A Randomized, Double-Blind, Placebo-Controlled Phase 1 Clinical Trial to Evaluate the Tolerability, Safety, Pharmacokinetic Profiles, and Immunogenicity of JS026 and JS026 in Together With JS016 Administered Intravenously to Healthy Chinese Subjects

This is a first-in-human (FIH), randomized, double-blind, placebo-controlled, single-center phase I clinical trial of JS026 and JS026 + JS016 Injection. The objective of the study is to evaluate the safety, tolerability, PK profile and immunogenicity of a single intravenous infusion of JS026 and JS026 + JS016 Injection in healthy subjects.
In this study, the single ascending dose design will be adopted, JS026 will be administered sequentially from low dose group to high dose group, and each subject can only receive an intravenous infusion at one dose level. Five dose groups (30 mg, 100 mg, 300 mg, 600 mg, and 1000 mg) will be set to receive an intravenous infusion of JS026, and two dose groups (300 mg JS026 + 1200 mg JS016, and 600 mg JS026+ 1200 mg JS016) will be set for JS026 + JS016. The investigational product and placebo will be distributed in each dose group in a ratio of 3:1. Four subjects will be enrolled in each of JS026 30 mg and 100 mg groups, and 8 subjects will be enrolled in each of other dose groups, totally 48 subjects.

Start Date16 Dec 2021

Sponsor / Collaborator

Shanghai Junshi Biosciences Co., Ltd.

NCT05205759

/ TerminatedPhase 3IIT

Adaptive, Randomized, Non-inferiority Trial to Evaluate the Efficacy of Monoclonal Antibodies in Outpatients With Mild or Moderate COVID-19

Currently, 3 anti-SARS-CoV-2 monoclonal antibody products have received Emergency Use Authorizations from the Italian Medicines Agency (AIFA) for the treatment of mild to moderate COVID-19 in non hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization (bamlanivimab plus etesevimab, sotrovimab, and casirivimab plus imdevimab). Differently from casirivimab/imdevimab and sotrovimab, the European Medicines Agency (EMA) has never recommended authorising the combination bamlanivimab/etesevimab for treating COVID-19. Moreover, the evidence on sotrovimab relies on the interim analysis results of an ongoing randomised placebo-controlled clinical trial [1], unlike the combinations bamlanivimab/etesevimab and casirivimab/imdevimab, whose results of the randomised placebo-controlled trials were published after having completed the enrolment [2,3]. The study aims at assessing the non-inferiority of bamlanivimab plus etesevimab and sotrovimab vs. casirivimab plus imdevimab on COVID-19 progression in patients aged at least 50 years at an early stage of the disease. The progression of COVID-19 disease (hospitalization, need for supplementary oxygen therapy at home, death) within 14 days of randomisation is the composite outcome variable on which the calculation of the sample size is based. Based on available data regarding the reduction in the number of hospitalisations and medical visits with the use of casirivimab plus imdevimab at an early-stage of COVID-19, a disease progression of 5% has been estimated in the reference arm. 5% delta margin was considered clinically relevant, taking into account both the estimates of disease progression in the study population in absence of early treatment with monoclonal antibodies (20%, based on national data) and the efficacy of the reference standard. Therefore, 1260 participants will be randomly assigned in an equal ratio between the reference standard and each of the other two experimental arms (1:1:1). Randomization will be computer-generated in permuted blocks with a stratification based on site.

Start Date09 Dec 2021

Sponsor / Collaborator

Azienda Ospedaliera Universitaria Integrata Verona

[+2]

NCT04790786

/ TerminatedPhase 4IIT

The UPMC OPtimizing Treatment and Impact of Monocolonal antIbodieS Through Evaluation for COVID-19 Trial

Multiple monoclonal antibodies (mABs) have been shown to reduce viral burden and improve clinical outcomes, have been granted FDA Emergency Use Authorization (EUA) for use in select populations, and are routinely used in the UPMC Health System, which has made expanded access a priority. However, the comparative effectiveness of these mABS is unknown. The National Academies of Sciences, Engineering, and Medicine has called for expanded access and clinical use of mABs, noting it is "critical to collect data and evaluate whether they are working as predicted". This pragmatic evaluation will determine the relative effects of the EUA-governed mABs versus each other. When U.S. government mAB policies change (e.g., FDA grants or revokes EUAs), UPMC Health System policies and the evaluated mABs will accordingly change.

