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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 4, 2017

 

 

CORVUS PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

     
Delaware 001-37719 46-4670809

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification Number)

 

863 Mitten Road, Suite 102
Burlingame, CA 94010
(Address of principal executive offices, including Zip Code)

 

Registrant’s telephone number, including area code: (650) 900-4520

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

¨Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 

 

 
 

 

Item 8.01Other Events.

 

On April 4, 2017, Corvus Pharmaceuticals, Inc. (“Corvus” or the “Company”) issued a press release announcing interim safety and efficacy results from its ongoing Phase 1/1b study demonstrating safety and clinical activity of lead checkpoint inhibitor CPI-444 in patients with advanced cancers. The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.

 

Item 7.01Regulation FD Disclosure.

 

On April 4, 2017, the interim data discussed above was presented in an oral plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C., by Leisha Ann Emens, M.D., Ph.D., study investigator and associate professor of oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center. A copy of the presentation, including a slide setting forth certain cautionary language intended to qualify the forward-looking statements included in the presentation, is furnished as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

 

The information in this Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01Financial Statements and Exhibits.

 

Reference is made to the Exhibit Index attached hereto.

 

 

 

 

 

 
 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  CORVUS PHARMACEUTICALS, INC.
       
Date: April 4, 2017 By: /s/ Leiv Lea  
    Leiv Lea  
    Chief Financial Officer 

 

 

 

 

 

 

 

 

 

 

 
 

 

EXHIBIT INDEX

 

 

Exhibit No.   Description
99.1   Press release titled, “Corvus Pharmaceuticals Announces Interim Results from Ongoing Phase 1/1b Study Demonstrating Safety and Clinical Activity of Lead Checkpoint Inhibitor CPI-444 in Patients with Advanced Cancers” dated April 4, 2017.
99.2   Presentation by Leisha Ann Emens, M.D., Ph.D., study investigator and associate professor of oncology at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, at AACR Annual Meeting 2017 on April 4, 2017.

 

 

 

 

 

 

 

 

 

 

 

EdgarFiling

EXHIBIT 99.1

Corvus Pharmaceuticals Announces Interim Results from Ongoing Phase 1/1b Study Demonstrating Safety and Clinical Activity of Lead Checkpoint Inhibitor CPI-444 in Patients with Advanced Cancers

– Clinical Data Presented in Oral Plenary Session at
American Association for Cancer Research (AACR) Annual Meeting 2017 –

– Data Supports Expansion of Three Additional Cohorts in Non-small Cell Lung Cancer Treated with Single Agent CPI-444, Renal Cell Cancer and Non-small Cell Lung Cancer Treated with CPI-444 in Combination with Atezolizumab –

 – Additional CPI-444 Data and Preclinical Data on Corvus’ Anti-CD73 Monoclonal Antibody
to be Presented in Poster Sessions –

BURLINGAME, Calif., April 04, 2017 (GLOBE NEWSWIRE) -- Corvus Pharmaceuticals, Inc. (NASDAQ:CRVS), a clinical-stage biopharmaceutical company focused on the development and commercialization of novel immuno-oncology therapies, today announced interim safety and efficacy results from its ongoing Phase 1/1b study. The data showed that treatment with CPI-444 as a single agent and in combination with atezolizumab (Tecentriq®) was well tolerated and resulted in anti-tumor activity in patients with multiple types of advanced solid tumors, including those resistant or refractory to prior treatment with anti-PD-1 or anti-PD-L1 antibodies. CPI-444 is a selective and potent inhibitor of the adenosine A2A receptor. Atezolizumab, developed by Genentech, a member of the Roche Group, is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1).

The interim data were presented today in an oral plenary session at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, D.C., by Leisha Ann Emens, M.D., Ph.D., study investigator and associate professor of oncology at the Johns Hopkins Sidney Kimmel Comprehensive Cancer Center.

“The data obtained to date are the first report of clinical activity of adenosine receptor blockade in cancer and indicate that CPI-444 provides disease control and induces tumor regression in a number of patients with extensive disease in several tumor types, many of whom are resistant/refractory to prior therapy with an anti-PD-(L)1 antibody,” said Richard A. Miller, an oncologist and co-founder, president and chief executive officer of Corvus. “In addition to the previously announced expansion of the single-agent renal cell cancer cohort, we have expanded three more cohorts -- the single agent non-small cell lung cancer patient cohort as well as the renal cell and non-small cell lung cancer patient cohorts treated with the combination therapy.”

