[Translation] A randomized, double-blind phase III clinical study of socazolimab injection plus platinum-containing chemotherapy with or without bevacizumab versus placebo plus platinum-containing chemotherapy with or without bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer

评价索卡佐利单抗注射液加含铂化疗联合/不联合贝伐珠单抗对比安慰剂加含铂化疗联合/不联合贝伐珠单抗用于一线治疗持续、复发或转移性宫颈癌患者的有效性和安全性

[Translation]

To evaluate the efficacy and safety of socazolimab injection plus platinum-containing chemotherapy with or without bevacizumab versus placebo plus platinum-containing chemotherapy with or without bevacizumab as first-line treatment for patients with persistent, recurrent or metastatic cervical cancer

Start Date20 Nov 2024

Sponsor / Collaborator

Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.

[+1]

NCT06459687

/ Not yet recruitingPhase 3

Efficacy and Safety of Socazolimab Combined With Chemotherapy With or Without Bevacizumab as First-Line Treatment in Persistent, Recurrent, or Metastatic Cervical Cancer: A Randomized, Double-blind, Placebo-controlled Phase III Study

The goal of this clinical trial is to evaluate the efficacy and safety of Socazolimab combined with chemotherapy with or without bevacizumab as first-Line treatment in persistent, recurrent, or metastatic cervical cancer. The main question it aims to answer is:
Does Socazolimab combined with chemotherapy with or without bevacizumab better benefit patients with persistent, recurrent, or metastatic cervical cancer as first-line treatment compared with placebo combined with chemotherapy with or without bevacizumab.
Participants will be treated with Socazolimab/placebo + chemotherapy ± bevacizumab) for 6
8 cycles (Q3w), following maintenance treatment of Socazolimab/placebo (Q3w).

Start Date01 Sep 2024

Sponsor / Collaborator

Lee's Pharmaceutical Holdings Ltd.

ChiCTR2300078237

/ SuspendedEarly Phase 1IIT

A single-arm exploratory clinical study of nab-paclitaxel combined with subcutaneous PD-L1 monoclonal antibody in the treatment of advanced and posterior triple-negative breast cancer

Start Date01 Dec 2023

Sponsor / Collaborator-

100 Clinical Results associated with Socazolimab

100 Translational Medicine associated with Socazolimab

100 Patents (Medical) associated with Socazolimab

373

Literatures (Medical) associated with Socazolimab

01 Apr 2025·JOURNAL OF IMMUNOTHERAPY

Comparison of Antitumor Effects of Combinations of Immune Checkpoint Inhibitors With Dendritic Cells Intratumorally Injected into Irradiated Mouse Adenocarcinoma

Article

Author: Lee, Hong-Rae ; Kang, Hyun Bon ; Koh, Eun-Kyoung ; Kim, YoungHee ; Song, Jin Hoo ; Park, Ga-Young ; Son, Woo-Chang ; Park, You-Soo ; Kim, Dong Won

Dendritic cells (DCs) are specialized immune cells that play a crucial role in presenting antigens and activating cytotoxic T lymphocytes to combat tumors. The immune checkpoint receptor programmed cell death-1 (PD-1) can bind to its ligand programmed cell death-ligand 1 (PD-L1), which is expressed on the surface of cancer cells. This interaction suppresses T-cell activation and promotes immune tolerance. Radiation therapy can increase the expression of PD-L1 on tumor cells, which can lead to a decrease in the effectiveness of the treatment, and detailed studies are needed to understand the mechanisms. As many patients develop resistance to chemotherapy and radiotherapy—either through lack of response or cancer recurrence—there is a critical need to maximize synergistic effects by selecting combination treatments that offer improved therapeutic efficacy with minimal side effects. In the present study, immature DCs (iDCs) were introduced directly into irradiated tumor sites (referred as IR/iDCs), and immune checkpoint blockades (ICBs) were administered intraperitoneally. We confirmed the antitumor effect of combining IR/iDCs and ICBs by examining tumor growth and mouse survival. The proportion of CD4+ and CD8+ T cells in splenocytes increased in the IR/iDCs-treated groups. Combining IR/iDCs with an anti-PD-L1 antibody led to a significant reduction in distant tumor growth and improved mouse survival rates compared with IR/iDCs alone or IR/iDCs + anti-PD-1 antibody. These findings suggest that integrating radiotherapy, DC-based immunotherapy, and ICB, specifically targeting PD-L1, may be an effective cancer treatment strategy.

01 Apr 2025·BIOMATERIALS

Bimetallic peroxide-based nanotherapeutics for immunometabolic intervention and induction of immunogenic cell death to augment cancer immunotherapy

Article

Author: Leong, Kam W ; Zhong, Yiling ; Liao, Zunde ; Zhou, Shiying ; Han, Min ; Leong, Kam W. ; Wu, Chuanbin ; Zhang, Dongmei ; Yi, Xiangting ; Zishan, Chen ; He, Yao

Immunotherapy has transformed cancer treatment, but its efficacy is often limited by the immunosuppressive characteristics of the tumor microenvironment (TME), which are predominantly influenced by the metabolism of cancer cells. Among these metabolic pathways, the indoleamine 2,3-dioxygenase (IDO) pathway is particularly crucial, as it significantly contributes to TME suppression and influences immune cell activity. Additionally, inducing immunogenic cell death (ICD) in tumor cells can reverse the immunosuppressive TME, thereby enhancing the efficacy of immunotherapy. Herein, we develop CGDMRR, a novel bimetallic peroxide-based nanodrug based on copper-cerium peroxide nanoparticles. These nanotherapeutics are engineered to mitigate tumor hypoxia and deliver therapeutics such as 1-methyltryptophan (1MT), glucose oxidase (GOx), and doxorubicin (Dox) in a targeted manner. The design aims to alleviate tumor hypoxia, reduce the immunosuppressive effects of the IDO pathway, and promote ICD. CGDMRR effectively inhibits the growth of 4T1 tumors and elicits antitumor immune responses by leveraging immunometabolic interventions and therapies that induce ICD. Furthermore, when CGDMRR is combined with a clinically certified anti-PD-L1 antibody, its efficacy in inhibiting tumor growth is enhanced. This improved efficacy extends beyond unilateral tumor models, also affecting bilateral tumors and lung metastases, due to the activation of systemic antitumor immunity. This study underscores CGDMRR's potential to augment the efficacy of PD-L1 blockade in breast cancer immunotherapy.

01 Mar 2025·JOURNAL OF INVESTIGATIVE MEDICINE

Fluorouracil enhances the anti-pancreatic cancer effect of anti-PD-L1 antibodies via up-regulating the expression of PD-L1 in cancer cells

Article

Author: Li, Na ; Gao, Siming ; Zhang, Lingling ; Zhang, Jiancong ; Xu, Hui ; Zhang, Sujing ; Wang, Cong ; Bo, Changwen ; Wang, Wei ; Zhang, Changwang ; Zheng, Zheng

Pancreatic cancer is characterized by occult onset, low early diagnosis rate, rapid progress, and poor prognosis. Due to the low response rate and low programmed cell death ligand 1 (PD-L1) expression in pancreatic cancer, the therapeutic application of PL-L1 inhibitors in pancreatic cancer is greatly limited. In vitro studies showed that the expression of PD-L1 increased in pancreatic cancer cells stimulated by fluorouracil (5-FU). We aim to explore the combined effect of 5-FU and anti-PD-L1 antibodies and to provide a reference for the clinical application of PD-L1 antibodies in pancreatic cancer. In the current study, male BALB/c mice were adopted to construct a tumor-bearing model of pancreatic cancer cells. 5-FU and anti-mouse PD-L1 antibodies were combined and administered to evaluate their synergistic effects. The enhancing immune cytotoxicity effect of 5-FU sensitizing the anti-PD-L1 antibody in vivo and in vitro was analyzed by immunohistochemistry and western blot assays. Results showed that 5-FU and anti-PD-L1 antibody combination increased the expression of PD-L1 and IFN-γ, and infiltration of CD8 + T lymphocytes in pancreatic xenograft tumor tissues, which was proven by immunohistochemistry and western analysis. Moreover, the combination with the 5-FU remarkably enhanced the immune cytotoxicity of anti-PD-L1 antibodies in mice. In vitro analysis demonstrates that 5-FU increases the expression of PD-L1 on the surface of pancreatic cancer cell lines via up-regulating nuclear factor kappa B (NF-κB) and Protein kinase B (AKT) pathways. This synergistic effect could be abolished by NF-κB and AKT inhibitors.

News (Medical) associated with Socazolimab

27 Mar 2025

·www.prnewswire.com

CStone Pharmaceuticals Announces 2024 Annual Results and Recent Business Progress

Financial Performance: Strong Year-over-Year Improvemen t - Total Revenue: RMB 407.2 million, including RMB 232.1 million in licensing and royalty income. - Net Loss Reduction: 71.5% year-over-year improvement. Key Product Advancements - Sugemalimab (Anti-PD-L1 mAb) - Regulatory Milestones: - China: Approved for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). - EU & UK: Approved for first-line treatment of stage IV non-small cell lung cancer (NSCLC); stage III NSCLC new indication application submitted to EMA. - Global Partnerships: Three strategic partnerships across 40+ countries, to accelerate global commercialization. - Avapritinib (AYVAKIT® ) - Localized Production: Approved for localized manufacturing in China, enhancing cost efficiency. - Commercial Collaboration: Partnered with Hengrui to expand market access in China. Clinical Pipeline Progress - CS5001 (ROR1 ADC): - Leading Position: Top 2 globally in clinical development for ROR1-targeted ADCs. - Phase I Clinical Data: Demonstrated encouraging monotherapy efficacy in aggressive/indolent lymphomas with a manageable safety profile; positioned for accelerated registration. - Phase Ib Expansion: Evaluating first-line/frontline, monotherapy/combination therapies in lymphomas and solid tumors across the U.S., Australia, and China. - CS2009 (PD-1/VEGF/CTLA-4 Trispecific Antibody): - First-in-Human Trial: Global Phase I study initiated in Australia; first patient dosed. - Preclinical Differentiation: Superior tumor suppression vs. benchmarked competitors; potential first-in-class/best-in-class IO backbone therapy. Pipeline 2.0: Fueling Long-Term Innovation - More than 9 Differentiated Candidates: Focus on first-in-class/best-in-class assets, including multispecific antibodies and ADCs, with global rights and broad therapeutic potential. - Proprietary ADC Platform: Enables rapid development of high-value candidates, reinforcing leadership in next-generation oncology. SUZHOU, China, March 27, 2025 /PRNewswire/ -- CStone Pharmaceuticals ("CStone", HKEX: 2616), a biopharmaceutical company dedicated to developing innovative cancer therapies, today reported 2024 annual results and recent business updates. Business Highlights For the year ended December 31, 2024 and up until the date of this results announcement, key milestones have been achieved across regulatory approvals, clinical advancements, and strategic collaborations, reinforcing our position as a leader in innovative therapeutics. A shortlist of our achievements over this period includes: Commercial Products • CEJEMLY® (sugemalimab), anti-PD-L1 antibody – Global expansion and regulatory approvals Sugemalimab secured three new drug application approvals in 2024, including its fifth indication in mainland China for first-line treatment of gastric/gastroesophageal junction adenocarcinoma (GC/GEJC). Sugemalimab also gained approvals in the EU and UK for first-line treatment of stage IV NSCLC, marking its entry into major international markets. We have recently completed the regulatory submission to the European Medicines Agency (EMA) for the new indication application of sugemalimab in the treatment of Stage III NSCLC. – Strategic alliances drive global commercialization Partnered with Ewopharma AG in May 2024 for commercialization in Central and Eastern Europe (CEE) and Switzerland. Collaborated with Pharmalink Store – L.L.C – O.P.C in November 2024 to expand access across the Middle East, North Africa (MENA) Region and South Africa. Entered an agreement with SteinCares in January 2025 for Latin America (LATAM). Additional partnerships in Western Europe, Southeast Asia, and Canada are anticipated in 2025. – Robust clinical data reinforce efficacy GEMSTONE-304 Study: Final progression-free survival (PFS) and interim overall survival (OS) data for the first-line esophageal squamous cell carcinoma (ESCC) published in Nature Medicine (February 2024). GEMSTONE-302 Study: Four-year OS data for stage IV NSCLC presented at the 2024 Congress of European Society for Medical Oncology (ESMO), confirming sustained survival benefits. GEMSTONE-303 Study: Final PFS and OS analysis for GC/GEJC with combined positive score (CPS) ≥5 published in the top-tier medical journal-Journal of the American Medical Association (JAMA) (February 2025). ESMO Guideline Recognition: CEJEMLY® recommended as first-line NSCLC therapy in ESMO's 2025 Non-Oncogene-Addicted Metastatic NSCLC Living Guidelines, covering both squamous and non-squamous NSCLC (February 2025). • AYVAKIT ® (avapritinib), KIT/PDGFRA inhibitor – Localized manufacturing in China The National Medical Products Administration of China (NMPA) approved domestic production of AYVAKIT ® tablets (300 mg and 100 mg) in June and August 2024 respectively. Full transition to localized supply is expected in 2025, improving cost efficiency. – NRDL inclusion enhances accessibility AYVAKIT® (avapritinib) has been included to China's National Reimbursement Drug List (NRDL), effective January 1, 2024 for unresectable or metastatic gastrointestinal stromal tumor (GIST), harboring the PDGFRA exon 18-mutated, including PDGFRA D842V mutations. This significantly improves AYVAKIT ®'s affordability for eligible patients. – Commercial partnership with Hengrui In July 2024, we forged a new partnership with Jiangsu Hengrui Pharmaceuticals Co., Ltd., granting them the exclusive promotion rights in mainland China to amplify commercial reach and profitability. • GAVRETO ® (pralsetinib), RET inhibitor – Progress towards localized manufacturing The NMPA's Center for Drug Evaluation (CDE) accepted the manufacturing localization and bioequivalence (BE) study application in April 2024, and regulatory review is ongoing. – Sustained collaboration with Allist Commercial operations has been transferred to Shanghai Allist Pharmaceuticals Co., Ltd in the first half of 2024 under an exclusive agreement signed in November 2023. Collaboration remains strong to maximize market penetration. Clinical Stage Core Assets • CS5001 (ROR1 ADC) – Phase Ib clinical trial with registration potential A global multicenter clinical trial of CS5001 is actively enrolling patients across the United States of America (U.S.), Australia and China. Recruitment is ongoing for monotherapy cohorts targeting aggressive and indolent advanced lymphomas with potential to be expanded into a Phase II single-arm registrational study. Additional cohorts, including CS5001 in combination with R-CHOP (Rituximab + Cyclophosphamide + Hydroxydaunorubicin + Vincristine + Prednisone) for the first-line diffuse large B-cell lymphoma (DLBCL), and CS5001 in combination with standard of cares (SOC) for front-line DLBCL will be initiated to expand the therapeutic potential of CS5001 across all DLBCL stages. CS5001 is also being studied as both a monotherapy and in combination with a PD-L1 inhibitor for advanced solid tumors, underscoring its versatility across oncology indications. – Compelling clinical data at ASCO & ASH 2024 Phase Ia data for CS5001 presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and the 66th American Society of Hematology (ASH) Annual Meeting demonstrated that CS5001 is so far the first receptor tyrosine kinase-like orphan receptor 1 (ROR1) antibody-drug conjugate (ADC) known to demonstrate clinical anti-tumor activity in both solid tumors and lymphomas. Clinical data of CS5001 revealed superior efficacy and favorable safety profile as a monotherapy for both aggressive and indolent advanced lymphomas. At the tentative recommended Phase II dose (RP2D) (125 μg/kg), CS5001 achieved an objective response rate (ORR) of 70% in non-Hodgkin lymphoma (NHL) and 100% in Hodgkin lymphoma (HL). These results support its potential as a faster-to-market candidate and a frontline combination therapy backbone. • CS2009 (PD-1/VEGF/CTLA-4 trispecific antibody) – Global Phase I clinical trial initiated A global multicenter first-in-human (FIH) trial among solid tumors has been launched in Australia in December 2024, with subsequent expansion to China and the U.S.. The first patient was dosed in March 2025. – Potential FIC/BIC next-generation I/O backbone Preclinical data presented at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) highlighted its first-in-class (FIC) or best-in-class (BIC) potential with superior antitumor activity compared to potential competitors benchmarks, including PD-1/CTLA-4 or PD-1/VEGF bispecific antibody and PD-1/ CTLA-4 combination therapies. Unique trispecific mechanism positions CS2009 as a next-generation immuno-oncology backbone with broad applicability. Preclinical/IND-enabling Stage Programs and ADC Platform CStone's preclinical pipeline includes more than nine promising candidates, each with global rights and focusing on FIC/BIC profiles with broad indications. These candidates include multispecific antibodies, ADCs and radionuclide drug conjugates (RDC) covering various therapeutic fields such as oncology, autoimmune diseases, and metabolic disorders. The Company is dedicated to delivering clinical value through the development of these Pipeline 2.0 candidates, which will undergo international, multi-center clinical trials to maximize their global potential. CStone has also developed an in-house ADC technology platform featuring proprietary linkers, optimized for diverse targets and payloads. This platform supports multiple upcoming ADC projects in Pipeline 2.0, including CS5007 (dual targeting epidermal growth factor receptor (EGFR) & human epidermal growth factor receptor 3 (HER3)), CS5005 (targeting somatostatin receptor 2 (SSTR2)), CS5008 (dual targeting delta-like ligand 3 (DLL3) & SSTR2) and CS5006 (targeting ITGB4). Future and Outlook As we look to the future, we reaffirm our commitment to advancing a robust and differentiated pipeline by prioritizing internal discovery capabilities and sustained R&D investments. Concurrently, we aim to maximize the global commercial potential of our approved therapies through strategic collaborations and localized manufacturing enhancements. Key growth drivers in 2025 include: • Clinical milestones – Progress CS5001 (ROR1 ADC) and CS2009 (PD-1/VEGF/CTLA-4 trispecific) towards pivotal trials and in parallel pursue global partnerships to expedite development. – Advance early-stage candidates (e.g., CS2011, CS5007, CS5005, CS5008, CS5006) into clinical stages within the next two years. • Commercial excellence – Maximize the value of approved products through strategic collaborations and manufacturing localization (e.g., AYVAKIT®, GAVRETO®) to enhance profitability and market reach. – Accelerate ex-China commercialization of CEJEMLY® (sugemalimab) via regional partnerships. • Innovation and technology – Strengthen proprietary platforms (e.g., ADC technology) to sustain pipeline growth. – Present key clinical data at major conferences (e.g., AACR, ESMO, ASH) Financial Highlights International Financial Reporting Standards (IFRS) Measures: • Revenue was RMB407.2 million for the year ended December 31, 2024, composed of RMB175.1 million in sales of pharmaceutical products (avapritinib and pralsetinib), RMB204.0 million in license fee income and RMB28.1 million in royalty income of sugemalimab, representing a year-on-year increase of RMB108.3 million, or 113.1%, in license fee which was largely offset by a decrease in revenue from sales of pharmaceutical products, such that total revenue decreased by RMB56.6 million, or 12.2%, year on year. • Research and development expenses were RMB134.7 million for the year ended December 31, 2024, representing a decrease of RMB393.1 million from RMB527.8 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third-party contracting costs. • Administrative expenses were RMB77.8 million for the year ended December 31, 2024, representing a decrease of RMB104.9 million from RMB182.7 million for the year ended December 31, 2023, primarily due to the decrease in employee costs. • Selling and marketing expenses were RMB133.8 million for the year ended December 31, 2024, representing a decrease of RMB65.5 million from RMB199.3 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs and others which was partially offset by an increase in channel service fee. • Loss for the year was RMB91.2 million for the year ended December 31, 2024, representing a decrease of RMB276.0 million, or 75.2%, from RMB367.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. • Cash and cash equivalents and time deposits were RMB672.9 million as of December 31, 2024. Non-International Financial Reporting Standards (Non-IFRS) Measures: • Research and development expenses excluding the share-based payment expenses were RMB124.7 million for the year ended December 31, 2024, representing a decrease of RMB410.0 million from RMB534.7 million for the year ended December 31, 2023, primarily due to the decrease in milestone fee and third party contracting costs. • Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB224.4 million for the year ended December 31, 2024, representing a decrease of RMB113.8 million from RMB338.2 million for the year ended December 31, 2023, primarily attributable to the decrease in employee costs. • Loss for the year excluding the share-based payment expenses was RMB94.0 million for the year ended December 31, 2024, representing a decrease of RMB236.2 million, or 71.5%, from RMB330.2 million for the year ended December 31, 2023, primarily attributable to a substantial decrease in operating expenses. 2024 Annual Results Conference Call The Company will host a 2024 annual results conference call at 10:00 a.m. (Beijing Time) on Friday March 28, 2025. Please attend the conference call through the link: (Password:067784). About CStone CStone Pharmaceuticals (HKEX: 2616), founded in late 2015, is an innovation-driven biopharmaceutical company focused on advancing cutting-edge oncology therapies. Committed to addressing unmet medical needs globally, the company has achieved remarkable milestones since its inception, including the successful launch of four novel therapeutics and securing 16 regulatory approvals across nine indications. CStone's robust pipeline features 16 high-potential candidates, including first-in-class and best-in-class assets such as antibody-drug conjugates (ADCs), multispecific antibodies, immunotherapies, and precision medicines. The company further distinguishes itself through a seasoned leadership team with comprehensive expertise in drug development—from preclinical research and clinical trials to manufacturing, business development, and commercialization. For more information about CStone, please visit . Forward-looking statements The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments. Disclaimer: only for communication and scientific use by medical and health professionals, it is not intended for promotional purposes. SOURCE CStone Pharmaceuticals WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Drug ApprovalLicense out/inClinical ResultASH

10 Mar 2025

·endpts.com

Sun Pharma to acquire Checkpoint Therapeutics and its anti-PD-L1 antibody

After months of searching for a partner for its recently approved cancer drug, Checkpoint Therapeutics has instead secured a buyer. India’s Sun Pharma is acquiring the immuno-oncology biotech for $4.10 per share, or roughly $355 million in cash, according to a Monday release . This purchase price is a 66% premium of Checkpoint’s stock $CKPT after the market closed Friday. The Waltham, MA-based biotech’s stock was up by as much as 65% before it reopened Monday. If its anti-PD-L1 antibody Unloxcyt is approved in certain markets in Europe, shareholders will also receive an upfront cash payment of $4.10 for each stock they hold. The deal is expected to close in the second quarter of this year. Checkpoint has said it was searching for a US commercial partner since Unloxcyt (cosibelimab) secured FDA approval in December for advanced skin cancer. Unloxcyt is Checkpoint’s first commercial drug. Sun Pharma, known for its generic drugs and the largest pharma company in India, is planning to use its global footprint to expand access to Unloxcyt, according to the Monday release. The company is a manufacturing giant with around 43 production facilities across six continents, according to its website. Unloxcyt was initially rejected by the FDA in December 2023 over manufacturing issues at its unnamed third-party contract manufacturer. The biotech then refiled its application in July 2024. In 2020, Checkpoint tapped Samsung Biologics to manufacture cosibelimab, with the deal set to expire in 2030, according to an SEC filing .

Drug ApprovalAcquisitionImmunotherapyADC

27 Nov 2023

·www.globenewswire.com

AIM ImmunoTech Bolsters Intellectual Property Estate for Ampligen® with Issuance of Two Key U.S. Patents

Extends certain exclusive U.S. rights to Ampligen for cancer and ME/CFS through 2039 Management discusses patent issuance and what this means in a brief video: here OCALA, Fla., Nov. 27, 2023 (GLOBE NEWSWIRE) -- AIM ImmunoTech Inc. (NYSE American: AIM) (“AIM” or the “Company”) today announced that the U.S. Patent and Trademark Office (USPTO) has issued U.S. patent No. 11,813,279 and 11,813,281 for Ampligen® titled “Compositions for cancer therapy and methods,” and “Methods for improving exercise tolerance in myalgic encephalomyelitis patients,” respectively. AIM Chief Executive Officer Thomas K. Equels stated: “Our ongoing effort to expand and solidify AIM’s global intellectual property estate is a foundational component of our development strategy for Ampligen. AIM’s expectation for Ampligen — both as a therapeutic for people suffering from dire diseases and as a valuable asset for our stockholders — is the driving force behind our multiple clinical studies in oncology, ME/CFS and Post-COVID conditions. These two new U.S. patents will serve to further strengthen the potential financial future of our company by extending certain sole rights to Ampligen and for these uses to 2039.” Click here to watch a brief video from the AIM management team discussing the issuance of the U.S. patents and what it means for the pipeline development strategy for Ampligen®. Oncology Patent The new patented methods involve the administration of a unique combination of two compounds to patients suffering from pancreatic cancer, renal cell carcinoma, colorectal cancer and/or melanoma. The first compound is an anti-PD-L1 antibody and the second compound is Ampligen. The combination of these compounds is designed to work synergistically to enhance the effectiveness of the treatment. The company believes this novel approach promises to revolutionize the treatment landscape for cancers that have historically been challenging to treat. As symptoms appear only in advanced stages and these cancers are extremely difficult to diagnose without deliberate screening, these cancers contribute to high mortality rates and are a significant burden on public health. The advancement, as claimed in the issued patent, is expected to significantly improve treatment outcomes for patients suffering from these cancers in ongoing and upcoming clinical trials. The granting of U.S. Patent No. 11,813,279 is not only a testament to AIM’s dedication to pioneering cancer treatment, but also opens new avenues for future research and therapy development. AIM, as patent holder, will have the sole rights to exclude other companies from using the claimed method for research or for treatment until August 9, 2039. On the other hand, AIM, either independently or with strategic licensed partners, will be able to continue refining and enhancing this patented treatment method. ME/CFS Patent Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) is a debilitating condition characterized by extreme fatigue, pain, and cognitive issues. The Centers for Disease Control and Prevention (CDC) estimates that between 836,000 and 2.5 million Americans suffer from ME/CFS. Addressing these severe symptoms has been a complex challenge for healthcare professionals. However, the issuance of U.S. Patent No. 11,813,281 represents a major leap forward, bringing new hope to those impacted by the enduring and debilitating symptoms of ME/CFS. The novel methods outlined in the new patent claims involve, at least, identifying individuals who have experienced ME/CFS symptoms for 2 to 8 years — a feature identified through extensive research — and treating these symptoms by administering Ampligen. This precision in treatment timing reflects a targeted, cutting-edge approach to personalized medicine in ME/CFS care and is expected to lead to significant improvements and effectiveness in ME/CFS symptoms in this population. U.S. Patent No. 11,813,281 bestows AIM ImmunoTech Inc. with the sole rights to exclude others from practicing the claimed methods of treating ME/CFS symptoms using Ampligen until January 12, 2040. This exclusivity fortifies AIM's position in the market by enabling development of a distinctive and unparalleled treatment option. Additionally, the patent paves the way for strategic alliances and licensing deals, endowing AIM with the unique opportunity to conduct further research and development of the claimed method, either independently or with licensed partners, to continue refining and enhancing this patented treatment method. About AIM ImmunoTech Inc. AIM ImmunoTech Inc. is an immuno-pharma company focused on the research and development of therapeutics to treat multiple types of cancers, immune disorders and viral diseases, including COVID-19. The company’s lead product is a first-in-class investigational drug called Ampligen® (rintatolimod), a dsRNA and highly selective TLR3 agonist immuno-modulator with broad spectrum activity in clinical trials for globally important cancers, viral diseases and disorders of the immune system. For more information, please visit aimimmuno.com and connect with the Company on Twitter, LinkedIn, and Facebook. Cautionary Statement This press release and linked video contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”). Words such as “may,” “will,” “expect,” “plan,” “anticipate” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. Many of these forward-looking statements involve a number of risks and uncertainties. Among other things, for those statements, the Company claims the protection of safe harbor for forward-looking statements contained in the PSLRA. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof.

ImmunotherapyPatent Expiration

100 Deals associated with Socazolimab

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Metastatic Cervical Carcinoma	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023
Recurrent Cervical Cancer	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Dec 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Extensive stage Small Cell Lung Cancer	NDA/BLA	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	13 Jul 2024
Uterine Cervical Cancer	Phase 3	-	Lee's Pharmaceutical Holdings Ltd.	01 Sep 2024
Osteosarcoma	Phase 3	-	Lee's Pharmaceutical Holdings Ltd.	01 Jun 2020
Metastatic melanoma	Phase 2	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	27 Sep 2021
Esophageal Squamous Cell Carcinoma	Phase 2	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	19 Nov 2020
Metastatic urothelial carcinoma	Phase 2	China	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Transitional Cell Carcinoma	Phase 2	China	Lee's Pharmaceutical Holdings Ltd.	10 Oct 2018
Carcinoma of extrahepatic bile duct	Phase 1	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	24 Mar 2021
Gallbladder Carcinoma	Phase 1	China	Zhaoke (Guangzhou) Oncology Pharmaceutical Ltd.	24 Mar 2021
Advanced Urothelial Carcinoma	Phase 1	China	Lee's Pharmaceutical Holdings Ltd.	10 Sep 2020

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04878016 (Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	498	Socazolimab + Carboplatin and Etoposide	jxvibybflu(vnimnqgqrq) = baneporkdb fcntcbalkl (qbqjphogog ) View more	Positive	13 Jan 2025
NCT04878016 (Pubmed) Manual	Phase 3	Extensive stage Small Cell Lung Cancer First line	498	Placebo + Carboplatin and Etoposide	jxvibybflu(vnimnqgqrq) = aazzcsgghn fcntcbalkl (qbqjphogog ) View more	Positive	13 Jan 2025
NCT04603846 (Pubmed \| Oncologist) Manual	Phase 1	Advanced Urothelial Carcinoma First line	20	Socazolimab+Albumin-bound Paclitaxel	pvatectfzq(yzcehzubkv) = All patients had TRAEs, most of which were grade 1 or 2. The common TRAEs (≥20%) were peripheral neurotoxicity, alopecia, rash, increased ALT, weight loss, weakness, pruritus, increased AST, increased γGT, increased ALP, neutropenia, emesis, and anorexia. bqirgjqkdl (bjppupwems ) View more	Positive	17 Oct 2024
NCT04460066 (ESMO2022) Manual	Phase 2	Locally Advanced Esophageal Squamous Cell Carcinoma Neoadjuvant	64	Socazolimab+nab-paclitaxel+cisplatin	jeaorkplxm(truuifqqfk) = subejwvsww fquknghoyc (mcdluhktlz ) View more	Positive	10 Sep 2022
NCT04460066 (ESMO2022) Manual	Phase 2		64	placebo+nab-paclitaxel+cisplatin	jeaorkplxm(truuifqqfk) = zpsoheizpb fquknghoyc (mcdluhktlz ) View more	Positive	10 Sep 2022
ESMO2022	Not Applicable	Small Cell Lung Cancer	-	Atezolizumab plus carboplatin and etoposide (ACE)	getahdpltx(nbihdrwika) = riesqtjokp rhqnvxdhpl (hoyxyilipy )	-	10 Sep 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab ( dose-expansion phase)	fvknwpxygi(qlhhqncsko) = gyhgsjczik ivncxthglx (qcggvjmofx ) View more	Positive	02 Jun 2022
NCT03676959 (ASCO2022) Manual	Phase 1	Metastatic Carcinoma to the Uterine Cervix	104	socazolimab (CPS < 1)	fvknwpxygi(qlhhqncsko) = wjlkncwhdy ivncxthglx (qcggvjmofx ) View more	Positive	02 Jun 2022
NCT04603846 (ASCO2022) Manual	Phase 1	Advanced Urothelial Carcinoma First line	20	nab-paclitaxel+socazolimab	bvfgzeonxm(ooawnhhtba) = nqvenshmyu azqscjcjag (lfjninrkqc ) View more	Positive	02 Jun 2022
NCT04346914 (ESMO_ELCC2022 \| ESMO_ELCC2022) Manual	Phase 1	Extensive stage Small Cell Lung Cancer First line	20	Socazolimab+carboplatin+etoposide	oakvmbgjfy(ooczyfjtwm) = gwpzryydhy vprczizbae (kyutxpyzug ) View more	Positive	03 Apr 2022
NCT03676959 (phase I plus expansion study, IGCS2021)	Phase 1	Metastatic Carcinoma to the Uterine Cervix PD-L1-positive	-	Socazolimab 5mg/kg	yfkwzhphvp(bugfcikoej) = fiztaxcitx dmtjobnvzb (cqilegmoji, 10.9 - 27.4) View more	Positive	01 Nov 2021
NCT04603846 (ZKAB001, CSCO2021)	Phase 1	Extensive stage Small Cell Lung Cancer	20	ZKAB001+卡铂+依托泊苷	czhmuixnjx(qobdfytxng) = 最常见治疗相关不良事件包括血小板计数降低(30.0%)、贫血(25%)、中性粒细胞计数降低(20%)、高血糖症(20%)和白细胞计数降低(20%) xietjzrtou (nkfldzqglb )	-	25 Sep 2021
CSCO2020	Phase 2	Uterine Cervical Cancer	60	ZKAB001	uunsfnfqkf(mjtlagraip) = 31/60(51.7%)名患者出现一项或多项治疗相关不良反应(TRAEs)，大部分TRAEs为1或2级，仅有2患者(3.3%)出现3级或以上TRAEs。最常见的TRAEs包括状腺功能减退症(8例，13.3%)，白细胞计数降低(6例，10.0%)，类风湿因子升高(5例，8.3%)，贫血(4例，6.7%)和天门冬氨酸氨基转移酶升高(3例，5.0%)。1人因为不良事件而退组。 sdcubnxyab (baeryqluty ) View more	-	19 Sep 2020

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