Start Date10 Mar 2021

Sponsor / Collaborator

University of Pittsburgh Medical Center

[+1]

100 Clinical Results associated with Etesevimab

100 Translational Medicine associated with Etesevimab

100 Patents (Medical) associated with Etesevimab

163

Literatures (Medical) associated with Etesevimab

31 Dec 2025·Emerging Microbes & Infections

Discovery of a pan anti-SARS-CoV-2 monoclonal antibody with highly efficient infected cell killing capacity for novel immunotherapeutic approaches

Article

Author: Gros, Nathalie ; Chentouf, Myriam ; Calderon, Hugo ; Juan, Manel ; Lyonnais, Sebastien ; Roux-Portalez, Vincent ; Ngo, Giang ; Souchard, Manon ; Simonelli, Luca ; Dinter, Heiko ; Vazquez, Mario ; Tamagnini, Elia ; Chable-Bessia, Christine ; Pedotti, Mattia ; Marsile-Medun, Soledad ; Pugnière, Martine ; Pelegrin, Mireia ; Naranjo-Gomez, Mar ; Varani, Luca ; Abba Moussa, Daouda ; Martineau, Pierre

Unlocking the potential of broadly reactive coronavirus monoclonal antibodies (mAbs) and their derivatives offers a transformative therapeutic avenue against severe COVID-19, especially crucial for safeguarding high-risk populations. Novel mAb-based immunotherapies may help address the reduced efficacy of current vaccines and neutralizing mAbs caused by the emergence of variants of concern (VOCs). Using phage display technology, we discovered a pan-SARS-CoV-2 mAb (C10) that targets a conserved region within the receptor-binding domain (RBD) of the virus. Noteworthy, C10 demonstrates exceptional efficacy in recognizing all assessed VOCs, including recent Omicron variants. While C10 lacks direct neutralization capacity, it efficiently binds to infected lung epithelial cells and induces their lysis via natural killer (NK) cell-mediated antibody-dependent cellular cytotoxicity (ADCC). Building upon this pan-SARS-CoV-2 mAb, we engineered C10-based, Chimeric Antigen Receptor (CAR)-T cells endowed with efficient killing capacity against SARS-CoV-2-infected lung epithelial cells. Notably, NK and CAR-T-cell mediated killing of lung infected cells effectively reduces viral titers. These findings highlight the potential of non-neutralizing mAbs in providing immune protection against emerging infectious diseases. Our work reveals a pan-SARS-CoV-2 mAb effective in targeting infected cells and demonstrates the proof-of-concept for the potential application of CAR-T cell therapy in combating SARS-CoV-2 infections. Furthermore, it holds promise for the development of innovative antibody-based and cell-based therapeutic strategies against severe COVID-19 by expanding the array of therapeutic options available for high-risk populations.Trial registration: ClinicalTrials.gov identifier: NCT04093596.

04 Feb 2025·The Journal of Infectious Diseases

Viral and Symptom Rebound Following Anti–Severe Acute Respiratory Syndrome Coronavirus 2 Monoclonal Antibody Therapy in a Randomized Placebo-Controlled Trial

