff date of March 20, 2025, are as follows: Continued tolerable and manageable safety profile was observed with AU-007 as a monotherapy and in combination with low-dose, subcutaneous aldesleukin at all doses evaluated in Phase 1 dose escalation. No dose-limiting toxicity occurred throughout Phase 1 dose escalation. Most drug-related adverse events were mild and transient Grade 1 or 2 events. The most common treatment-related adverse events in patients who received AU-007 and low-dose, subcutaneous aldesleukin were Grade 1 or 2 fatigue (21%), pyrexia (21%), chills (19%) and infusion-related reaction (15%). The incidence of Grade 3 or 4 treatment-related adverse events in patients who received AU-007 and low-dose, subcutaneous aldesleukin was cytokine release syndrome (1%), lymphopenia (8%) and anemia (3%). All events were transient and resolved, and there were no Grade 5 treatment-related adverse events. Durable objective responses were observed in patients with multiple tumor types enrolled in the Phase 1 dose escalation and Phase 2 cohorts. One patient with metastatic bladder cancer that progressed on an anti-PD-L1 treatment was treated with AU-007 every two weeks (Q2W) and one loading dose of low-dose, subcutaneous aldesleukin, has an ongoing metabolic complete response and continues on treatment for two years. One patient with metastatic nasopharyngeal head and neck cancer that progressed on five prior systemic therapies received AU-007 and low-dose, subcutaneous aldesleukin Q2W. This patient experienced an unconfirmed complete response after 20 months and continues on treatment. Three patients with melanoma refractory to either prior anti-CTLA-4 and anti-PD-1 or anti-PD-1 and anti-LAG-3 therapy were treated with AU-007 Q2W and one loading dose of low-dose, subcutaneous aldesleukin, and experienced deep and durable tumor shrinkages of 100% (complete response in all target lesions, continues on study for 13+ months), 58% (continues on study for 10+ months) and 48% (on study for 13 months). One patient in dose escalation with acral melanoma that progressed rapidly on prior anti-PD-1 therapy received AU-007 and one loading dose of low-dose, subcutaneous aldesleukin. This patient remained on AU-007 therapy for 11 months with disease control. The regimen of AU-007 and low-dose, subcutaneous aldesleukin exhibits distinct pharmacodynamic effects in the class and continues to drive durable decreases in Tregs, increases in CD8 T cells, and corresponding increases in CD8/Treg ratios. A decrease in Tregs appears to be a critical determinant of observed efficacy, with Tregs decreasing in the periphery in the presence of AU-007 at all dose levels. This finding supports AU-007's overall mechanism of action to control and redirect endogenously produced IL-2 and exogenously administered IL-2 to reduce the Treg population and increase circulating CD8 effector T cell populations. Treg cells are highly immunosuppressive cells that can blunt the immune response to tumors and reduce the durability of responses and progression-free survival. The Phase 2 expansion cohorts evaluating AU-007 and a single loading dose of low-dose, subcutaneous aldesleukin continue to enroll patients with advanced cutaneous melanoma who have failed prior checkpoint inhibitor therapy as well as patients with PD-L1+ non-small cell lung cancer (NSCLC) who have failed prior checkpoint inhibitor therapy. An additional Phase 2 cohort is evaluating AU-007 and low-dose, subcutaneous aldesleukin combined with avelumab (checkpoint inhibitor with ADCC effector function; anti-PD-L1) in PD-L1+ NSCLC in patients who have failed prior checkpoint inhibitor therapy. As announced earlier this month, a new Phase 2 cohort evaluating AU-007 and a single subcutaneous loading dose of low-dose aldesleukin combined with nivolumab (checkpoint inhibitor; anti-PD-1) as a second-line treatment for cutaneous melanoma is enrolling patients who have not received a prior BRAF/MEK inhibitor. Aulos anticipates presenting preliminary clinical data from these two Phase 2 expansion cohorts in the second half of 2025. The poster, "AU-007, a human monoclonal antibody (mAb) that binds to IL-2 and inhibits CD25 binding, plus low-dose aldesleukin, in advanced solid tumors: Phase 2 update," (Abstract CT178) is accessible to meeting registrants as an electronic poster on the AACR 2025 virtual meeting platform. It is also available on the Aulos Bioscience website in the Abstracts and Publications section. To learn more about the AU-007 clinical trial program, please visit (identifier: NCT05267626). For patients and providers in the U.S., please visit For patients and health professionals in Australia, please visit About AU-007AU-007 is a human IgG1 monoclonal antibody designed by leveraging artificial intelligence that is highly selective to the CD25-binding portion of IL-2. With a mechanism of action unlike any other IL-2 therapeutic in development, AU-007 redirects IL-2 to reinforce anti-tumor immune effects. This is achieved by preventing IL-2, either exogenous or secreted by effector T cells, from binding to trimeric receptors on regulatory T cells while still allowing IL-2 to bind and expand effector T cells and NK cells. This prevents the negative feedback loop caused by other IL-2-based treatments and biases the immune system toward activation over suppression. AU-007 also prevents IL-2 from binding to CD25-containing receptors on eosinophils, as well as vasculature and pulmonary endothelium, which may significantly reduce the vascular leak syndrome and pulmonary edema associated with high-dose IL-2 therapy. About AulosAulos Bioscience is an immuno-oncology company working to revolutionize cancer patient care through immune-activating antibody therapeutics that direct patients' immune systems toward killing tumor cells. Matching world-class machine learning from co-founder Biolojic Design with an in-depth understanding of the immune system, Aulos' initial clinical candidate, AU-007, is a human antibody designed by leveraging artificial intelligence that harnesses the power of IL-2 to induce tumor killing while limiting the immunosuppression and toxicities typically associated with this validated pathway. The company was founded by Biolojic Design and Apple Tree Partners (ATP) and is led by pioneers in the fields of artificial intelligence, antibody development and cancer immunotherapies. For more information, visit X (@AulosBioscience) and LinkedIn. View source version on Contacts info@ Media inquiries: Mike Beyer, Sam Brown LLC / 312-961-2502 / mikebeyer@
