Globally, the prevalence of various chronic diseases continues to rise, including different types of cancers, autoimmune diseases, and inflammatory conditions, while the demand for immunotherapy drugs is also increasing. The growing research and development activities focused on creating novel immunotherapies for various chronic diseases may drive the expansion of the global immunotherapy drug market.According to Mordor Intelligence, the compound annual growth rate of the immuno-oncology drug market size from 2024 to 2029 is expected to reach 8.40%.

FromPharmCube DatabaseLearned,Founded in2005Year'sAnaptysBioIs a clinical-stage biotechnology company focused on providing innovative immunotherapies (including cancer immunotherapy and autoimmune therapy),In 2017, the company went public on Nasdaq through an IPO. Looking at the company's previous financing information, the 2017 IPO only raised $75 million, which seems not so "impressive" in today’s pharmaceutical investment and financing market. However, by generating revenue through collaborative research and development, the company is about to "make it to" its twentieth anniversary.

PharmCube Database: Company Information

Although the Phase 2 clinical trial data of Etokimab announced in 2020 failed to meet expectations, the full FDA approval in February 2023 of GSK's (GlaxoSmithKline) cancer immunotherapy Jemperli (dostarlimab) for a type of endometrial cancer should serve as the best encouragement for AnaptysBio. This is because dostarlimab was initially developed by AnaptysBio and later licensed to Tesaro (acquired by GSK). Through this product "bridge," AnaptysBio also initiated more collaborations with GSK on additional products, including dostarlimab (PD-1 antagonist), cobolimab (GSK4069889, TIM-3 antagonist), and GSK4074386 (LAG-3 antagonist, which has since been discontinued). As of March 22, 2024, AnaptysBio had a market capitalization of $580 million. As of the closing on April 15, the company’s market capitalization was approximately $569 million, with each share valued at $21.27.

Market Capitalization

Focus on Immune Cell Regulation

AnaptysBioThe R&D pipeline mainly focuses on immune cell modulators, including immune cell agonists and cytokine antagonists.The two cytokine antagonists under development are intended for out-licensing. In addition, the various therapeutic antibodies in GSK's immuno-oncology portfolio mentioned above were also developed and licensed by AnaptysBio.

Note: Cytokines are expressed at low levels or not expressed in normal organisms, and are transcribed and translated during abnormal states (disease and defense). Cytokines can regulate cellular responses in inflammation. Excessive cytokines can cause systemic or local toxic effects, so their activity must be restricted by inhibiting the synthesis and release of cytokine levels (or by utilizing antagonistic mechanisms) to strictly control cytokine levels.

1、Rosnilimab

RosnilimabIs a new typePD-1Checkpoint Agonist Antibodies, Can Reduce OveractiveTCellular Inflammation.PD-1+ T cells are widely present in the inflamed tissues and periphery of RA (rheumatoid arthritis) and UC (ulcerative colitis). The potent depletion and agonistic effects of Rosnilimab can reduce T cell proliferation and inflammatory cytokines that cause joint damage, primarily by optimizing PD-1+ T cell inhibitory signaling through the formation of tight immune synapses.

Phase 1 clinical trial studies showed that monthly SC (subcutaneous) administration in 144 healthy volunteers from the SAD (Single Ascending Dose) and MAD (Multiple Ascending Dose) cohorts demonstrated good safety and tolerability. The Phase 2a clinical trial for the treatment of Alopecia Areata (AA) (Q4W SC administration for 6 months) was well-tolerated with no significant safety signals.

Rheumatoid Arthritis (RA) is an autoimmune disease characterized by erosive arthritis. The current research on Rosnilimab focuses on moderate to severe RA.Proceed to clinical trials2bPeriod, the study was conducted in2023Starting from the third quarter of the year, it is expected to2025Top-line data obtained in the middle of the year. The trial is recruiting patients for a placebo-controlled study.

Ulcerative colitis (UC) is a common chronic non-infectious inflammatory bowel disease, mainly characterized by diarrhea, mucus and bloody stools, and abdominal pain. Research on Rosnilimab for moderate to severe UCProceed to clinical trials2Period, the study was conducted in2023Starting from the fourth quarter of the year, it is expected2026Top-line data obtained in the first half of the year.

2、ANB032

ANB032Is AntiBTLAAgonist monoclonal antibody, with the potential to treat various systemic inflammatory diseases.Under normal physiological conditions, after BTLA binds to its ligand, the herpesvirus entry mediator, it can inhibit the over-activation of lymphocytes in the body, playing a negative regulatory role in the body's anti-tumor immune response and preventing damage to itself by the immune system. Studies show that the expression of BTLA (B and T Lymphocyte Attenuator) is higher in malignant tissues than in normal tissues, and higher BTLA expression correlates with higherHVEN(Herpesvirus Invasion Medium)Expression is positively correlated.

In April 2022, AnaptysBio reported the top-line data from the Phase 1 clinical trial of ANB032, which showed good safety and tolerability, as well as rapid and sustained pharmacokinetic and pharmacodynamic profiles.ANB032TargetingAD(Clinical Trials for Patients with Atopic Dermatitis)2bPhase Research From2023Starting from the second quarter of the year, it is expected2024Top-line data achieved in the year.

Sanofi's OX40L AntibodyAmlitelimab is also a drug developed for the treatment of atopic dermatitis, and the data from its Phase 2b clinical trial showBiomarkers of both the Th2 pathway and the Th17/Th22 pathway were significantly reduced. ANB032 more broadly inhibits the secretion of Th1, Th2, Th17, and Th22 cytokines in AD patient-derived PBMCs (peripheral blood mononuclear cells) compared to anti-OX40L.

3、ANB033AndANB101

ANB033Is AntiCD122High-affinity antagonist that can reduce pathogenicityTCells andNKCell, Expected2024Submission in the second quarter of the yearINDApplication.CD122 is the common β subunit of the IL-15 and IL-2 receptors, and CD122 antagonist antibodies can effectively inhibit IL-15 and IL-2. Both IL-15 and IL-2 mediate the proliferation and survival of NK cells and T cell subsets, as well as the secretion of inflammatory cytokines (IFNγ) during the T cell activation process.

ANB101YesBDCA2Modulator monoclonal antibody, which can effectively inhibit the secretion of interferon and immune activation. Expected2024Submitted in the second half of the yearINDApplication.BDCA2 is a molecule specifically expressed on pDCs (plasmacytoid dendritic cells), which are a subclass of dendritic cells (DC) specialized in secreting Type I interferons (IFN-I) and are also capable of delivering antigens to the adaptive immune system.

1、Imsidolimab

Imsidolimab is an antibody that inhibits the function of the interleukin-36 receptor (IL-36R).AnaptysBioIn the study of its use for treating generalized pustular psoriasis (GPP), currently advanced to clinical trials3Period.The IL-36 signaling pathway plays a key regulatory role in driving various inflammatory diseases and altering the tumor microenvironment. GPP is a systemic, life-threatening inflammatory disease associated with unregulated IL-36 signal transduction. Patients experience high fever, elevated serum CRP, and increased levels of inflammatory cytokines (e.g., IL-8). It is characterized by widespread pustules, and severe GPP patients may die from cardiopulmonary failure, exhaustion, toxicity, and infection.

In October 2023, Anaptysbio announced the topline data from the GEMINI-1 trial of the Phase 3 clinical study of Imsidolimab. The GEMINI-1 trial is a 4-week randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of the product in patients experiencing GPP flares. The results showed,ImsidolimabReached the primary endpoint with a single intravenous dose.750mg ImsidolimabLater, on the4Zhou achieved rapid clearance of pustules, erythema, and scaling, while the topline data also demonstrated good safety and tolerability. CompletionGEMINI-1The patients in the trial were subsequently enrolled.GEMINI-2Trial, which mainly evaluates the prevention and long-term administration via subcutaneous injection monthly over three years./Or reduce recurrenceGPPEfficacy and Safety of Seizure Severity. Subjects receive monthly200mgSubcutaneous InjectionImsidolimabOr placebo, depending on whether they areGEMINI-1Responders, partial responders, or non-responders to treatment.

AnaptysBioPlanned in2024Publicly disclosed at the medical conference in the second half of the yearGEMINI-1Comprehensive data of the trial andGEMINI-2Top-line results. In addition, the company expects to2024Before the third quarter of the yearFDASubmission of Biologics License Application (BLA）。

2、Etokimab（IL-33AntagonistmAb）

Etokimab is a monoclonal antibody that specifically inhibits interleukin-33 (IL-33). IL-33 is an inflammatory factor constitutively expressed in the nuclei of pulmonary epithelial cells, which can rapidly respond to environmental damage and stress stimuli, thereby being released extracellularly, subsequently triggering allergic inflammatory responses and playing a critical role in initiating respiratory inflammatory diseases such as asthma.