Article

Author: Li, Jonathan ; Wohl, David ; Daar, Eric ; Cardoso, Sandra ; Corado, Katya ; Eron, Joseph J ; Pedersen, Susan ; Taiwo, Babafemi ; Ignacio, Rachel Bender ; Sieg, Scott ; Newell, Matthew ; Giganti, Mark ; Roa, Jhoanna ; Ritz, Justin ; Jennings, Cheryl ; Singh, Upinder ; Hughes, Michael D ; Rwakazina, Irene ; Colsh, Kelly ; Patel, Nilam ; Daar, Eric S ; Fletcher, Courtney ; Shahkolahi, Akbar ; Li, Jonathan Z ; Margolis, David ; Evering, Teresa ; Hosey, Lara ; Currier, Judith S ; Jilg, Nikolaus ; Gottesman, Joan ; Dragavon, Joan ; Jagannathan, Prasanna ; Evering, Teresa H ; Javan, Arzhang Cyrus ; Hughes, Michael ; Kosmyna, Jan ; Moser, Carlee ; Eron, Joseph ; Beck, Justine ; Gapara, Morgan ; Currier, Judith ; Greenfelder, Brian ; Wohl, David A ; Murtaugh, William ; Perelson, Alan ; Fischer, William ; Chew, Kara ; Pillay, Sandy ; Smith, David (Davey) ; McGinley, Brooke ; Smith, Davey M ; Chew, Kara W ; Riviere, Cynthia

AbstractWe explored viral and symptom rebound after coronavirus disease 2019 amubarvimab-romlusevimab monoclonal antibody therapy versus placebo in the randomized ACTIV-2/A5401 trial. Participants underwent nasal severe acute respiratory syndrome coronavirus 2 polymerase chain reaction testing at study days 3, 7, 14, and 28. Viral rebound was defined as RNA ≥3 and ≥0.5 log10 copies/mL increase from day 3 or 7, and symptom rebound as hospitalization or any moderate/severe symptom for ≥2 days after initial symptom improvement. There was no difference in viral rebound (∼5%/arm) (analysis population n = 713) or symptom rebound among participants who initially improved (hazard ratio, 0.95 [95% confidence interval, .52–1.75]; analysis population n = 574); <1% had both viral/symptom rebound.

02 Jan 2025·Journal of Chemotherapy

Comparison of bamlanivimab with or without etesevimab and casirivimab-imdevimab in clinical outcomes in patients with COVID-19: a systematic review and meta-analysis

