PD-1

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Akeso Biopharma (9926.HK) is pleased to announce the enrollment of the first patient in its randomized, controlled, multicenter Phase III clinical study (AK117-302) for head and neck squamous cell carcinoma. This trial evaluates the innovative PD-1/VEGF bispecific antibody ivonescimab in combination with Akeso's next-generation CD47 monoclonal antibody ligufalimab (AK117) against pembrolizumab for the first-line treatment of PD-L1 positive (CPS≥1) recurrent/metastatic squamous cell carcinoma of the head and neck (R/M HNSCC). The AK117-302 study represents a significant milestone as the first Phase III clinical trial globally to investigate a CD47 monoclonal antibody therapy for solid tumors. This trial is the fifth Phase III study for ivonescimab, utilizing PD-1/L1 monoclonal antibody therapy as a positive control, and the third Phase III study comparing ivonescimab with pembrolizumab. The AK117-302 trial underscores Akeso's commitment to advancing the field of cancer immunotherapy and establishing a global standard of care for cancer treatment. Furthermore, it highlights our capability to maximize the number of cancer patients globally that can benefit from our product portfolio through a strategic approach to clinical development. In 2022, there were 770,000 new cases of head and neck cancer globally, with 84,000 cases reported in China. Squamous cell carcinoma of the head and neck (HNSCC) accounts for over 90% of these cancers. Unfortunately, the five-year survival rate for patients with recurrent/metastatic HNSCC (R/M HNSCC) is just 3.6%. While targeted therapies and immunotherapies have improved treatment options, the median overall survival (OS) remains below one year. Pembrolizumab has emerged as the first-line standard treatment for R/M HNSCC and is recommended in both CSCO and NCCN guidelines. However, many patients do not respond adequately, and the overall survival benefit remains limited. There is a critical unmet need for more effective therapies to help HNSCC patients achieve long-term survival. At the 2024 European Society for Medical Oncology (ESMO) Congress, Akeso reported initial positive data on its combination therapy of ivonescimab and ligufalimab. This combination demonstrated significant tumor reduction and survival benefits, particularly for HNSCC patients, who require rapid tumor shrinkage. The preliminary efficacy data from this therapy surpassed that of previously disclosed PD-1 studies, positioning it as a potentially new immunotherapy option for HNSCC patients. About Ligufalimab (AK117) AK117, independently developed by Akeso, is a next-generation humanized lgG4 anti-CD47 antibody without hemagglutination effect. AK117 can bind to CD47 expressed on tumor cells and block the interaction between CD47 and SIRPα, in order to enhance the phagocytic activity of phagocytes on tumor cells, thereby inhibiting the growth of tumors. Currently, several phase II clinical trials are underway to investigate the potential of AK117 in combination with azacitidine for hematological tumors, as well as AK117 alone or in combination with ivonescimab and cadonilimab for various solid tumors. Preliminary studies have shown promising efficacy and safety profiles, with no observed dose-limiting toxicity events. Additionally, the Chinese Phase II clinical study of the first-line treatment for unfit AML using AK117 in combination with venetoclax and zzacitidine, as well as the international multicenter Phase II clinical study of AK117 for treating MDS, are both ongoing with patient enrollment. About Ivonescimab (AK112/SMT112) Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics's license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab's first indication has been approved in China, and Akeso is conducting 6 registrational trials versus anti-PD-1/L1 therapeutics. Akeso is also conducting multiple clinical trials of ivonescimab covering 17 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer. About Akeso Akeso (HKEX: 9926.HK) is a leading biopharmaceutical company committed to the research, development, manufacturing and commercialization of the world's first or best-in-class innovative biological medicines. Founded in 2012, the company has created a unique integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the core, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode, and has gradually developed into a globally competitive biopharmaceutical company focused on innovative solutions.With fully integrated multi-functional platform, Akeso is internally working on a robust pipeline of over 50 innovative assets in the fields of cancer, autoimmune disease, inflammation, metabolic disease and other major diseases. Among them , 22 candidates have entered clinical trials (including 11 bispecific/multispecific antibodies and bispecific antibody-drug conjugates). Additionally, 5 new drugs are commercially available, and 5 new drugs across 7 indications are currently under regulatory review for approval. Through efficient and breakthrough R&D innovation, Akeso always integrates superior global resources, develops the first-in-class and best-in-class new drugs, provides affordable therapeutic antibodies for patients worldwide, and continuously creates more commercial and social values to become a global leading biopharmaceutical enterprise. SOURCE Akeso, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Late-breaking abstract featuring IGNYTE clinical trial data, including subgroup and initial biomarker analyses, selected for oral presentation Data from ARTACUS clinical trial of RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies selected for encore poster presentation WOBURN, Mass., Oct. 30, 2024 (GLOBE NEWSWIRE) -- Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, today announced that a late-breaking abstract featuring the IGNYTE clinical trial primary analysis has been selected for oral presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC 2024) being held November 6-10, 2024, in Houston, Texas. Data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies will also be shared in an encore poster presentation. Presentation Details Title: Primary analysis of the registration-intended cohort of patients with anti-PD1 failed melanoma from the IGNYTE trial of RP1 plus nivolumab, including clinical subgroup and initial biomarker dataAbstract Number: 1504Presentation Session Title: Session 204 – Clinical Late-Breaking Abstract SessionDate and Time: Saturday, November 9, 2024, 11:45 am – 12:45 pm CSTPresenter: Michael K. Wong, MD, PhD, University of Texas MD Anderson