In August 2020, AnaptysBio reported the top-line data from the interim analysis at week eight of the Phase 2 study (ECLIPSE trial) of Etokimab for the treatment of chronic rhinosinusitis with nasal polyps. Unfortunately, neither the Q4w nor the Q8w treatment groups achieved superiority over placebo.Nasal Polyps Score (NPS) and Sinus Outcomes Test22（SNOT-22）。Secondary analysis showed that, compared with placebo, NPS and blood eosinophil levels improved in patients with asthma and non-asthma comorbidities, and ACQ-5 (Asthma Control Questionnaire) scores also improved in the asthma subgroup.CurrentEtokimabReady for clinical trials2b/3Phase Research,AnaptysBio also believes that the pipeline may be developed for other non-respiratory diseases, such as allergies, gastrointestinal, etc.

In addition to the above-mentioned R&D pipelines, AnaptysBio is also collaborating with GSK on the development of other drugs, primarily Jemperli (dostarlimab) and Cobolimab (GSK4069889). According to the agreement, GlaxoSmithKline PLC is responsible for the ongoing research, development, commercialization, and production of these drugs.

JemperliIs a programmed death receptor1（PD-1) blocking antibody, can bind withPD-1Receptor binding and blocking it with its ligandPD-L1AndPD-L2Interaction.In the United States, Jemperli is used in combination with carboplatin and paclitaxel, or as a monotherapy, for the treatment of adult patients with dMMR (mismatch repair deficient) recurrent or advanced endometrial cancer. According to FDA approval, these patients must have received or followed a prior platinum-based regimen in any setting and are not candidates for curative surgery or radiation. The supplemental Biologics License Application for the newly approved combination therapy of carboplatin and paclitaxel for dMMR/MSI-H (microsatellite instability-high) primary advanced or recurrent endometrial cancer received Breakthrough Therapy Designation and Priority Review from the U.S. FDA. Jemperli is also indicated for patients with dMMR recurrent or advanced solid tumors who have progressed on or after prior treatment and have no satisfactory alternative treatment options.2024Year3Month16Day,GSKPublisheddostarlimabClinical Trials of Combination Therapy for More Patients with Primary Advanced or Recurrent Endometrial Cancer3Phase Research, also known asRUBYTrial, a global, randomized, double-blind, multicenter clinical trial consisting of two parts3Phase study, for patients with primary advanced or recurrent endometrial cancer. The trial results showed that the overall survival (OS) in the first part...OS) results and the second part of the progression-free survival (PFS) The results are statistically and clinically significant.

Pharmcube Database: Drug Research and Development Information

CobolimabIs AntiTIM-3Antagonist, under development for the treatment of lung cancerCOSTARTrial, Expected2024Top-line data to be released in the second half of the year.

Note: Dostarlimab was developed by AnaptysBio and licensed to Tesaro in March 2014 through a collaboration and exclusive license agreement. In 2019, GSK acquired Tesaro and obtained Jemperli and Zejula.

Earn Income through Collaboration

On March 11, 2024, AnaptysBio Inc. announced its financial status for the year 2023.2023Annual cooperation revenue is1720"Million US dollars,"The same period last year was $10.3 million, and this change was mainly due to the increase in royalty revenue recognized from the sales of Jemperli, which was offset by a development milestone achieved for Cobolimab in 2022.R&D expenses are1.323Billion US dollars,The same period last year was $88.8 million, and this growth was mainly due to the manufacturing and development costs of Rosnilimab, ANB032, and ANB033.General and Administrative Expenses4190"Million USD,"The same period last year was 36.6 million US dollars.Annual Net Loss1.636Billion USD, or net loss per share6.08USD,Net loss of $128.7 million and net loss per share of $4.57 in the same period last year.

As of December 31, 2023, the total amount of cash, cash equivalents, and investments was $417.9 million, compared to $584.2 million as of December 31, 2022, representing a decrease of $166.3 million. This reduction was primarily related to cash used in operating activities and a $50 million stock repurchase program.

Reference:

NMPA/CDE

Pharnex Cloud Data, www.pharnexcloud.com

FDA/EMA/PMDA；

Relevant companies' public disclosures (unless otherwise noted, images in the main text are from the companies' official websites);

https://www.anaptysbio.com/；

https://www.cas.cn/syky/202207/t20220711_4841183.shtml；

https://www.gsk.com/en-gb/media/press-releases/positive-ruby-phase-iii-data-show-potential-for-jemperli-dostarlimab-combinations-in-more-patients-with-primary-advanced-or-recurrent-endometrial-cancer/；

https://www.mordorintelligence.com/en/industry-reports/immunotherapy-drugs-market; etc.