Article

Author: Dai, Kaili ; Luo, Linna ; Liu, Junzhao ; Yang, Mingyang

145

News (Medical) associated with Etesevimab

17 Jan 2025

·www.globenewswire.com

Junshi Biosciences Announces Toripalimab’s Approval in Australia

SHANGHAI, Jan. 17, 2025 (GLOBE NEWSWIRE) -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced that toripalimab, the anti-PD-1 monoclonal antibody self-developed by the company, has obtained the marketing authorization issued by the Therapeutic Goods Administration of the Australian Government Department of Health and Aged Care (the “TGA”). The New Chemical Entity (the “NCE”) application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent, locally advanced nasopharyngeal carcinoma (“NPC”) and toripalimab, as a single agent, for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy has been approved by TGA. Toripalimab has become the first and only immuno-onocology treatment for NPC in Australia. This NCE application was submitted under Project Orbis. Project Orbis, initiated and advocated by the Oncology Center of Excellence (OCE) of the US Food and Drug Administration (the “FDA”), provides a collaborative mechanism and framework among the FDA and regulatory authorities in other countries and regions allowing different regulatory authorities to jointly review the applications for registration of oncology drugs. Toripalimab was the first domestic oncology drug included in Project Orbis. Additionally, the TGA also granted an orphan drug designation to toripalimab for the treatment of NPC, which has accelerated the review and registration process to a certain extent. General Manager and CEO of Junshi Biosciences, Dr. Jianjun ZOU, said, “Toripalimab has made significant strides in its internationalization. As of today, toripalimab has been approved in 35 countries across four continents and offers hope to patients worldwide. This recent approval in Australia is not only extremely meaningful to the nasopharyngeal carcinoma patients there, but it also represents our company’s continued efforts toward globalization. In the following days, we will closely collaborate with our partner Dr. Reddy’s Laboratory to expedite toripalimab’s availability in Australia, ensuring that local patients can benefit from this treatment as soon as possible.” M.V. Ramana, CEO of Branded Markets, Dr. Reddy’s, said: “This approval is a significant milestone in our collaborative efforts with Junshi Biosciences to make their novel treatment available to patients around the world. Toripalimab is the first and only immuno-onocology treatment for nasopharyngeal carcinoma in Australia, and meets a significant unmet need for patients. In oncology, our offerings aim to build an end-to-end ecosystem of care – access to current standard of care cancer medicines across multiple countries globally, innovation in formulations, strategic collaborations for novel innovative molecules, beyond-the-pill support such as nutrition and digital tools. Following our successful launch of toripalimab in India, we are looking forward to bringing it to patients in Australia and other markets in the coming days.” NPC is a malignant tumor that occurs in the epithelium mucosae of the nasopharynx and is one of the most common types of head and neck cancers. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Toripalimab is the only preferred regimen recommended for the comprehensive treatment of recurrent or metastatic NPC in the National Comprehensive Cancer Network (NCCN) Guidelines (Version 1.2025) for head and neck cancers. The approval of the NPC indications is primarily based on the results from JUPITER-02 (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study for the first-line treatment of NPC, NCT03581786), and the results from POLARIS-02 (a multi-center, open-label, pivotal Phase 2 clinical study for second-line or later treatment of recurrent or metastatic NPC, NCT02915432). The JUPITER-02 study is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and is the world’s first Phase 3 clinical study in which there is preset statistical verification (Type I error control) for Overall Survival (“OS”) in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The results of the study were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2), and were subsequently featured on the cover of Nature Medicine (IF: 58.7). The results were also published in full in the Journal of the American Medical Association (JAMA, IF: 63.1). The results of the study showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab in combination with chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (“ORR”) and longer duration of response (“DoR”), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data was presented at ASCO 2024, with a 5-year survival rate of 52%. The POLARIS-02 results were published online in January 2021 in the Journal of Clinical Oncology. The results showed that toripalimab demonstrated durable antitumor activity and a manageable safety profile in patients with recurrent or metastatic NPC who had failed prior chemotherapy, with an ORR of 20.5%, a DoR of 12.8 months, and a median OS of 17.4 months. As of today, toripalimab has been approved for marketing in over 35 countries and regions in 4 continents, including China, Hong Kong SAR, the United States, the European Union, the UK, Australia, India, Jordan, etc. About Toripalimab Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and to induce PD-1 receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Europe and Southeast Asia. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy;recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy;locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy;in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC;in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC);in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC);in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC;in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC);in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC);in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC). The 10 indications have been included in the National Reimbursement Drug List (NRDL) (2024 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma, perioperative treatment of NSCLC, treatment of RCC and treatment of TNBC. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. Internationally, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan, Australia and other countries and regions. In addition, toripalimab BLAs are under reviews in many countries around the globe, including the Singapore Health Sciences Authority (HSA). About Junshi Biosciences Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s products have received approvals in China and international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody. Toripalimab has been approved in over 35 countries and regions including China, the US, and Europe. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://www.junshipharma.com. Junshi Biosciences Contact Information IR Team:Junshi Biosciencesinfo@junshipharma.com+ 86 021-6105 8800 PR Team:Junshi BiosciencesZhi Lizhi_li@junshipharma.com+ 86 021-6105 8800

Clinical ResultDrug ApprovalPhase 3ASCOImmunotherapy

14 Jan 2025

·www.businesswire.com

Adimab Provides Update on Pipeline

LEBANON, N.H.--( BUSINESS WIRE )--Adimab, LLC, the global leader in the discovery and engineering of fully human monoclonal and multispecific antibodies, today announced that five therapeutic products containing molecules discovered or optimized by Adimab have been approved for commercial sale. Adimab’s first partnered program to receive approval was Innovent’s TYVYT ® (sintilimab injection), which is currently marketed by Innovent and Lilly in China for seven cancer indications. Other commercial products containing molecules from Adimab include: Innovent’s SINTBILO ® (tafolecimab injection), a PCSK9 program approved in China for the treatment of adult patients with primary hypercholesterolemia and mixed dyslipidemia. IASO Bio’s FUCASO ® (equecabtagene autoleucel), a BCMA CAR-T program approved in China for the treatment of patients with multiple myeloma. Invivyd’s PEMGARDA™ (pemivibart), a SARS-CoV-2 monoclonal antibody approved for prophylactic emergency use to prevent COVID-19 infection in the United States. Checkpoint Therapeutic’s UNLOXCYT™ (cosibelimab) received BLA approval December 2024 in the United States for multiple myeloma. There are 11 additional Adimab-associated programs that are currently in Phase II or Phase III (pivotal) trials. The total number of Adimab-associated clinical programs initiated by our partners has now reached 78. "Helping our partners get new therapies on the market to treat patients has been our goal from day one," explained Ryan McGovern, Chief Financial Officer of Adimab. “Given our high number of currently-approved and late-stage programs, we made the decision in 2024 to move royalty rights on our more advanced assets into a separate business unit called Adimab Royalty Company (ARC), which provides a unique opportunity for investors interested in an advancing, diversified portfolio of royalty-bearing assets. The rapid clinical and commercial advancement of so many exciting therapies is driving the value of ARC in addition to validating our core business at Adimab, which remains focused on generating new therapeutic candidates for our partners.” “Therapeutic product development has many challenges, and it is truly meaningful when programs are approved and reach patients. Over time, we have succeeded in building a valuable, sustainable business because of our relentless focus on high-quality execution for our partners without the distraction and conflict of an internal development pipeline. Also critical to our success are our continuous investment in improving the Adimab platform, our discipline on the expense side, our highly talented and committed employees, and our supportive investor base,” said Philip T. Chase, Chief Executive Officer of Adimab. “We have been a reliable collaborator since 2009 and those looking to discover protein-based therapeutics know that we will continue to be a dependable resource for years to come.” Adimab partners have exercised more than 115 commercial licenses to option rights to advance programs into clinical development. In 2024, 11 partners exercised commercial options including BMS, NextPoint, Regeneron, REGiMMUNE, SixPeaks Bio, Santa Ana Bio, Triveni Bio, and Werewolf, among others. Technologies Antibody Discovery: Adimab discovers therapeutic antibodies in IgG and VHH formats through our proprietary yeast-based technology. Adimab can utilize its fully human synthetic diversity as well as additional diversities from in vivo sources. Antibodies from Adimab have exquisite specificity and are utilized in a variety of modalities, including monoclonal and multispecific formats, CAR-Ts, ADCs, etc. Engineering: Adimab has developed and refined its engineering capabilities over thousands of lead antibody optimization efforts. The process starts with one or more partner-selected lead antibodies with the goal of optimizing potency, specificity, and/or developability. In addition to Adimab-discovered antibodies, engineered antibodies can originate from outside sources, typically to fix undesirable properties of antibodies from in vivo and phage-based technologies. Adimab also applies its engineering expertise to cytokines, TCRs, and other proteins. Multispecifics: Adimab has extensive bispecific and multispecific know-how and capabilities, including proprietary solutions for both Fc (HC:HC) and Fab (HC:LC) heterodimerization, to allow for the generation of numerous bispecific and multispecific product designs with excellent developability properties. Additionally, Adimab can perform common light chain and fragment-based discovery and engineering necessary for certain partner-desired formats. T Cell Engagers: Adimab has a highly characterized suite of functional and diverse CD3 (both IgG and VHH binders) and CD28 antibodies to generate bi- and multi-specific T cell engagers. Adimab has partnered this program non-exclusively with more than 25 partners, to date. Complex Targets: Certain membrane-obligate proteins (e.g., GPCRs and ion channels) are often poorly behaved outside their native membrane environment. For these targets, Adimab has developed proprietary in vitro and in vivo discovery workflows that rely solely on the target being expressed in its native membrane and without the need for antigen mimetics. The company has employed these workflows numerous times to generate robust panels of functional and specific antibodies to these classically difficult targets, which are then further extensively engineered with our yeast platform. About Adimab Adimab is the leading provider of therapeutic antibody discovery and engineering technologies. This includes naïve discovery from synthetic libraries in yeast or B cells (mice and humans), antibody engineering and optimization, multispecific antibody engineering, and a portfolio of proprietary CD3 and CD28 antibodies licensed non-exclusively for bispecific applications. Adimab focuses solely on its partners and not on developing an internal product pipeline. Since 2009, Adimab has partnered with over 130 pharmaceutical and biotechnology companies, generating more than 600 therapeutic programs, over 75 clinical programs, and multiple approved products. The Adimab technology has been transferred and implemented at Biogen, GSK, Lilly, Merck, Novo Nordisk, and Takeda. Funded discovery partners include leading pharmaceutical companies, such as Alnylam, Bristol Myers Squibb, Novartis, Regeneron, Vertex and others. Adimab has also partnered with many early-stage venture-backed companies, including Dragonfly, NextPoint, Santa Ana Bio, Tizona, TRex Bio and others, as well as mid-size public biopharmaceutical companies such as Alector, Cullinan Therapeutics, Innovent, iTeos, Mersana, Scholar Rock, and others. Adimab’s integrated antibody discovery and engineering platform provides unprecedented speed from antigen to purified, full-length human IgGs. Adimab offers fundamental advantages by delivering diverse panels of therapeutically relevant antibodies that meet the most demanding standards for affinity, epitope coverage, species cross-reactivity, and developability. Adimab enables its partners to rapidly expand their biologics pipelines through a broad spectrum of technology access arrangements. For more information, visit http://www.adimab.com .

Drug ApprovalPhase 3

19 Nov 2024

·www.globenewswire.com

Junshi Biosciences Announces UK MHRA Approval for Marketing of Toripalimab

Nov. 16, 2024 -- Shanghai Junshi Biosciences Co., Ltd (Junshi Biosciences, HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, and its wholly-owned subsidiary, TopAlliance Biosciences Inc. (TopAlliance Biosciences), announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved toripalimab (UK trade name: LOQTORZI®) for the treatment of two indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma (NPC); Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma (ESCC). In UK, toripalimab is the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC, regardless of PD-L1 status. NPC is a malignant tumor that occurs in the nasopharyngeal mucosal epithelium and is one of the most common types of head and neck cancers globally. According to GLOBOCAN 2022 statistics, the number of newly diagnosed NPC cases in 2022 exceeded 120,000 worldwide. Due to the location of the primary tumor, surgery is rarely an option. The latest European Society of Medical Oncology (ESMO) Guidelines recommend immunotherapy combined with chemotherapy as the first-line treatment for recurrent or metastatic NPC. The approval of the NPC indication is primarily based on the results from the JUPITER-02 study (a randomized, double-blind, placebo-controlled, multinational multi-center Phase 3 clinical study, NCT03581786). JUPITER-02 is the first international multi-center, double-blind, randomized Phase 3 clinical study in NPC immunotherapy with the largest sample size, and the world’s first Phase 3 clinical study with preset statistical verification (Type I error control) for overall survival (“OS”) in first-line immunotherapy combined with chemotherapy for NPC compared to chemotherapy alone that demonstrated a survival benefit. The study results were presented in an oral report during the Plenary Session of the 2021 annual meeting of the American Society of Clinical Oncology (ASCO) (#LBA2) and were subsequently featured on the cover of Nature Medicine. The results were also published in full in the Journal of the American Medical Association (JAMA). Results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy reduced the risk of disease progression by 48% and the risk of death by 37%. The median progression-free survival (“PFS”) in the toripalimab plus chemotherapy group was prolonged by 13.2 months compared to chemotherapy alone, from 8.2 months to 21.4 months. In addition, patients treated with this combined therapy achieved a higher objective response rate (ORR) and longer duration of response (DoR), with a complete response (CR) rate of 26.7%, and no new safety signal was identified. Long-term survival follow-up data, presented at ASCO 2024, reported a 5-year survival rate of 52.0%. EC is one of the most common malignant tumors in the alimentary tract. According to GLOBOCAN 2022 statistics, esophageal cancer is the 11th most commonly diagnosed cancer and the seventh leading cause of cancer death worldwide, with over 511,000 new cases and over 445,000 deaths in 2022. ESCC and esophageal adenocarcinoma are the two main histological subtypes of esophageal cancer. The approval of the ESCC indication is primarily based on the results from the JUPITER-06 study (a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study, NCT03829969). The study aimed to evaluate the efficacy and safety of toripalimab in combination with paclitaxel/cisplatin (TP) for the first-line treatment of advanced ESCC compared with placebo in combination with chemotherapy. The results were first presented in an oral session during the ESMO Congress 2021 and later published in Cancer Cell and Journal of Clinical Oncology, two leading international oncology journals. Study findings showed that toripalimab in combination with chemotherapy resulted in superior PFS and OS in patients with advanced or metastatic ESCC, the median OS was prolonged by 6 months to 17 months and the risk of disease progression or death in patients was significantly reduced by 42%. Futhermore, there was a significant improvement in survival benefits regardless of PD-L1 status. Dr. Jianjun ZOU, General Manager and CEO of Junshi Biosciences, said, “The approval of toripalimab by MHRA marks another significant milestone for toripalimab in Europe, not only making toripalimab the first and only drug in UK for the treatment of NPC, but also the only first-line treatment for ESCC, regardless of PD-L1 status. We are extremely proud to introduce innovative Chinese biopharmaceuticals to Europe that can address longstanding unmet medical needs of the patients there. Moving forward, we will remain committed to our globalization strategy, ‘In China, For Global.’ We will continue working towards the commercialization of toripalimab, and offer high-quality, innovative, domestically developed medicines to benefit more patients around the world.” Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. ore than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin. In the Chinese mainland, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI®). Currently, there are ten approved indications for toripalimab in the Chinese mainland: unresectable or metastatic melanoma after failure of standard systemic therapy; recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy; locally advanced or metastatic urothelial carcinoma that failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy; in combination with cisplatin and gemcitabine as the first-line treatment for patients with locally recurrent or metastatic NPC; in combination with paclitaxel and cisplatin in first-line treatment of patients with unresectable locally advanced/recurrent or distant metastatic esophageal squamous cell carcinoma (ESCC); in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC); in combination with chemotherapy as perioperative treatment and subsequently with monotherapy as adjuvant therapy for the treatment of adult patients with resectable stage IIIA-IIIB NSCLC; in combination with axitinib for the first-line treatment of patients with medium to high risk unresectable or metastatic renal cell carcinoma (RCC); in combination with etoposide plus platinum for the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC); in combination with paclitaxel for injection (albumin-bound) for the first-line treatment of recurrent or metastatic triple-negative breast cancer (TNBC). The first six indications have been included in the National Reimbursement Drug List (NRDL) (2023 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma. In October 2024, toripalimab for the treatment of recurrent or metastatic NPC was approved in Hong Kong SAR, China. In terms of international layout, toripalimab has been approved for marketing in the United States, the European Union, India, the UK, Jordan and other countries and regions. In addition, the Australia Therapeutic Goods Administration (TGA) and the Singapore Health Sciences Authority (HSA) accepted the new chemical entity application and the new drug application for toripalimab in combination with cisplatin and gemcitabine, for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and for toripalimab, as a single agent, for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy, respectively. Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R&D pipeline comprising over 50 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Five of the company’s innovations have already reached the Chinese or international markets, one of which is toripalimab, China’s first domestically produced and independently developed anti-PD-1 monoclonal antibody, approved in over 35 countries and regions including China, the US, and Europe. Additionally, more than 30 drugs are currently in clinical development. During the COVID-19 pandemic, Junshi Biosciences actively shouldered the social responsibilities of a Chinese pharmaceutical company through its involvement in developing etesevimab, MINDEWEI®, and other novel therapies for the prevention and treatment of COVID-19. With a mission of “providing patients with world-class, trustworthy, affordable, and innovative drugs,” Junshi Biosciences is “In China, For Global.” At present, the company boasts approximately 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing, Guangzhou, etc.). For more information, please visit: http://junshipharma.com. The content above comes from the network. if any infringement, please contact us to modify.