Cancer Center Title: Safety and efficacy results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)Abstract Number: 693Date and Time: Friday, November 8, 2024Presenter: Diwakar Davar, MD, UPMC Hillman Cancer Center About Replimune Replimune Group, Inc., headquartered in Woburn, MA, was founded in 2015 with the mission to transform cancer treatment by pioneering the development of novel oncolytic immunotherapies. Replimune’s proprietary RPx platform is based on a potent HSV-1 backbone intended to maximize immunogenic cell death and the induction of a systemic anti-tumor immune response. The RPx platform is designed to have a unique dual local and systemic activity consisting of direct selective virus-mediated killing of the tumor resulting in the release of tumor derived antigens and altering of the tumor microenvironment to ignite a strong and durable systemic response. The RPx product candidates are expected to be synergistic with most established and experimental cancer treatment modalities, leading to the versatility to be developed alone or combined with a variety of other treatment options. For more information, please visit www.replimune.com. Forward Looking StatementsThis press release contains forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements regarding the design and advancement of our clinical trials, the timing and sufficiency of our clinical trial outcomes to support potential approval of any of our product candidates, our goals to develop and commercialize our product candidates, patient enrollments in our existing and planned clinical trials and the timing thereof, and other statements identified by words such as “could,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “will,” “would,” or similar expressions and the negatives of those terms. Forward-looking statements are not promises or guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in such forward-looking statements. These factors include risks related to our limited operating history, our ability to generate positive clinical trial results for our product candidates, the costs and timing of operating our in-house manufacturing facility, the timing and scope of regulatory approvals, the availability of combination therapies needed to conduct our clinical trials, changes in laws and regulations to which we are subject, competitive pressures, our ability to identify additional product candidates, political and global macro factors including the impact of the coronavirus as a global pandemic and related public health issues and the Russian-Ukrainian and Israel-Hamas political and military conflicts, and other risks as may be detailed from time to time in our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q and other reports we file with the Securities and Exchange Commission. Our actual results could differ materially from the results described in or implied by such forward-looking statements. Forward-looking statements speak only as of the date hereof, and, except as required by law, we undertake no obligation to update or revise these forward-looking statements. Investor InquiriesChris BrinzeyICR Westwicke339.970.2843chris.brinzey@westwicke.com Media InquiriesArleen GoldenbergReplimune917.548.1582media@replimune.com

Marengo's precision, Vβ chain targeted T cell activator technology reinvigorates anti-tumor immune responses in refractory tumor models Invikafusp alfa is being evaluated as a single-agent in an ongoing Phase 1/2 clinical trial (STARt-001) to treat PD(L)1 resistant "cold" cancers First disclosure of preliminary Phase 1 clinical results from the STARt-001 study CAMBRIDGE, Mass., Oct. 30, 2024 /PRNewswire/ -- Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering novel approaches to precision T cell activation, today announced first-in-human clinical data for its lead selective T cell activator, invikafusp alfa (STAR0602), will be presented in a late-breaking oral presentation at the Society for Immunotherapy of Cancer's (SITC) 39th Annual Meeting taking place November 8-10th, 2024 in Houston, Texas. Presentation details: Title: A Phase 1/2 study of Invikafusp alfa (STAR0602), a first-in-class TCR β chain-targeted bispecific antibody, as monotherapy in patients with antigen-rich solid tumors resistant to anti-PD(L)1 Conference: 39th SITC Annual Meeting Abstract Number: LBA-1470 Session Title: Late-Breaking Abstract Session 2 Session Date and Time: Saturday, November 9, 2024, 11:45 AM - 12:15 PM Presenter: James L. Gulley, M.D., Ph.D. (National Cancer Institute, Bethesda, Maryland, USA) About Marengo Therapeutics Marengo Therapeutics, Inc. is a clinical-stage biotechnology company advancing innovative T cell-targeting therapies to revolutionize cancer treatment. The company's proprietary Selective T Cell Activation Repertoire (STAR™) platform is designed to selectively engage distinct T cell subsets by targeting the Vβ chain of the T cell receptor (TCR), empowering the immune system to combat cancer. To learn more, visit marengotx.com. About the STAR™ Platform Marengo's STAR™ platform is a multi-specific antibody-fusion technology derived from a proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR. These antibodies are fused with T cell co-stimulatory moieties to promote durable anti-tumor immune responses. About Invikafusp alfa (STAR0602) Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform. It is designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR activation with a T cell co-stimulatory signal in a single molecule. This innovative approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity and enabling durable tumor clearance. Extensive preclinical studies demonstrate STAR0602's potent anti-tumor activity in both mouse and human ex vivo models via a novel mechanism of action. About the STARt-001 Clinical Study STARt-001 is a Phase 1/2 clinical trial evaluating the safety, tolerability, and preliminary efficacy of invikafusp alfa as a monotherapy in biomarker-selected patients with advanced antigen-rich solid tumors, including PD-1 refractory and rare tumor types. The trial consists of two parts: Phase 1 dose escalation and Phase 2 dose expansion. For more information, visit clinicaltrials.gov (Identifier: NCT05592626). Patients interested in participating in this study at the National Cancer Institute (NCI) can contact NCI's toll-free number: 1-800-4-CANCER (1-800-422-6237) (TTY: 1-800-332-8615), visit the website at , or email [email protected]. Marengo Contacts: Media: Peg Rusconi | [email protected] Investors: Svetlana Makhni | [email protected] SOURCE Marengo Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED