Arcus Biosciences, Inc.

DUBLIN--( BUSINESS WIRE )--The "Cancer Immunotherapy Markets. The Race for the Cures. Market Forecasts for Immuno-Oncology Therapeutics by Therapy, by Cancer and by Customer including Executive and Consultant Guides. 2023 to 2027" report has been added to ResearchAndMarkets.com's offering. A revolution in cancer therapy is underway. New therapy based on using the body's natural immune defenses is having unprecedented success. CAR-T Cells? Checkpoint Inhibitors? Cytokines? Find out about the technology in readily understood terms that explain the jargon. Already worth billions the global market is poised for dramatic growth. The impact on the health care industry is enormous. The report forecasts the market size out to 2027. Find the opportunities and the pitfalls. Understand growth expectations and the ultimate potential market size. Make investment decisions and valuations with confidence using the latest data. This report explores the opportunity in this market and what companies are poised to benefit. Key Topics Covered: 1 Market Guides 1.1 Situation Analysis 1.2 Guide for Executives and Marketing Staff 1.3 Guide for Investment Analysts and Management Consultants 2 Introduction and Market Definition 2.1 What is Cancer Immunotherapy? 2.2 Immunotherapy - the looming cures 2.3 Market Definition 2.4 Methodology 2.5 U.S. Medical Market and Pharmaceutical Spending - Perspective 2.5.1 Global Expenditures for Medicines 3 Immunotherapy - Guide to Immune Technologies 3.1 The Immune System 3.1.1 Innate immune system 3.1.2 Adaptive immune system 3.1.3 Tumor immunology - the immune surveillance system 3.2 Immuno Oncology Technologies 3.2.1 Monoclonal Antibodies 3.2.2 Cancer vaccines 3.2.3 Cytokines 3.2.4 Cell Based Therapies 3.2.5 Inhibitors/Agonists 3.2.6 Antibody Drug Conjugates 3.2.7 Others 4 Industry Overview 4.1 Market Players - Roles & Impacts 4.1.1 Drug manufacturers - Larger/pharmaceutical 4.1.2 Drug manufacturers - Generic 4.1.3 Contract Research and Manufacturing 4.1.4 In Vitro Diagnostics Industry 4.1.5 Drug Marketing Companies 4.1.6 Biotechnology Companies 4.1.7 Regulatory Bodies 5 Market Trends 5.1 Factors Driving Growth 5.1.1 Outcome potential 5.1.2 Fast tracking 5.1.3 Funding 5.1.4 Technology Environment 5.1.5 Target Solutions 5.2 Factors Limiting Growth 5.2.1 Cost of Treatment 5.2.2 Clinical Trials Role 5.2.3 Combinations 5.2.4 Protocols 5.3 Therapeutic Technology Development 5.3.1 Combinations - Issues and Complexity 5.3.2 Preference for a drug 5.3.3 Problems of Immunity Engineering 5.3.4 The Role of Cost 5.3.5 The Disruption Dynamic 5.3.6 CAR-T Cell Therapy 5.3.7 The Next Five Years 6 Cancer Immunotherapy Recent Developments 6.1 Recent Developments - Importance and How to Use This Section 6.2 Continued Success with Immunotherapy in Melanoma 6.3 AC Immune Receives FDA Fast Track Designation 6.4 LTZ Announces Financing 6.5 Immunotherapy for Cancer Overview 6.6 Implantable device shrinks pancreatic tumors 6.7 mRNA Vaccine And Immunotherapy Reduce Melanoma Recurrence 6.8 Towards a Universal Cancer Immunotherapy 6.9 New Strategy May Improve T-Cell Therapy in Solid Tumors 6.10 Immunotherapy linked to increase in Medicare spending 6.11 Immunotherapy Effective with Ovarian Cancer 6.12 Cancer Immunotherapy Granted Fast Track 7 Profiles of Key Immunotherapy Companies AbbVie Achilles Therapeutics Acumen Pharmaceuticals Adagene Adaptimmune Therapeutics Adicet Bio ALX Oncology Holdings Ambrx Biopharma Amgen Apexigen Arcus Biosciences argenx AstraZeneca Atreca Avalo Therapeutics Avid Bioservices Bavarian Nordic BioAtla Biogen Inc. BioNTech Bolt Biotherapeutics Bristol-Myers Squibb Candel Therapeutics Caribou Biosciences Celldex Therapeutics Checkpoint Therapeutics Chinook Therapeutics Corvus Pharmaceuticals Cullinan Oncology Eli Lilly EOM Pharmaceuticals Evaxion Biotech Genenta Science Gilead Sciences Gracell Biotechnologies Greenwich LifeSciences Gritstone bio Harpoon Therapeutics ImmunityBio Immunocore Holdings Immunome IMV Inc Incyte Indaptus Therapeutics Instil Bio Iovance Biotherapeutics Johnson & Johnson Marker Therapeutics Medicenna Therapeutics Merck & Co. Merus Moderna Mustang Bio Nanobiotix Neoleukin Therapeutics Novartis Novavax Oncorus PDS Biotechnology Pfizer Regeneron Pharmaceuticals Roche Sanofi Sensei Biotherapeutics Senti Biosciences Surface Oncology Takeda Pharmaceutical TC Biopharm ThermoGenesis Holdings UroGen Pharma Werewolf Therapeutics Xilio Therapeutics Zymeworks 8 The Global Market for Immuno-Oncology Therapeutics 8.1 Global Market Overview by Country 8.2 Global Market by Therapy 8.3 Global Market by Cancer 8.4 Global Market by Customer 9 Global Immuno-Oncology Therapy Markets - By Therapy 9.1 MAB 9.2 Cytokine 9.3 Vaccine 9.4 Cell Based 9.5 Inhibitor/Agonist 9.6 Other IO Therapy 10 Global Immuno-Oncology Therapeutic Markets - By Cancer 10.1 Breast 10.2 ColoRectal 10.3 Cervical 10.4 Lung 10.5 Precancer 10.6 Prostate 10.7 Melanoma 10.8 Blood 10.9 Other Cancer 11 Global Immuno-Oncology Therapeutic Markets - By Customer 11.1 Pharma 11.2 Clinic 11.3 Other Customer For more information about this report visit https://www.researchandmarkets.com/r/8355qg About ResearchAndMarkets.com ResearchAndMarkets.com is the world's leading source for international market research reports and market data. 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The addition of chemotherapy to Gilead's Trodelvy and Merck's Keytruda didn't appear to offer more benefit in first-line non-small cell lung cancer. Gilead Sciences has been looking for a win for Trodelvy after two surprise trial failures earlier this year. But it looks like that win won’t come from a triplet regimen that combines the antibody-drug conjugate with Merck’s Keytruda and chemotherapy in newly diagnosed non-small cell lung cancer (NSCLC)A combination of Trodelvy, Keytruda and carboplatin triggered 43.1% and 39% tumor response rates in treatment-naïve NSCLC patients with nonsquamous and squamous histologies, respectively, according to results from cohort C and D of the phase 2 EVOKE-02 trial presented at the 2024 World Conference on Lung Cancer.Nonsquamous patients who took the triplet lived a median 8.1 months without disease progression, compared with 11.1 months for squamous patients. The patients had various levels of PD-L1 expression and no actionable genomic alterations.The results are disappointing because in cohort B of the EVOKE-02 trial, Trodelvy and Keytruda—without chemo—showed a 44% response rate in front-line patients with PD-L1 tumor proportion scores (TPS) below 50% regardless of histology, according to results published last fall. In cohort A, the doublet pulled off a 67% response rate across histologies in PD-L1-high patients, according to an update in May.More than 80% of patients in cohort C and D had PD-L1 TPS scores below 50%.Bilal Piperdi, M.D., who leads oncology clinical development at Gilead, argued that the new findings from cohort C and D support the company’s phase 3 strategy. The EVOKE-03 trial, launched last year, is testing Trodelvy-Keytruda doublet in PD-L1-high first-line NSCLC.“We’re really not finding a lot of differentiation from additional chemotherapy in combination with [Trodelvy],” Piperdi said in an interview with Fierce Pharma. “So, it is giving more confidence in our current ongoing strategy with [Trodelvy plus Keytruda] with full doses of [Trodelvy].” It’s worth noting that investigators had to lower Trodelvy’s dose from the original 10 mg/kg to 7.5 mg/kg in the triplet tests after a planned safety evaluation flagged an increased risk of neutropenia. About two-thirds of patients in the efficacy analysis received the lower dose.The latest Trodelvy data also mirrored findings from a study of AstraZeneca and Daiichi Sankyo’s rival TROP2 ADC, datopotamab deruxtecan (Dato-DXd). In the early-phase TROPION-Lung02 trial, a doublet combination of Dato-DXd and Keytruda induced a 52% response rate in first-line NSCLC patients without actionable genomic alterations. The number was 56% for a triplet that also includes chemo, according to an update in May.The median PFS was 11.1 months for the AZ doublet and 6.8 months for the triplet. Researchers have attributed the lower PFS for the triplet to more patients receiving a lower dose of Dato-DXd and a higher proportion of patients with brain metastases.At the time, Leerink Partners analysts wrote in a note that the data “suggest that the addition of chemo is unwarranted.”Still, AZ’s phase 3 TROPION-Lung07 study for Dato-DXd in first-line, PD-L1-low nonsquamous NSCLC patients includes a triplet arm, and the phase 3 AVANZAR study is combining AZ’s Imfinzi with Dato-DXd and chemo also in first-line NSCLC.After Trodelvy recently failed as a monotherapy in second-line NSCLC, EVOKE-03 is the sole phase 3 study for the Gilead drug in the cancer type. In terms of the number of trials, the first-to-market TROP2 ADC is falling behind its would-be rivals. AZ/Daiichi and Merck together have a dozen global phase 3 trials running for their TROP2 candidates in various combinations and treatment settings, including in the postsurgical adjuvant setting for early-stage tumors. Piperdi suggested that Gilead is “reasonably invested” in NSCLC across the three EVOKE studies. He also pointed to Gilead’s partnership with Arcus Biosciences on the PD-1 inhibitor zimberelimab and TIGIT inhibitor domvanalimab. Gilead is pairing those two immune checkpoint inhibitors with Trodelvy in a mid-stage platform study.“We had a really nicely built program for lung cancer, and I think there’s going to be a lot of data that’s going to read out that will really help us out to where else we can push the envelope,” Piperdi said.Gilead has many options but wants to think carefully about where to place its Trodelvy investments in first-line NSCLC, he said.“I think earlier lines of treatment are even more interesting,” he said. “But we’re waiting to see how the landscape changes.”

Hercules’s loan is expected to hold Arcus up as the company continues to run at a net loss. Image: Shutterstock/ Tada Images Arcus Biosciences has announced a loan from financer Hercules Capital valued at as much as $250m, contingent on the advancement of the company’s therapeutic candidates. Arcus released the news after the markets closed yesterday (27 August), outlining an initial $50m granted at the deal’s close, with another $100m available at Arcus’s discretion. Provided Hercules Capital approves, a further $100m can be drawn. The five-year loan and four-year interest-only period may each be extended another year should Arcus initiate Phase III trials for its cancer therapies, a HIF-2α inhibitor casdatifan and the CD73 inhibitor quemlicustat, and meet regulatory milestones, respectively. The deal comes as the company continues its financial recovery. Arcus’s share price dropped from a high of $49.1 in November 2021 to $13.10 in November 2023. When the market opened today (28 August), the share price stood at $17.3; the company is valued at $1.6bn. Arcus CEO Dr. Terry Rosen said, “This non-dilutive facility enhances our already strong cash position and enables us to expand and accelerate our development program for casdatifan across multiple settings in ccRCC (clear cell renal cell carcinoma).” If approved, the HIF-2α inhibitor is projected to enter the market in 2028 potentially earning annual global revenues of $64m, increasing to $69m by 2030. Arcus plans to present data from their Phase I/Ib casdatifan trial ARC-20 (NCT05536141) later this year. See Also: AstraZeneca may pull plug on UK vaccine manufacturing plans Touchlight to supply GMP dbDNA for UK Zika vaccine study GlobalData is the parent company of Pharmaceutical Technology . The loan will contribute to the $1bn in cash reserves held by Arcus as of 30 June this year. Much of this funding comes from the company’s 10-year deal signed with Gilead Sciences in 2020. As per Arcus’s Q2 2024 report, Gilead may purchase up to 35% of Arcus stock , of which it owned 32.9% at the end of Q2 2024, and appoint three Arcus board members. Gilead has done so, and appointed Gilead CEO Johanna Mercier among others. Arcus also secured funding from other partnerships, including through an exclusive licence to quemliclustat in Asian markets , excluding China, to Taiho Pharmaceuticals. Despite this, Arcus reported net losses of $93m in Q2 2024 compared to $75m in Q2 2023. Another group of investigational drugs for the company is the checkpoint inhibitors domvanalimab and zimberelimab. Both target programmed cell death protein 1 and are being developed in non-small cell lung cancer under a collaboration between Arcus and Gilead in an active Phase III trial (NCT05502237). GlobalData estimates domvanalimab plus zimberelimab to yield $1.37bn in sales in 2030, including profit shares and royalties.