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Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Preclinical	United States	Eli Lilly & Co.	09 Feb 2021
COVID-19	Discovery	United States	Eli Lilly & Co.	09 Feb 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04427501 (BLAZE-1, Pubmed \| Infect Dis Ther)	Phase 3	COVID-19	354	Bamlanivimab 350/700 mg + Etesevimab	oqhaepwepf(btkmpbxycp) = teqfzisstn ucvdwveeuw (fgeiqlzzcw, 6.6 - 15.0)	Positive	04 Sep 2024
				Placebo	oqhaepwepf(btkmpbxycp) = nxnfncavyp ucvdwveeuw (fgeiqlzzcw, 26.9 - 42.6)
NCT04427501 (BLAZE-1, Pubmed \| Open Forum Infect Dis)	Phase 3	COVID-19	769	Bamlanivimab and Etesevimab	mzwdyuetag(kdsaynicgc) = bbyldwepmq kqhbwrkcuq (opctpsdjqy )	Positive	01 May 2022
				Placebo	mzwdyuetag(kdsaynicgc) = pppbtjdsrz kqhbwrkcuq (opctpsdjqy )
NCT04634409 (BLAZE-4, FDA) Manual	Phase 2	COVID-19	150	Bamlanivimab 700mg+Etesevimab 1400 mg+Bebtelovimab 175mg (High Risk Subjects; Treatment Arms 12-13)	yccaezvzoq(jqhgwayksu) = fscqbtyqqd clhikwmknx (lyxamblcui )	Positive	11 Feb 2022
				Bebtelovimab 175mg (High Risk Subjects; Treatment Arms 12-13)	yccaezvzoq(jqhgwayksu) = zmtdudrofs clhikwmknx (lyxamblcui ) View more
NCT04634409 (BLAZE-4, FDA) Manual	Phase 2	COVID-19	380	Bamlanivimab 700mg+Etesevimab 1400 mg+Bebtelovimab 175mg (Low Risk Subjects; Treatment Arms 9-11)	vmzvezotfa(pndnqcksxz) = bdiicpyqlc ygcnabpyjn (roiswuqlje ) View more	Positive	11 Feb 2022
				Bebtelovimab 175mg (Low Risk Subjects; Treatment Arms 9-11)	vmzvezotfa(pndnqcksxz) = sjyicvydih ygcnabpyjn (roiswuqlje ) View more
NCT04634409 (BLAZE-4, FDA) Manual	Phase 2	COVID-19	176	Bamlanivimab 700mg+Etesevimab 1400 mg+Bebtelovimab 175mg (High Risk Subjects; Treatment Arm 14)	ddeklwrawg(llxlsdcspa) = xgrgqaymwg hujzszrdml (kxeyhjyumg ) View more	Positive	11 Feb 2022
NCT04441931 (CTgov)	Phase 1	-	26	Placebo (Pooled Placebo)	eitkncphpe(ssigwyhinw) = oerbwedsif bmcblsefyq (tsfzdivhxl, wwrrdgblap - ohwbwmxhdk)	-	06 Dec 2021
				LY3832479 (700 mg LY3832479 IV)	eitkncphpe(ssigwyhinw) = smcxbclbng bmcblsefyq (tsfzdivhxl, tgpmzqlbqx - xhmdhdtgrg) View more
NCT04427501 (BLAZE-1, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 2/3	COVID-19	1,035	bamlanivimab+etesevimab	(wwmmfnnctt) = ywurabelxc kvetzjkdky (btytwnnfwk ) View more	Positive	07 Oct 2021
				Placebo	(wwmmfnnctt) = bsdlumklff kvetzjkdky (btytwnnfwk ) View more
NCT04441918 (Pubmed) Manual	Phase 1	COVID-19	40	Etesevimab	-	Positive	16 Jul 2021
				Placebo
NCT04427501 (BLAZE-1, FDA) Manual	Phase 2	COVID-19	369	Bamlanivimab 2800mg+Etesevimab 2800mg	(rysepwrcdz) = Most subjects, including those receiving placebo, effectively cleared virus by Day 11. txafxucmpo (kicdwnlxpo ) View more	Positive	09 Feb 2021
				Bamlanivimab 700 mg

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