RCUS Arcus Biosciences Inc.

35.26
+1.01  (+3%)
Previous Close 34.25
Open 34.26
52 Week Low 9.85
52 Week High 42.36
Market Cap $2,289,195,699
Shares 64,923,304
Float 51,546,017
Enterprise Value $1,511,308,330
Volume 366,883
Av. Daily Volume 533,157
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Upcoming Catalysts

Drug Stage Catalyst Date
AB928, AB680 and zimberelimab - ARC-6
Metastatic castrate-resistant prostate cancer (mCRPC)
Phase 1/2
Phase 1/2
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AB154 + Zimberelimab (AB122) (ARC-7)
Non-small cell lung cancer (NSCLC)
Phase 2
Phase 2
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Etrumadenant, carboplatin, pemetrexed (ARC-4)
Non-small cell lung cancer
Phase 1/2
Phase 1/2
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AB680 +Zimberelimab (AB122) - ARC-8
Pancreatic Cancer
Phase 1
Phase 1
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Drug Pipeline

Drug Stage Notes
Domvanalimab + zimberelimab vs. zimberelimab vs. chemotherapy (ARC-10)
Non Small Cell Lung Cancer
Phase 3
Phase 3
Phase 3 trial has been initiated.
Domvanalimab (AB154) and Imfinzi (durvalumab) - PACIFIC-8
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
Phase 3 trial to commence 2H 2021.
Etrumadenant + eganelisib (IPI-549) - ARC-2
Triple negative breast cancer (TNBC) and ovarian cancer
Phase 1
Phase 1
Phase 1 initial data due presented at SABCS Annual Meeting, December 9, 2020. 2/18 response rate (partial responses - PR) for doublet regimen. 5/12 responses for triplet (1 complete response, 4 had a PR).
Etrumadenant plus mFOLFOX-6 (ARC-3)
Colorectal cancer
Phase 1
Phase 1
Phase 1 initial biomarker data presented at SITC November 9-14, 2020.
Etrumadenant (AB928) + Zimberelimab (AB122)
Solid tumors
Phase 1
Phase 1
Phase 1b trial ongoing.

Latest News

  1. - Multiple key data read-outs expected for 2021, including the ARC-7 interim analysis in 2Q21

    - Domvanalimab's advancement into a registrational study coupled with recent IND clearance for AB308, Arcus's FcR-enabled anti-TIGIT antibody, reinforces Arcus's position as a leader in the anti-TIGIT field

    - Promising early data in first-line metastatic pancreatic cancer for AB680, the first small-molecule CD73 inhibitor to enter clinical development, were presented at ASCO GI in 1Q21

    - Gilead's recent increased investment in Arcus demonstrates the strength of our ongoing collaboration and Gilead's confidence in Arcus's clinical-stage pipeline and R&D capabilities

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company…

    - Multiple key data read-outs expected for 2021, including the ARC-7 interim analysis in 2Q21

    - Domvanalimab's advancement into a registrational study coupled with recent IND clearance for AB308, Arcus's FcR-enabled anti-TIGIT antibody, reinforces Arcus's position as a leader in the anti-TIGIT field

    - Promising early data in first-line metastatic pancreatic cancer for AB680, the first small-molecule CD73 inhibitor to enter clinical development, were presented at ASCO GI in 1Q21

    - Gilead's recent increased investment in Arcus demonstrates the strength of our ongoing collaboration and Gilead's confidence in Arcus's clinical-stage pipeline and R&D capabilities

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today reported financial results for the fourth quarter and year ended December 31, 2020 and provided operational highlights.

    "With $735 million in cash at the end of the year, plus $220 million from Gilead's recent equity investment, we are extremely well-positioned to accelerate the advancement of our pipeline, initiate our first registrational trials for domvanalimab, and deliver multiple readouts from the randomized portions of our ongoing clinical studies," said Terry Rosen, Ph.D., CEO. "These readouts include the interim analysis for ARC-7, our Phase 2 randomized study evaluating domvanalimab and zimberelimab in first-line, PD-L1 high, non-small cell lung cancer, in the second quarter of 2021, as well as initial data from our randomized studies evaluating our A2a/A2b adenosine receptor antagonist, etrumadenant. In 2021, we also expect to continue to advance AB680, our CD73 inhibitor, in pancreatic cancer and to expand the clinical program for this first-in-class small molecule to other tumor types. We are also pleased to announce that we received IND clearance for AB308 in January, allowing us to achieve a new milestone with five molecules now in clinical development, and we expect to advance at least one new small molecule program into clinical development in the second half of 2021."

    Corporate and Partnership Updates

    • Announced that Gilead increased its ownership in Arcus from approximately 13.0% to 19.5%. The $220 million received from this investment will enable Arcus to accelerate the development plans for Arcus's five clinical-stage molecules.
    • Continued to advance our clinical collaboration with AstraZeneca for the conduct of PACIFIC-8, a registrational trial designed to evaluate domvanalimab and durvalumab in Stage 3 non-small cell lung cancer (NSCLC). We expect this trial to start in the second half of 2021.
    • Expanded our relationship with Wuxi Biologics and Arcus's portfolio of molecules targeting the ATP-adenosine axis through a licensing and collaboration agreement with WuXi for anti-CD39 antibodies. We expect to file an IND for an antibody from this program in 2022 and to develop it in combination with our first-in-class small molecules targeting other points of intervention in this pathway.
    • As part of our option agreement with Taiho for their development and commercialization of Arcus's molecules in Japan and other territories in Asia (excluding China), Taiho is planning to initiate clinical development of zimberelimab, our anti-PD-1 antibody, to advance assets in their portfolio. To date, Taiho has exercised its option rights to zimberelimab and etrumadenant.

    Domvanalimab (FcR-silent TIGIT antibody)

    Recent Highlights:

    • Initiated ARC-10, Arcus's first registrational trial, evaluating domvanalimab + zimberelimab vs. zimberelimab vs. chemotherapy in first-line PD-L1≥50%, locally advanced or metastatic NSCLC. This "two-in-one" study involves a single trial to support the potential approvals of both zimberelimab monotherapy and domvanalimab + zimberelimab, and the timing of the study initiation aligns well with the planned interim analysis for ARC-7 in the second quarter. We expect to initiate other registrational trials for domvanalimab later in the year.

    Upcoming Milestones:

    • Interim analysis from ARC-7, our randomized, three-arm Phase 2 trial ongoing in the U.S. and Asia, evaluating zimberelimab + domvanalimab vs. zimberelimab vs. zimberelimab + domvanalimab + etrumadenant in first-line PD-L1≥50% locally advanced or metastatic NSCLC, is expected in the second quarter of 2021, and we plan to provide a directional update on the data at that time. We expect to present data from this analysis at a medical conference in the second half of 2021.

    AB680 (CD73 inhibitor)

    Recent Highlights:

    • Presented promising preliminary data from the dose-escalation portion of ARC-8, our Phase 1/1b study evaluating AB680 in combination with zimberelimab and gemcitabine/nab-paclitaxel (G/NP) in first-line metastatic pancreatic cancer at the ASCO GI Conference in January.
      • As of the efficacy data cut-off date (DCO) of 12/9/20, 17 patients across the four dose-escalation cohorts (25mg, 50mg, 75mg and 100mg) were evaluable for response. In these patients, the objective response rate (ORR) was 41% (three confirmed partial responses (PRs), four PRs pending a second confirmatory scan). One of the confirmed PRs converted to a complete response after the DCO.
      • The confirmed ORR for Abraxane® (nab-paclitaxel), as stated in its FDA approved label for use in combination with gemcitabine, is 23%. To date, PD-1 antibodies have not shown any benefit when added to G/NP in this setting.1,2,3,4
    • Initiated enrollment of the dose-expansion portion of ARC-8 using a dosing regimen of 100mg of AB680 administered intravenously every two weeks. Due to ARC-8's rapid enrollment, we expect to open a control arm of AB680 plus G/NP by the end of this quarter, which will inform the design of a potential registrational trial. We and our investigators continue to be encouraged by the number of responses seen in ARC-8, and if data continue to look promising, we anticipate discussing these data with health authorities later in the year.
    • Nearing completion of a study with the oral formulation of AB680 in healthy volunteers. Having both oral and intravenous formulations of AB680 will give us flexibility to customize AB680's dosing regimens based upon the combination partner.
    • Initiated enrollment of our first cohort evaluating the combination of AB680 and etrumadenant. This cohort is part of our ongoing ARC-6 metastatic castrate-resistant prostate cancer (mCRPC) platform study. We also intend to evaluate AB680 + etrumadenant combinations in our ARC-9 metastatic colorectal cancer (mCRC) platform study and to evaluate other AB680 combinations in other settings and tumor types.

    Upcoming Milestones:

    • More mature data from ARC-8, including data from the dose-escalation and dose-expansion cohorts, are expected to be presented at a medical conference in the second half of 2021.

    Etrumadenant (A2a/A2b adenosine receptor antagonist)

    Recent Highlights:

    • Initiated the Stage 2 randomized portion of the etrumadenant + zimberelimab + docetaxel cohort in ARC-6, our ongoing Phase 1b/2 platform study evaluating etrumadenant-based combinations in mCRPC. Stage 2 was initiated after passing the Stage 1 futility assessment and is evaluating etrumadenant + zimberelimab + docetaxel vs. a docetaxel control arm.
    • Initiated ARC-9, a randomized Phase 1b/2 platform study to evaluate etrumadenant in combination with other agents in 2L+ mCRC based on intriguing durability and response data, particularly those in late-line mCRC patients, from the ARC-3 study.

    Upcoming Milestones:

    • Updated data from ARC-3, including overall survival and progression-free survival data for the 3L+ mCRC cohort, will be presented at the American Association for Cancer Research (AACR) Virtual Meeting being held April 10-15, 2021 (week 1) and May 17-21, 2021 (week 2).
    • Initial data from Stage 1 of ARC-6 are expected to be presented in the second quarter of 2021. These data will be from the etrumadenant + zimberelimab + docetaxel cohort in 2L mCRPC in patients that failed androgen deprivation therapy. Initial data from the Stage 2 randomized portion, which compares this etrumadenant combination to docetaxel, are expected to be presented in the second half of 2021.
    • Initial randomized data from ARC-4, our ongoing study evaluating etrumadenant + zimberelimab + chemotherapy vs. zimberelimab + chemotherapy in EGFRmut tyrosine kinase inhibitor (TKI)-relapsed and refractory NSCLC, are expected to be presented at a medical conference in the second half of 2021.

    Other Programs

    • Received IND clearance for AB308, Arcus's FcR-enabled anti-TIGIT antibody, in January. We plan to evaluate AB308 in settings where the depletion of TIGIT-bearing cancer cells could be beneficial, such as certain hematological malignancies.
      • Our Phase 1/1b dose-escalation study for AB308, which will leverage Arcus's anti-TIGIT antibody development experience, is designed to quickly establish the safety, pharmacokinetics and pharmacodynamics of AB308 in combination with zimberelimab and could enable the advancement of AB308 into a registrational trial by year-end 2021.
    • Initiation of clinical development for our HIF-2a inhibitor is anticipated in the second half of 2021.

    Financial Results for the Fourth Quarter and Full Year Ended December 31, 2020

    • Cash, cash equivalents and investments were $735.1 million as of December 31, 2020, compared to $188.3 million at December 31, 2019. After December 31, 2020, Arcus received an additional $220.4 million in proceeds from the sale of equity to Gilead. The increase from December 31, 2019 to December 31, 2020 was primarily due to net proceeds of $326.2 million from the May 2020 public equity offering and $375 million received upon closing of the Gilead agreements, partially offset by cash utilized for our operations. We expect cash, cash equivalents and investments on-hand to be sufficient to fund operations at least through 2023.
    • Revenues: Collaboration and license revenues were $9.5 million for the three months ended December 31, 2020, compared to $9.8 million for the same period in 2019. The revenues in 2020 were comprised of $7.7 million from our Gilead collaboration and $1.8 million from our Taiho agreement for both partners' ongoing rights to access our research and development pipeline. The revenues in 2019 were solely from our Taiho agreement and related to $8.0 million for Taiho's exercise of its option for rights to zimberelimab as well as $1.8 million for Taiho's ongoing rights to access our research and development pipeline. Collaboration and license revenues were $77.5 million for the full year ended December 31, 2020, compared to $15.0 million for the same period in 2019.
    • R&D Expenses: Research and development expenses were $48.7 million for the three months ended December 31, 2020, compared to $20.7 million for the same period in 2019. The increase was primarily due to increases in manufacturing and clinical costs required to supply and conduct our ongoing clinical studies, as well as increases in employee compensation costs driven by an increase in our headcount, approximately $2.6 million of which consists of non-cash stock-based compensation. Research and development expenses were $159.3 million for the full year ended December 31, 2020, compared to $78.5 million for the same period in 2019.
    • G&A Expenses: General and administrative expenses were $12.8 million for the three months ended December 31, 2020, compared to $6.6 million for the same period in 2019. The increase in expense was due to increases in employee compensation driven by an increase in headcount, approximately $2.9 million of which consists of non-cash stock-based compensation costs. Additional increases in legal and accounting expenses resulted from ongoing public company compliance obligations. General and administrative expenses were $42.4 million for the full year ended December 31, 2020, compared to $25.2 million for the same period in 2019.
    • Net Loss: Net loss was $51.9 million for the three months ended December 31, 2020, compared to a net loss of $16.6 million for the same period in the prior year. The increase in net loss was primarily attributable to an increase in operating expenses as noted above. Net loss for the full year ended December 31, 2020 was $122.9 million, compared to $84.7 million for the same period in 2019.

    Arcus Clinical Trials Referenced Above

    Trial Name

    Arms

    Setting

    Status

    NCT No.

    ARC-3

    Etruma + mFOLFOX

    CRC

    Initial Study

    NCT03720678

    ARC-4

    Etruma + Zim + Carbo/Pem vs. Zim + Carbo/Pem

    TKI R/R EGFRmut NSCLC

    Ongoing Randomized Phase 1/2

    NCT03846310

    ARC-6

    Etruma + Zim + SOC vs. SOC

    2L/3L CRPC

    Ongoing Randomized Phase 2

    NCT04381832

    ARC-7

    Zim vs. Zim + Dom vs. Zim + Dom + Etruma

    1L NSCLC (PD-L1 ≥ 50%)

    Ongoing Randomized Phase 2

    NCT04262856

    ARC-8

    AB680 + Zim + Gem/NP vs. AB680 + Gem/NP*

    1L PDAC

    Ongoing Randomized Phase 1/1b

    NCT04104672

    ARC-9

    Etruma + Zim + mFOLFOX vs. SOC

    2L/3L/3L+ CRC

    Initiated Randomized Phase 2

    NCT04660812

    ARC-10

    Chemo vs. Zim mono vs. Zim + Dom

    1L NSCLC (PD-L1 ≥ 50%)

    Initiated Registrational

    NCT04736173

    PACIFIC-8

    Durva ± Dom

    Curative-Intent Stage 3 NSCLC

    Expected initiation 2H21 Registrational

    NA

    CRC: colorectal cancer, NSCLC: non-small cell lung carcinoma, CRPC: castrate-resistant prostate cancer, PDAC: pancreatic ductal adenocarcinoma

    *Randomization is expected to open by end of 1Q21.

    1. Von Hoff DD, et al., N Eng J Med. 2013; 369(18):1691.

    2. https://packageinserts.bms.com/pi/pi_abraxane.pdf

    3. Weiss GJ, et al., Invest New Drugs. 2018; 36(1):96.

    4. Zev A., et al., Clin Cancer Res. 2020; 26(18): 4814.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has five molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, and pancreatic cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1 ≥ 50% metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus etrumadenant with zimberelimab. In addition, domvanalimab has advanced into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab + domvanalimab and a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage 3 NSCLC setting. AB308, an anti-TIGIT antibody that is FcR-enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, was in-licensed to enable the development of Arcus's combination regimens and is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements. All statements regarding events or results to occur in the future contained herein, including, but not limited to, Arcus's expectations for the company and its ability to advance, expand and accelerate the progress of its pipeline and clinical development programs, anticipated milestones and associated timelines and Arcus's expectation that cash, cash equivalents and investments on-hand to be sufficient to fund operations through at least 2023 are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: the inherent uncertainty associated with the COVID-19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; our dependence on our collaboration with Gilead for the successful development and commercialization of our investigational products; the inherent uncertainty associated with pharmaceutical product development and clinical trials; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; the emergence of adverse events or other undesirable side effects; risks associated with preliminary and interim data; and changes in the competitive landscape for our programs. Risks and uncertainties facing Arcus are described more fully in Arcus's annual report on Form 10-K for the year ended December 31, 2020 filed on February 24, 2021 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

    The Arcus name and logo are trademarks of Arcus. All other trademarks belong to their respective owners.

    Source: Arcus Biosciences

    ARCUS BIOSCIENCES, INC.

    Consolidated Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)

     

     

     

    (Unaudited)

     

     

     

     

     

     

     

     

    Three Months Ended

     

    Year Ended

     

     

    December 31,

     

    December 31,

     

     

    2020

     

    2019

     

    2020

     

    2019

    Revenues:

     

     

     

     

     

     

     

     

     

     

     

     

    License revenue

     

    $

    -

     

     

    $

    8,000

     

     

    $

    55,096

     

     

    $

    8,000

     

    Collaboration revenue

     

     

    9,487

     

     

     

    1,750

     

     

     

    22,421

     

     

     

    7,000

     

    Collaboration and license revenue

     

     

    9,487

     

     

     

    9,750

     

     

     

    77,517

     

     

     

    15,000

     

    Operating expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

     

    48,712

     

     

     

    20,686

     

     

     

    159,348

     

     

     

    78,481

     

    General and administrative

     

     

    12,787

     

     

     

    6,591

     

     

     

    42,404

     

     

     

    25,228

     

    Total operating expenses

     

     

    61,499

     

     

     

    27,277

     

     

     

    201,752

     

     

     

    103,709

     

    Income (loss) from operations

     

     

    (52,012

    )

     

     

    (17,527

    )

     

     

    (124,235

    )

     

     

    (88,709

    )

    Non-operating income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

    Interest and other income, net

     

     

    159

     

     

     

    929

     

     

     

    1,377

     

     

     

    5,201

     

    Gain on deemed sale from equity method investee

     

     

    -

     

     

     

    -

     

     

     

    613

     

     

     

    -

     

    Share of loss from equity method investee

     

     

    -

     

     

     

    -

     

     

     

    (613

    )

     

     

    (1,202

    )

    Total non-operating income, net

     

     

    159

     

     

     

    929

     

     

     

    1,377

     

     

     

    3,999

     

    Net income (loss)

     

     

    (51,853

    )

     

     

    (16,598

    )

     

     

    (122,858

    )

     

     

    (84,710

    )

    Other comprehensive income (loss)

     

     

    (37

    )

     

     

    11

     

     

     

    (20

    )

     

     

    171

     

    Comprehensive loss

     

    $

    (51,890

    )

     

    $

    (16,587

    )

     

    $

    (122,878

    )

     

    $

    (84,539

    )

    Net income loss per share, basic and diluted

     

    $

    (0.82

    )

     

    $

    (0.38

    )

     

    $

    (2.24

    )

     

    $

    (1.93

    )

    Weighted-average number of shares used to

    compute basic and diluted net loss per share

     

     

    63,527,932

     

     

     

    44,056,407

     

     

     

    54,787,118

     

     

     

    43,825,991

     

    Selected Consolidated Balance Sheet Data

    (In thousands)

     

     

     

    December 31,

     

     

    December 31,

     

     

     

    2020

     

     

    2019

     

    Cash, cash equivalents and investments in marketable securities

     

    $

    735,086

     

     

    $

    188,270

     

    Total assets

     

     

    772,292

     

     

     

    203,110

     

    Total liabilities

     

     

    269,988

     

     

     

    39,268

     

    Total stockholders' equity

     

     

    502,304

     

     

     

    163,842

     

     

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  2. Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the following upcoming 2021 virtual investor conferences:

    • 10th Annual SVB Leerink Global Healthcare Conference, Friday, February 26 at 12:00 pm ET
    • Cowen 41st Annual Health Care Conference, Tuesday, March 2 at 11:10 am ET
    • Barclays Global Healthcare Conference, Wednesday, March 10 at 1:15 pm ET

    A live audio webcast of each presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of each webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences…

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that management will present at the following upcoming 2021 virtual investor conferences:

    • 10th Annual SVB Leerink Global Healthcare Conference, Friday, February 26 at 12:00 pm ET
    • Cowen 41st Annual Health Care Conference, Tuesday, March 2 at 11:10 am ET
    • Barclays Global Healthcare Conference, Wednesday, March 10 at 1:15 pm ET

    A live audio webcast of each presentation will be available by visiting the "Investors" section of the Arcus website at www.arcusbio.com. A replay of each webcast will be available for at least two weeks following the live event.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1-high metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus AB928 with zimberelimab. In addition, domvanalimab is advancing into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab + domvanalimab and a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage III NSCLC setting. AB308, an anti-TIGIT antibody that is FcR enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, was in-licensed to enable the development of Arcus's combination regimens and is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Source: Arcus Biosciences

    View Full Article Hide Full Article
  3. - Gilead to purchase additional shares in Arcus, increasing its ownership to 19.5%, further aligning the two companies

    - Proceeds of $220 million to support and accelerate Arcus's comprehensive clinical development plans

    - Increase in ownership does not impact any other terms of the existing Arcus-Gilead alliance agreement, including those relating to the opt-ins, R&D sharing or future economic or commercial rights

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that Gilead Sciences is increasing its ownership in Arcus to 19.5%, from approximately 13%, by purchasing 5,650,000 additional shares of Arcus's common stock at a per share purchase…

    - Gilead to purchase additional shares in Arcus, increasing its ownership to 19.5%, further aligning the two companies

    - Proceeds of $220 million to support and accelerate Arcus's comprehensive clinical development plans

    - Increase in ownership does not impact any other terms of the existing Arcus-Gilead alliance agreement, including those relating to the opt-ins, R&D sharing or future economic or commercial rights

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that Gilead Sciences is increasing its ownership in Arcus to 19.5%, from approximately 13%, by purchasing 5,650,000 additional shares of Arcus's common stock at a per share purchase price of $39.00.

    "Gilead's additional investment in Arcus demonstrates the strength of our relationship, a recognition of the depth of our pipeline and our shared commitment to bringing innovative, transformative therapies to cancer patients as quickly as possible," said Terry Rosen, Ph.D., Chief Executive Officer of Arcus. "The proceeds from this financing will support and enable the acceleration of our development plans for our four clinical-stage molecules, including AB680, our small molecule CD73 inhibitor, for which we recently presented encouraging data in first-line metastatic pancreatic cancer. We appreciate Gilead's continued confidence in Arcus and our ability to execute. We look forward to providing a multitude of data readouts across our entire portfolio of clinical molecules, including the ARC-7 study interim analysis for domvanalimab expected in the second quarter, throughout what we expect will be a transformational year for the company."

    The Arcus-Gilead partnership, which closed in July 2020, includes an Option, License and Collaboration Agreement, a Common Stock Purchase Agreement, and an Investor Rights Agreement. Collectively, this transaction established a 10-year partnership to co-develop and co-commercialize next-generation cancer immunotherapies, provided for an initial equity investment and upfront payment to Arcus totaling $375 million, and gave Gilead the right, but not the obligation, to make additional equity investments in Arcus by purchasing additional shares of Arcus's common stock. Arcus and Gilead entered into an amended and restated Common Stock Purchase Agreement to provide for this purchase of 5,650,000 additional shares of Arcus's common stock. No other agreements or terms were amended. Following this investment, Arcus expects its cash and investments to fund its operations through at least 2023.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1-high metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus AB928 with zimberelimab. In addition, domvanalimab is advancing into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab + domvanalimab and a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage III NSCLC setting. AB308, an anti-TIGIT antibody that is FcR enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, was in-licensed to enable the development of Arcus's combination regimens and is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Forward-Looking Statements

    This press release contains forward‐looking statements. All statements regarding events or results that may occur in the future contained herein, including, but not limited to, the expected benefits of this transaction, Arcus's ability to provide a multitude of data readouts, including the ARC‐7 interim analysis, throughout the year and Arcus's expectation that its cash and investments can fund operations through at least 2023, are forward‐looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward‐looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: the closing of Gilead's stock purchase is subject to satisfaction of customary closing conditions, which, if they do not occur, could prevent or delay Gilead's purchase of Arcus comment stock, Arcus's dependence on its collaboration with Gilead for the successful development and commercialization of its investigational products; the inherent uncertainty associated with pharmaceutical product development and clinical trials; the inherent uncertainty associated with the COVID‐19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; risks associated with preliminary and interim data; the emergence of adverse events or other undesirable side effects; delays in Arcus's clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; and changes in the competitive landscape for Arcus's programs. Risks and uncertainties facing Arcus are described more fully in Arcus's quarterly report on Form 10‐Q for the quarter ended September 30, 2020 filed on November 5, 2020 with the SEC, particularly under the caption "Risk Factors". You are cautioned not to place undue reliance on the forward‐looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward‐looking statements contained in this press release.

    Source: Arcus Biosciences

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  4. - 41% objective response rate (ORR) observed to-date across first four cohorts in the Phase 1 dose-escalation portion of ARC-8, comparing favorably to the current standard-of-care

    - Initiated Phase 1b expansion portion of study

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today presented preliminary data from the dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in metastatic pancreatic cancer at the ASCO 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI).

    The ongoing, open-label, multicenter trial is a Phase 1/1b study evaluating…

    - 41% objective response rate (ORR) observed to-date across first four cohorts in the Phase 1 dose-escalation portion of ARC-8, comparing favorably to the current standard-of-care

    - Initiated Phase 1b expansion portion of study

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today presented preliminary data from the dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in metastatic pancreatic cancer at the ASCO 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI).

    The ongoing, open-label, multicenter trial is a Phase 1/1b study evaluating the safety profile and clinical activity of AB680 in combination with nab-paclitaxel plus gemcitabine (NP/Gem) and zimberelimab, an anti-PD-1 antibody, as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC).

    • Preliminary Safety Results (as of the safety DCO of Nov. 11th 2020)
      • 19 patients had received AB680 plus NP/Gem plus zimberelimab at doses of AB680 ranging from 25 to 100 mg, administered once every two weeks.
      • Across all four dose-escalation cohorts, no significant additive toxicity from AB680 plus NP/Gem plus zimberelimab has been observed beyond that expected from NP/Gem plus anti-PD-1 combined.
        • One dose-limiting toxicity (Grade 2 autoimmune hepatitis) occurred in the 50mg AB680 cohort; the event resolved completely with steroid treatment, and the patient resumed study treatment, including immunotherapy, without subsequent autoimmune events.
        • The most common treatment emergent adverse events (AE) were fatigue (68%), anemia (53%), alopecia (42%), diarrhea (42%) and neutrophil count decrease (42%). These AE results are very similar to what would be expected with NP/Gem alone.
      • Since the safety DCO, no additional dose-limiting toxicities have been reported.
    • Preliminary Efficacy Results (as of the efficacy DCO of Dec. 9th 2020)
      • 17 out of 19 patients enrolled in the Phase 1 dose-escalation portion of the study were evaluable for response, and 16 of the evaluable patients remained on active treatment at the time of the efficacy DCO.
      • 88% (15/17) of patients experienced at least some shrinkage of their lesions.
      • 41% ORR (7/17) was observed for the AB680 combination across all dose-escalation cohorts, including one patient who converted to a complete response for both target and non-target lesions since the efficacy DCO.
        • Of the partial responses (PRs), 3 are confirmed responses and of the 4 unconfirmed responders, 3 responded at the first tumor assessment and the fourth responded at the second tumor assessment, and all remain on study.
      • For patients that had been on drug for more than 16 weeks, an 85% disease control rate (11/13) was achieved with the AB680 combination.
      • Treatment benefit appears durable; of the evaluable patients from the first three dose-escalation cohorts, 10 of 12 (83%) continue on treatment with a median time on treatment of 180 days.
      • The last drug to be approved in the first-line metastatic pancreatic cancer setting is Abraxane® (nab-paclitaxel). As stated in the FDA approved label for Abraxane® (nab-paclitaxel) for use in combination with gemcitabine in first-line metastatic pancreatic cancer:
        • The ORR from the registrational Phase 3 study was 23%.1,2
        • A 48% DCR (>16 weeks) was achieved in the registrational Phase 3 study.

    "Based on the results to date, 100mg of AB680 every two weeks has been selected as the dose for the Phase 1b expansion portion of the trial. Given the lack of toxicity observed from the addition of AB680 to chemotherapy and anti-PD-1 therapy to date, we are also evaluating a 125mg every two weeks cohort," said Bill Grossman, MD, PhD, Chief Medical Officer of Arcus. "We believe that AB680 has the potential to represent the first meaningful advancement for the treatment of pancreatic cancer since Abraxane was approved in 2013. Assuming AB680 continues to show encouraging clinical activity in the ongoing expansion portion of the trial, we expect to open a randomized control arm in ARC-8 shortly."

    "I am encouraged by the emerging safety and efficacy data from this AB680-based novel therapeutic regimen in my patients," said Johanna Bendell, MD, Chief Development Officer and Director, Drug Development Unit Nashville, Sarah Cannon Research Institute at Tennessee Oncology. "The initial response rate is promising, and thus far there has not been significant additive toxicity from AB680 to chemotherapy. There is a need for advances in the treatment of metastatic pancreatic cancer, and this unique molecule has the potential to improve outcomes for patients with this difficult-to-treat disease. I look forward to continuing to work closely with the Arcus team to further evaluate the role of AB680."

    Even with recent advancements in cancer therapies, such as anti-PD-1 antibodies, additional clinical benefit over NP/Gem alone has not been demonstrated in pancreatic cancer. Overall, PDAC has a 5-year survival rate of less than 10%,1,3 and high expression of CD73 has been shown to be associated with poor prognosis.4 One hypothesis is that the presence of high adenosine levels in the tumor impairs the ability of the highly immunogenic standard-of-care chemotherapeutic regimen to generate a full T cell response. Therefore, blockade of adenosine generation by inhibiting CD73 may restore this immune response, which may be further enhanced by the addition of anti-PD-1 therapy.

    Arcus expects to report more mature data from the Phase 1/1b portions of ARC-8, including data on progression-free survival, at medical conferences later this year.

    Additional information about the data may be found in the poster presented at ASCO GI, which is located on the Arcus website at Arcus Publications.

    Pancreatic Cancer

    Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States1 and the seventh leading cause of cancer-related deaths worldwide3.

    Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent neoplastic disease of the pancreas, with high metastatic potential, accounting for more than 90% of all pancreatic malignancies and is a highly devastating disease with poor prognosis and rising incidence.5,6

    Few treatment options exist for metastatic pancreatic cancer, and response rates to the standard of care therapy of gemcitabine/nab-paclitaxel remain very low. Based on the FDA approved label for nab-paclitaxel in combination with gemcitabine, the phase 3 registrational trial demonstrated objective and complete response rates in patients with metastatic pancreatic cancer that were 23% and <1%, respectively.1,2

    To date, addition of anti-PD-1 antibodies to gemcitabine/nab-paclitaxel in controlled clinical trials in this setting has shown no added benefit when compared to that obtained with the chemotherapy alone.7,8

    About ARC-8 Study

    ARC-8 is a Phase 1/1b study to evaluate safety and tolerability of AB680 + zimberelimab (AB122) + chemotherapy in patients with treatment-naive metastatic pancreatic adenocarcinoma.

    For additional information on this trial (NCT04104672), please visit www.clinicaltrials.gov.

    About AB680

    AB680 is an extremely potent and selective small-molecule CD73 inhibitor designed to provide differential benefits relative to monoclonal antibodies, such as greater inhibition of CD73 enzymatic activity (both soluble and cell-bound) and deeper tumor penetration. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types, including pancreatic cancer.4 By effectively eliminating CD73-derived adenosine, AB680 may improve the efficacy of treatment approaches expected to elicit anti-cancer immune responses (e.g., platinum-based chemotherapy with/without anti-PD-1 therapy). AB680 was the first small-molecule CD73 inhibitor to enter the clinic and demonstrated a favorable safety profile with a long half-life in a healthy volunteer study. AB680 is currently in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first dual A2a/A2b adenosine receptor antagonist to enter the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1-high metastatic non-small cell lung cancer (NSCLC) evaluating zimberelimab monotherapy, domvanalimab with zimberelimab and domvanalimab plus AB928 with zimberelimab. In addition, domvanalimab is advancing into ARC-10, Arcus's "two in one trial" to support the potential approvals of both zimberelimab and zimberelimab + domvanalimab and a registrational study, in collaboration with AstraZeneca, evaluating the curative-intent stage III NSCLC setting. AB308, an anti-TIGIT antibody that is FcR enabled, is advancing into clinical development to investigate additional indications, with a focus on hematological malignancies. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, was in-licensed to enable the development of Arcus's combination regimens and is being evaluated in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including, but not limited to, the potential benefit of AB680 combination therapy for patients with pancreatic cancer, Arcus's development plans for AB680 and the progress and anticipated milestones from the ARC-8 study, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: the inherent uncertainty associated with pharmaceutical product development and clinical trials; risks associated with preliminary and interim data; the emergence of adverse events or other undesirable side effects; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; the inherent uncertainty associated with the COVID-19 pandemic, including the duration and/or severity of the outbreak and actions by government authorities to contain or slow the spread of the virus; and changes in the competitive landscape for our programs. Risks and uncertainties facing Arcus are described more fully in Arcus's quarterly report on Form 10-Q for the quarter ended September 30, 2020 filed on November 5, 2020 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

    The Arcus name and logo are trademarks of Arcus. All other trademarks belong to their respective owners.

    References

    1. Von Hoff DD, et al., N Eng J Med. 2013; 369(18):1691.

    2. https://packageinserts.bms.com/pi/pi_abraxane.pdf

    3. Rawla P, Sunkara T, and Gaduputi V., World J Oncol. 2019; 10(1):10.

    4. Zhou L, et al., J Mol Med (Berl). 2019;97(6):803.

    5. Kleeff J, et al., Nat Rev Dis Primers. 2016; 2:16022.

    6. Orth M, et al., Radiat Oncol. 2019; 14(1):141.

    7. Weiss GJ, et al., Invest New Drugs. 2018; 36(1):96.

    8. Zev A., et al., Clin Cancer Res. 2020; 26(18): 4814.

    Source: Arcus Biosciences

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  5. - Preliminary data from the first dose-escalation cohorts, reported in an abstract released today, demonstrate encouraging signs of clinical activity for AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy

    - Additional data, as of a cut-off date of December 9, 2020, to be presented at ASCO-GI on January 15th

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that preliminary data from the ongoing dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab (anti-PD-1) and nab-paclitaxel…

    - Preliminary data from the first dose-escalation cohorts, reported in an abstract released today, demonstrate encouraging signs of clinical activity for AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy

    - Additional data, as of a cut-off date of December 9, 2020, to be presented at ASCO-GI on January 15th

    Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that preliminary data from the ongoing dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in combination with zimberelimab (anti-PD-1) and nab-paclitaxel plus gemcitabine (chemotherapy) in front-line metastatic pancreatic cancer will be presented in a poster session at the ASCO 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI) being held January 15th – 17th, 2021.

    "While recent cancer breakthrough therapies, most notably anti-PD-1 antibodies, have led to dramatic improvements in outcomes in many cancer settings, this is not the case for pancreatic cancer, which remains a devastating diagnosis for patients. We are highly encouraged by the preliminary data from our Phase 1 trial for AB680 in combination with anti-PD-1 therapy and chemotherapy, in which we have seen promising clinical activity in these difficult to treat patients. Importantly, this experimental regimen has been well tolerated, and early safety data indicate that this AB680 combination regimen appears to have a side effect profile similar to that of anti-PD-1 therapy and chemotherapy," said Bill Grossman, M.D., the Chief Medical Officer of Arcus. "We look forward to presenting updated data from the Phase 1 portion of this trial at ASCO GI on January 15th, wherein we will report more mature safety and clinical response data, including those from the 100mg dose cohort."

    The clinical activity and safety profile observed to date with AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy support its recent advancement into the ongoing Phase 1b expansion portion of the study, as well as plans to open a randomized control arm for the Phase 1b expansion. Dosing of AB680 100mg I.V. every two weeks has been selected for this portion of the study.

    Full details of the presentation are as follows:

    Abstract/Poster Title: ARC-8: Phase I/Ib study to evaluate safety and tolerability of AB680 + chemotherapy + zimberelimab (AB122) in patients with treatment-naive metastatic pancreatic adenocarcinoma (mPDAC)

    Abstract No: 404

    Poster Session: Pancreatic Cancer

    Available Date: January 15, 2021

    Time: 5:00 a.m. PT

    In addition to the presentation on AB680, Arcus will also highlight the design of the recently initiated ARC-9 randomized Phase 2 study to advance etrumadenant in late-line colorectal cancer:

    Abstract/Poster Title: ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC)

    Abstract No: TPS150

    Trials in Progress Poster Session: Colorectal Cancer

    Available Date: January 15, 2021

    Time: 5:00 a.m. PT

    Pancreatic Cancer

    Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States1 and the seventh leading cause of cancer-related deaths worldwide2.

    Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent neoplastic disease of the pancreas, with high metastatic potential, accounting for more than 90% of all pancreatic malignancies and is a highly devastating disease with poor prognosis and rising incidence.3,4

    Few treatment options exist for metastatic pancreatic cancer, and response rates to the standard of care therapy of gemcitabine/nab-paclitaxel remain very low. Based on the FDA approved label for nab-paclitaxel in combination with gemcitabine, the phase 3 registrational trial demonstrated overall and complete response rates in patients with metastatic pancreatic cancer that were 23% and <1%, respectively. 1,5

    To date, addition of anti-PD-1 antibodies to gemcitabine/nab-paclitaxel in controlled clinical trials in this setting has shown no added benefit when compared to that obtained with the chemotherapy alone.6,7

    About ARC-8 Study

    ARC-8 is a Phase 1/1b study to evaluate safety and tolerability of AB680 + zimberelimab (AB122) + chemotherapy in patients with treatment-naive metastatic pancreatic adenocarcinoma.

    For additional information on this trial (NCT04104672), please visit www.clinicaltrials.gov.

    About AB680

    AB680 is an extremely potent and selective small-molecule CD73 inhibitor designed to provide differential benefits relative to monoclonal antibodies, such as greater inhibition of CD73 enzymatic activity (both soluble and cell-bound) and deeper tumor penetration. CD73 is the primary enzymatic producer of immunosuppressive adenosine in the tumor microenvironment, and high CD73 expression is associated with significantly poorer prognosis in several tumor types, including pancreatic cancer. 8 By effectively eliminating CD73-derived adenosine, AB680 may improve the efficacy of treatment approaches expected to elicit anti-cancer immune responses (e.g., platinum-based chemotherapy with/without anti-PD-1 therapy). AB680 was the first small-molecule CD73 inhibitor to enter the clinic and demonstrated a favorable safety profile with a long half-life in a healthy volunteer study. AB680 is currently in a Phase 1/1b study for the treatment of first-line metastatic pancreatic cancer.

    About Arcus Biosciences

    Arcus Biosciences is an oncology-focused biopharmaceutical company leveraging its deep cross-disciplinary expertise to discover highly differentiated therapies and to develop a broad portfolio of novel combinations addressing significant unmet needs. Arcus currently has four molecules in clinical development: Etrumadenant (AB928), the first and only dual A2a/A2b adenosine receptor antagonist in the clinic, is being evaluated in multiple Phase 2 and 1b studies across different indications, including prostate, colorectal, non-small cell lung, pancreatic and triple-negative breast cancers. AB680, the first small-molecule CD73 inhibitor to enter the clinic, is in Phase 1/1b development for first-line treatment of metastatic pancreatic cancer in combination with zimberelimab and gemcitabine/nab-paclitaxel. Domvanalimab (AB154), an anti-TIGIT monoclonal antibody and new potential immuno-oncology backbone therapy, is in a three-arm randomized Phase 2 study for first-line treatment of PD-L1-high metastatic non-small cell lung cancer evaluating zimberelimab monotherapy, AB154 with zimberelimab and AB154 plus AB928 with zimberelimab. Zimberelimab (AB122), Arcus's anti-PD-1 monoclonal antibody, is also being evaluated in a Phase 1b study as monotherapy for cancers with no approved anti-PD-1 treatment options, and in various combinations across the portfolio. For more information about Arcus Biosciences, please visit www.arcusbio.com.

    Forward-Looking Statements

    This press release contains forward-looking statements. All statements other than statements of historical facts contained herein, including, but not limited to, Arcus's development plans for AB680, are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Arcus's actual results, performance or achievements to differ significantly from those expressed or implied. Factors that could cause or contribute to such differences include, but are not limited to: risks associated with preliminary and interim data; the emergence of adverse events or other undesirable side effects; delays in our clinical trials due to difficulties or delays in the regulatory process, enrolling subjects or manufacturing or supplying product for such clinical trials; and the inherent uncertainty associated with pharmaceutical product development and clinical trials. Risks and uncertainties facing Arcus are described more fully in Arcus's quarterly report on Form 10-Q for the quarter ended September 30, 2020 filed on November 5, 2020 with the SEC. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Arcus disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.

    The Arcus name and logo are trademarks of Arcus. All other trademarks belong to their respective owners.

    References

    1. Von Hoff DD, et al., N Eng J Med. 2013; 369(18):1691.

    2. Rawla P, Sunkara T, and Gaduputi V., World J Oncol. 2019; 10(1):10.

    3. Kleeff J, et al., Nat Rev Dis Primers. 2016; 2:16022.

    4. Orth M, et al., Radiat Oncol. 2019; 14(1):141.

    5. https://packageinserts.bms.com/pi/pi_abraxane.pdf

    6. Weiss GJ, et al., Invest New Drugs. 2018; 36(1):96.

    7. Zev A., et al., Clin Cancer Res. 2020; 26(18): 4814.

    8. Zhou L, et al., J Mol Med (Berl). 2019;97(6):803.

    Source: Arcus Biosciences

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