Interim safety data on 113 patients and efficacy data for 96 patients enrolled in the study were presented at the AACR conference. Patients with the following histologies were enrolled: 28% triple negative breast cancer (TNBC); 25% non-small cell lung cancer (NSCLC); 12% melanoma (MEL); 12% renal cell cancer (RCC) and 23% others. The median age of the patients was 64 years. All patients had failed approved therapies for their disease, having received a median of two prior treatment regimens (range: 1-5), and 56 percent were resistant or refractory to prior treatment with anti-PD-(L)1 antibodies. Ninety percent of patients had visceral metastases including 37% with liver and 9% with brain metastases.  For patients with RCC and NSCLC, the median number of prior therapies was 4 and 3, respectively.  Seventy nine percent and 75%, of RCC and NSCLC patients, respectively, were resistant/refractory to prior anti-PD-(L)1 therapy. The efficacy endpoints of the study are response rate and disease control rate (defined as complete response, partial response or stable disease).

Interim results showed that disease control (with a median follow up of 16 weeks, range 4-44 weeks) was observed in 38 percent of those receiving CPI-444 as a single agent (N=52) and in 39% of those receiving the combination (N=44), for an overall disease control rate of 38% in 96 evaluable patients. Disease control rates by tumor type and treatment are shown in the following table.

    
 CPI-444
(n=52)		CPI-444 / atezolizumab
 (n=44)		All Subjects
(n=96)
All subjects20 (38%)17 (39%)37 (38%)
Prior anti-PD-(L)1 experience
 - Naïve
 - anti-PD-(L)1 resistant
   or refractory
13/29 (45%)
7/23 (30%)


5/18 (28%)
12/26 (46%)


18/47 (38%)
19/49 (39%)

Disease histology
 - NSCLC
 - MEL
 - RCC
 - TNBC
 - Others
4/14 (29%)
2/5 (40%)
3/5 (60%)
7/17 (41%)
4/11 (36%)
5/10 (50%)
2/6 (33%)
5/5 (100%)
3/14 (21%)
2/9 (22%)
9/24 (38%)
4/11 (36%)
8/10 (80%)
10/31 (32%)
6/20 (30%)
    

Additional results presented showed:

Additional Data Presented in Poster Sessions at AACR
Additional data on CPI-444 will be featured in poster sessions tomorrow at the AACR Annual Meeting as follows:

Preclinical data on Corvus’ humanized monoclonal anti-CD73 antibody, CPX-006, that is currently in IND-enabling studies will also be presented tomorrow in a poster session (Abstract #5577). Elevated CD73 expression has been observed in human tumors and shown by others to be prognostic in some indications. Corvus’ data shows that CD73 protein is broadly expressed across multiple tumor types in both immune cells and tumor cell compartments and that complete inhibition of CD73 enzyme activity is essential to overcome immune-suppression in vitro. In contrast to other antibodies tested, CPX-006 completely inhibits CD73 catalytic activity in primary human cells and restores T-cell proliferation and cytokine secretion in an adenosine-mediated immunosuppressive environment.

Phase 1/1b Trial Design
The Phase 1/1b trial is designed to examine the activity of CPI-444 as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody. Patients with non-small cell lung cancer (NSCLC), melanoma, renal cell cancer (RCC), triple-negative breast cancer (TNBC), MSI-H colorectal cancer, head and neck cancer, bladder cancer and prostate cancer who have failed standard therapies are eligible. The efficacy endpoints of the study are response rate and disease control rate which is defined as complete response, partial response (reduction of > 30% tumor volume) or stable disease (change in tumor volume of between 20% growth of tumor and 30% reduction of tumor volume).  Patients with minor tumor responses are those with changes in tumor volume of 0% to ≤ 30% reduction in tumor volume.  Patients are treated until disease progression or evidence of Grade 3 or 4 toxicity.

The dose-selection part of the study included four cohorts of 12 patients each (N=48) – three cohorts treated with single agent CPI-444 (100 mg twice daily for 14 days; 100 mg twice daily for 28 days; 200 mg once daily for 14 days) and one cohort treated with the combination (CPI-444 50 mg or 100 mg twice daily for 14 days combined with atezolizumab). A treatment cycle is 28 days. Based on biomarker analyses showing sustained, complete blockade of the adenosine A2A receptor in peripheral blood lymphocytes, and evidence of immune activation in circulating lymphocytes, an optimum single agent and combination dose of 100 mg twice a day for 28 days was selected for the second part of the study. As defined in the protocol, patients in the dose-selection stage of the trial receiving the dose and schedule selected for evaluation in the second part of the study are included in the disease-specific cohort efficacy analysis.

The second part of the study is evaluating CPI-444 as a single agent in five disease-specific cohorts (NSCLC, MEL, RCC, TNBC, and a category of “other” that includes MSI-H colorectal cancer, bladder cancer and prostate cancer) and CPI-444 in combination with atezolizumab in five additional matched disease-specific cohorts. Each of the 10 cohorts is initially enrolling 14 patients, but may be expanded based on efficacy. To date, the following cohorts have been expanded in size: the single-agent and combination cohorts of patients with renal cell cancer and the single agent and combination cohorts of patients with non-small cell lung cancer.

About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development and commercialization of small molecule and antibody agents that target the immune system to treat patients with cancer. These agents block or modify crucial immune checkpoints and reprogram immune T-cells. Corvus’ lead product, CPI-444, is a checkpoint inhibitor that is designed to disable a tumor’s ability to subvert attack by the immune system by inhibiting adenosine in the tumor microenvironment. CPI-444 is a small molecule that is taken orally. CPI-444 is currently being evaluated in a multicenter Phase 1/1b clinical trial in patients with various solid tumors. This successive expansion cohort trial is examining the activity of CPI-444 both as a single agent and in combination with Genentech’s atezolizumab, an anti-PD-L1 antibody. Corvus is conducting the trial with Genentech, a member of the Roche Group, under a clinical trial collaboration the two companies entered into in October 2015. For more information, visit www.corvuspharma.com.

Tecentriq® (atezolizumab) is a registered trademark of Genentech.

Forward-Looking Statements
This press release contains forward-looking statements, including statements related to the potential safety and efficacy of CPI-444, both as a single agent and in combination with anti-PD-1, anti-PD-L1, or other therapies, the Company’s ability to develop and advance product candidates into and successfully complete clinical trials, including the Company’s Phase 1/1b clinical trial of CPI-444, the basis for any future clinical trials with CPI-444, the utility of biomarker data collected and the suitability of the dosing regimen selected for the Company’s Phase 1/1b clinical trial of CPI-444. All statements other than statements of historical fact contained in this press release are forward-looking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s control. The Company’s actual results could differ materially from those stated or implied in forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 10, 2017, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular, the following factors, among others, could cause results to differ materially from those expressed or implied by such forward-looking statements: the Company’s ability to utilize biomarker data, select a suitable dosing regimen and demonstrate evidence of efficacy and safety for CPI-444 during its Phase 1/1b clinical trial; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of early clinical trials may not be predictive of future results; the unpredictability of the regulatory process; and regulatory developments in the United States and foreign countries. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the events and circumstances reflected in the forward-looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward-looking statements. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:
Jason Coloma
SVP, Chief Business Officer
Corvus Pharmaceuticals, Inc.
+1-650-900-4511
JColoma@corvuspharma.com

Media Contact:
Julie Normart
Pure Communications
+1-415-946-1087
jnormart@purecommunications.com

Exhibit 99.2

 

CPI - 444, an oral adenosine A2A receptor ( A2AR ) antagonist, demonstrates clinical activity in patients with advanced solid tumors Leisha A. Emens 1 , John Powderly 2 , Lawrence Fong 3 , Joshua Brody 4 , Patrick Forde 1 , Matthew Hellmann 5 , Brett Hughes 6 , Shivaani Kummar 7 , Sherene Loi 8 Jason Luke 9 , Daruka Mahadevan 10 , Ben Markman 11 , Ian McCaffery 12 , Richard Miller 12 , and Ginna Laport 12 1 Johns Hopkins University, Baltimore MD ; 2 Carolina BioOncology Institute, Charlotte NC ; 3 University of California, San Francisco, San Francisco CA ; 4 Mount Sinai School of Medicine, New York NY ; 5 Memorial Sloan Kettering Cancer Center, New York NY ; 6 Royal Brisbane and Women’s Hospital, Herston, Australia 7 Stanford University School of Medicine, Palo Alto CA ; 8 Peter MacCallum Cancer Center, Melbourne, Australia ; 9 University of Chicago, Chicago IL ; 10 University of Arizona, Tucson AZ ; 11 Monash Health, Victoria, Australia ; 12 Corvus Pharmaceuticals, Burlingame CA 1

 
 

This presentation contains forward - looking statements, including statements related to the potential safety and efficacy of CPI - 444, both as a sin gle agent and in combination with anti - PD - 1 and anti - PD - L1 , the utility of biomarker data collected and the suitability of the dosing regimen selected for the Company’s Phase 1/ 1b clinical trial of CPI - 444. All statements other than statements of historical fact contained in this press release are forward - l ooking statements. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expre ssi ons. Forward - looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond the Company’s con trol. The Company’s actual results could differ materially from those stated or implied in forward - looking statements due to a number of factors, including but not limited to, risks detailed in the Company’s Annual Report on Form 10 - K for the year ended December 31, 2016, filed with the Securities and Exchange Commission on March 10, 2017, as well as other documents that may be filed by the Company from time to time with the Securities and Exchange Commission. In particular , t he following factors, among others, could cause results to differ materially from those expressed or implied by such forward - looking statements: the Company ’s ability to utilize biomarker data, select a suitable dosing regimen and demonstrate evidence of efficacy and safety for CPI - 444 during its Phase 1/ 1b clinical trial; the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials; the results of early clinical trials may not b e p redictive of future results. Although the Company believes that the expectations reflected in the forward - looking statements are reasonable, it cannot guarantee that the events a nd circumstances reflected in the forward - looking statements will be achieved or occur, and the timing of events and circumstances and actual results could differ materially from those projected in the forward - looking statements. Accordingly, you should not place undue reliance on these forward - looking statements. All such state ments speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward - looking statements, whether as a result of new information, future events or otherwise. Additional information may be available in press releases or other public announcements and public filings made a fte r the date of this presentation. This presentation concerns products that have not yet been approved for marketing by the U.S. Food and Drug Administration (“ FDA ”). No representation is made as to their safety or effectiveness for the purposes of which they are being investigated. 2 Forward Looking Statements

 
 

Disclosure Information 3 3 I have the following financial relationships to disclose: Consultant for : Vaccinex , Celgene, Bristol Meyers Squibb, AstraZeneca, Amgen, Syndax , Molecuvax , eTHeRNA , Peregrine, Bayer Grant/Research support from : Genentech/Roche, EMD Serono , Maxcyte , Merck, AstraZeneca, Aduro , Corvus I will discuss the following off - label use and/or investigational use: CPI - 444 alone and combined with atezolizumab for advanced solid cancers. Study funding provided by Corvus Pharmaceuticals. Roche Genentech provided atezolizumab and support for biomarker analyses AACR Annual Meeting 2017: Leisha A. Emens

 
 

Adenosine Signaling Suppresses Immunity in the Tumor Microenvironment 4 • PD - 1/PD - L1 antibodies are effective immunotherapies with response rates ~20 - 30% • Novel agents that enhance response or overcome resistance to immunotherapy are a high priority • The adenosine pathway is a potential new immunotherapy target

 
 

CPI - 444: A Novel Inhibitor of the A2AR Pathway • Pharmaceutical Properties – Molecular weight = 407Da – A2AR Ki= 3.5 nM – > 55 - fold selective over A1R, >400 - fold A2BR and A3R – Oral bioavailability >50 % – Plasma half life: ~ 10 - 14 hours • Single agent activity in multiple preclinical models* – Synergy with anti - PD - (L)1 and anti - CTLA - 4 antibodies and other checkpoint inhibitors • Well - tolerated in early trials with healthy volunteers and ADHD patients • This is the first evaluation of safety and clinical activity of an A2AR antagonist in patients with cancer CPI - 444 *See Abstract #5598 N N N N N NH 2 O N O O 5

 
 

A Phase 1/1b , Open - Label, Multicenter, Repeat - Dose, Dose - Selection Study of CPI - 444 as a Single Agent and in Combination with Atezolizumab ( a tezo ) in Patients with Selected Incurable Cancers Primary Objectives – Evaluate the safety of CPI - 444 alone and with atezo – Identify a recommended dose and schedule for CPI - 444 alone and with atezo • S afety, PK and PD data* – Measure the clinical activity of CPI - 444 alone and with a tezo • ORR, CBR and DOR* 6 *PK – pharmacokinetics; PD = pharmacodynamics; ORR = overall response rate; CBR - clinical benefit rate; DOR = duration of respon se

 
 

Trial Design: Step 1 Dose Selection (Accrual completed) 7 Select Single Agent Dose Select Combination Dose** 100 mg CPI - 444 BID days 1 - 14/28 days* 100 mg CPI - 444 BID 28 days continuous* 200 mg CPI - 444 daily days 1 - 14/28 days* 50 mg CPI - 444 BID d1 - 14/28 days with 840 mg atezo every 2 weeks* 100 mg CPI - 444 BID 14 or 28 days with 840 mg atezo every 2 weeks* DLT evaluation DLT evaluation Eligibility • Selected incurable cancers: NSCLC , Melanoma, RCC, TNBC, Others (UBC, CRPC, CRC - MSI+, SCCHN) • 1 to 5 lines of prior therapy • Stable, treated brain metastases allowed • Resistant/refractory (R/R) to prior anti PD - 1/PDL - 1 allowed • PD - L1, CD73, A2aR expression not required for enrollment *1 cycle=28 days **See Abstract #5593

 
 

Trial Design: Step 2 Cohort Expansion by Disease (Accrual ongoing) 8 *Others: CRPC, CRC - MSI, UBC, SCCHN Randomize Single Agent Arm Expansion Combination Arm Expansion NSCLC N=14 MEL N=14 RCC N=14 TNBC N=14 Others* N=14 NSCLC N=14 MEL N=14 RCC N=14 TNBC N=14 Others * N=14 Potential expansion to 26 and 48 patients

 
 

Patient Demographics/Disease Characteristics* Median age, years (range) 64 (36 – 85) Gender, n (%) Female Male 58 (51%) 55 (49%) ECOG performance status 0 1 47 (42%) 66 (58%) TNBC NSCLC MEL RCC Others 32 (28%) 28 (25%) 14 (12%) 14 (12%) 25 (23%) Median # of prior regimens 2 (1 – 5) Prior Chemotherapy Prior anti - PD1/PD - L1 exposure Naïve Resistant/Refractory Visceral metastases Liver Brain 90 (80%) 50 (44%) 63 (56%) 102 (90%) 42 (37%) 10 (9%) • Enrollment (n=113) • Step 1: n = 47 (33 single agent) • Step 2: n = 66 (26 single agent) • Heavily pre - treated with extensive disease • Over half with disease resistant/refractory to PD - 1/PD - L1 antibodies *Data cutoff: Mar 2017 9

 
 

Treatment - Related Adverse Events (AE) 10 • Median duration of treatment: 9 weeks (range: up to 40+) • 56% of patients experienced a treatment - related AE (any grade) • No grade 3/4 AEs with single agent CPI - 444 • Immune - related AEs seen only with combination of CPI - 444 and atezo (n=1 for each): - Pancreatitis (Gr 2) - Autoimmune hemolytic anemia (Gr 3) - Meningoencephalitis/thrombocytopenia (Gr 4) Adverse Events > 5% Frequency (Gr 1/2) Single Agent Combo Nausea 14% 13% Pruritus 10% 9% Fatigue 5% 7% Abdominal Pain 5% --- Rash 5% --- Diarrhea 5% --- Pyrexia 5% 7% Decreased Appetite 5% 7% Chills 5% ---

 
 

Overall Patient Outcomes Disease Control Rate (CR, PR, SD) in Evaluable Patients 11 CPI - 444 (n=52) CPI - 444/ Atezolizumab (n=44) All Subjects (n=96) All subjects 20 (38%) 17 (39%) 37 (38%) Prior PD - 1/PD - L1 Experience Naïve Resistant/Refractory 13/29 (45%) 7/23 (30%) 5/18 (28%) 12/26 (46%) 18/47 (38%) 19/49 (39%) Disease Histology - NSCLC - MEL - RCC - TNBC - Others 4/14 (29%) 2/5 (40%) 3/5 (60%) 7/17 (41%) 4/11 (36%) 5/10 (50%) 2/6 (33%) 5/5 (100%) 3/14 (21%) 2/9 (22%) 9/24 (38%) 4/11 (36%) 8/10 (80%) 10/31 (32%) 6/20 (30%) • Median follow up time for DCR: 16 weeks (range, 4 - 44 weeks) • 23/37 of PR and SD patients remain on study

 
 

Clinical Activity: Overall Patient Population* 12 • SDs and PRs observed with CPI - 444 alone and in combination with atezo % Change from Baseline *Patients with disease evaluable by CT, n= 70 Treatment : Single Agent Combination

 
 

Clinical Activity: By Disease Type 13 • Tumor regression observed in RCC, NSCLC, TNBC, SCCHN and CRC % Change from Baseline OTHER TNBC MEL NSCLC RCC

 
 

Clinical Activity by Prior PD - (L)1 Experience 14 • CPI - 444 has activity in patients resistant/refractory to PD - 1 blockade • 2 PRs and 7 minor regressions in PD - 1 resistant/refractory patients • 1 PR and 4 minor regressions in PD - 1 naïve patients % Change from Baseline Resistant/Refractory Naive

 
 

Duration of Treatment 15 OTHER TNBC MEL NSCLC RCC Single Agent CPI - 444 CPI - 444 Combined with Atezo

 
 

Tumor Regression in Nivolumab Refractory Lung Cancer Single Agent CPI - 444 Pre - treatment 2 months of treatment 16 • 2 prior chemotherapy regimens • Refractory to nivolumab • Started single agent CPI - 444

 
 

Regression in Nivolumab Resistant Lung Cancer Combination CPI - 444/Atezolizumab Pre - treatment 2 months on treatment 17 • 1 prior chemotherapy • Responded to nivolumab, then progressed • Started CPI - 444 + atezo

 
 

Tumor Regression in Nivolumab Refractory Renal Cancer Single Agent CPI - 444 Pre - treatment 3 months of treatment 18 • Five prior regimens including TKIs and mTOR inhibitor • Tumor progression on nivolumab • Started CPI - 444

 
 

19 Serial Biopsies of Liver Metastasis from PD - 1 Refractory RCC Patient Treated with Single Agent CPI - 444 18 Pre - treatment Post treatment (2 months) Inflammatory Infiltrate in Tumor = 1% Inflammatory Infiltrate in Tissue = 20% CD8 + in tumor = 14% CD8 + in tissue > 70 %; no tumor cells detectable Inflammation and CD8 + T Cell Infiltration After Progression on PD - 1 Therapy Increased with Single Agent CPI - 444 Therapy H&E H&E IHC IHC See Abstract #5593

 
 

Conclusions • CPI - 444 is well tolerated as a single agent and in combination with atezo – Most common Grade 1/2 toxicities: nausea, fatigue, pruritus – irAEs of hemolytic anemia (Gr3), meningoencephalitis (Gr4), and pancreatitis (Gr2) seen with combination therapy • Selected dose of CPI - 444 is 100 mg bid continuous • Observed clinical activity: – As single agent and in combination with atezo in multiple tumor types in advanced cancer patients – In patients refractory/resistant to PD - 1/PD - L1 blockade – 23/37 patients with PR/SD remain on study median 16 weeks • I ncreased inflammation and CD8 + T cells in biopsy observed in an anti PD(L) - 1 - experienced patients responding to single agent CPI - 444 20

 
 

Acknowledgements • The patients and their families • Participating Centers: Carolina BioOncology Institute, Columbia University Medical Center, Cross Cancer Institute, Emory University, Indiana University, Johns Hopkins University, Juravinski Cancer Centre, Karmanos Cancer Center, Mary Crowley Cancer Research Centers, Medical College of Wisconsin, Memorial Sloan Kettering Cancer Center, Monash Health, Mount Sinai, Royal Brisbane and Women’s Hospital, START, University of California at San Francisco Medical Center, University of Arizona Medical Center, University of Chicago Medical Center, University of Colorado Cancer Center, University of Pittsburgh, University of Washington, Washington University at Saint Louis • C olleagues at Corvus • Colleagues at Roche Genentech 21